The TPH REB has developed an Informed Consent Checklist to assist researchers in developing information/consent forms and processes which address key elements of informed consent. The Principal Investigator is required to submit the completed checklist when they submit a research proposal for TPH Research Ethics Review
The following information is primarily based on the requirements outlined in the TCPS2 (2014) Ch.3. It includes general information about the process and requirements for obtaining initial and ongoing consent from research participants or their authorized third parties, information about requirements for documenting consent, and special situations where these requirements may be altered. In addition to meeting the requirements outlined in the TCPS2 researchers are responsible for ensuring that all applicable legal and regulatory requirements are met.
What is informed consent?
Informed consent is voluntary consent given by a research participant after the participant has been adequately informed about the research project in plain language.
Research participants must have the capacity to provide informed consent. Assessing capacity involves determining whether a prospective participant sufficiently understands the nature of the research project and associated risks, consequences, and potential benefits.
A person may have diminished capacity but still be able to participate in certain types of research. Researchers must involve participants who lack the capacity to consent on their own behalf as much as possible in decision making when seeking consent from an authorised third party in accordance with the best interests of the prospective participant. (See Section 7c, Articles 3.9, 3.10, and 3.11 in Ch.3 of the TCPS2 (2014).
Provision of consent is an ongoing process. Researchers have a responsibility to provide participants and authorised third parties, if relevant, with all information relevant to participants’ ongoing consent to participate in research and to inform participants of changes in the project that may affect them, particularly those that affect the risks or potential benefits of the research.
In clinical trials information should also be provided about stopping rules (i.e., statistically significant end points and safety considerations determined in advance, which, once reached, dictate that the trial must be terminated) and when researchers may remove participants from the trial (e.g., participants who are not following procedures; safety reasons).
How should the information be provided?
This information can be conveyed in a variety of ways. For example, written information may be supplemented with audio/visual aids/visual presentations; intermediaries with language skills may share information.
Prospective participants should be provided with adequate time to assimilate the information provided and pose questions before deciding whether or not to participate. The amount of time required depends on factors such as:
- the magnitude and probability of harms
- the complexity of the information provided
- the setting in which the information is given
How should consent be documented?
Participants’ written consent is the most common means of demonstrating consent. However, in some types of research and for some groups/individuals other means of providing consent can be used (e.g., oral consent, completion of a questionnaire, a verbal agreement, a handshake, or, in some cultures, the giving and receiving of gifts which symbolizes the establishment of a relationship comparable to consent).
Where there are valid reasons for not recording consent in writing, the procedures to seek and obtain consent must be documented.
It may be advisable to leave a written statement of the information conveyed in the consent process with the participant. However, researchers should not leave any documentation with participants if it may compromise their safety or confidentiality or if it does not align with cultural norms.
Alteration of Consent in Special Situations
1. Certain Types of Minimal Risk Research
The REB may approve research without requiring the researcher to obtain participants’ consent if all of the following apply:
- the research involves no more than minimal risk to participants
- the research does not involve a therapeutic/clinical/diagnostic intervention
- lack of consent is unlikely to affect the participant’s welfare
- it is impossible or impracticable (i.e., would pose undue hardship that jeopardizes the conduct of the research) to carry out the research and answer the question properly, given the research design, if participants’ prior consent is required
- the researcher indicates that whenever possible and appropriate, after participation or at a later time during the study, participants will be debriefed and provided with additional pertinent information at which point they will have the opportunity to refuse consent
2. Studies Involving Partial Disclosure or Deception
If studies involve partial disclosure or deception and an alteration to the requirement for prior consent has been allowed, participants must be able to indicate their consent or refusal at the conclusion of the project following debriefing.
If participants express concerns about their participation, the researcher may provide the option of removing data. If the research proposal does not permit the withdrawal of data, the identity of participants shall be protected at all times during and following the completion of the project.
Participants who express concern about the conduct of the project at the time of debriefing or the limits imposed on withdrawing their data should be given the contact information for the REB(s) that approved the research. Researchers must report any concerns about the conduct of the project raised by participants at the time of debriefing to the REB.
Please note: In clinical trials neither the participants nor the researchers know the treatment arm to which the participant is allocated. As long as participants are informed of the probability of their assignment to each arm of the trial, this random and blind assignment does not constitute a waiver or alteration of consent.
3. Secondary Use of Identifiable Information
Researchers who have not obtained consent from participants for secondary use of identifiable information (i.e., information originally collected for a purpose other than research) shall only use the information for research purposes if they demonstrate to the REB that:
- identifiable information is essential to the research
- use of the identifiable information without the participant’s consent is unlikely to adversely affect the welfare of the participants
- appropriate measures will be taken to protect the privacy of individuals and to safeguard the information
- the researchers will comply with any known preferences previously expressed by individuals about any use of their information
- it is impossible or impracticable (i.e., undue hardship/onerousness that jeopardizes conducting the research (e.g., very large group, members likely to be deceased, geographically dispersed or difficult to track, or tracking may raise additional privacy concerns)) to seek consent
- any other necessary permission for secondary use of information for research purposes has been obtained (See Ch.5, section D of the TCPS2 (2014)
4. Critical Inquiry
When social sciences or humanities researchers seek information that critiques or challenges the policies or practices of institutions, organizations, governments, interest groups, corporations, or other entities researchers do not need to seek their permission to proceed with the proposed research. This is because failure of the institution, organization, government, interest group, corporation, or other entity to endorse the research should not be a barrier to receiving ethical approval. However, the researcher needs to inform prospective participants: (a) that organizational permission has not been obtained, (b) about the views of the organization regarding the research, if these are known and (c) of any foreseeable risks associated with their participation.