Transcript Less Frequently Used Types of INDs

Less Frequently Used Types of
INDs
IRB EDUCATION FOR JUNE 2013
Review from February 2013
 What is an Investigational New Drug Application
(an “IND”)?
 What are the differences between an emergency
and a non-emergency use?
 How is the IRB involved?
What qualifies as an “emergency” for “emergency IND
for single use” purposes?
 To be considered “emergency
use” that is exempt from
prospective IRB approval,
look to the FDA’s definition of
the term.
 “Emergency use” has two
essential components:
1.
2.
a life-threatening situation in
which no standard
acceptable treatment is
available and
insufficient time to convene
a quorum for full-board IRB
approval.
IND: The Informed Consent Component
 The “informed consent statement” for the IND is a statement from the
physician that informed consent and approval of the use by an appropriate
IRB will be obtained prior to initiating treatment.
 The patient must understand the investigational nature of the drug, and
typically, the manufacturer will supply the consent form.
 However, the IRB is NOT involved in the review or approval of the consent
form if the situation meets the criteria for “emergency use.”

Instead, in the case of an emergency IND for use with only one patient,
treatment may begin WITHOUT prior IRB approval as long as the IRB is
notified of the emergency treatment within five working days of the
emergency use of the test drug.
 21 CFR 56; 21 CFR 50; and 21 CFR 312
Waiver of Consent
 Consent must be obtained, UNLESS the investigator and another
physician believe and will certify, in writing, all of the following:
1.
The human subject is confronted by a life-threatening situation that
necessitates the use of the test article (an investigational drug, device, or
biologic).
2.
Informed consent cannot be obtained because of an inability to
communicate with, or to obtain legally-effective consent from, the subject
or the subject’s legally-authorized representative (“an individual or judicial
or other body authorized under applicable law to consent on behalf of a
prospective subject to the subject’s participation in the procedure(s)
involved in the research”).
3.
Time is not sufficient to obtain consent.
4.
No alternative method of approved or generally-recognized therapy is
available that will provide an equal or greater likelihood of saving the
subject's life.
IRB Notification
 Notification of the IRB
v.
IRB Approval
 5-day time frame
 Sponsor-Investigator’s
letter to the IRB
Planned Emergency Research
 What are the elements of
“emergency research?”




The research has the prospect of
providing a direct benefit to the
patient.
The research must involve an
investigational article.
The article, in order to be
effective, must be administered
before informed consent from
the subject (or from the
subject’s legally-authorized
representative) can be obtained.
There is no reasonable way to
identify, prospectively,
individuals likely to become
eligible for participation in the
research.
Concerns Regarding Emergency Research
 What are the concerns
surrounding emergency
research?
 How does the FDA
address these concerns?
 21 CFR 50.24
Waiver of Consent with Emergency Research
 Elements of emergency
research are fulfilled
 Potential benefit shown for
research subjects
 Risk analysis completed
 Need for waiver established
 Investigator shows
commitment to contacting
LARs, as applicable
Waiver of Consent
 IRB has reviewed and approved
all consent procedures and
documents
 Additional protections include
the following (at a minimum):

Consultation with community
representatives

Public disclosure

Regarding the risks and
possible benefits of the study

Regarding the results of the
study upon completion
Additional Protections (Continued)
 Establish an independent
data monitoring committee
 Investigator shows
commitment to contacting
family members, as
applicable
 IRB is responsible for
procedures related to
informing the subject,
subject’s LAR, or subject’s
family member
Conclusion
 Other points to
consider
 IRB Education,
Part 2 for
June 2013