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.

Institute of Medicine worries that public trust is threatened by deaths

April 4, 2002. Boston Globe. Institute of Medicine worries that public trust is threatened by deaths. By Michael Kranish and Alice Dembner. The IOM report did not satisfy some longtime observers. ”The IOM committee, headed by a Harvard University dean, disingenuously recommended entrusting `the responsibility for ensuring that protective rules…

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…

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MAD IN AMERICA – important new book

January 7, 2002 FYI MAD IN AMERICA (Perseus Press), a new book by Robert Whitaker, a prize winning science journalist, is sure to cause a stir. Whitaker holds psychiatry’s feet to the fire by examining the evidence in the professional psychiatric literature, FDA documents, published treatment outcome studies–including the World…

FDA: Regulatory Protections for Children

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.

Testimony Re: Research Involving Children

Submitted to the Office of Human Research Protection
by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc.

AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of prescribing untested drugs for children, as is currently the operational system, or conducting meaningful trials to determine both safety and effectiveness.

Boston Globe series by Alice Dembner documents harm to children in clinical trials

Feb-March, 2001. Boston Globe series by Alice Dembner documents harm to children in clinical trials DANGEROUS DOSAGE Published on February 18, 2001. Author(s): Alice Dembner, Globe Staff TESTING CHILDREN’S DRUGS Published on March 18, 2001. TEDDY BEARS AND VEILED THREATS Published on March 20, 2001. Author(s): Alice Dembner, Globe Staff…

Harvard-affiliated gene studies in China face federal inquiry

Harvard-affiliated gene studies in China face federal inquiry – Boston Globe. August 1, 2000. Harvard-affiliated gene studies in China face federal inquiry, by Deborah Nelson. Genetic research in China is booming. The biotech industry, in collaboration with scientists from America’s elite research centers & the U.S. government, is looking at…