century

A Secret Sculpture Built for John F. Kennedy's Grave Vanished in the 1970s. Half a Century Later, the Mystery Has Been Solved

The bronze wreath immortalized the moment when the members of the Honor Guard removed their hats and placed them on the president's grave during his burial




century

Back in the 19th Century, Your Election Ballot Could Double as a Work of Art

During and after the Civil War, inventive illustrations allowed Democrats and Republicans to turn American ballots into powerful propaganda




century

Discover the Mysteries of Italy's Park of Monsters, a 16th-Century Garden Filled With Strange, Colossal Stone Creatures

The Sacro Bosco's meaning is the subject of debate, with scholars alternatively describing the sprawling complex as a memorial, an allegorical site or a tribute to ancient civilizations




century

This 19th-Century 'Toy Book' Used Science to Prove That Ghosts Were Simply an Illusion

"Spectropia" demystified the techniques used by mediums who claimed they could speak to the dead, revealing the "absurd follies of Spiritualism"




century

Equipped for the 21st century

Despite having a degree, a young woman in Bangladesh finds it impossible to get a job until she completes an OM computer course.




century

18th Century Sculpture Bought For Rs 540 Could Sell For Over Rs 2.68 Crore

A marble bust bought for £5 (around Rs 540) and long used as a doorstop may soon fetch over £2.5 million (Rs 2.68 crore).




century

18th Century Sculpture Bought For Rs 540 Could Sell For Over Rs 2.68 Crore

A marble bust bought for £5 (around Rs 540) and long used as a doorstop may soon fetch over £2.5 million (Rs 2.68 crore).





century

Governor Carney Honors Four Century Farm Families, 2022 Marks 35th Year of Delaware Century Farm Program

Governor Carney, Deputy Secretary of Agriculture Nikko Brady, and state legislators honored four Delaware farm families for their commitment to keeping farmland within the family for 100 years.




century

Delaware Inducts Three Farm Families into Century Farm Program

Governor Carney, Secretary of Agriculture Scuse, and state legislators inducted three Delaware farm families into the Century Farm Program, honoring them for their commitment to keeping farmland within the family for 100 years. Delaware Secretary of Agriculture Michael T. Scuse also took the opportunity to announce a new program related to long-term ownership of family farms.




century

Jimmy Carter Turns 100 - 1st Ever US President To Reach Century Mark

Jimmy Carter celebrated his 100th birthday on Tuesday - the first ever US president to reach the century mark and another extraordinary milestone for the one-time peanut farmer who found his way to the White House.




century

The monkeys that science has experimented on for over a century

The monkeys that science has experimented on for over a century




century

Next 10,000 years of Greenland ice sheet could be decided this century

Carbon emissions within the next 50 years could lead to a tipping point where large parts of the Greenland ice sheet melt over the next 10,000 years




century

Meta AI tackles maths problems that stumped humans for over a century

A type of mathematical problem that was previously impossible to solve can now be successfully analysed with artificial intelligence




century

Waiver of Informed Consent - proposed changes in the 21st Century Cures Act

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21st Century Cures Act:


In another tweet, he suggests that the act will "decimate" informed consent in drug trials. Subsequent responses and retweets  did nothing to clarify the situation, and if anything tended to spread, rather than address, Feuerstein's confusion.

Below is a quick recap of the current regulatory context and a real-life example of where the new wording may be helpful. In short, though, I think it's safe to say:


  1. Waiving informed consent is not new; it's already permitted under current regs
  2. The standards for obtaining a waiver of consent are stringent
  3. They may, in fact, be too stringent in a small number of situations
  4. The act may, in fact, be helpful in those situations
  5. Feuerstein may, in fact, need to chill out a little bit


(For the purposes of this discussion, I’m talking about drug trials, but I believe the device trial situation is parallel.)

Section 505(i) - the section this act proposes to amend - instructs the Secretary of Health and Human Services to propagate rules regarding clinical research. Subsection 4 addresses informed consent:

…the manufacturer, or the sponsor of the investigation, require[e] that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings.

[emphasis  mine]

Note that this section already recognizes situations where informed consent may be waived for practical or ethical reasons.

These rules were in fact promulgated under 45 CFR part 46, section 116. The relevant bit – as far as this conversation goes – regards circumstances under which informed consent might be fully or partially waived. Specifically, there are 4 criteria, all of which need to be met:

 (1) The research involves no more than minimal risk to the subjects;
 (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
 (3) The research could not practicably be carried out without the waiver or alteration; and
 (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In practice, this is an especially difficult set of criteria to meet for most studies. Criterion (1) rules out most “conventional” clinical trials, because the hallmarks of those trials (use of an investigational medicine, randomization of treatment, blinding of treatment allocation) are all deemed to be more than “minimal risk”. That leaves observational studies – but even many of these cannot clear the bar of criterion (3).

