AHRP Press Release Children Policy Recommendations

AHRP Recommendations for the protection of children in clinical research

(1) Federal regulations are predicated on our moral responsibility to protect children – who are not volunteers – from being subjected to medical or behavioral experiments that are not in their best interest. Thus, federal regulations – 45 CFR 46 Sub-part D – restrict the use of children in medical experiments involving greater than minimal risk, if there is no potential medical benefit for them or their condition.

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."

“Precursors to Diabetes in Japanese American Youth”

Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01

The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry and 150 Caucasians. The experiment is not approvable under federal regulations, 45 CFR 46 Subpart D because it involves greater than minimal risk and no potential direct benefit to the children.

Media interviews Dr. Meryl Nass re: anthrax vaccine and anthrax attacks

Dr. Meryl Nass, a member of the board of directors of The Alliance for Human Research Protection (AHRP), is an acknowledged expert on anthrax, biological terrorism, and is a US authority on adverse reactions due to the anthrax vaccine. Dr. Nass has been a leading opponent of U.S. military policies that continue to treat military servicemembers as a ready pool of experimental subjects, in the absence of meaningful informed consent.

Dr. Nass will be appeaing on several national and international TV and radio programs:

Critique: U.S. to Vaccinate 500,000 Workers Against Smallpox

Dr. Meryl Nass

An estimated 500,000 first responders, lab and hospital workers will receive smallpox vaccine, the DHHS announced yesterday.

This is an interesting announcement, because to my knowledge there exist no FDA-licensed smallpox vaccines.

There are three vaccine candidates whose safety and efficacy are uncertain at this time.

The first vaccine made available was Wyeth’s Dryvax, which was pulled out of storage after approximately thirty years.

Memorandum in Opposition to California AB 2328

REASONS FOR OPPOSITION:

Researchers would not be required to first try approved treatments, if any exist, before entering the patient into a medical experiment that may be "risky."

Researchers would not be required to consult with an independent medical expert, a non-researcher who would consider the patient’s best medical interests as paramount.

Researchers would not be required to disclose their own professional and financial interests deriving from the experiment.

Researchers would not be required to fully disclose to the patient’s family what happened to other patients who had already participated in the experiment.

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."

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AHRP Press Release Re: Maryland Court of Appeals Decision

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…

Conflicts of Interest Undermine Safety for Human Subjects

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.

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AHRP endorsement of the Maryland Court of Appeals Decision

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…

Comments on AHRP Amicus Brief (Kennedy Krieger)

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

AHRP Comments on Landmark Decision by the Court of Appeals of Maryland

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.