SOP TABLE OF CONTENTS - Dalhousie University 2014-02-28 SOP TOC – titles only EMS Research Standard Operating Procedures (SOPs) Emergency Health Services EHS Operations Management

1 2014-02-28 SOP TOC – titles only

EMS Research Standard Operating Procedures (SOPs)

Emergency Health Services EHS Operations Management

Dalhousie University Division of EMS (Department of Emergency Medicine)

SOP TABLE OF CONTENTS

Number Name 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process 4 Research Ethics Board Approval 5 EHS Data Request for the Purpose of Research 6 Research Agreements – Collaborations 7 Research Funding and Grants 8 Responsibilities of the Principal Investigator 9 Departure of Principal Investigator from EHS/CDHA

10 Delegation of Study Duties 11 Obtaining Informed Consent in Clinical Trials 12 Obtaining Consent in Other Studies 13 Privacy and Confidentiality of Research Data 14 Retention of Research Records - Archiving of Research Study Documents 15 Conflict of Interest Management 16 External Audits of Research Studies

These research SOPs are adopted with permission from the CDHA Research Manual. Researchers are responsible to follow the policies and procedures of their research ethics board and research financial services departments. The most recent version of these SOPs may be found at: http://emergency.medicine.dal.ca/DivEMS.cfm

Page 1 of 3 NS EMS RESEARCH SOP 1

EMS Research Steering Committee

Nova Scotia EMS Research

Standard Operating Procedure

SOP #: 1 Title: Research Manual

Approval Date: 2013 05 01 Review Date: 2015 05 01 Revision Date:

Signature of Research Manual Sub-committee Chair:

POLICY

1. The EMS Research Steering Committee SOP sub-committee shall develop and maintain

a set of policies and procedures in a specialty policy manual called the Research

Manual.

2. All EMS research in Nova Scotia shall be conducted and administered in accordance

with the Research Manual.

PROCEDURE

1. RESEARCH MANUAL SUB-COMMITTEE MEMBERSHIP

a. The Research Manual Sub-Committee is a sub-committee of the EMS Research

Steering Committee (RSC).

i. Chair: EHS Medical Director of Research

ii. Members: EHS/EMC Research Leader, EHS Program Document

Coordinator

2. POLICY DEVELOPMENT OR REVISION



a. The Chair of the Research Manual sub-committee determines whether a

proposed policy/procedure is appropriate for inclusion in the Research Manual.

i. Suggestions for Research Manual SOPs can be made in writing by email

to the Chair of the Research Manual committee, or as an agenda item at

the RSC meetings.

b. The Research Manual sub-committee ensures that SOPs included in the

Research Manual adhere to all relevant EHS, EMC, Dalhousie, CDHA and other

relevant institution policies, procedures, and guidelines.

c. The Research Manual sub-committee provides the RSC with an opportunity to

review each draft SOP and provide input.

i. The SOP sub-committee chair forwards draft SOPs to the Dalhousie

University Administrative Assistant for forwarding to the RSC for review.

RSC members will provide feedback directly to the SOP committee chair.

3. POLICY IMPLEMENTATION

a. The EHS Program Document Coordinator will coordinate editing and version

control of each SOP in the Research Manual. The Research Manual sub-

committee chair will give final approval for each SOP.

b. The Dalhousie University Division of EMS Administrative Assistant will maintain

the most current versions of the Research Manual SOPs on the Dalhousie

Division of EMS website. Superseded or obsolete policies are removed and

archived. Links to this webpage may be made from other sites (such as EHS and

EMC), but the master copy will be maintained on the Dalhousie Division of EMS

website.

c. A notice will be posted on the Division of EMS website, alerting readers of an

updated or new SOP.

d. The Dalhousie Division of EMS administrative assistant will maintain one master

hard copy at the Division of EMS for reference and archiving, and may provide

hard copies, upon request, for those without computer access.

4. POLICY MAINTENANCE

a. The Research Manual sub-committee will review each SOP every 24 months.

Policies will also be revised as necessary.

5. POLICY COMPLIANCE

a. Those who wish to conduct EMS research in Nova Scotia are responsible to be

aware of the most current version of the Research Manual SOPs.

b. EMS study investigators are to ensure their staff and co-investigators are aware

of and comply with the Research Manual.

ABBREVIATIONS

1. SOPs: Standard Operating Procedures

2. RSC: EMS Research Steering Committee

3. EHS: Emergency Health Services



4. EMC: Emergency Medical Care, Inc.

5. CDHA: Capital District Health Authority

RELATED SOPs

1. SOP 2. EMS Research Steering Committee






SOP #: 2 Title: Research Steering Committee



POLICY

1. Representatives of relevant organizations shall regularly meet at the Emergency Medical

Services (EMS) Research Steering Committee to:

a. Review study protocols to evaluate their impact on the representatives'

respective organizations.

b. Discuss the study proposal at the next committee meeting or forward comments

to the Committee Chair.

c. Advise on prioritization of research projects competing for the same resources.

d. Promote prehospital research involving EMS and/or paramedics.

e. Provide feedback to investigators on their protocol and study plan.

PROCEDURE

1. The Steering Committee will meet the first Wed of every second month (see reference

2).

2. Submission of EMS Research Study Protocol



a. All proposed EMS research protocols must be submitted electronically to the

Division of EMS Research Administrative Assistant by the second Wednesday of

the month to be reviewed at the next meeting at [email protected]

b. Submission to the Research Steering Committee must occur prior to research

ethics board submission.

c. Submission to the Research Steering Committee should occur prior to

submission for a grant.

RELATED SOPs

1. SOP 3. EMS Study Review Process

RELATED DOCUMENTS

1. EMS Research Steering Committee Terms of Reference. March 2013. Available from:

http://emergency.medicine.dal.ca/divemsdocuments/Prehospital%20Steering%20Commi

ttee%20Terms%20of%20Reference%20June%2016-2010.pdf

mailto:[email protected]

http://emergency.medicine.dal.ca/divemsdocuments/Prehospital%20Steering%20Committee%20Terms%20of%20Reference%20June%2016-2010.pdf







SOP #: 3 Title: EMS Study Review Process



POLICY

1. The Emergency Medical Services (EMS) Research Steering Committee (RSC) shall

review all EMS research studies proposed to be conducted in Nova Scotia.

2. The purpose of the review is to provide feedback, identify resources required and

support that can be offered, and to determine impact on each organization.

PROCEDURE

1. STUDY SUBMISSION

a. The investigator and team will draft their research ethics submission and/or study

protocol

i. Every study conducted in the EMS (prehospital/out-of-hospital) setting

should be reviewed by the RSC prior to submission to a research grant

competition and/or to a research ethics board (REB).

ii. Submission should be made to the Dalhousie University Division of EMS

Administrative Assistant two weeks prior to the RSC meeting.

iii. Submission is to be made by email to: [email protected]

mailto:[email protected]



2. RSC MEETING

a. The RSC meets the first Wednesday of every second month.

b. Each RSC member organization is responsible to review the study for impact to

their organization, and to vet it through their organization within two weeks of

RSC meeting.

3. FEEDBACK AND LETTER(S) OF SUPPORT

a. RSC chair provides feedback back to investigator, and signed letters of support,

as required for ethics submission, grant submission or other required letters of

support.

i. For CDHA research ethics submission, the ‘Letter of Support for

Collaboration with EHS’ is required, and is to be signed by:

1. Director, Dalhousie Division of EMS

2. Medical Director of Research, Emergency Health Services

3. Director or Senior Manager, Emergency Medical Care, Inc.

4. RESEARCH OPERATIONS

a. If the proposed study may have impact on operations at EHS/EMC, a research

operations committee meeting will be convened.

5. ONGOING RESEARCH SUPPORT

a. Study progress will be monitored at the Division of EMS Steering Committee,

which meets the first Wednesday of every second month.

