# 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

# behav: unfrequent events under radical uncertainty; rats tend to avoid black swan situations.

AA << present a novel experimental design that aims at measuring the extent to which animal subjects are sensitive to rare and extreme events and, in addition, how rats respond to those very unfrequent events under radical uncertainty. (..) the novelty of (AA) design is that it provides two direct measures that help interpreting (..) behavioral data: Total Sensitivity to Rare and Extreme Events, and One-sided Sensitivity to Rare and Extreme Events with Black-Swan Avoidance/Jackpot-Seeking behaviors as limiting cases. >>️

<< First, most rats (..) can be grouped into a moderate to high Total Sensitivity group. This means that most rats diversify their choices across options in such a way that they more often rely on convex ones than on concave ones overall. Therefore, they tend to seek extreme gains/Jackpots and to avoid extreme losses/ Black Swans. In addition, most rats (..) tend to exhibit Black Swan Avoidance, which indicates that, given Total Sensitivity, they tend to try more often to avoid Black Swans than to seek Jackpots. (AA) interpret such a behavior as significant aversion towards uncertainty about rare and extreme losses.  >>️

<< all rats diversify their choices across a set of options, which is reminiscent of observed behaviors such as, for example, bet-hedging in animals and financial portfolio strategies used by humans >>

️

<< results from similar experiments among different species might be of interest for the analysis of neurobiological substrates involved in decision-making and its evolutionary traits in the context of rare and extreme events. >>️

Mickael Degoulet, Louis-Matis Willem, et al. Decision-Making in Rats is Sensitive to Rare and Extreme Events: the Black Swan Avoidance. bioRxiv 10.1101/2021.11.01.466806v1. Nov 04, 2021. 

https://www.biorxiv.org/content/10.1101/2021.11.01.466806v1

 Keywords: behav, game, decision-making, bet-hedging, trading, uncertainty, gain, loss, black swan 

#life: reliability, deception and lies of a signal (among the Siberian jay Perisoreus infaustus)

<< Deception and lies are surprising aspects of human communication and the use of language in which false information is intentionally communicated to others, allowing an individual to gain an advantage over the recipient of such false information. However, language is actually highly pro-social and cooperative and is mainly used to share reliable information. >>️

<< a number of species are able to deceive their conspecifics, including some species of primates and birds like the Siberian jay (Perisoreus infaustus). Siberian jays live in territorial groups and have an elaborate communication system: A wide range of calls allow them to warn each other of the presence of different predators as well as the behaviour of their fiercest enemy, the hawk. >>

<< Occasionally, however, neighbours intruding into a group's territory use the same calls that would otherwise indicate the presence of a perched hawk for a different purpose. Their aim is to deceive the members of the group about the presence of the predator, thus scaring them away to get access to their food.  >>

<< It is a commonly observed phenomenon in the animal kingdom that warning calls are used to deceive others. Clearly, the recipients of the false information potentially pay a high price if they ignore the warning, >>  Filipe Cunha. 

<< Siberian jays thus have a simple rule to avoid being tricked: They only trust the warning calls from members of their own group, meaning cooperation partners. Familiarity alone is not enough, otherwise the birds would also have trusted the calls of their neighbours, >> Michael Griesser. ️

Daniel Schmidtke. Trust among corvids. University of Konstanz. Jun 1, 2021. 

https://www.sciencedaily.com/releases/2021/06/210601135719.htm

Filipe C. R. Cunha, Michael Griesser. Who do you trust? Wild birds use social knowledge to avoid being deceived. Science Advances. Vol. 7, no. 22, eaba2862. doi: 10.1126/ sciadv.aba2862. May 28, 2021. 

https://advances.sciencemag.org/content/7/22/eaba2862    

Also

2068 - chaotic probabilities. 

(quasi-stochastic poetry)

https://inkpi.blogspot.com/2006/10/2068-chaotic-probabilities.html

keyword "fake" in FonT

https://flashontrack.blogspot.com/search?q=fake

# life: a tiny pill against two unfavorable hypotheses on serial coronavirus pandemics - to avoid the socio-economic psycho-behavioral fallout caused by 1or2achoos (e.g. from Wuhan)

<< Pfizer Inc. said it has begun human safety testing of a new pill to treat the coronavirus that could be used at the first sign of illness. If it succeeds in trials, the pill could be prescribed early in an infection to block viral replication before patients get very sick. The drug binds to an enzyme called a protease (Pfizer’s oral protease inhibitor, code-named PF-07321332,) to keep the virus from replicating. >>

<< In lab tests, it worked against many coronaviruses, including the original SARS virus and MERS. Additionally, the coronavirus protease doesn’t mutate much, which means the therapy is likely to work equally well against numerous variant strains, >>

️

<< This is really a potential game changer, >>️  Mikael Dolsten️

Robert Langreth. Pfizer Begins Human Trials of New Pill to Treat Coronavirus. 

