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:
- Whether the samples will be identifiable
- Who owns the specimen - may donors withdraw specimens from the repository or otherwise indicate who may use the tissue and for what purpose?
- What type of privacy and confidentiality have been assured?
- A clear description of the operation of the cell repository
- The specific types of research to be conducted
- Repository storage and database management practices should be reviewed and approved by an IRB
- Repositories should have written template submittal agreements for tissue collectors that require documentation of informed consent from donor-subjects
- The donor-subject informed consent document and process should be approved by an IRB
- IRB approved recipient user-agreements should clearly outline acceptable use of the specimens and restrict the sharing of identifiable donor information
- A Certificate of Confidentiality should be considered
- Recipient agreements for researchers obtaining samples or data should clearly acknowledge the acceptable purpose and use of the materials
- Additional IRB review (both by the repository and also by the researcher's assured institution) should be obtained for projects that will exceed the original scope
- State or local laws or regulations and institutional policies which provide additional protections for human subjects must be adhered to
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