UK Office of Research Integrity

IRB Application: Vulnerable Populations

Section 5
FORM T.   Research Involving Adults with Impaired Consent Capacity

There are additional issues that need to be addressed when a research protocol involves adults who may be unable to provide legally effective informed consent because of impairment in consent capacity.  

The IRB requests completion of form T for research protocols that target populations with known impairment as well as studies in which the illness or situational factors could impact consent capacity or produce fluctuations in consent capacity.   If you are proposing research with the potential to enroll one or more adults with consent capacity impairment, please mark the appropriate selection(s) in the applicable question in the General Information Sheet [Form A].

In conducting its review, the IRB will assess three dimensions of risk: (1) Research risk; (2) Likelihood that the target population for the study has impaired consent capacity; and (3) The likelihood that consent capacity might change over time. Based on the overall assessment, the IRB has determined recommended obligations and duties of the investigator in regard to capacity assessment and safeguards. 

To facilitate this process, the online version of Form T allows the investigator to self-assess the dimensions relative to his/her protocol.  The Form T calculates a composite score and launches a hard copy plan (printable Form T) with IRB recommended assessment options and suggested safeguards.  You (the investigator) may use the recommended assessment or provide rationales for alternative protections.  Upon completion, you must save and print hard copies of Form T for inclusion in the IRB submission.   

Some of the assessment options for studies with high composite scores recommend adaptations or use of validated tools.  The following provides information regarding use and access to validated consent capacity assessment tools:

    1. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR; Appelbaum & Grisso, 2001)
      1. Semi-structured interview, tailored to protocol
      2. Administration takes 15-30 minutes, and substantial training is required for valid administration and interpretation
      3. Available from Amazon.com
    2. The University of California, San Diego Brief Assessment of Capacity to Consent (UBACC; Jeste et al., 2007) is available on line
      1. 10-item scale; may be tailored to protocol
      2. Less than 5 minutes to administer, minimal training needed
      3. AMA terms of use for the UBACC

If you do not wish to utilize the online version of Form T, he/she should refer to the University of Kentucky IMPAIRED CONSENT CAPACITY POLICY [PDF] Table 1 Research Dimensions and Categories.  Select the categories appropriate to the study population for (1) Research risk; (2) Likelihood that the target population for the study has impaired consent capacity; and (3) The likelihood that consent capacity might change over time.  Upon request, the ORI will provide you with a manual copy of Form T pre-populated with the composite score and IRB recommendations.  Complete the manual form and include with the IRB application.  Send request for manual copies of Form T to: Belinda Smith @ belinda.smith@uky.edu or Judi Kuhl @ jehrig@uky.edu

For additional information, review the University of Kentucky Impaired Consent Capacity Policy [PDF] and/or the presentation handout “Assessing Consent Capacity in Clinical Research: New Directions” [PDF] also available on the Educational Materials, Regulations and Policy Guidance web page or contact the Office of Research Integrity at 859-257-9428.

 

Back to Top