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Consent for Use of Stored Patient Specimens for Future Testing
This study is currently recruiting patients.
| Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood, urine, tissue, and/or other body fluids) in other studies that may include genetic testing at some later date and that are not yet planned. This study also aims to obtain an extra blood sample that will be saved for genetic testing at some later date that is not yet planned. To advance human health, it is important that human biological materials continue to be available to the biomedical research community. During AACTG clinical trials, samples of HBM have been or will be obtained and stored until analyzed. However, some HBM may be left over after protocol completion. Questions may arise after study completion that can be answered only with stored specimens and not with specimens collected after study completion. To improve understanding of HIV and the best way to manage the disease, it is very important that HBM be available to investigators for future analyses that are yet to be determined.
| Condition |
|---|
| HIV Infections |
MedlinePlus related topics: AIDS
Study Type: Observational
Study Design: Natural History
Official Title: Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses
Expected Total Enrollment: 50000
To advance human health, it is critical that human biological materials continue to be available to the biomedical research community. During the performance of past, present, and future AACTG clinical trials, samples of HBM (e.g., blood, other body fluids, tissue, cells, and/or DNA) have been or will be obtained and stored until analyzed, as defined by the particular protocol for which the patient provided consent. However, some HBM may be left over after protocol completion. Valuable opportunities may arise after the design of a study. Many of these opportunities may be addressed only with archived, rather than prospectively collected, HBM. To improve understanding of HIV disease and its optimal management, it is, therefore, critical that HBM be available to investigators for subsequent unspecified analyses.
This study involves 2 stages. The initial Pilot Stage is performed at 4 AIDS Clinical Trial Units (ACTUs) and is done to help anticipate and therefore avoid any logistical difficulties related to protocol performance that may occur during large-scale implementation. After completion of the Pilot Stage, the Open Stage begins, in which all Adult ACTUs may participate. All patients are asked to sign the consent and specify whether or not they agree to allow their left-over samples to be used for secondary analyses and/or whether or not they agree to have one 14 ml blood sample drawn under this study for DNA archiving to use for currently unspecified genetic analyses. Only under extraordinary circumstances will any individual patient from whom HBM was obtained be notified of any test result that arises from secondary testing. Patients who do not agree to either option will indicate this on the informed consent and have no further involvement in this study. Declining consent does not in any way jeopardize participation in any other current or future AACTG clinical trials. Consent may be obtained at the same time the patient is being enrolled into any AACTG clinical trial, at some interval after the patient has entered but is still on an AACTG trial, or at any time after the patient completed participation in an AACTG trial. The goal of this study is to allow archived HBM to be used for research purposes, while protecting the identity of patients from whom such samples were obtained. The focus is to obtain permission to analyze archived HBM in ways not planned at the time the initial informed consent was obtained for another clinical trial and, therefore, not specified in the original protocol or informed consent documents.
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Patients may be eligible for this study if they are:
Location
and Contact
Information
More Information
Haga clic aquí para ver información sobre este ensayo clínico en español.
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