Characteristics and Outcomes of a Capacity-to-Consent Assessment Service

NCT03258606 | Completed

• 2 other identifiers: 99991711917-CC-N119
• Study Type: observational
• Target: 1,098
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Many medical conditions such as Alzheimer s disease limit the ability of people to think clearly. For medical scientists to best study these medical conditions, they need to enroll some people who may not be able to consent to participate in research on their own. Before these individuals enroll in research it is important to assess whether they are able to consent or whether someone else will need to consent for them. The NIH Clinical Center has a team that performs these assessments. A team like this can be useful for two reasons. First, it helps to protect the rights of research participants. Second, it makes it possible to study medical conditions that could not be studied otherwise. In this study we will look back at the records of the NIH Clinical Center team to review the process and results of these assessments. We expect to learn how the capacity assessments were done. We will learn what factors make people more or less able to consent. We will learn who consented for the research participants when they could not consent on their own, for example a spouse or an adult child. These results are likely to be useful to other researchers who wish to study diseases that limit cognitive ability. Objective: To study the process and outcomes of capacity assessments of people who may not be able to consent to research. Eligibility: People of all ages, genders, races, ethnicities, and languages whose ability to consent was assessed at the NIH Clinical Center at some time during the years 1999-2016. Design: This study will only review existing records. There will not be any active participants. Records will be reviewed for research only. This will take place in the Clinical Center. It will be done by staff of the Department of Bioethics and the Human Subjects Protection Unit (HSPU). The study will collect data from the Bioethics Consult database. It will also collect data from HSPU records. Researchers will look at demographic data. They will look at details of capacity evaluations. Personal data will not be extracted from existing records.

Conditions

Cognitive Dysfunction

Keywords

Surrogate; Decision Making; Capacity to Consent; Cognitive Impairment; Enrollment; Natural History

Outcome Measures

Primary Outcomes (1)

• Whether prospective research participants were judged to be able toconsent or not.

  Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained for doing so.

  At record review

Secondary Outcomes (2)

• Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.

  At record review

• Whether the consulting team considered it ethically acceptable toenroll the participant in research and how consent was obtained for doing so.

  At record review

Study Arms (1)

Individuals with affected capacity to consent

Individuals with who were unable to consent and were allowed by protocol to give surrogate consent.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals who came to the NIH Clinical Center for possible enrollment in research whose capacity to consent or assent was evaluated by the Bioethics Consultation Service (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent Assessment Team (ACAT), and all surrogate decision makers of individuals who were unable to consent and were allowed by protocol to give surrogate consent.

You may qualify if:

• Participant ages 7 to 99
• Participants must have undergone some type of capacity evaluation, consent or assent monitoring, or surrogate assessment, by the BCS, HSPU, or ACAT.
• Children (or adults) who were seen by the consultation service for the purposes of either evaluating their ability to assent or for assent monitoring

You may not qualify if:

• Pregnant women or prisoners will not be included

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marion Danis, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 23, 2017
• Study Start: June 26, 2017
• Primary Completion: August 10, 2018
• Study Completion: April 9, 2021
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)