Chunk #45 — 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
When the Common Rule does apply, ethical duties will devolve on the biobank with implications for return of IFs and IRRs. These will include the duty to address risks and potential benefits (if any) to those participating in the research; IFs and IRRs carry both. However, whether or not biobank research constitutes research involving human subjects under the Common Rule, there is increasing agreement that biobanks at least have the responsibility to address in their planning and in any informed consent documents whether IFs and IRRs will be offered back to individual contributors and, if so, how.26(p38), 65,75(p72), 76,77(p11) For example, NCI’s 2011 Best Practices for Biospecimen Resources states, “The informed consent document should state whether individual or aggregate research results will be released to the human research participant, the participant’s healthcare provider, or the participant’s family and, if so, the mechanism for communicating such results…. The procedure for opting out of all communications should be clearly indicated.”26(p38)
