INSTITUTIONAL REVIEW BOARD
RELIANCE ON A NON-UCI IRB
REGISTRATION FORM
Instructions: Complete this form if you are requesting to rely on a non-UCI IRB to review the
proposed research.
Submission to the UCI IRB:
1. Confirm that the research is eligible based on the IRB reliance agreement. Be sure to read the
applicable web page carefully (web links below).
2. Complete this form, depending on the type of IRB reliance, additional documentation may
need to be completed and provided with this form.
3. Send the signed, completed form and any required materials/supplemental documents
to the UCI IRB, via e-mail to: irb@research.uci.edu or via hard copy to: Office of Research,
5171 California, Suite 150, Irvine, CA 92617, Zot Code 7600.
4. If the research requires other regulatory or institutional reviews (e.g., CPTRMC, COIOC, RSC,
IBC), documentation of these approvals must be provided to UCI IRB prior to UCI IRB
providing an acknowledgement of the reliance.
A. SELECT THE REVIEWING IRB:
Children’s Hospital Orange County (CHOC), MemorialCare Health System, (MHS) and UCI
IRB Reliance (CMU): for collaborative research conducted across these entities and their
associated sites.
CHOC
MHS
National Cancer Institute Central Institutional Review Board (NCI CIRB): The NCI Adult
CIRB – Late Phase Emphasis reviews Phase III Cooperative Group studies from ACOSOG,
GOG, NSABP, RTOG, and SWOG.
University of California IRB Reliance: for collaborative research conducted across multiple UC
campuses. Indicate the Reviewing UC IRB:
Berkeley
San Francisco
Davis
Los Angeles
Santa Barbara
Merced
Santa Cruz
Riverside
San Diego
Lawrence Berkeley National Lab
Western IRB (WIRB): WIRB reviews Phase III or Phase IV industry-authored, industry-funded
clinical trials where the Sponsor/CRO has contracted with WIRB to provide IRB services for sites
conducting the study.
Other non-UCI IRB - List IRB:
Criteria – UCI LR is collaborating with non-UC investigator. The human research activities
conducted by the UCI study team constitute Expedited level research. No UCI study team
member has a disclosable financial interest that would require review by the UCI Conflict of
Interest Oversight Committee (COIOC). UCI will establish an IRB Authorization Agreement with
the Reviewing IRB’s Institution.
UCI HRP version: January 2014
Page 1 of 11
NAME OF COLLABORATING INVESTIGATOR:
NAME OF INSTITUTION:
CONTACT INFORMATION FOR REVIEWING IRB:
B. RESEARCH STUDY BASICS:
TITLE OF THE STUDY:
UCI LEAD RESEARCHER NAME:
The Lead Researcher must meet the eligibility requirements or obtain a Faculty Sponsor.
UCI FACULTY SPONSOR NAME:
UCI DEPARTMENT/RESEARCH UNIT FOR THIS STUDY:
LEVEL OF REVIEW: Specify the level of review as determined by the Reviewing IRB.
Exempt Registration – Category(ies):
Expedited Review – Category(ies):
Full Board Review
TYPE OF RESEARCH: Are the Purpose/Aims of the research Biomedical/Clinical or
Social/Behavioral/Educational?
Biomedical
Social or Behavioral
STUDY FUNDING: Indicate funding source(s).
Grant/Subaward - Provide the UCI proposal number(s):
Contract/Subcontract - Provide the Sponsor name(s):
Department or campus funds (includes department support, unrestricted funds, start-up funds,
personal funds, campus program awards, UROP, etc.)
Non-cash support from manufacturer/sponsor (e.g., providing drug, device, research materials)
– Detail the type of support being provided:
Subject/subject's insurance/third party payer
Student project – no campus or extramural funding
C. RESEARCH STUDY SPECIFICS
RESEARCH SITES: Check all sites where UCI investigator(s) will conduct research
activities (e.g., recruitment, and research procedures including accessing identifiable,
private information about participants).
UCI HRP version: January 2014
Page 2 of 11
UCI Main Campus
UCIMC and/or UCIMC satellite clinics (i.e., Anaheim, Santa Ana)
Beckman Laser Institute and Medical Clinic
Institute for Clinical Translational Science (ICTS) (UCI Campus or Medical Center)
Gottschalk Medical Plaza
Other UCI Site(s), including UCI-leased space - identify:
Other Non-UCI Site(s) & Locations (i.e., not UCI, UCIMC, or UCI owned/leased space
- identify:
SUBJECT POPULATIONS/DATA SOURCES: Check all subject populations/data sources that
apply to the research.
