Medical Research Misconduct Proceedings: New HHS-ORI Final Rule; Key Procedural Reforms and Requirements
Foley partner Monica Chmielewski, vice chair of the firm’s Health Care Practice Group, is speaking in the upcoming Strafford webinar “Medical Research Misconduct Proceedings: New HHS-ORI Final Rule; Key Procedural Reforms and Requirements” on December 4.
The U.S. Department of Health and Human Services Office of Research Integrity (HHS-ORI) recently issued its highly anticipated final rule revising the procedures and requirements for medical research misconduct proceedings in response to technological changes and policy developments that have occurred since the regulations were released nearly 20 years ago.
The final rule applies to all institutions that receive Public Health Service funding for research activities including hospitals and health care systems, colleges and universities, and medical schools. While the effective date of the final rule is January 1, 2025, institutional compliance will be required as of January 1, 2026, to give covered entities time to update institutional policies and procedures. Therefore, counsel should understand the final rule’s requirements so they can assist their clients with compliance measures.
Key provisions of the final rule include, among others, new or revised requirements related to:
- Inquiry and investigation processes,
- Confidentiality and disclosure of misconduct proceedings,
- Sequestration of records and evidence,
- The Subsequent Use Exception to the six-year statute of limitations, and
- A streamlined appeals process.
The final rule also includes a revised definition of plagiarism and new definitions of intentionally, knowingly, or recklessly as applied to alleged misconduct.
This session will closely examine the highly anticipated final rule recently issued by the HHS-ORI revising the procedures and requirements for medical research misconduct proceedings. The panel will address key changes, including new procedural requirements and definitions, and discuss the impact on covered entities. The panel will also offer best practices for compliance.
CLE
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
