Research Involving Human Participants Ethics

Policy Number
3404
Responsibility
VP Academic
Approved
Board of Governors
Previous Name
Research on Human Participants Ethics
Effective Date
October 14, 2004
Amended
July 19, 2023
Context/Purpose

NOTE:  This Policy complies with the requirements of the Canadian Institutes of Health Research (“CIHR”), Natural Sciences and Engineering Research Council of Canada (“NSERC”), Social Sciences and Humanities Research Council of Canada (“SSHRC”), and Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (“TCPS 2 (2022)”).  

The purpose of this policy is to provide guidance and to ensure that all research conducted under the auspices of, in affiliation or in collaboration with the Justice Institute of British Columbia (“JIBC” or the “Institute”) will fulfill highest ethical standards in conducting research involving human participants to ensure their rights are respected and protected. 

Policy Statement

Researchers at or associated with JIBC are required to follow research ethics protocols to ensure their research protects human participants. JIBC’s Research Ethics Board (“REB”) reviews and approves all research that involves human participants in accordance with this Policy. With the exception of research exempt from REB review as described in this Policy, REB approval is required before the research is started regardless of the funding sources or location of the project. 

Scope

This Policy applies to all persons engaged in research with human participants at JIBC, including students, faculty, staff and administrators.

Research Ethics Review
Research Requiring REB Review (TCPS 2 (2022), Chapter 2, Article 2.1)

The following requires ethics review and approval by an REB before the research commences. Research involving:

  • Living human participants; and
  • Human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.
Research Exempt from REB Review (TCPS 2 (2022), Chapter 2, Articles 2.2, 2.3, and 2.4)

Research does not require REB review when it relies exclusively on information that is:

  • Publicly available through a mechanism set out by legislation or regulation and that is protected by law; or
  • In the public domain and the individuals to whom the information refers have no reasonable expectation of privacy.

REB review is not required for research involving the observation of people in public places where:

  • It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
  • Individuals or groups targeted for observation have no reasonable expectation of privacy; and
  • Any dissemination of research results does not allow identification of specific individuals.

REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording of dissemination of results does not generate identifiable information. 

Activities Not Requiring REB Review (TCPS 2 (2022), Chapter 2, Articles 2.5 and 2.6)

Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review.

Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review.

Relationship Between Research Ethics Review and Scholarly Review (TCPS 2 (2022), Chapter 2, Article 2.7)

As part of research ethics review, the REB shall review the ethical implications of the methods and design of the research.

Research Ethics Board Review Shall Be Continuing (TCPS 2 (2022), Chapter 2, Article 2.8)

Following initial REB review and approval, research ethics review shall continue throughout the life of the project.

Approach to Research Ethics Board Review

This section introduces the concepts of risks and potential benefits of research, as well as their balance in research ethics review and the conduct of research.

Concepts of Risks and Potential Benefits (TCPS 2 (2022), Chapter 2, Articles 2.9, 2.10, and 2.11)

The REB shall adopt a proportionate approach to research ethics review such that, as a preliminary step, the level of review is determined by the level of risk presented by the research: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the research.

When describing the foreseeable risks and potential benefits of research involving participants who are also exposed to other risks, researchers should clearly distinguish between the risks that are attributable to the research, and the risks to which participants would normally be exposed.

In their evaluation of risk, REBs should evaluate those risks that are attributable to the research.

Where researchers intend to conduct research involving humans based on their membership in specific communities, researchers should consider relevant guidance in Procedure 3404-010 on research involving First Nations, Inuit and Métis peoples of Canada, when appropriate.

Definitions

Critical Inquiry – The analysis of social structures or activities, public policies or other social phenomena.

Incidental Findings – A discovery about research participants or prospective participants that is made in the course of research, but is outside the objectives of the research study.

Minimal Risk Research – Research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research. 

Participant – An individual whose data, biological materials, or responses to interventions, stimuli, or questions by a researcher are relevant to answering the research question(s). Also referred to as a ‘human participant,’ and in other policies/guidance as ‘subject’ or ‘research subject.’

Pilot Study – A smaller version of the main study intended to assess the feasibility and/or inform the design of the main study. 

Research – An undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. 

Research Activities – Original careful, critical, disciplined inquiry directed toward the clarification and/or resolution of problems to establish facts, principles, or generalizable knowledge.

Researcher/Investigator – Any person associated with the JIBC who undertakes to conduct research. This includes employees and students as well as persons from the community who are associated with a JIBC-generated research project. The Principal Investigator is the person who has the primary responsibility for a research project.

Research Proposal – The written document submitted to the JIBC Research Ethics Board in advance of research commencing.

Vice-President, Academic (VPA) – The person responsible for all education programs at the Institute.

Student Awareness

Students are required to make themselves aware of all JIBC policies and procedures. Lack of awareness of this or any other JIBC policy does not excuse a student from responsibility for their actions. 

Employee Awareness

Employees are required to make themselves aware of all JIBC policies and procedures. Lack of awareness of this or any other JIBC policy does not excuse an employee from responsibility for their actions. 

Confidentiality and Documentation

1. JIBC recognizes the confidentiality interests and privacy rights of all parties involved in an investigation under this Policy and must protect personal information in accordance with the Freedom of Information and Protection of Privacy Act, subject to the exceptions thereunder.

2. JIBC may disclose information relating to allegations of a breach of this Policy in certain circumstances, including but not limited to where:

a. necessary to ensure the requirements of procedural fairness are met;

b. the sharing of personal information is necessary for the protection of the health or safety of any individual;

c. the sharing of personal information is required or authorized by law; or

d. the person the information is about has consented to the release of the personal information.

3. All persons involved in an investigation under this Policy are required to keep the allegation and information relating to the investigation confidential, and are not to disclose the allegation or information revealed to them through the investigation to others, except as may be expressly permitted or as required by law. Individuals involved in investigations should be aware that while confidentiality is expected, anonymity cannot be guaranteed.

4. All documentation related to a Decision, President’s Decision or Appeal under this Policy will be kept in the personnel file or the Official Student Record, as appropriate. If the latter, it will be stored in accordance with the Student Records Policy.

No Retaliation

1. It is contrary to this Policy for anyone to retaliate, engage in reprisals or threaten to retaliate against a person for:

a. reporting any alleged violation of this Policy; or

b. having participated or co-operated in an informal process or investigation under this Policy.

2. Anyone who engages in such retaliation will be subject to Disciplinary or Corrective Measures up to and including suspension, expulsion or termination from JIBC.

Related Policies and Procedures

Documents and Forms