Laboratory Medicine and Biorepositories

Biorepositories provide access to specimens for biomarker investigation of subjects with or without a given condition or clinical outcome. They must record collection, transport, processing, and storage information to ensure that specimens are fit-for-use once a particular analyte has been identified as a candidate biomarker. Ongoing (post-collection) clinical and outcome documentation provides more value to researchers than a static, clinical snapshot at the time of collection. Frequently, biorepository specimens are residua from those obtained for clinical management of a patient; whether routine clinical processing is acceptable, given the stability profile for a given analyte, will dictate whether non-standard processing will be required. Introducing nonstandard steps into clinical lab processing in order to preserve an analyte such as RNA or protein requires careful workflow planning. Accreditation for biorepositories is now available; standards have been developed to ensure that biorepository personnel, equipment, laboratory space, information systems, and policies/procedures, including those for quality management, meet the same high standards by which clinical laboratories are judged and accredited. An additional accreditation standard relates to the development of, and adherence to, policies surrounding informed consent. The current regulatory landscape for pediatric specimen research requires consideration of many issues around informed consent, assent, and reconsent at the age of majority for the collection and use of identifiable specimens for research. Consideration of these requirements based on the current (and evolving) regulatory landscape can be difficult, in light of pending legislative and regulatory changes. Issues surrounding return of incidental findings is another challenge for institutional review boards.