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Regulatory Oversight › Institutional Review Board (IRB)

Health Care Compliance Association (HCCA)

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

Health Care Compliance Association (HCCA) on

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)

As AI-Assisted Research Advances, Experts Share Worries, Oversight Strategies; Collaboration Urged

Health Care Compliance Association (HCCA) on

At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more

K&L Gates LLP

Health Care Triage: Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

K&L Gates LLP on

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more

Bass, Berry & Sims PLC

GAO to Investigate PE-Backed Institutional Review Boards

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The Government Accountability Office (GAO) has agreed to investigate the operations of for-profit Institutional Review Boards (IRBs) following a request made by Senators Elizabeth Warren (D-MA), Sherrod Drown (D-OH), and...more

K&L Gates LLP

OHRP Provides Draft Guidance Regarding the Common Rule’s Public Health Surveillance Exclusion

K&L Gates LLP on

On November 19, 2018, the U.S. Department of Health and Human Services, Office for Human Research Protections (“OHRP”) announced the availability of additional draft guidance related to a new exclusion from regulatory...more

Hogan Lovells

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

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On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

Hogan Lovells

FDA and OHRP Finalize Joint Guidance on IRB Meeting Minutes

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Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more

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