[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
