FDA issues Final Guidance on Informed Consent

The U.S. Food and Drug Administration (FDA) issued the final document, "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors". The guidance provides the FDA's recommendations regarding informed consent and describes regulatory requirements to help assure the protection of the rights and welfare of clinical trial participants. The document finalizes the draft guidance entitled, "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors," issued on 15 July 2014, and supersedes FDA's guidance entitled, "A Guide to Informed Consent," issued in September 1998.

Responsibilities for Informed Consent

According to the agency, the guidance is intended to assist institutional review boards (IRBs), clinical investigators and sponsors involved in clinical trials in carrying out their responsibilities related to informed consent. IRBs, clinical investigators, and sponsors share responsibility for ensuring that the informed consent form and process is adequate and meets FDA's regulatory requirements. Following are the specific areas that should be considered.

The IRB is responsible for:

  • Review of all informed consent materials (including recruitment materials, such as advertisements, and information provided in addition to the informed consent form), for adequacy and appropriateness of wording and use of standardized language.
  • Review of the consent process.
  • Review of updated informed consent documents.
  • Identification of revised consent forms. The IRB should ensure that there is a way to identify a revised consent form so that continued use of a previously approved version does not occur.

The Clinical Investigator is responsible for:

  • Obtaining the legally effective informed consent of subjects. If the investigator delegates this responsibility, FDA expects that the individual to whom the responsibility is delegated be qualified by education, training, and experience to perform this activity.
  • Considering the potential effects that a financial relationship might have on the clinical trial or on interactions with subjects.

The Sponsor is responsible for:

  • Considerations for multicenter clinical trials. For these trials, changes may need to be made to the consent form to address local and institutional requirements. For changes that affect the rights, safety, or welfare of the subjects, the FDA expects the sponsor to share the revisions with all investigators and their IRBs.
  • Sponsor personnel providing technical support and/or recording study-related information for the test article (e.g. a medical device). If sponsor personnel will be present during the procedure or follow-up, or if the activities of the sponsor personnel directly affect the subject, those activities should be described in the informed consent form.

For more information please see FDA's document Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors.

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