Guidance: Informed Consent Process
Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if they are to make an informed decision. We ensure respect for persons by providing information needed for thoughtful consent for a voluntary act.
Informed consent is an ongoing process that begins with recruitment and continues through the completion of the study.
The first step is to provide potential subjects with general information about the nature of the study and why they might be suited to participate. The recruitment flyers, websites, and phone scripts are part of this process. All recruitment materials must be reviewed by an IRB prior to implementation.
Once someone indicates interest in joining a study, details should be presented by a study team member who is knowledgeable about both the study and informed consent.
- Provide information about the research in language the subject can understand. Encourage questions and query for understanding. Note that for children (see Guidance about children) and for those who do not understand written English language documents, this requires additional steps (which require IRB approval). See the IRBMED's guidance for non-English speaking/reading subjects.
- Provide an explanation of the difference between treatment and research.
- Provide time for subjects to consider all options. The riskier the study, the more time that is usually required.
- Provide answers to all of the subject's questions before the decision is made.
- Provide documentation about the research (including calendars, instructions, etc.) that the subject can refer to later. A copy of the consent document must be provided to the subject (or the subject’s legally authorized representative) and the original signed consent document should be retained in the study records. Note that the regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred. All materials provided to subjects need IRB approval.
- Provide on-going opportunities to re-affirm consent throughout the study. Remind the subject about important information. Provide new information as it becomes available. Ask the subjects if they still want to participate. Document these interactions.
At each study visit encourage subjects to ask questions and raise concerns. Thus, informed consent becomes an ongoing, interactive process, rather than a one-time information session. Following good clinical practice (GCP) these discussions should be recorded in the subjects' records.
Important note for UMHS studies: A copy of the complete (every page) signed consent form should be placed in the UM medical record of subjects, particularly when the research intervention may affect other treatment or care (in most cases this means scanning the document into CareWeb). However, doing so may not be appropriate in all cases (for example if identification of the subject as a study participant might put the subject at risk of criminal prosecution or harm to reputation).
- Office of Human Research Protections (OHRP)
- National Cancer Institute, 'A Guide to Understanding Informed Consent'
- Food and Drug Administration (FDA)
Original 7-1-05, Updated 7/24/2012