STANDARD OPERATING PROCEDURES (SOPs)...CCNSW Ethics Committee SOPs March 20131 Cancer Council NSW Ethics Committee STANDARD OPERATING PROCEDURES (SOPs) Contact information: Dr John

CCNSW Ethics Committee SOPs March 2013 1

Cancer Council NSW Ethics Committee

STANDARD OPERATING PROCEDURES (SOPs)

Contact information: Dr John Williams Research Governance Officer [email protected] (02) 9334 1993



Table of Contents

Page

Acronyms and Definitions

Relevant Laws, Regulations and Guidelines

SOP001 Function of the CCNSW Ethics Committee

SOP002 Membership composition of the CCNSW Ethics Committee

SOP003 Appointment of members to the CCNSW Ethics Committee

SOP003 Appendix 1 – Letter of Appointment to Ethics Committee

SOP003 Appendix 2 – Confidentiality Undertaking

SOP003 Appendix 3 – Cancer Council NSW Ethics Committee Conflict of Interest Policy and Guidelines

SOP003 Appendix 4 – Declaration of Interest – Committee members

SOP004 Orientation of new members to the CCNSW Ethics Committee

SOP005 Submission procedures for new applications for ethical assessment by the CCNSW Ethics Committee

SOP006 Processing of applications for review by the CCNSW Ethics Committee

SOP006 Appendix 1 – Acknowledgement of Application

SOP007 Preparation of meeting agendas for the CCNSW Ethics Committee

SOP008 Conduct of CCNSW Ethics Committee meetings

SOP009 Consideration of applications for ethical assessment by the CCNSW Ethics Committee

SOP010 Attendance of the Chief Investigator at a CCNSW Ethics Committee meeting

SOP011 External Expert Reviewers

SOP011 Appendix 1 – Declaration of Interest – Expert reviewers

SOP012 Expedited review by the CCNSW Ethics Committee

SOP013 Review of Low and Negligible Risk applications and Receipt of New Datasets by the Cancer Council NSW Ethics Committee.

SOP013 Appendix 1 – Notification to Cancer Council NSW Ethics Committee of New Dataset Received

SOP014 Preparation of minutes of CCNSW Ethics Committee meetings

SOP015 Notification to researchers of decisions by the CCNSW Ethics Committee on new applications

SOP015 Appendix 1 - CCNSW Ethics Committee letter requesting further information from investigator regarding the project

SOP015 Appendix 2 – CCNSW Ethics Committee letter reminder letter regarding request for further information

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SOP015 Appendix 3 - CCNSW Ethics Committee letter granting ethical approval for a project

SOP015 Appendix 4 - CCNSW Ethics Committee letter for projects not approved

SOP016 Submission of amendments and extensions to approved projects

SOP016 Appendix 1 - Format for CCNSW Ethics Committee letter approving requested amendments

SOP016 Appendix 2 - Format for CCNSW Ethics Committee letter requesting further information from an investigator regarding proposed changes

SOP017 Handling of adverse events

SOP018 Monitoring of projects granted ethical approval by the CCNSW Ethics Committee

SOP018 Appendix 1 – CCNSW Ethics Committee Annual/Final Report Form

SOP019 Complaints concerning the conduct of a research project

SOP020 Withdrawal of Ethical Approval/ Suspension of research

SOP020 Appendix 1 – CCNSW Ethics Committee letter ordering immediate suspension of research

SOP020 Appendix 2 – CCNSW Ethics Committee letter regarding continued withholding of ethical approval

SOP020 Appendix 3 – CCNSW Ethics Committee letter approving modified research proposal after withdrawal of ethical approval

SOP020 Appendix 4 – CCNSW Ethics Committee letter to Lead Ethics Committee regarding ethical concerns

SOP020 Appendix 5 – CCNSW Ethics Committee letter to partnered Ethics Committees regarding withdrawal of ethical approval

SOP021 Concerns and complaints relating to the CCNSW Ethics Committee’s ethical review process

SOP021 Appendix 1 – CCNSW Ethics Committee letter to acknowledge receipt of complaint

SOP022 Complaints concerning CCNSW Ethics Committee’s rejection of an application for ethical approval

SOP022 Appendix 1 – CCNSW Ethics Committee letter to acknowledge receipt of complaint regarding rejection of an application

SOP023 Assessment of multi-centre projects by the CCNSW Ethics Committee

SOP024 Record keeping

SOP025 Handling of conflicts of interest

SOP026 Reporting requirements of the CCNSW Ethics Committee

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SOP027 Review of CCNSW Ethics Committee Standard Operating Procedures, Charter and Terms of Reference

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Acronyms AHEC Australian Health Ethics Committee CCNSW Cancer Council NSW CEO Cancer Council NSW’s Chief Executive Officer HoMER Harmonisation of Multi-centre Ethical Review HREC Human Research Ethics Committee NHMRC National Health and Medical Research Council

Definitions

The following terms and definitions are used by the Committee. They are consistent with the definitions contained in the NSW Health Privacy Manual (Version 2), 2005 and the National Health and Medical Research Council (NHMRC) National Statement on the Ethical Conduct of Research Involving Humans, 2007.

Epidemiological Research – Epidemiological research is concerned with the description of health and welfare in populations through the collection of data related to health and the frequency, distribution and determinants of disease in populations, with the goal of improving health. Some epidemiological research may require whole of population studies and be beyond an individual institution or organisation. Epidemiological research is part of wider public health and health services research concerned with improvements of health and welfare in human populations and with improving the efficiency and performance of human health services. Public health and health services research are usually or often carried out with human participants, or data or biological samples from them, and provide important new knowledge that is not readily obtainable in other ways.

Executive – A sub-committee, consisting of at least the Chairperson, and the Research Governance Officer, and where available, another member of the Committee. External – Outside Cancer Council NSW

Harmonisation of Multi-centre Ethical Review (HoMER) – A system established by NHMRC to enable multi-centre research projects to be assessed by an accredited (lead) ethics committee. Internal – Within Cancer Council NSW

Relevant Laws, Regulations and Guidelines The following legislation and policy and guideline documents should be considered in the preparation of applications to the Committee, and consideration of applications by the Committee.

a) The National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research, 2007;

b) NHMRC’s Australian Code for the Responsible Conduct of Research, 2007; c) NHMRC’s Guidelines Approved Under Section 95 of the Privacy Act 1988, 2001; d) NSW Health’s Privacy Manual (Version 2), 2005;


e) NSW Health’s Health Records and Information Privacy Act 2002; f) NSW Health’s Policy Directive Research - Model for Single Ethical & Scientific

Review of Multi-Centre Research, 2007; g) The NSW Aboriginal Health Information Guidelines, 1998 (prepared as a

Memorandum of Understanding between the Minister for Health of NSW, the NSW Department of Health, and the NSW Aboriginal Health Resource Cooperative Limited); and

h) CPMP/ICH135/95 Note for Guidance on Good Clinical Practice, 2000, an internationally accepted standard for the design, conduct, recording and reporting of clinical trials which has been adopted by Australia’s Therapeutic Goods Administration [TGA]), see www.tga.gov.au.

NHMRC documents are available from NHMRC, telephone: (02) 6217 9000 or at www.nhmrc.gov.au. NSW Health (now called the NSW Ministry of Health) documents are available at www.health.nsw.gov.au. The NSW Aboriginal Health Information Guidelines are available from the Aboriginal Health and Medical Research Council at www.ahmrc.org.au.



Standard Operating Procedures Reference Number: SOP001 Date: March 2013 Subject: Function of the Cancer Council NSW Ethics Committee. Purpose: To describe the function of the Cancer Council NSW Ethics Committee.

Overall Function

1. The primary objective of the Cancer Council NSW (CCNSW) Ethics Committee is to protect the mental and physical welfare, rights, dignity and safety of research participants, to facilitate ethical research through efficient and effective review processes, to promote ethical standards of human research and to provide ethical review of research applications in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research, 2007.

Scope of Responsibilities

2. The functions of the Ethics Committee are:

a) to provide independent, competent and timely review of the ethical acceptability of research projects involving humans;

b) to provide ethical oversight, monitoring and advice for research projects involving humans; and

c) to prescribe the principles and procedures to govern research projects involving human participants, human tissue and/or personal records.

3. Research projects may include, but are not limited to, epidemiological and public health

research and research involving social and psychological investigations in relation to cancer.

4. The Committee will assess projects submitted to it for review in accordance with the

National Statement on Ethical Conduct in Human Research, 2007 (and any other legal requirements) in order to determine their ethical acceptability.

5. Under the Harmonisation of Multi-centre Ethical Review (HoMER) accreditation awarded

to the CCNSW Ethics Committee by the governing body, NHMRC, the Committee will assess national multi-centre research projects of a population health and/or public health, qualitative health research, or market research nature.



Standard Operating Procedures Reference Number: SOP002 Date: March 2013 Subject: Membership composition of the Cancer Council NSW Ethics Committee. Purpose: To describe the composition of members of the Cancer Council NSW Ethics Committee. 1. The Committee will have a minimum of eight members. The core membership of the

Committee will be in accordance with the National Statement on Ethical Conduct in Human Research, 2007 and any amendments to the National Statement as issued from time to time by NHMRC.

2. The core membership comprises:

a) a chairperson; b) two laypeople (one man and one woman) not affiliated with CCNSW, and

not currently involved in medical, scientific, legal or academic work; c) two people with knowledge of, and current experience in, the areas of

research regularly considered by the Committee; d) a person with knowledge of, and current experience in, the professional

care, counselling or treatment of people; e) a minister of religion or a person who performs a similar role in a

community; and f) a lawyer.

3. It is incumbent on the Committee to satisfy itself, and where uncertain to request the

Research Governance Officer to make investigation, as to the bona fides and qualifications of prospective members to the Committee.

4. At least two-thirds of members must be external to CCNSW.

5. To ensure the membership will enable the Committee to address all relevant

considerations arising from the categories of research likely to be submitted for review, and to ensure that a quorum is reached at all meetings (refer to SOP008), some or all of the categories defined at point 2 (above) may be represented by more than one person.

6. Additional members may be appointed to ensure the Committee has the expertise

required to assess the applications regularly submitted for its consideration. If additional members are appointed, the composition of the Committee will continue to reflect diversity and balance in its membership, including with respect to gender and the relative proportion of institutional and non-institutional members.

7. Where required, the Committee may seek advice and assistance from professionals in a

given field specifically to assist with consideration of a project (see SOP011). The Committee must be satisfied that such experts have no conflicts of interest in relation to the project under consideration, arising from any personal involvement or participation in the project, any financial interest in the outcome of the project, or any involvement in a competing project.


Cancer Council NSW Ethics Committee Standard Operating Procedures

Reference Number: SOP003 Date: March 2013 Subject: Appointment of members to the Cancer Council NSW Ethics Committee. Purpose: To describe the appointment and terms of appointment of members of the

Cancer Council NSW Ethics Committee. 1. Vacant positions on the Ethics Committee must in all cases be advertised on the

CCNSW website for a period of one month. Members may also be recruited through the following means and directed to the advertisement on the CCNSW website, including:

a) spontaneous expressions of interest; b) nominations from CCNSW Board members, staff, other Committee members and

volunteers; c) externally advertised calls for expressions of interest on other websites in

addition to the CCNSW website, including for example: i. FIDO (skilled volunteer recruitment website); ii. Go Volunteer; iii. the volunteer section of the Sydney Morning Herald and/or iv. the research sections of university websites;

d) use of Social Media such as Facebook and/or Twitter.

2. Prospective members will be asked to provide a copy of their Curriculum Vitae to the Research Governance Officer. Members must agree to their name and profession being made available to the public.

3. Members are appointed as individuals for their expertise rather than in a representative

capacity. 4. A selection committee, consisting of at least the Chairperson and the Research

Governance Officer, will interview the prospective applicant, consult with other Committee members and make a recommendation regarding their appointment to the CCNSW Board. Prospective members may be invited to attend a meeting of the Committee as an observer.

5. Members of the Committee are appointed by the CCNSW Board and will be sent a letter

of appointment as contained in SOP003 Appendix 1. Members will be advised by the Secretariat on behalf of the Board when their term has expired. Members are appointed for a term of two years and may serve three consecutive terms as a representative of any particular membership category.

6. The Chairperson and the Deputy Chairperson will be appointed by the Board via the

appropriate modification of the letter of appointment contained in SOP003 Appendix 1. The Committee may nominate candidates for the position of Deputy Chairperson. In the absence of the Chairperson, the Deputy Chairperson will perform the role and duties of the Chairperson.


7. The letter of appointment will include the date of appointment, length of tenure and date at which this ends, assurance that indemnity will be provided in respect of liabilities that may arise in the course of bona fide conduct of their duties as a Committee member.

8. Upon appointment, members will be provided via email with the following

documentation:

a) the CCNSW Ethics Committee Terms of Reference; b) the CCNSW Ethics Committee Standard Operating Procedures; c) the CCNSW Ethics Committee Conflict of Interest Policy and Guidelines; d) the Confidentiality Undertaking form, which they must sign and return to the

Secretariat (see clause 8); e) the Declaration of Interest form, which they must sign and return to the

Secretariat (see clause 8); f) a list of current members’ names and contact information including that of the

Research Governance Officer; g) NHMRC National Statement on Ethical Conduct in Human Research, 2007; h) a copy of the NHMRC Human Research Ethics Handbook; i) a copy of the Health Records and Information Privacy Act 2002 (NSW); j) a copy of the statutory guidelines under the Health Records and Information

Privacy Act 2002 as appropriate, specifically the “use or disclosure of health information for research purposes”; and

k) any other relevant information regarding the Committee’s processes, procedures and protocols.