Mar 23, 2021 17:38 CET. 

https://www.bloomberg.com/news/articles/2021-03-23/pfizer-begins-human-trials-of-new-pill-to-treat-coronavirus

Christie Aschwanden. Five reasons why COVID herd immunity is probably impossible. Nature 591, 520-522. doi: 10.1038/ d41586-021-00728-2. Mar 18, 2021. 

https://www.nature.com/articles/d41586-021-00728-2

Angela L. Rasmussen, Saskia V. Popescu. SARS-CoV-2 transmission without symptoms.  Science, 2021; 371 (6535): 1206-1207 doi: 10.1126/ science.abf9569   

https://science.sciencemag.org/content/371/6535/1206

Also

keyword 'virus' in FonT: 

https://flashontrack.blogspot.com/search?q=virus

keyword 'virus' in Notes (quasi-stochastic poetry):

https://inkpi.blogspot.com/search?q=virus

# life: At this point ... are you a pseudo naked mole-rat? Well, it would be useful ...

<< African naked mole-rats are sometimes referred to as animal superheroes. They resist cancer, tolerate pain, and live a remarkably long time. They're also known for their ability to handle high levels of carbon dioxide and can go for several minutes without oxygen. >>

AA << may have found the mole-rats' kryptonite: they need high levels of carbon dioxide to function. (..) the mole-rats don't just tolerate high levels of carbon dioxide in their crowded nests; it appears that they actually require it. When they reach the hot surface and start heat-induced hyperventilation in the fresh air, it sends them into seizures. >>

AA << found that this curious need for carbon dioxide is explained by the presence of a missense mutation in a gene that encodes the major neuronal chloride transporter known as KCC2. >>

Similarly, families of people << with a genetic predisposition for febrile seizures carry the very same genetic change. >>

<< The identification of the genetic polymorphism in the naked mole-rat KCC2 was a surprise, (..) Aside from a small subset of humans, naked mole-rats are now the only other mammals known to harbor this variant. >> Martin Puskarjov.

Naked mole-rats need carbon dioxide to avoid seizures and here's why. Cell Press. Apr 30, 2020. 

https://phys.org/news/2020-04-naked-mole-rats-carbon-dioxide-seizures.html

Michael Zions, Edward F. Meehan, et al. Nest Carbon Dioxide Masks GABA-Dependent Seizure Susceptibility in the Naked Mole-Rat. Curr Biol. doi: 10.1016/j.cub.2020.03.071. Apr 30, 2020.

https://www.cell.com/current-biology/fulltext/S0960-9822(20)30478-4

Also 

the 'naked mole-rats paradox'

Scientists explain why naked mole-rats' longevity contradicts accepted aging theory. Missouri University of Science and Technology. Feb 10, 2020.

https://phys.org/news/2020-02-scientists-naked-mole-rats-longevity-contradicts.html

Wenyun Zuo, Xiaolong Tang, Chen Hou. Why Naked Mole-Rats Have High Oxidative Damage but Live a Long Life: A Simple Explanation Based on the Oxidative Stress Theory of Aging. 

Adv Geriatr Med Res. 2(1): e200006. doi: 10.20900/agmr20200006. Jan 7, 2020. 

https://agmr.hapres.com/htmls/AGMR_1164_Detail.html

Also

keyword 'naked' in FonT

https://flashontrack.blogspot.com/search?q=naked

# gst: tiny deviations (inside a phase transition) to avoid a near-complete annihilation.

<< Recently discovered ripples of spacetime called gravitational waves could contain evidence to prove the theory that life survived the Big Bang because of a phase transition that allowed neutrino particles to reshuffle matter and anti-matter, >>

<< According to the Big Bang theory of modern cosmology, matter was created with an equal amount of anti-matter. If it had stayed that way, matter and anti-matter should have eventually met and annihilated one to one, leading up to a complete annihilation.

