News & Analysis as of

Research and Development Ethics

Health Care Compliance Association (HCCA)

Their Terms Ended by Trump, SACHRP Members Form New Committee, Vow to Continue ‘Mission’

Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research...more

Mintz - Health Care Viewpoints

OHRP Workshop Highlights Artificial Intelligence Uses, Concerns in Human Research

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Health Care Compliance Association (HCCA)

What do burglars do on WFH Day?

Perhaps you haven’t pondered this question. On work-from-home days, do burglars break into their own homes? Or is this time spent doing research, preparing plans, taking online training courses on emerging best practices,...more

Health Care Compliance Association (HCCA)

Where’s the Proof? NSF OIG Provides Insights on Crafting That All-Important Investigation Report

Report on Research Compliance Volume 20, no. 10 (October, 2023) Please don’t send uncorrected transcripts of interviews conducted via Zoom or other means to the National Science Foundation (NSF) Office of Inspector General...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: October 2023

Report on Research Compliance Volume 20, no. 10 (October, 2023) The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its...more

Perkins Coie

Biden Administration Updates Roadmap for AI Research and Development

Perkins Coie on

The National Science and Technology Council (NSTC) recently bolstered the Biden administration’s continued focus on responsible artificial intelligence (AI) development by announcing an update to the National Artificial...more

Pillsbury Winthrop Shaw Pittman LLP

White House Announces Plan to Boost AI Research and Deployment

On May 23, the White House revealed three new steps advancing the research, development and deployment of AI technology nationwide. The Biden Administration has updated the National Artificial Intelligence R&D Plan for...more

Dickinson Wright

Keeping Pace in Clinical Research: The Common Rule Picks up Speed

Dickinson Wright on

In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more

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