Research with Human Participants

Research with Human Participants

The Research Ethics Board (REB) is responsible for the review and approval of research protocols involving human participants and ensures that the highest ethical standards in the conduct of research by Bishop’s University researchers are upheld and in compliance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) and the Bishop’s University Research Ethics Policy.

All research that involves human participants (interviews, questionnaires, surveys, etc.) requires ethics review and approval before the research is started. The Tri-Council Policy Statement defines research as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation (p. 7).

Tutorial for the Tri-Council policy statement (TCPS 2): Ethical conduct for research involving humans. This tutorial provides an applied approach to the guidance provided in TCPS 2. This self-paced course is a media-rich learning experience that features interactive exercises and multi-disciplinary examples. This tutorial consists of eight modules ranging from the policy’s core principles to REB review. It is designed primarily for the use of researchers and REB members – thought REB members strongly encourage faculty members to recommend this training to their students conducting research with human participants.

Submission process for research that involves human participants is done via the BU Research Portal. Members of the Bishop’s Community can request an account by contacting Raphaelle Mercier Gauthier, Research Officer (rmercier@ubishops.ca).

Submission Process – Bishop’s Projects

Submission Process – Bishop’s Projects

When conducting research with human participants, please complete and submit the Ethics Submission Form for Research Involving Human Participants in the BU Research Portal.

You are Project Submit to
Faculty member No more than minimal risk/More than minimal risk REB
Class Instructor Data kept for publication and/or involving minors (under 18**) or vulnerable populations and/or substances administered to the participants REB
Class Instructor Data not kept for publication ERCSR
Graduate Student* No more than minimal risk/More than minimal risk REB
Undergraduate Student More than minimal risk and/or Involving minors (under 18**) or vulnerable populations and/or Substances administered to the participants REB
Undergraduate Student No more than minimal risk ERCSR

* Please note that Graduate Students registered at other Universities supervised or co-supervised by Bishop’s University Faculty members must submit their ethics protocols to the REB at their home institutions, and not to the Bishop’s University REB.

** However, please note that in Quebec, a minor 14 years of age or over may give consent alone to minimal risk research. If your participants fit this scenario, you will submit to the ERCSR.

Submission Process – Multi-Institutional Projects

Submission Process – Multi-Institutional Projects

Projects led by a Quebec University

Under an agreement between Quebec universities, the review and approval of research protocols involving no more than minimal risk shall be undertaken by the Research Ethics Board of the university under whose auspices the Principal Investigator carries out research. Where research protocols are approved by the Research Ethics Board of another Quebec university under the agreement, Bishop’s University shall recognize the certificate of approval unless Bishop’s Research Ethics Board determines that the research entails more than minimal risk as specified by the TCPS2.

Once the certificate of approval from the other Quebec university is obtained, the Bishop’s co-investigator should submit the Declaration of Multi-Institutional Research in the BU Research Portal. The Bishop’s REB will then review the form to confirm that the project involves no more than minimal risk and validate the ethics certificate issued by the lead institution. A letter confirming Bishop’s REB approval will be sent to the Bishop’s co-investigator.

Projects led by a Quebec affiliated university centre (CAU), university hospital (CHU), or university institute (IU), or by a university located outside of Quebec

For such projects, if the researcher at Bishop’s is the principal investigator or a co-PI on the research project, the researcher should submit the Ethics Submission Form for Research Involving Human Participants in the BU Research Portal.

If the researcher at Bishop’s is a co-investigator on the research project, and if the project involves no more than minimal risk, the researcher should submit the certificate of approval from the principal investigator’s REB using the Declaration of Multi-Institutional Research in the BU Research Portal.

Projects conducted by a researcher from another university with participants from Bishop’s (employees or students)

The researcher must submit to the Bishop’s REB the ethics protocol approved by their institution and the certificate of approval from the said institution when the collaboration of individuals affiliated with Bishop’s is required for the project. It could be at different stages of the project: recruitment, data collection, analysis, etc. In all other cases, Bishop’s REB approval is not required. The documents must be submitted by email to Raphaelle Mercier Gauthier (rmercier@ubishops.ca).

Research Ethics Board Guidelines and Forms

Research Ethics Board Guidelines and Forms

Deadlines: 1st of the month (September – June), or the following business day if the 1st of the month falls on a weekend or holiday. The REB meets on the second Friday of each month during the academic year. Minimal risk protocols submitted to the REB during the summer months will be given delegated review.

