Abstract
Palliative care research raises a host of ethical concerns. Obtaining informed consent
from seriously ill patients and their families is often perceived as an additional
burden. Alternative approaches to traditional written informed consent reflect the
changing nature of modern trial design, embracing real-world effectiveness and pragmatic
clinical trials with those who are seriously ill. Ethicists, clinical investigators,
and regulatory bodies have acknowledged the challenges to rigorous, meaningful, and
generalizable research across diverse patient populations in real-world settings.
The purpose of this article is to describe how these clinical trial designs have driven
innovation in methods for achieving informed consent, with a focus on palliative care
research. In this article, we describe and provide examples of consent waivers and
three types of alternative approaches to consent, including broadcast notification
and integrated and targeted consent. We also present our experiences in an ongoing
palliative care clinical trial, specifically using broadcast notification. Working
with participants and regulatory oversight organizations, investigators can address
the limits of traditional written informed consent and adopt innovative consent models
to advance the science of palliative care. Research is now needed to determine the
impact of these differing consent models on clinical trial recruitment, enrollment,
and retention, as well as participants’ informed understanding of their research participation
using such models.
Key Words
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Article info
Publication history
Published online: October 28, 2020
Accepted:
September 30,
2020
Identification
Copyright
© 2020 Published by Elsevier Inc. on behalf of American Academy of Hospice and Palliative Medicine.
