Why were new approaches to Nuremberg sought in 2017 and codified

According to the below paper, revisions in the 1991 “common rule” were proposed in 2011, a revision of the revision proposed in 2015, and final rules issued in 2017.⁹

SOME ‘ACTIVITIES’ NOT RESEARCH BY DECREE. HA!

shouldn’t the individual and not the decree be the judge of that?

torture and risking life and limb. that is what is covered. by decree no other activities. Because if it’s not torture its mission creep of what Nuremberg was about. so what adverse consequence in the opinion of the individual is torture by result.

One IRB BOARD DECIDES THE INFORMED CONSENT REQUIREMENTS hm. if you compromise that one institution … examples the IRB board could review includes gene editing.

Good Lord, it does seem they thought gene editing might be on the horizon.

It is the 2017 timing of these changes that seem odd to me. How about you?

IT IS THAT ONE BOARD DECIDES IT ALL.

“Revisions in the 1991 “common rule” were proposed in 2011, a revision of the revision proposed in 2015, and final rules issued in 2017.⁹ Proposed revisions sought to accomplish 4 major things: treat biospecimens like people, reduce the types of research covered by the regulations, use a single institutional review board (IRB) to review research conducted at multiple institutions, and improve the informed consent process. All but the first were adopted.”

“The second proposed change was to reduce the types of research to which the regulations applied. Nuremberg was focused on potentially lethal experiments (some with death as the endpoint) that risked life and limb and were better classified simply as murder and torture. There has been considerable complaint over the past 20 years that the mission of IRBs in reviewing research has suffered from “mission creep” (by including more and more kinds of research activities) and that measures are needed to rein in the growing mandate of IRB review.¹⁵ In response, the new regulations specifically decree that some activities are not research for the purposes of the regulations, for example, “scholarly and journalistic activities,” public health surveillance, use of biospecimens by criminal justice agencies, and national security activities. Other research is simply exempt from the regulations, including educational research, benign behavioral interventions, secondary research on biospecimens, demonstration projects, and taste and food quality evaluation. There is nothing in these subject matter limitations that the judges at Nuremberg would object to.

The third major proposal concerns IRBs, which are relevant to informed consent because the IRB must approve the form and process informed consent takes. The proposal calls for a single IRB review to be sufficient for research conducted at more than 1 institution. Although IRB review was not required by the Nuremberg Code at all, doing away with the requirement for all but 1 institution involved in a multicenter research trial could gut the review requirement of any real meaning. This is because the structure of the regulations requires holding the individual institution “responsible for safeguarding the rights and welfare of human subjects.”^9(p7265) The single IRB requirement risks replacing ethics with efficiency and can be justified, if at all, only in no or very low risk studies.¹⁶

On the other hand, a single, national IRB that had a majority public representation and met in public could usefully (and efficiently) set and enforce rules for extreme and unusual human experiments—experiments that local IRBs have no expertise in.¹⁷ Examples might include xenografts, the artificial heart, and human gene editing. Another useful reform would be a requirement for the majority of the IRB members to be representative of the public (appreciating that this proposal has little current support and will require considerable effort and funding) rather than the current requirement that IRBs have at least 1 member who is not “affiliated with” the institution.¹⁷ Under existing regulations, all members of an IRB but 1 could have an inherent conflict of interest because they can be employed by or affiliated with the institution. The judges at Nuremberg would not likely have approved this accountability mechanism.”

I find this an odd timing, and disturbing changes that were sought.

Imaging perverting Nuremberg to actually permit gene editing without informed consent, for instance. Or defining what is experimenting on humans by decree.

Defining under what circumstances we can have our personal autonomy over our body or not.

I believe in the Rule of Law and good old fashioned common sense.

So I ask you.

Is a system to enable experimenting on humans being set up through the very protections that came from the pursuit of justice for the worst abominations anyone can imagine. Nuremberg came out of the holocaust. The principles underpinning that document should never be diluted.