March 2006

Researchers in the 21st century face many challenges not the least of which is learning to establish repositories or banks for human biological materials. This article describes basic information regarding the collection, storage and distribution of biological materials for research.

Collection of biological materials

Human biological materials range from tissue samples to blood, sputum, urine, bone marrow, and cell aspirates. Commonly these materials are referred to as "specimens". Specimens may be in existence at the time of the research and archived for clinical purposes, obtained during a research study and stored for future use, or may need to be fresh and require prospective collection. Both existing and prospectively collected specimens can be stored in repositories or banks.

Repositories can vary in size from small collections under control of one or two individuals to large collections under the control of a department or large multi-site research project.

Storage of biological materials

One of the first recommendations for setting up a repository or bank is to establish policies that guarantee the security and confidentiality of specimens and any data associated with the samples. It is important to consider who will have access to the stored specimens and how identifiable information will be kept confidential. The researcher may want to consider obtaining a Certificate of Confidentiality as added protection for banked specimens.

Distribution of biological materials

Procedures should also be established for the distribution of specimens to other researchers. One recommendation is that specimens be anonymized prior to their distribution. Anonymized means that specimens were originally collected with a direct identifier but that identifier has been irretrievably stripped away. Specimens can also be obtained in such a way that identifiable information was never collected. These types of specimens involve the lowest level of risk. Banked specimens may also be stored with codes or numbers attached which link them to identifiable data.

There is justification for use of tissues obtained clinically for research. However, unless a compelling rationale can be given by the researcher for the use of coded or linked specimens they should be anonymized prior to distribution.

Additionally, specimens may have been obtained during one research study, banked in a repository and are now being requested for use in another research project. It is important for the researcher to take a thorough look at the original consent form in order to comply with the wishes of the subject with regard to future use. These specimens may contain codes or numbers that link them to identifiable information. Prior to distribution for future research these biological materials should be anonymized.

After a repository has received review and approval by an Institutional Review Board (IRB), each subsequent study involving the specimens housed in the repository will require an independent review by the IRB. The researcher plays a critical role in ensuring that use of human biological materials are conducted in an ethical manner that protect the subjects from whom they were obtained.

*Sobel, M. & Hansen, K. (2005). Banking of Human Biological Materials for Research. In E. A. Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (pp. 433-437). Sudbury, MA: Jones and Bartlett.