[Federal Register Volume 62, Number 169 (Tuesday, September 2, 1997)]
[Rules and Regulations]
[Pages 46198-46199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50, 56, 312, 314, 601, 812, and 814

[Docket No. 97N-0342]


Implementation of Emergency Research Informed Consent Waiver 
Rule; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of a public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the implementation of a final rule that defined conditions 
for an exception to the normal requirements for obtaining informed 
consent from persons participating as subjects in research. FDA is 
holding the public meeting because some parties interested in research 
conducted under the final rule have expressed to FDA a need for 
additional information on acceptable implementation procedures. The 
purpose of this public meeting is to provide an open discussion of the 
issues involved in implementing the requirements of the rule.
DATES: The public meeting will be held on September 29 and 30, 1997. On 
September 29, 1997, the meeting will be from 9:30 a.m. to approximately 
5:30 p.m. On September 30, 1997, the meeting will be from 8 a.m. to 
approximately 11:45 a.m. Registration is recommended by September 19, 
1997. Opportunity for public participation will be provided during both 
days of the meeting. Written comments will be accepted until October 
31, 1997.

ADDRESSES: The public meeting will be held at the Bethesda Holiday Inn, 
8120 Wisconsin Ave., Bethesda, MD. Written information and comments 
related to the meeting should be sent to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Two copies of any comments are to be submitted, 
except that individuals may submit one copy.
FOR FURTHER INFORMATION CONTACT: Glen D. Drew, Office of Health Affairs 
(HFY-20), Food and Drug Administration, 5600 Fishers Lane, rm. 15-22, 
Rockville, MD 20857, 301-443-1382, FAX 301-443-0232.

SUPPLEMENTARY INFORMATION: The purpose of this public meeting is to 
provide an open discussion of the issues involved in implementing the 
requirements of the final rule. Participants will be encouraged to 
discuss their perspectives on implementation of the final rule. Members 
of the public are encouraged to attend and provide comments during 
periods of open discussion and to provide written comments to the 
docket. Written comments by interested parties are encouraged, whether 
or not they are able to attend the public meeting.
    The requirement for obtaining the informed consent of persons 
participating in clinical research as research subjects has long been 
recognized, and has been included in FDA's regulations since the early 
1960's. The current regulations on informed consent part 50 (21 CFR 
part 50) and institutional review boards (IRB's) (21 CFR part 56) were 
finalized in 1981. Those regulations require that clinical researchers 
obtain informed consent from all subjects, with narrowly limited 
exceptions.
    As the field of emergency medicine evolved, treatments were 
developed for conditions such as head trauma, stroke, and heart attack 
that were previously considered hopeless. The need for the development 
of treatment methods where only unsatisfactory methods existed and to 
determine the effectiveness of new treatments was recognized in the 
medical community. The importance of obtaining informed consent as an 
integral part of the protection of human subjects was also recognized. 
The Subcommittee on Regulation, Business Opportunities, and Technology 
of the House Committee on Small Business, held a hearing on May 23, 
1994, that addressed problems encountered in securing informed consent 
of subjects in clinical trails of investigational drugs and medical 
devices. A coalition of acute resuscitation and critical care 
researchers held an October 1994

[[Page 46199]]

conference on the issues involved. In January 1995, FDA and the 
National Institutes of Health cosponsored a public forum on informed 
consent in clinical research conducted in emergency circumstances. In 
the Federal Register of September 21, 1995 (60 FR 49086), FDA proposed 
to amend its regulations to provide an exception to informed consent 
for research of emergency treatment for persons with acute and 
unpredictable life-threatening illnesses. After analysis of over 90 
comments, in the Federal Register October 2, 1996 (61 FR 51498), FDA 
published the final rule (Sec. 50.24) that is the subject of this 
public meeting. The Department of Health and Human Services 
simultaneously published (61 FR 51531, October 2, 1996) a functionally 
equivalent waiver of its human subject protection regulations (45 CFR 
part 46).
    The exception to the normal requirements for obtaining informed 
consent (61 FR 51531) is narrow in scope and available for research 
conducted in emergency circumstances on treatments for life-threatening 
conditions. The exception requires additional protections beyond those 
provided for human research subjects in other research.
    While Sec. 50.24 provides specific requirements for use of the 
exception to informed consent, FDA recognized that local conditions 
vary throughout the Nation, and placed considerable discretion and 
responsibility in the IRB's that will review proposed studies, the 
clinical investigators who will conduct the studies, and the sponsors 
who will initiate the studies and utilize the results. Questions have 
arisen as to the appropriate methods to satisfy the regulatory 
requirements imposed for use of the exception.
    At the public meeting, participants will examine the methods of 
providing the additional protections required when utilizing the 
exception to informed consent. Presentations and discussions will 
address the specific measures required. Participants will be provided 
opportunities to share their views and information regarding protocol 
design, study conduct, and experiences of clinical research conducted 
or planned under the exception to informed consent.
    On September 29, 1997, the meeting will open with discussions 
describing how the final rule was developed, what FDA expects to 
receive from sponsors, and how to determine whether clinical equipoise 
exists between standard therapy and an investigational procedure. 
Representatives of a study sponsor will describe how that study has 
been implemented at multiple study sites. A panel of experts will 
discuss issues related to consultation with representatives of the 
community where the research will be conducted and from which subjects 
will be drawn, if different, and disclosure of the research to the 
community. A session of open discussion will provide an opportunity for 
audience participation. A second panel of experts will discuss issues 
related to procedures for seeking consent from a subject's legal 
representative, and documenting the attempts to obtain consent. A 
session of open discussion will follow.
    On September 30, 1997, the meeting will open with presentations 
describing the function and operation of data safety monitoring boards 
that are required for studies under the final rule, as well as the 
other requirements of the final rule. A representative of a study 
sponsor will describe the preparation for and coordination of a multi-
site study. A panel of experts will discuss the circumstances in which 
it is appropriate to use the final rule, and how the different parties 
involved should interact with each other to produce a useful study. A 
session of open discussion will follow and then the meeting will 
conclude.
    All sessions of the meeting are open to the public; however, open 
seating is limited to 300. Those persons interested in attending should 
submit registration information, including name, organization name, 
address, telephone and fax numbers to the contact listed in this 
document. There is no registration fee for this public meeting, but 
advanced registration is recommended, as preregistrants will have 
preference if seating capacity is exceeded. Interested parties are 
encouraged to register early because space is limited.
    Interested persons may, on or before October 31, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding the workshop. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m. Additional information as well as a 
registration form is also available at FDA's website at http.//
www.fda.gov.


    Dated: August 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-23123 Filed 8-29-97; 8:45 am]
BILLING CODE 4160-01-F