News & Analysis as of

Policies and Procedures Scientific Research

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

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Hogan Lovells

Research security program guidelines: more work for federally-funded research institutions -Universities and academic research...

Hogan Lovells on

The White House Office of Science and Technology Policy (OSTP) has issued long-awaited Guidelines for Research Security Programs at Covered Institutions (“Guidelines”), which outline how federal research agencies must require...more

Goodwin

Form FDA 483 Response Best Practices Announced by the FDA

Goodwin on

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...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

Ankura

Strategies for Preventing Research Misconduct

Ankura on

It’s the type of scenario that can sully an institution’s reputation in an instant: A star researcher fabricates the results of experiments funded by grants. The data is published, the truth is discovered — and the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 9. In This Month's E-News: September 2022

Report on Research Compliance Volume 19, Number 9 (September, 2022) - According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los...more

Health Care Compliance Association (HCCA)

Lehigh U. Compliance Plan Provides Blueprint for Oversight, Audit Schedule

Report on Research Compliance 17, no. 9 (August 20, 2020) - As part of its recent settlement with the Department of Justice regarding allegations of False Claims Act (FCA) violations, Lehigh University of Pennsylvania is...more

Proskauer - Law and the Workplace

Creation of Fake Online Accounts to Study Algorithmic Bias Does Not Violate the Computer Fraud and Abuse Act, D.C. Court Rules

A federal judge recently held that researchers who violate a website’s terms of service by creating fake online accounts in order to study algorithmic bias in artificial intelligence software do not violate the Computer Fraud...more

Bass, Berry & Sims PLC

How Should Institutions Conducting Research Respond to COVID-19?

Bass, Berry & Sims PLC on

As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 3. In This Month's E-News: March 2020

Report on Research Compliance 17, no. 3 (February 20, 2020) - Despite its earlier agreement to repay just $5,442 in costs questioned by the National Science Foundation (NSF) Office of Inspector General, the University of...more

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