Use of Identifiable or Coded Data, Specimens, or Records
Use of California State Death Data Files Containing Personal Identifying Information
Adults Competent to Provide Informed Consent
Children/Neonates
Pregnant Women
Prisoners
Adults who are cognitively or medically impaired (may require surrogate consent)
Adults who are unable to read or speak English
UCI Students/Staff/Faculty
UCI Inpatients or Outpatients (Receiving Diagnosis/Treatment/Surgery)
Specify the maximum number of subjects and/or records at UCI:
Specify the maximum number of subjects and/or records across all participating sites:
RESEARCH PROCEDURES INVOLVED IN THE STUDY: Check all procedures that apply to
the research.
Analysis of Existing Identifiable or Coded Data, Specimens, Records, Charts, and Datasets
Surveys/Questionnaires/Interviews/Oral Histories
Audio, Video, Digital or Image Recording and/or Photography for Collection of Research Data
Behavioral Experiments (e.g., Cognition, Perception, Motivation, Communication, Behavior)
Studies Involving Incomplete Disclosure or Deception
Observation of Public Behavior
Evaluation of Programs or Services
International Research
Field Work Studies
Collection of Blood Samples (Venipuncture)
Collection of Other Samples/Specimens (e.g., tissue, saliva, urine)
Genetic Testing of Biological Specimens
Repository - Storage of Data and/or Biological Specimens for Future Research
Clinical Investigation involving an Approved or Investigational Drug
Clinical Investigation involving an Investigational Device
Experimental Surgical Procedures
Use of Placebo, Placebo Washout or Sham Procedure
UCI HRP version: January 2014
Page 3 of 11
Use of Radiopharmaceuticals or Radiation-Producing Machines (e.g., CT scan, DEXA, PET,
Radiation Therapy, SPECT, Scintigraphy, and X-Ray)
Other Imaging (e.g., MRI, fMRI, Ultrasound, Optical)
Other Non-Invasive Physical Measurements (e.g., ECG, EEG)
PROTECTED HEALTH INFORMATION: Specify if the research involves Protected Health
Information (PHI).
PHI is involved if any of the following are involved:
 Accessing or collecting information from a medical record
 Adding information to the subject’s medical record
 Creating or collecting information as part of health care
 Using information collected from the study to make health care decisions
Yes, PHI is involved.
All UCI personnel must use the UC HIPAA Research Authorization form when obtaining
informed consent for research that involves PHI. Non-affiliated institutions may also require
use of their version of the HIPAA authorization form to access their medical records. The
authorization form originates from the covered entity that owns the PHI.
No, PHI is not involved.
RECRUITMENT METHODS: Will the UCI Study Team recruit subjects?
YES
NO
If yes, provide UCI IRB a copy of any IRB approved recruitment materials.
INFORMED CONSENT PROCESS: Will the UCI Study Team obtain informed consent from
subjects? Check all boxes that apply to the research study.
YES
NO
If yes, specify the IRB-approved Informed Consent Process. Check all boxes that apply.
Signed Informed Consent is required. Provide IRB approved Consent Document(s) to UCI IRB.
Signed Assent is required. Provide IRB approved Consent Document(s) to UCI IRB.
Signed HIPAA Research Authorization is required. Provide HIPAA Research Authorization
to UCI IRB.
Use of Short Form Consent Process has been granted by the Reviewing IRB – Specify
languages:
Waiver of Informed Consent (i.e., No Consent) has been granted by the Reviewing IRB
Waiver of Assent (i.e., No Child Assent) has been granted by the Reviewing IRB
Waiver of Signed Informed Consent (Oral Consent required) has been granted by the
Reviewing IRB
Waiver of Signed Assent (Oral Child Assent required) has been granted by the Reviewing IRB
Waiver of Partial HIPAA Authorization (recruitment purposes only) has been granted by the
Reviewing IRB
Waiver of HIPAA Research Authorization (i.e., No Authorization) has been granted by the
UCI HRP version: January 2014
Page 4 of 11
Reviewing IRB
D. STUDY TEAM MEMBERS
1. List all study team members engaged in human subject research activities.
2. If the team member is UCI personnel, include his/her UCI email address; otherwise provide
evidence of meeting or exceeding UCI’s Human research Protections education requirements
(e.g., CITI certificate and HIPAA tutorial).
3. Specify each individual’s role on the study (i.e. Co-Researcher or Research Personnel).
4. List Faculty Sponsor as Co-Researcher. Faculty Sponsors have research oversight
responsibilities.
5. You may copy and paste more rows for Co-Researchers and Research Personnel as necessary.
Co-Researchers (CR) are usually senior members of the project staff. Individuals who are involved in the design
and conduct of the study, finalizing informed consent, determining subject eligibility, performing data collection,
interpreting and/or analyzing subject identifiable records or data; and authors on presentations or manuscripts
related to the research. Research Personnel (RP) often assist in data collection, data entry and data analysis.
RP are sometimes co-authors on presentations or manuscripts related to the research.
