Eiseman et al. (2003) note that “[i]n most cases, the procedure for prioritizing requests for rare or precious tissue is the same as that used for easily available tissue” but that some repositories have “specific policies for regulating the distribution of the last sample of a particular specimen” and that such policies are considered best practice (pp. 102–103). However, there are no generally-recognized protocols for evaluating whether and when to exhaust a specimen.

The committee recommends that the following considerations be taken in account in evaluating whether any given specimen should be made available for research:

  • The age of the specimen.
  • The disease state that it represents.
  • The specimen’s medical, scientific, and historical23 significance.
  • The condition of the specimen and its fitness for the proposed use.
  • Whether a proposed use would exhaust the research potential of the specimen.
  • Whether the same research need might be met by another, less rare specimen or another source of specimens.
  • The importance of the public-health or military need the proposed use aims to meet.

The JPC should also develop criteria for determining when a collection of specimens—rather than an individual sample—is unique or has special medical, scientific, or historic value, and for managing access to such collections.

The JPC does not have any specific policy regarding how the depletion of a repository specimen should be factored into decisions regarding access to it, beyond ensuring that all applicable CAP and CLIA–CLIP retention requirement are met (Baker personal communication, 2011). The committee believes that the JPC needs such a policy to ensure that the repository remains a resource for otherwise unobtainable material. The committee recommends that the JPC establish criteria for deciding whether to deplete a specimen to exhaustion. The criteria should be determined in close consultation with pathology subspecialty experts in and outside the JPC. Detailed recommendations are beyond the scope of the present committee’s task but the criteria may include such considerations as the following:

  • Retaining a set percentage of the tissue-containing portion of a tissue block unless a designated repository officer authorizes its use.

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23The National Museum of Health and Medicine (http://www.medicalmuseum.mil) houses military pathology specimens with historical value and would be the authority on this question.



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