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FDA: Regulatory Protections for Children
Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP
To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration, Dockets Management Branch (HFA-305) Food and Drug Administration
Re: COMMENT ON: Docket #00N-0074 April 24, 2001 Interim Rule: "Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products
Excerpt: The FDA rightly chose not to permit the section 46.408 (c) waiver by IRBs of parental or guardian permission, as it leaves the specific circumstances for such a violation of parental rights to the discretion of local Institutional Review Boards (IRB). Given the stream of revelations of gross ethical and procedural violations at one after another of the nation’s premier research institutions, assumptions that “procedural safeguards are in place,” or that IRBs can be relied upon to make decisions that protect the best interests of human subjects – adults and children – has been debunked.
Children are Humans: Don’t Sacrifice their Rights, Dignity & Welfare
We are writing about the Pediatric Research Equity Act of 2003 (S 650). We are in full agreement that children should have the same safeguards as adults; that medications used in children be thoroughly tested for safety, effectiveness and appropriate dose. However, S 650 does not do this. Instead, it requires that children be used to test all drugs as a condition of licensure by FDA – unless a waiver is obtained from the Secretary of the department of Health and Human Services under section 505B.
AHRP Testimony: Protections for Foster Children Enrolled in Clinical Trials Submitted to Cong.Ways & Means Hearing
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) https://ahrp.org 142 West End Ave. Suite 28P New York, NY 10023 Testimony by The Alliance for Human Research Protection Committee on Ways and Means Hearing on Protections for Foster Children Enrolled in Clinical Trials May 18, 2005 On March 10, 2004, The ALLIANCE…
AHRP Speaks Out | Bias/Fraud | Business of Medicine | Concealed Data | Corporate-Corrupted Medicine | Corrupt Practices | Corrupt Public Health | Corrupted Science | Covid Pandemic | Current Controversies | Current Medical Atrocities | Global Public Health Institutions | Medical Research Ethics | Medical Safety Issues | Newsflash | Pharma Corrupt Influence | Unethical Experiments | Vaccine Controversies | Vaccine mandates | Vaccine RisksEndonuclease Fingerprint Indicates a Synthetic Origin of SARS-CoV-2
Endonuclease Fingerprint Indicates a Synthetic Origin of SARS-CoV-2 SARS-CoV-2 is the virus that caused the disease COVID-19. A detailed analysis of the evidence regarding the origin of the virus by a team of US and German forensic scientists led them to conclude that: “Both the restriction site fingerprint and the…
AHRP Speaks Out | Presentations by AHRP/Board Members | Presentations of Interest | Vera Sharav, AHRP Board MemberTo Obey or Not Obey with Holocaust Survivor Vera Sharav
Vera Sharav is a Holocaust survivor and founder of the Alliance for Human Research Protection. She’s spent decades advocating for ethical medical standards and individual rights. Known for her outspoken views on public health, Vera has been deemed controversial for comparing the Holocaust with the global response to the COVID-19…
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Action Alliance, a group of German activists hosted, “75 Years of the Nuremberg Code — Never Again Forced Medical Procedures,” a public conference on August 20th in Nuremberg, Germany, commemorating the 75th anniversary of the Nuremberg Code. 75th Anniversary of Nuremberg Code Event — Watch CHD.TV Livestream Aug. 20 https://live.childrenshealthdefense.org/nuremberg-75-chd-tv-exclusive-interviews…
