Academic and Clinical Research


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Commentary from the Academic and Clinical Research Group
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The Academic and Clinical Research Group provides a broad range of support to the research oversight arms and administrations of universities, academic medical centers, hospitals, physician groups, and other research sites as well as to academic research organizations, site management organizations, and related research service providers. We offer advice and assistance in every aspect of the research cycle, including drafting of research-related policies, negotiation of sponsored research agreements, negotiation of research affiliation agreements with academic partners and collaborating research sites, compliance with requirements for human and animal subject protections, adherence to restrictions and requirements in grants and other funding awards, and observance of internal and external rules concerning research misconduct and conflicts of interest. We counsel clients on all areas of human subjects research and general research compliance law, including issues relating to informed consent, unique challenges arising from specific research protocols, establishment of tissue or data repositories and downstream uses of research materials, research on products regulated by the U.S. Food and Drug Administration (FDA), compliance with requirements for research sponsored by the U.S. Department of Health and Human Services (including the National Institutes of Health (NIH) and the Centers for Disease Control), evolving standards related to clinical trials transparency both with respect to FDA clinical trials registration and the European Medicines Agency draft guidance, and development of research plans and support structures for global research projects. We also work closely with clients on issues specific to “bench” or “laboratory” science, including research on human embryonic stem cells and induced pluripotent stem cells, requirements imposed by the U.S. Clinical Laboratory Improvement Amendments as they relate to the research context and the return of information to participants, and frontier challenges posed by genome sequencing research, including genome-wide association studies.
We interact with relevant U.S. federal agencies (e.g., the Office for Human Research Protections, the FDA, the Office for Civil Rights, and the Office of Research Integrity) to obtain informal and formal guidance related to specific questions, as well as in conjunction with for-cause or not-for-cause investigations or audits. Clients preparing for accreditation by the Association for the Accreditation of Human Research Protection Programs or other independent accrediting bodies rely on us to guide them through the process. We also monitor developments in U.S. and foreign laws, regulations, and guidance relating to research matters, and assist clients in drafting comments in response to significant notices of proposed rulemaking.
Composed of attorneys from the firm’s Health Care Group, the Academic and Clinical Research Group is accustomed to dealing with issues at the intersection of health care law and research, including compliance with: the evolving requirements of U.S. privacy laws (e.g., HIPAA and HITECH) and foreign privacy laws; U.S. and foreign transparency requirements; fraud and abuse laws; Medicare secondary payer rules and the National Coverage Determination for Routine Costs in Clinical Trials; FDA regulatory requirements such as the restrictions on the promotion of pharmaceutical products and medical devices, the requirements to bring FDA-regulated products to market, the treatment use of investigational products under expanded access protocols and in the context of humanitarian use devices, and special rules regarding the use of human cells, tissues, and cellular and tissue-based products; institutional overhead cost principles of the U.S. Public Health Service and Office of Management and Budget; laws applicable to sensitive information, such as genetic, substance abuse, and mental health information; and state, federal, and foreign prohibitions or disclosure requirements applicable to industry gifts and payments to researcher-clinicians.
We try to work in the capacity that best suits an organization’s existing compliance structure. For example, in the case of internal investigations of potential research compliance lapses, we are prepared either to oversee and manage the investigation or to serve as counsel or staff to internal committees charged with conducting the investigation. We can also begin assisting at the point of communicating with relevant government agencies and oversight bodies to which the issues and their resolution must be reported. We have also been utilized as part of an organization’s corrective action plan in response to identified noncompliance, working closely with the implicated investigator and research staff on behalf of the organization to help train and assist the investigator in his or her compliance rehabilitation. Similarly, we provide adjunct staffing on routine or special projects when an organization’s research compliance, integrity, conflicts, or legal office intermittently requires additional resources.
Recent representative projects that members of the Academic and Clinical Research Group have handled include:

  • Advice to an academic medical center concerning proposed collaborations with industry to develop translational medicine opportunities
  • Investigation on behalf of a large university into allegations of research misconduct and noncompliance by an international researcher in connection with NIH-supported global clinical research studies
  • Provision of training on laws and regulations applicable to human subjects research to an organization’s research community in response to a corrective action plan mandated by the U.S. Office for Human Research Protections
  • Provision of training and analytical tools to a university’s institutional and individual conflicts of interest committees
  • Investigation of a complex financial relationship between an investigator and a commercial sponsor and development of recommendations concerning a management plan and systematic changes to the institution’s administration of gifts and sponsored research funding
  • Advice to a large university concerning the termination of a principal investigator and the transfer of multiple NIH- and sponsor-supported studies to a new institution
  • Advice to a pediatric teaching hospital regarding NIH data ownership rules applicable to cooperative group research studies
  • Advice to a medical school and affiliated teaching hospital seeking to establish a large-scale tissue and data repository
  • Assistance with an investigation into noncompliance by an allied health provider in the research context, and advice on the interaction of U.S. licensure and credentialing requirements with research compliance
  • Policy guidance and comprehensive training to a large academic medical center Institutional Review Board on international research issues
  • Advice to a site management organization regarding HIPAA compliance in the provision of research management services to trial sites
  • Service as the acting Research Integrity Officer for a medical school, coordinating faculty research misconduct inquiries and investigations during a staffing transition
  • Analysis of the various legal, regulatory, and ethical factors involved in the development of a cancer center’s policy governing return of incidental findings and research results in genome sequencing studies 
  • Negotiation of clinical trial agreements (including contentious provisions concerning payment for care for subject injury and data ownership) and related research agreements on behalf of the research components of a health care system specializing in the health of women and newborns
  • Advice to a hospital system on implications of the NIH Grants Policy Statement on structuring affiliations, contracts, and disbursement of funds for an NIH-supported study
  • Negotiation of contracts for an NIH-grantee with subcontractors and analysis of permissible relationships under NIH guidance and the grant award


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