[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
