Chunk #44 — 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
As noted above, a fundamental complexity attending biobank research is that some currently falls under the Common Rule and some does not. Biobanks that are collecting their own data and/or samples for research, as well as biobanks receiving data and/or samples collected for other purposes but conveyed with participant identifiers, will be conducting research on human subjects under the Common Rule. However, biobanks receiving data and/or samples that were not collected for the biobank and have identifiers removed, will not. A major caveat is that if samples or data are re-identified, the Common Rule will apply.16
