Excerpt

Although the linkage of patient registry data with biorepositories has great potential, there are many challenges that must be addressed in developing and operating a biorepository, as well as in linking data from biorepositories to registries. The purpose of this white paper is to provide an in-depth discussion of the use of biorepositories in medical care and clinical research, especially in the context of patient registries. This paper focuses on the use of biorepositories within the United States. Additional issues, including differences in regulatory environments, laws governing the import and export of samples, and cultural views on biospecimen collection, must be taken into account for repositories that collect biospecimens outside of the United States; a full discussion of these issues is beyond the scope of this paper. Where topics are well-covered in other materials, references and/or links are provided.

Contents

• Reviewers (alphabetical)
• Introduction
• Patient Registries and Biorepositories
• Types and Uses of Biorepositories and Their Application to Registries
• Linking a Patient Registry and Biorepository
• Development of a Biorepository
  • Planning Considerations
  • Operational Considerations
  • Linkage of Registry Data to a Biorepository
• Ethical and Regulatory Considerations
  • Regulatory Considerations
  • Informed Consent
• Challenges in Developing and Using Biorepositories
• Conclusions
• References

Suggested citation:

Greenberg B, Christian J, Henry LM, Leavy MB, Moore H. Biorepositories. White Paper, addendum to Registries for Evaluating Patient Outcomes: A User’s Guide, Third Edition. (Prepared by L&M Policy Research, LLC, under Contract No. 290-2014-00004-C.) AHRQ Publication No. 17(18)-EHC014-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2018. www.effectivehealthcare.ahrq.gov. DOI: https://doi.org/10.23970/AHRQREGISTRIESBIO.

This report is based on research conducted by L&M Policy Research, LLC, with partners OM1 and IQVIA, under contract to the Agency for Healthcare Research and Quality, Rockville, MD (Contract No. 290-2014-00004-C). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the authors have any affiliations or financial involvement that conflicts withthe material presented in this report.

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