With the increased use of human biological samples from tissue banks and repositories for research purposes, ethical and regulatory dilemmas exist regarding the distribution and use of these materials in research projects. The implications that this has on individuals and families when these samples are used for genetic research increase the regulatory and ethical burdens.
This policy encompasses all cells, cell lines, and tissues that are derived from human beings, deceased or living
When research involves identifiable human specimens, each research use must receive prospective IRB review and approval.
Research on tissue samples obtained from an established research repository
Recipient-investigators should have a written data use agreement with the repository
OHRP does not consider research involving specimens to involve human subjects as defined under 45 CFR 46.102(f) if the following conditions are both met:
1. The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals
2. The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain
Examples of acceptable conditions:
Office for Human Research Protections (OHRP) – Guidance for Research Involving Coded Private Information or Biological Specimens