Archived human tissues and specimens may be retained for long-term storage by freezing or preserving in fixatives. Often, these samples have been collected during the course of medical care (retrospectively) or expressly for the purpose of establishing a research tissue repository (prospectively). Although use of biobanks for the potential benefit to medical knowledge and society is commonly accepted, concerns about the identifiability of specimens and implications regarding research findings warrant careful consideration by the IRB.
The following information applies to research repositories of identifiable materials (either directly or through links maintained by the submitter or biobank) from living individuals. See Materials methodology for guidance regarding specimens obtained for non-research purposes.
In addition to the basic Elements of Informed Consent, the following information should be shared with research biobank donor-subjects:
OHRP (formerly OPRR) Guidance: Issues to Consider in the Research Use of Stored Data or Tissues
Is this human subjects research? OHRP Guidance: Research Involving Coded Private Information or Biological Specimens and Video
Cite Banking of Human Biological Materials for Research chapter of IRB Textbook