Lead Researcher:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed, and the individual’s relevant qualifications
(training, experience): <Type here>
Co-Researcher(s):
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications
(training, experience): <Type here>
Co-Researcher(s):
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications
UCI HRP version: January 2014
Page 5 of 11
(training, experience): <Type here>
Co-Researcher(s):
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed, and the individual’s relevant qualifications
(training, experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed, and the individual’s relevant qualifications
(training, experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications
(training, experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed, and the individual’s relevant qualifications
(training, experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications
(training, experience): <Type here>
UCI HRP version: January 2014
Page 6 of 11
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed, and the individual’s relevant qualifications
(training, experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications
(training, experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed, and the individual’s relevant qualifications
(training, experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Email address: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Obtain Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications
(training, experience): <Type here>
UCI ADMINISTRATIVE CONTACT PERSON & UCI EMAIL ADDRESS (optional) :
UCI HRP version: January 2014
Page 7 of 11
DEPARTMENTAL OR ORGANIZED RESEARCH UNIT (ORU) APPROVAL
The Department Chair’s signature is required if the study will be performed under the auspices of a
Department (includes campus centers and school-based research units). If the Department Chair is a
member of the study team (including Faculty Sponsor), approval must be obtained from the next highest
level of administrative authority [i.e., School Dean, Executive Vice Chancellor (the Vice Chancellor for
Research signs on behalf of the EVC)].
The ORU Director's signature is required if the study will be performed under the auspices of an ORU. If
the ORU Director is a member of the study team on this application (including Faculty Sponsor),
approval must be obtained from the Vice Chancellor for Research.
Department or ORU Assurance Statement:
By signing below, I hereby confirm that I have reviewed this registration form, the protocol, and other
study materials. I certify that:
1. The research is appropriate in design (i.e., the research uses procedures consistent with sound
research design, the study design can be reasonably expected to answer the proposed question,
and the importance of the knowledge expected to result from the research is known).
2. The Lead Researcher (and Faculty Sponsor) is competent to perform (or supervise) the study.
3. All study team members have disclosed to the COIOC any personal financial interests in the
research.
4. There are adequate resources and funds available to support performance of this research,
including costs associated with subject injury.
______________________________________________________
Typed Name of UCI Department Chair/ORU Director
______________________________________________________
Signature of UCI Department Chair/ORU Director
______________
Date
UCI HRP version: January 2014
Page 8 of 11
INVESTIGATOR’S ASSURANCE
University of California, Irvine
Institutional Review Board
Study Title:
As Lead Researcher at UCI, I have ultimate responsibility for the performance of this study at UCI, the
protection of the rights and welfare of the human subjects, and strict adherence by the co-investigators
and research personnel conducting research at my institution to all Reviewing Institutional Review Board
(IRB) requirements, federal regulations, state statutes, and Reviewing institutional policies and
procedures for research involving human subjects.
I hereby assure the following:
1. The information provided in this application/worksheet is accurate to the best of my knowledge.
2. All named individuals on this project have read and understand the procedures outlined in the
protocol and their role on the study.
3. All named individuals on this project have completed the required electronic educational research
tutorials and have been made aware of the "Common Rule" (45 CFR Part 46), applicable Food and
Drug Administration (FDA) regulations (21 CFR Parts 50, 56, 312 and 812), have read the Belmont
Report, and UCI's Federalwide Assurance (FWA) that are available on the Human Research
Protections Program (HRP) website.
4. All experiments and procedures involving human subjects performed by the UCI study team will be
under my supervision or that of another qualified professional listed on this protocol.
5. I understand that, should I use the project described in this application as a basis for a proposal for
funding (either intramural or extramural), it is my responsibility to ensure that the description of
human subjects use in the funding proposal(s) is identical in principle to that contained in this
application. I will submit modifications and/or changes to the Reviewing IRB as necessary to ensure
these are identical.
I, as the Lead Researcher of this study at UCI, and all co-investigators and research personnel
agree to comply with all applicable requirements for the protection of human subjects in
research including, but not limited to, the following:
1. Obtaining the legally effective informed consent or assent of all human subjects and/or consent of
their legally authorized representatives (unless waived) and using only the currently approved,
stamped consent form (if applicable). Obtaining HIPAA Research Authorization from human
subjects or their legally authorized representatives, as applicable (unless waived).
2. Making no changes to the approved protocol or consent form without first having submitted those
changes for review and approval by the Reviewing IRB, unless the changes are necessary to
eliminate an apparent immediate hazard to subjects. Changes made to eliminate hazards to UCI
subjects must be reported to the Reviewing IRB according to the Reviewing IRB’s policies and
procedures as well as to UCI IRB via the AE/UP reporting process.
