The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review.

ABSTRACT: Importance. Oncology trials often entail high-stakes interventions where potential for morbidity and fatal side effects, and for life-prolongation or cure, intensify bioethical issues surrounding informed consent. These challenges are compounded in multistage randomized trials, which are prevalent in oncology. Objective. We sought to elucidate the major barriers to informed consent in high-stakes oncology trials in general and the best consent practices for multistage randomized trials. Evidence Review. We queried PubMed for original studies published from January 1, 1990, to April 5, 2018, that focused on readability, quality, complexity or length of consent documents, motivation and sickness level of participants, or interventions and enhancements that influence info

SUBMITTER: Nathe JM 

PROVIDER: S-EPMC6440043 | biostudies-literature | 2019 Jan-Jun

REPOSITORIES: biostudies-literature