PRIM&R Service Award Presentation, and Plenary IX: Decentralized Clinical Trials (DCTs): Considerations of and for IRB review

The final day of PRIMR22 will start with the presentation of the PRIM&R Service Award to John H. Parrish, DVM, PhD, ACLAM, LSSBB, Attending and University Veterinarian, Clemson University, followed by Plenary IX.

Plenary IX Descriptor:DCTs may increase enrollment both by lessening the burden of participation and by increasing the geographical footprint of recruitment (including both underserved urban and rural areas), although barriers to implementation exist. Among these barriers is the relative lack of familiarity with the ethical issues presented by DCTs, particularly given their wide variation in study design, conduct, and scope that, in turn, present difficulties for IRB review and approval. These issues include electronic informed consent, tele- and/or video-medicine and home health visits, investigational drug delivery, remote monitoring, digital data collection, data transfer, data sharing, privacy, confidentiality, participant data literacy and access, and others. The recommendations for IRB review by a multi-disciplinary group of clinical trial stakeholders (e.g., IRB professionals, academia, technology companies, patients, pharmaceutical sponsors) will be presented and discussed.