AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 2, 2002 Francis Fukuyama:Don’t Alter Human Nature FYI Human nature "is fundamental to our notions ofjustice, morality and the good life." In an interview in The New…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 25, 2002 Federal Agency Does Not Adequately Enforce Federal Standards of Ethics andSafety. FYI The Boston Globe takes a critical look at the federalOffice of Human…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 14, 2002 Whistle-Blower SaysMarketers Broke the Rules to Push a Drug (Neurontin) FYI The New York Times reports that court papers in a civillawsuit "may provide a…
AHRP Alliance for Human Research Protection AHRP Speaks Out Return to Home PageAHRP Speaks Out Press ReleasesOctober 29, 2001 FYI Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That…
Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That 6-to-1 landmark decision severely criticized the practice of exposing healthy children to risks of harm in health related research. Children, we must bear in mind, are powerless to exercise that inviolable human right, the right to refuse to assume risks for research.
Will this decision undermine the legitimacy of research that puts healthy children at risk in clinical trials? AHRP believes it will, and that the decision will be sustained by other courts in other states.
October 1, 2001 Following the August 16, 2001 landmark decision* of the Maryland Court of Appeals, the Alliance for Human Research Protection (AHRP) became interested in the case involving exposure of children to lead paint. We were particularly drawn to the Court’s clear and unambiguous recognition of the rights of…
Text of AHRP Amicus Brief filed with the Maryland Court of Appeals in support of the Court’s ruling against Kennedy Krieger Institute for exposing children to lead poison in an experiment. The Court of Appeals Decision Validates AHRP’s Stand Against Using Children in Harmful Research Experiments.
Following the August 16, 2001 landmark decision of the Maryland Court of Appeals, the Alliance for Human Research Protection (AHRP) became interested in the case involving exposure of children to lead paint. We were particularly drawn to the Court’s clear and unambiguous recognition of the rights of children and their families to appropriate safeguards in medical research settings.
http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf
Research Protection for Children AHRP Return to Home Page Research Protection for Children September 21, 2001Human values vs. $$$:Children at Risk in Research FYI A consortium of powerful research lobbyists led by Johns Hopkins University are demanding that the Maryland Court of Appeals modify its ruling in the University’s…
A landmark decision by Maryland’s highest court, the Court of Appeals of Maryland, is a victory for the human rights of children. The decision affirms the responsibility of parents, the government, researchers and institutional review boards (IRB) to protect children from non-therapeutic experiments that may put their health at risk.
AHRP Alliance for Human Research Protection AHRP Speaks Out Return to Home PageAHRP Speaks Out Press ReleasesAugust 17, 2001 Following the August 16, 2001 landmark decision* of the Maryland Court of Appeals, the Alliance for Human Research Protection (AHRP) became interested in the case involving exposure of children to…
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.
