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

NCT03258606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1098

Last updated 2023-02-24

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Marion Danis, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2018-08-10
Completion
2021-04-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258606 on ClinicalTrials.gov