Characteristics and Outcomes of a Capacity-to-Consent Assessment Service
Public ClinicalTrials.gov record NCT03258606. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03258606
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,098 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 7 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2017
- Primary completion
- Aug 9, 2018
- Completion
- Apr 8, 2021
- Last update posted
- Feb 23, 2023
2017 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03258606, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2023 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03258606 live on ClinicalTrials.gov.