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The Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms

When the current federal administration took office, it issued a memorandum requiring, among other things, that federal agencies delay the issuance of new or proposed rules to the Office of the Federal Register until further...more

The NIH IDC – Where Are We Now

On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced...more

FDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants

On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance titled “Key Information and...more

ORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct

On October 5, 2023, the U.S. Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) issued a Notice of Proposed...more

OHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 30

On July 1, 2022, the Office for Human Research Protections (OHRP) published a draft guidance document for public comment on the “Use of a Single Institutional Review Board for Cooperative Research” (“Draft Guidance”)....more

Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to...more

A Guide to Practical, Regulatory, and Reputational Risk Management

Ransomware Particularly Inflicts Health Care and Life Sciences Organizations - Ransomware is a malicious cyber threat vector that employs encryption malware to prevent users from accessing their systems and data unless...more

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