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Federal Regulations Drop Informed Consent Rules in Medical Studies – HotAir

The federal government has changed the regulations that require informed consent for medical experiments. If a review board decides that informing people of risks will interfere with medical research, it can waive the requirement.

No, this is not a conspiracy theory. You can find the change right there in the federal register.

The rules change is said to include only “minimal risk” studies, but then again, we have been told repeatedly that medical procedures like getting a COVID vaccine are risk-free, and things like puberty blockers are “completely reversible,” so you might think twice about their definition of “minimal risk.”

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.

Uh, wut?

While I am reasonably certain that an Independent Review Board wouldn’t waive informed consent for an experimental brain surgery, I am absolutely certain that people who think that testing a vaccine on 8 mice proves it is safe and effective for billions of humans don’t share my understanding of “minimal risk.”

Unsurprisingly the people engaged in research were over the moon about the changes, and flooded the comments with approving missives:

Comment 1) A majority of general comments favor the Agency’s efforts to harmonize FDA’s human subject protection regulations with the revised Common Rule. These comments generally support the proposed rule because it would reduce administrative burdens on IRBs and researchers, reduce research costs, facilitate valuable research, or address public health concerns without compromising subjects’ rights, safety, or welfare.

Yep–the people who want to experiment on subjects were very happy to have the rules relaxed.

Who could have guessed that would happen?

(Response 1) FDA agrees that this rule will facilitate investigators’ ability to conduct certain minimal risk clinical investigations that could lead to healthcare advances through development of products to diagnose or treat diseases or other conditions, without compromising subjects’ rights, safety, or welfare. To the extent that the studies described in the comments would constitute FDA-regulated clinical investigations that could not be carried out under our current regulations, we agree that this final rule may help enable such research and that a waiver of informed consent is ethically justifiable for certain types of investigations.

“Advances through development of products to diagnose or treat diseases or other conditions.” You mean medical research, don’t you? Isn’t that what medical research is?

So what they mean is that they want to do medical research, and pesky potential patients may not want to be experimented on, so let’s cut them out of the process. After all, those 8 mice who prove the safety and effectiveness of vaccine boosters don’t consent, so why should human beings be allowed to muck up the works?

I mean, really, they are just plebs. We wouldn’t do this in real people like journalists, politicians, or corporate leaders. Just those excess carbon bags walking around emitting greenhouse gases. There are way too many of them anyway.

Opponents point to the Nuremberg codes which explicitly prohibit waiving informed consent for medical research, because we saw what Nazis did.

The FDA–we aren’t Nazis, so it’s OK.

(Comment 2) Of the comments that oppose the proposed rule, two oppose it because they assert that waiving consent conflicts with existing ethical and international standards, such as the Belmont Report, the Nuremberg Code, the Declaration of Helsinki, and the International Covenant on Civil and Political Rights (ICCPR). Two other comments suggest that FDA withdraw the proposal because the underlying law and revised Common Rule are defective and “against the spirit” of human subject protection.

(Response 2) FDA disagrees with the comments opposing the rule. We believe that the rule upholds the principles underlying existing ethical standards, while accounting for advances in the conduct of FDA-regulated clinical investigations. It is also consistent with the obligations of the ICCPR and the U.S.’ reservations, declarations, and understandings to the Covenant (see,


Ref. 1). The standards referenced in the comments emphasize the importance of voluntary informed consent for research participants. As stated in the proposed rule, obtaining informed consent from those who volunteer to participate in research is a fundamentally important principle of human subject protection. However, there are some situations in which important research cannot practicably be conducted if informed consent is required. This rule permits a waiver of consent in limited circumstances, consistent with the statutory amendments Congress made in section 3024 of the Cures Act. The waiver is only permitted in circumstances where the risks posed to subjects by the research are minimal and where an IRB has reviewed the research and determined, among other things, that the waiver or alteration will not adversely affect the rights and welfare of subjects. If research can be practicably carried out without a waiver of informed consent, investigators cannot obtain a waiver under this rule.

Think about that: the FDA wants to gut informed consent because, well, people won’t consent to certain things. So screw ’em.

Additionally, the ethical principles identified in many of the national and international guidelines for research conduct, such as the three ethical principles described in the Belmont Report (respect for persons, beneficence, and justice), should be considered and weighed within the context of a particular clinical investigation, as the consideration of each principle depends on multiple factors associated with the investigation, such as research methodologies or participant populations. This rule permits a waiver or alteration of consent only in limited circumstances where the risks posed to subjects by the research are very low. We believe that with the protections in place under this rule (including the requirement for an IRB to find and document that the waiver or alteration will not adversely affect the rights and welfare of subjects), the balance between respect for persons and beneficence should come out in favor of facilitating research that satisfies the criteria in § 50.22 by permitting waiver or alteration of informed consent requirements to advance the public health. Additionally, although informed consent is a critical element of FDA’s regulations that reflects the principle of respect for persons through the exercise of autonomy, we believe that the criteria provided in this rule also reflect the principle of respect for persons. For example, in a minimal risk clinical investigation for which an IRB waives consent, ensuring that the rights and welfare of subjects are not adversely affected by the waiver demonstrates respect for persons, as does providing additional pertinent information about the investigation to subjects whenever appropriate (Ref. 2).

As you can see, it’s all handwaving. They want to do certain research. They worry that people won’t want to be subjects of that research. They believe the research will be good. And, after all, it’s “minimal risk,” right?

So just do it and screw ’em.

Do you trust the researcher’s definition of “minimal risk?” I sure don’t. How many drugs have been approved that have been taken off the market because they harm people? How often have we been lied to? Didn’t the people who did the Tuskeegee experiments think they were benefiting society, and besides, those people got syphilis by having sex, and everybody has sex so it is a common risk encountered in everyday life.

That is the definition of minimal risk. It might happen to you in the normal course of life. Whatever that is. Car accidents happen in the normal course of life but we don’t use human beings as crash test dummies.

This does more than stink. It sets us back 50 years in medical ethics. Or what we think when we think medical ethics since every principle of ethics has been violated in the past four years.

This is insane. And it flew under the radar since few people read the federal register. Thanks to Josh Walkos we know about it. Now, can we do something about it.

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