9. Members are required to sign a Confidentiality Undertaking (SOP003 Appendix 2) upon appointment, stating that all matters of which they become aware during the course of their work on the Committee will be kept confidential. Committee members are also required to read the CCNSW Ethics Committee Conflict of Interest Policy and Guidelines (SOP003 Appendix 3) and sign the Declaration of Interest form (SOP003 Appendix 4).

10. To ensure that the Committee remains current and up-to-date in approach, the

Committee will aim to replace a minimum of one member per year. 11. CCNSW indemnifies members when they are acting in good faith for the purposes of

discharging their roles as Committee members. 12. Members are not offered remuneration. Members will be reimbursed for legitimate

expenses incurred in attending Committee meetings, such as parking expenses. 13. Membership will lapse if a member fails to attend three (3) consecutive meetings of the

Committee without apology, unless exceptional circumstances exist. The Chairperson will notify both the member and the CCNSW Board in writing of such lapse of membership.

14. Members may seek a leave of absence from the Committee for extended periods, and

steps may be taken to fill the vacancy. Written applications for a leave of absence must be addressed to the Chairperson at least one month before the official leave of absence is to commence. The Chairperson will determine whether final approval of a leave of absence should rest with the CCNSW Board.

15. Members may be asked to participate in relevant specialised working groups as

required.


16. All members are expected to attend NSW Health and NHMRC education and training sessions or other sources of education at least once during every term of membership. Reasonable costs associated with attendance at training and education sessions will be met by Cancer Council NSW.

17. The Board may terminate the appointment of a member at any time The Board may terminate the appointment of any member of the Committee if the Board is of the opinion that:

a) this is necessary for the proper and effective functioning of the Ethics Committee;

b) the person is not a fit and proper person to serve on the Ethics Committee; and/or

c) the person has failed to carry out their duties as an Ethics Committee member.

18. A member may resign from the Committee at any time upon giving notice in writing to

the Chairperson. Steps will be taken to fill the vacancy of the former member as per clause 1.


SOP003 Appendix 1 <<date>> <<Title and Name>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Title and surname>>, Re: Appointment to Ethics Committee Following our Board meeting on [date], it gives me great pleasure to appoint you as a [position] on the Cancer Council NSW Ethics Committee. Your appointment as a [position] is in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research, 2007, which stipulates a requirement for “at least one member who is a [position]”. Members of the Cancer Council NSW Ethics Committee are appointed for a term of two years and may serve a maximum of three consecutive terms. The end of your first term will be <<date>>, or the meeting subsequent to this date. Cancer Council NSW looks forward to the contribution you will make as a member of the Ethics Committee. In accordance with our Standard Operating Procedures, you will be presented with a range of information to assist you in your role on the Ethics Committee, including the National Statement on Ethical Conduct in Human Research, 2007; the Health Records and Information Privacy Act 2002 (NSW); the Cancer Council NSW Ethics Committee Standard Operating Procedures and Terms of Reference; and additional information as necessary. This information will be sent via email. As a member of the Ethics Committee, you are indemnified against any liabilities that may arise in the course of bona fide conduct of your duties. If you have any queries please contact the Cancer Council NSW Research Governance Officer [Insert best contact] on [(XX) XXXX XXXX] Yours sincerely, <<insert name of CEO>> CEO Cancer Council NSW


SOP003 Appendix 2

CONFIDENTIALITY UNDERTAKING I, [NAME], [POSITION] understand that, in reviewing projects during my tenure on the Cancer Council NSW Ethics Committee, I will have access to confidential information about research projects and the affiliated researchers and organisations. I undertake to strictly preserve the confidentiality of the information presented to me in the course of ethical review. In order to fulfill this undertaking, I will not release any information about a project or persons involved in projects that I review, and acknowledge that the papers I receive for the purpose of ethical review, whether in electronic or paper format, are intended for the addressee only and not for public viewing.

Signed: ..............................................................................................

in the presence of

(name): ..............................................................................................

(signature): ..............................................................................................

(position): ..............................................................................................

Date: ..............................................................................................

SOP003 Appendix 3: Ethics Committee Conflict of Interest Policy and Guidelines

Ethics Committee Conflict of Interest Policy and Guidelines Month 2013

Cancer Council NSW

Ethics Committee

CONFLICT OF INTEREST

Policy and Guidelines

Approved by the Board of Cancer Council NSW Month 2013



Contents Background Conflict of Interest Financial conflicts of interest may arise Where a close personal relationship exists Other conflicts that may arise Principles – Conflict of Interest Ethical Standards Public Scrutiny Decision Making Private and Employment Interests Public Interest Gifts and Benefits Preferential Treatment Insider Information Property of Cancer Council NSW Post Cancer Council NSW Ethics Committee Activity Guidelines In the development of Policy and Procedures In giving ethical approval on behalf of Cancer Council NSW for research projects If involved with research projects making application to Cancer Council NSW for ethical approval Disclosure Procedures Disclosure Notice Confidential Notice Final Determination Remedy Reservation of Right Consequences Annual Reporting References



Background The Cancer Council NSW Ethics Committee (‘the Ethics Committee’) is a committee that reports to the Board of Cancer Council NSW. The Ethics Committee is responsible for providing ethical assessment of proposals to use health data able to identify individuals that is held by Cancer Council NSW for research or other purposes. It also provides ethical assessment of proposals for research involving human participants conducted by staff of Cancer Council NSW. In assessing the ethical acceptability of these proposals, the Ethics Committee examines the extent of their compliance with NHMRC’s guidelines for Human Research Ethics Committees as stated in the NHMRC National Statement on Ethical Conduct in Research Involving Humans, 2007, and Cancer Council NSW’s Privacy Management Plan. The Guiding Principles outlined in the Charter of the Ethics Committee highlight that:

A properly constituted Ethics Committee must assess all research activity undertaken at Cancer Council NSW involving humans and/or requiring access to health data able to identify individuals held by Cancer Council NSW.

There will be a transparent and systematic process for ensuring that research proposals meet appropriate ethical standards.

The Ethics Committee will in all aspects operate consistent with the NHMRC National Statement on Ethical Conduct in Research Involving Humans, 2007.

One in three people in Australia will be diagnosed with cancer, and therefore it is to be expected that research into cancer, including research into cancer epidemiology and public health implications, will be a major focus in the research arena. There is significant collaboration between the limited number of cancer research institutions in Australia. Consequently, it is recognised that in order to ensure compliance with the National Statement on Ethical Conduct in Research Involving Humans, 2007, for the composition of an Ethics Committee, and that ethical review of research proposals involves experienced researchers who are familiar with the type of research under review, there will be times when a member of the Ethics Committee is closely affiliated with the research being reviewed or has a connection that could be considered influential. In addition, Cancer Council NSW’s internal Cancer Research Division employs researchers who actively compete for research funding, ensuring that Cancer Council NSW is involved in ongoing, leading-edge research and thus better able to maintain a strategic national and international health research presence. It is critical that this expertise is available and worth preserving (Canadian Institutes of Health Research 2005). However, this structure, combined with NHMRC requirements for an appropriately constituted Ethics Committee, that could leave Cancer Council NSW open to criticism that conflicts of interest may arise. Conflict of Interest A conflict of interest is a situation where an individual, or the organisation he or she represents or has an interest in, has a real, potential or perceived, direct or indirect competing interest with Cancer Council NSW’s activities. This competing interest may result in the individual, or others related to them, or entities in which they have an interest, being in a position to benefit from the situation, or in Cancer Council NSW being prevented from



achieving a result which would be in the best interests of the public and Cancer Council NSW. Conflict under this policy is interpreted broadly (Canadian Institutes of Health Research 2003). More specifically, in relation to the Ethics Committee, conflict of interest means a situation where the private or employment interests of an Ethics Committee member, or other persons participating in the work of the Committee, influence or compromise the performance of that person in the conduct of their Ethics Committee activities, including developing Committee policy, making decisions as to the ethical acceptability of a proposed project, or disclosing research outcomes related to ethics. Apparent conflicts may undermine trust and be as damaging as an actual conflict (Australian National University 2002b).

There are many possible sources of conflicts of interest. Conflicts can arise from commercial interests; ethical, political or religious views; or personal relationships. The ‘benefits’ that may be obtained from a situation where there is a conflict of interest may be tangible (e.g., approval for a project in which a person has an interest) or intangible (e.g., the achievement of the good opinion or status due to influence of another person with a conflict of interest being exercised). The potential for a conflict does not necessarily imply wrongdoing on anyone's part. The most common conflicts are those arising from commercial interests and close personal relationships (Australian National University 2002a). The following covers situations that are broader than those likely to be apparent with the work of the Ethics Committee but may impact upon them; hence they are included in these Guidelines: Financial conflicts of interest may arise:

Where an Ethics Committee member, or other person participating in the work of the Ethics Committee, also has an employment or personal interest (or a person with whom the member has a close personal relationship has an employment or personal interest) in research that may be considered by the Ethics Committee.

From an Ethics Committee member, or other person participating in the work of the Ethics Committee, having financial involvement in an external company that may have an interest in the research being ethically approved and therefore allowed to proceed under Cancer Council NSW’s auspices, such that the member’s activities with the Ethics Committee could lead to professional, personal or economic gain, thereby providing incentive to bias the decision making of the Ethics Committee in relation to ethics approval and any advice and/or conditions that may be provided on the design, conduct or reporting of research.

Where a close personal relationship exists:

The relationship between the parties should not affect the interests of Cancer Council NSW, the work of the Ethics Committee, other parties or the research being conducted.

Because the effects on other people are frequently not apparent to the persons involved in a close personal relationship, anyone with such an involvement should be attentive to the feelings of colleagues and to the potential conflicts of interest that may be involved.



o One party should not be the direct supervisor of the other. o One party should not be involved in decision-making or procedures leading to the

ethics approval of research. o One party should not have access to the personal files of the other (Australian

National University 2002a). Other conflicts that may arise:

Remunerated or honorary positions and other connections with educational institutions which may give rise to a conflict of interest, including relevant external government or public committees, such as other research councils, charities, Government Departments, professional bodies and training organisations.

Prolonged absence - a staff member having a commitment outside the Ethics Committee that involves frequent or prolonged absence from Ethics Committee meetings.

Gifts or offers of gifts of significant value, other than official gifts, and ex gratia payments (Australian National University 2002a).

Both the membership of the Ethics Committee and the guiding principles, while being supported by the Board and the Ethics Committee, pose challenges in their application. As discussed above the expertise required for the appropriate assessment and review of research necessarily requires the active engagement of cancer research experts. In Australia, this pool is limited and inevitably the people concerned have developed collegial links even if they reside and work in different organisations and jurisdictions. Members of the Ethics Committee who are researchers, no matter how ethical their conduct may be, could be perceived as having a potential interest in many of the projects reviewed by the Ethics Committee, merely because of their career choice and work. The objectives of the Ethics Committee also conceal inherent ethical risks relating to potential for real or perceived conflicts of interest to arise for Ethics Committee members. The following table outlines some of these risks against the objectives:



Objective

Potential for Real or Perceived Conflicts of Interest to Arise

Ensure that all CCNSW research activity involving humans complies with National Health and Medical Research Council (NHMRC) guidelines for Human Research Ethics Committees as stated in the National Statement on Ethical Conduct in Research Involving Humans, 2007, and the Cancer Council’s Privacy Management Plan.

Policies and procedures may be oriented to aspects of cancer research aligned to particular interests and engagement of members of the Ethics Committee.

Policies and procedures may have inbuilt disincentives to the facilitation of cancer research that is outside the particular interests and engagement of members of the Ethics Committee.

Being in a position to influence access to subject records or databases such that the research outcomes could be affected.

The imposition of processes or policies from external organisations which could compromise the ethical standards of the research.

The robustness of procedures for the independent review of projects such as: o The mechanisms for ensuring transparency

and accountability of all processes and each decision point.

o The selection process for independent external expert reviewers.

o Processes for ensuring independence, identifying and disclosing conflicts of interest in relation to independent external expert reviewers.

o The decision making discretions of the Ethics Committee in relation to recommendations made by independent external expert reviewers.

o The existence and application of appeal procedures for dealing with complaints of conflicts of interest.

Protection of the rights and welfare, including privacy and confidentiality, of participants and/or their health records involved either directly or indirectly in the proposals considered by the Ethics Committee. Promote ethical standards of human research and information privacy by provision of guidance to investigators. Facilitate ethical research through efficient and effective review processes. Ensure that all releases of health data held at Cancer Council NSW are in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans, 2007, and relevant privacy legislation.



