Submission of Non-Identifiable Materials to the Repository
May 22, 1997

In response to requests from the National Institute of General Medical Sciences (NIGMS), the Office for Human Research Protections(OHRP) provides the following clarification regarding submission of "non-identifiable" materials to the Human Genetic Cell Repository.

As Chart 1 illustrates, human subjects are involved in research when the research involves (i) an intervention or interaction with a living individual that would not occur (or would occur in some other fashion) but for the research; or (ii) the use of identifiable private data or information in a form associable with a living individual [also see 45 CFR 46.102 (f).

Human subjects would not be involved when material submitted to the Repository satisfies both of the following conditions:

(1) The material, in its entirety, was collected for purposes other than submission to the Repository (e.g., the material was collected solely for clinical purposes, or for legitimate but unrelated research purposes, with no "extra" material collected for submission to the Repository).
and
(2) The material is submitted to the Repository without any identifiable private data or information (i.e., no codes or linkers of any sort may be maintained, either by the Submitter or by the Repository, that would permit access to identifiable private data or information about the living individual from whom the material was obtained).

While OHRP requires neither an Assurance of Compliance nor a Certification of Institutional Review Board (IRB) review [45 CFR 46.103(a),(f)] for activities that do not involve human subjects, local institutional requirements regarding review of such activities are, nevertheless, binding. Some institutions may require IRB or administrative review of all research activities involving human materials, even where "human subjects" are not involved.

For Additional Information:

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