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Department of Health and Human Services (HHS) Regulatory Requirements Office for Human Research Protections (OHRP)

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

McDermott Will & Schulte

FDA, OHRP Issue Joint Guidance on Collection of Tissue Biopsies in Clinical Trials

On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more

Ropes & Gray LLP

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

Ropes & Gray LLP on

On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

Holland & Knight LLP

HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations

Holland & Knight LLP on

The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more

Health Care Compliance Association (HCCA)

After GAO Report, OHRP Asks SACHRP to Tackle Elusive Goal: Define, Measure IRB Effectiveness

After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more

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