Characteristics and Outcomes of a Capacity-to-Consent Assessment Service
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 7 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | May 31, 2020 |
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.
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.
Objective: To characterize the process and outcomes of capacity assessments of individuals
who may be unable to consent to participate in research.
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.
Design: Retrospective record review
Outcome measures: The primary outcome measure will be whether prospective research
participants were judged to be able to consent or not. Secondary measures will include:
whether the consulting team considered it ethically acceptable to enroll the participant in
research; how consent was obtained for doing so; and descriptive features of the consults
such as the Institute that requested the consult, protocols for which consults were
requested, and diseases that prompted capacity assessments, among other descriptive
characteristics.
who may be unable to consent to participate in research.
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.
Design: Retrospective record review
Outcome measures: The primary outcome measure will be whether prospective research
participants were judged to be able to consent or not. Secondary measures will include:
whether the consulting team considered it ethically acceptable to enroll the participant in
research; how consent was obtained for doing so; and descriptive features of the consults
such as the Institute that requested the consult, protocols for which consults were
requested, and diseases that prompted capacity assessments, among other descriptive
characteristics.
- INCLUSION CRITERIA:
- 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
Exclusion Criteria:
-Pregnant women or prisoners will not be included
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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