ABBREVIATIONS


2. REB: Research Ethics Board


4. EMC: Emergency Medical Care, Inc.

RELATED SOPs

1. SOP 2. EMS Research Steering Committee

RELATED DOCUMENTS

1. EMS Research Support Process Figure. Version 2012 06

2. EHS Program Document 16006.00. EHS Research Policy

3. CDHA Research Ethics Board Letter of Support for Collaborating with EHS. Available at:

http://www.cdha.nshealth.ca/discovery-innovation/documents

4. EMC Operations Policy 904 (under revision)






SOP #: 4 Title: Research Ethics Board Approval

Approval Date: 2013 07 24 Review Date: Revision Date:


DEFINITIONS

1. ETHICAL ACCEPTABILITY: The acceptability of a research project based on the

foreseeable risks, potential benefits and ethical implications associated with the

research.

2. RESEARCH ETHICS BOARD (REB): An established body consisting of researchers,

lawyers, community members and others, whose mandate under the Tri-Council Policy

Statement is to ensure the safety, rights and well-being of research participants, by

determining the ethical acceptability of all research involving human participants.

3. RESEARCH PARTICIPANT: An individual whose data, responses to interventions,

questions or stimuli are relevant to answering a research question.

POLICY

1. Every study conducted in the Nova Scotia EMS system must be approved by or granted

a waiver from an appropriate research ethics board (REB) prior to commencing.

a. Most EMS studies will use the Capital District Health Authority (CDHA) REB,

unless agreed upon by the EMS Research Steering Committee.

b. Studies approved at REBs outside of Nova Scotia may require review by a Nova

Scotian REB.



2. The role of the REB is to assess all research involving EMS patients, employees,

resources and data. The REB shall:

a. Review a study prior to commencement, deciding to approve or reject a study,

based on its ethical acceptability.

b. Review ongoing research for ethical acceptability.

c. Terminate or impose modifications to ongoing or proposed research based on its

ethical acceptability.

3. Activities such as quality improvement studies, program evaluation activities, and performance reviews or testing when used exclusively for assessment, management or improvement purposes does not constitute research, and therefore shall be excluded from the REB review process.

a. However, if those leading the project are interested to present their findings outside of EMS or publish their findings, or if they are unsure if their project is a study or not, they are to seek the advice of the REB. Obtain an answer in writing.

PROCEDURE

1. Determine if a proposed activity constitutes research that involves EHS participants (see

Policy point 3, above).

2. Confirm if the lead investigator meets the qualifications of an investigator, as per the

REB.

a. If not, a supervising investigator must oversee the conduct of the study and REB

submission.

3. Submit a research proposal to the appropriate REB for review.

4. The REB shall accept the submission, impose modifications or reject the study, based

on the study’s ethical acceptability. The REB shall also make a determination as to the

frequency and nature of continuing ethics reviews throughout the project.

5. A study may proceed only after the REB has granted approval. A researcher must abide

by all REB mandated guidelines.

6. If at any time during a study the research protocols change or unforeseen risks or

circumstances arise, the principal investigator is responsible for contacting the REB; and

communicating the change in writing.

a. The principal investigator is responsible for closely monitoring the ongoing safe

conduct of the study.

b. The REB may mandate the study have an independent data safety monitoring

board, to ensure ongoing safety of the study.



7. The REB must be notified in writing upon the conclusion of the study.

ABBREVIATIONS



3. EMS: Emergency Medical Services


RELATED SOPs

1. SOP 3. EMS Research Study Review Process

2. SOP 8. Responsibilities of the Principal Investigator

RELATED DOCUMENTS

REFERENCES

1. Canadian Institute of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010. Retrieved from: www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

2. Capital Health, Research Manual-Research Ethics and Board Jurisdiction, August 2012.

Retrieved from: http://policy.nshealth.ca/Site_Published/DHA9/PolicyManualView.aspx.

These research SOPs are adopted with permission from the CDHA Research Manual. Researchers are responsible to follow the policies and procedures of their research ethics board and research financial services departments. The most recent version of these SOPs may be found at: http://emergency.medicine.dal.ca/DivEMS.cfm Page 1 of 2 NS EMS RESEARCH SOP 5




SOP #: 5 Title: Request for Data for the Purpose of Research

Approval Date: 2013 05 23 Review Date: Revision Date: 2014 02 28


POLICY

1. All data requests must adhere to SOP 13. 2. All data requests will be reviewed and approved, based on their origin and purpose, as

outlined in EHS Research Request for EHS System Data Policy (Policy #2501). 3. EHS and/or EHS Operations Management may recover costs associated with requests

by charging a fee to the requester, as approved by the EHS Executive Director on a case by case basis.

PROCEDURE

1. All information requests will be submitted to the EHS Secretariat using the Request for Data form (Appendix A).

2. Research Data Requests Approval • All research must be reviewed by the EMS Research Steering Committee (RSC). • After feedback has been provided to the investigator from the RSC, the request

must be submitted to EHS. • EHS will review and approve the data request.


3. Once approved, EHS will provide the investigator with an estimate of the time to complete the request.

4. Data requests will be prioritized based on multiple factors, including: [1] date of receipt, [2] resources required for the request and other requests in the queue, and [3] urgency of the request.

5. Once the data request is completed, EHS will provide the data to the requestor in a secure manner acceptable to provincial and research ethics guidelines.

• Unsecure email transfer of data is not acceptable.

ABBREVIATIONS

1. SOPs: Standard Operating Procedures 2. EHS: Emergency Health Services

RELATED SOPs

1. SOP 13. Privacy and Confidentiality of Research Data

RELATED DOCUMENTS

1. EHS Research Policy (#2500) 2. EHS Research Request for EHS System Data Policy (Policy #2501) 3. EHS Confidentiality of Patient Information Policy (Policy #2200) 4. SOP Research Steering Committee 5. Research Steering Committee TOR

APPENDIX

1. EHS Research Request for Data form (attached) 2. EHS Policy 2501 (attached)






SOP #: 6 Title: Research Collaboration Agreements



DEFINITIONS

1. COLLABORATOR: The EHS system (EHS, EHS Operations Management and affiliates)

is considered a research collaborator when a request is made of EHS to contribute data,

access to patients, staff or other resources for the purposes of completing a study.

2. RESEARCH COLLABORATION AGREEMENT: A written agreement between EHS

and/or EHS Operations Management and the PI (or designate) detailing the services

required, volume required, the expected date of completion and reimbursement required

for these services, as applicable.

3. RESEARCH ETHICS LETTER OF SUPPORT: A letter of support provided to the

investigator for the purpose of submission to a research ethics board. The purpose of

this letter is to demonstrate EHS, EHS Operations Management and the Dalhousie

University Division of EMS agree to participate in the conduct of the study. Support from

all three organizations must be confirmed in writing.

POLICY



1. For all studies in which EHS and EHS Operations Management are collaborators, a

research agreement is to be written, agreed upon and signed by the Principal

Investigator and signed by the appropriate signatories of the EMS RSC.

a. A letter of support for research ethics may suffice for this purpose. This will be

determined by the RSC.

b. If a REB letter of support is not sufficient (e.g., if a charge will be passed on to

the investigator), a separate research agreement is required.

c. This letter will be approved and signed by the PI (or designate) and appropriate

EHS/EHS Operations Management signatories prior to the initiation of the study.

PROCEDURE

1. The PI or appropriate designate will submit the study proposal for Research Steering

Committee (RSC) review (SOP 3).

2. The RSC will determine if letter of support for research ethics will suffice, or if a specific

research agreement is warranted.

a. EHS and EHS Operations Management representatives on the RSC will consult

with their organizations as necessary on this decision.

