4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for IRB review of research involving subjects who have impaired decision-making capacity.


2.0 Policy

It is the policy of the Organization that research involving subjects who have impaired decision-making capacity must include appropriate additional protections in accordance with the ethical principles described in the Belmont Report, and the requirements of 45 CFR 46.111(b) and 21 CFR 56.111(b), as applicable.


3.0 Definitions


4.0 Assessment of Capacity to Consent


5.0 Appointment and Authority of the LAR or IAS


6.0 Assent and Dissent


7.0 Acceptable Research Involving Decisionally Impaired Subjects


8.0 Additional Protections

In consideration of the characteristics of the subject population, the nature of the research and the risk level, the IRB will determine what additional protections are necessary. Additional protections for vulnerable subject populations which include individuals who are decisionally impaired are described in HRPP policy 4.1 (Additional Protections for Vulnerable Populations).


9.0 IRB Review


10.0 Disclosure and Consent for Continuing Participation

If a person with diminished capacity regains capacity during the conduct of the research, they must be fully informed about the research and the circumstances of their enrollment. Their consent to continue in the research protocol must be obtained in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).


11.0 Disclosure After the Research has Been Completed

If a person with diminished capacity regains capacity following completion of the conduct of the research, they must be fully informed about the research and the circumstances of their enrollment.



DOCUMENT HISTORY:

 Written: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

 Revised: 1/29/2018 - revision not documented

 Revised: 12/8/2022 - Revised definition of LAR as per 45 CFR 46.102(i); deleted reference to pre-2018 Common Rule; defined IAS and clarified priority order of IAS by referencing Nebraska Medicine policy MS14; defined dissent; deleted reference to LAR ICF.

 Revised: 11/27/2024 - modified definition of capacity to remove extraneous language; revised “Cognitively impaired” to “decisionally impaired”; added reference to Children’s Nebraska policy (Consent for Treatment); stylistic and other minor changes.


Revision #13
Created 24 October 2019 21:37:34 by Autumn M Eberly
Updated 28 May 2025 15:38:11 by Robert A Lewis