Free and Informed Consent

Procedure Number: 
003
Policy Number: 
3404
Responsibility: 
Vice-President, Academic
Approved: 
Vice President, Academic
Effective: 
November 17, 2009
Last Amended: 
September 10, 2014
Review: 
September 10, 2016
Procedure Statement: 

NOTE:   This Procedure is consistent with the Tri-Council Policy Statement TCPS2: Chapter 3, The Consent Process. 

1.     Consent Must Be Voluntary

Consent must be given voluntarily and, where feasible, may be withdrawn at any time. In considering the voluntariness of consent, REB’s and researchers should be cognizant of situations where undue influence or the offer of incentives may undermine the voluntariness of a participant’s consent to participate in research.

2.     Consent Must Be Informed

Subject to the exceptions in 6 and 7 below, researchers are required provide to prospective participants or authorized third parties, full and frank disclosure of all information relevant to free and informed consent. The following list is illustrative of the requirements needed for full disclosure. Where specific research merits other aspects of disclosure, there may be requirements above and beyond this list.

a.  Information that is being used to invite individuals to participate in a research project;

b.  A comprehensible statement of the research purpose, the identity of the researcher, the identity of the funder or sponsor, and the expected duration and nature of participation as well as a description of research procedures, and an explanation of the responsibilities of the participant;

c.  A comprehensible description of reasonably foreseeable harms and benefits, both to the participants and in general, that may arise from research participation, as well as the likely consequences of non-action, particularly in research related to treatment, or where invasive methodologies are involved, or where there is a potential for physical or psychological harm;

d.  An assurance that prospective participants are under no obligation to participate; have the right to withdraw at any time without prejudice to pre-existing entitlements; and throughout the course of the research will be given, in a timely manner, information that is relevant to their decision to continue or withdraw from participation;

e.  Information concerning the possibility of commercialization of research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors;

f.  The measures to be undertaken for dissemination of research results, and whether participants will be identified directly or indirectly;

g.  The identity of the qualified designated representative who can explain scientific or scholarly aspects of the research;

h.  Information on the appropriate resources outside the research team to contact regarding possible ethical issues in the research;

i.  An indication of who will have access to information collected on the identity of participants, descriptions of how confidentiality will be protected, and anticipated uses of data;

j.  Information on the circumstances under which the researcher may terminate the participant’s participation in the research;

k.  Information on any costs, payments, reimbursement for expenses or compensation for injury; and

l.  A statement to the effect that, by consenting, participants have not waived any legal rights.

3.     The Duty to Inform Is Ongoing

Free and informed consent must be maintained throughout participation in the research.

4.     Incidental Findings

In their research proposal, researchers must:

a.  Develop a plan for handling incidental findings that their research may reveal and submit their plan to the Research Ethics Board (REB); and

b.  Advise potential participants of the plan in writing for handling incidental findings in order to obtain free and informed consent.

5.     Consent Should Precede Research

a.  In general, research with human participants will begin only after the participants or their authorized third-party decision-makers have provided their free and informed consent.

b.  Although consent is not required from an organization in order to conduct research on that organization, as a courtesy JIBC researchers will be expected to inform organizations that they are undertaking such research.

c.  When conducting research on an organization, researchers are required to inform potential participants who work within that organization of the extent to which the organization is or is not collaborating with the research. Risk to participants from the organization will need to be evaluated in relation to the participants’ position of power within the organization.

6.     Consent May Not Be Required

The Research Ethics Board (REB) may approve a research proposal and may waive the requirement to obtain informed consent, provided that the REB finds and documents that:

a.  The research involves no more than minimal risk to the participants;

b.  The waiver is unlikely to adversely affect the well-being and welfare of the participants;

c.  The research could not practicably be carried out without the waiver;

d.  Whenever possible and appropriate, the participants will be provided with additional pertinent information after participation; and

e.  The waived consent does not involve a therapeutic intervention.

7.      Consent in Individual Medical Emergencies

Subject to all applicable legislative and regulatory requirements, research involving medical emergencies will be conducted only if it addresses the emergency needs of individuals involved, and then only in accordance with criteria established in advance of such research by the REB.

The REB may allow research that involves medical emergencies to be carried out without the free and informed consent of the participant or of his or her authorized third party, or power of attorney, if all of the following apply:

a.  A serious threat to the prospective participant requires immediate intervention;

b.  Either no standard efficacious care exists or the research offers a real possibility of direct benefit to the participant in comparison with standard care;

c.  Either the risk of harm is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the participant;

d.  The prospective participant is unconscious or lacks capacity to understand risks, methods and purposes of the research;

e.  Third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and

f.  No relevant prior directive by the participant is known to exist.

For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the REB will ensure that, as a minimum, the following conditions are met:

a.  The researcher must seek free and informed consent from an authorized third party and shall show how that consent will be sought from the authorized third party, as well as how the participants’ well-being and welfare will be protected;

b.  The authorized third party must not be the researcher or any other member of the research team;

c.  The ongoing consent of an authorized third party will be required throughout the participation in research of an individual who lacks capacity to consent on his or her own behalf; and

d.  When a participant who was entered into a research project through third-party authorization acquires or regains capacity during the course of the research, his or her informed consent will be sought as a condition of continuing participation.

Where free and informed consent has been obtained from an authorized third party and in those circumstances where a legally incompetent individual understands the nature and consequences of the research, the researcher must seek to ascertain the wishes of the individual concerning participation. The potential participant's dissent will preclude his or her participation.

8.     Consent Must Be Documented

Evidence of free and informed consent must be contained either in a signed consent form or in documentation by the researcher of other means of consent. Consent may also be demonstrated solely by the actions of the participant - for example, through the return of a completed questionnaire.

Last updated June 23, 2015