The increasing complexity of conflicts, including those of personal relationships and financial gain from outside commercial activities and infringement of intellectual property rights, make clear principles and procedures essential. The provisions of State and Commonwealth legislation, organisational and professional codes of conduct and ethics and policy require all Ethics Committee Members to behave in good faith, avoid conflicts of interest and act with propriety when making decisions about ethical matters. Related to this is the common law obligation of confidentiality. All Ethics Committee members must ensure that sensitive and confidential matters relating to the ethical review of research or administration of Cancer Council NSW and the Ethics Committee are not improperly disclosed, either internally or externally. Principles – Conflict of Interest It is the policy of Cancer Council NSW that its staff, and others acting on its behalf, conduct themselves according to the principles and procedures outlined in this document; avoid ethical, legal, financial, or other conflicts of interest; and ensure that their activities and interests do not conflict with their obligations to any research funded or conducted by Cancer Council NSW, or their welfare. This includes Ethics Committee members. In meeting the objectives of the Ethics Committee, members shall: Ethical Standards

Act with honesty and uphold the highest ethical standards in order to honour and enhance public confidence in Cancer Council NSW's ability to act in the public interest and for long term public good.

Public Scrutiny

Perform their Ethics Committee responsibilities and arrange their private affairs in a manner that will bear the closest public scrutiny, an obligation that is not necessarily fully discharged by simply acting within the law.

Decision Making

In fulfilling their Ethics Committee duties and responsibilities, make decisions in the interest of Cancer Council NSW, with a view to the public interest, and with regard to the merits of each case.

Private and Employment Interests

Disclose fully any employment or private interests that could be affected by actions of Cancer Council NSW or that could put ethical practice at risk.

Public Interest

Recognise the potential that their employment or private affairs could cause real, potential or apparent conflicts of interest to arise in relation to their Ethics Committee obligations; and if such a conflict does arise between the employment or private interests of an individual and the official Committee duties and responsibilities of that individual, the conflict shall be disclosed and all steps taken to resolve it, minimising the impact on the interests of Cancer Council NSW.



Gifts and Benefits Not solicit or accept transfer of economic benefit, other than incidental gifts, customary hospitality, or other benefits of nominal value from persons, groups or organizations having, or likely to have, dealings with Cancer Council NSW unless the transfer is pursuant to an enforceable contract or property right of Ethics Committee member.

Preferential Treatment

Not step out of their official Committee roles or misuse confidential Committee documents or business to assist private entities or persons in their dealings with Cancer Council NSW where this would result in preferential treatment to any person or organisation.

Insider Information

Not knowingly take advantage of, or benefit from, material information that is not generally available to the public that is obtained in the course of their official Committee duties and responsibilities.

Property of Cancer Council NSW

Not directly or indirectly use, or allow the use of property of Cancer Council NSW of any kind, for anything other than officially approved activities.

Post Ethics Committee Activity

Not act, after they leave the Ethics Committee, in such a manner as to take improper advantage of their previous office (Canadian Institutes of Health Research 2003).

Guidelines Cancer Council NSW requires that conflicts are managed according to the following steps when they arise or can be imputed to arise:

1. disclose always; 2. manage the conflict where appropriate; and 3. prohibit any activity when necessary to protect the public interest or the interests of

Cancer Council and the Ethics Committee (Australian National University 2002a).

Disclosure by an Ethics Committee member or staff member must be made when there is potential for conflict, or the perception that a conflict may exist. Disclosure must be full and prompt, and made in writing. In the case of close personal relationships, either party to the relationship can make a disclosure. The primary obligation is to notify, in advance, any potential conflict. Written approval should be obtained before any commitment is made that might involve a conflict (Australian National University 2002a). Not providing notification of a potential conflict could be regarded as a serious matter, may affect the person’s ongoing involvement with the Ethics Committee and in extreme cases may warrant legal action. A third party, being aware of a potential or actual conflict of interest, should also report it. There may be occasions when a conflict becomes known after the fact of a decision or determination. In these cases, as soon as the conflict becomes evident, it must be reported



to the Ethics Committee Chairperson. Cancer Council NSW may decide to investigate the circumstances of the decision or determination, including whether a different decision or determination ought to be made. Cancer Council NSW may also determine that an investigation should be undertaken to determine whether other action is required.

PRIVACY

Cancer Council NSW recognises that the disclosure by an individual of a potential conflict could involve the disclosure of personal information. Cancer Council NSW adheres to information privacy principles and will treat information provided in accordance with these principles. Any individual who is concerned about the potential ramifications of disclosing particular information may raise their concerns directly with the Chief Executive Officer (CEO) of Cancer Council NSW or their delegate, particularly if they feel it is inappropriate to disclose such information to the Ethics Committee Chairperson. The CEO or their delegate will determine how and to whom any information is subsequently disclosed bearing in mind the requirements of this policy and the privacy of the individual concerned (Australian National University 2002a).

In order to comply with this policy, members of the Ethics Committee: In the development of policy and procedures

Must as individuals and as a Committee be aware of their potential to influence the substance of policy and procedures developed for the purposes of meeting the Ethics Committee’s objectives; and take active steps to test any Committee decision and output for such bias.

In giving ethical approval on behalf of Cancer Council NSW for research projects

The presumption is that the recommendations of any external expert reviewers of research projects will be accepted by the Ethics Committee as they are recommended. Should the Ethics Committee have strong reasons not to accept the recommendations of any external expert reviewers regarding ethical approval, the CEO or their delegate must be formally notified and review the Ethics Committee’s reasons for taking the view they have. Where any recommendations made by external expert reviewers vary from an evaluation by the Ethics Committee, and the Ethics Committee is unwilling to adopt the recommendations, the Ethics Committee must demonstrate that their decision is made without bias and the justification for the decision should be provided in writing for formal review by the CEO or their delegate.

If involved with research projects making application to Cancer Council NSW for ethical approval

May be part of a research team applying to Cancer Council NSW for the ethical approval of a research project.



Must disclose their involvement to the Chair of the Ethics Committee if they are part of the research team or in any situation that could be perceived as creating a conflict of interest when seeking ethics approval for a research project sponsored by their organisation.

Must remove themselves from all evaluation and decisions or recommendations for ethics approval undertaken by the Ethics Committee when it includes a research project in which they are involved.

Disclosure Procedures The Chair of the Ethics Committee is responsible and accountable to the Board of Cancer Council NSW for monitoring the exclusion of the Committee Members in the decision-making processes when a disclosure of interests or a complaint of a conflict of interest is made. Disclosure Disclosure of a conflict of interest, whether real, potential or apparent, must take place as soon as the individual becomes aware of the conflict. This may be, for example, in the case of a research project at a meeting when an individual becomes aware that a research project is being proposed or considered; at the first opportunity after an individual becomes interested in an existing or proposed research project; or at the first possible moment when they become involved with Ethics Committee and a research project pre-exists. The member will then withdraw from the meeting during any Ethics Committee discussion or consideration of the matter relevant to the conflict of interest. The member will not participate in the discussions and will not be entitled to vote in any decision with respect to any matter relevant to the conflict of interest. The Committee may, at its discretion, request such information as it deems fit in relation to the matter relevant to the conflict of interest. Notice The person making the disclosure should do so : either in the ‘Declaration of Interests Register’ if present at the Committee Meeting; via noting in person at the meeting; or by notifying the Secretariat prior to the Committee Meeting.

Details of the declaration of interest with respect to any disclosure will be documented formally in the minutes of the Committee meeting with any discussion or determinations of Committee.

Any times the member making the disclosure leaves and returns to the meeting will also be minuted.



Confidential Notice In the event that the matter to be disclosed is of a confidential or sensitive nature that would cause undue prejudice through open disclosure, then such matters may be disclosed in confidence to the Chair of the Ethics Committee. If, after receiving such disclosure the Chair determines that such matters, in the discretion of the Chair, are not of a confidential or sensitive nature or that the principles or interests of Cancer Council NSW would not be fulfilled without full and open disclosure, then the Chair shall notify the disclosing individual of same and give such individual the opportunity to make such full disclosure. If the affected individual fails to make such disclosure, it shall then be considered a breach of this policy. Final Determination Cancer Council NSW, or its delegate, shall determine in each case whether or not a disclosed interest is acceptable and may continue. The criteria for acceptability may vary and may include, without limit, those principles considered relevant by Cancer Council NSW. Remedy Where a disclosed interest is determined to be unacceptable by Cancer Council NSW, they shall make a determination that protects the public interest and the interests of Cancer Council NSW, such determination to be made by the Board or their delegate. Reservation of Right Where an individual fails to disclose a conflict or an interest according to this policy or according to other laws or regulations in NSW, Cancer Council NSW reserves all rights which it may have to deal with the situation or conflict and individual involved. Consequences Failure to comply with these policies may lead to removal from the position the individual holds on the Ethics Committee and Cancer Council NSW. Annual Reporting Cancer Council NSW will include a Conflict of Interest statement in the Annual Report each year outlining any relevant matters that have arisen in the Ethics Committee during the reporting year. The Conflict of Interest Report will include:

o A brief statement outlining the nature of the conflict of interest or perceived conflict of interest that arose;

o The number of times that it arose; and o How the conflicts of interest were managed.



References Australian National University (2002a) Conflict of Interest and Commitment, Policy Number

1303a/2002. Canberra. Available at: http://www.anu.edu.au/cabs/policies/1303a_conflictofinterest.pdf. Accessed: 24 January 2004.

Australian National University (2002b) Intellectual Property: Ownership, Protection and Commercialisation, Policy Number 1298b/2002. Canberra. Available at: http://info.anu.edu.au/policies/Policies/Legal/Other/1298b_intellectualproperty.pdf. Accessed: 24 January 2004.

Canadian Institutes of Health Research (2003) Conflict of Interest Policy. Available at: http://www.cihr-irsc.gc.ca/e/19039.html. Accessed: 18 August 2005.

Canadian Institutes of Health Research (2005) Policy on Confidentiality, Conflict of Interest and Privacy Issues in Peer and Relevance Review (CCIP): Policy Guidelines and Implementation Procedures. Available at: http://www.cihr-irsc.gc.ca/cgi-bin/print-imprimer.pl. Accessed: 18 August 2005.

Gray G (2003) Managing conflict of interest - Ethics Live! @CIHR, Canadian Institutes of Health Research 2005. Available at: http://www.cihr-irsc.gc.ca/e/18726.html. Accessed: 16 August 2005.


SOP004 Appendix 3 Declaration of Interests form – Ethics Committee Members Before beginning a term on the Cancer Council NSW Ethics Committee, nominated persons should declare any ongoing interests in the outcome of research applications and in the future declare any conflict of interest in the review of projects as they arise. An interest can include financial gain or personal interest in the review of a project. An interest in the review of projects may stem from being directly involved in the project, closely affiliated with the organisation conducting the research, being in close relationship with researchers involved in the project, or being involved in a competing project. If you are unsure whether certain circumstances could be considered a conflict of interest, you should discuss this with the Research Governance Officer. Failure to declare interests may result in the termination of your position on the Committee and/or projects reviewed while you had a conflict of interest may need to be re-reviewed. After reading the above information and the Cancer Council NSW Ethics Committee Conflict of Interest Policy and Guidelines, please sign the declaration below;

a) I [NAME] have read the Cancer Council NSW Ethics Committee Conflict of Interest Policy and Guidelines and declare that I do not have any ongoing conflict of interest in the ethical review of projects as a [POSITION ON COMMITTEE] for the Cancer Council NSW Ethics Committee.

b) I declare that should a conflict of interest arise in the course of my involvement with

the Cancer Council NSW Ethics Committee I will declare this interest as soon as it arises so the necessary arrangements can be made.

c) I acknowledge that my term on the Committee may be terminated and that any

projects reviewed while I had a conflict of interest may need to be re-reviewed.

d) I declare that I have not been subject to any adverse finding in a professional context or professional disciplinary matter, which may prejudice my standing as a Committee member.

Signed: ..............................................................................................

in the presence of Ethics Committee member

(name): ..............................................................................................

(signature): ..............................................................................................

(position): ..............................................................................................

Date: ..............................................................................................



Standard Operating Procedures Reference Number: SOP004 Date: March 2013 Subject: Orientation of new members to the Cancer Council NSW Ethics Committee. Purpose: To describe the procedure for the orientation of new members.

1. New Committee members must be provided with adequate orientation including reference materials as described in Point 7 of SOP003.

2. Orientation may involve all or some of the following:

a) introduction to other Committee members prior to the meeting; b) informal meeting with Chairperson and Research Governance Officer to explain

their responsibilities as a Committee member and Committee processes and procedures;

c) an opportunity to observe one or more Committee meetings before their appointment takes effect;

d) ‘partnering’ with another Committee member in the same category; and/or e) priority given to participation in training sessions.



Standard Operating Procedures Reference Number: SOP005 Date: March 2013 Subject: Submission procedure for new applications for ethical assessment by the

Cancer Council NSW Ethics Committee. Purpose: To describe the procedure for the submission of new applications to the

Cancer Council NSW Ethics Committee. 1. All proposals submitted to the Committee for ethical assessment must be made on the

National Ethics Application Form (NEAF) or Low and Negligible Risk Form (LNRF) available at www.ethicsform.org/au; and must be accompanied by the documentation specified in the application form.

2. Instructions for completing the NEAF and LNRF application forms are available on the

same website (www.ethicsform.org/au) and will assist in accurate completion of the application.

3. The Committee will require all sections of the application form to be completed.

Incomplete application forms will generally be returned to the applicant for completion. However, at the discretion of the Research Governance Officer, minor omissions may be remedied by the applicant within a specified time frame.

4. The applicant will be required to submit as many copies of the application and supporting

documentation as the Committee considers necessary to enable it to carry out a proper review.

