FORM: Application for Initial Review
NUMBER
HRP-211
DATE
11/26/2013
Use for new proposals
(Make copies of pages as needed)
PAGE
1 of 6
IRB Number: (if known)
Protocol Name:
Principal Investigator Name, Email, Phone:
PI Department:
PI Title:
Primary Contact Name, Email, Phone:
Author of Protocol
☐ UC Davis Researcher
☐ Researcher From Other Institution
☐ Private Sponsor
☐ Cooperative Group
☐ Other:
Name of Funding Source
Funding Source ID
Funding Sources
Grant Office ID and Grant Title, if applicable
Names of all personnel involved in this protocol’s design, conduct, or reporting
Name and Title
Institution and Department
Involved in
consent?
Principal Investigator:
Co-Principal Investigator:
Please note a Co-PI is required for
clinical trials
Investigators and staff conducting research involving more than minimal risk to subjects must complete the CITI human subjects online
training program. Investigators and staff conducting research involving no more than minimal risk to subjects must complete either the online
CITI program or the NIH Program. Investigators and staff conducting clinical trials are required to take GCP training, either through CITI or by
providing a copy of their ACRP or SoCRA certification. Required training must be renewed every three years
NIH Protection
CITI Human
Human Research
CITI GCP
ACRP/SoCRA
Involved in
Name and Title
Subjects Training
Participants
Training
Certified
consent?
Course
Course (PHRP)
FORM: Application for Initial Review
NUMBER
DATE
PAGE
HRP-211
11/26/2013
2 of 6
Financial Interest Declaration
 “Related Financial Interest” means any of the following interests in the sponsor, product(s) or service(s) being tested, or competitor of the sponsor held
by the individual or the individual’s immediate family that was received within the last 12 months or that you expect to receive in the next 12 months:
o Ownership interest of any value including, but not limited to stocks and options, exclusive of interests in publicly-traded, diversified mutual funds.
o Compensation of any amount including, but not limited to honoraria, consultant fees, royalties, or other income.
o Proprietary interest of any value including, but not limited to patents, trademarks, copyrights, and licensing agreements.
o Board or executive relationship, regardless of compensation.
o Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated
research institute, academic teaching hospital, or medical center.
 “Immediate Family” means spouse, domestic partner, children, and dependents.
Yes
No
Yes
NA
No
Yes
No
Do any personnel involved in the design, conduct, or reporting of the protocol have a Related Financial Interest, as defined
above?
If yes to above, have you submitted the appropriate financial interest disclosure forms (e.g., 700-U, Form 800 and
Supplemental Form), which can be found at the Office of Research Forms webpage?
If yes, please attach determination from the Conflict of Interest Committee (COIC).
Does your study have any actual or perceived conflict of interest as defined by institutional policies PPM 230-05 or PPM 23007, which can be found at the Office of Research Policies webpage?
If yes, please attach determination from the Conflict of Interest Committee (COIC).
Provide an Investigator Protocol (See TEMPLATE PROTOCOL (HRP-503) for instructions)
Provide the following documents when they exist or are applicable:








Point-by-point response (For a response to modifications to secure approval, deferral, or disapproval)
Evaluation of any Related Financial Interest.
Appendices to this form
Written materials meant to be seen or heard by subjects
o Evaluation instruments and surveys
o Advertisements (printed, audio, and video)
o Recruitment materials and scripts
o Consent documents (The IRB does not require an informed consent document for HUD use.)
o If consent will not be documented in writing, a script of information to be provided orally to subjects
o Foreign language versions of the above
Complete sponsor protocol
DHHS grant application, DHHS protocol, and DHHS-approved sample consent document
For Department of Energy (DOE) research, a completed “Checklist for IRBs to Use in Verifying that HS Research Protocols are In Compliance with
Department of Energy (DOE) Requirements”
Sponsor Fee Form
Yes
No
Does your study involve cancer patients or their data (i.e. data, Medical records, etc.)?
If yes, please attach approval from the Cancer Center Scientific Review Committee (CCSRC).
Yes
No
Does your study involve radiation?
If yes, please attach approval from the Radiation Use Committee (RUC).
