Effect of Spice Consumption on the Microbiome in Healthy Subjects: A Pilot Study
Phase: NA
Conditions: Microbiota
Sponsor: University of California, Los Angeles

UNIVERSITY OF CALIFORNIA, LOS ANGELES 
BERKELEY • DAVIS • IRVINE • LOS ANGELES • MERCED • RIVERSIDE • SAN DIEGO • SAN FRANCISCO 
 
UCLA 
SANTA BARBARA • SANTA CRUZ 
DAVID GEFFEN SCHOOL OF MEDICINE AT UCLA 
CENTER FOR HUMAN NUTRITION 
1000 VETERAN AVENUE, A-650 REHAB. BUILDING 
BOX 951742 
LOS ANGELES, CALIFORNIA 90095-1742 
PHONE: (310) 206-1987 
FAX: (310) 206-5264 
November 1, 2019 
PRS Reviewer 
Clinicaltrials.gov 
To whom it may concern 
Thank you for your review of (NCT03676803, IRB# 17-000617 with most recently updated 
approval dated August 11, 2017) study titled “Effect of Spice Consumption on the 
Microbiome in Healthy Subjects: A Pilot Study”, per your request, I am submitting the IRB 
application.  
If possible, we would like to keep this documentation confidential. 
Sincerely, 
Zhaoping Li, MD, PhD 
Professor of Medicine 
UCLA Geffen School of Medicine 
Chief, UCLA Center for Human Nutrition 

