Research Enterprises

Entities that engage in research are subject to an increasing number of regulations affecting the research enterprise. Such regulations include those relating to financial reporting, human subjects, animal welfare, research integrity, FDA clinical trials, conflicts of interest and privacy. Fortunately, most research institutions do not have extensive experience investigating violations of research regulations. Unfortunately, that lack of experience results in poor compliance with the regulations and institutions responding inadequately to federal and state regulators.

We have worked with research entities including:

• Academic medical centers
• Colleges
• Universities
• Large pharmaceutical companies
• Life sciences start ups
• Independent diagnostic testing facilities
• Developers of medical equipment and supplies

Our firm has over 20 years of experience supporting institutional investigations and responses to alleged regulatory violations, both domestically and internationally. In addition to our experience and expertise in responding after a problem has arisen, we are asked to support preventative efforts. We frequently are asked to conduct training for institutional officials and administrators on responsible conduct of research, legal regulatory requirements, foci of enforcement activity, and best practices on the efficient resolution of investigations and responses to regulators.

We also are engaged in teaching, and reviewing the implementation of regulations governing non-clinical and clinical trials. These regulations encompass the roles and responsibilities of sponsors, investigators, and other personnel; design and adherence to protocols and standard operating procedures; recruiting and correctly consenting trial participants; disclosing and addressing relevant financial relationships; and relationship to, impact on, and coordination with FDA submissions.