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.
Get full access to this article
View all access options for this article.
References
1.
Association of Clinical Research Professionals, Code of Ethics and Professional Conduct (2016), available at <www.acrpnet.org/about/code-of-ethics> (last visited January 16, 2017); American College of Cardiology Foundation and the American Heart Association, “The ACCF and AHA Codes of Conduct in Human Subjects Research,” Journal of the American College of Cardiology 44, no. 8 (2004): 1724-1728; American College of Emergency Physicians, Policy Statement: Code of Ethics for Emergency Physicians (2017), available at <www.ACEP.org/clinical-practice> (last visited January 16, 2017).
2.
C. W.Lidzet al., “How Closely do Institutional Review Boards Follow the Common Rule?”Academic Medicine87, no.7 (2012): 969-974.
C.Grady, “Enduring and Emerging Challenges of Informed Consent,”New England Journal of Medicine372, no. 9 (2015): 855-862.
5.
Id.
6.
G.Henderson, “Is Informed Consent Broken?”American Journal of the Medical Sciences342, no. 4 (2011): 267-272.
7.
See Grady, supra note 4; Henderson, supra note 6.
8.
See Henderson, supra note 6.
9.
S.Kimat al., “Do Clinicians Follow a Risk-Sensitive Model of Capacity-Determination? An Experimental Video Survey,”Psychosomatics47, no. 4 (2006): 325-329; D.V. Jeste et al.,“A New Brief Instrument for Assessing Decisional Capacity for Clinical Research,” Archives of General Psychiatry 64, no. 8 (2007): 966-974.
10.
Institutional Review Board, Office for Human Research Protection, Mayo Clinic, Informed Consent and Assessment of Capacity to Consent to Research, (2016), available at <http://mayocontent.mayo.edu/irb> (March 1, 2017).
11.
K. L.Triebelet al., “Decision-making Capacity and Competency,” in M. A.Buddet al., eds., Practical Psychology in Medical Rehabilitation (Cham, Switzerland: Spiner International Publishing, 2017): at 343-352.
12.
J.Karlawishet al., “Cognitive Impairment and PD Patients' Capacity to Consent to Research,”Neurology81, no. 9 (2013): 801-807. See also Triebel et al., supra note 11; I. Moran-Sanchez et al., “Assessment of Capacity to Consent to Research Among Psychiatric Outpatients: Prevalence and Associated Factors,” Psychiatric Quarterly 87, no. 87 (2016): 89-105.
13.
See Moran-Sanchez et al., supra note 12.
14.
D.Bracken-Rocheet al., “The Vulnerability of Psychiatric Research Participants: Why This Research Ethics Concept Needs to be Revisited,”Canadian Journal of Psychiatry61, no. 6 (2016): 335-339.
15.
See Kim et al., supra note 9; Jeste et al., supra note 9.
16.
See Karlawish et al., supra note 12.
17.
P. S.Appelbaum and T.Grisso, MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) (Sarasota, FL: Professional Resources Press, 2001): at 11.
18.
Id.
19.
See Kim et al., supra note 9; Grady, supra note 4.
20.
University of California at San Diego Research Protections Program, Decision-making Capacity Guidelines, available at <http://irb.ucsd.edu> (last visited 1/16/17); University of Pittsburgh Human Subjects Protection Program, Decision-making Capacity, available at <http://irb.upitt.edu> (last visited January 16, 2017); University of Kentucky Office of Research Integrity, Impaired Consent Capacity Policy, available at <http://www.research.uky.edu/ori/ORIForms/62-Impaired-Consent-Capacity-Policy.pdf>(last visited January 16, 2017); see also supra note 10.
21.
See University of Kentucky Office of Research Integrity, supra note 20.
22.
See Appelbaum and Grisso, supra note 17.
23.
See Moran-Sanchez et al., supra note 12. See also Appelbaum and Grisso, supra note 17.
24.
L. B.Dunnet al., “Prevalence and Correlates of Adequate Performance on a Measure of Abilities Related to Decisional Capacity; Differences Among Three Standards for the MacCAT-CR in Patients with Schizophrenia,”Schizophrenia Research89, no. 1-3 (2007); 110-118.
25.
P. S.Appelbaum, “Assessment of Patients' Competence to Consent to Treatment,”New England Journal of Medicine357, no. 18 (2007): 1834-1840.
26.
See Jeste et al., supra note 9.
27.
See Appelbaum and Grisso, supra note 17.
28.
Council for International Organizations of Medical Sciences (CIOMS), “International Ethical Guidelines for Biomedical Research Involving Human Subjects” (Geneva, Switzerland: 2002); International Conference on Harmonisation (ICH) Steering Committee,” ICH Harmonized Tripartite Guideline,” (1996).
29.
See National Commission, supra note 3. See also CIOMS, supra note 28.
30.
See ICH, supra note 28; CIOMS, supra note 28.
31.
W.Rogerset al., “Why Bioethics Needs a Concept of Vulnerability,”International Journal of Feminist Approaches to Bioethics5, no. 2 (2012): 11-22; J. Aldridge, “Working with Vulnerable Groups in Social Research: Dilemmas by Default and Design,” Qualitative Research 14, no. 1 (2014): 112-130; F. Luna, “Elucidating the Concept of Vulnerability: Layers Not Labels,” International Journal of Feminist Approaches to Bio-ethics 2, no. 1 (2009): 121-139.
32.
See Aldridge, supra note 31.
33.
See Luna, supra note 31; Bracken-Roche et al., supra note 14.
University of Minnesota Human Research Protection Program, Policy-Research Involving Adults with Absent, Diminished, or Fluctuating Capacity to Consent to Participate in Research (2017), available at <http://www.research.umn.edu/irb/toolkit.html> (last visited January 16, 2017).
U.S. Department of Health and Human Services (DHHS), Waiver of Informed Consent Requirements in Certain Emergency Research 45 C.F.R. 46 (1996).
39.
See ICH, supra note 28; see supra note 3.
40.
U.S. Department of Health and Human Services (DHHS), IRB Waiver or Alteration of Informed Consent. 45 C.F.R. § 46.116d (1996).
41.
R. E.McKinneyet al., “Use of Altered Informed Consent in Pragmatic Clinical Research,”Clinical Trials12, no. 5 (2015): 494-502; B. Koenig, “Have We Asked Too Much of Consent?,” Hastings Center Report 44, no. 4 (2014): 33-34.
42.
N. W.Dickertet al., “Confronting Ethical and Regulatory Challenges of Emergency Care Research with Conscious Patients,”Annals of Emergency Medicine67, no. 4 (2016): 538-545.
43.
M. H.Biroset al., ”Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent,”Academic Emergency Medicine22, no. 3 (2015): 340-346.
