The COVID-19 pandemic and associated social distancing measures are creating unprecedented challenges for everyone working in clinical trials and drug development. In this series, we’re sharing some of the ways VeraSci is addressing these challenges.
With many study subjects isolating themselves at home and many sites concerned about seeing subjects in-person for routine study visits, we are seeing an increased interest in remote visits. Sponsors that consider this for their studies often choose to complete the remote visits with video conferencing tools in order to allow more interaction between sites and subjects. Even for those with experience using video in clinical trials, using it in a home-based setting brings unique challenges.
IRB / Consent Updates
It is expected that changes to the protocol and what subjects are being asked to do will require updates to consent forms and IRB / Ethics Committee approval. Consent Form language may need to include elements such as whether the video conferences are being recorded and, if so, where any recordings are being stored.
There are a number of technology platforms available for remote visits and videoconferencing. The US Department of Health and Human Services (DHHS) in their Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency provides both a list of providers that should not be used as well as a list of technology vendors that represent that they are HIPAA-compliant and will enter into HIPAA business associate agreements (BAAs). Video platforms may also require validation. We recommend that sponsors complete their own evaluation of any vendor they use to ensure they meet study needs applicable security and privacy regulations. The sponsor may also need to generate their own procedures to outline the appropriate use of any product that is chosen. Additionally, if the video will be set up in a way where the patient’s face or other identifying information is visible and being recorded, this would constitute Protected Health Information (PHI) under HIPAA and would need to be treated accordingly. If the videos are recorded, the sponsor or their video vendor may need to consider options to de-identify the video in order to obscure any audio or visual identifiers that are included in the recording.
Videoing study participants in their homes rather than in a clinic setting brings about potential issues related to non-participants ending up on video. In the clinic, you’d never experience another family member wandering into the video, but this is something that does happen when you’re recording in someone’s home. Non-participants typically fall into two groups—those who incidentally end up in the video and those who are needed for the video. The incidental group includes people walking through the background, coming over to talk to the participant during the visit, or even in pictures in the background of the video. Most of these issues can be mitigated by preparing the subject ahead of time. Ask the subject to go to a private area for the study visit and instruct others in the household not to come in during the visit and to remove any visible photos or items with identifying information (e.g. diplomas). These steps should minimize the risks of capturing video of people not involved in the study. Depending on the study and the patient population, it may be necessary to include another person in the video to help with set-up or provide other assistance. Studies in elderly patient populations may require a caregiver or family member to assist in setting up the technology. In these cases, you may need to get consent from the caregiver or family member, particularly if the video is being recorded.
There may be logistical challenges in setting up video for at home visits. It is important to think the issues through in advance keeping in mind the specific needs of the study and the patient population. It may be necessary to provision devices, device stands and/or internet connectivity solutions to subjects prior to the home visit. Providing detailed instructions for set-up in advance of the visit will make things go more smoothly.
Adding video home visits to studies will require increased support for both technology and logistics. Project teams and technology providers need to be prepared to provide more intensive support than is usually needed. VeraSci’s comprehensive training approach includes step-by-step set-up guides for subjects and raters. In addition, raters are trained on any scale modifications, the equipment they will need to use during the session, and equipment the subject will need to use during the session. There should be Helpdesk staff available to address and resolve questions and issues from site staff.
If you have questions or are interested in more information about implementing video for remote visits and assessments, contact us.