Yes
No
Does your study involve stem cells?
If yes, please attach approval from the Institutional Biosafety Committee (IBC).
Approval from the Stem Cell Research Oversight Committee (SCROC) is also required.
Yes
No
Does your study have any actual or perceived conflict of interest as defined by institutional policy?
If yes, please attach determination from the Conflict of Interest Committee (COIC).
Yes
No
Yes
No
Does your study involve Recombinant DNA Molecules and Human Gene Transfer?
If yes, please attach


Approval Letter from the NIH Recombinant DNA Advisory Committee (RAC) and
Approval Letter from the UC Davis Institutional Biosafety Committee (IBC).
Does your NEW study include patient care services billed in the UC Davis Health System?
If yes, please complete the Qualifying Clinical Trials form (QCT) and attach with the submission.
FORM: Application for Initial Review
NUMBER
DATE
HRP-211
11/26/2013
Principal Investigator Acknowledgement
PAGE
3 of 6
I will conduct this protocol in accordance with requirements in the INVESTIGATOR MANUAL (HRP-103) listed in the section “What are my obligations
after IRB approval?” Please also attach ADMNISTRATIVE APPROVALS (HRP-226).
I attest that the personnel delegated are qualified to perform the protocol procedures assigned to them and that all conflicts of interest these individuals
have with this research have been reported to the UC Davis Conflict of Interest Committee. I also attest that these individuals have received the training
or have the qualifications indicated above. (electronic signatures not accepted at initial review)
Principal Investigator signature
Date
FORM: Application for Initial Review
NUMBER
DATE
PAGE
HRP-211
11/26/2013
4 of 6
Appendix A: External Sites
Complete for each external site at which the principal investigator will conduct or oversee the protocol
Site name
Contact name
Contact phone or email
Will site’s IRB
review the
protocol?
Yes
No
Will site rely on
this institution’s
IRB?
Yes
No
FORM: Application for Initial Review
NUMBER
HRP-211
DATE
11/26/2013
PAGE
5 of 6
Appendix B
Drugs, Biologics, Dietary Supplements, and Foods
List all:
 Unapproved drugs/biologics being used in the protocol
 Approved drugs/ biologics whose use is specified in the protocol1
 Foods or dietary supplements whose use is specified in the protocol
Generic Name
Brand Name
Submit a package insert or investigator
brochure for each listed drug
Protocol is being
conducted:
Under IND#
IND#(s)
Submit evidence of IND#(s)2
Without IND#
Sponsor
Who holds the IND?
Submit approved IND application(s)
(Form 1571) and FDA approval letter(s))
for IND#(s)
Investigator
Other
Specify:
“Specified in the protocol” means that the protocol requires the one or more subjects to use the drug, biologic, dietary
supplement, or food as part of study participation, regardless of whether its use is standard of care. For example, if the
protocol indicates that “subjects in group 1 will take 650 mg of aspirin in response to a headache” the use of aspirin is
specified by the protocol. If the protocol indicates that “subjects in group 1 may take 650 mg of aspirin in response to a
headache” the use of aspirin is not specified by the protocol
2
Acceptable evidence includes: Sponsor protocol with the IND#, communication from the sponsor documenting the IND#,
or FDA approval letter indicating IND#
1
FORM: Application for Initial Review
NUMBER
HRP-211
DATE
11/26/2013
PAGE
6 of 6
Appendix C
Devices
List all:
 Investigational and/or cleared/approved devices being evaluated for safety or effectiveness
 Humanitarian Use Devices (HUD)
Name
Submit product labeling for each item
listed
Under IDE#
Protocol is being
conducted:
Under HDE#
IDE#(s) or
HDE#(s)
Under abbreviated IDE requirements
Submit evidence of IDE#(s) or DE#(s)3
Submit an explanation of why the device
is a non-significant risk
None of the above
Sponsor
Who holds the IDE?
Other
3
Submit approved IDE application(s) and
FDA approval letter(s) for IDE#(s)
Investigator
Specify:
Acceptable evidence includes: Sponsor protocol with the IDE#/HDE#, communication from the sponsor documenting the
IDE#/HDE#, or FDA approval letter indicating IDE#/HDE#