News & Analysis as of

New Guidance Scientific Research

Bergeson & Campbell, P.C.

White House OSTP Issues Agency Guidance for Gold Standard Science 

On June 23, 2025, the White House Office of Science and Technology Policy (OSTP) announced that it issued agency guidance for implementing Gold Standard Science in the conduct and management of scientific activities. As...more

Akin Gump Strauss Hauer & Feld LLP

Restoring Gold Standard Science (Trump EO Tracker)

Orders the Director of the Office of Science and Technology Policy (OSTP Director) to issue guidance for agencies on implementation of “Gold Standard Science” in the conduct and management of their respective scientific...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

McDermott Will & Schulte

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Epstein Becker & Green

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more

Bass, Berry & Sims PLC

OSTP Issues Guidance to Agencies to Implement NSPM 33—Key Takeaways for Institutions Conducting Federally-Funded Research

Bass, Berry & Sims PLC on

On January 4, the White House Office of Science and Technology Policy (OSTP) issued guidance for federal agencies to implement National Security Presidential Memorandum 33 (NSPM 33). NSPM 33 was issued in January 2021 at the...more

Eversheds Sutherland (US) LLP

An apparent 180 degree turn by the Service with research credit claims

On January 3, 2022, the IRS Office of Chief Counsel released an interim guidance memorandum (the Interim Guidance), along with a set of FAQs, to provide IRS Examining Agents with procedural guidance for applying Field...more

Bass, Berry & Sims PLC

NIH Begins Implementation of OSTP Foreign Influence Recommendations for Research Institutions

Bass, Berry & Sims PLC on

As part of the government’s broader efforts to combat foreign threats to U.S.-funded scientific research, the National Institutes of Health (NIH) and White House Office of Science and Technology Policy (OSTP) have announced...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 9. In This Month's E-News: September 2020

Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

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