3. If a separate research collaboration agreement is required, the following steps will be

followed:

a. Once the research agreement is drafted, it will be forwarded to EHS and EHS

Operations Management Senior Leadership for review and approval.

b. Once signed by EHS and EHS Operations Management, the agreement is sent

to the PI for signature.

c. All parties retain a copy of the fully executed research agreement for their

records.

4. Repeat steps a-d if amendments are required.

ABBREVIATIONS

1. PI: Principal Investigator




RELATED SOPs


2. SOP 4. Research Ethics Board Approval

3. SOP 5. EHS Data Request for the Purpose of Research

RELATED DOCUMENTS



1. EHS Request for EHS System Data Policy (Policy #1009).

2. EHS Confidentiality of Patient Information Policy (Policy #1010)

3. CDHA REB EHS Letter of Support. Retrieved from:


REFERENCES

2nd Edition of the Tri-Council Policy Statement: Ethical Conduct of Research

Involving Humans (TCPS 2, 2010)

CDHA Research Manual, Policy and Procedure RS 01-003. Research Agreements

December 2012.

http://policy.nshealth.ca/Site_Published/dha9/document_render.aspx?documentRen

der.IdType=6&documentRender.GenericField=&documentRender.Id=42938

CDHA Research Manual, Policy and Procedure RS 01-005. Hospital Service

Agreements August 2012.

http://policy.nshealth.ca/Site_Published/dha9/document_render.aspx?documentRen

der.IdType=6&documentRender.GenericField=&documentRender.Id=37282






SOP #: 7 Title: Research Funding and Grants



DEFINITIONS

1. DIRECT COSTS: Costs directly associated with a research project (e.g., salaries, tests,

procedures, consumables, equipment)

2. OVERHEAD COSTS: Expenditures incurred by the institution where the research is

conducted (and account is held) which are not readily identifiable as direct expenses of a

particular study.

3. FUNDING AGENCY: an agency that provides financial support for a research study.

May include, by is not limited to, the study sponsor or a granting agency.

4. SPONSOR: an individual, company, institution or organization that initiates, manages,

has regulatory responsibility for (if applicable), and may fund (in whole or in part) a

research study.

POLICY

1. Submissions for research grants should be reviewed by the EMS RSC prior to

submission for the grant competition.

2. Research grants cannot be held in a private, business or government bank account.

They must be deposited into a research account at a university or health authority. For

most NS EMS research studies, this will be Dalhousie University or CDHA.



3. The principal investigator (or supervising investigator), and ultimately his or her

department or division head at the university or health authority is ultimately responsible

for research accounts.

4. In general, research accounts should not be permitted to run a deficit. Policies at the

institution holding the account should be consulted.

5. Institutions holding research accounts may charge for overhead costs, which should be

budgeted into research grant application budgets. Policies at the institution holding the

account should be consulted.

6. The PI must understand the regulations for the grant, including what is acceptable

expenditures.

PROCEDURE

1. Responsible investigators are to consult the procedures of the institution in which their

research grant will be deposited.

ABBREVIATIONS



RELATED SOPs



RELATED DOCUMENTS

1. CDHA RS 01-006. Overhead Costs for Research

2. CDHA RS 01-009 General Research Accounts

3. CDHA RS 01-008 Research Account Deficits



REFERENCES

CDHA Research Manual, Policy and Procedure RS 01-006. Overhead Costs for

Research. October 2011.

http://policy.nshealth.ca/Site_Published/DHA9/document_render.aspx?documentRe

nder.IdType=6&documentRender.GenericField=&documentRender.Id=42995

CDHA Research Manual, Policy and Procedure RS 01-008. Research Account

Deficits. June 2011.



CDHA Research Manual, Policy and Procedure RS 01-009. General Research

Accounts. June 2011.



http://policy.nshealth.ca/Site_Published/DHA9/document_render.aspx?documentRender.IdType=6&documentRender.GenericField=&documentRender.Id=42995






Responsibility of the Principal Investigator



SOP #: 8 Title: Responsibilities of the Principal Investigator



DEFINITIONS

1. ETHICAL ACCEPTABILITY: The acceptability of a research project based on the study’s

foreseeable risks, potential benefits and ethical implications.

2. RESEACH ETHICS BOARD (REB): An established body consisting of researchers,

lawyers, community members and others, whose mandate is to ensure the safety, rights

and well-being of research participants, through the reviewing the ethical acceptability of

all EHS research involving human participants.

3. PRINCPAL INVESTIGATOR: The researcher who holds overall accountability for a

research project at a study site. The PI is responsible for the delegation of research

tasks and holds final decision making ability in a team research environment.

4. INFORMED CONSENT: A process in which an individual consents to participation in a

research study after they have been provided all relevant information pertaining to their

participation in the study.

5. INVESTIGATIONAL PRODUCT: A pharmaceutical form of an active ingredient, a

genetic, biologic, or natural health product, a medical device, or a placebo being

tested or used as a reference in a clinical trial.



6. RESEARCH PARTICIPANT: An individual whose data, responses to interventions,

questions or stimuli are relevant to answering the research question posed by a

researcher.

7. RESEARCH TEAM: The group of researchers headed by the principal investigator(s)

who are responsible for conducting a research project.

8. STUDY PROTOCOL: A document that denotes the objectives, design, and methodology

of a research project.

9. SUBINVESTIGATOR: A researcher who is recruited to a research project to assist in

tasks as delegated by the principal investigator.

10. SUPERVISING INVESTIGATOR: If the principal investigator is a trainee, student or

does not have sufficient credentials (according to the REB), a supervising investigator

with these credentials is required to oversee the study.

POLICY

1. All EHS research projects are to be overseen by a principal investigator (PI). A research

study shall only have one PI per study and/or research site. For clinical trials, the PI is to

be designated as the qualified investigator.

2. The PI has overall accountability of a study. Although specific research tasks may be

delegated to members of a research team, overall clinical, ethical, scientific, financial

and administrative conduct, as well as the upholding of patients’ rights and safety is to

be the final responsibility of the PI.

3. A principal investigator must:

a. Have suitable credentials; including education, training and experience to

assume responsibility of a research project.

b. Determine resource requirements and study feasibility prior to the

commencement of a study.

c. Ensure a study receives initial Research Ethics Board (REB) approval and

provide continuing documentation to the REB as per REB mandates.

d. Ensure that the rights and welfare of research participants are upheld.

e. Assure the integrity, security and validity of data.

f. Assure proper administrative and research related documentation is recorded.

g. Coordinate and delegate research among the research team (if applicable)

h. Provide, in conjunction with the EHS Provincial Medical Director (PMD),

oversight for all trial-related clinical and medical decisions. The ultimate clinical

oversight of care in EHS lies with the EHS PMD.

i. Provide oversight of the research project and manage the research protocol.

j. Assure the proper use and storage of investigational products (if applicable).



BACKGROUND

1. Credentials

a. The principal investigator is to:

i. Ensure that he/she has the education, training and experience

requirements to lead a study as per EHS research guidelines.

ii. Have knowledge of and abide by EHS research standard operating

procedures (SOPs), ethical procedures and regulatory mandates.

iii. Maintain a current Curriculum Vitae.

iv. Maintain a current licence to practice (if applicable).

2. Determination of Feasibility and Resources

a. Prior to the commencement of a study the Principal Investigator is to:

i. Design a study protocol and assess study feasibility

ii. Consider the ethical acceptability of the study

iii. Determine if the time frame and sample size/distribution requirements of

the study are attainable and reasonable.

iv. Determine if the data to be collected will answer the study question

v. Determine if additional assistance are required to conduct the study

vi. Ensure safeguards are in place as per EMS research SOPs to protect the

security and validity of the data as it is collected and stored.

vii. Determine the study budget and ensure that funding is in place is to

support the study.

