Screening Protocol for the Evaluation of Research Participants
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2006 |
| End Date: | June 2010 |
Evaluation of Potential Research Subjects - Screening Protocol for Clinical Studies
Background:
- The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to
develop a pool of potential participants for research studies. Because some of the data
collected during screening are used later for research, the screening itself is considered a
study. An applicant to any NIDA study is considered a participant in NIDA screening.
Objectives:
- To identify, recruit, and screen participants for NIDA research protocols.
Eligibility:
- Individuals 18 years of age and older who are able to provide informed consent.
Design:
- Individuals who are eligible for screening will undergo two interviews: a telephone
interview and an in-person interview. The phone interview will determine eligibility
for the in-person interview.
- The in-person interview may require up to five visits to NIDA. The in-person visit will
involve any or all of the following procedures: (1) full physical examination and
medical history; (2) psychiatric interview; (3) psychological testing; (4)
electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally
invasive procedures as directed by the research staff.
- During screening, a photograph will be taken for confirmation of identity during
subsequent visits for other studies.
- No clinical care will be provided as part of screening.
- The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to
develop a pool of potential participants for research studies. Because some of the data
collected during screening are used later for research, the screening itself is considered a
study. An applicant to any NIDA study is considered a participant in NIDA screening.
Objectives:
- To identify, recruit, and screen participants for NIDA research protocols.
Eligibility:
- Individuals 18 years of age and older who are able to provide informed consent.
Design:
- Individuals who are eligible for screening will undergo two interviews: a telephone
interview and an in-person interview. The phone interview will determine eligibility
for the in-person interview.
- The in-person interview may require up to five visits to NIDA. The in-person visit will
involve any or all of the following procedures: (1) full physical examination and
medical history; (2) psychiatric interview; (3) psychological testing; (4)
electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally
invasive procedures as directed by the research staff.
- During screening, a photograph will be taken for confirmation of identity during
subsequent visits for other studies.
- No clinical care will be provided as part of screening.
Through its clinical research protocols, the NIDA IRP attempts to: elucidate the nature of
drug abuse and addiction; determine the potential use of new therapies, both pharmacological
and psychosocial; and decipher the long-term effects of drugs of abuse on the development,
maturation, function, and structure of the brain and other organ systems. In support of the
IRP's work, the scientific goal of this screening protocol is to assess potential research
participants' eligibility for NIDA IRP research studies. Screening will include medical and
psychological tests and procedures. The data collected during screening are a unique and
valuable source of information that aids in NIDA's mission. Therefore, a secondary goal of
this protocol is to obtain data that characterizes the population of subjects contacting
NIDA about research participation and to analyze data so obtained, such as that on the
prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases.
drug abuse and addiction; determine the potential use of new therapies, both pharmacological
and psychosocial; and decipher the long-term effects of drugs of abuse on the development,
maturation, function, and structure of the brain and other organ systems. In support of the
IRP's work, the scientific goal of this screening protocol is to assess potential research
participants' eligibility for NIDA IRP research studies. Screening will include medical and
psychological tests and procedures. The data collected during screening are a unique and
valuable source of information that aids in NIDA's mission. Therefore, a secondary goal of
this protocol is to obtain data that characterizes the population of subjects contacting
NIDA about research participation and to analyze data so obtained, such as that on the
prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases.
- INCLUSION CRITERIA:
1. Adults (at least age 18)
2. Ability to understand and answer the questions as posed.
EXCLUSION CRITERIA:
1. Inability to provide valid informed consent.
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