Ethics - Research with Humans

Category: Research
Number: RCH-020-010
Audience: All members of the University's research community
Issued: March 10, 2015
Revised: May 28, 2015
Owner(s): VP (Research)
Approved by: Board of Governors
Contact: Director, Research Office - 306-585-4775

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 (TCPS2), 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, 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 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,

a)    All research that involves living human subjects requires review and approval by an REB in accordance with this Policy Statement, before the research is started except as stipulated below.

b)    Research involving human remains, cadavers, tissues, cells, proteins, biological fluids, embryos or foetuses shall also be reviewed by the REB.

c)    Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews, is not required to undergo ethical review.  Such research only requires ethical review if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 of this Policy.  (Article 2.3: REB review is normally required for research involving naturalistic observation.  However, research involving observation of participants in, for example, political rallies, demonstrations or public meetings should not require REB review since it can be expected that the participants are seeking visibility).

d)    Quality assurance studies, performance reviews or testing within normal educational requirements should not be subjects to REB review.

Definitions

  • Human Data - information about an individual collected through or used in the research project such that the individual would be defined as a human participant.
  • Human participants or participants - those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.
  • REB – Research Ethics Board
  • Research - an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation (TCPS, Art 2.1).

Policy

Research Ethics

Consistent with the Tri-Council Policy Statement, the University of Regina has mandated the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of the institution, 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. In making its decisions, the REB will follow the specific guidelines laid out in Articles 2 through 13. Where issues raised in individual REB applications are not addressed specifically in the guidelines, the REB shall use the three core principles (Respect for Persons, Concern for Welfare and Justice) of the TCPS2 to assess the ethical considerations of the proposal.

The University of Regina has one REB.  In the case of research undertaken by undergraduate students within a course, the REB has delegated this review to approved departmental or faculty level ethics review committees.  Copies of all approved protocols must be forwarded to the REB. It is the responsibility of departments to ensure that the highest ethical standards are met. The REB shall maintain the right of monitoring such research.  Undergraduate research that involves more than minimum risk to participants cannot be delegated for departmental review and requires REB approval.

The REB will take a proportionate approach to the review of proposals as outlined in 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, Innovation and Partnership 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.

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, Innovation and Partnerships with documentation certifying that all research with humans pertaining to the grant in question has been completed.

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 Regina Qu’Appelle Health Region that allows for a common application form and consent template.

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 document for a brief discussion of issues that may arise from the possibility that local REB’s may reach different conclusions about aspects of the same project.

Non-Compliance

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/Scholarly Misconduct.

Allegations of Research Ethics Misconduct

An allegation of research ethics misconduct must be presented to the department head or dean of the person being accused of misconduct, a designate, or the Vice-President (Research). It must be in writing and signed.

The University will deal promptly (according to the Allegations and Processes sections of the Research Integrity policy) with all allegations of research misconduct.

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 principle investigators) are responsible for ensuring everyone who works under their supervision, directly or indirectly, understands and complies with this policy. They 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 are advised to complete the Panel on Research Ethics tutorial, Course on Research Ethics (CORE).

Consequences for Noncompliance

The University conducts an inquiry and, if necessary, an investigation of every allegation of research ethics misconduct. Where research ethics misconduct is judged to have occurred, the University will apply remedies consistent with the seriousness of the misconduct, up to and including termination of the member’s position with the University and referral to a law enforcement agency.

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

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