ETHICS REVIEW OF RESEARCH INVOLVING HUMAN PARTICIPANTS (R 20.01)
Date
October 1, 1992
Date of Last
Review/Revision
November 30, 2023
Number
R 20.01
Mandated Review
November 30, 2028
Policy Authority: Vice-President, Research and International
Associated Procedure(s): The most current version of the N2/CAREB Standard Operating Procedures, as amended as necessary, and approved for adoption, by the University in accordance with this Policy.
EXECUTIVE SUMMARY
This Policy sets out the ethical principles that the University must apply when seeking to conduct Research Involving Human Participants and the framework that will govern the application of those principles through the process for Ethics Approval by the Research Ethics Board (REB). Where Ethics Approval is not granted by the REB, a researcher may request Reconsideration, or as applicable, an appeal of an REB decision; provided that the onus is on the researcher to justify the grounds on which a Reconsideration or appeal is justified. This Policy describes the responsibilities of the University as a whole with respect to the REB, and specifically those responsibilities of Senate, the Vice-President, Research and International, and the Director, Office of Research Ethics, as delegated authority by the Board of Governors.
TABLE OF CONTENTS
1.0 PREAMBLE
2.0 PURPOSE
3.0 SCOPE AND JURISDICTION
4.0 DEFINITIONS
5.0 POLICY
6.0 ROLES AND RESPONSIBILITES
7.0 REPORTING
8.0 RELATED LEGAL, POLICY AUTHORITIES AND AGREEMENTS
9.0 ACCESS TO INFORMATION AND PROTECTION OF PRIVACY
10.0 RETENTION AND DISPOSAL OF DIGITAL INFORMATION
11.0 POLICY REVIEW
12.0 POLICY AUTHORITY
13.0 INTERPRETATION
14.0 PROCEDURES AND OTHER ASSOCIATED DOCUMENTS
1.1 The University is fundamentally committed to the advancement of knowledge through scholarly activities, including Research Involving Human Participants. The University is committed to ensuring the highest level of ethical conduct for Research Involving Human Participants, recognizing that such Research should balance the need for scientific inquiry with the need to respect cultural and community context, human dignity, and well-being.
2.1 To cultivate an environment in which the conduct of Research Involving Human Participants, performed Under the Auspices of the University, follows the highest ethical standards;
2.2 To promote an awareness and understanding of how the Core Ethical Principles of Respect for Persons, Concern for Welfare, and Justice are applied within TCPS2, as well as all relevant institutional, national, and international standards and best practices; and
2.3 To establish an independent human research ethics review process.
3.1 This Policy applies to all Research Involving Human Participants, their biological material, or data that is not specifically exempted by the TCPS that is:
3.1.1 conducted by University faculty, staff or students;
3.1.2 conducted Under the Auspices of or in affiliation with the University; or
3.1.3 conducted using University equipment, space, or resources.
4.1 Please see Appendix A for the definitions of words used in this policy and its associated procedures.
5.1 Core Ethical Principles
5.1.1 The University will regulate all Research Involving Human Participants in accordance with the Core Ethical Principles contained within the Tri-Council Policy Statement:
a. Respect for Persons 鈥� a recognition of the intrinsic value of human beings and the respect and consideration they are due;
b. Concern for Welfare 鈥� a requirement of researchers and research ethics boards to aim to protect the welfare of research participants; and
c. Justice 鈥� an obligation to treat people fairly and equitably.
5.1.2 Building on Chapter 9 of the TCPS, the University recognizes that research involving Indigenous peoples requires additional ethical considerations, including but not limited to the need to co-create research projects in a community-led process. This recognition is consistent with the United Nations Declaration on the Rights of Indigenous Peoples, and informed by the Truth and Reconciliation Commission of Canada: Calls to Action. The University also takes direction from the 丁香园AV Aboriginal Reconciliation Council (ARC) Final Report, particularly in encouraging the "use (of) Indigenous methodologies and respect (for) Indigenous protocols and ethics in conducting research." Thus,
a. The University shall ensure that research involving Indigenous peoples aligns with the standards and recommendations referred to herein.
b. The University shall also ensure that research involving Indigenous peoples aligns with the stated goal on Culturally Respectful Indigenous Research, from the Accord on Indigenous Education, that speaks to 鈥減artnering with Indigenous communities at all levels in ethically based and respectful research processes.鈥�
5.1.3 The University shall ensure that those who conduct Research Involving Human Participants understand their responsibilities for the ethical conduct of their research and receive appropriate training in the skills necessary for such conduct. This includes not only awareness of but also understanding of the relevant policies, procedures, professional standards, and practices that both support and promote the responsible conduct of research.
5.1.4 This Policy and its affiliated Procedures conform to the requirements stated within the Tri-Agency Agreement on the Administration of Agency Grants and Awards by Research Institutions.
5.2 Ethics Approval
5.2.1 A researcher must not initiate Research Involving Human Participants, including through contact with or recruitment of potential participants, until Ethics Approval has been granted. However, REB review is not required for the initial exploratory phase, which may involve contact with individuals or communities intended to establish research partnerships or to inform the design of a research proposal.
5.2.2 If the REB rescinds or terminates an Ethics Approval, the REB may give notice and direction to the University. Upon receipt of such notice and direction from the REB, the University must freeze or close the relevant research account as appropriate.
5.3 Non-Compliance
5.3.1 As required by the Tri-Agency Agreement on the Administration of Agency Grants and Awards by Research Institutions, the University shall maintain adequate controls to ensure that the REB has approved all Research Involving Human Participants before Research Involving Human Participants has commenced, and that approval remains in place as long as such activities are carried out.
