Introduction
The U.S. Food and Drug Administration (FDA) has taken a significant step towards ensuring the protection of human subjects in clinical investigations by releasing its final guidance for industry titled Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. This guidance, which supersedes the previous 1998 version and finalizes the 2014 draft guidance, aims to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical trials of FDA-regulated products.
Ensuring Ethical and Informed Participation
Informed consent is a fundamental principal of ethical clinical research, ensuring that participants fully understand a study’s purpose, procedures, potential risks, and benefits before deciding to participate. This new FDA guidance not only consolidates the agency’s recommendations on informed consent but also outlines regulatory requirements that contribute to safeguarding the rights and welfare of human subjects in clinical investigations.
What’s Inside the Guidance?
The guidance provides clear insights into FDA’s regulatory expectations for informed consent procedures and roles. It begins by offering comprehensive guidance on regulatory requirements, underscoring the responsibilities of IRBs, clinical investigators, sponsors, and the FDA concerning informed consent. The guidance then addresses commonly asked questions, clarifying doubts and promoting a thorough understanding of the process.
Staying Up-to-Date with Evolving Standards
Since the draft guidance was introduced in 2014, several revisions have been made to the Federal Policy for the Protection of Human Subjects, commonly known as the “2018 Common Rule.” This set of requirements aims to safeguard individuals participating in research supported by the Department of Health and Human Services (HHS) and other relevant federal departments and agencies. The FDA is diligently working to align its practices with the 2018 Common Rule while remaining consistent with other legal mandates.
Looking Ahead
The release of this new guidance underscores the FDA’s commitment to ensuring that clinical trials are conducted ethically and with the utmost respect for the rights and well-being of participants. However, it is important to note that the guidance does not address potential future changes to FDA’s informed consent regulations that could emerge from harmonization efforts with the 2018 Common Rule. The FDA retains the flexibility to amend this guidance to reflect any such developments or to address new inquiries about informed consent.
Guidance Practices and Flexibility
This guidance is issued in line with FDA’s good guidance practices regulation and represents the agency’s current perspective on informed consent. While it doesn’t establish binding rights for individuals or organizations, it offers valuable recommendations and suggestions. The term “should” in FDA guidance indicates suggestions or recommendations rather than strict requirements.
Conclusion
As the FDA continues to evolve its practices in line with contemporary ethical considerations and federal regulations, this new guidance serves as a crucial resource for all stakeholders engaged in clinical investigations of FDA-regulated products. By providing clarity on informed consent procedures and expectations, the FDA takes a substantial stride toward enhancing the integrity and ethics of clinical research.
