Medical Research/Clinical Trials

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The regulatory environment surrounding clinical trials, particularly trials involving human subjects, is becoming increasingly complex as federal and state governments try both to encourage participation in trials for the accelerating number of new drugs and medical devices being introduced and to respond to growing concerns about the efficacy of current human subjects protections. Federal developments in recent years, such as the issuance of a national coverage decision for Medicare coverage of the routine costs of care resulting from clinical trials and legislative efforts such as the passage of incentives for pharmaceutical manufacturers to develop and test pediatric drugs, are taking place against a backdrop of a number of widely publicized research mishaps involving human subjects. Baker Donelson's attorneys possess significant experience in navigating regulatory developments affecting clinical trials and in representing institutions and investigators in every major phase of clinical trial work.

Representative Matters

  • Drafted joint venture agreements and research and licensing agreements by and among health care institutions, medical researchers and pharmaceutical companies.
  • Guided clients through the legal issues relevant to Phases I – IV of the FDA/NDA Clinical Trials Process.
  • Comprehensively analyzed the standards of the relevant federal agencies with jurisdiction over human subjects protection.
  • Prepared informed consent documents that are compliant with applicable federal human subjects standards, such as FDA standards, and with HIPAA privacy regulations.
  • Provided overviews of the various regulatory and accreditation standards that are applicable to potential conflicts of interest in clinical research.
  • Analyzed the application of federal and state fraud and abuse statutes to the financial relationships created by clinical trials.
  • Reviewed physician compensation relationships with drug company clinical trial sponsors.
  • Advised Institutional Review Boards regarding the approval of clinical trials.
  • Drafted clinical study agreements entered into by institutions and investigators with the sponsors of clinical trials, and drafted agreements entered by investigators with sub-investigators.
  • Developed comprehensive guidelines for utilization by a health system of outside IRBs.
  • Advised Contract Research Organizations (CROs) and Site Management Organizations (SMOs).
  • Provided counseling as to the impact of the Medicare reimbursement rules for routine patient care costs in clinical trials.