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 to 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 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

One Month Left to Submit Comments on HIPAA Request for Information

Last month, the Office for Civil Rights ("OCR") within the U.S. Department of Health and Human Services ("HHS") published a Request for Information ("RFI") looking for recommendations and public input regarding the Health Insurance...

Matter

Research Misconduct

Represented various hospital systems in connection with research misconduct investigations, including advising on the internal investigation, assisting with the drafting of required reports, and communicating with federal regulators and respondents' legal counsel.

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...

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

Institutional Review Board

Assisted a prominent university with the development of a NIH-funded national IRB reliance model in facilitation of NIH's Single IRB Review Policy.

Publication/Podcast

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Earlier this month, the U.S. Food and Drug Administration ("FDA") issued new guidance ("Guidance") for sponsors, investigators, and institutional review boards ("IRBs") regarding how recent changes to the Federal Policy for Protection of Human...

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

Research Non-Compliance Investigations

Publication/Podcast

Is Cybersecurity on Your 2019 Work Plan?

On December 28, 2018, the U.S. Department of Health and Human Services ("HHS") closed out the year by releasing long-awaited voluntary cybersecurity guidelines for the health care industry.[ 1 ] The four-volume publication, developed...

Matter

Conflicts of Interest

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