Precision medicine and other healthcare initiatives have resulted in the unprecedented need for “fit for purpose” biospecimens that must be of high quality in order to drive rigorous and reproducible research that eventually leads to better treatment modalities and improved patient outcomes. A number of research studies have shown that many cancer research studies could not be reproduced [1]. National Cancer Institute (NCI) surveys found that 60% of researchers questioned their results because of poor quality biospecimens and more than 80% limit the scope of their work due to the lack of high quality biospecimens [2]. Consequently, the purpose of a Biorepository is to facilitate this process by collecting and distributing high quality biospecimens to support basic research and clinical trials. However, this is not as simple as collecting a piece of tissue or tube of blood and distributing to researchers. Academic medical centers have larger numbers of ongoing research projects and clinical trials. In addition, other institutions may request transfer of biospecimens for screening, enrollment or as part of ongoing clinical trials at those institutions, anywhere in the country. This complex process requires significant operational and logistical oversight in order to meet the specific research and clinical trial protocol requirements that are in place as well as to make sure patient are protected . In general, all tissue (and data) collected from living donors and for use in federally funded research must have informed consent in order to protect research participants (see the story about Henrietta Lacks [3]). Research projects and clinical trials involving human samples are subject to regulatory oversight. Institutional Review Boards (IRB) scrutinize proposals to ensure that informed consent is included at the time of collection, unless research meets certain criteria described in federal regulations. Patients need to be aware and more importantly, specific language is included explaining what will happen to their biospecimens. IRB’s also assess protocols to safeguard patient protected health information (PHI).
In 2012, the College of American Pathologist in collaboration with the NCI and the International Society for Biological and Environmental Repositories (ISBER) introduced the first national (and international) biorepository accreditation program [4]. While biorepositories are not required to be accredited, many biorepositories seek out accreditation for a number of reasons. Primarily, it indicates that a biorepository meets or exceeds established best practice standards and demonstrates a commitment to consistent evaluation and improvement of technical and operational practices. Onsite inspections ensure that repositories adhere to best practices and quality standards and provides a recognized seal of approval. The goal is to increase the confidence in biospecimen integrity by ensuring that biospecimens:
- Meet all appropriate ethical and legal requirements for biospecimen use under IRB-approved research
- Maintain biospecimen chain of custody tracking to reduced risk of misidentification and or release of PHI
- Have appropriate facilities and infrastructure to support repository operations, including storage and temperature monitoring
- Follow best practice policies and procedures for sample release
- Ensure quality assurance of pre-analytic, analytical and post analytical sample pathways so that they are well-controlled and optimal for research purposes·
Accredited biorepositories strengthen the local biomedical research enterprise. Technically, centralized specimen processing builds consistency and accuracy into sample workflow. They reinforce funding applications because best practices are used during biospecimen collection, processing and distribution. Accredited biorepositories meet and follow the ethical and legal requirements that support IRB approved research. Finally, accreditation brings external distinction to the institution and a badge of recognition to biorepository staff.
1. Begley, C.G. and L.M. Ellis, Drug development: Raise standards for preclinical cancer research. Nature, 2012. 483(7391): p. 531-3
2. Massett, H.A., et al., Assessing the need for a standardized cancer Human Biobank (caHUB): findings from a national survey with cancer researchers. J Natl Cancer Inst Monogr, 2011. 2011(42): p. 8-15.
4. Schmelz, M. and S. Silver, Letter to the Editor: Validation of Biorepository Quality- Accreditation. Biopreserv Biobank, 2023. 21(2): p. 217-218.
Written By: Luis Chiriboga, PhD, HT (ASCP), QIHC (ASCP)
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