Institutional Review Board (Irb)

INSTITUTIONAL REVIEW BOARD (IRB)

RELIANCE REGISTRATION FORM

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For IRB Office Use Only

Instructions: Complete this form if the UCI investigator is relying on IRB approval from another IRB or in the case that a UCI investigator is initiating an IRB reliance as part of one of the established agreements as noted below.

NOTE: Throughout this document, “Reviewing IRB” refers to the IRB issuing approval for the research (also known as the “IRB of Record”).

Submission to the UCI IRB:

1.  Review the UCI webpage applicable to the IRB reliance you are requesting (e.g. CMU, NCI CIRB, UC). If eligible, complete this form.

2.  Depending on the IRB Reliance, additional documentation may be required. Be sure to read the applicable web page and complete the necessary supplemental documentation.

3.  Send the signed, completed form and any required supplemental materials to the UCI IRB, via e-mail to: or via hard copy to: Office of Research, 5171 California, Suite 150, Irvine, CA 92617, Zot Code 7600.

Please select the situation that best applies to this research:
Established IRB Reliance Agreements:
CMU IRB Reliance: The Children’s Hospital Orange County, MemorialCare Health System & UCI IRB Reliance may be used for collaborative research conducted across sites. The UCI Lead Researcher must review the CMU IRB Reliance webpage to confirm eligibility prior to completing this form. Additional documentation is required. See the CMU Reliance webpage for further details.
NCI CIRB Reliance: The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) may be used for phase III adult and pediatric cancer clinical trials.
UC IRB Reliance: The University of California IRB Reliance may be used for collaborative research conducted across multiple UC campuses. The UCI Lead Researcher must complete Relying Investigator information on UC IRB Reliance Registry web page. See the UC IRB Reliance webpage for further details.
Requesting to rely on another IRB, not listed above. UCI will need to establish an IRB Authorization Agreement with the Reviewing IRB’s Institution. The proposed research fits the following criteria:
Requesting to Rely on Another IRB: UCI Investigator is collaborating with a non-UC investigator. UCI is not the prime awardee on the award/contract. The human research activities conducted by the UCI Investigator involve no more than minimal risk. No UCI research team member has a disclosable financial interest that would require review by the UCI Conflict of Interest Oversight Committee (COIOC). The collaborating institution has obtained IRB approval. The UCI Investigator is requesting to rely on their IRB approval.
Requesting to Rely on Another IRB: UCI may be the prime awardee of the award/contract; however the human research activities will primarily be conducted by a non-UC Investigator at the Reviewing IRB’s institution. The human research activities conducted by the UCI Investigator involve no more than minimal risk. No UCI research team member has a disclosable financial interest that would require review by the COIOC. The collaborating institution has obtained IRB approval. The UCI Investigator is requesting to rely on their IRB approval.
NAME OF COLLABORATING INVESTIGATOR:
NAME OF INSTITUTION:
CONTACT INFORMATION FOR REVIEWING IRB:
TITLE OF THE STUDY:
UCI LEAD RESEARCHER:
Note: This individual must be affiliated with UCI and meet campus Lead Researcher eligibility requirements.
UCI FACULTY SPONSOR (if required):
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:
Specify if the Purpose/Aim is Biomedical or Social/Behavioral
Biomedical
Social or Behavioral
STUDY FUNDING:
Indicate how the study costs will be supported.
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, etc.)
Non-cash support from manufacturer/sponsor (e.g., free drug, device, research materials)
Subject/subject's insurance/third party payer
Student project that will incur no costs
UCI STUDY TEAM MEMBERS:
All UCI study team members are required to complete human research protections education requirements (i.e., CITI and HIPAA Research tutorials).
1.  List all UCI personnel engaged in human research activities.
2.  Include their UCI email address.
3.  Specific role on the study (i.e. Co-Researcher or Research Personnel).
UCI ADMINISTRATIVE CONTACT PERSON(optional):
PERFORMANCE SITES:
Check all of the performance sites for the research. Note: A performance site is any location where study procedures, research activities, or subject identifiable data will be used for the study.
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
Fairview of Metropolitan State Hospitals
Kaiser Permanente Southern California Component Sites
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, Records, Charts
Adults Who Are Competent to Give Informed Consent (no surrogates)
Children
Pregnant Women/Fetuses/Neonates
Adults who are Cognitively, Psychologically, or medically impaired and may require surrogate
consent
Prisoners
Subjects who are unable to read or speak English
UCI Students/Staff/Faculty
UCI Inpatients or Outpatients (Receiving Diagnosis/Treatment/Surgery)
State Death Data Files Containing Personal Identifying Information
Specify the maximum number of subjects and/or records at UCI:
Specify the maximum number of subjects and/or records at all participating sites:
RESEARCH PROCEDURES INVOLVED IN THE STUDY:
Check all boxes that apply to the research.
Analysis of 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 (Deception)
Observation of Public Behavior
Evaluation of Programs or Services
International Research
Field Work Studies
Use of Approved or Investigational Drug
Clinical Device Study
Use of Placebo, Placebo Washout or Sham Procedure
Experimental Surgical Procedures
Collection of Blood Samples (Venipuncture)
Collection of Other Samples/Specimens (e.g., saliva, urine)
Storage of Data and/or Specimens for Future Research
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
Collection of Genetic Specimens or Genetic Testing Studies
PROTECTED HEALTH INFORMATION:
Specify if the study 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 hospital or clinical 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. Note: 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:
Specify who will be responsible for subject recruitment. Check all boxes that apply to the research.
Study Team from the reviewing institution will be responsible subject recruitment.
UCI Study Team Members will be responsible for subject recruitment.
Other (specify):
Recruitment Materials – Check all boxes that apply to the research study.
Recruitment Materials approved by the Reviewing IRB will be used. Note: A copy of all
Applicable IRB approved Recruitment Materials must be submitted to the UCI IRB for review.
Recruitment Materials approved by the Reviewing IRB and modified for UCI will be used. Note:
A copy of all applicable UCI specific Recruitment Materials must be submitted to the UCI IRB
for review.
There are no Recruitment Materials.
INFORMED CONSENT PROCESS:
Specify who will be responsible for obtaining informed consent from subjects. Check all boxes that apply to the research study.
Study Team from the reviewing institution will be responsible for obtaining informed consent.
UCI Study Team Members will be responsible for obtaining informed consent.
Other (specify):
Specify the IRB-approved Informed Consent Process. Check all boxes that apply to the research.
Signed Informed Consent is required Note: A copy of all applicable IRB approved Consent
Document(s) must be submitted to the UCI IRB for review.
Signed Assent is required Note: A copy of all applicable IRB approved Assent Form(s) must
be submitted to the UCI IRB for review.
Signed HIPAA Authorization is required
Waiver of Informed Consent (i.e., No Consent) has been granted by the Reviewing IRB
Waiver of Assent (i.e., No Assent) has been granted by the Reviewing IRB
Waiver of Signed Informed Consent has been granted by the Reviewing IRB
Waiver of Signed Assent 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 Authorization has been granted by the Reviewing IRB
Consent Documents – Check all of the following boxes that apply to the research study.
Reviewing IRB Approved Consent Document(s) will be used. Note: A copy of all applicable
IRB approved Consent Document(s) must be submitted to the UCI IRB for review.
Reviewing IRB Approved Consent Document(s) modified for UCI will be used. Note: A copy of
all applicable UCI specific Consent Document(s) must be submitted to the UCI IRB for review
and approval.