But our existence contradicts this theory. To overcome a complete annihilation, the Universe must have turned a small amount of anti-matter into matter creating an imbalance between them. >>  

<< the Universe went through a phase transition so that neutrinos could reshuffle matter and anti-matter. >>

Showing how the tiniest particles in our Universe saved us from complete annihilation. Kavli Institute for the Physics and Mathematics of the Universe. Feb 3, 2020.

https://m.phys.org/news/2020-02-tiniest-particles-universe-annihilation.html

Jeff A. Dror, Takashi Hiramatsu, et al.  Testing the Seesaw Mechanism and Leptogenesis with Gravitational Waves.  Phys. Rev. Lett. 124, 041804. doi: 10.1103/PhysRevLett.124.041804. Jan 28, 2020. 

https://journals.aps.org/prl/abstract/10.1103/PhysRevLett.124.041804

# behav: walking with turning

<< Normal human locomotion in daily life involves walking with turning, not just straight line walking. (..) the metabolic rate while walking in circles increases with decreasing radius for fixed speed. (..) this increase in energy cost for turning has behavioral implications >>

<< to save energy, (..) humans should walk slower in smaller circles, slow down when path curvature increases when traveling along more complex curves, turn in place around a particular optimal angular speed, and avoid sharp turns but use smooth gentle turns while navigating around obstacles or while needing to turn while walking. >>

Geoffrey L. Brown, Nidhi Seethapathi, Manoj Srinivasan. Walking with turning: energy optimality explains walking behavior while turning and path planning. arXiv: 2001.02287v1 [q-bio.NC]. Jan 7, 2020.

https://arxiv.org/abs/2001.02287

# chem: mimic a stable photosynthesis (inside a porous 'scaffold' to avoid deactivation / decomposition)

<< When molecules of cobalt oxide cubane, so named for its eight atoms forming a cube, are in solution, the catalytic units eventually collide into one another and react, and thus deactivate. To hold the catalysts in place, and prevent these collisions, the researchers used a metal-organic framework as a scaffold.  >>

<< Our study provides a clear, conceptual blueprint for engineering the next generation of energy-converting catalysts, >> T. Don Tilley

Theresa Duque. Here comes the sun: a new framework for artificial photosynthesis. Lawrence Berkeley National Laboratory. Jun 18, 2019

https://m.phys.org/news/2019-06-sun-framework-artificial-photosynthesis.html

Andy I. Nguyen, Kurt M. Van Allsburg, et al. Stabilization of reactive Co4O4 cubane oxygen-evolution catalysts within porous frameworks. PNAS 116 (24) 11630-11639. doi: 10.1073/pnas.1815013116. Jun 11, 2019.

https://www.pnas.org/content/116/24/11630

# behav: to avoid zombification (among humble cockroaches)

<< The emerald jewel wasp (Ampulex compressa) is renowned for its ability to zombify the American cockroach (Periplaneta americana) with a sting to the brain. >>

<< many cockroaches deter wasps with a vigorous defense. Successful cockroaches elevated their bodies, bringing their neck out of reach, and kicked at the wasp with their spiny hind legs, often striking the wasp's head multiple times (..) >>

<< Thus, for a cockroach not to become a zombie, the best strategy is: be vigilant, protect your throat, and strike repeatedly at the head of the attacker. >>

Catania K.C. How Not to Be Turned into a Zombie. Brain Behav Evol. 1-15 Oct 31, 2018.  doi: 10.1159/000490341

https://www.karger.com/Article/Abstract/490341

Karate kicks keep cockroaches from becoming zombies, wasp chow. Vanderbilt University. Oct 31, 2018.

https://m.phys.org/news/2018-10-karate-cockroaches-zombies-wasp-chow.html

Also

<< cockroaches aren’t a nuisance. They’re "gregarious insects" that can teach us about how groups approach collective decision-making. >>

Erin Blakemore. Cockroaches Have Personalities, Too. Smithsonian.com Feb 4, 2015.

https://www.smithsonianmag.com/smart-news/cockroaches-have-personalities-too-180954140

# ai.bot: a pulsatile semantic approach to assist in the drafting of sci/tech reports

<< At IBM Research AI, [AA] built an AI-based solution to assist analysts in preparing reports. >>

<< An AI-assisted solution can help analysts to prepare complete reports and also avoid bias based on past experience. >>

Oktie Hassanzadeh. Semantic concept discovery over event databases. IBM. July 17, 2018.

https://m.phys.org/news/2018-07-semantic-concept-discovery-event-databases.html

https://www.ibm.com/blogs/research/2018/07/semantic-concept-discovery/   

Oktie Hassanzadeh, Shari Trewin, Alfio Massimiliano Gliozzo. Semantic Concept Discovery Over Event Databases. ESWC. Feb 14, 2018.

https://2018.eswc-conferences.org/paper_182/

FonT

sarebbe davvero singolare, sorprendente, se, dopo l'analisi dei dati, una AI "decidesse" di scrivere il report finale in forma poetica, magari con un approccio quasistocastico, fuzzy, per la stesura del testo ...

