Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Study Details
Study Description
Brief Summary
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.
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| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 to meet secondary and exploratory objectives. This protocol will allow for additional laboratory and data analyses to be continued to complete the analyses described under closed NIAID protocol #14-I-0011, Phase 1 Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study Participants Participants on the studies' samples that are transferred to this protocol |
Outcome Measures
Primary Outcome Measures
- Continued analysis [Ongoing]
The objective of this protocol is to continue to have human subjects' protection oversight by the NIH IRB while making stored specimens and/or data available to approved research laboratories and investigators after the study of specimen origin has been terminated. Continued analyses will be for the purpose of research, exploratory immunology, and infectious disease research within the original study objectives and consents under which the specimens and data were collected. Manuscript completion for the primary study objectives will also be covered under this or the original study protocol.
Eligibility Criteria
Criteria
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institute of Allergy and Infectious Diseases (NIAID) | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Principal Investigator: Mark Connors, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 999919074
- 19-I-N074