Please note that researchers must provide annual or final reports to the REB in regards to their completed or continuing projects. Extension request forms must be submitted when a research project extends over the approved protocol’s original end date. These forms, known as Event Form can be accessed by clicking on the relevant protocol under the Applications: Post-Review section of the BU Research Portal. Note that no work with human participants may continue if the researcher does not hold a valid ethics approval.

Release of funds

This form allows researchers to apply for the early release of funds to enable the initial phases of their work not involving human participants. It can be accessed by clicking on the relevant grant application to which the ethics protocol is linked, under the Applications: Post-Review section of the BU Research Portal. Note that no work with human participants can begin until a full protocol is submitted to the REB and approval is obtained.

Non-Disclosure Agreement

All research personnel, paid or unpaid, must sign the Non-Disclosure Agreement prior to beginning their work on a research project involving human participants.

Signature page for students submitting protocols in Romeo (PDF)

All students who submit a protocol to the Research Ethics Board must upload this signature page, signed and dated by their supervisor(s).

Supervisors: Please also note that the supervisor assumes responsibility for the scholarly review of their student’s submission. The REB reserves the right to reject any submissions that do not meet basic scholarly and disciplinary standards. If this happens, the supervisor and the student will be required the complete the TPCS2 Core Training, and provide their certificate when resubmitting. Any subsequent occurrences would result in the REB Chair issuing a formal letter, with a copy to the Department Chair. In such eventuality, the REB will be expecting a formal response from the supervisor.

Letters of consent / Lettres de consentement

These forms are designed to offer a standard template for obtaining participants’ informed consent. The letters of consent are available in both French and English.

English:
General
Online survey
Minors / Inapt adults

Français:
Général
Sondage électronique
Mineurs / adultes inaptes

Recruitment material (PDF)

This document is designed to offer a standard of the elements that should be found in recruitment material used to recruit participants.

Ethics Review Committee for Student Research Guidelines and Forms

Ethics Review Committee for Student Research Guidelines and Forms

Deadlines: 15th of the month (September – June), or the following business day if the 15th of the month falls on a weekend or holiday. The ERCSR meets on the last Friday of each month (September – June). Protocols submitted to the ERCSR during the summer months will be reviewed by the REB.

Undergraduate researchers must provide final reports to the ERCSR in regards to their completed projects. Final Report forms are available in the BU Research Portal under the Events tab associated with an approved ethics protocol.

Non-Disclosure Agreement

All research personnel, paid or unpaid, must sign the Non-Disclosure Agreement prior to beginning their work on a research project involving human participants.

Signature page for students submitting protocols in Romeo (PDF)

All students who submit a protocol to the Ethics Review Committee for Student Research must upload this signature page, signed and dated by their supervisor(s).

Supervisors: Please also note that the supervisor assumes responsibility for the scholarly review of their student’s submission. The ERCSR reserves the right to reject any submissions that do not meet basic scholarly and disciplinary standards. If this happens, the supervisor and the student will be required the complete the TPCS2 Core Training, and provide their certificate when resubmitting. Any subsequent occurrences would result in the REB Chair issuing a formal letter, with a copy to the Department Chair. In such eventuality, the REB will be expecting a formal response from the supervisor.

Letters of consent / Lettres de consentement

These forms are designed to offer a standard template for obtaining participants’ informed consent. The letters of consent are available in both French and English.

English:
General
Online survey
Minors / Inapt adults

Français:
Général
Sondage électronique
Mineurs / adultes inaptes

Recruitment material (PDF)

This document is designed to offer a standard of the elements that should be found in recruitment material used to recruit participants.

Research Internships Outside Bishop’s

Research Internships Outside Bishop’s

Bishop’s students have the opportunity to do internships at other universities within the core of their studies. When a project involves human participants, students must ensure that the supervisor at the host university has received all the necessary certificates to undergo their research project. Prior to undertaking their work outside Bishop’s, students must submit a Research Internship Outside Bishop’s form in the BU Research Portal. A copy of the host institution’s ethics certificate must be provided.

If the project involves human participants and cannot receive ethics approval from the host institution, students must submit a research protocol to the Ethics Review Committee for Student Research, via the Research Portal, before the works begins.

Video Tutorials for the Research Portal

Video Tutorials for the Research Portal

Video tutorial – BU Research Portal (faculty members):

Video tutorial – BU Research Portal (students):

For further information, please contact:

Cristian Berco, Ph.D.
Chair, Research Ethics Board
cberco@ubishops.ca
Office: Morris 23
819-822-9600 ext. 2412

Raphaëlle Mercier Gauthier, M.Sc.
Research Officer
rmercier@ubishops.ca
Office: McGreer 225
819-822-9600 ext. 2578