HLB regularly counsels clients, including researchers, research institutions, hospitals, academic medical centers, physician groups, and biotechnology and medical device companies, in clinical research contracting and compliance. Our ability to help clients navigate these complex legal and regulatory issues is particularly strengthened by our broad health law experience and the fact that many HLB attorneys have clinical or scientific backgrounds.
In particular, HLB often advises clients on compliance with federal, state and international laws and regulations regarding the collection, transfer and sharing of data. Our team will work to ensure compliance with applicable laws regarding regulatory review and approvals in the research process, human subject protection requirements, as well as assist with the drafting and negotiation of clinical trial and material transfer agreements and policies and protocols.
Some of the routine services that our Research Practice Group may provide include:
- Negotiation of clinical trial agreements and other research affiliation agreements.
- Compliance with human subject research protections.
- Drafting of research-related policies.
- Advising on application of federal and state fraud and abuse and physician self-referral laws in the research context.
- Intersection with international, federal and state privacy laws and regulations, such as GDPR and HIPAA.
- Advising Institutional Review Boards (IRBs).
- Pharmaceutical pricing and clinical trial billing compliance.
- Assistance with government audits and investigations related to research, including responses to "whistleblowers."
- Scope of practice issues.
- Medical Staffing issues.
- Conflicts of interest.
With enforcement actions on the rise, HLB offers clients the benefit of broad health law expertise and knowledge to ensure that research is conducted in compliance with all applicable federal and state statutes and regulations.
HLB Clinical Research Intelligence
HLB frequently issues content through published articles, blog posts, and other materials to keep our clients informed on legal developments and insights. Our most recently published materials related to clinical research follow. To view older materials, please visit the News and Publications tabs on this page.
- Foreign Interests and Conflicts of Interest in Research, June 2019
- CMS Proposes Coverage with Evidence Development for CAR T-Cell Therapies, March 2019
- OHRP Provides Draft Guidance Regarding the Revised Common Rule Implementation Timeline and Transition of Existing Studies, January 2019
- June 5, 2019
- March 7, 2019
- OHRP Provides Draft Guidance Regarding the Revised Common Rule Implementation Timeline and Transition of Existing StudiesJanuary 30, 2019
- September 24, 2018
- February 22, 2017
Health Law Perspectives
- August 27, 2019
- June 20, 2019
- May 29, 2019
- April 15, 2019
- March 27, 2019
- January 15, 2019
- September 2018
- June 2018