Each day, numerous individuals contribute to scientific research, yet understanding the complexities and implications of participation can be challenging. In response, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections have introduced a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent,” aiming to streamline the comprehension of informed consent forms. The guidance proposes two key requirements under the revised Common Rule:
- emphasizing the presentation of essential research information clearly and concisely;
- ensuring that the entire informed consent process promotes comprehension of participation rationale.
Stakeholders, including research sponsors, investigators, and institutional review boards (IRBs) who wish to provide feedback towards refining the informed consent process should review the draft guidance and submit their feedback by April 30, 2024.
Access the full text and draft guideline here.
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
- No official support by any organization(s) has been provided or should be inferred
