News & Analysis as of

National Institute of Health (NIH) Investigations

Health Care Compliance Association (HCCA)

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

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

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more

Health Care Compliance Association (HCCA)

NIH Disavows China Initiative, Offers ‘Trusted Asians’ Support But Cases, Questions Linger

In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

K&L Gates LLP on

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

Health Care Compliance Association (HCCA)

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

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

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2023

Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more

Akin Gump Strauss Hauer & Feld LLP

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

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 2. In This Month’s E-News: February 2023

Report on Research Compliance Volume 20, Number 2. (January 2023) -Hired under the Intergovernmental Personnel Act (IPA), staff referred to as IPAs assist the National Science Foundation (NSF) as temporary directors,...more

Health Care Compliance Association (HCCA)

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

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

Cohen Seglias Pallas Greenhall & Furman PC

More Than a Box to Check: The Importance of Making Specific Findings of Intent in Research Misconduct Cases

Stirrings in Congress in the early 1980s, initially led by a young Al Gore, Jr., focused on emerging concerns of misconduct in scientific research. Following public interest and the resulting congressional hearings, federal...more

Health Care Compliance Association (HCCA)

As NIH Strives to Reduce Sexual Harassment, Many Details Remain Hidden, Institutions Balk

Report on Research Compliance 18, no. 8 (August, 2021) - NIH is continuing to face pushback and questionable actions by institutions grappling with agency-funded “superstar” principal investigators (PIs) who sexually...more

Health Care Compliance Association (HCCA)

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

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