5. A levy will not be charged for applications submitted for assessment by the Committee. 6. The Research Governance Officer will undertake an administrative review of the

application prior to acceptance onto, and distribution of, the agenda, to ensure that the application has been completed and that there are no obvious omissions.

7. Applications must be received by the Research Governance Officer at least twelve (12)

working days before each scheduled Committee meeting. The scheduled meeting dates and corresponding application closing dates should be available from the Research Governance Officer and from the Cancer Council NSW website. The Committee will consider completed applications at its next available meeting provided that the application is received by the relevant closing date.



Standard Operating Procedures Reference Number: SOP006 Date: March 2013 Subject: Processing of applications for review by the Cancer Council NSW Ethics

Committee. Purpose: To describe the process of each application once it has been received for

ethical assessment by the Cancer Council NSW Ethics Committee. 1. The Research Governance Officer will assign an identification number, known as the

Project Reference Number, to each application. The Project Reference Number is assigned according to the next available sequential number in the CCNSW Ethics database maintained by the Research Governance Officer. The date of all meeting(s) at which the project is discussed is also recorded on the Ethics database.

2. The Research Governance Officer will open and maintain a restricted access electronic

file for each application, which will include the original application and all subsequent information and correspondence relevant to the application.

3. The Research Governance Officer will record the application on the CCNSW Ethics

database, including NHMRC prescribed items of information such as Project Reference Number, name of the responsible institution or organisation, name of the Chief Investigator, title of the project and whether the project is multi-centre.

4. The Research Governance Officer will acknowledge acceptance of the application for

ethical review by issuing an acknowledgement email (or, where no email address is provided, letter as per SOP006 Appendix 1) to the Chief Investigator within five (5) working days of receipt of the application. The acknowledgement communication will include the date of the meeting at which the application will be reviewed, as well as the unique Project Reference Number assigned by the Research Governance Officer to the project.

5. The application will be included on the agenda of the Committee’s next scheduled

meeting, provided that the application is received by the relevant closing date, and in the case of a ‘Provisional’ Committee meeting, sufficient applications have been received to warrant convening of the ‘Provisional’ meeting.


SOP006 Appendix 1 <<date>> <<Chief Investigator’s Title and Name>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Chief Investigator>>, Re: Project No. xxx

Project Title: Thank you for submitting the above project which will be considered by the Cancer Council NSW Ethics Committee at its meeting on [insert date]. Should you have any queries about this response please contact the [Insert best contact] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely, Research Governance Officer Cancer Council NSW Ethics Committee



Reference Number: SOP007 Date: March 2013 Subject: Preparation of meeting agendas for the Cancer Council NSW Ethics

Committee. Purpose: To describe the process and format of the agenda for a meeting of the Cancer

Council NSW Ethics Committee. 1. The Research Governance Officer will prepare an agenda for each Committee meeting. 2. All completed applications and relevant documents received by the Research

Governance Officer by the closing date will be included on the agenda of the Committee’s next available meeting.

3. The meeting agenda and associated documents will be prepared by the Research

Governance Officer and posted to all Committee members at least nine (9) days prior to the next meeting.

4. Correspondence and other documents received after the closing date will be included

on the agenda at the discretion of the Chairperson/Research Governance Officer. Under no circumstances will late (new) applications for research be tabled at the meeting.

5. The agenda format will include the following items:

a) apologies for absence; b) declarations of interest; c) minutes of previous meeting; d) business arising; e) new applications; f) amendments to applications previously given ethics approval; g) annual reports; h) other business; and i) date of next meeting.

6. To ensure confidentiality, the agenda is to be distributed by hand delivery, courier, or

express post, to Committee members external to CCNSW and will remain confidential in accordance with the signed Confidentiality Undertaking (SOP003, Appendix 2).



Standard Operating Procedures Reference Number: SOP008 Date: March 2013 Subject: Conduct of Cancer Council NSW Ethics Committee Meetings. Purpose: To describe the format of meetings of the Cancer Council NSW Ethics

Committee.

1. The Committee will meet at least bi-monthly, from February to December. The scheduled

meeting dates and corresponding application closing dates should be publicly available on the CCNSW website from 1 January and also obtainable from the Research Governance Officer on request.

2. Meetings will be held at the CCNSW Head Office, 153 Dowling St Woolloomooloo.

3. Members will advise the Research Governance Officer as soon as practicable if they are

unable to attend a meeting. 4. The Chairperson may cancel a scheduled meeting if it has been determined that there

are insufficient agenda items to warrant a meeting, or a quorum cannot be achieved (refer to Point 10 below).

a) Where there are insufficient agenda items to warrant convening a meeting, the

Research Governance Officer will consult with all affected researchers to determine which agenda items can be postponed until the next scheduled meeting. If agenda items have a genuine urgency then the Research Governance Officer will disseminate those agenda items to the Committee for consideration and comment via group email correspondence or via teleconference.

b) Where a quorum is not achieved, the Committee will convene within five (5) working

days of the cancelled meeting to ensure all agenda items are considered. This may occur by teleconference or email discussion if it is not possible to reschedule a face-to-face meeting at short notice.

5. Meetings will be scheduled initially for two (2) hours. If the Committee’s business has not

been completed within the two (2) hour period, then the Committee may either continue the meeting until all agenda items have been considered, defer consideration of later agenda items until the next scheduled meeting, or schedule an additional meeting. If an additional meeting is called for, then the meeting should be held as soon as possible.

6. The Committee meeting should be conducted in private, to ensure confidentiality and

open discussion. Members should be encouraged to raise any concerns. 7. Where practicable, Committee meetings should be conducted face-to-face but in some

circumstances, one or more members may participate via telecommunications link.

8. In exceptional circumstances, a full Committee meeting may be conducted in which all members participate via telecommunications link.


9. Members who are unable to attend a meeting may contribute prior to the meeting through either written or oral submissions to the Research Governance Officer or Chairperson. These submissions should normally be received at least three (3) working days prior to the meeting so that copies of written submissions may be made available in advance to members. The Chairperson will raise the absent member’s comments as appropriate throughout the meeting in order that other members may consider them during their own deliberations. The ‘Apologies’ section of the minutes will record receipt of these submissions (specifying whether they were written or oral). The minutes will also record the Chairperson’s reference(s) to these submissions throughout the meeting.

10. A quorum must be present in order for the Committee to reach a final decision on any

agenda item. A quorum will exist when a representative of each of the following categories is present (or as described in Point 11 below, has provided written comment prior to the meeting):

a) a chairperson;

b) at least two (2) members who are lay people, one man and one woman, who have no affiliation with the researcher’s institution or organisation, and who are not currently involved in medical, scientific, legal or academic work;

c) at least one (1) member with knowledge of, and current experience in, the areas of research that are regularly considered by the Committee;

d) at least one (1) member with knowledge of, and current experience in, the professional care, counseling or treatment of people;

e) at least one (1) member who is a minister of religion, or a person who performs a similar role in the community; and

f) at least one (1) member who is a lawyer. 11. In the event of a representative of a core category not being in attendance at a meeting,

an ethical determination cannot be made without written comment from the absent representative(s) prior to the meeting, or by their written ratification of the decisions of the Committee. In such circumstances, there must be at least five (5) members physically present to achieve a quorum, including one of each of the following categories: Chairperson/Deputy Chairperson, lay person, and a researcher familiar with the types of applications that are normally reviewed by the Committee.

12. Any member of the Committee who has any interest, financial or otherwise, in an

application or other related matter considered by the Committee, should as soon as practicable declare such interest. The Committee will determine if this results in a conflict of interest for the member, and if so, the member will withdraw from the meeting until the Committee’s consideration of the relevant matter has been completed. All declarations of interest and the absence of the member concerned will be minuted.



Standard Operating Procedures Reference Number: SOP009 Date: March 2013 Subject: Consideration of applications for ethical assessment by the Cancer Council

NSW Ethics Committee. Purpose: To describe the process of the Cancer Council NSW Ethics Committee’s

consideration of applications for ethical assessment. 1. The Committee will consider a new application at its next available meeting provided

that the application is received by the relevant closing date. 2. The application will be reviewed by all members of the Committee present at the

meeting. Members may also provide written or oral comments in lieu of attendance. Any conflicts of interest must be declared by Committee members prior to discussions on related matters.

3. The Committee will assess multi-centre research applications in accordance with

SOP023. 4. The Committee will assess each application for ethical acceptability in accordance with

the NHMRC National Statement on Ethical Conduct in Human Research, 2007. The Committee must ensure that it is sufficiently informed on all aspects of a research protocol, including its scientific validity, in order to make an ethical assessment.

5. It is incumbent on the Committee to satisfy itself, and where uncertain to request the

Research Governance Officer to make investigation, as to the bona fides and qualifications of the researchers making application to the Committee.

6. The Committee will consider whether an advocate for any participant or group of

participants should be invited to the Committee meeting to ensure informed decision-making.

7. Where research involves the targeted recruitment of persons unfamiliar with the English

language, the Committee will ensure that the Participant Information Sheet is translated into the participant’s language and that an interpreter is present during discussion of the project. These costs will be covered by the applicant.

8. The Committee, after consideration of an application at a meeting, will make one of the

following decisions:

a) to approve the project as being ethically acceptable, with or without conditions;

b) to defer making a decision on the project until the clarification of information or the provision of further information to the Committee;

c) to request modification of the project; or

d) to reject the project.


9. In order to facilitate consideration of an application, the Committee may invite the applicant to attend the relevant meeting to answer questions (see SOP010).

10. The Committee will endeavour to reach a decision concerning the ethical acceptability of

a project by unanimous agreement. Where a unanimous decision is not reached, the decision will be considered to be carried by a majority of two-thirds of members who examined the project, provided that the majority includes at least one layperson. Any minority view of two or more members will be noted in the minutes.

11. For projects where the Committee has requested clarification, the provision of further

information, or modification of the project, the Committee may choose to delegate the authority to review that information and approve the project between meetings to one of the following:

a) Chairperson alone; or

b) Chairperson, in oral or written consultation with one or more named members that were present at the meeting or who submitted written comments on the application; or

c) an Executive consisting of at least the Chairperson and the Research Governance Officer, and where available, another member of the Committee.

In such circumstances, the Committee will be informed at the next meeting of the final decision taken on its behalf, including the applicant’s response and the reason for the decision taken, whereupon the Committee will ‘note’ the decision.

The person(s) delegated such authority under this clause may decide that the information should be considered at a further meeting of the Committee.

12. The Committee may conduct expedited review of projects in accordance with SOP012. 13. A member of the Committee may appoint a ‘spokesperson’ for the project, for the

purpose of discussion of the project at the Committee’s meeting. The spokesperson is required to give a verbal summary of the project and highlight any issues of concern. It should be noted that the spokesperson’s role does not involve a more detailed review of the application than that conducted by other members. The spokesperson simply reminds other members of key issues involved. The spokesperson is designated to a project via a consecutive listing of Committee members. A spokesperson is not designated an application based on their relevant expertise. New Committee members are incorporated into this system after four meetings. If the designated spokesperson cannot attend the meeting then the next member from the consecutive listing is approached.

14. The duration of ethical approval given to any project will be the length of the project as

indicated on the NEAF or LNRF plus one year to a maximum of five years. If the project extends past the five-year period, then submission of a new application in the appropriate format (that is, either a new NEAF or a new LNRF, both available at www.ethicsform.org/au; see SOP005) at that time will be necessary for the Committee to reconsider the ethical acceptability of the project.



Standard Operating Procedures Reference Number: SOP010 Date: March 2013 Subject: Attendance of the Chief Investigator at a Cancer Council NSW Ethics Committee

meeting. Purpose: To describe the process of the Cancer Council NSW Ethics Committee’s inviting

the Chief Investigator to attend a Committee meeting. 1. At the request of the Committee, the Chief Investigator may be invited to attend a

Committee meeting to make a formal presentation or respond directly to requests from the Committee for further information, clarification or reassurance.

2. Where the Chief Investigator is unable to attend, another key investigator or collaborator

may attend if appropriate. Representatives of any sponsors may not attend. Other members of the research team may attend with the Chief Investigator.

3. The Chief Investigator may also attend meetings via teleconference. 4. Where deemed appropriate by the Chairperson, confidentiality undertakings (SOP003,

Appendix 2) will be signed by investigators before their attendance at a meeting, whether in person or by teleconference.



Standard Operating Procedures Reference Number: SOP011 Date: March 2013 Subject: External Expert Reviewers. Purpose: To describe the process of the Cancer Council NSW Ethics Committee’s seeking

the advice of an external expert reviewer.

1. If the Committee lacks the necessary expertise to make a decision on an application

with respect to either scientific merit or specialist ethics issues (refer to National Statement on Ethical Conduct in Human Research, 2007 5.1.33 and 5.2.19), it may seek the advice of one or more external expert reviewers identified by the Committee and/or the researcher; or through the established processes of the CCNSW Research Review Committee, coordinated by the Office of the Chief Executive Officer.

2. Where the advice of external expert reviewers is to be sought in a procedure coordinated by the Research Governance Officer, this advice will be sought using the following procedure:

a) The Research Governance Officer or Chairperson will ensure that the opinion of

the researcher is sought concerning objections to potential reviewers identified by the Committee;

b) The external expert reviewer(s) will be provided with the CCNSW Ethics Committee Policy and Guidelines, and will declare any conflict of interest and sign the Declaration of Interest Form for Expert Reviewers (SOP011 Appendix 1);

c) The Research Governance Officer or Chairperson will write to the external expert

reviewer(s) seeking written advice prior to the meeting; and

d) A copy of the advice received will be made available to Committee members, subcommittee or other appropriate members, prior to the meeting or tabled at the meeting. The advice will be appended to the minutes.

