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MACQUARIE UNIVERSITYHUMAN RESEARCH ETHICS COMMITTEES
PRIOR REVIEW FORM (PREF)
Guidelines for submission of applications:Complete this form if your research lists Macquarie University (MQ) and/or Macquarie University Hospital (MUH) as a site, and you have received approval from one of the following:
NSW Health HRECs (or state-equivalent) or Lead HRECs http://www.health.nsw.gov.au/ethics/research/contactshrec.asp
Cancer Institute NSW Clinical Research Ethics Committee http://www.cancerinstitute.org.au/cancer_inst/research/ethics.html
An Australian University registered with the NHMRC
http://www.nhmrc.gov.au/health-ethics/human-research-ethics-committees-hrecs
Researchers are reminded that projects may not commence at MQ or MUH without the written approval of one of the Macquarie University Human Research Ethics Committees see National Statement 5.2.5 - 5.2.12 and The Code section 1.6.
Complete this PREF electronically—hand-written forms will not be accepted.
PREFs must be signed by the Principal Investigator (MQ staff member, or supervisor in the case of student research). Unsigned applications will not be accepted.
PREFs must be submitted to the Ethics Secretariat via email as a PDF document, in addition to:
1. One (1) copy of the National Ethics Application Form (NEAF) or ethics application form—as submitted to the HREC from which you have already received approval—plus all approval correspondence.
2. One (1) copy of each different Participant Information and Consent Form (PICF) relevant to this site (i.e. MQ and/or MUH) on the MQ/MUH template.
3. One (1) copy of each different recruitment advertisement relevant to this site.
Please submit your application electronically to [email protected].
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MACQUARIE UNIVERSITYHUMAN RESEARCH ETHICS COMMITTEES
PRIOR REVIEW FORM (PREF)
ALL RESEARCHERS MUST COMPLETE SECTIONS 1–10ALL QUESTIONS MARKED WITH * ARE COMPULSORY
To use checkboxes correctly in Microsoft Word:
Select the relevant response.
Double-click the checkbox beside your response.
When the menu appears, go to the “Default value” heading and select “Checked”.
Click “OK”.
For further information on how to complete this form see:
National Statement http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e72-jul09.pdfAustralian Code for the Responsible Conduct of Research (The Code) http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/r39.pdfMacquarie University Code for the Responsible Conduct of Research
http://www.mq.edu.au/policy/category.html#research
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OFFICIAL USE ONLY
SURNAME:
REF. NO.:
ARCHIVE: 7 25
SECTION 1: TITLE
*1.1 Full project title
SECTION 2: INVESTIGATORS AND RESEARCH PERSONNEL
List the details of the Principal Investigator, and any Co-Investigators, Associate Investigators, Supervisors, Research Assistants or Research Co-ordinators who will be conducting research at Macquarie University and/or Macquarie University Hospital.
*2.1 Principal Investigator/Supervisor at this siteThe Principal Investigator is:
Responsible for the research being conducted at the MQ/MUH. A Macquarie University staff member. The first point of contact for the MQ HREC regarding this protocol.
Note: If the project is to be undertaken by an Honours/Masters/PhD student, the supervisor will be considered the Principal Investigator. The student may be named as a co-investigator.
Title Prof
Dr Mr
Mrs Ms Other:
First name:
Surname:
MQ Staff no.
Full mailing address:
Faculty Human Sciences
Medicine and Health Sciences
Science and Engineering
Business and Economics
Arts
Department/Unit:
Position:
Tel No. (W):
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Tel No: (H):
Mobile No:
Fax number:
E-mail address:
Relevant qualifications and expertise:
*2.2 How many known other investigators/personnel will play a specified role in the conduct of the research project at this site?
0 Proceed to Section 3. 1 or more Complete 2.3.
2.3 Other Investigator(s)/Personnel at this site
Role Co-Investigator Associate Investigator
Research Assistant Research Coordinator
Title Prof
Dr Mr
Mrs Ms Other:
First name:
Surname:
Investigator type Staff Student
Staff/Student no.
Full mailing address:
Faculty Human Sciences
Medicine and Health Sciences
Science and Engineering
Business and Economics
Arts
Department/Unit:
Position:(students to specify degree/course)
Tel No. (W):
Tel No: (H):
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Mobile No:
Fax number:
E-mail address:
Relevant qualifications and expertise:
Note: To list additional “Other Investigators/Personnel”, please copy and paste the above table into the space below and complete the details for all personnel at this site.
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SECTION 3: FUNDING AND SUPPORT
*3.1 Is this a funded project or do you intend to apply for funding?
