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Chunk #16 — (1) Blurring the Boundary between Research and Treatment — (b) Returning Results

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What research ethics should learn from genomics and society research: lessons from the ELSI Congress of 2011.
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More specific contexts were also explored, providing evidence of complexity in assessing the issue. For example, research on pharmacogenomics, which evaluates genetic variations in an individual’s genome to predict how a patient may respond to a particular therapy or dose, may involve fewer risks and more benefits (with likely high clinical utility) compared to returning results from research on disease susceptibility studies [E-6, Dressler]. A very different context for the debate on return of results was described by Laura Beskow [E-6], in her work on ethical challenges in genotype-driven research recruitment. This type of research design is a powerful tool for understanding human genetic variation. However, opinions differ regarding whether and how to provide the genetic findings that prompted recruitment of an individual participant. Researchers and IRBs must consider the potential harms of not disclosing to an individual the genetic variation that has prompted their recruitment into a genotype-driven study, and compare these with the potential harms that arise from offering to disclose information about the individual subject’s genetic make-up that is of uncertain significance and, often, ultimately meaningless.