3. Where the Committee decides that it cannot make a decision until advice has been obtained from an expert reviewer, the following procedures will be adopted:

a) Notification will be sent to the applicant following the meeting advising that a final

decision will not be made on the application until advice is obtained from an expert reviewer. The letter will notify the applicant of the issues of concern to the Committee, but not request further information or clarification. In circumstances where external expert review is sought, the researcher will be given the option to identify experts to whom they object and to nominate reviewers they believe would be appropriate;

b) The Committee will select suitable external expert reviewer(s) during the subsequent meeting, and record the decision in the minutes. Alternatively, the Chairperson or the Research Governance Officer will identify suitable expert(s) following the meeting;


c) The Chairperson or Research Governance Officer will initially contact the prospective expert reviewer(s) by phone or email to establish their availability to provide expert advice within the required time frame. The Chairperson or Research Governance Officer will establish that the nominated reviewer(s) do/does not have any connection with the research or with any competing research that might give rise to a conflict of interest. The Chairperson or Research Governance Officer will advise the external expert reviewer(s) about confidentiality requirements and obtain a signed Confidentiality Undertaking and Declaration of Interest Form prior to obtaining advice;

d) The Research Governance Officer will specify in writing to the external expert

reviewer(s) the issues of concern to the Committee and the expert advice required. A copy of the application form will be provided together with any relevant supporting documentation. The request will be made within 10 working days of the meeting. The external expert reviewer(s) will be asked to respond in writing within 10 working days of receiving the documents; and

e) It will be made clear to the applicant that the opinion of the Committee on the research application is the independent opinion of the Committee.


SOP011 Appendix 1 Declaration of Interests form – Expert Reviewers Before undertaking a review of a Cancer Council NSW Ethics application, expert reviewers must declare any conflict of interest in the applications being considered. An interest can include financial gain or personal interest in the review of a project. An interest in the review of projects may stem from being directly involved in the project, closely affiliated with the organisation conducting the research, in close relationship with researchers involved in the project, or involved in any competing research. If you are unsure whether certain circumstances could be considered a conflict of interest, you should discuss this with the Research Governance Officer. Failure to declare interests may result in the need to re-review projects reviewed while you had a conflict of interest. After reading the above information and the Cancer Council NSW Ethics Committee Conflict of Interest Policy, please sign the declaration below;

a) I [NAME] of [ORGANISATION, where appropriate] have read the Cancer Council NSW Ethics Committee Conflict of Interest Policy and do not have any conflict of interest in the ethical review of project for which I have been asked to provide review.

b) I acknowledge that any projects reviewed while I had a conflict of interest may need

to be re-reviewed.

Signed: ..............................................................................................

in the presence of

(name): ..............................................................................................

(signature): ..............................................................................................

(position): ..............................................................................................

Date: ..............................................................................................



Standard Operating Procedures Reference Number: SOP012 Date: March 2013 Subject: Expedited review by the Cancer Council NSW Ethics Committee. Purpose: To describe the procedure for the expedited review of research by the Cancer

Council NSW Ethics Committee. 1. The Committee may establish an Executive, consisting of at least the Chairperson and

the Research Governance Officer, and where considered preferable and/or appropriate by the Chairperson and Research Governance Officer, another member of the Committee. Expedited review of research projects may be undertaken in the following circumstances:

a) research which is being conducted primarily at another institution/Health Service and has been approved by another Ethics Committee, but which involves a minimal risk component to be conducted at Cancer Council NSW; and/or

b) minor amendments requested by the Committee to projects already considered by the Committee.

2. Any new research, whether of low to negligible risk or otherwise (including the

notification of receipt of new datasets; see SOP013), will not be considered for expedited review. In such cases, both researchers and the Committee should follow the procedures set out in SOP009 or SOP013, as appropriate.

3. At the discretion of the Chairperson, expedited review of research projects which meet either of the criteria listed at clause 1 (above), may be undertaken between scheduled meetings either by the Chairperson alone, or by the Executive as defined at Point 1 (above). The Chairperson or Executive may seek advice from other Committee members or suitably qualified experts, as appropriate, before reaching a decision.

4. The Chairperson and/or Executive may consider other items of business such as project

annual reports or adverse events (where the decisions and necessary actions are obvious and straightforward).

5. The decisions of the Chairperson and/or Executive will be tabled for noting at the next Committee meeting.



Standard Operating Procedures Reference Number: SOP013 Date: March 2013 Subject: Review of Low and Negligible Risk applications and Receipt of New Datasets

by the Cancer Council NSW Ethics Committee. Purpose: To describe the procedure for the review of low and negligible research by the

Cancer Council NSW Ethics Committee.

1. Research with the potential to be of Low and/or Negligible Risk (LNR) to participants

must be considered by the Executive, consisting of the Chairperson and Research Governance Officer, before the application can begin. The Research Governance Officer is to be advised of the new project and be provided with either a written or verbal project brief for LNR assessment. This project brief must address:

a) purpose; b) staff involved; c) funds; d) recruitment process; e) data collection methodology; f) dissemination of data; and g) intention to publish.

2. The Executive will consider the project brief and make one of the following decisions:

a) acceptable for LNR consideration; b) requires more information or modification to assess LNR acceptability; or c) not accepted as a LNR project, meaning a full NEAF will be required for

submission.

The Research Governance Officer will notify the researcher of the decision.

3. The LNR application will be submitted to the Research Governance Officer, along with all documents required for review.

4. The Committee will consider the LNR application at the next meeting and will make one of the following decisions:

a) approval of the project as ethically acceptable, with or without conditions; b) deferral of a decision on the project until the clarification of information or the

provision of further information; c) request for modification of the project; or d) rejection of the project.

5. For projects where the Committee has requested clarification, the provision of further

information, or modification of the project, the Committee may delegate to the Chairperson the authority to review and make a decision based on the additional material provided by the researchers. Such review and decisions by the Chairperson will be presented for noting by the Committee at the next meeting.


6. Research with the potential for physical or psychological harm should not be considered under LNR review. This includes research involving invasive physical procedures and research exploring sensitive personal or cultural issues.

7. Researchers who are in receipt of new datasets must advise the Committee of the

receipt of the dataset and the proposed uses of the data via a submission of a ‘Notification to Access a New Dataset’ form (SOP013 Appendix 1), along with a letter from the dataset custodian approving the proposed uses of the dataset. The Committee will then ‘note’ receipt of the new dataset. Simple noting of the dataset does not confer ethical approval of specific projects. Research projects which will use the data must be granted project-specific ethical approval, which can only be granted by the Committee following consideration an LNR or NEAF (as appropriate) which describes in detail the proposed project and the way in which the dataset will be used.

SOP 013 Appendix 1


Notification to Cancer Council NSW Ethics Committee of New Dataset Received Name of dataset

Dataset provided by

Data received (date)

Description of data

Purpose of the data

Data security procedures

Data custodian

Personnel with access to the dataset

Limitations on use (if any)

Evidence of approval to use data

Other comments

Responsible investigator

Date

This notification does not in itself constitute an application for ethical approval. Ethical approval can only be granted to a NEAF or LNR application that describes the way a specific project will use the data contained in the notified dataset.



Standard Operating Procedures Reference Number: SOP0014 Date: March 2013 Subject: Preparation of minutes of Cancer Council NSW Ethics Committee meetings. Purpose: To describe the process and format for minutes of a meeting of the Cancer

Council NSW Ethics Committee.

1. The Research Governance Officer will prepare and maintain minutes of all meetings of the Ethics Committee.

2. The format of the minutes will include the following items:

a) apologies for absence; b) declarations of interest; c) minutes of the previous meeting; d) business arising; e) new applications; f) amendments to applications previously given ethics approval; g) annual reports; h) other business; and i) date of next meeting

3. The minutes should include a record of decisions taken by the Committee as well as a summary of the Committee’s discussion. This includes reference to views expressed by absent members (see SOP008).

4. In relation to the review of new applications or amendments, the minutes will record a summary of the main ethical issues considered, including any requests for additional information, clarification or modification of the project.

5. In recording a decision made by the Committee, any significant minority view (i.e. two or more members) will be noted in the minutes.

6. To encourage free and open discussion and to emphasise the collegiate character of the Committee, particular views should not be attributed to particular individuals in the minutes, except in circumstances where a member seeks to have his/her opinions or objections recorded.

7. Declarations of conflicts of interest by any member of the Committee and the absence of the member concerned during the Committee’s consideration of the relevant application will be minuted.

8. The minutes will be produced as soon as practicable following the relevant meeting and should be checked by the Chairperson, Deputy Chairperson or a member of the Committee, for accuracy.

9. The minutes will be circulated to all members of the Committee both after they are approved by the Chairperson and again as an agenda item for the next meeting. All members will be given the opportunity to seek amendments to the minutes prior to ratification of the minutes.

10. The minutes will be formally ratified at the next Committee meeting.


11. The final approved copy of each meeting’s minutes will be retained in electronic copy (restricted access).

12. A summary report, based on the minutes, will be prepared for the CCNSW Board meeting following the Ethics Committee meeting.



Standard Operating Procedures Reference Number: SOP015 Date: March 2013 Subject: Notification to researchers of decisions made by the Cancer Council NSW

Ethics Committee on new applications. Purpose: To describe the process of notifying applicants of the outcome of the Cancer

Council NSW Ethics Committee’s ethical assessment. 1. The Research Governance Officer will report in writing to the applicant of the Committee’s

decisions regarding their application within 10 working days of the meeting. 2. Notification of the Committee’s deliberation should include reference to the meeting date at

which the project was considered. 3. If the Committee determines that further information, clarification or modification is required

before an application is considered, the correspondence to the Chief Investigator should clearly set out the information, clarification or modification that is required and reasons for this determination. The format for a letter of this nature is set out in SOP015 Appendix 1. Where appropriate, requests for additional information/clarification/ modification should refer to the NHMRC National Statement on Ethical Conduct in Human Research, 2007 or other relevant pieces of legislation.

4. If the requested information, clarification or modification is not received from the Chief

Investigator within three months or three meetings (whichever occurs later), the application will be dismissed and the investigator will be required to re-submit the application at a later date. The Research Governance Officer will send a letter (see SOP015 Appendix 2) at the two-month mark or after the second meeting to remind the Investigator of the request for information, clarification or modification.

5. The Committee will endeavor to openly communicate with applicants to resolve outstanding

requests for further information, clarification or modification of projects relating to ethical issues. The Committee may nominate one of its members to communicate directly with the applicant, or invite the applicant to attend the relevant meeting.

6. If an application is approved, the approval letter (see SOP015 Appendix 3) should include

reference to the following:

a) title of the project; b) name of the Chief Investigator(s); c) unique Project Reference Number, assigned by the Research Governance Officer; d) the version number and date of all documentation reviewed and approved by the

Committee including Participant Information Sheets, Consent Forms, advertisements, questionnaires etc;

e) date of the meeting at which the project was first considered; f) date of approval; g) the requirement for the project to be conducted in accordance with the NSW Health’s

Privacy Manual Version 2, 2005 and (where applicable) the NHMRC National Statement on Ethical Conduct in Human Research, 2007;

h) the length of time the approval is valid;


i) the conditions outlined below and any other conditions of approval the Committee has set:

i. The project will be carried out as described in the application and in accordance with ALL subsequent correspondence.

ii. The Chief Investigator will advise the Committee of any changes to the project or its conduct, if any unforeseen events that might affect continued ethical acceptability of the project or adverse events take place, or if the project is abandoned for any reason. New ethical approval must be sought for substantially altered or revised research protocols.

iii. In order to fulfill monitoring requirements of the Committee and the NHMRC, a progress report is required annually and at the completion of the project. The report should be received by the Committee by the date specified (refer to SOP018 to determining the due date) for its consideration. Ethical approval may lapse unless the report is received.

iv. Any other information the Committee deems necessary.

7. If the Committee determines that a project is ethically unacceptable, the notification of the Committee’s decision should include the grounds for rejecting the project with reference to the NHMRC National Statement on Ethical Conduct in Human Research, 2007 or relevant legislation. A format for a letter of this nature is set out in SOP015 Appendix 4.

8. The status of the project will be updated on the CCNSW Ethics database.


SOP015 Appendix 1

<<date>> <<Chief Investigator’s Title and Name>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Chief Investigator>>, Re: Project No. xxx

Project Title: Thank you for submitting the above project which was first considered by the Cancer Council NSW Ethics Committee at its meeting on [insert date]. In order to determine the ethical acceptability of your project, please respond to the following request for additional information/modification/clarification [delete whichever is not applicable]: [list each request separately]

To facilitate the Committee’s consideration of your project, please provide the requested information as soon as possible. Your response may be emailed to the Research Governance Officer at [email protected]. You will receive an email acknowledging receipt of your response. If you do not receive this acknowledgement then you should contact the Research Governance Officer. Please note that if a response is not received within three months the project will be dismissed and you will be required to re-submit the project for review at a later date. Should you have any queries about this response please contact the [Insert best contact] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely, <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Project Title: Thank you for submitting the above project which was first considered by the Cancer Council NSW Ethics Committee at its meeting on [insert date]. The Committee requested additional information/modification/clarification as per the letter dated <<date>> and advised that if a response was not received within three months of the letter the project would be dismissed and you would be required to re-submit the project for review at a later date. In order to determine the ethical acceptability of your project, please respond to the following request for additional information/modification/clarification [delete whichever is not applicable]: [list each request separately]

To facilitate the Committee’s consideration of your project, please provide the requested information by <<date>>. Your response may be emailed to the Research Governance Officer at [email protected]. Should you have any queries about this response, please contact [Insert best contact] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely, <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Project Title:

Thank you for submitting the above project, which was considered by the Cancer Council NSW Ethics Committee at its meeting on <<date>>. I am pleased to advise that the Committee has recommended that ethical approval be granted.

