Academic & Clinical Research

Highlights

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ACADEMIC & CLINICAL RESEARCH BLOG
Commentary from the Academic and Clinical Research Group
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Recognized in the 2017 U.S. News - Best Lawyers "Best Law Firms" rankings.

Overview

Our academic and clinical research attorneys provide legal counsel at every stage of the research cycle, from idea to execution, including with respect to funding, contracting, ethical oversight, and responding to any identified problems or concerns.

Our attorneys provide advice and assistance with the following, along with many novel issues that arise with changes in research methods, partnerships, and ethical norms:

  • Cooperative IRB review models and associated IRB authorization (reliance) agreements to comply with “single IRB” mandates and funding requirements for multi-site research
  • Collaborations with industry to serve as sites for clinical trials and develop translational medicine opportunities
  • Institutional or governmental investigations into allegations of research misconduct or noncompliance in connection with federally funded research, including facilitating discussions with government authorities, guiding or staffing internal proceedings, handling legal disputes, and implementing corrective action plans
  • Development of policies and procedures to implement regulatory requirements and accommodate changes in regulations (e.g., the revised Common Rule, HIPAA, PHS conflict of interest regulations)
  • Development and implementation of international research studies
  • Design, development, implementation, and research use of data and tissue repositories
  • Acquisitions, consolidations, or other corporate restructurings that involve the transfer of, or otherwise impact, clinical research operations