No Skip to 3.7
Yes Please complete 3.2 to 3.6First, please list the funding bodies that support this project or to which submission is planned.
3.2 Please indicate the status of this funding.
Approved Skip to 3.4.
Pending
Submitted
Not yet submitted
Specify the planned date of submission:
/ /
3.3 Will this study still be undertaken if funding is not successful?
No
Yes
3.4 Please state the title of the project as it appears on your grant application.
Please attach one (1) copy of your grant application.
3.5 Will this research be undertaken on behalf of (or at the request of) a commercial entity or any other sponsor?
No
Yes First, please attach one (1) copy of your research contract.Second, refer to MQ HREC fee structure on our website.Finally, please complete and attach (1) copy of the MQ research agreement.
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3.6 Where the project is a collaborative enterprise with any organisations or individuals including contracted research activities undertaken through one of the University’s corporate entities (e.g. Access Macquarie, MGSM Pty Ltd), please identify which organisation and individual will have the primary responsibility for the project.
Organisation(s):
Individual(s):
*3.7 In undertaking this research at MQ/MUH, do any “conflict of interest” issues arise that have not already been detailed in your NEAF?
Please refer to National Statement chapter 5.4.
For instance, are any of the researchers in a dual role such as researcher/clinician, researcher/carer, researcher/employer, etc.? Or do any of the researchers have access to personal files/databases as a condition of employment rather than as a researcher?
No
Yes Any “conflicts of interests” must be declared on all Participant Information and Consent Forms (PICFs).Please provide details of the “conflict of interest” and considerations or mechanisms in place to address these issues.
*3.8 Do the researchers at MQ/MUH have any affiliation with or financial involvement in any organisation or entity with direct or indirect interests in the subject matter or materials of this research?
No
Yes Please provide details.
*3.9 Do the researchers at MQ/MUH expect to obtain any direct or indirect financial or other benefits from conducting this project?
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No
Yes Ensure that such benefits are included in the Participant Information and Consent Forms (PICFs).Please provide details.
*3.10 Have conditions been imposed upon the use, publication or ownership of the results including the review of data, manuscript draft or scientific presentation by any party other than the listed researchers that have not already been detailed in your NEAF or ethics application?
No
Yes Please provide details.
Note: The Committee is unlikely to approve arrangements that involve the censorship of research findings in publications.
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SECTION 4: PRIOR ETHICAL REVIEWS
*4.1 Indicate the proposed start date of the project at this site.
Date:
/ /
*4.2 Indicate the proposed finish date of the project at this site.
Date:
/ /
Note: Approval is given for a five-year period, conditional on completion of a yearly Progress Report (using the Progress Report Form). After five years—from the original approval date—you will need to submit a Final Report for the work and a new application for approval if you wish the project to continue. The five-year time limit enables the Committee to fully review research in an environment where legislation, guidelines and codes are always changing.
*4.3 To how many other HRECs have you submitted a proposal relating to this research project?
None
One or more Please give the name(s) of the HREC(s) and indicate the status of the application(s).
HREC(s):
Status: Submitted Deferred Rejected Approved
Please attach one (1) copy of your NEAF or ethics application form and all approval correspondence.
*4.4 Has this project been previously submitted to/approved by one of MQ’s HRECs?
No
Yes Please state the reference number and original date of approval.
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Reference no.:
Date:
/ /
*4.5 Are you applying for a new period of ethics approval because the previous approval period has expired (i.e. It has been at least five years since the original approval was granted)?
No
Yes Please append your final report to this application and indicate below any differences between this application and the previously approved project.
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SECTION 5: NATURE OF RESEARCH
*5.1 Do the research methods and processes that will occur at MQ/MUH differ from those detailed in your NEAF or ethics application form?
No
Yes Please describe these differences below.
*5.2 Does the research involve limited disclosure to participants?
No
Yes Please articulate your reasoning below.
*5.3 Are you asking the MQ HREC to waive the requirement of consent?
No
Yes Please articulate your reasoning below.
*5.4 Do the basis, background evidence, hypotheses and/or aims of the research proposed to occur at MQ/MUH differ from those detailed in your NEAF or ethics application form?
No
Yes Please describe these differences below.
*5.5 Does the research involve a practice or intervention which is an alternative to a standard practice or intervention?
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No
Yes Please explain how the practice/intervention differs.
*5.6 Are there any additional risks to participants as a result of participation in this research project at MQ/MUH that have not already been detailed in your NEAF or ethics application form?
No Skip to 5.11.
Yes Please complete 5.7 to 5.10.First, please list the risks (e.g. physical or psychological distress).
