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.

Sunday Respite: Monsoon’s Dance

For those of us who could use some time out with all the news going on, this once should do it. Some beautiful photography as well. Have a wonderful day. Karunesh Monsoon’s Dance.

Sunday Respite: Never Ending Love

This probably will be my last “Winter” themed Sunday respite. Spring sure is in the air, but Winter is not done with us yet. I chose Yakuro’s “Never Ending Love” for today’s respite. Have a wonderful day. I suggest watching the video in full screem.

Pope Francis: ‘Muslim Terrorism Does Not Exist’

Put this down as my religion post for the week. First we have  “NY Catholic Church Holding Lessons To Promote Islam As A Religion Of Peace” via WXXI,  then we have Pope Francis not letting up. He hits the big ones, denying Islamic terrorism, and of course the so-called “ecological crisis” of Global Warming. First NY:

Kelly said he has held two of these sessions previously at other churches and was met with a positive response.

“We had about 80 people in each of the parishes participate. And it was very exciting because people were reticent or not willing to ask questions very much but by the end I think people felt much more comfortable.”

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In an impassioned address Friday, Pope Francis denied the existence of Islamic terrorism, while simultaneously asserting that “the ecological crisis is real.”

“Christian terrorism does not exist, Jewish terrorism does not exist, and Muslim terrorism does not exist. They do not exist,” Francis said in his speech to a world meeting of populist movements.

What he apparently meant is that not all Christians are terrorists and not all Muslims are terrorists—a fact evident to all—yet his words also seemed to suggest that no specifically Islamic form of terrorism exists in the world, an assertion that stands in stark contradiction to established fact.

“No people is criminal or drug-trafficking or violent,” Francis said, while also suggesting—as he has on other occasions—that terrorism is primarily a result of economic inequalities rather than religious beliefs. “The poor and the poorer peoples are accused of violence yet, without equal opportunities, the different forms of aggression and conflict will find a fertile terrain for growth and will eventually explode.”

The Pope also reiterated his conviction that all religions promote peace and that the danger of violent radicalization exists equally in all religions. (Ed comment: I don’t recall Jesus telling us to slay our adversaries)

“There are fundamentalist and violent individuals in all peoples and religions—and with intolerant generalizations they become stronger because they feed on hate and xenophobia,” he said.

While denying the existence of Islamic terrorism, Francis also seemed to condemn the denial of global warming, asserting that “the ecological crisis is real.”

“A very solid scientific consensus indicates that we are presently witnessing a disturbing warming of the climatic system,” he said.

We know “what happens when we deny science and disregard the voice of Nature,” the Pope said. “Let us not fall into denial. Time is running out. Let us act. I ask you again—all of you, people of all backgrounds including native people, pastors, political leaders—to defend Creation.”

Keep reading…

Meet ‘Sensitivity Readers’ looking for thought crimes prior to publication

So many are disturbed about the coming fascist State brought about by the election of Trump. Yet it is the Progressives who have integrated themselves and their purity of thought into the job description of a “sensitivity reader.” So meet the new propagandists who will ensure every word written conforms to the dictates of the Progressives. Here from Moonbattery:

…Censors who study manuscripts for thought crimes so that books can be revised or rejected prior to publication are called “sensitivity readers.” The Chicago Tribune approvingly defines a sensitivity reader as “a person who, for a nominal fee, will scan the book for racist, sexist or otherwise offensive content.”

“The industry recognizes this is a real concern,” said Cheryl Klein, a children’s and young adult book editor and author of “The Magic Words: Writing Great Books for Children and Young Adults.” Klein, who works at the publisher Lee & Low, said that she has seen the casual use of specialized readers for many years but that the process has become more standardized and more of a priority, especially in books for young readers.

Rigid control of what young people read is a higher priority, because their opinions are more malleable, still being in the process of forming.

Sensitivity readers have emerged in a climate – fueled in part by social media – in which writers are under increased scrutiny for their portrayals of people from marginalized [i.e., politically favored] groups, especially when the author is not a part of that group.

If you portray characters in any light that could possibly be construed as reflecting negatively on a politically preferred group like blacks, you are a racist thought criminal; good luck getting published. Avoiding this problem by ignoring blacks is exclusionary and therefore also racist. The only course of action that is not racist is to crowd your work with cartoonishly correct black characters who have been explicitly approved by the thought police. If you do that you are not racist; you are a cultural expropriator. More at Moonbattery

‘Today, I am a Muslim too’ – Welcome to New York City

USA: ‘Today, I am a Muslim too’ – thousands of New Yorkers decry Trump’s travel ban so reads the headline.

The Arab call to prayer in the heart of New York City. One of the loudest spokesperson’s was Sarsour a woman to keep  our eye on. She was front and center with the Women’s March held recently. Anyone who doesn’t denounce her is questionable in my book. She is out there supporting Sharia law. Perhaps Planned Parenthood could include an educational program concerning what Sharia law entails for women while they are infiltrating our schools. Throw in Chelsea Clinton to the mix.

Muslims and Muslim sympathizers protested Donald Trump today in New York’s Times Square. Chelsea Clinton boasted about being there with her daughter, Charlotte. Hamas darling, Linda Sarsour was also there spreading hysteria and propaganda about President Donald Trump.

In Sarsour’s speech, she reminded people about the executive order that Democratic President FDR passed which put Japanese Americans in internment camps implying that Muslims and minorities could possibly suffer the same fate under a Trump presidency.

There was also a loud Arab call to prayer during this protest in NYC. In an Islamic call to prayer (adhan), the Muslim is shouting Allahu Akbar which translates to ‘God is greater’ or ‘God is greatest’. They mean that their ‘god’ is greater than your God and or the government. This is a blatant act of Islamic supremacy.

Gateway Pundit/

Sunday Respite – Ask the Mountains

I chose Vangelis “Ask the Mountains” for my respite. This is a stunner as far as a visual experience. I highly recommend watching this in full screen. You may need some Dramamine.

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