Our academic and clinical research clients understand that the pursuit of scientific innovation at the cutting-edge comes with complex regulatory requirements and ethical responsibilities.
At Epstein Becker Green, we provide support to the research oversight and administrative arms of academic medical centers (AMCs), universities, research institutes, provider and insurance organizations, and other related stakeholders in pursuit of their research missions. Members of our Academic and Clinical Research practice group have worked with many of the nation’s premier research institutions and their research ethics boards, giving them insight into how outside research counsel can lend value to an institution’s research program. This experience also enables our group to facilitate academic-industry collaborations by identifying the issues of critical importance to the parties and finding solutions that work.
Clients turn to us for advice and assistance in every aspect of the research cycle, including drafting research-related policies, negotiating research agreements, and advising on regulatory compliance. We advise clients on the many overlapping regulatory frameworks applicable to their research programs, including the Common Rule, federal funding requirements, Food and Drug Administration (FDA) regulations, and HIPAA’s protection of protected health information in research. Our advice includes related areas faced by research institutions and Institutional Review Boards (IRBs), such as expanded access to investigational products for treatment use. We also counsel clients on state and federal laws applicable to research involving genetic, substance abuse, and mental health information, and assist institutions in meeting research integrity and conflicts of interest requirements under relevant federal regulations.
Our strengths are highlighted in the following related areas:
Human Subjects Protections
Our group guides clients through all aspects of compliance with the laws, regulations, sub-regulatory guidance, and industry best practices that protect human research participants at both the federal and state level. Clients look to us for advice across all areas of human subjects research, including research policy development, the review of allegations of noncompliance with applicable laws and related reporting obligations, and approaches to structuring a broad range of human subjects research projects. From interventional trials to online and mobile app research to research repositories, our group has experience with the unique legal issues presented. We also help clients navigate the line between human subjects research and quality improvement or other types of projects on the periphery of research that may not trigger the same rules or oversight. With a team that includes former in-house counsel at universities or AMCs and several current or former members of IRBs, we work directly with IRB directors, institutional officials, vice presidents of research, and investigators, among other institutional stakeholders, to navigate novel or complex issues and develop ethical and legally compliant solutions.
Drugs, Devices, and Other Therapies
Our clients participate in industry-sponsored investigations of drugs, devices, and other therapies and are also leaders of these investigations through their investigator-initiated studies. We help clients—and help clients to help their investigators—with all aspects of compliance with FDA regulations in connection with this critical work. Key areas of assistance and advice include application and interpretation of the FDA’s investigational new drug and investigational device regulations, manufacturing of tissue/cell based therapies for research uses, electronic record and signature requirements, and related agency guidance. Most recently, in the context of precision medicine initiatives, the COVID-19 pandemic, and otherwise, we have helped clients chart a course to the use and development of laboratory developed tests, with the attendant challenges arising from the evolving oversight framework in that area. Our group also assists academic and clinical research clients with implementing compliant and ethically sound structures for identification and recruitment of potential trial participants in collaboration with sponsors and their contract research organizations. Outside of the research context, we have deep experience advising clients on the use of investigational products to treat patients under the FDA’s expanded access framework and under federal and state Right to Try laws.
Privacy and Research
The protection of research participants’ health and other personal information is, at its core, both a human subjects protection issue and a regulatory concern for clients under such legal frameworks as HIPAA, various state laws and regulations, the European Union General Data Protection Regulation (GDPR), and many other countries’ expanding privacy laws. We are adept at evaluating the information flow contemplated by a research study and assisting clients in ensuring that research proceeds within applicable privacy frameworks. We have been advising on the complicated intersection of HIPAA and the conduct of research since the implementation of HIPAA’s original privacy regulations, gaining the insights necessary to predict how HIPAA requirements may further evolve in the future. In the event of potential breaches of research-related data, or research participant privacy complaints, we have the necessary experience to conduct a nuanced and research-tailored analysis, performing risk assessments and providing advice with an understanding of the research context in which the matter arises and addressing overlapping and sometimes inconsistent notice obligations to the IRB and to state and federal agencies. Clients also look to us to help structure data research repositories in a manner that will permit the sharing of information required to develop the repository and any anticipated downstream research uses, as well as the de-identification of large data sets (“big data research”) to enable longitudinal linking and other similar uses. Clients benefit from our considerable experience identifying and interpreting state law requirements that apply to the protection of sensitive information (e.g., HIV, genetic, mental health information). With respect to the GDPR, we provide training and analysis to research institutions and their IRBs and research contracting offices to help identify categories of research and related activities that may trigger the GDPR, and supply policies, privacy notices, consent language, and template agreements to facilitate compliance, as necessary.
Contractual relationships with collaborators, vendors, IRBs, funders, commercial sponsors and partners, and other research stakeholders are the vehicles that allow clients to accomplish their research mission, pursue scientific innovation, and translate discoveries from bench to bedside. We work across the spectrum of research contracting, from non-disclosure and confidentiality agreements for potential collaborative opportunities, to agreements with external partners related to early-stage laboratory research efforts, clinical trial agreements with company sponsors, research support or grant agreements with funders and collaborators, and materials transfer and data transfer agreements to document the exchange of information and specimens. We have particular experience in structuring academic research consortia, clinical trial networks, data sharing consortia, quality improvement consortia, and large multi-site trials where our client serves as the prime grantee and/or coordinating center. Members of our group have been at the forefront of contracting around IRB reliance arrangements, including direct involvement in the development of the SMART IRB agreement on behalf of the NIH grantee for that project. Our understanding of the regulatory underpinnings and practical realities of conducting research (both clinical and pre-clinical) allows us to evaluate the institutional risks and craft terms that are most favorable to our clients.
Internal Investigations Related to Research
Our group is regularly asked to conduct or guide research-related internal reviews and investigations relating to human subjects protections (and associated reporting to FDA, the Office for Human Research Protections, and others), research misconduct (both within the strict meaning of the federal policy on research misconduct, with associated reporting to the Office of Research Integrity and similar enforcement bodies, and the penumbral definitions of particular institutional policies), research-related conflicts of interest, and federal grants compliance matters, including in connection with internal reviews to prevent undue foreign influence. Our extensive experience with internal compliance investigations has accustomed us to the special challenges posed by internal investigations that implicate differing regulatory frameworks and internal offices, and which require skillful coordination among parallel fact-finding systems and procedures. We coordinate as necessary with our colleagues in our Health Care and Life Sciences Investigations and Enforcement group, to the extent voluntary self-disclosures through the HHS OIG protocol or otherwise are indicated.