SUBJECT:

PURPOSE:

New York City
Thursday
September 8, 2005
10:30 AM
250 Broadway
Assembly Hearing Room 1923, 19th Floor
New York, NY

Several hundred children in foster care in New York City were among the HIV-positive children who participated in clinical trials of drugs to treat HIV or AIDS for more than a decade. The drugs had been approved for treating adults with HIV/AIDS. But before they could be approved for treating children, they had to go through clinical trials involving children.

The U.S. Department of Health and Human Services’ Office of Human Research Protections has raised questions about whether proper consent had been obtained from the child’s biological parent or otherwise, and whether other procedures were followed. The agency is continuing its investigation, research and policy development.

The New York City Administration for Children’s Services (ACS) is developing policies and procedures to protect any child in its care who may participate in a drug clinical trial. ACS has also contracted with the Vera Institute of Justice to conduct an independent review of policies that were in place at the time of the trials and to assist in the development of new policy. An Oversight Committee, comprised of a panel of national health care experts, has been convened to review and assist ACS in developing new policy and to review the findings from the independent review.

Children placed in the State’s custody should be protected by placing the physical, mental and emotional needs of the children above all else. The Committees are holding this hearing to determine if a need exists for State legislation relating to consent to participate in drug clinical trials by children in foster care or to provide other protections.

Please see the reverse side for a list of subjects to which witnesses may direct their testimony.

Persons wishing to present pertinent testimony to the Committees at the above hearing should complete and return the enclosed reply form as soon as possible. It is important that the reply form be fully completed and returned so that persons may be notified in the event of emergency postponement or cancellation.

Oral testimony will be limited to 10 minutes’ duration. In preparing the order of witnesses, the Committees will attempt to accommodate individual requests to speak at particular times in view of special circumstances. These requests should be made on the attached reply form or communicated to Committee staff as early as possible. In the absence of a request, witnesses will be scheduled in the order in which reply forms are postmarked.

Ten copies of any prepared testimony should be submitted at the hearing registration desk.

In order to further publicize these hearings, please inform interested parties and organizations of the Committees’ interest in hearing testimony from all sources.

In order to meet the needs of those who may have a disability, the Assembly, in accordance with its policy of non-discrimination on the basis of disability, as well as the 1990 Americans with Disabilities Act (ADA), has made its facilities and services available to all individuals with disabilities. For individuals with disabilities, accommodations will be provided, upon reasonable request, to afford such individuals access and admission to Assembly facilities and activities.

SELECTED ISSUES TO WHICH WITNESSES MAY DIRECT THEIR TESTIMONY:

1. Who can or should be able to give consent for the participation of a child in the State’s care in a clinical trial? What should be the rule in instances when the parent’s rights have been terminated, when the parent(s) can not be found or when the parent(s) refuse to provide consent? How are these issues being addressed? What is the best approach in these complicated circumstances? Is there a need to provide a statutory procedure for obtaining consent?

2. Once consent is given, what is the process for removing a child from a clinical trial upon the request of an advocate, parent or legal guardian? What process would ensure that participation in the trial is in the best interest of the child?

3. Current regulations set forth by the U.S. Department of Health and Human Services require that "risk" and "potential treatment benefit" must be taken into consideration when determining if a child should participate in a clinical trial. How has this requirement harmed or helped children in the State’s care? How is minimal risk defined? Has "risk" been evaluated differently for children in foster care versus children who are not in foster care? What constitutes a "potential treatment benefit"? Has "treatment benefit" been evaluated differently depending upon what insurance coverage or provider the child has? Should definitions of various levels of "risk" or type of "treatment benefit" be included in any legislative proposal? Should these definitions be more specific for vulnerable populations?

4. How has ACS been tracking the children that participated in clinical trials? How many of these children have been helped or harmed by these clinical trials? Have there been any deaths due to participation in a clinical trial?

5. Would establishing an independent office to oversee and investigate practices within the State’s child welfare and juvenile justice system be beneficial?

6. Federal regulations require that an Advocate be appointed for each child who participates in a clinical trial, with exceptions. It appears that some of the children in the State’s care who participated in these trials did not have an advocate. Would a mandatory Advocate for each child participating in a clinical trial ensure that participation is in the best interest of the child?

7. There have been reports of foster parents losing a child back to the system for not complying with the drug regime. The foster parent(s) felt that the child became worse off as a result of the drugs. Foster parents have the most interaction and oversight of the child and could provide vital information about side effects or unintended consequences of the clinical trial. What should foster parents do if they feel that a child in their care is having side effects or is extremely ill from participation in a clinical trial? Who should the foster parent report this information to? What role should foster parents have in this process, if any?

8. Is there appropriate oversight of the Institutional Review Boards (IRB)? Should the State enhance the oversight of the IRBs? Do the IRBs have adequate resources to ensure clinical trials are ethical and that participants are protected?

PUBLIC HEARING REPLY FORM

Persons wishing to present testimony at the public hearing are requested to complete this reply form as soon as possible and mail or fax it to:

Judi West
Legislative Analyst
Assembly Committee on Children and Families
Room 522 Capitol
Albany, New York 12248
Email: westj@assembly.state.ny.us
Phone: (518) 455-4371
Fax: (518) 455-4693

I will address my remarks to the following subjects:

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