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

Our attorneys provide advice and assistance with the following, along with many novel issues that may arise as a result of 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 multisite research
  • Collaborations with industry to serve as sites for clinical trials and development of 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

Firm Highlights

Publication/Podcast

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to...

Publication/Podcast

COVID-19 Expanded Access Template

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements...

Publication/Podcast

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...

Matter

Research Non-Compliance Investigations

Test Tubes
Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

Matter

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Matter

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...

Publication/Podcast

Responsible Research During the COVID-19 Pandemic

Publication/Podcast

FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App

On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “ Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency ” with new information...