Informed Consent Process
The conduct of research involving human participants requires that participants are provided with the opportunity to give informed consent prior to their participation in the research. The process of obtaining this consent can be carried out in a number of ways, and where warranted, should be revisited during the research (where the research takes place over a prolonged period, or where information emerges during research that might influence a participant's decision to remain in the study).
Except in specific circumstances, informed consent must be obtained using a written consent form, which you review with participants and which you both sign prior to the start of the research. This document must provide research participants with sufficient information about the research to ensure that they understand the procedures or activities in which they will be involved, and the risks and potential benefits of the research. It must also inform them of their rights with respect to participation, i.e., that research participation is voluntary and that they have the right to withdraw at any time. The more risk that is posed to research participants by a given study, the greater the care and comprehensiveness of the consent process that will be required by the Institutional Review Board (IRB).
The specifics that are required for informed consent can be found in the Guide to Creating an Informed Consent and the Elements of Consent.
Examples of consent forms can also be found at:
Consent Form (pdf)
Oral Consent (pdf)
Where the research is particularly complex or poses significant risk, it is recommended that the consent form be provided to participants in advance of whatever activity they will be involved in (i.e., focus group, behavioral experiment, life histories) so that they have a chance to consider their participation prior to their arrival at the research venue.
Where different groups of participants will be involved in different aspects of the study, a consent form specific to each group's participation must be developed, to avoid confusion or misinterpretation.
In your application, you must describe the process that will be used to obtain consent, including who will do it, when it will be done (in relation to when the research will take place) and where it will be done.
In some specific instances, written and signed consent forms may not be culturally or contextually appropriate, and may actually constitute a risk to research participants, or may not be sensible where literacy limitations of participants are a concern. In these cases, oral consent may be appropriate and the procedures to be used in obtaining it and documenting it, along with the reasons why written consent is not appropriate, must be stated in your IRB application. In such cases, an information letter provided to the participant can ensure the accuracy and consistency of conveying necessary information to participants. This information would consist of the same Elements of Consent, however, without the requirement of a participant's signature. Instead, the investigator should either record consent (audio or video) or certify such consent has been obtained (see Oral Consent example (pdf)).
Waiver of Consent
Where there are specific situations where the IRB may waive the requirement for obtaining informed consent (written or oral). This may only be done when research falls under the "Exempt for Further Review" category of IRB review AND all of the following four conditions pertain:
- where the risks to participants are minimal
- where obtaining consent is practicably impossible
- where no therapeutic intervention is involved in the research,
- where the waiver does not violate the rights or well-being of the participants
You must demonstrate in writing in their application that these four conditions exist for the IRB to grant such a waiver.
Third-Party Consent Process
Where it is not clear that potential participants have the capacity to provide informed consent, or if the research participants are of a population recognized as lacking the capacity to provide informed consent (e.g., young children, adults under the influence of judgment-impairing substances), informed consent must be obtained from an individual who bears responsibility for decisions concerning the well-being of the participant (e.g., parent, caregiver, guardian, etc). In the case of children ages 6 to 18 who are not yet capable of legal consent a Child Assent form (pdf) must be used in addition to the Parent Consent form (pdf).
Where this impairment is temporary, you must describe how consent will be obtained from the participants when they are deemed to have regained decisional capacity. Where a participant lacking decisional capacity is able to provide assent for the research (i.e., express their willingness at the time of participating in the research), this should also be sought. Researchers must provide a description in the protocol of the criteria that they will use to judge either assent or dissent of a participant.
The process of obtaining consent is not limited to the initial discussion and signature of the consent form. During the course of the research, new information about the study, or knowledge regarding the risks of study participation may be learned which must be disclosed to participants. It is your responsibility to ensure that this is done. This would be achieved through:
- submitting an amendment to the Institutional Review Board describing the changes to the recruitment/consent process, and
- informing and reconfirming consent of those currently involved in the study, and
- modifying the consent process/form for new participants
In some circumstances (e.g., aboriginal research) it may be important to seek consent from the community as a whole in addition to getting consent from individual participants. It is your responsibility to consider whether this is needed, and if so, to describe how such consent will be sought.