3. Communication with the appropriate Research Ethics Board

a. A principal investigator is to:

i. Provide a research proposal and all requested documents to the EMS

Research Steering Committee prior to the commencement of a study.

ii. Provide a research proposal and all requested documents to the

appropriate REB prior to the commencement of a study.

iii. Provide continued documentation to the REB as per their request.

iv. Notify the REB in writing if there is a change in the study protocol, or if an

unforeseen risk or circumstance arises.

v. Notify the REB in writing upon the conclusion of the study.

1. If applicable, indicate any long term risks arising from the study

and if the unblinding of results is occurring.

vi. Follow all REB mandated actions, recommendations and directives.

4. Assure patient welfare and rights are maintained




i. Ensure that free and informed consent as per EHS policy is obtained prior

to participant enrolment in a study or the use of personal health

information occurs.

ii. Ensure ongoing consent is obtained (if applicable).

iii. Ensure that a participant’s rights, safety and well-being are paramount to

research objectives.

iv. Ensure that participant confidentiality is maintained through the use of

appropriate security measures as per REB guidelines and EMS research

SOPs.

v. Report all study related adverse effects to the REB as per REB

guidelines.

vi. Report all unusual clinical or operational occurrences to the EMS

Research Steering Committee.

5. Assure Data integrity, security and validity


i. Ensure that collected data is stored in a secure manner as per EMS

SOPs and provincially legislated guidelines.

ii. Ensure that research equipment is correctly functioning and calibrated

and/or that surveys and other means of data measurement are accurate,

timely and free of potential bias.

iii. Conduct data checks (or delegate checks to a sub-investigator) to ensure

that collected data is complete, accurate, timely and free of potential bias.

6. Documentation


i. Ensure that research related documents are properly collected and

stored.

ii. Ensure that administrative documents showing the allocation of funds and

budgeting are developed and retained.

iii. Ensure that all documentation is stored at the conclusion of a research

project as per EHS guidelines.

iv. Ensure that the research roles and responsibilities of principal and sub-

investigators (if applicable) are documented and retained.

7. Coordinate Research (if applicable)


i. Determine if the credentials of potential sub-investigators are suitable to

conduct research as per REB guidelines.

ii. Allocate research tasks and objectives to sub-investigators that are within

their scope.



iii. Share data or information with sub-investigators that is relevant to the

research study.

iv. Assume overall responsibility for the actions of sub-investigators when

they are correctly following study protocol and following EHS research

policy and procedures.

8. Provide, in conjunction with the EHS PMD, oversight for all trial-related clinical and

medical decisions. The ultimate clinical oversight of care in EHS lies with the EHS PMD.


i. Ensure that all study related clinical/medical interventions and decisions

are performed by qualified clinicians.

ii. Ensure that appropriate clinical care is provided to individuals who

experience adverse events.

iii. Ensure that follow-up of enrolled participants occurs (if applicable).

iv. Ensure that EHS front-line staff make receiving hospital staff aware of the

individual’s participation in the research study, to ensure that appropriate

care is provided (if applicable).

1. The PI should ensure hospitals that will receive patients enrolled

in an EMS study are aware of the details of the study.

9. Provide oversight and ensure compliance with study protocol.


i. Maintain an understanding of the study protocol and ensure that he/she

adheres to the protocol at all times.

ii. Ensure that sub-investigators are aware of the study protocol and adhere

to the protocol at all times. (if applicable)

iii. Advise the REB and any sub-investigators if there is a change to the

study protocol.

10. Assure the proper use and storage of investigational products (if applicable).

a. The Principal investigator is to:

i. Be knowledgeable in the proper use of the investigational product.

ii. Ensure that clinicians handling the investigational products are aware of

how to properly store, handle and administer (if applicable) the product.

ABBREVIATIONS







5. PMD: EHS Provincial Medical Director

RELATED SOPs



3. SOP 11. Obtaining Informed Consent in Clinical Trials

4. SOP 12. Obtaining Informed Consent in Other Studies

RELATED DOCUMENTS

REFERENCES

1. Canadian Institute of Health Research, Natural Sciences and Engineering Research

Council of Canada, and Social Sciences and Humanities Research Council of

Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving

Humans, December 2010. Retrieved from:

www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

2. Capital Health, Research Manual- Responsibilities of the Principal Investigator, May

2007. Retrieved from:

http://policy.nshealth.ca/Site_Published/DHA9/PolicyManualView.aspx

3. Health Canada. ICH Guidance E6: Guideline for Good Clinical Practice. (2004).

Retrieved from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-

ld/ich/efficac/e6-eng.php.






SOP #: 9 Title: Departure of Principal Investigator from EHS/CDHA



DEFINITIONS

1. PRINCIPAL INVESTIGATOR: The researcher who holds overall accountability for a

research project. The PI is responsible for the delegation of research tasks and holds

final decision making ability in a team research environment.

2. SPONSOR: An individual, company, institution, or organization which takes

responsibility for the initiation, management, and/or financing of a research project.

POLICY

1. A principal investigator (PI) must transfer their responsibilities to another investigator if

they intend to leave the organization(s) and/or are no longer able or willing to act as a PI

for a study.

2. The departing PI shall be responsible for locating a qualified replacement PI.

3. The departing and incoming PIs must inform the REB, EMS RSC and any sponsors in

writing.

4. The PI remains accountable for the study until a replacement PI is in place.



PROCEDURE

1. The departing PI shall:

a. Identify a qualified PI to replace him/her and ensure they agree to become PI for

the study or studies.

b. Complete any relevant documentation absolving him/her of legal, ethical and

financial responsibility for the project.

c. Inform the REB and EMS RSC in writing of the change in study personnel roles.

d. Ensure that all REB documentation and study planning documents are given to

the incoming PI.

e. Ensure that any stored or collected data be transferred to an incoming PI.

f. Follow intellectual property (SOP #17) policy if he/she wishes to retain intellectual

rights associated with the research material.

2. If the PI is requesting to relinquish responsibility due to a medical leave or leave of

absence, the PI shall indicate the expected length of their leave to determine if the study

can be resumed when the PI returns from leave.

3. If the PI is requesting to remain part of the study but no longer wishes to act as a PI the

departing PI shall remain PI until a suitable replacement can be found.

4. If the study has a supervising investigator, they may become PI, or seek a replacement

PI.

5. Research Grants and Accounts

a. The PI must contact the granting agency and institution administering the

funds to determine if a grant can be transferred to another PI.

ABBREVIATIONS




4. RSC: Research Steering Committee

RELATED SOPs


2. SOP 10. Delegation of Study Duties

3. SOP 17. Intellectual Property



RELATED DOCUMENTS

REFERENCES

1. Capital Health, Research Manual- Intellectual Property, June, 2005. Retrieved from:



Page 1 of 3 NS EMS SOP 10 DELEGATION OF STUDY DUTIES0




SOP #: 10 Title: Delegation of Study Duties



DEFINITIONS

1. DELEGATION LOG: A record of the research tasks delegated to investigators or others

during the course of a research project.

2. PRINCIPAL INVESTIGATOR: The person responsible for the conduct of an EMS

research study.

3. RESEARCH ETHICS BOARD: An established body consisting of researchers,

clinicians, lawyers, community members and others, whose mandate is to ensure the

safety, rights and well-being of research participants, by determining the ethical

acceptability of all EHS research involving human participants.

4. RESEARCH SITE: The location(s) where study-related activities are conducted.

5. SPONSOR: An individual, company, institution, or organization which takes

responsibility for the initiation, management, and/or financing of a research project.

6. SUB-INVESTIGATOR: A researcher who is recruited to a research project to assist in

tasks as delegated by the principal investigator.



