08/16/2023
Photo by Austin Schmid on Unsplash
The US Food and Drug Administration (FDA) published finalized guidance on “Informed Consent” August 2023. It finalized the “Informed Consent Information Sheet” which was previously in draft since July 2014 and supersedes the final guidance “A Guide to Informed Consent” from September 1998. It is applicable for IRBs, investigators, and sponsors. Since the 2014 draft guidance, the 2018 Common Rule (45 CFR 46 Subpart A) was published and the guidance “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations” was finalized. The 2018 Common Rule includes human subject protection requirements when participating in research that is conducted or supported by federal departments or agencies that have adopted the Common Rule. Informed consent requirements changed significantly.
The 2018 Requirements for informed consent include 1) changes to the content, organization, and how the information is presented in the informed consent form, 2) changes to the basic and additional elements of informed consent, and 3) changes to the informed consent process that ensures the participant has adequate information for making an informed decision. The Common Rule guidance mentions that there is no need for different consent forms for FDA versus HHS studies. The FDA is currently underway in harmonizing their regulations with the 2018 Common Rule.
The guidance includes the reminder that informed consent is more than a signature on a document but is a process of providing adequate information for the participant to make an informed decision, adequate time to have questions answered, and importantly, to continue to provide information during their participation in the study
Additional content on reimbursements related to coercion and undue influence are included in the final guidance, similar to what is included in ICH E6(R3) (Reasonable reimbursement of participants for travel and lodging is not typically coercive ICH E6(R3) Section 1.1.8, added in R3) and the information sheet “Payment and Reimbursement to Research Subjects” from January 2018.
The section of 10 additional considerations was expanded to 16 and presented as a frequently asked questions format. The questions include:
What are some considerations for enrolling a child into a clinical investigation?
Are there any additional protections required when enrolling children who are wards of the state?
What are some considerations for enrolling non-English speaking subjects?
What process should be followed when it is expected that subjects who do not understand English will be enrolled?
What process should be followed when the enrollment of subjects who do not understand English is not expected?
What should be considered when enrolling subjects with low literacy and numeracy?
What should be considered when enrolling subjects with physical or sensory disabilities?
What should be considered when enrolling adult subjects with impaired consent capacity?
Who can serve as a legally authorized representative (LAR) and what is their role?
How can informed consent be obtained through electronic methods?
Can a subject participate in more than one clinical investigation simultaneously?
How should data be handled when an enrolled subject decides to withdraw from a trial?
What steps should be taken to inform subjects when a study is suspended or terminated?
Should subjects be informed of aggregate study results at the completion of a trial?
Is informed consent required to review patient records?
How should subjects be informed of new information that may affect their willingness to continue participation in the research?
The final Informed Consent guidance begins to harmonize informed consent with the Common Rule and may be updated to provide additional harmonization. Does the final guidance impact the way your organization does informed consent? We would love to hear from you!
- The Clinical Pathways Team
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