Investigations, National Institute of Health (NIH), Department of Health and Human Services (HHS)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

Health Care Compliance Association (HCCA) on 5/9/2025

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

Long-Awaited Changes to Research Misconduct Rules Have Arrived

K&L Gates LLP on 10/1/2024

On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Health Care Compliance Association (HCCA) on 11/27/2023

Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Research Security: New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks & Research Data With the U.S. Prime...

Akin Gump Strauss Hauer & Feld LLP on 9/27/2023

On September 15, 2023, the National Institutes of Health (NIH) moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation...more

Report on Research Compliance Volume 20, Number 1. With Greater Than Half Its Positions Vacant, OHRP Employing More Technology,...

Health Care Compliance Association (HCCA) on 12/28/2022

The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more

Report on Research Compliance Volume 18, Number 3. In This Month's E-News: March 2021

Health Care Compliance Association (HCCA) on 2/24/2021

Report on Research Compliance 18, no. 3 (March 2021) - ◆ A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct...more