POLICY

1. A principal investigator (PI) may delegate study duties to sub-investigators or other study

personnel as deemed necessary. When establishing and conducting a study involving

sub-investigator(s) and the delegation of study duties, a PI must:

a. Ensure that a sub-investigator has the appropriate qualifications, including

education, training and experience to assume responsibility of delegated tasks

within a research project.

b. Document the delegation of study tasks before beginning a study through the

completion of a delegation log.

c. Provide ongoing documentation updated throughout the course of the research

project and properly archive documentation at the conclusion of the study.

d. Remain cognizant that regardless of the delegation of tasks, the overall research

project accountability remains the responsibility of the PI.

PROCEDURE

1. After initial REB approval and the determination that assistance will be required to

complete the research project, the PI is to:

a. Develop a delegation log to keep track of responsibilities. The delegation log can

take any format but shall at minimum include the following:

i. The principal investigator’s name, location and organization.

ii. The research centre, site number or EHS bases from which a study is to

be conducted (if applicable).

iii. The study name/ number

iv. The sponsor’s name (If applicable).

v. The names of all sub-investigators involved in the study.

vi. The responsibilities of all investigators in the project, including all

procedures outlined in the REB approved protocol.

vii. It is good practice in all studies, and may be required in some studies, to document the following:

a. Start dates of the delegation (the date of full REB study approval or the date the person became involved with the study, unless otherwise specified).

b. A signature provided by all investigators recognizing that they have read the REB approved protocols, and understand their delegated tasks and responsibilities within the research project.

c. A signature or initials provided by the PI to authorize each entry. d. Record stop dates of the delegation of tasks for persons who

cease to be involved with the study. b. Ensure the delegation log remains complete, accurate, and up to date.

2. It is also good practice in all studies, and may be required in some studies, to document

the following at the conclusion of the study:



a. Ensure that stop dates of the delegation are recorded for each person listed; b. Verify, sign, and date the log; c. Archive the original log with other study documents as per REB requirements.

ABBREVIATIONS




RELATED SOPs



RELATED DOCUMENTS

REFERENCES

1. Capital Health, Research Manual-Delegation of Study Duties, May 2007. Retrieved

from: http://policy.nshealth.ca/Site_Published/DHA9/PolicyManualView.aspx

2. Canadian Institute of Health Research, Natural Sciences and Engineering Research

Council of Canada, and Social Sciences and Humanities Research Council of Canada,

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans,

December 2010. Retrieved from:

www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf


http://www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf






SOP #: 11 Title: Obtaining Informed Consent in Clinical Trials



DEFINITIONS

1. CLINICAL TRIAL: Any research study that prospectively assigns human participants or

groups of humans to one or more health-related interventions to evaluate the effects on

health outcomes. Interventions include but are not restricted to: drugs, cells and other

biological products, surgical procedures, radiologic procedures, devices, behavioural

treatments, process-of-care changes, preventive care, etc. This definition includes

Phase I to Phase IV trials.

2. INFORMED CONSENT: A process by which a participant voluntarily confirms his/her

willingness to participate in a particular trial, after having been informed of all aspects of

the trial that are relevant to the participant’s decision to participate. Informed consent is

documented by means of a written, signed and dated Informed Consent Form (ICF).

3. SPONSOR: An individual, company, institution or organization which takes responsibility

for the initiation, management and/or financing of a clinical trial.

4. PARTICIPANT: An individual who participates in a clinical trial, either as a recipient of

the investigational product(s) or as a control.



BACKGROUND

1. This standard operating procedure describes the procedure for obtaining free, written informed consent from each participant (or his/her representative) prior to their participation in an EMS clinical study.

2. Obtaining consent is a process involving dialogue between the research investigators, research staff, clinicians and research participants. Effective communication is the key to enabling participants to make informed decisions about participation in a research study.

3. Written informed consent will always be obtained before any study-related procedures are undertaken, unless permission is given by an REB for an alternate form of consent.

PROCEDURE

1. RESPONSIBLE PERSONNEL

a. Consent must only be obtained by persons who possess the knowledge

necessary to adequately present the pertinent risks, benefits, and alternative

treatments, and who have been assigned this task on the delegation and

signature list / log.

b. Any research team member obtaining consent must be fully informed and familiar

with the entire contents of the consent form.

c. The Principal Investigator, Co-Investigators, and study coordinators are usually

involved in obtaining informed consent. The study coordinators must be well

trained and under the supervision of the investigator. In some studies, the

clinicians (e.g., EHS paramedics) may be delegated to obtain informed consent.

2. INFORMED CONSENT TRAINING

a. EHS staff who will be required to obtain informed consent from EHS patients who

may become study participants must receive specific training on this. Successful

completion of the training will be documented and only those who have

completed the training will obtain informed consent.

3. DRAFT THE INFORMED CONSENT FORM AND OBTAIN SPONSOR AND REB

APPROVAL

a. In some circumstances, the REB may approve the use of a short-form ICF (with

later follow-up with standard ICF), verbal assent for consent or waiver for the

need for consent.

4. OBTAINING CONSENT IN SPECIAL CIRCUMSTANCES

a. The research protocol should describe how arrangements for any special

requirements such as translation services or large print consent forms will be

made available.

b. In certain acute circumstances, an abbreviated consent will first be obtained.

c. The researcher should consult with the REB for further guidance if he/she is

unsure about any specific circumstances related to obtaining informed. Consent.



5. CONSENT IN EMERGENCY SITUATIONS

a. As per section 4.8.15 of ICH GCP guidelines, in emergency situations when prior

consent of the participant is not possible, the consent of the participant’s legally

acceptable representative, if present, should be requested prior to enrollment.

b. When neither prior consent from the participant nor consent from the participant’s

legal representative is not possible, enrollment of the participant should require

measures described in the protocol and/or elsewhere, with documented approval

of the REB.

c. This may be in the form of verbal assent or waiver for the need for informed

consent.

d. The REB may approve an exception to the requirement for informed consent, if

all stipulations of Article 3.8 of the TCPS are fulfilled (Chapter 3B) (2).

e. The participant or the participant’s legally acceptable representative should be

informed about the trial as soon as possible and consent to continue and other

consent obtained as appropriate.

6. DOCUMENTATION OF THE INFORMED CONSENT PROCESS

a. The PI and the study research coordinator are responsible for the documentation

of the Informed consent process.

b. The Informed consent form will be stored with the study documents. The

research protocol should explicitly state how this documentation will be

transferred from the EHS staff to the research staff.

PROCEDURE

1. RESPONSIBLE PERSONNEL

a. Document who is responsible for obtaining informed consent on the study

delegation log. In the case where the paramedics are obtaining consent, the EHS

site investigator should be named on the delegation log, and a list kept of all of

the trained paramedics who are conducting the consent process.

2. INFORMED CONSENT TRAINING

a. Training for EHS staff should include a review the ICH GCP guidelines for

informed consent, and specific training on obtaining consent for the particular

study, in accordance to the REB-approved study protocol.

b. The research coordinator will record documentation of training in a training binder

on a yearly basis.

3. DRAFT THE INFORMED CONSENT FORM AND OBTAIN SPONSOR AND REB

APPROVAL

a. Draft the informed consent form (ICF) as per the relevant REB’s policies,

procedures, and templates. Ensure that the ICF accurately reflects the protocol

and contains all required elements, and that it is written in language that is

understandable to research participants.



b. Submit the draft ICF to the sponsor for approval, if applicable.

c. Prior to submitting the ICF and associated information to the REB, the Principal

Investigator reviews the information and signs the appropriate forms.

d. Submit the sponsor-approved ICF to the REB for review. If revisions are

required, ensure that the changes are acceptable to the sponsor before

submitting the revised ICF to the REB.

e. Send a copy of the approved ICF and documentation of REB approval to the

sponsor, if applicable.

f. Maintain the approved ICF and associated REB documentation in the study files.

4. OBTAIN INFORMED CONSENT FROM RESEARCH PARTICIPANTS

a. Identify potential study participants and assess inclusion and exclusion criteria.

