“COVID-19 has helped us work closer toward an equitable, accessible, and efficient clinical research system,” Calzone said. “We developed strategies to design more pragmatic and efficient clinical trials and minimize burdens on research sites and participants. Telehealth stands to help improve patient access to high-quality cancer care.”

Ethical Considerations for Research in the Telehealth Era

Many aspects of oncology research have evolved because of the pandemic and electronic tools, including administering interventions remotely and having clinical encounters via telehealth. Calzone, a research geneticist at the National Cancer Institute’s Center for Cancer Research, urged attendees to consider several important factors as they adapt:

• The laws in their particular state and surrounding states (where patients may reside)
• Whether surveys and questionnaires can be administered remotely, securely, and without compromising tool validity
• Who should be present at each telehealth appointment and who should not (e.g., parent/guardian, translator, legally authorized representative of a cognitively impaired patient)
• Ways to prevent patients from being distracted (such as driving during an appointment)
• Potential privacy risks of third-party applications that have been permitted by the federal government during the pandemic (e.g., Facetime, Zoom)

If a research study must pivot to a virtual or remote format midcourse, several revisions may have to be made to the protocol, Calzone said, including:

• Procedures for virtual or remote e-consent
• Procedures for telehealth encounters
• Definitions of the scope and procedures for transferring clinical care of study patients to local healthcare providers
• Outline of specific procedures for remote encounters
• Proper storage of investigational agents when transferring them to local providers
• Dispensing and administering investigational agents (for example, home delivery, home nursing, alternate site)

Obtaining Remote or Electronic Consent

Berry, a professor of biobehavioral health and health informatics at the University of Washington, discussed the utility and future of electronic consent. Options include getting verbal consent over telephone or video or using electronic agreements via websites and apps.

“In addition to avoiding potential exposure during the pandemic, we can continue to use e-consent in the future to save time, money, and energy,” she said. “But the same essential elements of consent are required; the system must include a way to ensure that the person electronically signing the informed consent is the subject who will be participating; and you must be able to verify identity with a birth certificate, government-issued passport, driver’s license, or security questions.”

Berry offered many tips when obtaining e-consent:

• Make sure the platform is secure, and share security information with participants.
• Use simple, concise language and bullets for readability.
• Consider offering multiple languages.
• Provide support for people who have limited computer skills, visual or auditory impairment, or no Internet access.
• Add audio, video, and graphics—but only if they don’t distract.
• Implement a quiz at the end to measure participants’ understanding of essential information.
• Include a feature for online withdrawal of consent for those who wish to drop out.
• Use the same system to keep participants informed throughout the study (e.g., results and follow-up). 

Both presenters emphasized that if any aspect of a research protocol is changed, researchers may have to consult the institutional review board, ask participants for additional consent, and communicate changes to the sponsor.