Clinical research sits at the crossroads of several complex sets of laws and is accordingly one of the most regulated areas of the health care industry. Health care providers must comply with human subject protection regulations, rules on billing for research services and other issues unique to research, while continuing to remain cognizant of all of the regular business and compliance issues that affect their operations. 

Boult Cummings Clinical Research attorneys represent hospitals, physicians and other health care providers engaged in research, as well as advise institutional review boards. Our goal is to provide our client with straightforward, clear guidance that will enable them to navigate through these myriad laws to achieve their objectives.

We advise clients on both the business and compliance aspects of research. From a business perspective, we assist clients in drafting and negotiating research agreements with study sponsors and provide advice on the coverage and billing of study services. In the compliance area, we work with clients to ensure adherence to all applicable federal and state laws, including regulations on human subject protection, FDA and OHRP requirements, HIPAA and other patient privacy issues.

We also serve as counsel to institutional review boards to assist them in fulfilling their obligations under federal law. This work includes providing guidance on adherence to "Common Rule" human subject protection requirements, reviewing protocols and informed consent documents, attending IRB meetings, drafting policies designed to comply with regulatory requirements, advice on FDA and OHRP requirements, and counseling IRBs on HIPAA issues related to research.