Human Research Protections
News Brief
FALL 2013
Inside this issue:
Waiver of Written (Signed) Informed Consent
An Institutional Review Board (IRB) is able to waive the requirement to obtain signed
informed consent in two situations:
 The only record linking the participant and the research would be the consent document;
 The principal risk would be potential harm resulting from a breach of confidentiality;
 Each participant will be asked whether the participant wants documentation linking the
participant with the research, and the participant's wishes will govern; and
 The research is not a clinical investigation subject to FDA regulations.
Waiver of
Written
(Signed)
Informed
Consent
1
OR
 The research presents no more than minimal risk of harm to participants and
 The research involves no procedures for which written consent is normally required
outside of the research context.
What is a clinical investigation?
A clinical investigation as any experiment that involves a test article and one or more
human subjects and that either is: 1) subject to requirements for prior submission to the
FDA, OR 2) Not subject to requirements for prior submission to the FDA under these
sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended
to be submitted later to, or held for inspection by, the FDA as part of an application for a
research or marketing permit.
Researchers interested in obtaining a waiver of
written (signed) informed consent should make sure
that their research qualifies for one of the above
options, and should address how the research qualifies 
for each of the option's requirements in the Appendix

P of the electronic IRB Application.
HRP Staff
Contact
Information
AND
Education
&
Reminders:
Expiration
of IRB
Approval
2
APPLICABLE FEDERAL
REGULATIONS
OHRP: 45 CFR 46.117
FDA: 21 CFR 50 & 21 CFR 56
In cases where the documentation requirement for
informed consent is waived, the IRB often requires the researchers to provide participants
with a written statement regarding the research. This written statement requires prospective
IRB approval. The template Study Information Sheet can be used as a guide. The written
statement is presented to the prospective subject as part of the informed consent process.
As part of the verbal consent process, the researcher should;
 Explain the study to the prospective subject including a discussion of the study purpose,




procedures, risks, benefits, compensation, and alternatives to participation, but above all,
that participation is completely voluntary;
Provide the prospective subject the Study Information Sheet for review, when applicable;
Allow the potential subject sufficient time to ask questions;
Assure that the prospective subject understands the research procedures (e.g., ask open
ended questions);
Answer the prospective subject questions and obtain the subject’s verbal agreement to
participate in the research.
A Note About Online Research: When administering the Study Information Sheet via an
online method, consent is assumed if the participant starts the study procedures (e.g., online
survey).
Page 1
HRP Staff Contact Information
Education and
Page 2
Reminders:
Institutional Review Board ’A’
IRB Team ‘D’
[Biomedical]
[Biomedical
IRB Chair: Tahseen Mozaffar, MBBS
Expedited and Exempt Submissions]
Matt Kinder, CIP
Jessica Sheldon, CIP
949-824-9819
Administrator
Mihaela Nistor, CIP
949-824-3711
Senior Analyst
Analyst
There is no grace
period extending
the conduct of
research beyond the expiration
date of IRB approval. The study
expires at midnight of the date
specified on the approval letter
and the informed consent
document.

If the IRB does not re-approve
the research by the specified
expiration date, study activities
must cease (note: this includes
access to identifiable data),
pending re-approval of the
research by the IRB.

Once notified of the expiration, if
the Investigator feels that stopping ongoing research-related
interventions or interactions
would jeopardize the rights or
welfare of current subjects, the
Investigator must immediately
submit to the IRB Chair a list of
research subjects for whom
expiration of the research would
cause harm.

The Investigator may work with
HRP Staff to facilitate the
communication with the IRB
Chair.

The IRB Chair reviews this list
and allows individual participants
to continue participating in the
research interventions or interactions only when the IRB
determines that it is in their best
interests. However any
information collected during the
lapse in approval may not be
used for research.

Remember: submit a continuing
protocol application at least 30
days prior to expedited review
and at least 60-90 days prior for
full committee review.
949-824-3831
Le’Quan Jackson
Joy Chu

jessica.sheldon@uci.edu
Senior Analyst
mnistor@uci.edu
Approval
IRB Vice Chair: Ruth Mulnard, RN, DNSc
Administrator
mkinder@uci.edu
Expiration of IRB
949-824-6662
ldjackso@uci.edu
Michael Baird
949-824-6068
Analyst
joy.chu@uci.edu
949-824-0665
—————————————————
—————————————————
Institutional Review Board ‘B’
Karen Allen, MA, CIP
bairdm@uci.edu
[Biomedical]
Director
IRB Chair: Kenneth Linden, MD, PhD
Research Protections
Cheree DuBose, CIP
karen.allen@uci.edu
Administrator
949-824-2576
cheree.dubose@rgs.uci.edu
949-824-1558
Beverley Williams, CIP
Assistant Director
Human Research Protections
Open Position
949-824-5746
Senior Analyst
beverley.williams@uci.edu
Theresa Sanchez, CIP
Debbie Melamud, MPH
Analyst
949-824-2125
tmsanche@uci.edu
——————————————————
Administrator
Human Research Protections
debbie.melamud@uci.edu
Human
Institutional Review Board ‘C’
Research
[Social - Behavioral]
Protections
IRB Chair: Elizabeth Cauffman, PhD
U.S. Mail:
Valerie Sanchez, MA, CCRP
Office of Research
Administrator
University of California, Irvine
949-824-4779
5171 California Ave., Suite 150
valerie.ms@uci.edu
Irvine, CA 92697-7600
Melissa Camarena
The Office is Open:
Senior Analyst
Monday—Friday
949-824-7114
8am—5pm
mccamare@uci.edu
Open Position
Analyst
General Email:
IRB@research.uci.edu
Web:
http://www.research.uci.edu/
FALL 2013