News & Analysis as of

Life Sciences The Common Rule

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. In This Month’s E-News: December 2022

The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

Bass, Berry & Sims PLC on

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

McDermott Will & Emery

European Data Protection Supervisor Issues Opinion on Conducting Research Involving European Personal Data

McDermott Will & Emery on

The European Data Protection Supervisor, the independent European Union authority responsible for data protection regulatory oversight, issued a preliminary opinion on data protection and scientific research. The Opinion...more

McDermott Will & Emery

California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

McDermott Will & Emery on

On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more

Verrill

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

Verrill on

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more

Nelson Mullins Riley & Scarborough LLP

A Framework for Readying Your Institution for Complying With the Revised Common Rule

Earlier this year, the long-awaited revision to the Federal Policy for the Protection of Human Subjects, known as the ‘‘Common Rule,’’ was published in the Federal Register (the ‘‘Final Rule’’). 82 Fed. Reg. 7149 (Jan. 19,...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

King & Spalding

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

King & Spalding on

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

Mintz - Health Care Viewpoints

The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The...more

Cooley LLP

Blog: “Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

Cooley LLP on

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more

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