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Scientific Research

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - September 8th - 11th, Scottsdale, AZ

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more

K&L Gates LLP

Client Conversations With Craig Budner: Interview With Patrick Krill, Lawyer, Addiction Counselor, and Researcher

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Patrick Krill is a lawyer, addiction counselor, and founder of Krill Strategies—a consulting firm dedicated to improving mental health and well-being in the legal profession. Patrick is widely recognized as a leading...more

Goodwin

The Data Shift: UK Sets a New Course With 2025 Data (Use and Access) Act

Goodwin on

The Data (Use and Access) Bill passed both Houses of UK Parliament and received Royal Assent on 19 June 2025, now becoming the Data (Use and Access) Act 2025 (“DUA Act”). This is the final iteration of the Data Protection and...more

Bergeson & Campbell, P.C.

White House OSTP Issues Agency Guidance for Gold Standard Science 

On June 23, 2025, the White House Office of Science and Technology Policy (OSTP) announced that it issued agency guidance for implementing Gold Standard Science in the conduct and management of scientific activities. As...more

A&O Shearman

Data (Use and Access) Act gets Royal Assent

A&O Shearman on

On June 19 2025, the Data (Use and Access) Act (DUA Act) received Royal Assent, having passed both Houses of Parliament on June 11 2025. The Data (Use and Access) Bill was first introduced in the House of Lords on October 23...more

Cooley LLP

The Data (Use and Access) Bill: What Businesses Need to Know

Cooley LLP on

The UK’s Data (Use and Access) Bill (DUA Bill) completed its passage through Parliament on 11 June 2025 and is now awaiting Royal Assent. Once enacted, it will introduce a series of targeted updates to the UK’s data...more

Jackson Lewis P.C.

USCIS Makes Changes to TN Policy Manual: Key Updates for Employers

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USCIS has released an update to its Policy Manual, bringing significant changes to regulations on the TN nonimmigrant visa classification and perhaps some employers’ practices. For instance, because of changes to the...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Bergeson & Campbell, P.C.

President Signs EO to Restore Gold Standard for Science, Calls for Reevaluation of Biden Administration’s Scientific Integrity...

On May 27, 2025, President Trump signed an Executive Order (EO) on “Restoring Gold Standard Science.” 90 Fed. Reg. 22601. The EO states that the Trump Administration “is committed to restoring a gold standard for science to...more

MG+M The Law Firm

EPA Terminates Research Grants on PFAS Exposure and Reduction in Agriculture

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The Environmental Protection Agency (EPA) recently terminated over $15 million in grants for research aimed to reduce potential exposure to “forever chemicals,”, i.e., per and poly-fluoroalkyl substances (PFAS), from food to...more

Carlton Fields

“Restoring Gold Standard Science” Executive Order Steps Away From Biden Administration’s “Equitable” Approach

Carlton Fields on

Both President Trump’s and President Biden’s administrations have emphasized in executive orders and presidential memoranda the need for objective, science-based decision-making. However, Trump’s May 23, 2025, Executive Order...more

Hogan Lovells

MAHA Commission Releases Make Our Children Healthy Again Assessment

Hogan Lovells on

Yesterday, the Make America Healthy Again (“MAHA”) Commission released its highly anticipated Make Our Children Healthy Again Assessment (“Assessment”), which aims to examine “the root causes of deteriorating child health.”...more

Akin Gump Strauss Hauer & Feld LLP

Restoring Gold Standard Science (Trump EO Tracker)

Orders the Director of the Office of Science and Technology Policy (OSTP Director) to issue guidance for agencies on implementation of “Gold Standard Science” in the conduct and management of their respective scientific...more

Dorsey & Whitney LLP

The Next Front in the Administration’s Sponsored Research Crackdown: What Recipients of Federal Funding - Particularly Grantees -...

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The Trump Administration’s effort to remake the Federal government’s relationship with Higher Ed and research grantees continues to gather steam, and an unprecedented recent letter to Harvard presages a potentially new front:...more

King & Spalding

New Federal Court Decision Holds Proposition 65 Warnings Are Not Required Where There Was No Scientific Consensus on the...

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In an important decision under California’s Proposition 65, a federal court recently ruled that businesses cannot be required to provide a product warning under Proposition 65 where there is no scientific consensus on whether...more

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

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The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Health Care Compliance Association (HCCA)

New NIH Head: Indirect Payments ‘Tips’; Republican Senator Calls Them ‘Grift’

Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more

Hinckley Allen

Impact of the Trump Administration’s Executive Orders and Actions for Academic Institutions & Federal Funded Research Community

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The Trump Administration’s first two months have been marked by a flurry of actions impacting federal grant recipients, federal contractors, and academic and scientific researchers. These unprecedented measures, including...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 24th - 27th, Chicago, IL

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more

Dorsey & Whitney LLP

NIH’s New Unilateral Change to Your Institution’s Indirect Rate: An Old-School Breach of Contract?

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On Friday, February 7, the National Institutes of Health (“NIH”) issued Policy Statement Supplemental Guidance affecting budgets both for active grants and for future grants, which was set to take effect on Monday, February...more

Latham & Watkins LLP

The NIH Funding Cuts: Implications and Status of Lawsuits

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The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 2nd - 4th, Orlando, FL

Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more

Wiley Rein LLP

Capping It All Off: NIH Caps Indirect Rates for Grants

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SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...more

Dorsey & Whitney LLP

Federal Assistance in Jeopardy? What to Know about OMB Guidance About Hundreds of Billions in Federal Research and Loans to...

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On January 27, the Acting Director of the Office of Management & Budget issued a new Memorandum (M-25-13) that presages significant disruption—if not outright cancellation—of many federal assistance awards. ...more

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