Your discussion is going to be centered around the challenges of informed consents as it relates to genetic research specifically. What do you believe is a main challenge with this process?
Bertha: Genetic research is a quickly evolving branch of science that continues to morph depending on new discoveries, applications and the relevance in the field of medical discoveries. But applying the Federal Regulations, which evolve very slowly to this new technology, becomes almost a retrospective, knee-jerk reaction. That ends up affecting the progress of the study, as well as the rights of the human subjects involved.
What about the issue of returning research results? How is this topic relevant to current day researchers?
Bertha: This issue really manifested itself as everyone tried to do the right thing. But the question remains – what do you do with data that you discover during the scope of the research that provides, unwittingly, information that is useful or medically relevant to the subjects involved in the study? Are you legally obligated to disclose this information?
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