“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.

Acute Respiratory Distress Syndrome – ARDSNet experiment criticized – OHRP

Acute Respiratory Distress Syndrome – ARDSNet experiment criticized – OHRP Fri, 28 Feb 2003 An Acute Respiratory Distress Syndrome (ARDS) study conducted between 1996 and 1999, on critically ill patients at 20 medical facilities (14 major research centers belonging to the ARDS Network), was published in The New England Journal…

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.

Article

Why did OHRP SHRED informed consent documents? Sat, 25 Oct 2003 China Daily’s premier medical correspondent, XIONG LEI, raises embarrassing questions that should trouble Americans, not just the bioethics and research community. She makes a plea for justice for some 200,000 Chinese farmers who were used in 12 genetic experiments…

Harvard research in China: Open Letter to Pres. Summers

Harvard research in China: Open Letter to Pres. Summers Sat, 12 Apr 2003 On May 15, 2002, The Boston Globe reported that Lawrence Summers, the President of Harvard University, “expressed deep regret that a dozen Harvard-run genetic studies in China failed to give test subjects adequate information about potential pitfalls.”…

Dissenting Opinion – Proposed Children’s Workgroup Reinterpretation of Fed Regs 45 CFR 46 sects. 404 & 406

Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406) May 14, 2002 To: Alan Fleischman, MD, Chair, Children’s Workgroup of NARPAC        Mary Faith Marshall, Ph.D., Chair, NARPAC From: Vera Hassner Sharav Re: Dissenting Opinion re: Report to NHRPAC, proposing…

InfoMail for May 13, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav May 13, 2002 Experimentationon Newborns: Is it Ethical? FYI The Wall Street Journal reported: "Oneoutrage now before a court has stunned even bioethicists who thought they’d seenit…

Conflicts of Interest in Clinical Trials

Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine

The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people – those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.

Sharav Presentation before US Army Medical Dept., May 6, 2002

CONFLICTS OF INTEREST Presented by Vera Hassner Sharav 14th TRI-SERVICE CLINICAL INVESTIGATION SYMPOSIUM Sponsored By THE U.S. ARMY MEDICAL DEPARTMENT And THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCMENT OF MILITARY MEDICINE May 5-7, 2002 The cornerstone of public trust in medical research is the integrity of academic institutions and…