IRB Protocol #______The Office of Research Compliance
FUNDED GRANT #______Phone (817) 272-3723
CONTRACT #______Fax (817) 303- 9187
THE UNIVERSITY OF TEXAS AT ARLINGTON
OFFICE OF RESEARCH COMPLIANCE
IRB Form #5
Request for Establishment of a Tissue/Data Repository
General:
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.
- 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.
- 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 who 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 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.
Additional Points:
1. Written informed consent is necessary for donors participating in repositories. A sample consent form is supplied on the IRB web page on the Office of Research Compliance 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 UTA 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 subjects.
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 UTA 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.
I UNDERSTAND THAT I AM RESPONSIBLE FOR THE ACCURACY OF THE STATEMENTS MADE IN THIS FORM AND FOR THE CONDUCT OF RESEARCH INVOLVING A TISSUE REPOSITORY.
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Principal InvestigatorDate
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Faculty Sponsor (if not the principal investigator)Date
Last Revised 10-01