# behav: reconciliation following conflicts in wolves compared to dogs

<< Highly cooperative social species are expected to engage in frequent reconciliation following conflicts in order to maintain pack cohesiveness and preserve future cooperation. >>

AA << provide evidence for reconciliation in captive wolves, which are highly dependent on cooperation between pack members, while domestic dogs, which rely on conspecific cooperation less than wolves, avoided interacting with their partners after conflicts. >>

Simona Cafazzo, Sarah Marshall-Pescini, et al. The effect of domestication on post-conflict management: wolves reconcile while dogs avoid each other. Royal Society Open Science. doi: 10.1098/rsos.171553.  July 4, 2018

http://rsos.royalsocietypublishing.org/content/5/7/171553 

Bob Yirka. Study suggests dogs have lost ability to reconcile after violent conflicts. July 4, 2018

https://m.phys.org/news/2018-07-dogs-lost-ability-violent-conflicts.html

# behav: to avoid a rat race

<< Mice can learn to overcome their naturally aggressive approach to conflict resolution, instead adopting a cooperative strategy >>

AA << demonstrate that pairs of mice can learn to coordinate their behaviour to achieve an egalitarian distribution of rewards — but only when rewards are delivered directly to the brain, rather than through food >>

Scott M. Rennie, Michael. L. Platt. Mice learn to avoid the rat race. Nature News and Views. Dec 21, 2017.

https://www.nature.com/articles/d41586-017-08835-9  

Choe Il-Hwan, Byun Junweon, et al. Mice in social conflict show rule-observance behavior enhancing long-term benefit. Nature Comm. 2017;  8 (1176).  doi: 10.1038/s41467-017-01091-5.  Nov 07, 2017

https://www.nature.com/articles/s41467-017-01091-5  

# age: senolytics, to stay young kill zombie cells

<< Killing off cells that refuse to die on their own has proved a powerful anti-ageing strategy in mice. Now it's about to be tested in humans >>

<< Surprisingly, senescent cells turn out to be slightly different in each tissue. They secrete different cytokines, express different extracellular proteins and use different tactics to avoid death. That incredible variety has made it a challenge for labs to detect and visualize senescent cells >> Judith Campisi.

<<  In young mice, no more than 1% of cells in any given organ were senescent. In two-year-old mice, however, up to 20% of cells were senescent in some organs.  But there's a silver lining to these elusive twilight cells: they might be hard to find, but they're easy to kill >> Valery Krizhanovsky.

<< I think senolytics are drugs that could come soon and be effective in the elderly now, even in the next few years >> Nir Barzilai.

To stay young, kill zombie cells. Nature 2017; 550: 448 – 50. doi:10.1038/550448a Oct 26, 2017

https://www.nature.com/news/to-stay-young-kill-zombie-cells-1.22872

# s-behav: mimic the sound of musk hogs to avoid being eaten

<< Bird or beast? A cuckoo seems to have learned how to mimic the sounds made by the pig-like peccaries it lives alongside, perhaps to ward off predators >>

Sandrine Ceurstemont. Cuckoos mimic the sound of musk hogs to avoid being eaten. July 3, 2017.

https://www.newscientist.com/article/2139386-cuckoos-mimic-the-sound-of-musk-hogs-to-avoid-being-eaten/

<< Acoustic communication is particularly important in environments such as dense tropical forests, where the dim light constrains the efficacy of visual signals >>

<< In these environments, complex species interactions could promote the evolution of acoustic signals and result in intriguing patterns of mimicry and convergence >>

AA << demonstrate that the acoustic characteristics of bill clacking in ground-cuckoos are more similar to teeth clacking of peccaries than to bill clacking of the more closely related Geococcyx roadrunner >>

Fabio Raposo do Amaral, Gabriel Macedo, et al. Bluffing in the forest: Neotropical Neomorphus ground-cuckoos and peccaries in a possible case of acoustic mimicry. J Avian Biol doi: 10.1111/jav.01266. June 29, 2017

http://onlinelibrary.wiley.com/doi/10.1111/jav.01266/full

# s-gene-behav: short horns for large results (in giant hissing cockroaches)

<< males from two species of giant hissing cockroaches from Madagascar may have evolved different physical characteristics based on their strategies for winning a female >>

<<  "These cockroaches are acting like red deer in the rut, competing for females by combat, but if they don't have the size and strength to win fights outright, they can try and sneak mates. A male cockroach seems to be adapted to be either a lover or a fighter, and what's interesting is that they do this before they become fully adult, at the final moult."  >>  Kate Durrant.

