Ethics, Department of Health and Human Services (HHS), Clinical Trials

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

Health Care Compliance Association (HCCA) on 7/1/2025

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

FDA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials

Foley & Lardner LLP on 2/4/2025

The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more

HHS offers flexibility on human subjects protection regs during COVID-19 pandemic

Hogan Lovells on 4/15/2020

On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more

OHRP Releases Guidance for Institutions Conducting Human Subjects Research During COVID-19

Bass, Berry & Sims PLC on 4/10/2020

The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more

[Event] Regional Compliance & Ethics Conference - February 27th - 28th, Anchorage, AK

Society of Corporate Compliance and Ethics... on 2/6/2020

This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Health Care Compliance Association (HCCA) on 12/20/2019

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more