The Office for Human Research Protections (OHRP) provides the following guidance in response to requests from Institutional Review Boards (IRB), the National Institute of General Medical Sciences (NIGMS), and the research community.

Local IRB Review

Collection of data and specimens for inclusion in the NIGMS Human Genetic Cell Repository should be subject to oversight by local Institutional Review Boards (IRBs) convened by the collecting institutions under OHRP-approved Assurances (1). The local IRB is familiar with the particular circumstances of its research setting and is in the best position to weigh critical considerations like local professional and community standards, institutional policies and resources, and the needs of differing patient or subject populations.

Informed Consent

Written informed consent should be obtained from each donor-subject in accordance with Department of Health and Human Services (HHS) regulations at 45 CFR 46.116.

Included among the basic elements of informed consent should be a clear description of (i) the operation of the cell repository; (ii) the specific types of research to be conducted; (iii) 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. Informed consent information describing the nature and purposes of the research should be as specific as possible. Where human genetic research is anticipated, informed consent information should include information about the consequences of DNA typing (e.g., regarding possible paternity determinations). Informed consent documents may not include any exculpatory language through which subjects are made to waive or appear to waive any legal rights.

The Cell Repository should provide tissue collectors with an NIGMS-approved sample informed consent document containing these elements and with a sample protocol for tissue collection. IRBs may request copies of these sample documents to assist in their review of local informed consent documents and protocols.

Oversight of Repository Activities

Operation of the NIGMS Human Genetic Cell Repository and its data management center should be subject to oversight by an Institutional Review Board (IRB) convened by the Coriell Institute of Medical Research under an OHRP-approved Assurance of Compliance. The IRB should review and approve a protocol specifying the conditions under which data and specimens may be accepted and shared, and ensuring adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. The IRB should also review and approve a sample collection and informed consent document for distribution to tissue collectors and their local IRBs. A Certificate of Confidentiality should be obtained to protect confidentiality of repository specimens and data.

Submittal Agreement

A written submittal agreement for tissue collectors should require written informed consent of the donor-subjects utilizing an informed consent document approved by the local IRB. It should also contain an acknowledgment that collectors 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.

Usage Agreement

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 OHRP-approved Assurance."

(1) Under certain circumstances, collecting institutions may elect to rely upon the Cell Repository IRB at the Coriell Institute. This requires a written Cooperative Amendment, signed by the collecting institution and the Coriell Institute, and approved by OHRP. Contact OHRP for details.

For Additional Information:

Office for Human Research Protections
Department of Health and Human Services
6100 Executive Boulevard, Suite 3B01, MSC-7507
Rockville, MD 20892-7507
e-mail: ohrp@od.nih.gov