Please refer to the REB-approved research protocol for complete description of

this procedure.

b. Ensure that the person obtaining informed consent has been assigned this task

on the delegation log. If a large group of clinicians are obtaining consent or the

initial consent, it is acceptable to list the person responsible (investigator) on the

delegation log. Document the training each clinician received with date, EHS

registration number and signature on the training log.

c. Ensure that informed consent is obtained before initiating any study-related

procedures.

d. Verify that the most recent REB-approved version of the ICF is used to obtain

consent.

e. When possible, ensure that there is ample time to conduct the informed consent

process and that the informed consent is obtained in an appropriate setting.

f. A verbal explanation and overview of the study using non-technical language is

usually first provided by the study coordinator, the investigator or their delegate.

At the end of the explanation and prior to the actual reading of the consent form,

the participant’s initial reaction is evaluated.

g. Ensure that prospective participants are aware that their involvement in the study

is completely voluntary and they are free to withdraw at any time without

repercussions.

h. Inform the prospective study participant about all aspects of the study. Review

the entire informed consent document with the participant.

i. Provide the participant with ample time to ask any question relevant to make

his/her decision to participate in the study. Answer all relevant questions and

concerns. Provide the participant with a copy of the ICF for further review.

j. Verify the participant understands the study by using open-ended questions. For

example: What is the purpose of the research? What are the risks? What are

the benefits? Provide additional clarification until you and the participant are

satisfied with their level of understanding. If this cannot be achieved, then

discontinue the consent process.



k. If the participant agrees to participate in the study, ask the participant to sign and

date the consent form.

l. The consent form is signed and dated by the medically qualified person who

provided the information, by the participant and by a witness.

m. The Research Coordinator verifies that all signature and date lines are complete.

n. Provide the participant with a photocopy of the signed informed consent form

prior to their participation in the study. The original copy is filed with the

participant’s other study related information (Note: If necessary, the ICF can be

copied prior to the investigator’s signature). Distribute any other copies as

required.

5. OBTAINING CONSENT IN SPECIAL CIRCUMSTANCES

a. If a potential study participant or their substitute decision maker is unable to read,

an impartial witness must be present during the entire informed consent

discussion. Refer to ICH GCP article 4.8.9.

b. If a potential study participant is not capable of providing informed consent then

consent must be obtained from their substitute decision maker.

c. The investigator should notify the REB if there are any exceptions,

inconsistencies or irregularities discovered with the consent process.

6. DOCUMENTATION OF THE INFORMED CONSENT PROCESS

a. EHS staff who obtain informed consent should document the following in the

narrative section of their participant care report:

i. Who participated in the consent discussion;

ii. If capacity to provide informed consent is in question, document the

circumstances and the involvement of any third parties;

iii. Whether the participant (and/or their representative) demonstrated

understanding of the study;

iv. All questions / concerns expressed by the participant (and/or their

representative) and whether they were addressed to their satisfaction;

v. Whether consent was obtained prior to initiating any study procedures,

and whether the participant (and/or their representative) was given a copy

of the signed ICF.

1. Note: It is good practice to record the dates and times that the

participant signed the ICF; received a copy of the signed ICF; and

began the first study procedure.

vi. Any exceptions, inconsistencies, or irregularities with the consent

process.

ABBREVIATIONS

1. ICF: Informed Consent Form 2. REB: Research Ethics Board 3. EHS: Emergency Health Services




RELATED SOPs

1. SOP 4. Research Ethics Board Approval 2. SOP 8. Responsibilities of the Principal Investigator 3. SOP 10. Delegation of Study Duties

RELATED DOCUMENTS

4. CDHA REB Guidelines for Consent Form Preparation and Use. 5. EMC Operations Policy 112. Completion of Patient Care Record 6. EHS Policy 6180. Medical Responsibilities of Paramedics 7. CDHA Research Policy. Delegation of Study Duties. RS-03-002. 8. CDHA. Definitions Used in Research Policies. July 29, 2012.

REFERENCES

1. World Health Organization 2. International Conference on Harmonization (2008) E6: Guideline for Good Clinical

Practice 3. International Conference on Harmonization (2008) E8: General Considerations for

Clinical Trials 4. Tri-council Policy Statement 2. Chapter 3, Article 3.8 (2010) 5. Health Canada. Division 5. Drugs for Clinical Trials Involving Human Subjects (2001).






SOP #: 12 Title: Obtaining Consent in Other Studies



DEFINITIONS

1. INFORMED CONSENT: A process by which a participant voluntarily confirms his/her

willingness to participate in a particular study, after having been informed of all aspects

of the study that are relevant to the participant’s decision to participate. Informed

consent is documented by means of a written, signed and dated Informed Consent Form

(ICF).

2. WAIVER OF INFORMED CONSENT: A research ethics board may waive the

requirement for researchers to obtain informed consent, following the requirements set

out in the Tri-Council Policy Statement 2.

3. PARTICIPANT: An individual who participates in a study, such as a patient or staff

member. Those individuals whose data, or responses to interventions, stimuli or

questions by the researcher, are relevant to answering the research question.

4. HUMAN RESEARCH: an undertaking (i.e., study) intended to extend knowledge through

a disciplined inquiry or systematic investigation that involves living human participants or

their biological materials.



5. IMPRACTICABILTY: Defined by the Personal Health Information Act (PHIA) as a

situation in which obtaining informed consent for a study is a “degree of difficulty higher

than inconvenience or impracticality but lower than impossibility.” (4)

POLICY

1. In all EMS research studies, research ethics board review (REB) and approval must be

obtained prior to enrolling participants, collecting data or screening participants for study

inclusion.

2. For consent to be informed, the following three principles must be adhered to:

a. Consent must be given voluntarily. Care must be taken to ensure the participant

is not under undue influence to participate in the study.

b. Consent must be informed. Full information must be provided to the participant

for them to make an informed decision about whether to participate.

c. Consent shall be an ongoing process. Researchers have a duty to inform

participants with all information relevant to their ongoing consent and

participation.

3. Informed consent should be obtained from participants prior to enrolment in a study or

the utilization personal health information for recruitment purposes.

4. In certain studies the need to obtain informed consent for screening or enrolment may

be waived.

a. Waiving of informed consent must be approved by a relevant REB who shall

determine that obtaining consent is either not necessary due to the nature of the

study or is impracticable based on the design of the study and /or population

being examined.

b. The REB may designate informed consent impracticable when:

i. The size of the study population makes obtaining informed consent from

every individual impracticable.

ii. A large proportion of the study population may have died or relocated

since the data were collected.

iii. There is a potential for introducing bias by obtaining informed consent, or

the process of obtaining informed consent will create hardship or burden

on the researcher or organization to the point that the research could not

be performed.

c. Under all circumstances obtaining informed consent shall only be waived after

the REB review and approval. For a study to proceed without informed consent,

the REB must determine that the benefits of the study outweigh the risk of

personal harm or infringement of the individual’s right to privacy and

confidentiality.

d. All data collection shall be in accordance with the REB approved protocols and

abide by all provincial and federal privacy and confidentially guidelines.



PROCEDURE

1. The research protocol and/or ethics submission documents will be reviewed by the EMS

RSC (as per SOP 4).

2. If informed consent is required for the study, the PI or designate must conduct a

discussion with the participant about the study and obtain informed consent prior to

enrolling the participant or collecting data.

3. If the need for informed consent is waived, the REB should provide the PI a letter

confirming this.

