Clinical trial NCT02091271: Screening Protocol to Evaluate Volunteers for NIA Approved Studies
Official title: Screening Protocol to Evaluate Volunteers for NIA Approved Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Volunteers
Keywords: Evaluation
Research
Healthy Volunteers
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2014-03-19
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The National Institute on Aging (NIA) Intramural Research Program (IRP) has a number ofiRB approved research studies involving human subjects, both normal volunteers and patients. As a means of identifying interested volunteers and other participants in the research process, this screening mechanism is established to identif'y potential eligible participants for NlA protocols.

To participate, volunteers/patients must meet the specific requirements of at least one of the available NlA research studies; this protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol and creating a contact database for approved NlA studies.

This protocol will facilitate their recruitment into NIA approved studies and provide NlA staff the opportunity to examine subjects where diagnostic observations can be documented and evaluated for research potential.

Detailed description: The screening protocol is designed to evaluate volunteers/patients for participation in IRB approved clinical studies of the National Institute on Aging (NIA). An additional purpose of this protocol is to develop a registry of individuals who have been evaluated through the NIA Clinical Research Unit screening clinic. To participate, volunteers/patients must meet the specific requirements of at least one of the available NIA research studies. This protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol, and it is used to develop a registry of individuals who meet eligibility criteria for existing research projects.

Eligibility criteria: * INCLUSION CRITERIA:

  1. All volunteers/patients who meet the criteria of an approved NIA protocol.
  2. People with diagnosed or undiagnosed conditions
  3. Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis

EXCLUSION CRITERIA:

1. Subjects unable to provide informed consent.
2. The volunteer/patient does not meet the criteria of any approved NIA protocol and does not wish to remain in the contact database for future studies.
3. Volunteer/patient has contacted the NIA Clinical Research Protocol Office and notified them that they would like to be removed and no longer contacted for NIA approved studies. They will be removed.

Primary outcomes:
measure: Develop a registry of individuals who meet eligibility criteria forexisting research projects
timeFrame: ongoing
measure: Evaluate volunteers/patients for participation in IRB approved clinicalstudies at NIA
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute of Aging, Clinical Research Unit
state: Maryland
Study officials:
affiliation: National Institute on Aging (NIA)
name: Chee W Chia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: