Rep. Herger Announces Hearing on Protections for Foster Children Enrolled in Clinical Trials

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Applied Clinical Trials

Congressman Wally Herger (R-CA), Chairman, Subcommittee on Human Resources of the Committee on Ways and Means, today announced that the Subcommittee will hold a hearing on protections for foster children enrolled in clinical trials.

WASHINGTON, May 11, 2005 - Congressman Wally Herger (R-CA), Chairman, Subcommittee on Human Resources of the Committee on Ways and Means, today announced that the Subcommittee will hold a hearing on protections for foster children enrolled in clinical trials.

The hearing will take place on Wednesday, May 18, 2005, in room B-318 Rayburn House Office Building, beginning at 2:00 p.m.

In view of the limited time available to hear witnesses, oral testimony at this hearing will be from invited witnesses only. Invited witnesses will include experts familiar with issues related to the enrollment of foster children in clinical trials. However, any individual or organization not scheduled for an oral appearance may submit a written statement for consideration by the Subcommittee for inclusion in the printed record of the hearing.

BACKGROUND:
Recent media reports raised concerns regarding protections in place prior to the enrollment of foster children in clinical drug trials. These included allegations that in some cases foster children may have been enrolled in studies without the benefit of certain protections, such as the appointment of an independent advocate for the child. At the same time, individuals familiar with these studies contend that the enrollment of foster children enhanced their health by offering the best medical treatment available and that independent advocates were not necessary in all cases.

For children who may not safely remain with their families, foster care is a temporary setting in which foster parents, social workers, and court personnel work to protect the child's best interests in lieu of their biological parents. Federal policy has been enacted, most recently with the Adoption and Safe Families Act of 1997 (P.L. 105-89), to ensure that the safety of foster children is paramount in any decision made on the child's behalf. This hearing will examine (1) policy issues surrounding the enrollment of foster children in clinical trials, and (2) whether adequate protections are in place to ensure the safety and well-being of foster children in such trials.

In announcing the hearing, Chairman Wally Herger said: "This hearing will explore issues surrounding the placement of foster children in clinical drug trials, including under what conditions participation is permitted. We are concerned about recent allegations involving the enrollment of foster children in such trials. This hearing will help us assess whether there is any substance to these allegations and if so, what response is appropriate."

FOCUS OF THE HEARING:
The focus of the hearing is on protections for foster children enrolled in clinical trials.

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:Please Note: Any person(s) and/or organization(s) wishing to submit for the hearing record must follow the appropriate link on the hearing page of the Committee website and complete the informational forms. From the Committee homepage, http://waysandmeans.house.gov, select "109th Congress" from the menu entitled, "Hearing Archives" (http://waysandmeans.house.gov/Hearings.asp?congress=17). Select the hearing for which you would like to submit, and click on the link entitled, "Click here to provide a submission for the record." Once you have followed the online instructions, completing all informational forms and clicking "submit" on the final page, an email will be sent to the address which you supply confirming your interest in providing a submission for the record. You MUST REPLY to the email and ATTACH your submission as a Word or WordPerfect document, in compliance with the formatting requirements listed below, by close of business Wednesday, June 1, 2005. Finally, please note thatdue to the change in House mail policy, the U.S. Capitol Police will refuse sealed-package deliveries to all House Office Buildings. For questions, or if you encounter technical problems, please call (202) 225-1721.

FORMATTING REQUIREMENTS:
The Committee relies on electronic submissions for printing the official hearing record. As always, submissions will be included in the record according to the discretion of the Committee. The Committee will not alter the content of your submission, but we reserve the right to format it according to our guidelines. Any submission provided to the Committee by a witness, any supplementary materials submitted for the printed record, and any written comments in response to a request for written comments must conform to the guidelines listed below. Any submission or supplementary item not in compliance with these guidelines will not be printed, but will be maintained in the Committee files for review and use by the Committee.

1. All submissions and supplementary materials must be provided in Word or WordPerfect format and MUST NOT exceed a total of 10 pages, including attachments. Witnesses and submitters are advised that the Committee relies on electronic submissions for printing the official hearing record.

2. Copies of whole documents submitted as exhibit material will not be accepted for printing. Instead, exhibit material should be referenced and quoted or paraphrased. All exhibit material not meeting these specifications will be maintained in the Committee files for review and use by the Committee.

3. All submissions must include a list of all clients, persons, and/or organizations on whose behalf the witness appears. A supplemental sheet must accompany each submission listing the name, company, address, telephone and fax numbers of each witness.

The Committee seeks to make its facilities accessible to persons with disabilities. If you are in need of special accommodations, please call 202-225-1721 or 202-226-3411 TTD/TTY in advance of the event (four business days notice is requested). Questions with regard to special accommodation needs in general (including availability of Committee materials in alternative formats) may be directed to the Committee as noted above.

CONTACT: (202) 225-1025

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