Repositories of Human Tissue and Databanks- PRO135   

Investigator Responsibilities

• Submits the IRB application eForm (FOR200).
• Develops and appropriate informed consent process.
• Supplies additional information as requested by the OIRB staff.

OIRB Responsibilities

Management Staff:

• Processes application submitted by researcher (see description of convened, expedited, exempt, or Not Human Subjects Research IRB review).
• During administrative review of protocols determines the following:
  • Is sample or data collection protocol informed consent document included;
  • Are other sites engaged in research per OHRP guidance document dated 1/26/99 (see http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm); if yes, request verification of FWA and IRB approval from other sites if not        included with the protocol;
  • Assesses if application requests the appropriate type of review;
  • Refers the application in accordance with procedure for convened, or expedited;
  • Refers the application back to the investigator for completion of new submission or revision, if request appears inappropriate;
  • Verifies if HIPAA privacy regulations are applicable and if the plan to obtain authorization for research is acceptable.

IRB Responsibilities

• Reviews and grants approval of a protocol specifying the conditions under which data and specimens may be accepted and shared and ensuring adequate provision to protect the privacy of subjects and maintain the confidentiality of  the data;
• Reviews sample or data collection protocol and informed consent process to determine that:
  • The conditions under which data and specimens may be accepted and shared. OHRP strongly recommends that one such condition stipulate that recipient-investigators not be provided access to the identities of donor-subjects or to information through which the identities of donor-subjects may readily be ascertained;
  • Collection of data and specimens are subject to oversight by local IRBs convened under applicable OHRP Federalwide Assurances;
  • Written informed consent is obtained from each donor-subject in accordance with HHS regulations at 45 CFR 46.116. In addition to the basic elements of informed consent process should be a clear description of (i) the operation of the repository; (ii) the types of research to be conducted, describing as specifically as possible; (iii) the conditions under which data and specimens will be released to recipient-investigators; and (iv) procedures for protecting the privacy of subjects and maintaining the confidentiality of data, (v) whether data or specimens are identifiable, coded, or de-identified, (vi) the process by which participants can withdraw data or specimens from the repository, and (vii) whether or not participant may be re-contacted for future studies;
  • Informed consent process information describes, as specifically as possible, the nature and purposes of the research should be as specific as possible;
  • Where human genetic research is proposed, informed consent process information includes information about the consequences of DNA typing (e.g., regarding possible paternity determinations);
  • Informed consent documents do not include any exculpatory language through which subjects are made to waive or appear to waive any legal rights;
  • A sample collection protocol and informed consent document for distribution to collector-investigators and their local IRBs is provided;
  • A written submittal agreement requires collector-investigators obtain written informed consent of the donor-subjects utilizing an informed consent document approved by the local IRB. It should also contain an acknowledgment that collector-investigators are prohibited from providing recipient-investigators with access to the identities of donor-subjects or to information through which the identities of donor-subjects may readily be ascertained.
  • A written usage agreement for recipient-investigators should include the following:
    • "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 Federalwide Assurance."