<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03258606</url>
  </required_header>
  <id_info>
    <org_study_id>999917119</org_study_id>
    <secondary_id>17-CC-N119</secondary_id>
    <nct_id>NCT03258606</nct_id>
  </id_info>
  <brief_title>Characteristics and Outcomes of a Capacity-to-Consent Assessment Service</brief_title>
  <official_title>Characteristics and Outcomes of a Capacity-to-Consent Assessment Service</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Many medical conditions such as Alzheimer s disease limit the ability of people to think&#xD;
      clearly. For medical scientists to best study these medical conditions, they need to enroll&#xD;
      some people who may not be able to consent to participate in research on their own. Before&#xD;
      these individuals enroll in research it is important to assess whether they are able to&#xD;
      consent or whether someone else will need to consent for them. The NIH Clinical Center has a&#xD;
      team that performs these assessments. A team like this can be useful for two reasons. First,&#xD;
      it helps to protect the rights of research participants. Second, it makes it possible to&#xD;
      study medical conditions that could not be studied otherwise. In this study we will look back&#xD;
      at the records of the NIH Clinical Center team to review the process and results of these&#xD;
      assessments. We expect to learn how the capacity assessments were done. We will learn what&#xD;
      factors make people more or less able to consent. We will learn who consented for the&#xD;
      research participants when they could not consent on their own, for example a spouse or an&#xD;
      adult child. These results are likely to be useful to other researchers who wish to study&#xD;
      diseases that limit cognitive ability.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study the process and outcomes of capacity assessments of people who may not be able to&#xD;
      consent to research.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People of all ages, genders, races, ethnicities, and languages whose ability to consent was&#xD;
      assessed at the NIH Clinical Center at some time during the years 1999-2016.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This study will only review existing records. There will not be any active participants.&#xD;
&#xD;
      Records will be reviewed for research only. This will take place in the Clinical Center. It&#xD;
      will be done by staff of the Department of Bioethics and the Human Subjects Protection Unit&#xD;
      (HSPU).&#xD;
&#xD;
      The study will collect data from the Bioethics Consult database. It will also collect data&#xD;
      from HSPU records.&#xD;
&#xD;
      Researchers will look at demographic data. They will look at details of capacity evaluations.&#xD;
&#xD;
      Personal data will not be extracted from existing records.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To characterize the process and outcomes of capacity assessments of individuals&#xD;
      who may be unable to consent to participate in research.&#xD;
&#xD;
      Study population: all individuals who came to the NIH Clinical Center for possible enrollment&#xD;
      in research whose capacity to consent or assent was evaluated by the Bioethics Consultation&#xD;
      Service (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent&#xD;
      Assessment Team (ACAT), and all surrogate decision makers of individuals who were unable to&#xD;
      consent and were allowed by protocol to give surrogate consent.&#xD;
&#xD;
      Design: Retrospective record review&#xD;
&#xD;
      Outcome measures: The primary outcome measure will be whether prospective research&#xD;
      participants were judged to be able to consent or not. Secondary measures will include:&#xD;
      whether the consulting team considered it ethically acceptable to enroll the participant in&#xD;
      research; how consent was obtained for doing so; and descriptive features of the consults&#xD;
      such as the Institute that requested the consult, protocols for which consults were&#xD;
      requested, and diseases that prompted capacity assessments, among other descriptive&#xD;
      characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Actual">April 9, 2021</completion_date>
  <primary_completion_date type="Actual">August 10, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Whether prospective research participants were judged to be able toconsent or not.</measure>
    <time_frame>At record review</time_frame>
    <description>Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained for doing so.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.</measure>
    <time_frame>At record review</time_frame>
    <description>Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whether the consulting team considered it ethically acceptable toenroll the participant in research and how consent was obtained for doing so.</measure>
    <time_frame>At record review</time_frame>
    <description>Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained fordoing so.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1098</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Individuals with affected capacity to consent</arm_group_label>
    <description>Individuals with who were unable to consent and were allowed by protocol to give surrogate consent.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All individuals who came to the NIH Clinical Center for possible enrollment in research&#xD;
        whose capacity to consent or assent was evaluated by the Bioethics Consultation Service&#xD;
        (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent Assessment Team&#xD;
        (ACAT), and all surrogate decision makers of individuals who were unable to consent and&#xD;
        were allowed by protocol to give surrogate consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Participant ages 7 to 99&#xD;
&#xD;
          -  Participants must have undergone some type of capacity evaluation, consent or assent&#xD;
             monitoring, or surrogate assessment, by the BCS, HSPU, or ACAT.&#xD;
&#xD;
          -  Children (or adults) who were seen by the consultation service for the purposes of&#xD;
             either evaluating their ability to assent or for assent monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Pregnant women or prisoners will not be included&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marion Danis, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surrogate</keyword>
  <keyword>Decision Making</keyword>
  <keyword>Capacity to Consent</keyword>
  <keyword>Cognitive Impairment</keyword>
  <keyword>Enrollment</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03258606
org study id: 999917119
secondary id: 17-CC-N119
nct id: NCT03258606
lead sponsor: 
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Whether prospective research participants were judged to be able toconsent or not.
time frame: At record review
description: Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained for doing so.
measure: Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.
time frame: At record review
description: Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.
measure: Whether the consulting team considered it ethically acceptable toenroll the participant in research and how consent was obtained for doing so.
time frame: At record review
description: Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained fordoing so.
arm group label: Individuals with affected capacity to consent
description: Individuals with who were unable to consent and were allowed by protocol to give surrogate consent.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Marion Danis, M.D.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction