News & Analysis as of

Medical Research Investigations

Goodwin

Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Society of Corporate Compliance and Ethics...

[Event] Higher Education & Healthcare Research Compliance Conference - June 10th - 12th, New Orleans, LA

Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...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

Health Care Compliance Association (HCCA)

DOJ: Stanford FCA Case Involved Failures to Disclose Foreign Support From Seven Countries

Report on Research Compliance 20, no. 11 (November, 2023) It wasn't just China. China is among the countries whose support for Stanford University investigators wasn’t reported to five federal research funding agencies,...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2023

Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - February 26th - 29th, Phoenix, AZ

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Jackson Walker

Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements

Jackson Walker on

Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 11th - 13th, Chandler, AZ

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

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 20, Number 1. In This Month’s E-News: January 2023

Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Health Care Compliance Association (HCCA)

NSF Award Mismanagement, Publication Ban Among Costly Actions by Researchers

Report on Research Compliance 19, no. 1 (January, 2022) - During the second half of fiscal year 2021, which ended Sept. 30, the National Science Foundation (NSF) collected more than $2.5 million from six universities and...more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 3. In This Month's E-News: March 2021

Report on Research Compliance 18, no. 3 (March 2021) - ◆ A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct...more

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