General Considerations
The process of free and informed consent refers to the dialogue, information sharing and general process through which prospective participants decide to participate in research involving themselves. (Tri-Council Policy Statement, Chapter 3)
The guidelines below have been developed based on the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) to describe specific procedures required by RITHIM when researchers are obtaining free and informed consent from prospective participants.
Process to Obtain Consent
Informed consent must be obtained from the prospective participant or if the participant is not able to give consent, from the participant’s legally acceptable representative (LAR) (e.g., parent, guardian or designated other) prior to involvement in any research related activity. Written evidence of informed consent should be obtained and must be obtained in the case of biomedical clinical trials. If an alternative to written evidence is proposed, the researcher must justify in their Harmony Health Research Application why written evidence will not be obtained.
The informed consent process begins when a member of the research team has the first contact with the potential participant or the LAR and continues through the course of the project. The initial contact should involve a discussion where a member of the research team gives information in simple, non-technical language that suits the individual’s level of understanding and provides adequate opportunities for the individual to ask questions and contemplate participation. After the exchange, the individual should be presented with an informed consent form and given sufficient time to read the form before deciding on participation.
Prior to obtaining consent, whether it is written or verbal, the research team member must ensure the prospective participant, or the LAR adequately understands the purpose of the research project, the nature and extent of the participation, and the risks involved. If the risk is high or the issues are complex it may be necessary to administer a series of oral or written questions to confirm comprehension.
To obtain written evidence of consent, have the potential participant or LAR initial each page of the informed consent form and sign the final page where indicated. The research team member obtaining consent must sign the form as well. If involved in the informed consent process, an impartial witness and/or interpreter is required to sign the informed consent form. Each signatory is to date their own signature.
The participant or LAR should receive a copy of the signed informed consent form for their records.
Who Can Obtain Consent
Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion. The TCPS 2 clearly instructs research ethics committees to pay particular attention to the elements of trust and dependency, for example with the doctor/patient or professor/student relationships, as these can impose undue influence on the individual in the position of dependence to participate in research projects (TCPS 2, Article 3.1).
For these reasons, CHIPER has concluded:
a) When the Principal Investigator is also the treating physician or clinician (nurse, social worker, etc.) the informed consent process must be supervised and conducted by an individual, who is not involved in providing medical care to the individual. Similarly, a teacher or supervisor must not obtain consent from their students or employees. The Principal Investigator remains responsible for ensuring the delegate conducting the free and informed consent process is trained and knowledgeable in all aspects of the project.
b) In special circumstances, (e.g., emergency situations when there may be insufficient time to contact the designated delegate), the Committee may consider an alternative to the recommended process of informed consent when it can be ascertained by the Principal Investigator that there is no individual other than the treating clinician/teacher/supervisor who is adequately trained in all aspects of the project to conduct the informed consent process. The Investigator must make this request through Harmony in their initial submission justifying the reasons and describing the process that ensures the prospective participants clearly understand the research role of their clinician/teacher/supervisor and that refusal to participate would not damage the therapeutic relationship or result in the withholding of health/educational services or affect performance appraisals. When the research is not time-sensitive, an alternative approach may involve the treating clinician/teacher/supervisor initially explaining the procedures and risks of the project, followed by the delegate obtaining the actual consent of the individual. The suggested approach is an attempt to avoid the potential for undue coercion or misconception of the intended research component when the treating clinician/teacher/supervisor obtains consent.
Participant Withdrawal
If a participant withdraws consent, retain the original informed consent form in the research file and make a note that the participant withdrew from the project. Participants must never be required to sign a document indicating their desire to withdraw or specifically required to notify the researcher in writing of their intent to withdraw. The participant’s verbal acknowledgement of withdrawal must be honored.
It is acceptable for the research team to ask questions to ascertain the level of participant withdrawal (e.g., withdrawal from treatment, procedures, long-term follow-up or all future contact). The discussion regarding the level of withdrawal should be documented by the research team.