That word “practicably” is a doozy.

Here’s an all-too-real example from recent personal experience. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure. It seems – but there is little hard data – that a lot of physicians do not strictly follow guidelines on when to perform the procedure. So we devise a study: whenever the procedure is performed, we ask the physician to complete a quick form categorizing why they made their decision. We also ask him or her to transcribe a few pieces of data from the patient chart.

Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial.

It’s a minimal risk trial, definitely: the trial doesn’t dictate at all what the doctor should do, it just asks him or her to record what they did and why, and supply a bit of medical context for the decision. All told, we estimated 15 minutes of physician time to complete the form.

The IRB monitoring the trial, however, denied our request for a waiver of informed consent, since it was “practicable” (not easy, but possible) to obtain informed consent from the patient.  Informed consent – even with a slimmed-down form – was going to take a minimum of 30 minutes, so the length of the physician’s involvement tripled. In addition, many physicians opted out of the trial because they felt that the informed consent process added unnecessary anxiety and alarm for their patients, and provided no corresponding benefit.

The end result was not surprising: the budget for the trial more than doubled, and enrollment was far below expectations.

Which leads to two questions:

1.       Did the informed consent appreciably help a single patient in the trial? Very arguably, no. Consenting to being “in” the trial made zero difference in the patients’ care, added time to their stay in the clinic, and possibly added to their anxiety.
2.       Was less knowledge collected as a result? Absolutely, yes. The sponsor could have run two studies for the same cost. Instead, they ultimately reduced the power of the trial in order to cut losses.


Bottom line, it appears that the modifications proposed in the 21st Century Cures Act really only targets trials like the one in the example. The language clearly retains criteria 1 and 2 of the current HHS regs, which are the most important from a patient safety perspective, but cuts down the “practicability” requirement, potentially permitting high quality studies to be run with less time and cost.

Ultimately, it looks like a very small, but positive, change to the current rules.

The rest of the act appears to be a mash-up of some very good and some very bad (or at least not fully thought out) ideas. However, this clause should not be cause for alarm.





century

Два «Хищника» и продолжение «Чужого» в планах у 20th Century Studios

Сразу два «Хищника» выйдут в 2025 году, рассказал Стив Асбелл, глава студии 20th Century Studios. В планах у компании также продолжение фильма «Чужой: Ромул».

Один из «Хищников» — это фильм с подзаголовком «Пустоши» и Эль Фаннинг в главной роли, он выйдет 7 ноября 2025-го. Второй — пока секретный, его должны выпустить перед «Пустошами». Обе части снял Дэн Трахтенберг, режиссер «Добычи».

Над продолжением фильма «Чужой: Ромул» работает его режиссер Феде Альварес. Новое соглашение с ним пока не заключили, но у постановщика уже есть идея, каким должен быть сиквел.

Глава 20th Century Studios также не исключил, что в дальнейшем студия займется и новым «Чужим против Хищника».




century

Meta AI tackles maths problems that stumped humans for over a century

A type of mathematical problem that was previously impossible to solve can now be successfully analysed with artificial intelligence




century

Unveiling the Reality of 21st-Century Human Rights Practices

Utilizing an extensive quantitative dataset, researchers from the University of Rhode Island assessed medlinkhuman rights/medlink practices globally,




century

Australia Must Get to Grips with Asian Century - 12 Feb

If we continue to ignore the rising economic success of our Asian neighbours we will lose our place as a G20 economy by 2030.




century

Not Gautam Gambhir, Ex-Coach Ravi Shastri's Tip Helped Sanju Samson Score A Century In 1st T20 Vs South Africa

Sanju Samson's explosive performance in the opening T20I against South Africa led India to a 61-run victory at Kingsmead. His impressive innings of 107 runs from just 50 balls included seven fours and ten sixes. This remarkable feat set a new




century

US-India Ties Will Shape the 21st Century, Says Mike Waltz on Future Prospects

Mike Waltz emphasises the significance of US-India ties for the 21st century, stating it will determine a century of light or darkness.




century

Drink Your Way To A Century : 5 Expert-Approved Beverages For A Long Life!

Do you know every sip you take can be a step toward a longer, healthier life? It's amazing how the right beverages can not only quench your thirst but also boost your lifespan. From antioxidant-packed teas to revitalising smoothies, these drinks




century

Worlding the south : Nineteenth-century literary culture and the southern settler colonies [Electronic book] / ed. by Sarah Comyn, Porscha Fermanis.

Manchester : Manchester University Press, [2021]




century

Working against the grain re-imagining Black theology in the 21st century [Electronic book] / Anthony G. Reddie.

London : Routledge, 2014.




century

The Winds of History : Life in a Corner of Rural Africa since the 19th Century [Electronic book] / Andreas Zeman.

