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NIH Rule change Re: Whistle blowers – Comments due before June 15
A request for comment about NIH proposed new research misconduct rule
See Fed Register:
http://ori.dhhs.gov/multimedia/acrobat/42CFRParts50and93.pdfThe new rule, I believe is meant to protect research institutions from the effective sting of a knowledgeable whistle blower.
The new rule would redefine whistle-blower as “complainant” and would limit the role of the complainant. Under the old rule, the whistle-blower participated in the process helping investigators by leading them to the evidence, etc.
- AHRP Speaks Out | Board of Directors | Business of Medicine | Corporate-Corrupted Medicine | Corrupt Practices | Corrupt Public Health | Investigations | Lawsuits | Miscellaneous | Newsflash
The Stench of Politics is Endangering Lives by Corroding the Practice of Medicine
Political Influence is Corroding the Practice of Medicine – Thereby Endangering Lives On October 11th, the public had an opportunity to bear witness to a hearing at which Dr. Meryl Nass had the opportunity to confront the medical collaborators who participated in a lynching. Honest doctors who prescribe medicines that…
Who is a Human Subject? Who has the Right to Informed Consent?
"The voluntary consent of the human subject is absolutely essential."
[Nuremberg Code, 1947]"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [ Code of Federal Regulations 45 CFR 46.102 (f)]
On October 30, 2001, the National Human Research Protection Advisory Committee (NHRPAC) signed off on recommendations redefining the term "human subject" in an effort to accommodate research that invades people’s privacy by declaring that "human subjects" are only those "who interact personally with research investigators."
Press Statement – FDA & Concealment of Suicide-Related Risks of Antidepressants
We are witnessing the unraveling of a system that was intended to ensure that marketed drugs met high safety standards; that physicians were informed about potential, serious adverse drug effects – so that they would prescribe judiciously; and that the integrity of the scientific literature was preserved. But that system has been hijacked by the drug industry – which has infected medical practice and medical research with detail men and informercials that make false claims while manipulating partial data to conceal adverse drug effects.
- AHRP Speaks Out | Current Controversies | Miscellaneous | Newsflash | Vera Sharav, AHRP Board Member
Time to Support Vera Sharav… The Unthinkable happened at Nuremberg – Again! By Senta Depuydt
Nuremberg has been the site of a serious issue this past week. Keeping the Nuremberg Protocol Safe and Sacred: Vera Sharav is Attacked for Bringing Attention to the Very Reason for the CODE! Please do not hesitate to share this information; abuse of this nature must not be tolerated….
AHRP Replies to OHRP Response re Surrogate Consent (ARDS Study)
Thank you for your considered response to our July 29 letter to the director of the Office of Human Research Protection.
We are astonished to learn that OHRP found that all 12 major research institutions involved in this multi-site trial had violated Federal protections (45 CFR 46.117):
(a) "in all cases OHRP found that the informed consent documents approved by the institutional review boards (IRBs) for the research failed to describe adequately the reasonably foreseeable risks and discomforts of the research."