FDA Warning Letter Re: Fatal Experiment: Hexamethonium Inhalation_Johns Hopkins Tue, 22 Apr 2003 An FDA Warning Letter was sent to Dr. Alkis Togias of the Johns Hopkins University Asthma & Allergy Center (March 31, 2003). The letter lists specific federal safety requirements and their violation in the hexamethonium inhalation experiment…
We are writing about the Pediatric Research Equity Act of 2003 (S 650). We are in full agreement that children should have the same safeguards as adults; that medications used in children be thoroughly tested for safety, effectiveness and appropriate dose. However, S 650 does not do this. Instead, it requires that children be used to test all drugs as a condition of licensure by FDA – unless a waiver is obtained from the Secretary of the department of Health and Human Services under section 505B.
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."
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) New York, NY 10023 212-595-8974 July 29, 2002 Greg Koski, MD, Ph.D. Office of the Secretary Office of Public Health and Science Office of Human Research Protection The Tower Building 1101 Wooten Parkway, Suite 200 Rockville, MD 20852 RELATED PAGES OHRP Investigation of…
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.
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.