München ; Wien : De Gruyter Oldenbourg, [2023]




century

The West and the Word : Imagining, Formatting, and Ordering the American West in Nineteenth-Century Cultural Discourse [Electronic book] / Steffen Wöll.

München ; Wien : De Gruyter Oldenbourg, [2020]




century

States and statistics in the nineteenth century : Europe by numbers [Electronic book] / Nico Randeraad.

Manchester : Manchester University Press, [2020]




century

Seventeenth-century libraries : problems and perspectives [Electronic book] / edited by Robyn Adams, Jacqueline Glomski.

Leiden ; Boston : Brill, [2023]




century

Progress and pathology : Medicine and culture in the nineteenth century [Electronic book] / ed. by Sally Shuttleworth, Melissa Dickson, Emilie Taylor-Brown.

Manchester : Manchester University Press, [2020]




century

Population, providence and empire : The churches and emigration from nineteenth-century Ireland [Electronic book] / Sarah Roddy.

Manchester : Manchester University Press, [2019]




century

Phrenitis and the Pathology of the Mind in Western Medical Thought : (Fifth Century BCE to Twentieth Century CE) [Electronic book] / Chiara Thumiger.

Cambridge : Cambridge University Press, 2023.




century

Noblewomen, aristocracy and power in the twelfth-century Anglo-Norman realm [Electronic book] / Susan M. Johns.

Manchester : Manchester University Press, [2018]




century

Muslim women of the Fergana Valley : a 19th-century ethnography from Central Asia [Electronic book] / Vladimir Nalivkin and Maria Nalivkina ; edited by Marianne Kamp ; translated by Mariana Markova and Marianne Kamp.

Bloomington, Indiana : Indiana University Press, [2016]




century

Humanitarian intervention in the long nineteenth century : Setting the precedent [Electronic book] / Alexis Heraclides, Ada Dialla.

Manchester : Manchester University Press, [2017]




century

A global clan : Scottish migrant networks and identities since the eighteenth century [Electronic book] / edited by Angela McCarthy.

London ; New York : Tauris Academic Studies, 2006.




century

Gender, law and economic well-being in Europe from the fifteenth to the nineteenth century : North versus South? [Electronic book] / edited by Anna Bellavitis and Beatrice Zucca Micheletto.

London ; New York : Routledge, Taylor and Francis Group, 2019.




century

Fathers, Pastors and Kings : Visions of episcopacy in seventeenth-century France [Electronic book] / Alison Forrestal.

Manchester : Manchester University Press, [2010]




century

Engine of modernity : The omnibus and urban culture in nineteenth-century Paris [Electronic book] / Masha Belenky.

Manchester : Manchester University Press, [2020]




century

A culture of curiosity : Science in the eighteenth-century home [Electronic book] / Leonie Hannan.

Manchester : Manchester University Press, 2023.




century

The Cambridge companion to the twentieth-century American novel and politics [Electronic book] / edited by Bryan Santin.

Cambridge ; New York, NY : Cambridge University Press, 2023.




century

Balancing the self : Medicine, politics and the regulation of health in the twentieth century [Electronic book] / ed. by Mark Jackson, Martin D. Moore.

Manchester : Manchester University Press, [2020]




century

Paris Olympics: Yves du Manoir — living over a century

It predated hockey’s Games debut and after 100 years, it will incidentally host the same sport; Harmanpreet sees this as motivation and wants to make it all the more memorable by winning gold




century

Magnetic Fields: Vibing to electronic music in a 17th century palace

A 200-km drive from Jaipur, Alsisar Mahal hosted a three-day music festival after two years in December



  • Life & Style

century

The refugee advantage [electronic resource] : English-language attainment in the early twentieth century / Ran Abramitzky, Leah Platt Boustan, Peter Catron, Dylan Connor, Rob Voigt

Cambridge, MA. : National Bureau of Economic Research, 2023




century

How engaged is the 21st century workplace?

A culture of merit, a flexible environment and empowering technology are key to engaging the workforce of today




century

Anthology of Japanese literature from the earliest era to the mid-nineteenth century / compiled and edited by Donald Keene.

New York : Grove Press, 1960.




century

Proletarian nights : the workers' dream in nineteenth-century France / Jacques Rancière ; translated from the French by John Drury ; with an introduction by Donald Reid.

London ; New York : Verso Books, 2012.




century

Ananth Tech hits a century of a different kind

EOS-8 turns 100th satellite that incorporated Ananth Tech components




century

Regards sur le réel : documentaires belges du 20e siècle = Belgische documentaires uit de 20ste eeuw = Belgian documentaries from the 20th century (1963-2000) / written and directed by Edmond Bernhard [DVD].

[Belgium] : Cinémathèque royale de Belgique, [2015]