5.7 Explain how these risks will be negated/minimised/managed.
5.8 Indicate who will be primarily responsible for dealing with any problems and their expertise in handling these.
5.9 Explain how these risks will be monitored.
5.10 Explain how these risks—if they result in harm to participants—will be reported.
*5.11 Are there any further ethical considerations that you wish to raise?
No
Yes Please detail these considerations below.
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SECTION 6: PARTICIPANT INFORMATION AND CONSENT
*6.1 How many participants are expected to be recruited from MQ/MUH?Comment on how this number will allow the aims of the study to be achieved.
No.:
Comment:
*6.2 What is the age range of participants involved in the study at this site?
Age range:
from
to
*6.3 Are the participants at this site MQ students, MUH staff and/or MUH patients?
No
Yes
*6.4 Describe the research data that will be collected directly from participants at MQ/MUH only.
*6.5 Using the relevant checkboxes below (more than one may apply), are the participants who are the focus of this project at MQ/MUH:
a. in a teacher–student relationship with the researchers?—see National Statement chapter 4.3
b. a teaching unit co-ordinator in which the research takes place? —see National Statement chapter 4.3
c. in an employer–employee relationship with the researchers? —see National Statement chapter 4.3
d. in any other dependent relationship with the researchers? —see National Statement chapter 4.3
e. Macquarie University staff members?
f. Aboriginal or Torres Strait Islander?—see National Statement chapter 4.7
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g. residing in countries outside Australia—see National Statement chapter 4.8
h. wards of state? —see National Statement chapter 4.2
i. prisoners or detainees? —see National Statement chapter 4.3
j. refugees or asylum seekers?
k. members of the armed services? —see National Statement chapter 4.3
l. mentally ill? —see National Statement chapter 4.5
m. intellectually impaired? —see National Statement chapter 4.5
n. physically disabled?
o. unconscious or critically ill patients? —see National Statement chapter 4.4
p. in a carer-client relationship with the researcher (e.g. medical practitioner, social worker, psychologist, legal practitioner, etc.)? —see National Statement chapter 4.3
q. in a carer-client relationship with other professional workers (e.g. medical practitioner, social worker, psychologist, legal practitioner, etc.)? —see National Statement chapter 4.3
If you checked any of the above, please give details and explain how you will mitigate any real or perceived pressure to participate—see National Statement 2.2.9.
*6.6 Who will be involved in the recruitment of participants at MQ/MUH?
*6.7 Will participants at MQ/MUH be involved in any related studies?
No
Yes Please provide further details.
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*6.8 What processes will be used to identify and select potential participants at MQ/MUH?
*6.9 Describe how and where the initial contact will be made with potential participants at MQ/MUH.
*6.10 Indicate where the research will be undertaken at MQ/MUH (e.g. clinics). Please specify all location(s) and venues (including the URL for web-based studies).
*6.11 Does recruitment for MQ/MUH involve a direct personal approach from the researchers to the potential participants?
No
Yes Please list the precautions that will be taken to minimise any pressure (real or perceived) on individuals to enrol—see National Statement 2.2.9.
*6.12 Does recruitment for MQ/MUH involve the circulation/publication of an advertisement?
No
Yes First, please provide one (1) copy of each different advertisement.Second, please indicate where and how often it will be published.
*6.13 Will written consent be obtained for all participants at MQ/MUH?
Yes For participants at MQ/MUH, please be sure to utilise the MQ PICF templates, which include the MQ logo and MQ HREC details.Please attach one (1) copy of each different PICF.
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No Please give your reasons in the textbox below.See National Statement Chapter 2.3 – Qualifying or waiving conditions for consent.
*6.14 Does your research at this site involve working with minors?A Working with Children Check is required for unsupervised contact with minors. Contact your Faculty for further information.
See National Statement 4.2.7 – Children and young people.
No Skip to 6.16.
Yes Please complete item 6.15
6.15 Will consent be obtained for minors participating in the research at MQ/MUH?
In projects involving children, parents should be asked to discuss the study with their children/child before signing the consent form, and researchers should obtain verbal consent from the child at the time the research is undertaken.
For studies involving adolescents, written consent should normally be obtained from a parent/guardian and children.
Note: Researchers may wish to consult Understanding Consent in Research Involving Children (Spriggs 2010) for additional guidance on this matter.
Yes
No Please use the textbox below to give your reasons.
*6.16 Please describe how participants (or those deciding for them) will be informed about the project and choose whether or not to participate.
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*6.17 If a participant (or person on behalf of a participant) chooses not to participate or to withdraw from the research, are there specific consequences they should be aware of prior to making these decisions?
