SRC Terms of Reference

History

These terms of reference were approved by the following Departments / Schools / Programs in the Faculty of Health Sciences:

• Bachelor of Health Sciences
• Medicine
• School of Nursing
• School of Rehabilitation Sciences

These terms of reference became effective January 15, 2007 under the joint Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board and were subsequently adopted by the Hamilton Integrated Research Ethics Board.

The SRC is a subcommittee of the Hamilton Integrated Research Ethics Board (HiREB), and was established to review minimal risk student research in the Faculty of Health Sciences (FHS), McMaster University.

Purpose

These terms of reference are constructed to conform to the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS) 2010, and amendments thereto.

Adoption and modification

These terms of reference, and any subsequent changes to them, must be approved by the HiREB.

Scope

All research involving humans as research participants must be reviewed by the HiREB. Research is defined as “a systematic investigation to establish facts, principles or generalizable knowledge”. This includes research conducted for a McMaster course that is supervised by an individual who is not affiliated with the University.

In general, research requiring review by a research ethics board includes not only experimental protocols, but also research involving ethnographic methods, questionnaires, interviews, or secondary use of data that are not in the public domain. It also extends to research involving human remains, tissues, biological fluids, or foetuses.

The HiREB SRC shall review research conducted by undergraduate and master’s students when: (1) it is conducted as part of an undergraduate or graduate course offered by a department in the FHS; and (2) it is not part of a faculty member’s research programme already subject to review by any other Ethics Board.

Undergraduate and master’s research for courses that are supervised by individuals outside the department shall be reviewed by the HiREB SRC unless it is subject to review by the HiREB or by another Ethics Board in compliance with the Tri-Council Policy.

Composition of Committee

The HiREB SRC is comprised of a minimum of 5 members representing the aforementioned programs / departments / schools participating in the Committee. In addition, membership may include a minimum of 2 student representatives, selected from the aforementioned programs / departments / schools on a rotating basis.

The Committee is encouraged to consult relevant experts on methodological issues within an outside the FHS as necessary.

Selection of Committee Members

Members (and any necessary replacements) shall be appointed by the Co-Chairs of the HiREB. Faculty members and students on the SRC shall serve staggered 2-year terms. Terms are renewable. The Chair of the Committee shall be selected by the Co-Chairs of the HiREB.

Rationale for the composition of the Committee

We believe that the selection of 5 faculty members, including a Chair, and 1-2 student members will provide sufficient range of experience and expertise to be able to assess the various methodological and ethical issues arising from applications in the FHS.

Information to be supplied

Applications may be made for an individual student project, for a generic project to be conducted by several members of a class, or by an entire class. Applications should be submitted in accordance with the instructions on the forms available at: http://www.fhs.mcmaster.ca/healthresearch/hireb/forms.html If in doubt about the form to be completed, please contact the Research Ethics Officer: http://www.fhs.mcmaster.ca/healthresearch/hireb/contact.html

For independent studies and seminar courses we encourage the student researcher to be involved in constructing the application, but the supervisor or course instructor must sign the final application. For large class projects we anticipate that the instructor will prepare the application, and that students will receive information and instruction concerning the ethical issues involved in research. The research may not begin until the HiREB SRC, or the HiREB (if the application has been referred there) has given its approval.

Process and procedure

Applications for REB Review (2 paper copies + an electronic copy) should be sent to the Health Research Services (HRS) office in the Faculty of Health Sciences, Health Sciences Centre Room 3H9, as soon as possible at the start of each term and/or at least four to five weeks prior to the date at which the research is to be started. The application will be sent to one or more members of the HiREB SRC for review. The reviewer will complete an evaluation form as part of the review process, and will notify the SRC Chair when the review is completed. (The reviewer may contact the applicant during the review process for clarification as needed.) The application and evaluation form will be reviewed and a final recommendation made by the SRC Chair who also will issue a final approval for the research project. A letter of approval for one year will be sent by the SRC Chair to the applicant following this process.

If approval is not achieved, the applicant will be notified of the decision and may be asked to amend the protocol and/or consent and other documents and to submit the revisions for review leading to final approval.

In reaching its decisions, the HiREB SRC will be guided by the principles outlined in the TCPS.

Applications will be approved for the academic year in which they will be conducted, i.e., for a period of one year, with the possible exception of course applications, and/or research for which an annual report is received and approval is granted for a subsequent one year period.

When/if required, the Committee shall make decisions in face-to-face meetings. However, proposals fitting the TCPS definition of minimal risk may be reviewed and approved by E-mail or mail circulation.

In decisions requiring a vote (for example, to reject an application, or to refer the application to the HiREB) a decision will be made based on a majority vote of Committee members.

If the HiREB SRC is reviewing an application in which a Committee member has a personal interest,  that member shall not be involved in the decision.

Referral to the Hamilton Integrated Research Ethics Board

The SRC may refer an application to the HiREB. Examples of situations in which referral to the full REB would be appropriate are research that exceeds minimal risk, research involving ethical or legal issues for which the ethics  committee members do not have adequate expertise, and/or cases for which conflicts of interest may arise. The student applicant will be advised by the SRC in this situation.

Appeals

Every attempt shall be made to work with the applicant to reach agreement through discussion, revision, and reconsideration. When agreement cannot be reached, decisions of the HiREB SRC may be appealed to the Appeal Board, whose decision shall be final.

Other responsibilities

The HiREB SRC also shall consider all other ethical issues that arise which concern FHS student researchers and human participants in research.

Reconsideration of these procedures

These procedures shall be reviewed by the HiREB Chair in consultation with the HiREB SRC on an annual basis, normally prior to the commencement of the Fall semester each September.