Human Research Protections
News Brief
SPRING 2012
INCREASED IRB FEES
Inside this issue:
Increased IRB
Fees
CITI Research
Tutorial
Requirement
Reminder
1
2
Effective April 1, 2012, the Human Research Protections unit in the Office of Research
will increase its Institutional Review Board (IRB) fee as follows:
Initial Review - Full Committee
$ 2200.00
Initial Review - Expedited
$ 1000.00
Continuing Review - Full Committee
$ 825.00
Continuing Review - Expedited
$ 500.00
Continuing Review 7-Year De Novo - Full Committee
$ 1500.00
Continuing Review 7-Year De Novo - Expedited
$ 725.00
This new fee structure applies to IRB Applications received on or after April 1, 2012 and
that meet the following criteria:
Human Research
Records
Retention
 Designed to assess the safety, efficacy, benefits, adverse reactions, and/or other
2
outcomes of drugs, devices, diagnostics, treatments, procedures, medical
evaluations, monitoring or preventive measures; and
 Fully or partially supported by an industry sponsor; and
 Meets UCI contractual requirements for industry-supported clinical trials.
HRP Staff
Contact
Information
AND
IRB fees are:
2
Education &
Reminders
IRB 101– A Workshop
for the New Submitter
A hands-on workshop for
individuals new to the IRB
submission process (or those
who need a refresher).
This 90-minute workshop
provides researchers and
research staff with the
resources they need to
submit a complete IRB
application package. For
more information and to sign
up for the workshop, visit the
UC Learning Center at:
http://www.uclc.uci.edu/
 NOT assessed on IRB modifications/amendments to approved studies or exempt
studies.
 NOT assessed on clinical studies supported by the National Institutes of Health or
other governmental or non-profit entities, on investigator-initiated studies that are
not fully or partially supported by an industry sponsor, or on industry-sponsored
studies that do not meet the above criteria.
In preparing budgets for new clinical trials, investigators should include the amount of
the IRB fees to be incurred during each year of the trial. These fees are in addition to
any costs the investigator might want to include for administrative activities that would
be provided by the study team, such as preparation of
the IRB applications and related transactions.
IRB fees are assessed as recharges to the account and
fund number assigned to the clinical trial. E-mail
notification is provided to the investigator and the
department business office regarding the amount and
date of each charge.
If you have questions please about the new IRB Fee
structure, please contact Karen Allen, Director, Research Protections at 949-824-1558
or karen.allen@uci.edu.
Page 1
Page 2
CITI Research Tutorial Requirement Reminder
Effective October 15, 2011, individuals engaged in human subjects research must
complete a Collaborative Institutional Training Initiative (CITI) educational course.
Completion of a CITI course is required prior to the submission of an IRB application for
individuals who intend to engage in human subject research at UCI.
Effective February 15, 2012, a CITI Refresher course is required for individuals who completed the Human
Research Tutorial more than five years ago.
There are five CITI course options for researchers:

Biomedical Basic course

Biomedical Refresher course

Social/Behavioral Basic course

Social/Behavioral Refresher course

Community-Based Researcher course (this course is for community members unaffiliated with UCI and
unaffiliated with another research or academic entity)
CITI courses can take 1—3 hours to complete and can be completed over multiple sessions.
UCI researchers may complete either a Biomedical course or a Social/Behavioral course based on which course
is most applicable to their research. UCI researchers must register with CITI using their UCI Net ID as
their CITI Username (if available) and UCI email address as their preferred email (required) as the
IRB database links to CITI through an individual’s UCI email address.
For UCI individuals who previously completed a CITI course within the past five years, they should go back to
CITI and affiliate with UCI. They also must update their profile for UCI to include their UCI email
address. Some individuals may need to complete additional modules depending on whether they previously
completed the CITI modules required by UCI. For non-UCI individuals (faculty, staff, students) they can
complete:

Community-Based Researcher course (this is a new course) – acceptable only for community members
who are unaffiliated with UCI or with another research or academic entity; or

Provide evidence of completion of their institution’s education requirement
We receive nightly updates from CITI therefore it can take up to 24 hours for CITI completion to be reflected
in HPS. CITI is not the only educational tutorial—don’t forget the HIPAA Research tutorial if Protected Health
Information (PHI) is involved! Completion of the HIPAA Research tutorial is noted immediately. If you have
additional questions regarding the tutorial requirements or the CITI course please contact the Human
Research Protections staff.
Human Research Records Retention
Researchers are required to retain all study records for a minimum of three years past the close of the
study. This includes approved IRB documents, as well as case-report forms, tapes or transcripts, and all
other data-collection instruments and source documents.
UC General Counsel recommends longer retention periods for certain research records:
 Research records involving the generation, disclosure, and/or use of Protected Health Information
(PHI) should be retained for six years.
 When children are research participants research records must be retained for seven years after all
children enrolled in the study reach the age of majority [age 18 in California].
 Research records involving pregnant women must be retained 25 years.
 Investigators conducting FDA-regulated studies are required by regulation to retain records for periods which may be significantly longer than six years after study closure of the IRB protocol at UCI.
See Records Retention Requirements for more details.
SPRING 2012
Page 3
HRP Staff Contact Information
Institutional Review Board “A”
IRB Team “D”
Biomedical
Biomedical
Matt Kinder, CIP
Education & Reminders:
HIPAA RESEARCH
AUTHORIZATION
Expedited and Exempt Submissions
Administrator
Jessica Sheldon, CIP
949-824-9819
Administrator
mkinder@uci.edu
949-824-3831
DOES YOUR IRB-APPROVED STUDY
REQUIRE HIPAA RESEARCH
AUTHORIZATION?
jessica.sheldon@uci.edu
Mihaela Nistor
HIPAA Research Authorization: HIPAA is the
Senior Analyst
Kaycie Craib
949-824-3711
Senior Analyst
mnistor@uci.edu
949-824-5057
intention of HIPAA is to protect patients
kcraib@uci.edu
from inappropriate disclosures of "Protected
Joy Chu
Analyst
949-824-6068
joy.chu@uci.edu
—————————————————
Institutional Review Board “B”
Biomedical
employability, etc. HIPAA affects only that
949-824-0665
research which accesses, uses, creates, or
bairdm@uci.edu
discloses PHI. The IRB acts as a Privacy
—————————————————
Board to review the use/disclosure of PHI
Karen Allen, MA, CIP
Director
Administrator
949-824-1558
Cheree DuBose, CIP
Senior Analyst
949-824-5622
karen.allen@uci.edu
Beverley Williams, CIP
Assistant Director
Human Research Protections
949-824-5746
besparza@uci.edu
cheree.dubose@rgs.uci.edu
Debbie Melamud, MPH
Theresa Sanchez, CIP
Analyst
949-824-2125
tmsanche@uci.edu
——————————————————
Administrator
Human Research Protections
debbie.melamud@uci.edu
Human Research
Protections
Institutional Review Board “C”
Social - Behavioral
U.S. Mail:
Office of Research
Christine Hegel-Cantarella, PhD
Administrator
949-824-4779
chegel@uci.edu
Alicia Asgari
Senior Analyst
should sign a HIPAA Research Authorization
Form or if a Waiver of Authorization may be
granted.
When the IRB determines that subjects
should sign a HIPAA Research
Authorization form in order to access,
use, create or disclose PHI for
research, subjects are to sign the UC
HIPAA Research Authorization form as
a part of the informed consent process.
Other non-affiliated medical centers
and institutions may also require that
researchers use their version of the
authorization form to access their
medical records.
For new studies, a completed HIPAA
Research Authorization form is required at
initial submission to the IRB. Once the
study is approved by the IRB, the HIPAA
Authorization form can be accessed in the
5171 California Ave., Suite 150
“IRB docs depot.” For older studies, go to
Irvine, CA 92697-7600
The Office is Open:
Monday—Friday
8am—5pm
“ORA Applications and Forms” and then
“IRB Forms” to access the UC HIPAA
Research Authorization Form to download a
form.
Remember:
The UC HIPAA Research Authorization
949-824-7114
General Email:
IRB@research.uci.edu
Le’Quan Jackson
We’re on the Web!:
949-824-6662
and to determine whether the subjects
University of California, Irvine
alicia.asgari@uci.edu
Analyst
harm to a person's insurability,
Analyst
Human Research Protections
valerie.ms@uci.edu
and Accountability Act of 1996. The
Health Information" (PHI) that can cause
Michael Baird
Valerie Sanchez, MA, CCRP
949-824-7109
acronym for the Health Insurance Portability
http://www.research.uci.edu/ora/
hrpp/index.htm
form is not the same as the HIPAA
Medical form that patients sign when
receiving medical care.
The UC HIPAA Research Authorization
form is study specific.
ldjackso@uci.edu
SPRING 2012