Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | December 31, 2029 |
Connors Protocol for the Management and Use of Stored Human Specimens
Background:
The HIV research program is part of the National Institute of Allergy and Infectious
Diseases. The program aims to learn more about HIV. It also aims to improve the health of
people with HIV and create HIV vaccines. People enrolled in prior HIV studies provided
samples or data. They consented for their samples or data to be used for future research.
Researchers want to keep studying the stored samples and data.
Objective:
To give approved researchers access to stored samples and data after the study of sample
origin is over. To do this with human subjects protection oversight by the NIH institutional
review board (IRB).
Eligibility:
The study populations were defined by the protocols under which the samples or data were
obtained: 11-I-0259, 13-I-0081, and 14-I-0011.
Design:
All participants consented to provide blood or other samples. Their consent included future
use of the samples.
Researchers will not contact participants without prior approval of the IRB or the original
study protocol.
Samples will be labeled with a code. They will not be labeled with information that
identifies the participants.
Participants data will be stored in computers. The computers will be protected with
passwords.
This protocol will be kept open as long as the samples or data can be used for future
research. When there is no longer a need, the samples may be moved if the IRB approves this.
Otherwise they will be destroyed.
The HIV research program is part of the National Institute of Allergy and Infectious
Diseases. The program aims to learn more about HIV. It also aims to improve the health of
people with HIV and create HIV vaccines. People enrolled in prior HIV studies provided
samples or data. They consented for their samples or data to be used for future research.
Researchers want to keep studying the stored samples and data.
Objective:
To give approved researchers access to stored samples and data after the study of sample
origin is over. To do this with human subjects protection oversight by the NIH institutional
review board (IRB).
Eligibility:
The study populations were defined by the protocols under which the samples or data were
obtained: 11-I-0259, 13-I-0081, and 14-I-0011.
Design:
All participants consented to provide blood or other samples. Their consent included future
use of the samples.
Researchers will not contact participants without prior approval of the IRB or the original
study protocol.
Samples will be labeled with a code. They will not be labeled with information that
identifies the participants.
Participants data will be stored in computers. The computers will be protected with
passwords.
This protocol will be kept open as long as the samples or data can be used for future
research. When there is no longer a need, the samples may be moved if the IRB approves this.
Otherwise they will be destroyed.
The HIV intramural research program of NIAID conducts clinical investigations to increase our
knowledge of the biology, pathogenesis and immunology of HIV infection and vaccine
development. After all study-related interventions, follow-up, and primary specimen and data
analyses are complete for an IRB-approved protocol, some human specimens may remain in
storage, and data may continue to be analyzed. This protocol will allow for additional
laboratory and data analyses to be continued under appropriate human subject protections
after the close of the original IRB-approved study protocol.
knowledge of the biology, pathogenesis and immunology of HIV infection and vaccine
development. After all study-related interventions, follow-up, and primary specimen and data
analyses are complete for an IRB-approved protocol, some human specimens may remain in
storage, and data may continue to be analyzed. This protocol will allow for additional
laboratory and data analyses to be continued under appropriate human subject protections
after the close of the original IRB-approved study protocol.
- The study populations were defined by the original protocols under which the stored
specimens and/or data were collected. The total population included on this omnibus
protocol comprises the
populations of other protocols.
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