3. Reporting any unanticipated problems involving risk to subjects or others, and potential
noncompliance to the Reviewing IRB in accordance Reviewing IRB’s policies and procedures. UCI
events must also be reported to UCI IRB via the electronic AE/UP reporting process. In addition, UCI
HIPAA privacy violations must be PROMPTLY disclosed to the UCI Privacy Officer. There are time
requirements for reporting these breaches of confidentiality, which, if not met, may result in monetary
damages to the researcher and the institution.
UCI HRP version: January 2014
Page 9 of 11
4. Responding appropriately to participants’ complaints or requests for information about the study; and
reporting to the Reviewing IRB and UCI IRB any participant complaints that are not resolvable by the
study team.
5. Promptly providing the Reviewing IRB and UCI IRB with any information requested relative to the
project.
6. Assuring the appropriate administration and control of investigational test articles (i.e., investigational
drugs, biologics or devices) by a qualified investigator or other appropriate individual or entity (e.g.,
UCIMC pharmacy), and assuring use and maintenance of an Investigational Drug/Biologic
Accountability Log or Device Accountability Log.
7. Assuring that the clinical research is registered with clinicaltrials.gov in accordance with Food and
Drug Administration (FDA) requirements for sponsor-investigators. For more information about this
topic, visit the National Institutes of Health Frequently Asked Questions or the HRP webpage. The
consequences of not meeting the registration requirements include monetary damages to the
researcher and the institution.
8. Obtaining continuing approval from the Reviewing IRB prior to study expiration. It may be necessary
to provide information about the progress of the study at UCI to the Primary PI at the site of the
Reviewing IRB who then submits for continuing approval. (I understand if the Primary PI fails to
apply for continuing review, approval for the study will automatically expire, and study activity must
cease until IRB approval is obtained).
9. Promptly and completely complying with an IRB decision to suspend or terminate its approval for
some or all research activities.
10. Submitting to a routine review of human subject research records. In an effort to ensure in part that
human subject research activities are conducted in accordance with regulations, laws and
institutional policies regarding the protection of human subjects, the Office of Research Oversight
(ORO) in the School of Medicine and the Education Quality and Improvement Program (EQUIP) unit
in Human Research Protections, Office of Research conduct periodic quality improvement
monitoring and educational outreach. The EQUIP unit monitors active biomedical research and
social, behavioral and educational research projects.
11. Filing a final report with Reviewing IRB at the conclusion of this project.
___________________________
Typed Name of Lead Researcher
___________________________
Signature of Lead Researcher
Date
___________________________
Typed Name of Faculty Sponsor
(if a Faculty Sponsor is required)
___________________________
Signature of Faculty Sponsor
_________
Date
UCI HRP version: January 2014
Page 10 of 11
DISCLOSURE OF INVESTIGATORS' FINANCIAL INTERESTS
University of California, Irvine
Institutional Review Board
Study Title:
In order to inform research subjects of circumstances that may affect their decision to participate in this
study, all researchers are required to disclose their financial interests with outside institutions.
The Lead Researcher of the protocol must ask the following question of all study team members:
"Do you, your spouse, and dependent children together have any disclosable financial interests
(i) that would reasonably appear to be affected by the research; or (ii) in entities whose financial
interests would reasonably appear to be affected by the research?"
Disclosable financial interests are:
 Ownership interest, stock, stock options, or other financial interest related to the research, unless it
meets all four tests:
 Less than $10,000 when aggregated for the immediate family and
 Publicly traded on a stock exchange and
 Value will not be affected by the outcome of the research and
 Less than 5% interest in any one single entity.
 Compensation related to the research, including salary, consultant payments, honoraria, royalty
payments, dividends, loans, or any other payments or consideration with value, including payments
made to the University Health Sciences Compensation Plan, unless it meets both of the following
tests:
 Less than $10,000 in the past year when aggregated for the immediate family and the
 Amount will not be affected by the outcome of the research.
 Proprietary interest related to the research including, but not limited to, a patent, trademark,
copyright or licensing agreement.
 Board or executive relationship (e.g., director, officer, partner, or trustee) related to the research,
regardless of compensation.
A member of the study team who answers in the affirmative must be listed in the box below. An
e-mail will be sent to the study team members listed below to obtain additional information regarding the
specific financial interest(s). IRB approval cannot be granted until all disclosures are reviewed.
List the Name(s) of Study Team Members who have Disclosable Financial Interests
(Include Lead Researcher, Co-Researchers, Research Personnel and, if applicable, Faculty Sponsor)
Lead Researcher Certification:
I certify that all members of the study team have answered the financial interest question and only the
individual(s) listed in the box above have a disclosable financial interest.
Signature of Lead Researcher: _____________________________________________
Date Signed: ____________________
UCI HRP version: January 2014
Page 11 of 11