Chunk #41 — PART II. CORE QUESTIONS — D. If Data and Samples Can Be Re-identified, Are There Any Biobank Research System Responsibilities to Offer Return of IFs and IRRs? — The ethics of return in biobank research systems
A robust and international ethics literature addresses ethical obligations of biobanks. Commentators query whether the complexities of biobank research call for expanding the roster of ethical precepts beyond those applicable to smaller-scale biomedical research.59,60 For example, some authors have explored the ethical obligations of genomic biobanks as public goods.61–64 Indeed, in some countries, biobanks are created by statute or structured as a nonprofit foundation or charitable organization.65 In the United States, biobanks created by NIH or another public entity (e.g., NIH’s dbGaP, or NCI’s caHUB) or funded publicly (e.g., the NIH-funded eMERGE Network) will bear public responsibilities accordingly. NCI, for example, in its Best Practices for biorepositories, stresses custodianship responsibilities: “[r]esponsible custodianship requires careful planning and transparent policies to ensure the long-term physical quality of the biospecimens, the privacy of human research participants, the confidentiality of associated data, and the appropriate use of biospecimens and data.”26(p31) There is a significant literature on the public responsibilities of population biobanks.66–69
