Tissue Repository Form by rogerholland


									                                                                       Office of Research Administration and Sponsored Projects
                                                                                                          Phone (972) 883-2313
                                                                                                             Fax (972) 883-2310

                                   THE UNIVERSITY OF TEXAS AT DALLAS
                           IRB Request for Establishment of a Tissue/Data Repository


The Office of Human Research Protections (OHRP) intends that the operation of any HHS-supported human
tissue or data repository and its management center should be subject to oversight by the IRB. The following
questions and request for information are related to this oversight function.

          1. As an attachment, please provide a flow chart detailing collection of specimens. This chart should
          include the amount of tissue, location of removal, and physician(s) who will remove the tissue.

          2. Will tissue or specimens be removed: [ ] specifically for the repository or [ ] collected from
          discarded materials? Ordinarily these samples will be discarded. If they are taken specifically for the
          purposes of the repository, a justification must be supplied below.

          3. Will the subject experience any increased risk as a result of the removal of the specimen or tissue.
                Yes          No

               If yes, a justification must be supplied below.

          4. Breach of patient confidentiality is the most likely risk experienced by subjects participating in the
             repository. it is the policy of the IRB that all specimens and data must be coded and links to the
             original donor must be encrypted and the encryption key kept only by the PI. It is also the policy of
             the IRB that no recipient-investigator whom will share the tissue specimens or data will have access
             to the identity of any donor.

               Detail below your plan for protecting the subjects from loss of confidentiality risks.

          5. If genomic DNA or cDNA will be collected or produced, describe below the length of time that the
             material will be stored and whether identifiers will be present. Note that donors must have the right to
             remove their DNA at any time if identifiers are present. In addition, description of experiments must
             be explicit if identifiers are present. If additional experiments are subsequently desired, a new
             submission must be submitted for full-board review prior to initiation.

Last Revised 03/05
                                                                      Office of Research Administration and Sponsored Projects
                                                                                                         Phone (972) 883-2313
                                                                                                            Fax (972) 883-2310

Additional Points:

1. Written informed consent is necessary for donors participating in repositories. A sample consent form is
supplied on the Office of Research Administration and Sponsored Projects web page. Note that genetic or DNA
studies require explanation of the risks inherent in such research in the consent form.

2. A specimen, tissue or data collection protocol to be followed by all collector-investigators and a sample
written informed consent document must be supplied to all collaborating institutions and their IRBs. The
research at these satellite institutions may not proceed until the UTD IRB has received notification of successful
review and approval by the satellite institution and their properly constituted local IRB. Attach the specimen,
tissue or data collection protocol.

3. Collector-investigators are prohibited from providing recipient-investigators access to the identities of donor-
subjects or other information that could lead to the identity of donor-subjects. This should be stated in a written
agreement from collector-investigators. This agreement should also indicate that the collector-investigator will
provide and execute a valid informed consent to all donor-subjects as required in 1 above. Please attach a copy
of the collector-investigator agreement.

4. A written usage agreement for recipient-investigators will include the following:

          “Recipient acknowledges that the conditions for use of this research material are governed by the
          Institutional Review Board with purview over sample or data repository, in accordance with federal
          regulations contained in 45 CFR 46. Recipient agrees to comply fully with all such conditions and to
          report promptly to the tissue or data repository any proposed changes in the research project and any
          unanticipated problems involving risks to subjects or others. Recipient remains subject to applicable
          State or local laws or regulations and institutional policies that provide additional protections for human

          This research material may only be utilized in accordance with the conditions stipulated by the IRB
          approving the tissue or data repository. Any additional use of this material requires prior review and
          approval by the UTD IRB and, where appropriate, by an IRB at the recipient site, which must be
          convened under an applicable OHRP-approved Assurance.”

5. A copy of a Certificate of Confidentiality, obtained from the funding agency, must be submitted to the IRB.
The certificate cannot be obtained until the protocol receives IRB approval, and should state that confidentiality
of human tissue repository specimens and data will be protected. Please submit a copy after you obtain it.

Last Revised 03/05

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