Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research

Journal of Medical Ethics 45 (1):18-21 (2019)
  Copy   BIBTEX

Abstract

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 92,991

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Update on Waiving Informed Consent in Emergency Research.Charles R. McCarthy - 1995 - Kennedy Institute of Ethics Journal 5 (4):385-386.
Emergency research without consent under polish law.Joanna Różyńska & Marek Czarkowski - 2007 - Science and Engineering Ethics 13 (3):337-350.

Analytics

Added to PP
2018-09-16

Downloads
27 (#608,699)

6 months
3 (#1,046,148)

Historical graph of downloads
How can I increase my downloads?