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Respect for Persons

From the Belmont Report:

"1. Respect for Persons. -- Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. . . .

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so."


Our current predicament, once again, highlights the erosion of protections for human subjects. Political beliefs aside (I am pro choice and support research involving fetuses and stem cells), I respect that other people do not feel the same way and may have such strong opinions and beliefs on the subject, that they will not want to get the J and J vaccine (now paused) because of this issue.


Recently, the Michigan legislature passed a law requiring people be informed that the J and J vaccine was developed using stem cells from aborted fetal tissue. While, I personally, do not have a problem with this, I accept that others do. The Governor had decided (against federal regulatory requirements) that people did not need to be informed of this fact.


When I was working on 2008-2009 pandemic vaccines for a large HMO, our IRB decided that the informed consent did not need to address that the genetic material for the H1N1 vaccine came from a virus originating in pigs, which could, in theory, represent a problem for some Jewish and Muslim people. After they approved the omission, there were various statements made by religious leaders that accepted the use of the genetic material and allowed vaccination, but there was no way to know if those leaders were authorized to speak for everyone within the two faiths. I objected to not informing the vaccine recipients because I respected that their views and religions are different from my own, and that they should be informed in order that they could make the appropriate decision for themselves.


The COVID-19 vaccines are still technically research. Emergency use is not approved. It's still investigational. Until the entire body of evidence is in, all investigational drugs and biologics must abide by the laws governing research. These laws, and even the Hippocratic oath, acknowledges that we must inform the recipients of experimental treatments of foreseeable topics that might affect their willingness to receive the experimental treatment and respect a person's right to choose for themselves.


First and foremost, to keep the trust of the public, we must not violate this basic rule - even if we disagree!



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