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Letter from the Bioethic comission regarding the meetings that took place some months ago..,,

Views: 55

Comment by Jay Sinn on July 30, 2011 at 9:02am
That testimony might have just changed the offical rules regarding HSR and clinical trials:
"Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators"
A Proposed Rule by the Food and Drug Administration on 07/26/2011
"
Summary

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects."
http://www.federalregister.gov/articles/2011/07/26/2011-18792/human...

And that just might stand to level the playing field for the subjects.
Comment by Miss Sickofit on July 31, 2011 at 9:11am
This country is a nightmare. That is the most depressing letter Ive ever read, and its REMOTE influencing, not REMOVE. PsychotroMic?--- its psychotronic!!!! Seriously, is this a joke?These people work for a presidential organization and they cant proofread? Why not just send us a text saying "Sry we r not helping u, peace out!"  What was the point of them having a meeting with victims then? I have no idea.  Seemed hopeful at the time.
Comment by Miss Sickofit on August 1, 2011 at 7:22am
Quote by Hitler:"How fortunate for governments that the people they administer don't think"
Comment by franko on August 1, 2011 at 8:05am

Ethics commission is run by the government, Obama is in on everything thats means hes a terorrist and owes each  T.I  20 million dollars.  Spread the word guys the world will know who the real terorrists are.

I have huge story  and the whole world will know Cops and FBI are gangstalking, cointelpro terorrists. They are torturing thousands of citzens, these people are all nasty terorrists criminals.

Comment by Jay Sinn on August 1, 2011 at 9:52am
from one of the transcripts:
"I don't deny that there are certain fundamental things one can read and learn. One takes drivers test, one has to learn what a left hand signal is and what a right hand signal is. But there is something off when people see the entire process, not as something they feel proud about, but as something they experience as, in a way mortifyingly stupid, and stupefying -- that is what it is, stupefying. "
http://bioethics.gov/cms/node/229

Not everyone in the med/psych/pharmacological industry is "out to get us". The Common Rule might just be revised...in our favor.
Comment by Jay Sinn on August 1, 2011 at 10:00am
This is what I mean:
http://www.federalregister.gov/articles/2011/07/26/2011-18792/human...

The problem with Human Subjects Research has always been the open interpritation of ethics as opposed to hard line law/regulation.
Comment by KELP on August 1, 2011 at 12:02pm

At least Sebelius and Friends realize the CIA needs to be told.....if we could only count on the CIA to honest about their research and not fudge their documentation in order to avoid an IRB in the future.

"In addition, the Central Intelligence Agency must comply with all subparts of 45 CFR part 46 under Executive Order 12333, and in accordance with the Intelligence Reform and Terrorism Protection Act of 2004 (Pub. L. 108-458, Section 8306), the Department of Homeland Security adopted policies implementing the protections for human research subjects under 45 CFR part 46 for research it conducts or supports."

 

http://www.federalregister.gov/articles/2011/07/26/2011-18792/human...

protections-enhancing-protections-for-research-subjects-and-reducing-burden#p-253

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