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 research team on this application (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 research 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 read the IRB Application and Protocol Narrative and

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.

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Typed Name of UCI Department Chair/ORU Director

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Signature of UCI Department Chair/ORU Director

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Date

INVESTIGATOR’S ASSURANCE

University of California, Irvine

Institutional Review Board

Study Title:

As Lead Researcher, I have ultimate responsibility for the performance of this study, the protection of the rights and welfare of the human subjects, and strict adherence by all co-investigators and research personnel to all Institutional Review Board (IRB) requirements, federal regulations, and state statutes for human subjects research.
I hereby assure the following:
1.  The information provided in this application 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 will be performed 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 IRB as necessary to ensure these are identical.
I 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 of all human subjects or their legally authorized representatives (unless waived) and using only the currently approved, stamped consent form (if applicable).
2.  Making no changes to the approved protocol or consent form without first having submitted those changes for review and approval by the UCI IRB, unless the changes are necessary to eliminate an apparent immediate hazard to subjects. Changes made to eliminate hazards to subjects must be reported to the IRB via the AE/UP reporting process within 10 working days.
3.  Reporting any internal and external adverse events, unanticipated problems, and/or protocol violations per UCI IRB policy. Some events are reportable within 10 working days of the researcher’s initial awareness of the event via the electronic AE/UP reporting process; others are reportable in a Summary Log at Continuing Review. In addition, 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.
4.  Responding appropriately to participants’ complaints or requests for information about the study; and reporting to the IRB any participant complaints that are not resolvable by the study team.
5.  Promptly providing the 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.  Registering clinical trials 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 review prior to study expiration (I understand if I fail 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. The Office of Research Oversight (ORO) in the School of Medicine performs ongoing routine reviews of open biomedical research protocols, 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. In addition, the HRP unit of the Office of Research has developed the Education Quality and Improvement Program (EQUIP). Through EQUIP, HRP staff conduct periodic quality improvement monitoring and educational outreach. EQUIP study monitoring primarily focuses on those studies conducted at the UC Irvine campus and typically includes social and behavioral research projects.
11.  Filing a final report with UCI HRP at the conclusion of this project.

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