FDA issues final guidance on obtaining informed consent in drug and device clinical trials

The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors comply with informed consent regulations for clinical investigations.

The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998. (RELATED: FDA Revises Policies on Obtaining Informed Consent in Clinical Trials, Regulatory Focus 15 July 2014).

The agency announced that it is engaging in separate efforts to harmonize this guidance with the 2018 Common Rule on federally funded clinical trials, and this guidance may be updated to incorporate these changes (RELATED: FDA seeks to harmonize human subject protections with revised Common Rule, Regulatory Focus 27 September 2022).

The document provides general guidance for informed consent, covering exceptions to informed consent, avoiding coercion and exerting undue influence on subjects, how to make language understandable to the subject or the legally authorized representative, and avoiding the use of exculpatory language on consent forms.

It also discusses the basic elements of informed consent, which addresses describing the clinical investigation, explaining the risk and discomforts as well as the benefits of the treatment to patients, and compensation and medical treatment in the event of an injury.

The guidance also addresses the roles of IRBs, clinical investigators, sponsors, and the FDA in the informed consent process, followed by a series of frequently asked questions.

Changes from the draft guidance include new language on examples of coercion and undue influences. For example, FDA “does not consider reimbursement for reasonable travel expenses to and from the clinical trial site (e.g., airfare, gas, tolls), and associated costs such as parking and lodging, to raise issues related to coercion and undue influence.”

It also adds that “reimbursement for other expenses may be considered by an IRB on a case-by-case basis, and IRBs should consider whether the proposed remuneration could be an undue influence. Payment for participation in research should be just and fair.”

The final version also includes additional text under the section on “financial relationships and interests” which specifies additional responsibilities of the IRB with respect to financial arrangements.

It states that “although the clinical investigators should consider these issues regarding financial relationships and interest, IRBs have the final responsibility of determining whether subjects should be provided with information regarding the source of funding, funding arrangement, or financial interests of parties involved in the clinical investigations as part of the informed consent process.”

The revision also includes new frequently asked questions which address the following:

considerations for enrolling children in a clinical investigation;
whether additional protections are required when enrolling children who are wards of the state;
considerations for enrolling non-English speaking subjects;
enrolling subjects with low literacy and numeracy;
enrolling subject with physical or sensory disabilities;
considerations for enrolling subjects with impaired consent capacity,
who can serve as a legally authorized representative;
obtaining informed consent through electronic means; and
whether subjects should be informed of aggregate study results at the conclusion of trials.

Guidance

Notice

FDA issues final guidance on obtaining informed consent in drug and device clinical trials

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