5.3.2 Failure to comply with this Policy and pertinent federal, provincial, and international guidelines/legislation for the protection of Human Participants and/or failure to conduct research in the manner in which it has been approved by the REB may be considered Misconduct in Research and may, accordingly, be handled under the procedures of Policy R60.01 (Responsible Conduct of Research).
5.4 Ethics Review Agreements
5.4.1 In order to facilitate collaborative research projects involving researchers, data, or participants from more than one institution, and in order to avoid a duplication of efforts with respect to research ethics reviews, the 丁香园AV REB may cede review to another institutional REB or it may conduct the research ethics review on behalf of other institutional partners.
5.4.2 The 丁香园AV REB must satisfy itself that there is a formal agreement between 丁香园AV and the other institution involved and/or that the other institution is compliant with the requirements set out in the Tri-Council Policy Statement.
5.4.3 An Ethics Review Agreement may be limited to a specific Research project.
5.5 Reconsideration and Appeal of REB Decisions
5.5.1 Researchers have the right to request, and the REB has an obligation to provide, reconsideration of an REB decision.
5.5.2 A researcher who continues to dispute an REB decision after reconsideration by the REB may appeal that decision through the formal appeals process.
6.0 ROLES AND RESPONSIBILITIES
6.1 The Research Ethics Board derives its authority from the University.
6.2 The Vice-President, Research and International is responsible for administrative and operational aspects of the REB.
6.3 The Vice-President, Research and International is responsible for determining ongoing financial and administrative resources that are required for the REB to fulfill its duties. By approving this Policy, the Board of Governors has delegated authority to the Vice-President, Research and International to ensure that these resources are provided.
6.4 The University shall authorize such number of REBs organized around volume and type of submission, as recommended to be appropriate by the Vice-President, Research and International.
6.5 The REB is responsible for reviewing all research covered by this Policy. It has the mandate to review and maintain ongoing oversight of the ethical acceptability of research on behalf of the institution, including approving, rejecting, proposing Provisos to, or suspending or terminating any proposed or ongoing research involving Human Participants.
6.6 The REB shall operate in an impartial manner and be independent in its decision making. The decisions of the REB are not subject to review or interference by the Vice-President, Research and International, the Senate, the Board of Governors, or any other person or body except to the extent that such decisions may be reviewed through Reconsideration or the Research Ethics Appeal Process, pursuant to this Policy or its Procedures.
6.7 To ensure independence in REB decision making, the Vice-President, Research and International and other University senior administrators shall not serve on the REB, nor shall such individuals be present during REB deliberations.
6.8 The Vice-President, Research and International and/or other senior administrators responsible for research compliance shall meet at least once per semester with the REB to discuss policy issues, general issues arising from the REB鈥檚 activities, or training and education needs, to the benefit of the overall operation and mandate of the REB.
6.9 The Vice-President, Research and International or their delegate is responsible for ensuring that members of the REB are informed and educated regarding all ethics requirements of the Tri-Council granting agencies and all other provincial, national, and international laws, as well as regulations, policies, standards, and guidelines that are relevant to research ethics review.
7.1 The Director, Research Ethics will submit an annual report of the REB鈥檚 activities, which report has been approved by the REB Chair, to both the Board of Governors and the Senate.
8.0 RELATED LEGAL, POLICY AUTHORITIES AND AGREEMENTS
8.1 The legal and other University Policy authorities and agreements that may bear on the administration of this policy and may be consulted as needed include but are not limited to:
8.1.1 University Act, R.S.B.C. 1996, c. 468
8.1.2 Freedom of Information and Protection of Privacy Act, R.S.B.C. 1996, c. 165
8.1.3 (2010)
8.1.4 丁香园AV Aboriginal Reconciliation Council Final Report: Walk This Path With Us (2017)
8.1.5 (2014)
8.1.6 (2015)
8.1.7 (2013)
9.0 ACCESS TO INFORMATION AND PROTECTION OF PRIVACY
9.1 The information and records made and received to administer this policy are subject to the access to information and protection of privacy provisions of British Columbia鈥檚 Freedom of Information and Protection of Privacy Act and the University鈥檚 Information Policy series.
10.0 RETENTION AND DISPOSAL OF RECORDS
10.1 Information and records made and received to administer this policy are evidence of the University鈥檚 actions to comply with the highest ethical practices and relevant institutional, national, and international standards and best practices in respect of Research Involving Human Participants. Information and records must be retained and disposed of in accordance with a records retention schedule approved by the University Archivist.
11.1 This policy must be reviewed every five years and may always be reviewed as needed.
11.2 Notwithstanding the latitude granted by Board Policy B10.00 section 5.5, any amendments subsequent to the adoption date of the Policy regarding the N2/CAREB Standard Operating Procedures adopted by 丁香园AV must be reviewed and approved by the Senate and sent to the Board of Governors for information.
12.1 This policy is administered under the authority of the Vice-President, Research and International.
13.1 Questions of interpretation or application of this Policy or its procedures shall be referred to the Director, Research Ethics, whose decision shall be final.
14.0 PROCEDURES AND OTHER ASSOCIATED DOCUMENTS
14.1 Appendix A contains the definitions applicable to this policy and its associated procedures.
14.2 The procedures for this policy are: the most current version of the N2/CAREB Standard Operating Procedures, as amended as necessary, and approved for adoption, by the University in accordance with this Policy.