Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/24/2018 |
| Start Date: | November 1, 2017 |
| End Date: | March 1, 2027 |
| Contact: | Margaret R Mahoney |
| Email: | researchvolunteer@mail.nih.gov |
| Phone: | (240) 665-0697 |
Objective: To screen and create a list of adult volunteers in good health for participation
in research studies conducted at the National Institutes of Health (NIH) in Bethesda,
Maryland. Develop a normative set of structural and functional brain MRI scans that are
linked to healthy research volunteer characteristics. Maximize scientific impact of data from
volunteers by broadly sharing with other researchers.
Study Population: Adult males and females in general good health who are 18 years of age and
older.
Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as
a healthy research volunteer can directly visit or be directed to visit the study website
where they will first consent electronically and then complete a set of online self-report
measures. Items may include: demographic information, mental health symptoms, disability
status, substance use patterns, handedness and clinical/family history. Individuals who are
flagged based on predetermined responses to survey items will be further screened by a member
of the study clinical team. If found to be ineligible for the study because of a clinically
significant or unstable medical or mental health condition, these individuals will be
referred back to the community and/or given information about NIMH clinical studies for which
they may be eligible. Respondents with no flags or who pass through additional screening will
be scheduled for an in-person assessment. During the outpatient appointment and after
in-person informed consent, participants will receive a brief clinical interview to screen
for current medical and mental conditions, and risk for self-harm. They will complete
assessments of psychological, emotional, physiologic, biological and cognitive functioning.
Participants will undergo a physical exam and be asked to provide blood and urine samples for
routine clinical labs as well as additional blood samples for future secondary analysis that
could include genetic or biomarker assays. Participants can separately consent for an
optional baseline brain magnetic resonance imaging (MRI) scan and an optional
magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that
if enrolled in the study, their de-identified data will be broadly and publicly shared
through NIH-approved data repositories. Participants in this recruitment and characterization
study will then be placed on a list of healthy research volunteers from which other NIMH IRP
studies may recruit according to the inclusion and exclusion criteria in their respective
IRB-approved protocols.
Outcome Measures: Outcome measures may include demographic data, mental and medical history
and symptoms, results of psychological, emotional, physiologic, biological, and cognitive
testing, physical exam and MRI findings.
in research studies conducted at the National Institutes of Health (NIH) in Bethesda,
Maryland. Develop a normative set of structural and functional brain MRI scans that are
linked to healthy research volunteer characteristics. Maximize scientific impact of data from
volunteers by broadly sharing with other researchers.
Study Population: Adult males and females in general good health who are 18 years of age and
older.
Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as
a healthy research volunteer can directly visit or be directed to visit the study website
where they will first consent electronically and then complete a set of online self-report
measures. Items may include: demographic information, mental health symptoms, disability
status, substance use patterns, handedness and clinical/family history. Individuals who are
flagged based on predetermined responses to survey items will be further screened by a member
of the study clinical team. If found to be ineligible for the study because of a clinically
significant or unstable medical or mental health condition, these individuals will be
referred back to the community and/or given information about NIMH clinical studies for which
they may be eligible. Respondents with no flags or who pass through additional screening will
be scheduled for an in-person assessment. During the outpatient appointment and after
in-person informed consent, participants will receive a brief clinical interview to screen
for current medical and mental conditions, and risk for self-harm. They will complete
assessments of psychological, emotional, physiologic, biological and cognitive functioning.
Participants will undergo a physical exam and be asked to provide blood and urine samples for
routine clinical labs as well as additional blood samples for future secondary analysis that
could include genetic or biomarker assays. Participants can separately consent for an
optional baseline brain magnetic resonance imaging (MRI) scan and an optional
magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that
if enrolled in the study, their de-identified data will be broadly and publicly shared
through NIH-approved data repositories. Participants in this recruitment and characterization
study will then be placed on a list of healthy research volunteers from which other NIMH IRP
studies may recruit according to the inclusion and exclusion criteria in their respective
IRB-approved protocols.
Outcome Measures: Outcome measures may include demographic data, mental and medical history
and symptoms, results of psychological, emotional, physiologic, biological, and cognitive
testing, physical exam and MRI findings.
Objective: To screen and create a list of adult volunteers in good health for participation
in research studies conducted at the National Institutes of Health (NIH) in Bethesda,
Maryland. Develop a normative set of structural and functional brain MRI scans that are
linked to healthy research volunteer characteristics. Maximize scientific impact of data from
volunteers by broadly sharing with other researchers.
Study Population: Adult males and females in general good health who are 18 years of age and
older.
Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as
a healthy research volunteer can directly visit or be directed to visit the study website
where they will first consent electronically and then complete a set of online self-report
measures. Items may include: demographic information, mental health symptoms, disability
status, substance use patterns, handedness and clinical/family history. Individuals who are
flagged based on predetermined responses to survey items will be further screened by a member
of the study clinical team. If found to be ineligible for the study because of a clinically
significant or unstable medical or mental health condition, these individuals will be
referred back to the community and/or given information about NIMH clinical studies for which
they may be eligible. Respondents with no flags or who pass through additional screening will
be scheduled for an in-person assessment. During the outpatient appointment and after
in-person informed consent, participants will receive a brief clinical interview to screen
for current medical and mental conditions, and risk for self-harm. They will complete
assessments of psychological, emotional, physiologic, biological and cognitive functioning.
Participants will undergo a physical exam and be asked to provide blood and urine samples for
routine clinical labs as well as additional blood samples for future secondary analysis that
could include genetic or biomarker assays. Participants can separately consent for an
optional baseline brain magnetic resonance imaging (MRI) scan and an optional
magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that
if enrolled in the study, their de-identified data will be broadly and publicly shared
through NIH-approved data repositories. Participants in this recruitment and characterization
study will then be placed on a list of healthy research volunteers from which other NIMH IRP
studies may recruit according to the inclusion and exclusion criteria in their respective
IRB-approved protocols.
Outcome Measures: Outcome measures may include demographic data, mental and medical history
and symptoms, results of psychological, emotional, physiologic, biological, and cognitive
testing, physical exam and MRI findings.
in research studies conducted at the National Institutes of Health (NIH) in Bethesda,
Maryland. Develop a normative set of structural and functional brain MRI scans that are
linked to healthy research volunteer characteristics. Maximize scientific impact of data from
volunteers by broadly sharing with other researchers.
Study Population: Adult males and females in general good health who are 18 years of age and
older.
Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as
a healthy research volunteer can directly visit or be directed to visit the study website
where they will first consent electronically and then complete a set of online self-report
measures. Items may include: demographic information, mental health symptoms, disability
status, substance use patterns, handedness and clinical/family history. Individuals who are
flagged based on predetermined responses to survey items will be further screened by a member
of the study clinical team. If found to be ineligible for the study because of a clinically
significant or unstable medical or mental health condition, these individuals will be
referred back to the community and/or given information about NIMH clinical studies for which
they may be eligible. Respondents with no flags or who pass through additional screening will
be scheduled for an in-person assessment. During the outpatient appointment and after
in-person informed consent, participants will receive a brief clinical interview to screen
for current medical and mental conditions, and risk for self-harm. They will complete
assessments of psychological, emotional, physiologic, biological and cognitive functioning.
Participants will undergo a physical exam and be asked to provide blood and urine samples for
routine clinical labs as well as additional blood samples for future secondary analysis that
could include genetic or biomarker assays. Participants can separately consent for an
optional baseline brain magnetic resonance imaging (MRI) scan and an optional
magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that
if enrolled in the study, their de-identified data will be broadly and publicly shared
through NIH-approved data repositories. Participants in this recruitment and characterization
study will then be placed on a list of healthy research volunteers from which other NIMH IRP
studies may recruit according to the inclusion and exclusion criteria in their respective
IRB-approved protocols.
Outcome Measures: Outcome measures may include demographic data, mental and medical history
and symptoms, results of psychological, emotional, physiologic, biological, and cognitive
testing, physical exam and MRI findings.
- INCLUSION CRITERIA:
1. 18 years of age and older.
2. Able to read, speak, and understand English.
3. Able to provide informed consent.
4. In current good general health.
EXCLUSION CRITERIA:
1. Have a history of significant or unstable medical or mental health condition requiring
treatment, such as heart or lung disease, depression or psychosis.
2. Endorse current self-injury, suicidal thoughts or behavior.
3. Have current illicit drug use by history or urine drug screen.
4. Are found to have an abnormal physical exam or laboratory result that may require
treatment or further evaluation.
5. Less than an 8th grade education or an IQ below 70.
6. Are an NIMH employee, staff member, or first degree relative (parent, sibling, child)
of an NIMH employee or staff member.
Optional Brain MRI scan exclusion criteria:
1. Metal in body which would make having an MRI scan unsafe
2. Being uncomfortable in small closed spaces such as the MRI machine
3. Inability to lie comfortably on back for at least 45 minutes
4. Pregnancy
Optional MEG recording exclusion criteria:
1. Metal in body which would cause artifacts on MEG recordings.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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