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IRBs and genome sequencing

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Cinnamon Bloss

Posts: 1

How should IRBs deal with full genome sequences, which are inherently identifiable?

Rubi Linares-Orozco

Posts: 33

Hi Cinnamon,

Are you dealing with specimens that were provided to you in a "de-identified" manner and you intend to sequence the sample which may lead to re-identification of the individual?
- in this case, the intent is to learn more about the capabilities of the genome sequencing process, and the focus is not necessarily to "identify" the specimen/data donor. I believe that the researcher has an ethical obligation to refrain from publishing or releasing the potential identifiers (if that is at all possible), after all the intent of the original specimen/data was to maintain it as "de-identified." Also if the researcher intends to share the samples with others, it is important that the sharing agreements (material/ data transfer) have a section that informs other researchers that these specimens should not be used to re-identify.

-If the data was provided with identifiers, I think it is important to look at what the informed consent stated about confidentiality and privacy. Hopefully there was no guarantee of "absolute confidentiality" as that would be deceiving. I believe transparency is key to this type of research. Its important that participants receive education, maybe even a statement that says "As it may be possible that at some point by sequencing your genome your identity will be known, we cannot guarantee that your identity will remain confidential." --Furthermore the participant should be informed of the potential harms that may arise from such a loss of confidentiality, or it maybe that with the changing landscape those harms are unknown/unforeseeable, which is OK as long as the researcher is transparent.

I'm sure both of these examples are dependent on a number of factors, and may not be so simple. However two things will always need to be addressed 1) what is the intent of the research 2) how will adequately inform the subject (beyond the piece of paper). This was a big discussion at PRIMR last November, I will dig up my notes from the presentations.