Capacity, Vulnerability, and Informed Consent for Research

被引：36
作者：
Biros, Michelle [1 ,2 ,3 ,4 ]
机构：
[1] Univ Minnesota, Sch Med, Emergency Med, Minneapolis, MN 55455 USA
[2] Univ Minnesota, Sch Med, Dept Emergency Med, Minneapolis, MN 55455 USA
[3] Natl Acad Med, Washington, DC 20001 USA
[4] Univ Minnesota, Vulnerable Populat, Human Subjects Protect Program, Minneapolis, MN 55455 USA
来源：
JOURNAL OF LAW MEDICINE & ETHICS | 2018年 / 46卷 / 01期
基金：
美国国家卫生研究院;
关键词：
DECISIONAL CAPACITY; CHALLENGES; PREVALENCE; FOLLOW;
D O I：
10.1177/1073110518766021
中图分类号：
B82 [伦理学（道德学）];
学科分类号：
摘要：
This article presents an overview for clinician investigators on the concepts of decision-making capacity and vulnerability as related to human subjects research. Tools for capacity assessment and unacknowledged sources of vulnerability are discussed, and the practical gaps in current informed consent requirements related to impaired capacity and potential vulnerability are described. Options are suggested for research discussions when full regulatory consent is not possible and an exception from informed consent does not apply.
引用
收藏
页码：72 / 78
页数：7
相关论文
共 31 条
  • [1] Working with vulnerable groups in social research: dilemmas by default and design
    Aldridge, Jo
    [J]. QUALITATIVE RESEARCH, 2014, 14 (01) : 112 - 130
  • [2] American College of Cardiology Foundation and the Ameri- can Heart Association, 2004, J AM COLL CARDIOL, V44, P1724
  • [3] American College of Emergency Physicians, 2017, POL STAT COD ETH EM
  • [4] [Anonymous], 1979, THE BELM REP
  • [5] [Anonymous], 2002, INT ETH GUID BIOM RE
  • [6] Appelbaum P. S., 2001, MACARTHUR COMPETENCE, P11
  • [7] Assessment of patients' competence to consent to treatment
    Appelbaum, Paul S.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2007, 357 (18) : 1834 - 1840
  • [8] Association of Clinical Research Professionals, 2016, CODE ETHICS PROFESSI
  • [9] Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent
    Biros, Michelle H.
    Dickert, Neal W.
    Wright, David W.
    Scicluna, Victoria M.
    Harney, Deneil
    Silbergleit, Robert
    Denninghoff, Kurt
    Pentz, Rebecca D.
    [J]. ACADEMIC EMERGENCY MEDICINE, 2015, 22 (03) : 340 - 346
  • [10] The "Vulnerability" of Psychiatric Research Participants: Why This Research Ethics Concept Needs to Be Revisited
    Bracken-Roche, Dearbhail
    Bell, Emily
    Racine, Eric
    [J]. CANADIAN JOURNAL OF PSYCHIATRY-REVUE CANADIENNE DE PSYCHIATRIE, 2016, 61 (06): : 335 - 339
1234