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FDA: Regulatory Protections for Children |
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Monday, 06 August 2001 |
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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. |
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Dissenting Opinion: Against Waiving Parental Permission for Research |
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Wednesday, 25 July 2001 |
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To: Mary Faith Marshall,
Ph.D, Chairperson, National Human Research Protections Advisory Committee, Department of Health and Human Services
Re: Specific Comment on FDA's
Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c)
Dissenting opinion of Vera
Hassner Sharav, Founder and President, AHRP: Alliance for Human Research
Protection, member, Children's Workgroup of the National Human Research
Protections Advisory Committee, Department of Health and Human Services
(HHS)
This dissenting opinion reflects
the position of AHRP and was prepared in collaboration with Howard Fishman,
M.S. W., M.Ed, and John H. Noble, Jr., PhD, AHRP board members. |
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Testimony Re: Research Involving Children |
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Thursday, 05 April 2001 |
Submitted to the Office of Human Research Protection
by
Vera Hassner Sharav
and
Marie M. Cassidy, Ph.D, D.Sc.
AHRP recognizes
that to include children in clinical trials for any medication presents
a dilemma of truly Solomonic proportions. It is a choice between continuing
the practice of prescribing untested drugs for children, as is currently
the operational system, or conducting meaningful trials to determine both
safety and effectiveness. |
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Chemically Induced Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research |
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Wednesday, 02 February 2000 |
Congressional
Testimony submitted by Vera Sharav
Statement For the Record
Submitted to
The
U.S. Senate Sub-Committee: Public Health
& Safety
of the Senate Health, Education, Labor
& Pensions Committee Hearing
Our efforts helped bring to public attention
major medical ethics violations in Federally-funded research in which
uninformed, vulnerable American citizens are put at high risks without
justification. As a result, such individuals have often suffered severe
consequences - some have lost their lives unnecessarily. Based on the
evidence - including testimonies by families and patients - we
believe five factors contribute to unethical human experiments:
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Evidence of Neuroleptic Drug-Induced Brain Damage in Patients |
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Monday, 31 January 2000 |
A partial, Annotated Bibliography
by Vera Hassner Sharav
For distribution: January, 2000
Although patients, families and the public were not informed - some
would argue they were deceived - clinical psychiatrists and researchers
have long known about severe adverse drug reactions (ADR) and disabling
changes in the central nervous system in a high percentage of patients
taking standard neuroleptic drugs. |
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Testimonies and Presentations