Please note that approval is valid for x year(s) from the date of this letter.

The following documentation has been reviewed and approved by the Ethics Committee

[insert the version number and date of all documentation reviewed and approved by the Committee including protocols, information sheets, consent forms, advertisements, questionnaires etc]

The project should be conducted in accordance with the NHMRC National Statement on Ethical Conduct in Human Research, 2007 and the NSW Health Records and Information Privacy Act 2002. Ethical approval is conditional upon adherence to these guidelines and the conditions outlined below. i) The research project will be carried out as described in the application and in

accordance with ALL subsequent correspondence.

ii) The Chief Investigator will advise the Committee of any changes to the project or its conduct; of any unforeseen events that might affect continued ethical acceptability of the project; of any serious or unexpected adverse events that take place; or if the project is abandoned for any reason. New ethical approval must be sought from the Ethics Committee, in the specified format, for changes to the research protocol, conduct of the research or length of ethics approval.

iii) In order to fulfill monitoring requirements of the Committee and the NHMRC, a report is required annually and at completion of the project. A form for providing this report to the Committee is attached. Your report should be received by the Committee by <<date>> for its consideration. If a report is not received, ethical approval may be withdrawn.

iv) <<Include any other conditions the Committee may have set>> [insert this paragraph if research is being carried out within an external organisation]. Although it is within this Ethics Committee’s Terms of Reference to review research which takes place within sites that fall under the NSW Health Single Ethical Review of Multi-Centre Research system, we note that other organisations within this system are not part of Cancer Council NSW. This approval does not have the effect of conferring any insurance or indemnity coverage on the external organisation by Cancer Council NSW in relation to this project, and any liabilities arising from the conduct of the project are entirely the responsibility of the organisation at which the research is conducted. Should you require any additional information regarding the Committee’s consideration of the application, please contact [Insert best contact] on [(XX) XXXX XXXX] or at [email protected].


Please quote Project No. xxx in all correspondence. Yours sincerely, <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Project Title: Thank you for submitting the above project, which was first considered by the Cancer Council NSW Ethics Committee at its meeting held on [insert date]. The Ethics Committee has determined that this project does not satisfy the necessary requirements for ethical approval for the following reasons: [list each reason separately. Each reason will refer to the relevant paragraph/s of the

National Statement on the Ethical Conduct of Research Involving Humans, 2007, relevant legislation or other applicable guidelines].

Should you wish to discuss the Ethics Committee’s decision, please contact [Insert best contact] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely, <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Reference Number: SOP016 Date: March 2013 Subject: Submission of amendments and extensions to approved projects. Purpose: To describe the procedure for the submission and Cancer Council NSW

Ethics Committee review of requests for amendments and extensions to approved protocols.

1. Proposed changes to approved research projects, conduct of the research, or requests

for extensions to the length of Ethics approval, must be submitted by the Chief Investigator to the Committee for review of the ethical acceptability of the proposed changes.

2. Requests will outline the nature of the proposed changes and/or request for extension, reason/s for the request, and an assessment of any ethical implications arising from the request on the conduct of the research. All amended documents must have the changes highlighted and contain revised version numbers and dates.

3. All requests for amendments will be reviewed by the Committee or, where deemed appropriate by the Research Governance Officer, its delegated Executive, at its next meeting, provided the request has been received by the Research Governance Officer by the agenda closing date.

4. The Committee will report in writing to the Chief Investigator, advising of the ethical decision of the proposed amendment and/or request for extension, within 10 working days of the meeting at which the request was considered (this may be the full Committee meeting or an Executive meeting). Where appropriate, the Committee will inform the applicant in writing that the amended research may commence.

5. A standard written response will be issued, in the format set out in SOP016 Appendix 1.

6. If the Committee determines that further information, clarification or modification is

required for the consideration of the request for amendment or extension, the correspondence to the Investigator should clearly articulate the reasons for this determination, and clearly set out the information, clarification or modification that is required. A format for a letter of this nature is set out in SOP016 Appendix 2. Where appropriate, requests for additional information/clarification/modification should refer to the NHMRC National Statement on Ethical Conduct in Human Research, 2007 or relevant legislation.

7. All reviewed requests for amendments and extensions will be recorded, and the status

of the project will be updated on the CCNSW Ethics database.

8. The duration of ethical approval given to any project will be a maximum of five years. If approval of a request for extension would extend the approval past the five-year period, then submission of a new application in the appropriate format will be necessary for the Committee to reconsider the ethical acceptability of the project at that time (see SOP009).


SOP016 Appendix 1


Project Title:

Thank you for your submission of a request for an amendment/extension to the above project, which was considered by the Cancer Council NSW Ethics Committee at its meeting on <<date>>.

I am pleased to advise that the Committee has granted ethical approval for the requested amendments, as follows: [insert summary of amendment request including the version number and date of all

documentation reviewed and approved by the Committee including protocols, information sheets, consent forms, advertisements, questionnaires etc]

Please note the following conditions of approval: The Chief Investigator will advise the Committee of any changes to the project or its

conduct; of any unforeseen events that might affect continued ethical acceptability of the project; of any serious or unexpected adverse events that take place; or if the project is abandoned for any reason. New ethical approval must be sought from the Ethics Committee, in the specified format, for changes to the research protocol, conduct of the research or length of ethics approval.

[list any other conditions of approval imposed by the Ethics Committee] Should you require any additional information regarding the Committee’s consideration of the application, please contact [Insert best contact] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Project Title:

Thank you for your submission of a request for an amendment to the above project, which was considered by the Cancer Council NSW Ethics Committee at its meeting of <<date>>. In order to determine the ethical acceptability of your amendment, please respond to the following request for additional information/modification/clarification [delete whichever is not applicable]: [list each request separately]

To facilitate the Committee’s consideration of your project, please provide the requested information as soon as possible. Your response may be emailed to the Research Governance Officer at [email protected]. Please note that if a response is not received within three months, the project will be dismissed and you will be required to re-submit the project for review at a later date. Should you require any additional information regarding the Committee’s consideration of the application, please contact [Insert best contact] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Standard Operating Procedures Reference Number: SOP017 Date: March 2013 Subject: Handling of adverse events. Purpose: To describe the process for the reporting and handling of adverse events for

projects approved by the Cancer Council NSW Ethics Committee. 1. As a condition of approval of each project, researchers must immediately report any and

all adverse events to the Committee (via a letter addressed to the Chairperson), including those that have occurred at any institution participating in the project.

2. Written notifications to the Committee of adverse events must include all relevant

documentation. This documentation will include as a minimum:

a) a detailed description of the adverse event;

b) advice from the Chief Investigator as to whether, in his/her opinion, the adverse event was related to the protocol;

c) advice from the Chief Investigator as to whether, in his/her opinion, the adverse event necessitates an amendment to the project and/or the Participant Information Sheet/Consent Form; and

d) advice from the Chief Investigator regarding the frequency of the event in relation to the total number of participants for the project in which the event occurred.

3. Adverse events may be reviewed by the full Committee, an Executive or Subcommittee

of the Committee, which will determine the appropriate course of action. This may include:

a) notation of the occurrence in the project’s file maintained in the CCNSW Ethics database;

b) increased monitoring of the project;

c) request for an amendment to the protocol and/or Participant Information Sheet/Consent Form;

d) suspension of ethical approval; and/or

e) termination of ethical approval.

Any such adverse events reviewed by an Executive or Subcommittee will be reported to the Committee at the next available meeting.

4. For adverse events deemed by the Chairperson as serious and requiring immediate

attention, the Chairperson will take such action as considered necessary. This may include:

a) referral to a scientific/technical subcommittee or the CCNSW Research Review

Committee or external experts;


b) request for additional information to be provided immediately;

c) immediate suspension of ethical approval; and/or

d) immediate termination of ethical approval;

5. The Committee will inform the Investigator that it has received notification of the serious or unexpected adverse event, and the course of action it has deemed necessary.



Standard Operating Procedures Reference Number: SOP018 Date: March 2013 Subject: Monitoring of projects granted ethical approval by the Cancer Council NSW

Ethics Committee. Purpose: To describe the monitoring procedures of the Cancer Council NSW Ethics

Committee for projects to which it has granted ethical approval. 1. The Committee will monitor the progress of all projects to which it has granted ethical

approval. In doing so, the Committee may request and discuss information on any relevant aspects of the project with the investigators at any time.

2. Monitoring responsibilities will include, at a minimum, obtaining an annual report on the

progress of the project and a final report at the project’s completion. Reports must be made in the format set out in SOP018 Appendix 1. Report Forms should be available from the Research Governance Officer and the Cancer Council NSW website.

3. The Committee may withdraw ethical approval if reports are not received. 4. To ensure a project is monitored annually, reports should be received in time for

consideration by the Committee at the meeting preceding the 12-month anniversary of the date of the ethical approval letter. For example, for a project granted ethical approval late April 1999, the annual report should be received by the closing date for the meeting preceding the end of April 2000. The Research Governance Officer will send a reminder when annual reports are due.

5. In addition to the annual reports, the Chief Investigator must immediately advise the

Committee in writing of anything which might warrant review of ethical approval of the project, including:

a) any proposed changes to the project or its conduct; b) any and all adverse events that take place; c) any unforeseen events that might affect continued ethical acceptability of the

project; and/or d) if the project is abandoned/discontinued for any reason.

An explanation and rationale for any proposed changes must be provided; and changes will not be automatically approved. Investigators are not to change any aspect of a project prior to receiving ethical approval for the change.

6. If a project has not commenced within two years from the date of ethical approval, then

ethical approval will lapse. If the investigator is still planning to undertake the project then a new submission to the Committee is required.

7. The Committee may adopt any additional appropriate mechanisms for monitoring,

including performing random audits of ‘active’ projects to ensure compliance with approval, for example: security of storage of data; the level of identification of data; and the existence of signed consent forms.


8. The Committee will determine whether and which additional forms of monitoring are

required for a project, based on its consideration of the risk to participants in the project.


SOP018 Appendix 1


Annual/Final Report (Please circle)

1. Project Number: Chief Investigator:

2. Title of Project:

3. Date of Project Approval by CCNSW Ethics Committee:

4. Name of CCNSW data collection(s) used (if applicable):

5. Name of Custodian(s) of the data collection(s) (if applicable):

6. Project Status: Not Started

Abandoned

In Progress Expected Completion Date:

Completed Actual Completion Date:

7. If the project has been abandoned or not started, please provide reasons:

8. Has the project protocol been changed since approval in any way that might affect participant involvement or change the information collected? (If yes, give details and indicate which changes have already been notified to the CCNSW Ethics Committee).

9. Have the ethical issues in the project changed? (If yes, indicate the changes):

10. List conditions imposed by the CCNSW Ethics Committee and indicate how each has been complied with.

11. Have any problems, complications or adverse events affecting human subjects arisen during, or as a result of, the project? (If yes, state what they were and the action taken to resolve them):


12. Do procedures for data handling and storage protect privacy in accordance with NHMRC guidelines? If not, in what way do they vary from these standards? (All data security must satisfy NHMRC guidelines) 13. Person responsible for data storage: 14. Medium of data storage: Paper / Electronic / Web-based / Other (Please specify): 15. Preliminary results, including any publications: (Relevant abstracts, articles etc. may be attached) (Maximum half a page) Name of Chief Investigator: Signature of Chief Investigator: Date: For Office Use Only:

Comments:



Standard Operating Procedures Reference Number: SOP019 Date: March 2013 Subject: Complaints concerning the conduct of a research project. Purpose: To describe the mechanism for receiving, handling and responding to

complaints concerning the conduct of a project approved by the Cancer Council NSW Ethics Committee.

1. A person, whether he/she is a project participant, researcher or other interested person, with a complaint about the conduct of a project, should bring the complaint to the attention of the Research Governance Officer in the first instance, detailing the grounds of the complaint.

2. The Executive, consisting of at least the Research Governance Officer and Chairperson,

and where deemed appropriate and/or preferable by the Executive, another Committee member, will investigate the complaint. The Chief Investigator of the project will be notified of the complaint. Further information from all relevant persons may be sought during the investigation of the complaint. In some cases, the Chief Investigator may be required to attend a Committee meeting or meet with the Executive to explain the situation. The Executive must respond urgently where there is any suggestion of harm to participants, researchers or any other persons.

3. The Executive, having considered the matter, will make a recommendation on the

appropriate course of action. This may involve consulting the entire Committee where appropriate, or the noting of the Executive recommendation at the next Committee meeting.

4. The Chairperson will, on the advice of the Executive or the Committee, inform the Chief

Investigator in writing of the result and the actions arising from the investigation. These actions may include:

a) a caution; b) increased monitoring by the Committee; c) the requirement for amendments to the project; d) suspension of ethical approval; and/or e) termination of ethical approval.

