# life: a new exception within the FDA Cures Act Informed Consent, the intriguing concept of 'Minimal Risk Clinical Investigations'.

<< 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. >>️

Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations. A Rule by the Food and Drug Administration on 12/21/2023. federalregister.gov 

https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical

FonT:  'Minimal Risk Clinical Investigations (MRCI)': here are intriguing both (i) the scientific formalization of the operational methods decided (case by case) by the FDA about MRCI and (ii) the possible strategies - if at least one exists - for avoiding the 'multitude of unaware' from this type of interception.

Also: Are you ready for all this?, in https://www.inkgmr.net/kwrds.html

Also: evitare (avoid), in Notes (quasi-stochastic poetry)  https://inkpi.blogspot.com/search?q=evitare

Also: avoid, in FonT https://flashontrack.blogspot.com/search?q=avoid

Also: Robert F. Kennedy's opinion on the issue https://twitter.com/RobertKennedyJr/status/1752126207821271080  

Keywords: life, FDA, informed consent, risk, minimal risk, minimal risk clinical investigations, avoidance, 1or2achoos, are you ready

# life: to protect freedoms, not just funding.

<< At Harvard University in Cambridge, Massachusetts, and Columbia University in New York City, cuts to previously granted federal research funds have been accompanied by demands from the government. If enacted, the changes to departmental oversight, disciplinary procedures, campus police and governance structures would allow the government to dictate hiring, student admissions and disciplinary decisions. >>

<< So far, the US science community has been outspoken about the threats that funding cuts pose to health, innovation and the economy. Yet, few researchers have decried the devastation wreaked on science by attacks on civil liberties and the rule of law. >>

Andrew M. Leifer, Andrea J. Liu, Sidney R. Nagel. US researchers must stand up to protect freedoms, not just funding. Nature 641, 592-593. May 13, 2025.

https://www.nature.com/articles/d41586-025-01466-5

Also: people who turn career into a game playing ... FonT. May 31, 2017.

https://flashontrack.blogspot.com/2017/05/s-game-people-who-turn-career-into-game.html

Also: minimal risk, in FonT 

https://flashontrack.blogspot.com/search?q=minimal+risk

Also: acad, in Font https://flashontrack.blogspot.com/search?q=acad.  acad, in Notes (quasi-stochastic poetry) https://inkpi.blogspot.com/search?q=acad

Also:  dance, game, transition, sars* covid* (aka 1or2achoos), forms of power, Mr. Donald, are you ready, in https://www.inkgmr.net/kwrds.html 

Also: nefst (e.g. not embedded, freestyle thinker) 

https://quod.lib.umich.edu/m/middle-english-dictionary/dictionary/MED20173/track

Keywords: life, acad, game, dance, transitions, nefst, 1or2achoos, minimal risk, turn career, forms of power, Mr. Donald, are you ready.

# life: apropos of saliva healers, herd immunity revisited and now hypothetically approachable even within NIH

<< President-elect Donald Trump is tapping Dr. Jay Bhattacharya, a Stanford University health researcher, to be the next director of the National Institutes of Health (NIH). >>

️

<< Bhattacharya was one of three authors of the document (#1). The declaration called for speeding herd immunity by allowing people at low risk to get infected while protecting those most vulnerable, like the elderly. >>

Rob Stein. Trump turns to critic of COVID mandates to run NIH. npr.org. 

Nov 26, 2024. 

https://www.npr.org/sections/shots-health-news/2024/11/26/nx-s1-5195168/nih-bhattacharya-trump-election-2024

<< The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk. We call this Focused Protection. >>

️

(#1) - Martin Kulldorff, Sunetra Gupta, Jay Bhattacharya. Great Barrington Declaration. Oct 4, 2020. https://gbdeclaration.org/

FonT

From my point of view 'herd immunity'  can be engineered if and only if, even in the case of sars-covid-19 or flu, simultaneous protection is used with an effective, easy available, antiviral drug.

