Part Five of Seven-Part Blog Series by Guest Blogger Patrick Taylor
The preamble to the NPRM justifies requiring consent for data and specimen research by contending that studies indicate that people want to be asked for permission. However, the literature on this topic is relatively thin. Available evidence suggests that many people, upon being informed that their heath data and tissues could or would be used in research without their consent (and nothing further is said to prompt the idea that research might delve into controversial matters) are generally fine with such use. But when also queried whether they would prefer to have been asked, people say they would. What the literature does not show is that people say: “I object to any use without my consent,” let alone “and I choose that over all the advantages of minimal risk research involving analysis by a computer of digitized files not humanly readable limited to disease-gene associations of thousands of medical records where consent would not be possible but the results will be essential or important to my health, the health of others, and the national health.” Pluralistic discussion of tradeoffs over time, or an extended, candid national dialogue about the reasons for the present rules, were not in the mix. Yet still, people said the opposite of “This must not occur without my consent!”
We have already seen one way in which the claim to be respecting the preference to be asked is untrue – it applies to only some research by some organizations. Now here is another. The commentaries to the NPRM celebrate as fact that a patient need be asked only once, for all time, and then the only acceptable “yes” answer grants permission for any research by anybody. It seems doubtful that a one-time consent to any future scientific research by any researcher for any purpose, without ever going back to inform or re-query, without any regulatory provisions ensuring it was revocable, was what participants meant by “being asked.” Rationally, that option is far worse than no consent, for reasons we shall come to. Read More
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