Letter Submitted to New England Journal of Medicine re ARDS Investigation

The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), involving critically-ill, mentally incapacitated human beings with acute respiratory distress syndrome (ARDS) – who did not give their informed consent.

The accompanying editorial, "Controlling Research Trials," by Dr. J.M. Drazen, who serves on the NHLBI advisory committee that had approved the disputed trial, reveals much about the NIH attitude toward the rest of the world.

AHRP Comments: DHHS COI Guidance for Human Subject Protection

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave. Suite 28P New York, NY 10023 April 4, 2003 Tommy Thompson, Secretary Department of Health and Human Services Dockets Management Branch (HFA–305), Docket Number 02N–0475, Food and Drug Administration, 5630 Fishers Lane, Room 1061 Rockville, MD 20852. Re: Docket…

References: Impact of FDA inclusion of children as test subjects

References for THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…

Infomail Archive Pre 2003

Infomail Archive – Pre 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav December 28, 2002: Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says “No immediate threat” December 24, 2002: Moral turpitude: Herpes experiment surpasses Tuskegee December 20,…

Article

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974             142 West End Ave Suite 28P                     FAX: 212-595-9086 New York, NY 10023 www.ahrp.org December 5, 2002 Mr. Edward Swindell Acting Associate General Counsel for Ethics Office of General Counsel, Ethics Division Department of Health and Human Services 200 Independence…

Article

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974               142 West End Ave Suite 28P               FAX: 212-595-9086 New York, NY 10023 www.ahrp.org December 5, 2002 Mr. Edward Swindell Acting Associate General Counsel for Ethics Office of General Counsel, Ethics Division Department of Health and Human Services 200 Independence Ave. SW…

AHRP Comments on Smallpox Vaccine Testing on Children 2 to 5 Years of Age

Recent public and professional debate about smallpox vaccine and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. Dryvax is a particularly impure product made of live vaccinia virus harvested from the pustules of calves infected with (it is believed) cowpox. Although the vaccine, which is scratched on the skin, only causes mild infections in most people, in a small but significant number the infection caused serious adverse reactions similar to the complications of the disease they were designed to prevent: painful, disfiguring skin disorders, blindness, neurological impairments and death.

Smallpox Vaccine plan: HHS Messengers Still Stumble

October 9, 2002 Smallpox Vaccine plan: HHS Messengers Still Stumble_NYT_WP The Administration’s shift in its smallpox vaccination policy is meeting with criticism from medical experts who are unconvinced that it is wise or justified to put millions of people at serious risk in (what amounts to) a massive human experiment–without…

Do the Ends Justify the Means in Human Research?

Do the Ends Justify the Means in Human Research? Thu, 5 Sep 2002 A moral struggle is taking place in which research stakeholders–including medical institutions that profit from biomedical research, and their emissaries in government oversight agencies–argue that ethics should be breached to further the interest of research. Patients’ rights…

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.

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…