Obtaining Informed Consent from human subjects is often thought of as simply getting a signature from participants on the consent form. Obtaining a signed consent form, however, is only part of an ongoing process of obtaining Informed Consent from participants throughout the entire span of their participation in the research.
Simply providing participants with the Required Elements of Informed Consent and obtaining a signature or verbal affirmation is not enough to satisfy the conditions for informed consent. Investigators have an ethical responsibility to go the distance and assess whether or not the participant understands the information presented, has the ability to give consent, and is free to make a voluntary choice. The process described below is meant to be a useful tool for reminding investigators of their ethical obligations and aiding them in creating an open dialogue between themselves and participants.
The 3 C's
The process of consent might best be conceptualized by the 3 C's: Contact, Conversation, and Confirmation.
Contact: In planning the consent process, investigators need to consider how to initiate contact with participants in a way that is non-intrusive.
Conversation: Investigators also need to determine when and how to discuss participation. When the research is complex or involves more than minimal risk, a discussion should occur well in advance of the actual research intervention and should include a description of what participation would involve. Potential participants should then be left to contemplate the conversation and given sufficient time to decide if they want to participate.
Confirmation: The investigator needs to confirm that an individual understands the research project, is capable of giving consent, and is, in fact, willing to participate. Keep in mind that a signature on a consent form is no guarantee that a participant comprehends the content. Investigators should be proactive in this regard, by probing participants with questions that elicit more that just "yes" or "no"; questions like, "Please tell me what you understand your participation to involve," etc.
According to regulations, "informed consent" refers to the knowledgeable agreement of an individual or her/his representative whereby she or he exercises free choice without any undue inducement or any element of force, fraud, deceit, duress, or other kinds of constraint or coercion. Put simply, there are three key conditions which must be satisfied in order for the participant's verbal or documented consent to be valid:
- The participant must be provided with essential information, (see "Required Elements" below)
- The participant must have the capacity to understand the information, and
- The participant must have the freedom to make a voluntary choice about participation.
In order for participants to be able to give Informed Consent to participate in research, they must be provided with sufficient information about the research in order to make an informed decision about whether or not they wish to participate. To ensure that participants are provided with sufficient information, the IRB requires that the following information be conveyed to potential participants:
- The purpose of research
- The expected duration of participation and the procedures involved in participation. (NOTE: It is very important that participants be told exactly what they will be asked to do if they participate in the research.)
- Any foreseeable risks and discomforts
- Any potential benefits to the participant or to society, if the research will not offer any direct therapeutic benefits to participants
- Procedures for protecting the confidentiality of personal information about the participants and any limits to the confidentiality (NOTE: It is important to keep in mind that participants have a right to know how their information will be protected. In addition, if there are circumstances under which information about them might be shared with others, they have a right to be informed of this.)
- A statement indicating that participation is voluntary and that a refusal to participate will involve no penalty. Participants should also be informed that they are free to discontinue participation at any time without penalty.
- Who they may contact if they have questions about the research (usually this is the investigator) or about their rights as a participant in research (typically the Research Services Compliance Manager)
- Other information that may be relevant to their participation, such as any costs to the participant or compensation provided, alternatives to participation, etc.
All of these elements must be communicated to all participants, unless the Investigator has an approved Request for Waiver of Informed Consent or Elements of Informed Consent.