ABBREVIATIONS




4. RSC: Research Steering Committee

RELATED SOPs

1. SOP 4: Research Ethics Board Approval

2. SOP 11: Obtaining Informed Consent in Clinical Trials

RELATED DOCUMENTS

1. EHS Request for EHS System Data Policy (1009.00)

2. EHS Confidentiality of Patient Information Policy (Policy #1010)

3. SOP Research Steering Committee

4. Research Steering Committee TOR

REFERENCES

1. TCPS 2, Chapter 2. Scope and Approach. Retrieved from:

http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

2. TCPS 2, Chapter 3. The Consent Process. Retrieved from:


3. CDHA. Consent Preparation and Use. 2006 Retrieved from:

http://www.cdha.nshealth.ca/discovery-innovation/research-ethics

4. Toolkit for Custodians: A Guide to the Personal Health Information Act. 2012. Retrieved

from www.novascotia.ca/dhw/phia/documents/PHIA-complete-toolkit.pdf



http://www.cdha.nshealth.ca/discovery-innovation/research-ethics

http://www.novascotia.ca/dhw/phia/documents/PHIA-complete-toolkit.pdf





SOP #: 13 Title: Privacy and Confidentiality of Research Data

Approval Date: Review Date: Revision Date:


DEFINITIONS

REQUESTOR: a person making a request for data to EHS, for the purpose of conducting a research study.

POLICY

1. The EMS Research Steering Committee (RSC) is committed to maintaining patient confidentiality at all times, and in accordance with institutional, provincial and national regulations.

2. Researchers should be familiar with the Personal Health Information Act (Nova Scotia, 2013) and how it impacts their study.

3. All research data should be handled in accordance with the EHS Confidentiality and Privacy policies.

4. All research data will be stored in accordance with SOP 14: Retention of Research Records.

PROCEDURE


1. The Requestor must sign the “declaration of confidentiality” portion of the Data Request Form prior to having their information request processed. See SOP 5: Request for Data for the Purpose of Research.

2. Requestors must maintain patient confidentiality. 3. Requestors must manage, store, retain and destroy data and records in accordance to

SOP 14 and institutional, provincial and federal regulations.

ABBREVIATIONS

1. SOPs: Standard Operating Procedures 2. EHS: Emergency Health Services 3. FOIPOP Act: Freedom of Information and Protection of Privacy Act 4. PHIA: Personal Health Information Act 5. DHW: Department of Health and Wellness

RELATED SOPs

1. SOP 5: Request for Data for the Purpose of Research 2. SOP 14: Retention of Research Records - Archiving of Research Study Documents

RELATED DOCUMENTS

1. Freedom of Information and Protection of Privacy Act. Nova Scotia Legislature. 1993. Retrieved from: http://nslegislature.ca/legc/statutes/freedom%20of%20information%20and%20protection%20of%20privacy.pdf

2. The Nova Scotia FOIPOP Review Office website: http://foipop.ns.ca/ 3. Personal Health Information Act. Nova Scotia Legislature. 2013. Retrieved from:

http://nslegislature.ca/legc/bills/61st_2nd/3rd_read/b089.htm 4. DHW PHIA website: http://novascotia.ca/dhw/phia/default.asp

REFERENCES

1. EHS Research Request for EHS System Data Policy 2. EHS Confidentiality of Patient Information Policy 3. Research Steering Committee Terms of Reference:


http://nslegislature.ca/legc/statutes/freedom%20of%20information%20and%20protection%20of%20privacy.pdf

http://nslegislature.ca/legc/statutes/freedom%20of%20information%20and%20protection%20of%20privacy.pdf

http://foipop.ns.ca/

http://nslegislature.ca/legc/bills/61st_2nd/3rd_read/b089.htm

http://novascotia.ca/dhw/phia/default.asp



These research SOPs are adopted with permission from the CDHA Research Manual. Researchers are responsible to follow the policies and procedures of their research ethics board and research financial services departments. The most recent version of these SOPs may be found at: http://emergency.medicine.dal.ca/DivEMS.cfm Page 1 of 4 NS EMS SOP 14




SOP #: 14 Title: Retention of Research Records



DEFINITIONS

1. PRINCIPAL INVESTIGATOR: The researcher who holds overall accountability for a research project. The PI is responsible for the delegation of research tasks and holds final decision making ability in a team research environment.

2. OPERATIONAL RESEARCH RECORD: documents directly related to the study itself, and fall under this policy. See Appendix A for a list of such documents.

3. RESEARCH RECORDS: Study related information in any format, received or generated during the course of a research study.

4. RECORD RETENTION: the safeguarding of records for a specified time to fulfill administrative, legal, operational and fiscal requirements.

5. RETENTION SCHEDULE: the plan for managing the life of a record, identifying how long it is to be retained and how it is to be destroyed at the end of its life.

6. SUBINVESTIGATOR: A researcher who is recruited to a research project to assist in tasks as delegated by the principal investigator.


POLICY

1. Research records are retained to enable subsequent evaluation of the conduct of the study and the quality of the data produced, and to meet regulatory requirements. Storage areas must be secure and should be organized for easy retrieval.

2. The retention of research records shall be the responsibility of the principal investigator (PI) or delegated party.

3. All research records shall be retained in accordance with the retention schedule of the authority REB, outlining the storage method, duration and destruction method.

4. Only the PI or delegates may authorize the retrieval of stored records. 5. Destruction of research records shall follow applicable federal, provincial and

organizational policies.

PROCEDURE

1. APPROVAL. a. The PI or designate should determine institutional, regulatory and sponsor

requirements for retaining study records. b. The storage location, retention period and method of destruction for retained

material are to be included in the REB submission and approved by the REB. 2. STORAGE.

a. Documents are to be stored in a manner that is compliant with privacy and confidentially legislation.

b. Research data is not to be stored on personal computers of researchers. c. The storage method may change depending on the phase of the study:

i. Records are considered ‘active’ when the study is open (e.g., data collection and analysis), and are usually stored in the study team’s location.

ii. After the study is closed or has been terminated, study records should be stored in EHS onsite storage. A suggested method is: compile all research records onto compact disk(s) and have stored at EHS or Dalhousie University office secure research offices.

d. The PI or delegate shall ensure at the conclusion of the study that: i. All duplicates/copies or drafts of research information held by the PI or

sub-investigators are destroyed in the manner approved by the REB. 3. DESTRUCTION.

a. Regulations dictate the amount of time in which research records must be stored (e.g., 25 or 7 years).

b. After this time has elapsed, the PI is responsible to confirm the records are no longer required. The PI may need to also confirm this with the sponsor.


c. Records are to be destroyed according to the method approved by the REB (e.g., shredding paper records or smashing/shredding CDs).

ABBREVIATIONS

1. PI: Principal Investigator 2. REB: Research Ethics Board

RELATED SOPs

1. SOP 8. Responsibilities of the Principal Investigator 2. SOP 10. Delegation of Study Duties

RELATED DOCUMENTS

REFERENCES

1. Capital Health, Research Manual- Retention of Research Records, March, 2012. Retrieved from: http://policy.nshealth.ca/Site_Published/DHA9/PolicyManualView.aspx

2. Department of Health and Wellness. (2013).Toolkit For Custodians: A Guide to the Personal Heath Information Act. Retrieved from: https://www.gov.ns.ca/dhw/phia/custodians.asp.

