For the study Im planning, I will receive specimens collected at sites outside the Bureaus facilities. What review or other arrangements are required?
In most case, if the specimens have already been collected for clinical purposes before the start of your study, and if personally identifying information has been removed from them, the study may be eligible for an exemption from review. Please note, however, that ethical considerations and institutional policy require that you not collaborate on research in any way with an institution which does not appropriately protect human subjects in research. Most teaching hospitals and universities have subject protection procedures in place. Most private practitioners and many community hospitals and community clinics do not. If you are to receive specimens — or accrue subjects or otherwise collaborate on research from such a site, please contact the Office of Research Development for arranging for an affiliation agreement to assure the protection of human subjects at your collaborating site.
