Informed Consent: Ethical Issues for Pathologists when Banking Human Tissue for Clinical Research

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The Journal of Molecular Diagnostics


Introduction: Recent advances in genetic, genomic and proteomic technology have increased the value of human tissue for medical research, particularly if the tissue is linked to clinical data from the tissue donor's medical record. The combination of large-scale molecular analysis and associated information about treatment and outcome allows for unprecedented data-mining. Hospitals serve as the major source of surgically excised tissue with linked clinical data, and pathologists are generally the unofficial stewards of this important resource. While hospital Institutional Review Boards are charged with protecting participants in clinical research, tissue repositories are typically not considered research per se, rather they provide the raw material for a variety of research projects. Therefore it is important that pathologists understand and become involved in the relevant patient protection issues, particularly informed consent. Methods: We performed a literature survey of informed consent in research tissue banking (both hospital-based and commercial). This included a review of all current regulations and guidelines that apply to the use of human tissue for clinical research. We also conducted interviews at several hospitals involved in tissue banking and several commercial biorepositories that collect tissue and medical record information from multiple sites. Results: We generated recommendations for best practices in informed consent. The issues include: consent for linked, unlinked and anonymous samples, ‘tiered’ consent, opting out, patient recontact, and necessary disclosures. We produced a web-based ethics guide for hospital IRBs, clinical researchers, and pathologists or other medical personnel involved in tissue baking and clinical data mining (http://www.usm.maine.edu/bioethics/biobank/). Conclusions: Not only are regulations lacking in this area, but there is a shortage of published information to assist hospitals in navigating the informed consent issues with regard to use of surgical tissue samples and linked clinical data for research. The issues are more complex when hospitals collaborate with commercial entities. We discuss the central problem of implementing an appropriate informed consent process when banking excised tissue. We focus on the role of pathologists in maintaining patient protection when storing and releasing tissue samples for clinical research.


Copyright © 2005 American Society for Investigative Pathology and Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.