News & Analysis as of

Scientific Research Regulatory Requirements

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

Sheppard Mullin Richter & Hampton LLP

Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Health Care Compliance Association (HCCA)

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

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

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

McDermott Will & Emery

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

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 9th, 8:00 am - 5:00 pm CT

Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more

K&L Gates LLP

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

K&L Gates LLP on

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more

Jones Day

UK Government Publishes Third Climate Change Risk Assessment January 17, 2022

Jones Day on

Three months after hosting the COP26 climate summit in Glasgow, and as required by the Climate Change Act 2008, the UK government published its third five-year risk assessment of climate change on the United Kingdom. This...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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 1. In This Month's E-News: January 2021

Report on Research Compliance 18, no. 1 (January 2021) - The National Science Foundation (NSF) will be accepting comments on a revised version of its Proposal & Award Policies & Procedures Guide (PAPPG) expected to be...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - June 1st - 3rd

Due to the COVID-19 pandemic, our Research Compliance Conference will be held virtually. Attendees will enjoy Research compliance sessions and industry updates in an interactive, online experience, plus have the opportunity...more

Polsinelli

Animal Testing to Decrease with New EPA Rules

Polsinelli on

The United States Environmental Protection Agency made two moves recently to reduce the use of animals in chemical testing and pesticide registration: One under FIFRA and one under TSCA. ...more

14 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide