Human Research Protections
News Brief
New Location—Office of Research / Human Research Protections
FALL 2010
The Human Research Protections (HRP) office relocated to
the University Research Park as of August 2nd.
Inside this issue:
New
1
Location for the
OR / HRP
1-2
No More
5171 California Avenue, Suite 150
Irvine, CA 92617-3067
Penalty
&
5171 California Avenue, Suite 150
Irvine, CA 92697-7600
Delivery Address – Please use this
address for express mail services (FedEx, UPS,
etc.) and delivery services:
Committees
Credits
Please make a note of our new contact
information:
Mailing Address – Please use this address as
the institutional address for all proposals to be
submitted to sponsors.
Other UCI
Compliance
With the exception of our mailing address and express mail/delivery service address, our other
contact information, including e-mail addresses, telephone and fax numbers will not
change. For more information on the move, visit:http://www.research.uci.edu/relocating.htm
3
“If You Have Questions” Section of the Consent Form
With the move, many of our forms had to be updated to reflect the new address for the
AHHRPP
Office of Research (OR) / HRP.
Re-accreditation
In regards to the Consent Form,
HRP staff will
automatically update the “If You Have Questions” section of the Consent Form, on
the researchers behalf, as e-submissions are received. An updated version of the
consent form, including the new address field for the OR/ HRP, is in process and
will be released shortly.
Other UCI Compliance Committees/Groups
IRB Staff
When a researcher submits a new study to the IRB, often, there are additional committees
Contact
that must approve the research. Some of these approvals are required before the IRB
will review the study.
Info
&
Education /
Reminders
4
Others are required prior to the initiation of research.
Why?
Various ancillary committees are involved as part of the submission process to insure
scientific merit, verify medical center resources, ensure proper registration and billing, to
propose the management of a positive financial conflict of interest to the IRB and to help
protect the physical safety of human research subjects (such as in the case of research that
involves radiation when the exposure is not considered standard of care).
Page 2 of this News Brief includes a reference chart, outlining the other compliance committees at UCI.
The chart highlights when review and clearance from the other compliance
committees are applicable and how IRB review is impacted. For additional information and
tips related to the IRB / other compliance committee submission process, refer to the OR/
HRP website at: http://www.research.uci.edu/ora/hrpp/otherreviews.htm
Page 2
Reference Chart: Other Compliance Committees
Committee
When is it needed?
Clinical Trials Protocol
Review and Monitoring
Committee (CTPRMC)
If a research study involves patients with cancer, participants at risk
for cancer, or participants of a study involving a specific cancer focus
(e.g., health education, quality of life, etc.)
Clinical Research
Finance Assessment
(CRFA)
Reviews all greater than minimal risk human research studies that
involve UCIMC clinical services as part of research or clinical care.
Responsible for proper registration and billing practices for all human subjects receiving clinical care while enrolled on a clinical research study.
Conflict of Interest
Oversight Committee
(COIOC)
Human Stem Cell
Research Oversight
(hSCRO)
Institutional
Biosafety Committee
(IBC)
Reviews all human subjects’ research studies where an investigator
and/or research team member has disclosed financial interests related to a research project conducted at UCI or using UCI resources
or facilities that involve the use of human subjects.
How does it impact
IRB review?
Documentation of CTPRMC approval
for full committee protocols is
required before IRB review.
CRFA approval is required before
study procedures can be initiated.
COIOC review is required before
IRB review.
COI review and management plan(s) are shared with the IRB . The
IRB makes the final determination and approval about the COI management plan as it pertains to the protection of human subjects.
Reviews all research or clinical investigations that involve the use of
human stem cells. Applies to the use of human pluripotent stem cells.
hSCRO approval is required before
IRB review.
Responsible for providing institutional oversight of recombinant
DNA research. In addition, the IBC oversees all activities using infectious agents, human and non-human primate blood, bodily fluids and
tissues in accordance with CDC guidelines.
IBC review and approval can run
concurrent with IRB review.
When the research involves rDNA
activities, IRB approval will be held
pending IBC approval.
Radioactive Drug
Research Committee
(RDRC)
The RDRC reviews research studies that involve the use of radioactive material in or on human subjects regardless of the amount of
radioactivity. The RDRC only reviews and approves basic research
studies, and does not review and approve studies intended to determine the safety and effectiveness of the drug in humans for such
purposes as carrying out a clinical trial, for example.
Radiation Safety
Committee (RSC)
All protocols involving radiation exposure to normal subjects, and/or
clinical human subjects when the exposure is not considered standard-of-care must be referred to the RSC sub- committee for review.
If needed, the study can be referred to a Full-Committee meeting for
a more extensive review.
RSC approval is required before
study procedures can be initiated.
UCIMC Surgical
Committee
Required for human subjects’ research that is conducted in surgical
units especially when investigational drugs and devices are being
used.
Surgical Committee approval is
required before study procedures
can be initiated.
RDRC review and approval is
generally required before IRB
review.
FALL 2010
Page 3
Use of the Social Sciences Lab– No More Penalty Credits
Investigators using the Social Sciences Lab as a research participant pool should note the
following change in lab policy: the use of “penalty credits” is no longer accepted. Instead of
receiving penalty credits, students who fail to follow any of the below lab policies two times (2x) during a
quarter will not be permitted to use the Human Subjects lab as a means to earn extra course credit for the
remainder of that quarter.
Students should:
Be sure that they meet the eligibility criteria for a research study before signing up.
Arrive on time or a little before since many studies begin exactly at the scheduled
time. Cancel any scheduled appointments, no later than one hour before the scheduled time.
For more information on using the Social Sciences Lab or for information on this change in policy, please
see the following website: https://experimetrix2.com/uci/ or contact Julie Hoigaard at (949) 824-1023.
UC Irvine Pursues AAHRPP Reaccreditation
Reaccreditation Starts Now – UC Irvine is again in the process of conducting a self-assessment
of its HRPP. We will submit our Association for the Accreditation of Human Research Protection
Programs, Inc. (AAHRPP) application for reaccreditation in December 2010. UC Irvine’s HRPP
received initial AAHRPP accreditation in September 2005. UC Irvine was the first university in
California and the first UC campus to receive AAHRPP accreditation.
AAHRPP Accreditation has Value – AAHRPP accreditation enhances UC Irvine’s reputation
and the quality of our research and gives us a competitive edge with sponsors. OHRP and the FDA
recognize the value of accreditation. Moreover, through the self-assessment process, the UC Irvine
HRPP continues to develop effective and efficient processes. Written policies and procedures have
been developed to reduce the need for the IRB to make decisions on a case-by-case basis, and to
provide guidance to investigators about human research protections issues and the IRB review
process.
AAHRPP Site Visit – We anticipate that AAHRPP will conduct a site visit in Spring 2011 during
which interviews will be scheduled with investigators, research personnel, University
officials, IRB members and staff selected by AAHRPP. Information about the site visit will be shared
with the research community as details become available. In preparation for the interviews, the Office
of Research will increase its education and outreach efforts to assure investigators, research
coordinators, IRB members and staff understand their roles and responsibilities in UC Irvine’s
HRPP.
Stay tuned for more details!
Fall 2010
HRP Staff Contact Information
Institutional Review Board “A”
Biomedical
Matt Kinder
Administrator
949-824-9819
Page 4
IRB Team “D”
Biomedical
Expedited and Exempt Submissions
mkinder@uci.edu
Open Position
Administrator
949-824-3831
Debbie Gonzalez
Senior Analyst
949-824-3711
Kristina Grimaldi
Senior Analyst
949-824-5057
Debbie.gonzalez@research.uci.edu
Kristina.grimaldi@research.uci.edu
Education & Reminders:
THE ‘EQUIP’ PROGRAM
Human Research Protections
(HRP) in the
Office of Research
launched the Education and Quality
and Improvement Program (EQUIP) in
2009.
Since that time, 6 monitoring visits
have been completed. Through feedback from the research teams, the
Open Position
Analyst
949-824-6068
Kin Hang
Analyst
949-824-0665
process overall has been positive with
kkhang@uci.edu
from the EQUIP team has been useful
—————————————————
—————————————————
in not only their current research but
Karen Allen
Director
Human Research Protections
949-824-1558
when considering future projects as
Institutional Review Board “B”
Biomedical
Valerie Sanchez
Administrator
949-824-7109
researchers agreeing that feedback
well.
Through EQUIP, HRP staff conduct
kallen@uci.edu
periodic quality improvement reviews
Beverley Esparza
Assistant Director
Human Research Protections
949-824-5746
and educational outreach in an effort to
Cheree DuBose
Senior Analyst
949-824-5622
cheree.dubose@research.uci.edu
besparza@uci.edu
vmiran@uci.edu
——————————————————
Institutional Review Board “C”
Social - Behavioral
Jessica Sheldon
Administrator
949-824-4779
jessica.sheldon@uci.edu
Alicia Asgari
Senior Analyst
949-824-7114
ateiman@uci.edu
Open Position
Analyst
949-824-6662
activities are conducted in accordance
with regulations and institutional policies regarding the protection of human
Theresa Sanchez
Analyst
949-824-2125
tmsanche@uci.edu
ensure that human subject research
subjects.
Human Research
This process is a requirement of our
Protections
Federalwide Assurance and an expecta-
U.S. Mail:
tion of AAHRPP, the accrediting body
Office of Research
University of California, Irvine
5171 California Ave., Suite 150
Irvine, CA 92697-7600
The Office is Open: Monday—Friday
8am—5pm
We’re on the Web!
http://www.research.uci.edu/ora/
hrpp/index.htm
for
human
research
protection
programs.
EQUIP primarily focuses on research
conducted on the Irvine campus and
reviews all levels of research; exempt,
expedited and full committee (greater
than minimal risk research).
Any questions about the EQUIP?
Email Beverley at besparza@uci.edu
Stay
tuned
for
future
announcements about EQUIP!
Fall 2010