<< Animals that must compete for a mate can do so in various ways: some males will defend a female from rival males by force, while others will sneak past larger males and mate with females behind their backs >>

<< These two strategies, 'fighters' and 'lovers', are associated with different behaviours and characteristics >>

AA << found that the Flat-horned cockroach, which is small with short horns (as its name suggests), was non-aggressive and had large testes, which indicates that it is more likely to avoid fighting by mating with females behind the backs of larger males, while the Wide-horned cockroach, which is large and heavily armoured with large horns, was highly aggressive in combat between males and was not well-endowed in terms of testes size >>

Species of giant cockroaches employ different strategies in the mating game. Nov. 8, 2016

http://m.phys.org/news/2016-11-species-giant-cockroaches-strategies-game.html

Kate  L.  Durrant, Ian  M.  Skicko, et al.  Comparative  morphological  trade-offs between  pre-  and  post- copulatory sexual selection  in  Giant  hissing cockroaches  (Tribe:  Gromphadorhini). Nature. Scientific Reports 6, Article  number:  36755. Publ online Nov. 07, 2016. doi: 10.1038/srep36755

http://www.nature.com/articles/srep36755

# s-phyto: the plastic mimicry of the 'palatable' small toropapa (Alseuosmia pusilla)

<< It has long been assumed that A. pusilla might avoid being eaten by insect or avian herbivores by mimicking the unpalatable P. colorata [Pseudowintera colorata]; until now, however, this assumption has lacked empirical evidence >>

New  research  uses  novel  approach  to  study  plant mimicry. June  13,  2016.

http://www.cdnsciencepub.com/news-and-events/press-releases/PR-CJB-2016-0049.aspx

<< 90% of leaf shape variation in the two species varied similarly across an altitudinal gradient >>

Karl G. Yager, H. Martin Schaefer, Kevin S. Gould. The significance of shared leaf shape in Alseuosmia pusilla and Pseudowintera colorata. Botany, 10.1139/cjb-2016-0049

http://dx.doi.org/10.1139/cjb-2016-0049

# s-brain: tracing Charlie ...

<< Do  you  like  surprises?  If  you  don’t,  it  might  be  because  our  nervous  system  works  very  hard  to avoid  being  surprised.  This  often  involves  the  nervous  system  trying  to  predict  or  “model”  its own  future  as  accurately  as  possible.  For  example,  when  we  are  listening  to  a  string  of  sounds that  appears  to  be  unpredictable,  such  as  a  Charlie  Parker-esque  saxophone  solo,  our  brain  will still  try  to  predict  what  the  next  note  will  be >>

Jonas Obleser. Perception:  Tell  me  something  I  don’t  know. DOI:  http://dx.doi.org/10.7554/eLife.15853 Published  April  19,  2016. eLife  2016;5:e15853

http://elifesciences.org/content/5/e15853v1

https://twitter.com/eLife/status/724269430989983744

# rmx-s-behav: a bizarre paddle game (about safety waves ...)

<< Males of a newly discovered species of jumping spider [Jotus remus] spend hours waving special paddle-shaped legs at prospective mates, in an effort to copulate without being attacked – or even eaten.

Mating can potentially cost you your life if you are a male spider. To avoid becoming lunch, Jotus remus plays a game first to tire out hungry females >>

https://www.newscientist.com/article/dn28756-male-spiders-lure-aggressive-females-with-peek-a-boo-paddle-game/

Jürgen  C.  Otto, David  E.  Hill. Males  of  a  new  species  of  Jotus  from  Australia  wave  a  paddle-shaped lure  to  solicit  nearby  females  (Araneae:  Salticidae:  Euophryini). PECKHAMIA 133.1, 7 January 2016,  1―39 urn:lsid:zoobank.org:pub:12A6DBBE-11EC-4DEB-9387-83F1AD727E6F    (registered  6  JAN  2016) 1 ISSN  2161―8526 (print) ISSN  1944―8120 (online)

http://peckhamia.com/peckhamia/PECKHAMIA_133.1.pdf