Research with Human Tissue and Biological Samples

Research with Human Tissue or Biological Specimens

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

  • The data use agreement should specify under what conditions the data is being released to the recipient-investigator(s)
  • The terms under which the data is released determine whether the research requires IRB oversight based on OHRP’s Guidance on Coded Data
    • If the specimen obtained is identifiable (i.e., can be linked to specific individuals, either directly or through a coding system, by the investigator or member of the research team), IRB review and approval is required
    • If the specimen is NOT identifiable as defined above, IRB review and approval is NOT required

 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

AND

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:

  • The key to decipher the code is destroyed before the research begins
  • The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased
  • There are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
  • There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

 

Office for Human Research Protections (OHRP) – Guidance for Research Involving Coded Private Information or Biological Specimens

http://www.hhs.gov/ohrp/policy/cdebiol.html

 

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