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# Califf Discusses More Clinical Research Options
- URL: https://www.fdaweb.com/califf-discusses-more-clinical-research-options/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156030

FDA commissioner **Robert Califf** used an *FDA Voices Catching Up with Califf* [column](https://www.fda.gov/news-events/fda-voices/increasing-options-clinical-research-facilitate-medical-product-development?ref=fdaweb.com) to discuss the agency’s work to harmonize clinical research regulations and facilitate the development of medical products to benefit public health. In the column, he writes that FDA has taken several steps to advance clinical research and ultimately promote the generation of evidence needed to demonstrate medical product safety and effectiveness.

Califf also says the agency is working to harmonize its human subject protection regulations, where appropriate, with the HHS common rule, the set of federal rules that protect people who participate in research.

The column cites an FDA final rule to help advance medical product development without compromising the rights, safety, and welfare of clinical research participants. Califf says the rule “provides an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the people participating in the research, and the research includes appropriate safeguards to protect the rights, safety, and welfare of participants.”

He says FDA anticipates the new rule will enable minimal-risk research that would not be practicable otherwise. It could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.

“Studies conducted with a waiver or alteration of informed consent under this final rule could result in more treatment and diagnostic options without compromising the rights, safety, and welfare of people participating in these studies,” Califf concludes.