Ethics - Research with Humans

Introduction

The University is committed to ensuring the highest standards of research ethics are understood and practiced in its community. This policy defines research ethics and research with humans and outlines the University’s processes for maintaining ethics throughout research at the University of Regina.

When humans, human tissues or human data are used in the course of research or other comparable activities, it is the primary concern of the University that the rights of the participants are respected and protected and that the procedures followed comply with ethical, scientific, methodological, medical, and legal standards. The University values the academic freedom of its researchers, and the ethics review process shall not unfairly censor researchers who support unorthodox views. However, academic freedom is complemented by the requirement that the rights of human participants be respected.

The University of Regina follows the national standards articulated in the second edition of the Tri-Council Policy Statement:  Ethical Conduct for Research Involving Humans. The guiding principles of this policy statement are:

• Respect for persons - This includes the recognition of the intrinsic value of human beings and respect for the autonomy of research participants.  Respect for autonomy is normally reflected in the requirement to seek free and informed consent from participants both prior to and during their participation in a research project.
• Concern for welfare – This is broadly construed to mean all aspects of a person’s life, including their physical and mental health, spiritual well-being, and other elements of their life circumstances.  Concern for welfare includes respect for the person’s privacy and confidentiality and requires that Research Ethics Boards (REB) and researchers adopt an attitude that aims to protect the welfare of research participants, minimize foreseeable risks to those participants and their communities, and inform research participants of those risks.
• Justice – This principle requires that people be treated equitably and fairly. The principle of justice takes into account the vulnerability of the person, the difference in power between participant and researcher, and seeks to equitably distribute the risks and benefits of research participation.

The University of Regina is party to the “Agreement on the Administration of Agency Grants and Awards by Research Institutions” which governs receipt of funds from Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council (NSERC), and Social Sciences and Humanities Research Council (SSHRC).  Section 3.4 of this Agreement states that the University must comply with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, second edition (TCPS 2), and any amendments. In addition, research must comply with any further related agency requirements, such as CIHR’s guidelines on research involving human stem cells.

Scope

This policy applies to all members of the University involved in research with human participants, human tissues or human data.  Members of the University of Regina include but are not limited to, faculty, professors emeriti, sessional lecturers, staff, trainees, graduate and undergraduate students who are registered or active in their program, adjunct professors, visiting professors, visiting scholars, professional affiliates, associate members, residents, and postdoctoral fellows at the University of Regina. 

This policy also applies to research with human participants, tissues or data undertaken by any person or Research Institute/Centre associated with the University of Regina, or using any University of Regina resources inclusive of persons (i.e., students, staff, faculty), or if funds for such purposes be accepted or accounts established.

In particular, all research that involves living human participants, and human biological materials, requires review and approval by an REB in accordance with this Policy Statement, before the research is started except as stipulated below.

Research requiring REB review includes:

1. Research with human tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva, body fluids, embryos, fetuses, fetal tissue, reproductive materials, and stem cells derived from living and deceased individuals;
2. Course-based research activities, the primary purpose of which is pedagogical;
3. Research with the secondary use of non-identifiable information;

1. Research relying exclusively on publicly available information as set out through legislation or regulation and protected by law;
2. Research relying on information in the public domain where there is no reasonable expectation of privacy;
3. Research involving the observation of participants in public places where there is no staged intervention by the researcher, no reasonable expectation of privacy and no identification of individuals within research results;
4. Research relying exclusively on the secondary use of anonymous information so long as no identifiable information is created;
5. Quality improvement, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes;
6. 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;
7. Research involving individuals who are not themselves the focus of the research, in order to obtain information. For example, to collect information from authorized personnel to release information or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or statistical reports;

   Researchers affiliated to institutions eligible for Agency funding are responsible for complying with all TCPS 2 guidance relevant to their research, even if their research is exempt from REB review.

Policy

Research Ethics

Consistent with the Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans, the University of Regina has mandated the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted within, or by members of the University, using the considerations set forth in the Tri-Council Policy as the minimum standard.  Such decisions will be based on ethical considerations.

The REB shall be constituted according to the current TCPS. Where issues raised in individual REB applications are not addressed specifically in the guidelines, the REB shall use the three core principles of the TCPS 2 (Respect for Persons, Concern for Welfare, and Justice) to assess the ethical considerations of the proposal.

The University of Regina has one REB.

