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Is there federal guidance on research using repository tissue?

According to the OHRP, (Issues to Consider in the Research Use of Stored Data or Tissues), investigators need a Written Usage Agreement that should include the following statements:

"Recipient acknowledges that the conditions for use of this research material are governed by the cell repository Institutional Review Board (IRB) in accordance with Department of Health and Human Services regulations at 45 CFR 46. Recipient agrees to comply fully with all such conditions and to report promptly to the cell 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 which provide additional protections for human subjects.

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

Also, OHRP recommends a Certificate of Confidentiality for the data and tissue. (See: confidentiality).