Participant Review Board PRB Forms
Informed Consent Instructions
Prior to conducting research with human participants (except when the research involves only anonymous surveys, naturalistic observations, or similar procedures), researchers enter into a social contract with participants, clarifying the nature of the research and what participants can expect to experience during the course of the study. Participants are informed of all features of the research that might influence their decision to participate. Researchers are to respect participant decisions to decline or discontinue participating in the research at any time for any reason and without penalty. Where possible, researchers make reference to participants' rights along these lines in their consent forms. It is the researchers' responsibility to protect human participants' rights and welfare at all times, including their right to have enough information about the study to make an informed decision as to whether or not they want to participate. Investigators are required to provide prospective participants with sufficient information and opportunity to consider that information. Every written consent form should obtain a statement of the participants' rights.
Basic elements of consent forms are summarized below:
- Introduction: This should include an invitation to the participant to participate, a statement that the study involves research, and who is conducting the study.
- Background: This should include the purpose of the study, relevant research questions, and brief background information on research that has been done in the area. All research terms should be well defined, the key elements of the research process indicated, and any experimental drugs or devices explained (if applicable).
- Duration: Participants should be informed of an estimate of the total amount of time the participant would expect to be involved in the study.
- Procedures: Explain tasks and procedures from the participant's point of view. Describe what the participant will be required to do in lay terms. If applicable, explain how participants are assigned to groups, including an explanation of the term "random assignment." For survey research, indicate that not all questions have to be answered. If applicable, identify additional procedures due to "research" participation (e.g., data collection instruments) separate from "treatment" (e.g., intervention) procedures. Be sure all procedures are explained and terms defined at an eighth-grade level.
- Risk/Benefits: Honestly explain risks, hazards, or discomforts, including the likelihood of risk. Describe any benefits to the participant and to society. If there are significant risks to participation, tell the participant under what conditions the study will be terminated. If applicable, identify the risks associated with being in the control group. Describe any inducement/compensation the participant will receive for participation.
- Confidentiality: Indicate that the data will be kept confidential and any limitations that there are to such confidentiality. Specify how long data will be retained until they are destroyed. If tape recordings or videotapes are to be made, explain who will have access and if they will be used for educational purposes, and when they will be destroyed.
- Voluntary Nature of the Study: A statement that participation is voluntary, and that refusal to participate (or the decision to discontinue participation) will not lead to any penalty or loss to which participants are otherwise entitled. This section should specify that the participant may discontinue participation at any time without penalty.
- Contacts and Questions: An explanation of whom to contact for answers to relevant questions about the research and/or participants' rights, and who to contact in the event of an injury related to the research.
- Compensation: Include a statement regarding compensation for injuries for studies involving physically invasive procedures.
- Statement of Consent: Provide a signature line for the participant and the person who is witnessing the participant consent. Parental signatures are required if the participants are children. Give the participant a copy of the signed consent form.
Additional elements of the informed consent form might include the following:
- A statement that the procedure(s) may involve risks that are not currently anticipated.
- References to circumstances under which the researcher may discontinue the participant's involvement without consulting the participant himself or herself;
- Reference to any additional cost to the participant that may result;
- A statement that significant new findings developed during the course of the study may relate to the participant's willingness to continue involvement