In this regard, a non-compassionate but logical easy approach could be the indirect inhalation of alcohol ~70% already at the first signs of rhinorrhea, as follows:

(-) start self-treatment (spray plus cotton mask):

Mar 20, 2020  https://flashontrack.blogspot.com/2020/03/life-funky-immediate-approach-of.html  

(-) outcomes

Jul 13, 2022  https://flashontrack.blogspot.com/2022/07/life-aproposito-di-1or2achoos-da-wuhan.html  

Oct 4, 2023 https://flashontrack.blogspot.com/2023/10/life-proposito-di-1or2achoos-da-wuhan.html  

Ultimately, here it could hypothesize a case of historic, singular checkmate of 'one against all'. Anzicheforse?

Also: drop, saliva, sars* covid* (aka 1or2achoos), virus, ethno, Mr. Donald, POTUS, tit-for-tat, game, in https://www.inkgmr.net/kwrds.html 

Keywords: life, drop, saliva, saliva healers, herd immunity, sars, mers, 2019ncov, sarscov2, covid19, coronavirus, 1or2achoos, virus, ethno, ethnomedicine, Donald, POTUS, tit-for-tat, game

PS: I couldn't say why, but in certain contexts, the incipit of an answer that the physicist Enrico Fermi https://it.m.wikipedia.org/wiki/Enrico_Fermi  gave to a journalist always comes back to my mind: 'the physics that is done in our laboratory ...' . 

An example of exceptional, clear, even poetic analysis and synthesis skills (in only 8 words).

# life: oops! It would appear that Mr. Donald intends to open hunt for Academics as well ... maybe these people are penniless immigrants too?

<< A prominent US scientific society altered its website to remove references to diversity and equity ― terms targeted by the administration of US President Donald Trump. Articles about scientists who are members of under-represented groups also temporarily vanished from the site, although they have since reappeared. >>

<< In an e-mail, ASM (Am Soc for Microbiol) president Theresa Koehler told Nature that the organization had followed legal advice to review all of its webpages, in the hope of protecting its federally funded programmes. >>️

Humberto Basilio. ‘We are a target’: scientific society under pressure after Trump DEI crackdown. Nature. doi: 10.1038/ d41586-025-00372-0. Feb 7, 2025. 

https://www.nature.com/articles/d41586-025-00372-0

Also: A new exception within the FDA Cures Act Informed Consent, the intriguing concept of 'Minimal Risk Clinical Investigations'. FonT. Feb 1, 2024. 

https://flashontrack.blogspot.com/2024/02/life-new-exception-within-fda-cures-act.html 

Also: ️<< You should never be comfortable, man. Being comfortable fouled up a lot of musicians. >> Miles Davis. https://www.azquotes.com/quote/527910 

https://x.com/SVG__Collection/status/1886745080066695455

Also: oops, Mr. Donald, forms of power, virus, sars* covid* (aka 1or2achoos), dance, are you ready for all this, in https://www.inkgmr.net/kwrds.html 

Keywords: life, oops, Mr. Donald, forms of power, acad, virus, sars, covid, 1or2achoos, dance, are you ready for all this

# life: dear Mr. Donald, fuzzy evidence should be sharper, sooner or later, by Nature

       Nature | 637 | 16 Jan 2025 | 517

<< Mr President-elect, science is a self-correcting process in which bad actors and wrong ideas sooner or later get rooted out and fuzzy evidence becomes sharper. That is the joy and the beauty of the method that has made the modern world what it is. >>️

Editorial. Dear Donald Trump: A letter from Nature on how to make science thrive. Nature 637, 517. Jan 15, 2025.

https://www.nature.com/articles/d41586-025-00050-1

Also: Mr. Donald, forms of power, virus, sars* covid* (aka 1or2achoos), dance, are you ready for all this, in https://www.inkgmr.net/kwrds.html 

Also: A new exception within the FDA Cures Act Informed Consent, the intriguing concept of 'Minimal Risk Clinical Investigations'. FonT. Feb 1, 2024. 

https://flashontrack.blogspot.com/2024/02/life-new-exception-within-fda-cures-act.html 

Also: 'acad' in FonT https://flashontrack.blogspot.com/search?q=acad    in Notes (quasi-stochastic poetry) https://inkpi.blogspot.com/search?q=acad 

Keywords: life, Mr. Donald, forms of power, virus, sars, covid, 1or2achoos, acad, dance, are you ready