News & Analysis as of

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

Davis Wright Tremaine LLP

Is AI Development "Research" Under HIPAA?

Continued advancement in artificial intelligence offers great promise to improve health care. But AI feeds on tremendous amounts of data, and using protected health information (PHI) to develop or improve AI often involves...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. With Greater Than Half Its Positions Vacant, OHRP Employing More Technology,...

The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...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

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

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On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

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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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more

K&L Gates LLP

Health Care Triage: When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives

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In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining...more

BCLP

Implications of CCPA and CPRA on Clinical Trial Data

BCLP on

Given the recent updates to CCPA, and the possible approval of California Privacy Rights Act (CPRA) which is on the November 3 ballot, it is increasingly likely that personal information collected in the course of clinical...more

Bradley Arant Boult Cummings LLP

Governor Approves CCPA Amendment to Further Except Healthcare and Research Information

Gov. Gavin Newsom recently approved A.B. 713, a bill that creates further CCPA exceptions for healthcare and research information. The bill is especially potent in the COVID-19 era where the need for medical research is...more

Bass, Berry & Sims PLC

OHRP Finalizes Guidance on Elimination of IRB Review of Research Applications and Proposals

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Today, the Office for Human Research Protections (OHRP) will publish a notice in the Federal Register that its “Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018...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

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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

Foley & Lardner LLP

FDA’s Response to HHS’ Revised Common Rule: Four Things to Know

Foley & Lardner LLP on

In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

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Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Hogan Lovells

FDA aims to harmonize its human subject protection regulations with Common Rule

Hogan Lovells on

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  ...more

K&L Gates LLP

FDA Releases Guidance on How Recent Changes to the Common Rule May Impact FDA-Regulated Clinical Trials

K&L Gates LLP on

On October 12, 2018, the U.S. Food and Drug Administration (“FDA”) released a guidance document titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations,” (the “Guidance...more

Bricker Graydon LLP

Clinical research compliance alert: Common Rule update - Additional proposed delay

Bricker Graydon LLP on

The Department of Health and Human Services (HHS) and 16 other federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) proposing to delay the compliance date for updates to the Common Rule for an...more

K&L Gates LLP

Federal Agencies Propose to Further Delay Implementation of Sweeping Revisions to the “Common Rule”—but Offer Incentives for...

K&L Gates LLP on

On April 20, 2018, as anticipated, 17 federal departments and agencies (the “Agencies”) issued a notice of proposed rulemaking (“2018 NPRM”) in which the Agencies propose a six-month delay to the general compliance date for...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

Shumaker, Loop & Kendrick, LLP

Client Alert: U.S. Department of Health and Human Services ("HHS") Delays Effective and Compliance Date for the Revised Common...

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” was originally published in 1991 and has been adopted and codified in separate regulations by HHS and 15 other federal departments and agencies. ...more

Bricker Graydon LLP

Clinical research compliance alert: Common Rule updated, effective date delayed

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The U.S. Department of Health and Human Services has delayed the effective and compliance date for the updates to the Common Rule for six months from January 19, 2018, until July 19, 2018. The updates make significant changes...more

K&L Gates LLP

Federal Agencies Delay Implementation of Common Rule Revisions

K&L Gates LLP on

On January 17, 2018, sixteen federal departments and agencies (the “Agencies”) delayed implementation of sweeping changes to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) adopted a year ago that...more

Bergeson & Campbell, P.C.

HHS Delays Common Rule Again

On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule. Final revisions were published on January 19,...more

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