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Rand Report

One if the first best practice guides for this emerging field is the Rand Report, Case Studies of Existing Human Tissue Repositories: Best Practices for a Biospecimen Resource for the Genomic and Proteomic Era (2003). The Report was prepared for the National Cancer Institute and the National Dialogue on Cancer. A number of profit and non-profit U.S. research repositories were included in the study. The Report is a preliminary step toward developing a model for a biospecimen network described as "a national, pre-competitive, regulatory compliant and genetic privacy protected, standardized, inclusive, highest quality network of biological sample(s) banks; developed in partnerships with and supported by cancer survivors/advocates; shared, readily accessible, and searchable using appropriate infomatics systems (e.g., amenable to molecular profiling capability)."

The Report devotes a chapter to "Privacy, Ethical Concerns, and Consent Issues" and identifies five Best Practices from their survey of repositories (p. 135):

• "Limit access to the codes that link patients' identifying information to their tissue specimens through physical and/or cyber procedures to minimize the chance of identifying information being released."
• "Require repositories to have IRB approval for the collection, storage, and distribution of biospecimens and associated data, and require researches requesting samples to have IRB review of research projects that will use the samples."
• "Use of a bioethics advisory board or other governance and oversight advisory board to provide another layer of review for privacy and confidentiality procedures."
• "Obtain tissue specimens from individuals who are fully informed about and have consented to both the collection of their tissue by the repository and its use for research purposes. Ideally, the consent process should occur separately from the surgical consent. However, this is not always possible, so at a minimum, the informed consent for the collection and research use of specimens should be a separate section of the surgical consent form that requires a separate signature."
• "Perform a tiered consent process that allows individuals to choose the type of specimen(s), if any, they want to donate (e.g., tissue, blood, or urine), the type of research the specimen can be used for (e.g., a specific research project, general research, or genetic research), and/or whether their medical records and outcomes data can be accessed."

The five recommendations on limiting access to identifying information (1.), oversight (2)(3), and informed tiered consent (4)(5) are important. This list is incomplete however. Consider a more detailed list of best practices below (See: Our Best Practices).