Samples of tissue resected at surgery may be requested for clinical research. This requires that a process be present for handling and fulfilling such requests.
Requirements for fulfilling requests for tissue samples:
(1) The laboratory has a policy and procedure for these requests.
(2) The requests should be cleared by the local human subjects research committee.
(3) Informed consent is obtained if required.
(4) Personal health information is protected unless the samples are de-identified.
(5) If a diagnostic paraffin block is requested, then the block may need to be retained until released under the tissue retention policy. For the College of American Pathologists the retention period is 10 years.
If the patient is enrolled in a clinical trial, then most of these requirements are already fulfilled.
If the sample is taken from a part of the specimen that is not used for diagnostic purposes, then the sample may be collected at or soon after surgery or when the specimen is discarded after the usual retention period.