5. The complainant will be advised in writing of the outcome of the investigation of the

complaint. 6. If the complainant is not satisfied with the outcome of the Committee’s investigation,

then he/she can refer the complaint to the CCNSW Board and/or (in accordance with clause 5.6.5 of the National Statement on the Ethical Conduct of Research Involving Humans, 2007) request an external agency or person to review the complaint.

7. Contact details of the Research Governance Officer must be provided to participants as

part of the information provided on entering a project, as a component of the Committee’s mechanism for receiving complaints.


8. At the Executive’s discretion, complaints received anonymously will be addressed via the same process.

9. All complaints received, and the relevant action taken, will be reported to the CCNSW

Board.



Standard Operating Procedures Reference Number: SOP020 Date: March 2013 Subject: Withdrawal of ethical approval and/or suspension of a research project. Purpose: To describe the procedure for the withdrawal of ethical approval of a research

project and/or the immediate suspension of research. 1. Where the Committee finds reason to believe that continuation of a research project will

compromise participants’ welfare, or that the research project is not being conducted in accordance with its ethical approval, it should immediately seek to establish whether ethical approval for the project should be suspended or withdrawn. This process should ensure that researchers and others involved in the project are treated fairly and with respect.

2. In such circumstances, the Committee will immediately notify the Chief Investigator and

the lead CCNSW Investigator (if CCNSW is involved). This notification must be confirmed in writing within three working days as per SOP020 Appendix1.

3. Upon receipt of the Chief Investigator’s letter of response, the Committee will determine

whether the reasons for withdrawing ethical approval have been adequately addressed. If the Committee is not satisfied that the reasons have been adequately addressed it will notify the Chief Investigator as per SOP020 Appendix 2. Conversely, if the Committee is satisfied that the reasons for withdrawal of ethical approval have been appropriately addressed, then ethical approval will be reinstated and the Investigator notified as per SOP020 Appendix 3.

4. The Committee cannot withdraw ethical approval from multi-centre studies that are

governed by a Lead Committee. It may, however, withdraw ethical approval from studies for which it is the primary NSW reviewing Committee (this may include, but is not limited to, research conducted in partnership between CCNSW and a University). The Committee can notify the Lead Committee which approved the project of its concerns as per the letter at SOP020 Appendix 4.

5. In the event that ethical approval is withdrawn by the CCNSW Ethics Committee for a

project that is operating in multiple states or countries, the Committee will notify the other approving bodies of the withdrawal within three working days of the determination, using the template letter provided at SOP020 Appendix 5.

6. An Investigator may not continue with the research if ethical approval has been

suspended or withdrawn; and must comply with any special conditions imposed by the Committee. The research may not be resumed unless either:

a) the Investigator subsequently establishes to the satisfaction of the Committee that

continuation will not compromise participants’ welfare; or

b) the research is modified to provide sufficient protection for participants, the modification is reviewed for its ethical acceptability, and the modified research is approved by the Committee.


7. The Research Governance Officer will update the Ethics Database to record the Committee’s decisions and the related actions of both the Committee and the Investigator.


SOP020 Appendix 1


Project Title: The above project was first approved by the Cancer Council NSW Ethics Committee on [date]. However, in recent discussion the Committee has concluded that the ethical acceptability of this project is questionable. Consequently, ethical approval has been withdrawn and the conduct of this research is to be suspended immediately until such time that the Committee believes that the research can and will be conducted in an ethical manner. The following reasons have been given for this suspension; 1. [List each reason separately. Each reason must refer to the relevant paragraph/s of the National Statement on the Ethical Conduct of Research Involving Humans, 2007, relevant legislation or other applicable guidelines]. This suspension includes all aspects of the research project. In order to re-obtain ethical approval for this project the identified issues must be dealt with. Should you wish to continue this research you will need to write to the Committee systematically addressing each of the issues above. You will also need to resubmit any affected documentation. Please confirm receipt of this notice including your planned approach to this suspension and the measures taken to ensure all aspects of the research project are ceased until further notice. Should you wish to discuss the Committee’s suspension of your project, please contact [insert name and contact details of Research Governance Officer and Chairperson]. Please quote Project No. xxx in all correspondence. Yours sincerely, <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee


SOP020 Appendix 2 <<Date>> <<Chief Investigator’s Title and Name>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Chief Investigator>>, Re: Project No. xxx

Project Title:

Thank you for your letter dated [date]. The Cancer Council NSW Ethics Committee has reviewed your submission of the above project [or response to the Committee’s concerns], following the project’s suspension and withdrawal of ethical approval on XXXX. The Committee does not believe you have adequately addressed the issues identified and therefore continues to withhold ethical approval.

The following reasons are provided for maintaining withdrawal of ethical approval: 1. [List each reason separately. Each reason must refer to the relevant paragraph/s of the National Statement on the Ethical Conduct of Research Involving Humans, 2007, relevant legislation or other applicable guidelines]. Should you require any additional information regarding the Committee’s continued withdrawal of ethical approval for this project please contact [insert name and contact details of Research Governance Officer and Chairperson] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee


SOP020 Appendix 3


Project Title:

Thank you for your letter dated [date]. The Cancer Council NSW Ethics Committee is satisfied that you have adequately addressed all the changes requested to the above project when ethical approval was initially withdrawn on the [date].

Please note that approval is valid for [x] year(s) from the date of this letter.

This approval includes the use of the following documents:

[insert the version number and date of all documentation reviewed and approved by the Committee including protocols, information sheets, consent forms, advertisements, questionnaires etc]

The project should be conducted in accordance with the NHMRC National Statement on Ethical Conduct in Human Research, 2007 and the NSW Health Records and Information Privacy Act 2002. Ethical approval is conditional upon adherence to these guidelines and the conditions outlined below. i) The research project will be carried out as described in the application and in

accordance with ALL subsequent correspondence.

ii) The Chief Investigator will advise the Committee of any changes to the project or its conduct, of any unforeseen events that might affect continued ethical acceptability of the project, of any serious or unexpected adverse events that take place, or if the project is abandoned for any reason. New ethical approval must be sought for changes to the research protocol, conduct of the research or length of ethics approval, from the Ethics Committee, in the specified format.

iii) In order to fulfill monitoring requirements of the Committee and the NHMRC, a report is required annually and at completion of the project. A form for reporting to the Committee is attached. Your report should be received by the Committee by <<date>> for its consideration. If a report is not received, ethical approval may be withdrawn.

iv) <<Include any other conditions the Committee may have set>> [insert if research is being carried out within an external organization]. Although it is within this Ethics Committee’s Terms of Reference to review research which takes place within sites that fall under the NSW Health Single Ethical Review of Multi-Centre Research system, we note that other organisations within this system are not part of the Cancer Council NSW. This approval does not have the effect of conferring any insurance or indemnity coverage on the external organisation by the Cancer Council NSW in relation to this project, and any liabilities arising from the conduct of the project are entirely the responsibility of the organisation at which the research is conducted.


Should you require any additional information regarding the Committee’s consideration of the application, please contact [Insert best contact] on [(XX) XXXX XXXX] or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee


SOP020 Appendix 4 <<date>> <<Chair of Lead Ethics Committee>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Chairperson>>, Re: Project No. xxx Project Title: It has been brought to the attention of the Cancer Council NSW Ethics Committee that continuance of the above research project may compromise participants’ welfare, and/or that the research project is not being conducted in accordance with its ethical approval. It is understood that the incident involves <<insert nature of concerns>>. As the <<insert name of Lead HREC>> is the Lead Ethics Committee for this project, the Cancer Council NSW Ethics Committee draws you attention to these concerns and awaits your decision. Correspondence may be directed to the Cancer Council NSW Research Governance Officer <<insert name of RGO>> who is available by telephone on 02 9334 1993 or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee


SOP020 Appendix 5 <<date>> <<Chairperson of partnered ethics committee>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Chairperson>>, RE: Project No. xxx Project Title: It has been brought to the attention of the Cancer Council NSW Ethics Committee that continuance of the above research project may compromise participants’ welfare, and/or that the research project is not being conducted in accordance with its ethical approval. It is understood that the incident involves <<insert nature of concerns>>. Accordingly, the Cancer Council NSW Ethics Committee has withdrawn ethics approval and conduct of the project suspended until such time as the Chief Investigator <<insert name of CI>> has satisfactorily addressed all concerns raised by the Committee. Those concerns are as follows: <<insert issues to be addressed>> Should you wish to discuss this matter further, please contact the Cancer Council NSW Research Governance Officer <<insert name of RGO>> on 02 9334 1993 or at [email protected]. Please quote Project No. xxx in all correspondence. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Reference Number: SOP021 Date: March 2013 Subject: Concerns and complaints relating to the Cancer Council NSW Ethics

Committee’s ethical review process. Purpose: To describe the procedure for receiving and handling concerns or complaints

from investigators about the Cancer Council NSW Ethics Committee’s review processes.

1. Any concern or complaint about the Committee’s review process should be directed to the attention of the Research Governance Officer, detailing in writing the grounds of the concern or complaint.

2. The Research Governance Officer will inform the Chairperson as soon as possible of

any complaints received. The Chairperson will send a letter of acknowledgement to the complainant (as per SOP021 Appendix 1), outlining the following mechanism for dealing with the complaint.

3. The Chairperson will instigate an investigation of the complaint and its validity, and

make a recommendation to the Committee on the appropriate course of action. This investigation will take no longer than ten (10) working days from the time of notification of the complaint or concern, unless exceptional circumstances exist.

4. If the complainant is not satisfied with the outcome of the Chairperson’s investigation,

then he/she can refer the complaint to the Chief Executive Officer (CEO) of CCNSW or their delegate, or request the Chairperson to do so, and/or (in accordance with clause 5.6.5 of the National Statement on the Ethical Conduct of Research Involving Humans, 2007) request an external agency or person to review the complaint.

5. The Chairperson of the Committee will provide the CEO with all relevant information

about the complaint, including:

a) the complaint; b) material reviewed in the Chairperson’s investigation; c) the results of the Chairperson’s investigation; and d) any other relevant documentation.

6. The CEO will determine whether there is to be a further investigation of the

complaint. 7. If the CEO determines there is to be a further investigation, then he/she will establish

a panel (independent of the Committee) to consider the complaint. Where there is to be no further investigation, the CEO will inform the complainant and the Chairperson of this.

8. The panel will include at least the following members:

a) the CEO or their delegate as Convener of the panel; and b) two nominees of the CEO (not members of the Committee).

9. The panel will afford the Committee and the complainant the opportunity to make

submissions.


10. The panel may access any documents relating to the application. The panel may

interview other parties, and seek any other internal and/or external expert advice. In conducting its review, the panel will be concerned with ascertaining whether the Committee acted in accordance with the NHMRC National Statement on Ethical Conduct in Human Research, 2007, its Terms of Reference, Standard Operating Procedures, and/or otherwise acted in a fair and unbiased manner.

11. The CEO will notify the complainant and the Committee of the outcome of the

investigation. The outcomes of this process may include:

a) the complaint is dismissed; or b) the complaint is referred back to the Committee for consideration, bearing in

mind the findings of the panel.

12. The panel may also make recommendations about the operation of the Committee including such actions as:

a) review Terms of Reference and Standard Operating Procedures; b) review committee membership; and/or c) take other such action as appropriate.

13. Should the Committee be requested to review its decision, then the outcome of this

review by the Committee will be final. 14. The panel or CEO cannot substitute its approval for the approval of the Committee.

15. All complaints received, and the relevant action taken, will be reported to the

CCNSW Board.


SOP021 Appendix 1 <<date>> <<Name of Investigator>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Name of Investigator>>, Re: Project No. xxx Project Title: It has been brought to my attention that you have raised concerns relating to the Cancer Council NSW Ethics Committee’s ethical review process when considering the above project at its meeting on <<insert date>>. I understand that your concern is <<insert detail of concern>>. As Chairperson of the Cancer Council NSW Ethics Committee I will instigate an investigation of the complaint and its validity, and make a recommendation to the Committee on the appropriate course of action. This investigation will take no longer than ten (10) working days from the date of this letter. In the event that you are not satisfied with the outcome of the investigation, you may refer the complaint to the Chief Executive Officer of Cancer Council NSW <<insert CEO name>>, and/or (in accordance with clause 5.6.5 of the National Statement on Ethical Conduct in Human Research, 2007) request an external agency or person to review the complaint. Should you wish to discuss this matter further, please contact the Cancer Council NSW Research Governance Officer <<insert name of RGO>> on 02 9334 1993 or at [email protected]. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Reference Number: SOP022 Date: March 2013 Subject: Complaints concerning the Cancer Council NSW Ethics Committee’s rejection

of an application for ethical approval. Purpose: To describe the procedure for receiving and handling complaints from

investigators about the Cancer Council NSW Ethics Committee’s rejection of an application.

1. A person with a concern or complaint about the Committee’s rejection of their

application should detail the grounds of the concern or complaint in writing and bring it to the attention of the Research Governance Officer.

2. The Research Governance Officer will bring any complaints to the attention of the

Chairperson as soon as possible after their receipt. The Chairperson will send a letter of acknowledgement to the complainant (SOP022 Appendix 1), outlining the following mechanism.

