Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors – August 2023, Good Clinical Practice
The FDA recently issued a new guidance, entitled “Informed Consent – Guidance for IRBs, Clinical Investigators, and Sponsors – August 2023, Good Clinical Practice”. This blog summarizes key points and frequently asked questions of this guidance.
High Level Review of Key Components
“This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent Information Sheet,” issued in July 2014. This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.”
The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998. 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.
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 and/or their legally authorized representative, and
• avoiding the use of exculpatory language on consent forms.
To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form; however, obtaining documentation of a subject’s informed consent is only part of the consent process.
Informed consent involves the following components:
• providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment,
• facilitating the prospective subject’s understanding of the information,
• providing adequate opportunity for the prospective subject to ask questions and to consider whether to participate,
• obtaining the prospective subject’s voluntary agreement to participate prior to enrollment, and
• continuing to provide information as the clinical investigation progresses or as the enrolled subject or situation requires.
The Guidance discusses the basic elements of informed consent, and addresses describing the clinical investigation, explaining the risk as well as the benefits of the treatment to patients, and compensation and medical treatment in the event of an injury.
It 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 different 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.”
The Guidance now includes 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.”
It 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.
Conclusion & Final Thoughts
The release of this new guidance highlights the FDA’s commitment to ensure that clinical trials are conducted ethically and with the utmost respect for the rights and well-being of participants. This new guidance serves as a key resource for all stakeholders engaged in clinical investigations of FDA-regulated products by providing clarity on informed consent procedures and expectations. It offers valuable recommendations and suggestions with the term “should” being used in the Guidance. To learn more, click here to read the Guidance in full.