As Oncology Research Pivots in Pandemic, Here’s How to Maintain Consent and Ethics

April 27, 2021

As health care has made countless adaptations to forge on during the COVID-19 coronavirus pandemic, oncology nurse researchers haven’t escaped the effects. During a session on April 27, 2021, for the 46th Annual ONS Congress™, Kathleen Calzone, PhD, RN, AGN-BC, FAAN, and Donna Berry, PhD, RN, AOCN®, FAAN, outlined specific ways researchers have pivoted with virtual approaches to continue their important work.

“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:

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:

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:

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.


Copyright © 2021 by the Oncology Nursing Society. User has permission to print one copy for personal or unit-based educational use. Contact pubpermissions@ons.org for quantity reprints or permission to adapt, excerpt, post online, or reuse ONS Voice content for any other purpose.