The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments

The Cures Act was passed in the tail end of 2016. Today I focus on Section 3023, 2024 regarding Informed Consent and why you should care. No longer is the Gold Standard of “Informed Consent” required if there are “no more of minimal risks to participants.” And who decides this? Yesterday I posted Trump hogties the EPA, will he stop their illegal human medical experiments? This is why you should care. But let me not get ahead of myself. I include a video.

A year and a half after the original bill left the House of Representatives, the much-discussed and highly anticipated 21st Century Cures Act became law on December 13, 2016. The legislation went through more than a few changes in those seventeen months; it expanded from four sections to twenty-five and from 362 pages to 966. Informed Consent Waiver or Alteration for Clinical Investigations

The Cures Act introduces the possibility of waiving or altering informed consent for some FDA-governed research. This decision could mark a major step in the required harmonization of regulations; the rules around waivers of informed consent are some of the significant differences between FDA and Common Rule requirements.

The law sets two requirements for waiving or altering informed consent:

  1. The research must pose no more than minimal risk to participants; and
  2. Other measures to protect study volunteers must be in place.

The bill does not specify who will confirm decisions about minimal risk or appropriate safeguards, but the requirements seem consistent with determinations that IRBs already make. From Quorum Review

From Science Blogs:

Worse, the bill undermines informed consent, as I discussed before. The provision is still there that would add another category of research for which it is acceptable to forego informed consent. Normally, it is only acceptable to skip informed consent when it is not feasible or it is contrary to the best interests of the subject. Add to that now that it would be acceptable to forego informed consent when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.” As Merrill Goozner put it and I agreed, even if the risk is minimal, why would the authors of this legislation waive a central tenet of international agreements designed to protect the rights of human subjects in clinical trials? I didn’t understand either (and still don’t), particularly since the act doesn’t define “minimal risk” or specify who determines whether a study is minimal risk.

In 24 States, 50 percent or more of babies are born on Medicaid

(CNSNews.com) – In 24 of the nation’s 50 states at least half of the babies born during the latest year on record had their births paid for by Medicaid, according to the Kaiser Family Foundation.

New Mexico led all states with 72 percent of the babies born there in 2015 having their births covered by Medicaid.

Arkansas ranked second with 67 percent; Louisiana ranked third with 65 percent; and three states—Mississippi, Nevada and Wisconsin—tied for fourth place with 64 percent of babies born there covered by Medicaid.

New Hampshire earned the distinction of having the smallest percentage of babies born on Medicaid. In that state, Medicaid paid for the births of only 27 percent of the babies born in 2015.

Virginia and Utah tied for the next to last position, with 31 percent of the babies born on Medicaid.

More at CNS

Planned Parenthood latest lie debunked – ‘We don’t provide prenatal care’

The most egregious fact is that Planned Parenthood is nothing but a money-making machine including selling baby parts. They kill babies. The mammogram lie that they provide mammograms has been debunked. Now the prenatal care myth goes the same way. Yet the CEO Richards continues her lies, even to congress.

Planned Parenthood CEO Cecile Richards likes to boast that her organization offers necessary prenatal care for women. Supporters of Planned Parenthood and Democrat politicians do the same — but surprise! — it’s just a myth. A video from Live Action shows Planned Parenthood clinics across the country telling callers they “don’t offer prenatal care.” One operator even says, “We specialize in abortions.” Callers are told over and over again that Planned Parenthood has no prenatal care or doctors, but they are reassured that if you need an abortion, you’ve come to the right place. Unbelievable:

Read more at: National Review

Planned Parenthood Richards caught in lies regarding Mammograms

October 1, 2015 — bunkerville

Stories that may be of interest done:

Clinton pays Planned Parenthood campaign funds to ‘get out the vote’  March 2016

Planned Parenthood paid millions in Medicaid fraud settlements  

 

Columbia University students support female genital mutilation

We discover how misinformed the Liberal bulwark of our elitist institutions are.The next generation of Progressives being groomed at our colleges are clueless or are willing to sacrifice the individual sexual pleasure of women on the altar of political correctness. They have no idea that this is a Muslim practice? Apparently not. They think Planned Parenthood should support this practice as well. Add this fact that the American Academy of Pediatrics supported a version of this practice by Pediatricians until there was such an outcry about it.

The human rights advocacy group the American Freedom Defense Initiative (AFDI) unveiled an alarming new video, filmed at Columbia University, showing that at Columbia University, an Ivy League school and one of the nation’s foremost centers of higher learning, most students are willing to condone female genital mutilation.

Out of the 20 students who were asked about the procedure, only one student rejected the idea of the organization performing the procedure. The rest of the students expressed support for the hypothetical idea, with one going so far as to emphasize that he supported the idea regardless of the female’s age.

EQUALITY NOW CALLS ON American Academy of Pediatrics TO REVOKE ELEMENTS OF ITS 2010 POLICY STATEMENT THAT ENDORSES PEDIATRICIANS’ “NICKING” OF GIRLS’ GENITALIA

NEW YORK, May 5 /PRNewswire-USNewswire/ — International human rights organization Equality Now is stunned by a new policy statement issued by the American Academy of Pediatrics (AAP), which essentially promotes female genital mutilation (FGM) and advocates for “federal and state laws [to] enable pediatricians to reach out to families by offering a ‘ritual nick’,” such as pricking or minor incisions of girls’ clitorises. The Policy Statement “Ritual Genital Cutting of Female Minors“, issued by the AAP on April 26, 2010, is a significant set-back to the Academy’s own prior statements on the issue of FGM and is antithetical to decades of noteworthy advancement across Africa and around the world in combating this human rights violation against women and girls. PR Newswire and Big Gornment for more information.

