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[White Paper] Assessing Uptake of Remote Consent for Clinical Trials: Opportunities to Reduce Patient Burden

Published on January 18, 2023 in White Paper

A white paper from the National Brain Tumor Society and the LUNGevity Foundation

Executive Summary

While the COVID-19 public health emergency has caused major disruption to many clinical studies, one positive outgrowth has been the opportunity afforded trials sponsors, investigators, and regulators to implement elements of decentralized trials in on-going clinical studies. Decentralized clinical trials are those in which some or all trial-related procedures and data acquisition take place at locations remote from the investigator, and have been championed as a means of increasing access to clinical trials by reducing travel-related burdens for participants. Guidance documents published by the U.S. Food and Drug Administration and the National Cancer Institute at the outset of the pandemic spelled out protocol modifications that sponsors, institutions, and investigators could utilize to minimize exposure to COVID-19 for study participants and personnel. One such accommodation, remote informed consent, eliminates the need to travel to the study site solely to provide consent to participate in a clinical trial, making it easier and safer for patients to enroll in studies.

As part of broader efforts to advance decentralization of clinical trials, LUNGevity Foundation and the National Brain Tumor Society analyzed existing informed consent policies from 16 major academic medical centers to examine uptake of electronic and remote consent practices at these institutions after COVID-19-related flexibilities had been in place for one year. Key findings of the evaluation include a lack of clarity within institutional policies and a lack of consistency across institutional policies concerning definitions and processes for electronic and remote informed consent. The authors highlight noteworthy policies and recommend that institutions adopt explicit, consistent, informed consent policies based on these examples as one meaningful step toward facilitating decentralized clinical trials and reducing burden on trial participants and their caregivers.

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