Regulatory laws that govern clinical research, which is one of the most-regulated areas of the healthcare industry. Our lawyers represent hospitals, physicians, and other healthcare providers and advise institutional review boards to provide straightforward, clear guidance that enables them to navigate these complex laws to achieve their objectives without violating legal or ethical standards.
With our regulatory work, our attorneys provide experienced counsel that is sensitive to the unique human and legal concerns related to clinical research. We have a long track record of using our approach 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 understand that the business side of clinical research is just as essential as the investigations themselves. Our attorneys excel at assisting clients in drafting and negotiating research agreements with study sponsors and providing advice on the coverage and billing of study services.
Bradley also partners with institutional review boards to provide guidance on adherence to “Common Rule” human subject protection requirements, review protocols, and informed consent documents; attend IRB meetings; draft policies designed to comply with regulatory requirements; advise on FDA and OHRP requirements; counsel on HIPAA issues related to research; and fulfill other obligations under federal law.