Premium
The Inevitability and Ethics of Inaccurate Screening in Clinical Trials: A Call for Research and Guidance
Author(s) -
Wendler David
Publication year - 2021
Publication title -
ethics and human research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.353
H-Index - 32
eISSN - 2578-2363
pISSN - 2578-2355
DOI - 10.1002/eahr.500098
Subject(s) - clinical trial , research ethics , engineering ethics , face (sociological concept) , psychology , medicine , medical physics , psychiatry , sociology , pathology , engineering , social science
Abstract Accurate screening of potential research participants is vital to ensuring the scientific, regulatory, and ethical appropriateness of clinical trials. Yet there are no definitive screening tests for many conditions, and many screening tests, even when implemented correctly, yield some inaccurate results. Sponsors, researchers, and review committees thus routinely face the question of when it is acceptable to approve and conduct clinical trials that rely on screening measures that are known to exclude some eligible individuals and to include some ineligible ones. This article calls attention to and proposes preliminary guidance to address this important issue.