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.

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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…

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.

InfoMail for April 29, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 29, 2002 China Daily: Harvard Project ViolatesFarmers’ Rights FYI American experiments on impoverished populations inunderdeveloped countries needs much more oversight than seems to have beenprovided. XIONG…

Protecting Human Subjects in Research: Are Current Safeguards Adequate?

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.

InfoMail for April 19, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 19, 2002 DHHS / FDA flip-flopsecond time re: " pediatric rule" FYI Tommy Thompson, Secretary of The Department of Health andHuman Services has reversed the FDA’s…

InfoMail for March 31, 2002

  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…

InfoMail for March 25, 2002

  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…

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."