OHRP | Alliance for Human Research Protection

AHRP Testimonies

Protecting Human Subjects in Research: Are Current Safeguards Adequate?
April 23, 2002November 21, 2014

Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.

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Miscellaneous

InfoMail for April 13, 2002
April 14, 2002November 21, 2014

AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 14, 2002Clinical Trials Given "At Your Own Risk" FYI TIME Magazine’s cover story, "At Your Own Risk,"(excerpts below) focuses on several high profile research scandals that…

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Miscellaneous

InfoMail for March 31, 2002
March 31, 2002November 21, 2014

AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 31, 2002 Harvard research jeopardizedthe welfare of disadvantaged Chinese people while violating federal regulations. FYI Sadly, Harvard joins the list of prestigious academicresearch institutions that have…

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Miscellaneous

InfoMail for March 25, 2002
March 25, 2002November 21, 2014

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…

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AHRP Speaks Out

Who is a Human Subject? Who has the Right to Informed Consent?
March 11, 2002November 21, 2014

"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."

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Unethical Experiments

The Prison as Laboratory_2002
January 10, 2002November 21, 2014

"The voluntary consent of the human subject is absolutely essential," reads the Nuremberg Code of 1947, which was drafted in direct response to the sheer barbarity of Nazi-era medical experiments on Jews and other captive groups.

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AHRP Testimonies | Scientism

AHRP Amicus Brief – Kennedy Krieger Institute
October 1, 2001March 5, 2025

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.

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AHRP Speaks Out

The Scientist News reports on AHRP as New Advocacy Group to Police Human Research
August 20, 2001November 20, 2014

A group of patient and social justice advocates plan to form an Alliance for Human Research Protection to provide oversight on clinical research from laypersons’ point of view, says John H. Noble Jr., a founder and professor of social justice at the Catholic University of America. He lambastes Internal Review Boards (IRBs) designed to protect human subjects as agents of institutions "who are hustling the bucks" from industry and other sources. Noble says IRBs need to be "severed from research institutions" and provided adequate resources as part of the accepted overhead costs of conducting clinical trials.

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AHRP Speaks Out

FDA: Regulatory Protections for Children
August 6, 2001November 21, 2014

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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Miscellaneous

Government Agency Caves in to Johns Hopkins pressure
July 21, 2001November 21, 2014

Government Agency Caves in to Johns Hopkins pressure July 21, 2001 In its July 19 letter to Johns Hopkins, the Office of Human Research Protection (OHRP) outlined serious violations beyond those in the experiment that killed a healthy volunteer. Those violations raised concerns about the safety of ALL human subjects…

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Miscellaneous

OHRP suspends Johns Hopkins Research license for Fed funded research
July 19, 2001November 21, 2014

OHRP suspends Johns Hopkins Research license for Fed funded research July 19, 2001 The death of Ellen Roche, a healthy young woman before she was killed in a fatal hexamethonium inhalation experiment at Johns Hopkins University, has opened Pandora’s box, demonstrating that the safety of human research subjects has had…

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Miscellaneous

Johns Hopkins Admits Fault in Fatal Experiment
July 17, 2001November 21, 2014

Johns Hopkins Admits Fault in Fatal Experiment July 17, 2001 The experiment that killed Ellen Roche, a healthy 24 year old volunteer–who was clearly not informed about the risks she was incurring by breathing hexamethonium–demonstrates that there are no protections that ordinary people can rely on, when they become research…

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