No
Yes Please detail these consequences below.
*6.18 Is there a possibility that individual participants may be identifiable by others and thereby be exposed to risks?
No
Yes Please detail these circumstances below.
*6.19 Will participants at MQ/MUH receive any financial or other benefits as a result of participation?
See National Statement sections 2.2.9 (Coercion and pressure), and 2.2.10-2.2.11 (Reimbursing participants).
If the proposed research activity involves Aboriginal and Torres Strait Islander people, refer to Principle 11 of the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) Guidelines for Ethical Research in Australian Indigenous Studies (http://aiatsis.gov.au/research/ethical-research/guidelines-ethical-research-australian-indigenous-studies
No
Yes Please indicate the amount/benefit and the justification.
*6.20 Are you recruiting any participants who will be attending for the purposes of therapeutic care?
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No
Yes Please provide the details of this care.
*6.21 Do you intend to access stored samples/stored medical information of individual participants for this research project and/or future research projects?
No
Yes Please describe how consent will be obtained from these individuals (or those acting on their behalf).
*6.22 Will the results of the research have significance for the welfare of the participants?
No
Yes Please describe your plan for making this information available to the participants.
*6.23 Is there a possibility that the research will involve the disclosure of unlawful conduct or concealment of a crime by individuals or groups?
No Skip to Section 7.
Yes Please continue to complete the remainder of Section 6.
6.24 Will investigators/researchers have a legal duty to disclose any of that information?
No Skip to Section 7.
Yes Please describe how this legal duty will be managed.
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6.25 What steps, if any, will be taken to protect participants?
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SECTION 7: OTHER ETHICAL CONSIDERATIONS
7.1 In the case of participants at MQ/MUH for whom competence in English is not adequate for informed consent, what arrangements have been made to ensure comprehension of the Participant Information & Consent Form? (See National Statement 5.2.16 – Participants’ interests)
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SECTION 8: PRIVACY AND CONFIDENTIALITY
*8.1 Please describe the information that will be collected directly from participants at MQ/MUH. Be specific where appropriate.
*8.2 Please indicate all research personnel (i.e. listed in Section 2 of this form) and others (e.g. student supervisors) who—for the purposes of this research—will have authority to use or have access to the information. In addition, please describe the nature of the use or access for each person.
NATURE OF USE/ACCESS
Principal Investigator/Supervisor
Other Investigator (1)
Other Investigator (2)
Others (specify):
*8.3 Please indicate the information that will be stored at the completion of this project and the conditions under which they will be stored.
*8.4 Please specify the form in which results will be reported and communicated to participants.
*8.5 Who will be responsible for communicating the project results to participants?
Principal Investigator/Supervisor
Other Investigator (1)
Other Investigator (2)
Others (specify):
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SECTION 9: PROJECT-SPECIFIC DETAILS
*9.1 Please indicate whether or not the participants in your research at MQ/MUH will be involved in any physically invasive or potentially harmful procedures that have not already been detailed in your NEAF or the ethics application form?
More than one category may be applicable.
Yes No
a. clinical trial (different from what is detailed in your NEAF)
b. drug administration
c. needle insertion
d. electromagnetic stimulation
e. chiropractic manipulation
f. other (explain)
9.2 If you answered ‘Yes’ to any of the items in 9.1.1, please state the nature of the procedures, all the risks involved and, where appropriate, quantify these risks (e.g. probability of any adverse events).
All this information must be included in the Participant Information and Consent Forms (PICFs).
*9.3 Is the research at MQ/MUH targeting any particular ethnic or community group?
No Skip to Declaration by Principal Investigator.
Yes Please complete all of items beginning with 9.7.First, please indicate which group is/groups are being targeted.
9.4 Will recruitment for MQ/MUH be conducted in consultation with a representative of this group?
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No Please answer 9.5 then skip to Declaration by Principal Investigator.
Yes Skip to 9.6.
9.5 Please provide your reasons for not undertaking any consultation.
9.6 Who is/are the representative/s with whom you have consulted, and how do they represent this group?
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SECTION 10: DECLARATION BY PRINCIPAL INVESTIGATOR
*10.1 To the best of my belief the proposed project at MQ/MUH conforms in all respects with the National Statement on Ethical Conduct in Human Research.
Information about and links to legislation, guidelines and codes governing research with humans is available at:
http://www.research.mq.edu.au/current_research_staff/human_research_ethics/human_research_ethics_resources_and_training
Signature of Principal Investigator:
Name of Principal Investigator:(BLOCK LETTERS)
Date:/ /
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