The REB will take a proportionate approach to the review of proposals as outlined in TCPS 2 Article 2.9. Research that is above minimal risk will be reviewed by the full REB. Research that is minimal risk will receive a delegated review as outlined in the REB terms of reference.

Research that poses minimal risk shall not normally require peer review for scholarly merit. For research that is above minimal risk, additional review shall not be required where there is an existing peer-review assessment (e.g., if the research was funded through a peer-review process). In cases where peer review is required, the Office for Research Services will co-ordinate a scholarly review of the research on behalf of the Research Ethics Board.

Initial approval is granted for one year, and can be renewed annually for a total of five years. In addition, the REB must review all substantive changes from approved research that affect participants at any stage of the process including, but not limited to, changes to the consent form, changes to the tasks or interventions involved in the research, or changes to measures to protect privacy and confidentiality. Any substantive change to the research should not be implemented without documented approval by the REB, except when necessary to eliminate an immediate risk to the participants. In addition, personnel changes must be reported to the REB.

No research funds related to an REB proposal will be released until REB approval is obtained. If a project finishes or expires, funding will be frozen until the researcher either submits another proposal, reopens an existing project, or provides the Office of Research Services with documentation certifying that all research with humans pertaining to the grant in question has been completed. In cases where research with humans will be delayed, early release of funds can be arranged through the Office of Research Services.

Review of Research in Other Jurisdictions

The REB at the University of Regina has the responsibility to ensure that all research conducted under its auspices, irrespective of the location where it takes place, follows the guidelines established by the current TCPS. Therefore, research approved elsewhere, through another REB or equivalent body, must also be reviewed by the REB at the University of Regina. The University has entered into a collaboration agreement with the University of Saskatchewan and the Saskatchewan Health Authority that allows for acceptance of REB approval from those institutions without additional review by the University of Regina REB.

Approval of a project by the REB is not a sufficient condition for a project to proceed.  It is incumbent upon the researcher to determine whether there is a requirement for ethical approval by another body (e.g., a hospital REB).  Researchers engaging in multi-center research are encouraged to review Chapter 8 of the Tri-council Policy Statement for a discussion of issues that may arise from the possibility that local REB’s may reach different conclusions about aspects of the same project.

Researchers are required to comply with regulatory requirements in other provinces (e.g. Provincial Privacy laws) and any requirement for local REB review. There may also be a need for legal agreements such as Data Sharing or Material Transfer Agreements.

Roles and Responsibilities

University

The University is responsible for providing the support and education required for all members of the University’s research community to develop and maintain the highest standards of ethics, integrity, accountability, and responsibility.

University community

Members of the University community are responsible for reporting all instances of research ethics misconduct and for cooperating fully in an inquiry or investigation into an allegation of research ethics misconduct.

People in Supervisory Positions

People in supervisory positions at the University (including principal investigators) are responsible for ensuring everyone who works under their supervision, directly or indirectly, understands and complies with this policy. Researchers are also responsible for ensuring their group’s work is valid.

Researchers

Researchers are responsible for understanding and complying with this policy and taking responsibility for their research. Researchers who will be conducting research with human participants must complete the Panel on Research Ethics tutorial, Course on Research Ethics (CORE) and, depending on the type of research they are doing, they may also be required to complete other regulatory courses or Training such as, but not limited to, the International Council on Harmonization Good Clinical Practice (ICHGCP) or Health Canada Division 5 training.

Consequences for Noncompliance

Failure to apply for and receive REB approval before conducting research with humans is one element of research misconduct. Breaches of the research ethics policy will be handled through provisions in the Research and Scholarly Integrity policy.

Allegations of Research Ethics Misconduct

A person who has reasonable grounds to believe that Research/Scholarly Misconduct is occurring or has occurred shall report the matter to the Vice-President (Research). An allegation must be in writing and signed. The University will deal promptly with all allegations of research misconduct (according to the Research and Scholarly Integrity policy).

The Vice-President (Research) will notify the appropriate funding agencies and professional associations as required.

Processes

Related Information

• Agreement on the Administration of Agency Grants and Awards by Research Institutions
• GOV-070-025 – Surveys
• GOV-022-005 - Code of Conduct
• GOV-022-010 - Conflict of Interest and Conflict of Commitment
• GOV-022-020 - Safe Disclosure
• GOV-022-025 – Research and Scholarly Integrity
• Tri-Agency Framework: Responsible Conduct of Research
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
• Tri-Council Policy Statement Tutorial: Course on Research Ethics (CORE)
• University of Regina - Human Ethics