[Federal Register Volume 59, Number 244 (Wednesday, December 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31252]


[[Page Unknown]]

[Federal Register: December 21, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0435]

 

Public Forum on Informed Consent in Clinical Research Conducted 
in Emergency Circumstances; Notice of Meeting

AGENCY: Food and Drug Administration and National Institutes of Health, 
HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) and the National 
Institutes of Health (NIH) are co-sponsoring a public meeting on 
informed consent in clinical research conducted in emergency 
circumstances. The purpose of the public meeting is to gather 
information and solicit the views of interested parties regarding 
issues related to the application of informed consent requirements in 
clinical research performed in emergency circumstances. Presentations 
and discussions will address ethical, medical, scientific, regulatory, 
and legal standards for the conduct of clinical research in emergency 
circumstances where obtaining the consent of the research subject or 
the authorized representative is not possible. Here, research in 
emergency circumstances relates to the testing of experimental 
therapies for individuals in life threatening circumstances rather than 
to public health emergencies. Several case studies that illustrate 
relevant issues will be presented and discussed. Critical elements in 
the design of clinical trials to test new therapeutic approaches in 
emergency circumstances also will be discussed. Participants will be 
provided opportunities to share their views and information regarding 
protocol design, study conduct, and patient experiences in clinical 
research in emergency circumstances within current regulatory 
guidelines.

DATES: The public meeting will be held on January 9, 1995, 8:30 a.m. to 
6 p.m., and January 10, 1995, 8:30 a.m. to 4 p.m. Because seating space 
is limited, early registration is recommended and pre-registrants will 
have seating preference. Submit written comments by February 7, 1995.

ADDRESSES: The public meeting will convene at the Bethesda Marriott 
Hotel, Congressional Ballroom, 5151 Pooks Hill Rd., Bethesda, MD 20814, 
301-897-9400. Submit written information and comments related to the 
meeting to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Persons interested in attending may 
pre-register by providing name, organization name, address, and 
telephone number to Ed Rugenstein, Sociometrics, Inc., 8300 Colesville 
Rd., suite 550, Silver Spring, MD 20910, 800-729-0890 or 301-608-2151 
(FAX 301-608-3542). There is no registration fee for this public 
meeting. Participants who wish to speak during the periods of public 
testimony should also inform Mr. Rugenstein that they request speaking 
time.

FOR FURTHER INFORMATION CONTACT:
    Glen D. Drew, Office of the Associate Commissioner for Health 
Affairs (HFY-20), Food and Drug Administration, rm. 15-22, 5600 Fishers 
Lane, Rockville, MD 20857, 301-443-1382 (FAX 301-443-0232), or
    Mary Groesch, Office of Science Policy and Technology Transfer, 
National Institutes of Health, Bldg. 1, rm. 218, 9000 Rockville Pike, 
Bethesda, MD 20892-0166, 301-496-1454 (FAX 301-402-0280).

SUPPLEMENTARY INFORMATION: FDA and NIH are holding this public meeting 
to gather information regarding issues related to the application of 
informed consent requirements in clinical research performed in 
emergency circumstances. A critical part of the process of considering 
these issues is an understanding of the views and experiences of 
members of the research community, lay public, and other interested 
parties. Therefore, the agenda includes periods for presentations on 
both days. Each speaker's presentation will be limited to five minutes 
in order to accommodate as many public speakers as possible. Those who 
request presentation time will be notified whether they can be 
accommodated, and if so, the approximate time they will be able to make 
their presentation. Transcripts of the public meeting may be requested 
in writing from the Freedom of Information Office (HFI-35), Food and 
Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 
20857, approximately 15 working days after the meeting, at a cost of 10 
cents per page. The transcript of the public meeting and copies of 
information and comments submitted to the meeting record will be 
available for examination at the Dockets Management Branch (address 
above) approximately 15 working days after the meeting, between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: December 14, 1994.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 94-31252 Filed 12-20-94; 8:45 am]
BILLING CODE 4160-01-F