Telehealth, Clinical Research and Informed Consent
By most any measure, one of the biggest impacts that COVID-19 has had on the practice of medicine is the shift toward more telemedicine visits. Although the practice of delivering health services over the phone or the Internet has been around for some time, it wasn’t until the pandemic forced communities to close that clinical practices started to explore the use of technologies to continue monitoring patients remotely.
The global health crisis has forced both health care providers and regulatory agencies to pivot toward digital health services. Clinical research is no exception. Many clinical research studies were put on hold in the early days and weeks of the pandemic in the United States. Researchers and their staff were deployed to support COVID-19 efforts. Regulatory agencies had to adapt guidelines for HIPAA and other issues for the new environment. Health insurers developed policies for telemedicine and reimbursement.
Although clinical research in COVID-19 still seems to dominate at research institutions, protocols not related to COVID-19 are starting to return. Studies that were paused are also being resumed, albeit slowly and cautiously. Each institution has to assess risk based on local risk factors and patient populations. For studies that are primarily computational, or do not require in-person interventions, telemedicine may continue to dominate.
For research professionals, one critical issue is the process for consenting, or re-consenting, patients. For studies that were paused, investigators may need to re-consent patients due to necessary changes in the protocol. Participants may have to confirm their willingness to continue their participation in a trial.
These and other issues require consideration of the process of obtaining consent. Research coordinators, while familiar with the protocols, may need to adapt to the method of consent and how they explain the studies to patients via these technologies. The 2018 regulatory changes to consent forms that require a concise summary may be helpful in helping to communicate with potential participants. The remote consenting process may require more dialogue with the patient to ensure understanding.
These new processes can be an adjustment for research coordinators or others obtaining consent. Proper training on process is critical to ensure informed consents are conducted appropriately and continue to protect human subjects.
CITI Program, a division of BRANY, is hosting a webinar on informed consent on September 30, 2020 at 2PM EST.