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Nov 07, 2019

Meeting of the Research, Development and Regulatory Roundtable (R3)

10:00 AM to 3:00 PM

Location: Washington, D.C.

Discussion topics: (1) Regulatory Challenges for Decentralized Clinical Trials, (2) Revised Common Rule.

  1. Regulatory Challenges for Decentralized Clinical Trials

Decentralized trials promise to modernize the research landscape, optimizing the trial experience for participants, investigators, and sponsors by increasing access to experimental and other therapies and rendering trials more convenient and accessible. However, clinicians and investigators must navigate long-standing regulations that vary across state and national borders and are often incongruent with virtual care and research. Relevant issues include healthcare licensure in different jurisdictions, requirements for face-to-face interactions between physician and participant, differences in data privacy laws, differences in the standard of care in different locations, risks to privacy and safety posed by home visits, and drug shipment laws. During the R3 meeting, we will discuss each of these issues from a legal and regulatory perspective, providing clarity when possible and identifying ambiguity when necessary.

  1. Revised Common Rule

The Common Rule discussion will address ambiguities in regulation when a central IRB is used, including whether the reviewing or local IRB is responsible for adhering to local regulations and what the responsibilities are for monitoring trial conduct from afar. The discussion will also address interpretations of the phrase ‘key information’ and determine how much authority an IRB retains after designating research for ‘limited review.’