3. Capital Health, Records Management for Research Records, July 23, 2013. Retrieved from: http://www.cdha.nshealth.ca/discovery-innovation/documents

APPENDIX A. Examples of Operational Study Records (3)

• Investigator’s Brochures and / or product monographs and updates signed protocol and amendments, if any

• Sample case report form (CRF) and subject diaries, with any revisions • Copies of signed, dated, completed CRFs and documentation of CRF corrections • Signed informed consent forms and any revisions • Any other written information provided to subjects • Advertisements for subject recruitment • Signed agreements between involved parties • Research Ethics Board (REB) membership lists • All correspondence with the REB, interim and final reports, and dated, documented REB

approvals • Health Canada authorization of the protocol and any amendments • Curriculum vitae and/or other documents evidencing qualifications of PI and sub-

investigators


https://www.gov.ns.ca/dhw/phia/custodians.asp



• Normal values / ranges, certifications / accreditations, quality control assessments / validations for all medical / laboratory / technical procedures / tests included in the protocol

• Sample of labels attached to investigational product containers • Instructions for handling investigational products and study-related materials (if not

included in protocol or Investigator’s Brochures) • Shipping records for investigational products and study-related materials • Decoding procedures for blinded trials • Investigational product accountability at the site • Documentation of investigational product destruction, if product destroyed at the site • Sponsor’s trial initiation monitoring report • Relevant communication with the sponsor’s representatives (e.g. letters, notes of

meetings and telephone calls) • Source documents (to include original documents related to the study, to medical

treatment, and history of subject) • Notification by originating investigator to sponsor of serious adverse events and related

reports • Notification by investigator to REB (and, where applicable, to regulatory authority) of

unexpected serious adverse drug reactions and other safety information • Notification by sponsor to investigators of safety information • Subject screening log • Subject identification code list • Subject enrollment log • Delegation logs and signature sheets • Records of retained body fluids / tissue samples, if any • Final report to the regulatory authority, if applicable • Clinical study report, if applicable • Pharmacy logs





SOP #: 15 Title: Conflict of Interest Management



DEFINITIONS

CONFLICT OF INTEREST: A conflict of interest may arise when activities or situations

place an individual or institution in a real, potential or perceived conflict between the

duties or responsibilities related to research, and personal, institutional or other interests.

These interests include, but are not limited to, business, commercial or financial interests

pertaining to the institution and/or the individual, their family members, friends, or their

former, current or prospective professional associates. It is also possible to have an

intellectual conflict of interest.

POLICY

1. A conflict of interest exists where:

a. an outside observer would question the ability of the researcher to make a proper

decision due to possible considerations of his or her private or personal interests;

and/or,



b. the public would believe that the trust relationship between the relevant parties

could not reasonably be maintained if they had accurate information on the

potential sources of conflict of interest.

2. The presence of a conflict of interest in the research setting can severely undermine the

trust relationship between researchers and research subjects, research sponsors,

research institutions, and the public.

a. Any real, potential or perceived conflicts should be openly disclosed and

managed appropriately.

PROCEDURES

Providing Conflict of Interest Details in Research Protocols

1. In order to detect the existence of possible conflict of interest in a study under review,

the researchers are to provide details about the following, which should be included in

the study protocol:

a. The research budget, including funding sources

b. Commercial and financial interests (e.g., stock or share holdings or future options

with the sponsoring company, travel benefits, per capita payments, etc.)

c. Consultative relationships

d. The relationship between the researcher and the proposed research subjects

e. Any constraints the researcher is under for data collection, analysis or

dissemination of findings

f. Any other information that may be relevant

2. Upon review of the protocol, the RSC may ask the researcher(s) to provide additional

details prior to a recommendation being made or letter of support provided.

Managing Conflicts of Interest of EMS Research Steering Committee Members

3. RSC members must disclose actual, perceived or potential conflicts of interest related to

the review of a study to the RSC.

a. RSC members have a conflict of interest related to the review of a study should

not participate in reviewing the study. This decision is to be made through

discussion and consensus among the RSC members.

b. This includes an RSC member participating in a review of a study in which they

are an investigator. The member may be present for the review, to provide any

clarifications necessary, but the Chair may ask the member to leave the room if

necessary for a recommendation free of conflict to be made.

Review of Bursaries and Abstracts



4. Disclosure of actual, perceived or potential conflicts of interest is also applicable to the

review of Division of EMS research bursary applications and EMS Research Day

abstract submissions.

a. Investigators on submissions under review should not be present or involved in

these reviews.

b. Individuals who are serving as EMS Research Day abstract reviewers or judges

should excuse themselves from scoring abstracts or presentations in which they

are an investigator or have a conflict of interest.

ABBREVIATIONS




RELATED SOPs


REFERENCES

1. Tri-Council Policy Statement 2, Chapter 7. Retrieved from:


2. Definition of “conflict of interest” based on Schedule 14 of the Memorandum of

Understanding (MOU) on the Roles and Responsibilities in the Management of

Federal Grants and Awards. www.nserccrsng.gc.ca/NSERC-CRSNG/Policies-

Politiques/MOURoles-ProtocolRoles/index_eng.asp

3. Dalhousie University Policy on Conflict of Interest (2002). Retrieved from:

http://www.dal.ca/content/dam/dalhousie/pdf/university_secretariat/Conflict_of_Intere

st.pdf

4. IWK Research Ethics Board Standard Operating Procedures (2010). Section 6.

Retrieved from: http://www.iwk.nshealth.ca/index.cfm?objectid=C1178EB6-F9E5-

0323-5FBCB18EABB1219E


http://www.nserccrsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp

http://www.nserccrsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp

http://www.dal.ca/content/dam/dalhousie/pdf/university_secretariat/Conflict_of_Interest.pdf

http://www.dal.ca/content/dam/dalhousie/pdf/university_secretariat/Conflict_of_Interest.pdf

http://www.iwk.nshealth.ca/index.cfm?objectid=C1178EB6-F9E5-0323-5FBCB18EABB1219E

http://www.iwk.nshealth.ca/index.cfm?objectid=C1178EB6-F9E5-0323-5FBCB18EABB1219E





SOP #: 16 Title: External Audits of Research Studies



DEFINITIONS

1. AUDIT: A systematic and independent examination of study-related activities and documents, to determine whether the evaluated activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol and all applicable standards.

2. EXTERNAL AUDIT: An audit performed by an external party such as the study sponsor (or its agents) or a research ethics board (REB).

3. INFORMED CONSENT FORM: A document confirming the research participant’s willingness to participate in a particular research study.

4. PRINCIPAL INVESTIGATOR (PI): The researcher who holds overall accountability for a research project. The PI is responsible for the delegation of research tasks and holds final decision making ability in a team research environment.

POLICY

1. PIs are to notify the approving REB and the EMS Research Steering Committee (RSC) regarding all external audits of research studies.


2. Any review of participants’ personal health information or research records by external auditors or others is to be performed in accordance with all institutional requirements and applicable legislation.

PROCEDURE

1. The PI or designate notifies the EMS RSC chairperson in writing or via email immediately upon learning of an upcoming external audit.

2. Before external auditors review any personal health information, the PI (or designate) verifies that the research participant (or designate) signed an informed consent form granting access to the auditing body, and ensures that review of the personal health information proceeds in accordance with institutional requirements and applicable legislation.

3. If auditors wish to remove copies of personal health information from the site, the PI ensures that these copies are de-identified prior to their removal.

4. The PI (or designate) notifies the REB and EMS RSC chair of any major findings within 14 days of the closing meeting with the auditors.

ABBREVIATIONS

1. REB: Research Ethics Board 2. EHS: Emergency Health Services 3. RSC: Research Steering Committee

RELATED SOPs

1. SOP 8. Responsibilities of the Principal Investigator 2. SOP 11. Obtaining Informed Consent in Clinical Trials 3. SOP 12. Obtaining Consent in Other Studies 4. SOP 13. Privacy and Confidentiality of Research Data

RELATED DOCUMENTS

1. EHS Research Policy (#1006) 2. EHS Request for EHS System Data Policy (Policy #1009) 3. EHS Confidentiality of Patient Information Policy (Policy #1010) 4. Research Steering Committee Terms of Reference:


REFERENCES




1. Capital Health. External Audits of Research Studies. Policy RS-04-003. March 2012. Retrieved from: http://policy.nshealth.ca/Site_Published/DHA9/document_render.aspx?documentRender.IdType=6&documentRender.GenericField=&documentRender.Id=43307

2. Canadian Institute of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010. Retrieved from: www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

3. Health Canada. International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (ICH GCP E6), 1997: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php



http://www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php