HIV/AIDS Specimen Repository, Guidance for Accessing Network Samples

Guidance for Accessing Network Samples

  • The evaluation of every request entails consideration of its scientific merit in the context of other investigations and the limited availability of specimens.
  • Because these specimens are a valuable resource, collaborating investigators should request the smallest amount (both type and number) needed to perform scientifically meaningful experiments. New research techniques or new areas of investigation should be proposed as a pilot study in order to minimize the use of specimens for risky, unproven approaches. Specimens from infants, paired maternal-infant transmission cases, newly seroconverted individuals and long-term nonprogressor are especially scarce and particular scrutiny will be placed on requests to use these limited resources. It may be desirable or necessary to modify study designs or utilize different materials to address the question where availability is limited.
  • In many cases, specimens are collected for predetermined purposes, specified in a research protocols. Surplus specimens from these studies may be available for use by external collaborators after the protocol-mandated research questions have been addressed.
  • Specimens will be provided to investigators for in vitro investigational research purposes and are not for use in humans. Specimens and/or products resulting from this research must not be sold or used for commercial purposes, nor can specimens be further distributed to third parties, without prior written approval.
  • In addition, specimens will be provided to the collaborating investigator only for the proposed investigation. Permission to use samples for other studies must be resubmitted as an addendum request prior to use.
  • All specimens that are released to collaborating investigators must have been collected under the auspices of an IRB-approved protocol and must be in compliance with 45CFR46. In addition, subjects must have authorized the collection of these specimens as part of the informed consent process and must be made fully aware that these specimens are being collected for future research. Any proposed new research on requested specimens should be considered research on human subjects, requiring compliance with IRB rules and Federal regulations. More information can be found in the NIH document Information for Research Using Human Specimens.
  • To ensure complete confidentiality for research subjects, patient identifiers, when they exist, will not be provided by DAIDS to investigators under any circumstance. Specimens are stored in repositories with unique identifiers. Specimens that are released to collaborators also may be coded.
  • The legalities of ownership vary depending on the funding mechanism of the study from which the specimens were obtained and other study factors, which may complicate the availability of specimens. Policies, procedures, and access to specimens will therefore vary accordingly. Unless otherwise stated, specimens collected by contractors are the property of the NIAID; specimens collected by grantees (including cooperative agreements) are the property of the awardee institution. DAIDS strongly encourages, but cannot mandate, that the grantee cooperate with the collaborating investigator.
  • Collaborating investigators should agree to acknowledge the support of the NIAID in all publications and presentations of studies using specimens supplied by DAIDS-supported repositories. The suggested form for acknowledgment is: "The following specimens were obtained through the [NAME OF THE PROGRAM], Division of AIDS, NIAID, NIH." Collaborating investigators should refer to each program's publication policy for further information.
  • Investigators are responsible for preventing accidental exposure to infectious agents by research personnel who work with HIV positive specimens. Each collaborating investigator must agree to assume full responsibility for informing and training all personnel in the dangers and procedures for safe handling of these and other specimens. Additionally, investigators must ensure compliance with all applicable Institution and Government health and safety regulations and the guidelines detailed in: CDC-NIH manual, Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th edition, 2009.
  • As a receiving party of specimens, the recipient and the recipient institution must agree to indemnify and hold harmless the United States, the repository contractor, and their suppliers and contributors of specimens, from any claims, costs, damages, or expenses resulting from injury (including death), damage or loss that may arise from the possession and use of DAIDS repository specimens. This may be formalized by a material transfer agreement form that each investigator must sign before receiving specimens.
Content last reviewed on April 27, 2007