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Medical Research Department of Health and Human Services (HHS)

Holland & Knight LLP

HHS Announces Updates to Policies on Research Misconduct

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The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on...more

Cohen Seglias Pallas Greenhall & Furman PC

ORI Unveils Final Rule on Research Misconduct: Key Changes for Institutions and Respondents

On September 12, 2024, the federal Office of Research Integrity (ORI) announced the release of the Department of Health & Human Services’ Final Rule on Public Health Service Policies on Research Misconduct. This marks the...more

Mandelbaum Barrett PC

Reclassifying Cannabis as Schedule III: Unpacking the Impact on Taxation, Medical Research, and Social Justice

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On April 30, 2024, the Associated Press reported a significant development in cannabis policy:  the U.S. Drug Enforcement Administration (“DEA”) is recommending reclassifying cannabis from Schedule I to Schedule III. This...more

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

Mintz - ML Strategies

New Biden Executive Order Emphasizes Women’s Health

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Following an initial funding announcement last month, the Biden administration has kept its foot on the gas to build out the White House Initiative on Women’s Health Research. Last month, we wrote about ARPA-H’s $100 million...more

Benesch

HHS and FDA Release Updated Guidance on Informed Consent

Benesch on

On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing...more

Sheppard Mullin Richter & Hampton LLP

Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more

McDermott Will & Emery

HHS and FDA Seek Comments on Informed Consent Draft Guidance

McDermott Will & Emery on

On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more

Epstein Becker & Green

FDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants

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On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance titled “Key Information and...more

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...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

Holland & Knight LLP

Holland & Knight Health Dose: January 24, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Husch Blackwell LLP

All the Outcomes of a Marijuana Reschedule

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Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When...more

McGlinchey Stafford

DEA is Going to Have a Hard Time Fighting Marijuana Rescheduling

McGlinchey Stafford on

Last week, the Department of Health and Human Services (HHS) released the full text of its letter (HHS Letter) to the Drug Enforcement Administration (DEA), recommending marijuana rescheduling from Schedule I to Schedule III....more

Husch Blackwell LLP

HHS Marijuana Recommendation Now on Blast

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In October 2022, President Biden asked the Department of Health and Human Services (HHS) and the Attorney General to review how marijuana is scheduled under federal law. In August 2023, the HHS marijuana recommendation went...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...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

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

McGuireWoods LLP

HHS Proposes Updates to 20-Year-Old Public Health Service Policies on Research Misconduct

McGuireWoods LLP on

The U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) released a notice of proposed rulemaking to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. HHS seeks...more

Hogan Lovells

ORI proposes long-anticipated overhaul of research misconduct regulations - Implications for research institutions, higher...

Hogan Lovells on

Last week, the U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) made the announcement many academic institutions, legal professionals, and observers in the research community had long been...more

Epstein Becker & Green

ORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct

Epstein Becker & Green on

On October 5, 2023, the U.S. Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) issued a Notice of Proposed...more

Troutman Pepper

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

Troutman Pepper on

It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more

Amundsen Davis LLC

Historic Cannabis Rescheduling on the Horizon? It's Up to the DEA Now

Amundsen Davis LLC on

In October of 2022, the Biden Administration started an official cannabis policy review process, which began with granting pardons to all people convicted of simple cannabis possession under federal law. At the time, this was...more

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

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On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more

McGlinchey Stafford

From Schedule I to Schedule III: Potential Shift in Marijuana’s Legal Status

McGlinchey Stafford on

Major news broke on August 30, 2023, as the U.S. Department of Health and Human Services (HHS) announced that it would recommend moving marijuana from Schedule I to Schedule III, as first reported by Riley Griffin for...more

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