3. The Research Governance Officer will instigate an investigation of the complaint and

its validity, confer with the Chairperson of the Committee and make a recommendation to the Committee on the appropriate course of action. This investigation will take no longer than ten (10) working days from the time of notification of the complaint or concern, unless exceptional circumstances exist.

4. If the complainant is not satisfied with the outcome of the Chairperson’s investigation,

then he/she can refer the complaint to the CEO or CCNSW Board, or request the Chairperson to do so.

5. The Chairperson will provide the CEO with all relevant information about the

complaint, including:

a) the complaint; b) material reviewed in the Chairperson’s investigation; c) the results of the Chairperson’s investigation; and d) any other relevant documentation.

6. The CEO will determine whether there is to be a further investigation of the complaint. 7. If the CEO determines there is a case to be investigated, then he/she will establish a

panel (independent of the Committee) to consider the complaint and will report the matter to the CCNSW Board.

8. The panel will include, at least, the following members:

a) the CEO or his/her nominee as convener of the panel; b) two nominees of the CEO (not members of the Committee); and c) an expert/s in the discipline of research of the project under consideration.

9. The panel will afford the Committee and the complainant the opportunity to make

submissions.


10. The panel may access any documents relating to the project. The panel may interview other parties, and seek any other internal and/or external expert advice.

11. The CEO will notify the complainant, the Board and the Committee of the outcome of

the investigation. The outcomes of this process may include:

a) the complaint is dismissed; or b) the complaint is referred back to the Committee for consideration, bearing in

mind the findings of the panel. 12. Should the Committee be requested to review its decision, then the outcome of this

review by the Committee will be final. 13. The panel or CEO cannot substitute its approval for the approval of the Committee.

14. All complaints received, and the relevant action taken, will be reported to the

CCNSW Board.


SOP022 Appendix 1 <<date>> <<Name of Investigator>> <<Address>> <<Address>> <<Suburb State Postcode>> Dear <<Name of Investigator>>, Re: Project No. xxx Project Title: It has been brought to my attention that you have raised concerns relating to the Cancer Council NSW Ethics Committee’s decision not to provide ethical approval for the above project at its meeting on <<insert date>>. I understand that your concern is <<insert detail of concern>>. As Chairperson of the Cancer Council NSW Ethics Committee, I will instigate an investigation of the complaint and its validity, and make a recommendation to the Committee on the appropriate course of action. This investigation will take no longer than ten (10) working days from the date of this letter. In the event that you are not satisfied with the outcome of the investigation, then you can refer the complaint to the Cancer Council NSW CEO <<insert CEO name>>. Should you wish to discuss this matter in greater detail you may contact the Cancer Council NSW Research Governance Officer <<insert name of RGO>> on 02 9334 1993 or at [email protected]. Yours sincerely <<insert name of Chairperson>> Chair Cancer Council NSW Ethics Committee



Standard Operating Procedures Reference Number: SOP023 Date: March 2013 Subject: Assessment of multi-centre projects by the Cancer Council NSW Ethics

Committee. Purpose: To describe the Cancer Council NSW Ethics Committee’s role in assessing

multi-centre projects under the Harmonisation of Multi-centre Ethical Review (HoMER) accreditation awarded to the Committee by NHMRC and the NSW Ministry of Health’s Single Review System of Multi-centre research.

1. To facilitate the review of multi-centre research the Committee may:

a) communicate with any other Ethics Committee; b) accept a scientific/technical and/or ethical assessment of the research by

another Ethics Committee; and/or c) share its scientific/technical and/or ethical assessment of the research

with another Ethics Committee. 2. Under the NHMRC’s Harmonisation of Multi-centre Ethical Review (HoMER), when

reviewing multicentre projects, the Committee will apply the following principles:

a) Efficiency: agreed timeframes for processes and procedures are adopted in all jurisdictional systems;

b) Trust: the single ethical review of a multi-centre research application is accepted by institutions without re-review by their institutional HREC;

c) Respect: the national approach accommodates the differences in jurisdictional statutory and administrative frameworks and institutional arrangements; and

d) Compliance: multi-centre single ethical review must meet the requirements of the National Statement on Ethical Conduct in Human Research, 2007 to protect human research participants as well as meeting relevant jurisdictional statutory and administrative frameworks.

3. Consistent with the HoMER accreditation awarded to the Committee by NHMRC, the

Committee will review multi-centre projects within the following categories:

a) market research; b) population health and/or public health; and/or c) qualitative research.

4. The Committee will review this research in accordance with procedures in SOP009

or SOP014 as appropriate, and apply the principles enshrined in the National Statement on Ethical Conduct in Human Research, 2007 to all decisions. The outcome of the ethical review will be communicated to the Chief Investigator, who will be responsible for subsequent communication to the investigators responsible for the research at each participating institution.

5. The Committee will monitor multi-centre research using a standard HREC template

as per the NHMRC Framework for Monitoring: Guidance for the national approach to single ethical review of multi-centre research, produced by the NHMRC in January 2012 and available on their website at www.nhmrc.gov.au.


6. The Committee will abide by NSW Ministry of Health’s Single Review System of Multi-centre research as outlined in the NSW Health Policy Directive Research - Model for Single Ethical & Scientific Review of Multi-Centre Research, 2007.

7. Committee members should note that the CCNSW Ethics Committee has not been

designated ‘Lead Committee’ status under the NSW Ministry of Health’s Single Review System of Multi-centre research. However, under the NSW Ministry of Health’s Single Review System of Multi-centre research, applications for Site-Specific Assessments (SSAs) may be submitted to the Committee. SSAs cover multi-centre research for which a full NEAF has been approved by a Human Research Ethics Committee designated by the NSW Ministry of Health as a ‘Lead Committee’, but in which some component of the research will take place at CCNSW. The NSW Ministry of Health states that the purpose of SSAs is to allow all organisations in which the research will be conducted to elicit information about the research project, thereby enabling them to consider on an individual basis whether the research meets their research governance requirements. These requirements are additional to the ethical and scientific acceptability of research and include consideration of: the investigator’s skills, training and experience; availability and suitability of facilities and resources for the proposed research; funding for the project; insurance and indemnity arrangements; contractual arrangements; and compliance with legislative requirements. It is necessary for the investigator to complete a separate SSA application form to be considered by each individual organisation, in addition to the NEAF to be considered by the ‘Lead Committee’, as the two forms seek different information and it is the research site which has responsibility for considering matters of research governance, rather than the HREC.

8. Initial assessment of SSAs submitted to the Ethics Committee will be undertaken by

the Research Governance Officer. Where no issues are identified, and provided the SSA has been signed off by the Director of the appropriate CCNSW Division, the Research Governance Officer will sign off on the SSA and this information will be presented for noting by the Ethics Committee at its next meeting.

9. Where the Research Governance Officer identifies concerns during the initial

assessment of an SSA, he or she will raise these concerns with the Chief Executive Officer of CCNSW or their delegate to resolve. When deemed appropriate by these parties, the Research Governance Officer will sign off on the SSA and this information will be presented for noting by the Ethics Committee at its next meeting.



Reference Number: SOP024 Date: March 2013 Subject: Record keeping. Purpose: To describe the procedure for the preparation and maintenance of records of

the Cancer Council NSW Ethics Committee’s activities. 1. The Research Governance Officer will prepare and maintain records of the

Committee’s activities, including agendas and minutes of all meetings of the Committee.

2. The Research Governance Officer will maintain a database of all applications

considered by the Committee. The database will record the following information:

a) unique Project Reference Number; b) Chief Investigator contact details; c) the name of the responsible institution or organization; d) title of the project; e) type of application (NEAF, LNR, SSA, amendment to existing project); f) date of ethics meeting(s); g) decision on ethical approval or non-approval including date of decision; h) ethics approval end date; i) due dates and receipt dates of annual reports; and j) occurrence of complaint or adverse event.

3. The Research Governance Officer will prepare and maintain a confidential, restricted

access electronic folder for each application. The folder will contain a copy of the application, including signatures, and any relevant correspondence including that between the applicant and the Committee, all approved documents and other materials used in correspondence with potential research participants.

4. All relevant records of the Committee, including applications, membership, minutes and correspondence, will be kept as confidential files in accordance with the requirements of the Health Records and Information Privacy Act 2002 and the State Records Act 1998.

5. To ensure confidentiality, all documents provided to Committee members which are

no longer required are to be disposed of in a secure manner, such as shredding or placed in confidential bins. Members who do not have access to secure disposal should leave their meeting documents with the Research Governance Officer for disposal.

6. Data pertaining to research projects will be held for sufficient time to allow for future reference. The minimum period for retention for non-clinical research is at least five years after the date of publication or completion of the research or termination of the project. Retention periods will comply with the NHMRC Australian Code for the Responsible Conduct of Research, 2007.

7. A register of all the applications received and reviewed will be maintained in

accordance with the NHMRC National Statement on Ethical Conduct in Human Research, 2007.



Standard Operating Procedures Reference Number: SOP025 Date: March 2013 Subject: Handling of conflicts of interest. Purpose: To describe the procedure for the handling of conflicts of interest of Cancer

Council NSW Ethics Committee members. 1. Before beginning a term on the Committee, applicants will read the CCNSW Ethics

Committee Conflict of Interest Policy and Guidelines (SOP003 Appendix 3) and sign the Declaration of Interest form (SOP003 Appendix 4).

2. A Committee member will, as soon as they are aware of a potential conflict of interest in a project or other related matter(s) considered by the Committee, inform the Chairperson and the Committee as to the nature of the conflict.

3. The Committee will determine whether this results in a conflict of interest for the member and if so, the member will withdraw from the meeting until the Committee’s consideration of the relevant matter has been completed. The member will not be permitted to adjudicate on the research.

4. In the event of an ongoing conflict of interest, the Committee in conjunction with the

Board if necessary, will establish a procedure to deal with the conflict.

a) if the conflict becomes apparent after the initial review of a project, the Committee’s Chairperson will review the conflict and determine the manner in which it may have affected the review of the application(s) concerned. Appropriate action will then be taken.

5. All declarations of conflict of interest, and, where relevant, the conflicted Committee

member’s absence during consideration of the relevant project will be minuted.



Reference Number: SOP026 Date: March 2013 Subject: Reporting requirements of the Cancer Council NSW Ethics Committee. Purpose: To describe the reporting requirements of the Cancer Council NSW Ethics

Committee.

1. Reporting to the Board of Cancer Council NSW. The Committee will submit to the Board a report on its activity at the Board meeting subsequent to the Ethics meeting.

2. Reports to the Australian Health Ethics Committee (AHEC) of the NHMRC.

Consistent with NHMRC requirements, the Australian Health Ethics Committee (AHEC) will request the CCNSW Chief Executive Officer to provide reports on the Committee’s activities at the end of each calendar year (see National Statement Clauses 2.46, 2.47 and 2.48). The Research Governance Officer will collate this documentation on behalf of the Chief Executive Officer, which includes information such as:

a) membership/membership changes; b) number of meetings; c) number of projects reviewed, approved and rejected; d) description of any research where ethical approval has been withdrawn

and general reasons for the withdrawal of approval; e) confirmation of participation by required categories of members; f) the number of protocols presented, the number approved, and the

number rejected; g) monitoring procedures implemented and any problems encountered; and h) complaints procedures implemented and number of complaints received.

3. The Committee will contribute as required to the preparation of CCNSW

organisation-wide reports to the NSW Privacy Commissioner in accordance with the requirements of the Health Records and Information Privacy Act 2002 (NSW) (Sections 59 to 63).

4. The Committee Terms of Reference, Standard Operating Procedures and membership will be available upon request to the general public.



Standard Operating Procedures Reference Number: SOP027 Date: March 2013 Subject: Review of Standard Operating Procedures, Charter and Terms of Reference. Purpose: To describe the procedure for the approval of amendments to Cancer Council

NSW Ethics Committee’s Standard Operating Procedures, Charter and Terms of Reference.

1. The Ethics Committee Standard Operating Procedures, Charter and Terms of

Reference will be reviewed at least every two years and amended as necessary. 2. The Standard Operating Procedures, Charter and Terms of Reference may be

amended by following the procedure below:

For proposals made by the Chairperson and/or Secretariat:

a) for a scheduled review of Standard Operating Procedures, Charter and Terms of Reference the Secretariat will undertake the initial review in conjunction with the Chairperson;

b) the proposals or changes must be in writing and circulated to all Committee members for consideration;

c) the views of the members should be discussed at the next Committee meeting, and a vote taken at that meeting. Any member unable to attend such a meeting may register his or her views in writing;

d) the proposal will be ratified if two-thirds of the members agree to the amendment(s);

e) the Research Governance Officer will submit the amended documentation to the Office of the CCNSW CEO for consideration by the CCNSW Board.

For proposals made by a Committee member:

a) the proposal must be in writing and circulated to all Committee members for

consideration; b) the views of the members should be discussed at the next Committee

meeting, and a vote taken at that meeting. Any member unable to attend such a meeting may register his or her views in writing;

c) the proposal will be ratified if two-thirds of the members agree to the amendment(s);

d) the Research Governance Officer will submit the amended documentation to the Office of the CCNSW CEO for consideration by the CCNSW Board.

Documents

STANDARD OPERATING PROCEDURES (SOPs)...CCNSW Ethics Committee SOPs March 20131 Cancer Council NSW Ethics Committee STANDARD OPERATING PROCEDURES (SOPs) Contact information: Dr John