Medical Research Misconduct Proceedings: New HHS-ORI Final Rule; Key Procedural Reforms and Requirements
Inquiry and Investigation, Confidentiality and Disclosure, Records Sequestration, Appeal Process, and More
A live 90-minute CLE video webinar with interactive Q&A
This CLE webinar will closely examine the highly anticipated final rule recently issued by the U.S. Department of Health and Human Services Office of Research Integrity (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.
Outline
- Introduction: history of the final rule
- The final rule
- New or revised definitions
- Inquiry and investigation processes
- Confidentiality and disclosure
- Sequestration of records and evidence
- The Subsequent Use Exception
- Appeals process
- Other notable changes
- Differences from the 2023 proposed rule
- Impact on covered entities
- Helping clients prepare for compliance
- Practitioner takeaways
Benefits
The panel will review these and other important considerations:
- How does the new final rule differ from the 2023 proposed rule?
- What are the new requirements related to misconduct investigation processes?
- How does the final rule clarify institutional confidentiality obligations?
- What new requirements impact the sequestration of records and evidence?
- How does the final rule provide for a clearer appeal process?
Faculty
Monica R. Chmielewski
Partner, Vice Chair Health Care Practice Group
Foley & Lardner
Ms. Chmielewski’s practice is solely focused on the representation of healthcare providers, pharmaceutical and... | Read More
Ms. Chmielewski’s practice is solely focused on the representation of healthcare providers, pharmaceutical and medical device companies, and pharmacies in healthcare, healthcare transactions, clinical research, supply chain, and food and drug law. She provides daily counsel to numerous health systems, hospitals, academic medical centers, pharmacies, and biotech, pharmaceutical and medical device companies. Ms. Chmielewski regularly assists clients with the following issues: regulatory compliance governing all aspects of clinical research, investigations of research misconduct, Institutional Review Board issues, the conduct of U.S. and international clinical trials, research grants and funding, government investigations and audits, pharmaceutical product promotion (including counsel on off-label promotion), 510K applications, the regulation of software as a medical device, preparation of research contracts, among other matters.
Close
Rebecca J. Merrill
Partner
Holland & Knight
Ms. Merrill focuses her national practice on advising healthcare providers and life sciences organizations on a range... | Read More
Ms. Merrill focuses her national practice on advising healthcare providers and life sciences organizations on a range of complex healthcare regulatory matters, including advising clients through internal and government directed investigations and with respect to FCA matters, Medicare and Medicaid overpayments, reimbursement issues and strategies, enrollment, licensure and scope of practice issues, fraud and abuse, and privacy, security and confidentiality matters. Ms. Merrill also counsels clients on clinical research matters, including regulatory aspects of conducting research; policies, procedures, workflows and operations; regulatory and transactional issues involved in the sharing of data and materials (including biospecimens); compliance; investigations and management of research misconduct allegations; conflicts of interest and commitment; and the development and negotiation of various clinical research and research adjacent contracts (including, e.g., clinical trial agreements, data sharing agreements, material transfer agreements, data registry and biorepository agreements, and development agreements). In addition, Ms. Merrill counsels health systems, providers and suppliers with regard to complex transactions and on a variety of corporate matters.
CloseEarly Discount (through 11/08/24)
Cannot Attend December 4?
Early Discount (through 11/08/24)
You may pre-order a recording to listen at your convenience. Recordings are available 48 hours after the webinar. Strafford will process CLE credit for one person on each recording. All formats include course handouts.