Jonathan M. Fishbein, M.D.
7945 Turncrest Drive
Potomac, Maryland 20854
May 9, 2005
The Honorable Daniel R. Levinson
Inspector General
U.S. Department of Health and Human Services
330 Independence Avenue, S.W.
Washington, D.C. 20201
Re: Allegations of Waste, Fraud and Abuse in the Use of Foster Children in Government-Sponsored AIDS Clinical Trials
Dear Mr. Levinson:
I am writing you in fulfillment of my obligation as a federal employee of the National Institutes of Health to report possible waste and fraud under Executive Order 12674 and 12731, and NIH Policy Manual, Section 1754(C)(1)(a),(b) and (c). Currently I am the Director of the Office of Policy in Clinical Research Operations (OPCRO) in the Division of AIDS of the National Institute of Allergy and Infectious Diseases (NIAID).
On Wednesday, May 4th, the Associated Press (AP) reported:
Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states.
The basic protection denied these foster children was the appointment of an advocate "to act in the best interests of the child", as explicitly required by 45 CFR 46.409:
§46.409 Wards.
(a) Children who are wards of the State or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is:
- related to their status as wards; or
- conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.
(b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
The AP report further states:
The research was conducted in at least seven states - Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas - and involved more than four dozen different studies. The foster children ranged from infants to late teens, according to interviews and government records.
These clinical research studies were funded primarily through grants awarded to researchers by the Division of AIDS (DAIDS).
I would like to bring to your attention that according to the NIAID Clinical Terms of Award: All clinical research supported by NIAID must comply with applicable Parts of U.S. Code of Federal Regulations, Title 45, Part 46 "Protection of human subjects." (Emphasis added)
The failure of numerous DAIDS/NIAID-sponsored researchers and their institutions to assure that foster children enrolled in their research were appointed individual advocates even where a foster parent exists constitutes a violation of the terms of their grant awards. By any definition, this is a severe violation because it directly impacts the health and safety of foster children, among the most vulnerable populations in our society.
Please be advised that 45 CFR 46.409 contains no exceptions to the requirement that foster children enrolled in research must be provided with advocates, although an advocate may serve more than one child.
The claim by some researchers that "oversight boards may decline to appoint advocates if they conclude the experimental treatment affords the same or better risk-benefit possibilities than alternate treatments already in the marketplace" is simply false. There is no provision in either law or regulation that allows researchers or their oversight boards to waive the rights of children in clinical trials to have advocates.
I ask that the your office immediately conduct an investigation to determine which foster children were denied their rights under the law and to seek a full recovery of grant funds from the researchers responsible for this lapse.
Furthermore, I respectfully suggest that your review include a comprehensive financial and protocol audit of each of the research entities and clinical trial sites involved in these studies. As part of this inquiry, the medical and study records of each foster child enrolled in their respective AIDS clinical trial should be examined to determine whether any of these children were subjected to unnecessary risk or injury owing to the toxicity of the drugs administered to them, and whether the researchers complied with their obligations to report all adverse events.
Your office should be aware that DAIDS/NIAID currently is soliciting applications for HIV/AIDS Clinical Trials Networks and Clinical Trial Units. Applications are due this month and in July, 2005, respectively. Funding for both is expected to total up to $300 million for the first year and may continue for up to seven years. (See: http://www2.niaid.nih.gov/newsroom/Releases/ctu2005)
It is expected that many of the investigators and their institutions responsible for enrolling foster children in AIDS clinical trials without the appointment of advocates will be competing for the upcoming award.
It is wholly inappropriate for DAIDS/NIAID to consider making awards to any of these applicants who have violated basic human research protections until a full, open and independent investigation has concluded and full restitution is made to both the government and the victims of these unlawful experiments.
Thank you for your time and attention to this important matter. Please feel free to contact me at my home telephone number, 301/XXX-XXXX if I can be of further assistance.
Sincerely,
Jonathan M. Fishbein, M.D.
Director, OPCRO
DAIDS/NIAID
Cc: Congressional Committees of Jurisdiction
U.S. Department of Justice
U.S. Government Accounting Office
Office for Human Research Protections
Office of Management Assessment
Office of Government Ethics