Healthy Volunteer Samples Clinical Trial
Official title:
Connors Protocol for the Management and Use of Stored Human Specimens
| Verified date | April 29, 2024 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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. ...
| Status | Enrolling by invitation |
| Enrollment | 1000 |
| Est. completion date | December 31, 2029 |
| Est. primary completion date | December 31, 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 116 Years |
| Eligibility | - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institute of Allergy and Infectious Diseases (NIAID) | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Continued analysis | 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. | Ongoing |