AMERICAN ACADEMY OF PEDIATRICS WITHDRAWS
POLICY STATEMENT ON FEMALE GENITAL CUTTING

More Fake News: Refugee TB cases three times greater than media reported

Why this story today? More for the point that we have been getting more fake news than we could possibly imagine. And this one could impact our health. We find out now that many States are not reporting or have under reported the number of TB cases in each State. Keep in mind, the TB of today is not your Grandparents TB. Many cases are extremely difficult to treat and have morphed into a virulent form. So put this one down as “Now you know.” Meanwhile, Obama rushes more refugees down our gullet before he departs.

Between 2012 and 2015, 1,565 refugees were diagnosed with active tuberculosis (TB) tbin the United States, according to annual reports published by the Centers for Disease Control (CDC).

The CDC data, which has been public but obscure until now, shows that the number of refugees diagnosed with active TB in recent years is more than three times greater than previously reported by any media outlet.

Example:

Georgia, for instance, is the most surprising untold story. During the four years between 2012 and 2015, 96 cases of active TB were diagnosed among refugees in the Peach State. On a per capita basis, Georgia has one of the highest instances of refugee TB of any state in the country. Yet nowhere has this important story been reported.

The number of refugees diagnosed with TB in the United States has increased every year since 2012, the first year the CDC began publishing data on foreign-born cases of the disease by category, when 358 were diagnosed. In 2013, 396 refugees were diagnosed with TB. The following year, 2014, 402 refugees were diagnosed with TB, and in 2015, the number of refugees diagnosed with TB rose again to 409. Data for 2016 has not yet been reported.

More at Breitbart for the full impact of this under and none reported story.

Spraying of chemical Naled comes to Miami, banned in 22 countries

The vision of crop dusters (actually helicopters) dive bombing Miami beach as tourists stretch out on the sand isn’t a pleasant one. Add that it is with a chemical Naled that has been banned in 22 countries in the European Union. But not to worry, the CDC, and the Surgeon General says it’s just fine. I would think if we can be mandated to “shelter in place” with a bit of police activity, this might be the time to mandate staying inside to reduce exposure and to make sure people are aware of the spraying at the least. As someone who lives part-time in Florida, I find it remarkable that we are and have been sprayed continuously without warning prior to any Zika virus, and everyone seemed to find it acceptable. Apparently now that spraying has come to Miami, a city, a question has been raised.

MIAMI BEACH (CBSMiami) — Dozens of protesters lined up in front of Miami Beach city hall as local leaders talked about a chemical causing debate in the Zika fight – Naled.

“This chemical was run out of Puerto Rico. It’s been banned in 22 European Unions and it’s the wrong message to be sent especially when you’re dealing with tourism here in Miami,” said business owner Chad Allison.

Mosquito control crews were set to spray Naled over Miami Beach, just like they did in Wynwood, starting Thursday but growing concerns from residents and local leaders prompted a delay.

“It came from the strong recommendation, from what we’ve been told, by the CDC, as well as the surgeon general, the Department of Agriculture and that decision, truly is solely made by the governor of the state of Florida,” said Levine on Tuesday.

Levine said he learned from the state on Tuesday through a news release that Florida Governor Rick Scott was mandating the spraying of Naled on the beach using its helicopters and its contractors – a decision that Mayor Gimenez is also supporting.

More with video at Miami CBS

Medical marijuana users now banned from owning or buying guns court rules

They are coming full bore at us in attempting to limit our Second Amendment rights. The wacko 9th Circuit has a new approach. I would ask them to explain the difference between alcohol and marijuana in making this determination. I wonder who is going to round up those who already have a gun?

If you have a medical marijuana card, the 9th U.S. Circuit Court of Appeals has ruled that you can’t buy a gun.

Earlier this week the U.S. Circuit Court of Appeals ruled that medical marijuana card holders do not have a 2nd amendment right to buy or own a firearm. The ruling applies to the nine Western states that fall under the court’s jurisdiction, including California, Washington, Oregon, Arizona, Nevada, and Alaska.

On Wednesday, in a 3-0 decision, the 9th Circuit agreed that Congress had reasonably concluded that marijuana and other drug use “raises the risk of irrational or unpredictable behavior with which gun use should not be associated.” The court’s ruling applied to nine Western states within the appeals court’s jurisdiction, including six that have legalized marijuana for medical or recreational purposes: California, Washington, Oregon, Arizona, Nevada, and Alaska.

Rainey plans to appeal the decision saying,  “We live in a world where having a medical marijuana card is enough to say you don’t get a gun, but if you’re on the no-fly list your constitutional right is still protected.” … “We are going to litigate this, exhaust whatever remedies we have,” Rainey said. “When this (ATF) letter was issued, it was issued as part of a deliberate attempt by the (U.S. Department of Justice) to quell a political movement.” More at Off Grid Survival

This earlier post might be of interest:

Will taking an anxiety pill let Obama take your guns?

%d bloggers like this: