March 09 2021
Written by Thomas Syverson, CCRP, CRA III at the University of Hawaii Cancer Center
Remote consenting can facilitate patient enrollment on clinical trials at centers with a large geographical catchment area as well as during the COVID-19 pandemic. For the University of Hawaii Cancer Center, primary affiliate of the Hawai‘i Minority Underserved NCORP, based in Honolulu on the Island of O‘ahu, remote consenting has proven to be a useful tool. It is utilized not only for subjects in rural areas of O‘ahu but has also allowed us to reach residents from neighboring islands and offers them the opportunity to participate in clinical trials.
Due to the COVID-19 pandemic, there was a push at our institution to implement remote consenting and to do so quickly. Although it may seem like a simple alternative to in-person consenting, there were a few things to consider before the process became streamlined and integrated into the workflow. We needed to establish a comprehensive remote consent policy for our multi-site, multi-hospital system, community practice. Other considerations included identifying which trials allowed for remote consenting, how to incorporate remote consenting within existing consenting practices/policies, best practices for documentation of the remote consent process, and much more. We consulted with our internal research coordinators, regulatory and compliance department, as well as our hospital partners on what would be feasible for our sites and our patients. We also followed CIRB guidelines for remote consenting since a majority of our studies fall under the CIRB. Ultimately, the University of Hawai‘i Cancer Center’s remote consent step-by-step process was drafted and incorporated as its own section within our Consent Process Working Practice Document.
The next step was to educate research staff at the UH Cancer Center and in our community hospitals on the policy and process. We accomplished this by disseminating the updated working practice document via email to our staff and key personnel throughout our sites. We also reviewed and discussed the process at our staff meetings and provided guidance to our sites if they had any institution-specific questions. Luckily we were able to outline a remote consent process that was generalizable and agreeable with the diverse policies of the hospital systems we work with.
Since implementing remote consenting at our site, we have found it greatly beneficial to facilitating participation in clinical trials, especially with neighbor island patients. We can say with confidence, remote consenting has allowed us to enroll multiple patients on trials. Recently, a study was slated to be closed within a couple of days prior to the patient deciding they wanted to participate. Since they lived on the island of Maui, remote consenting allowed him to enroll onto the trial without having the financial burden and heightened safety risk of flying on a plane to Oʻahu during a pandemic to sign the informed consent form. Although he still must come to Oʻahu for treatment, it was easing the burden up front that allowed the patient the opportunity to participate on this trial.
As the pandemic went on, research staff gained experience with the remote consent process and learned what works and what generally doesn’t work. One factor to take into consideration is computer literacy and/or access to technology such as computer, email, or fax machines. Some research staff found that patients living in rural zip codes may not own computers, home printers or use email, so the possibility of emailing the informed consent and the patient printing it was not an option. Some patients, eager to enroll on a clinical trial, were willing to use their local copy center store to receive or send the informed consent by fax. Mailing the informed consent was the most common method used and research staff quickly learned to factor in mailing times to and from the neighbor islands, especially during the holidays. Placing a follow-up phone call with the potential trial participant once the informed consent was mailed became another step in facilitating the remote consent process. The majority of remote consent discussions were conducted by telephone, even with the option of using the center’s HIPAA compliant computer conferencing account.
Implementing the remote consenting process during the uncertainties and inefficiencies of our initial lock downs and stay-at-home orders was no small feat. It has proven to be a beneficial tool that is made easier the more it is put into practice. While not a one-size-fits-all, remote consent can be a useful alternative, helping sites to not only boost accruals of patients in rural, underserved areas but as a way to maintain accruals during the COVID-19 pandemic.