Date: Tuesday, October 15, 2019 12:16:07 PM
ID: IRB#17-000617
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Study Title and Key Personnel
All items marked with a red asterisk (*) are required. Items without an asterisk may or may not be required depending on
whether the items are applicable to this study.
1.0
*Full Title of the Submission: 
Effect of Spice Consumption on the Microbiome in Healthy Subjects: A Pilot Study
Protocol Version Date and/or Number: 
Version 1.0, Dated 3/1/2017
2.0
*Working or Lay Title:  
The effect of spice consumption to increase the good bacteria in the human
3.0
Principal Investigator:
*Name: ZHAOPING LI
Degree(s):  If degrees are not shown here, please add them to
the next section, Section 1.1a/Item 1.0, which will then update the
Principal Investigator's webIRB account information.
MD, PhD
UCLA Title:  Professor of Medicine
*Will the Principal Investigator conduct the informed consent
process with potential study participants? 
Yes
No
Not Applicable
*Is the Principal Investigator an undergraduate student,
graduate student, post-doctoral fellow, or resident
physician?
Yes
No
If you answered "yes" to the above question, indicate the
Faculty Sponsor for this study.  
UCLA Policy 900 defines types of UCLA employees who may
be eligible to serve as a Principal Investigator. Check the
policy to see if the Principal Investigator for this study needs
an exception to the eligibility requirements. 
If
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ID: IRB#17-000617
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Other Personnel
All items marked with a red asterisk (*) are required. Items without an asterisk may or may not be required depending on
whether the items are applicable to this study.
1.0
Principal Investigator
  Name: ZHAOPING LI
*Please type the Degree(s): MD, PhD
  Principal Investigator's UCLA Department: MEDICINE-VA
WADSWORTH MED CTR
*Protocol's UCLA Home Department: MEDICINE-CENTER
FOR HUMAN NUTRITION
This response defaults to the PI’s payroll department. If you wish
to affiliate this protocol with another department, please select the
department from the list above.
For tips on effective search, please see guidance to the right.
2.0
If there will be other types of personnel working directly under the PI's supervision on
aspects of the study, provide their name, title and institution, indicate their
responsibilities, training and qualifications and complete Item 2.1.  
Please also indicate, if applicable, whether that person will obtain consent, manage device
accountability, have access to personally identifiable information and/or have access to the code key.
Please use a new entry to add each individual unless describing a class of individuals who rotate
through the study team (see guidance area to the right).
Note: If there will not be other types of personnel go to Item 3.0. 
Name, title,
institution
Study role(s): e.g., conduct interviews/surveys, recruit participants, obtain consent, review
records, etc.
There are no items to display
For existing protocols:  Item 2.0 has been modified and this
item cannot be edited.  When submitting an amendment
please use the information found in the text box below to
complete Item 2.0 above.
Briefly describe the other study personnel.
1.1
1.2
1.3
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ID: IRB#17-000617
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Type of Study Review
1.0
*Indicate the level of risk involved with this study.
(if there are multiple groups or phases associated with this study, select the highest level of risk.)
Minimal risk or no known risks - Click here for the OHRPP tip sheet on minimal risk.
Greater than minimal risk
2.0
*Indicate the type of review that you are requesting for this study. 
IRB Review: Expedited or Full Board
Certification of Exemption from IRB Review
If you indicated “IRB Review: Expedited or Full Board” as the type of review in item 2.0,
select the IRB that you think best matches your research.
Name
Description
Medical Institutional
Review Board 1
MIRB1 reviews general and internal medicine,
infectious diseases and ophthalmologic research.
Medical Institutional
Review Board 2
MIRB2 reviews oncology and hematology research.
Medical Institutional
Review Board 3
MIRB3 reviews neuroscience, neurology, psychiatric,
drug abuse and dental research.
North General
Institutional Review Board
NGIRB reviews research from the College of Letters &
Science and the Professional Schools.
South General
Institutional Review Board
SGIRB reviews social-behavioral research from the
Schools of Public Health, Nursing, and Medicine.
Please note: The above requests are for initial routing purposes only. The final decision
as to committee assignment and type of review, rests with OHRPP and/or the IRBs.
ID: IRB#17-000617
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Conflict of Interest Information
1.0
* Does the Principal Investigator, any of the key personnel, or their spouses, registered
domestic partners, or dependent children, have a financial interest in the sponsor
(profit, non-for-profit) of the research?
Yes
No
If yes, attach a completed copy of the Financial Interests Form for each person who
indicates a financial or related interest:
Document Name
Document Version #
There are no items to display
2.0
* Does the Principal Investigator, any of the key personnel, or their spouses, registered domestic partners,
or dependent children, have any financial interests related to the research sponsored by a government
agency?
Yes
No
If yes, attach a completed copy of the Financial Interests
Form:
Document Name
Document Version #
There are no items to display
3.0
* Indicate whether any of these financial interests have been submitted to or reviewed by the UCLA
campus Conflict of Interest Review Committee (CIRC):
Yes
No
If you have received a response from CIRC, attach it here: 
Document Name
Document Version #
There are no items to display
ID: IRB#17-000617
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1.1
2.1
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Study Locations
1.0
*Indicate the locations where any research activities will be performed by the UCLA
research team with participants and/or private information obtained. 
Check all that apply:
a. UCLA Sites or UCLA Health System Sites
b. Off Campus (in California)
c. Outside California (in the U.S.)
d. Outside the United States *See note at right
e. Internet
If you selected b, c or d above, please provide your
assurance that documentation of each site's permission to
conduct the research at the site(s) will be obtained and
maintained by the UCLA PI as applicable: 
Agree
2.0
*Is this a multi-institutional study (i.e., a collaborative project with other sites that
have their own IRBs or principal investigators)? 
(Includes but not limited to UC MOU and CTSI MOU collaborations where UCLA IRB review is
requested.)
Yes
No
If no, please skip directly to the next page, do not complete the questions below.
If yes, please answer items 2.1-2.3:
Will UCLA be responsible for the overall direction of the study at the other institutions?
Yes
No
Indicate the measures that will be taken to assure regulatory
compliance at each site and that the following types of
information will be communicated to the other sites: study
procedures; modifications to the protocol and related
documents; and safety updates, interim results and other
information that may impact risks to study participants. 
Check all that apply:
Conference calls or meetings with minutes distributed to
each site
1.1
2.1
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ID: IRB#17-000617
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Project Identification Information
1.0
*Type of Submission (Select one) 
Research Study
Application for Approval of "Research Participant Pool" or recruitment database only
2.0
*Type of Submission (Select one) 
For Amendments, do not undo the response below.  Undoing the response may remove sections of the
original application.
New Submission
Transfer of Ongoing Research from Another Site from Investigator moving to UCLA. Please complete Item
2.1.
If you selected "Transfer of Ongoing Research" in Item 2.0
indicate the current status of the study and a brief summary
of the work to date.
3.0
*Who developed this study?
Check all that apply:
UCLA investigator
Investigator from another institution
Industry/Pharmaceutical Company
Cooperative Group (e.g., Children's Oncology Group, AIDS Clinical Trial Group)
Other
If other, specify.
4.0
Review For and Reliance Upon External IRBs.
*Indicate if one of the following applies to this study. (Select one)
None of the options apply.
UCLA IRB to serve as IRB of record for another institution.
UCLA to RELY on another IRB.
This includes reliance using UC MOU, CTSI, NCI, RAND, and Western IRBs.
2.1
3.1
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ID: IRB#17-000617
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Lay Summary and Keywords
Please provide the following information about your study.
1.0
*Provide a brief lay summary describing this study.  (limit 500 words).
This proposed pilot study will assess the ability of daily consumption of 5 grams of mixed spices to alter the gut
microbiome composition compared to placebo in a free-living population. 30 subjects will be randomized to
consume either 5 grams of spice or matched placebo for 2 weeks in random sequence. Stool samples will be
collected at baseline and week 2 for sequencing of bacterial DNA to determine changes in the microbiota. The
objective of the proposed pilot study is to determine whether intake of spice per day will alter the intestinal
microflora leading to an increase in formation of short chain fatty acids. This project will provide novel preliminary
data for future research studies and to develop new consumer messages on the gut health benefits of spices.
New consumer information about the health benefit of spices will enhance the domestic and exported spice
industry and increase consumption of spices.
2.0
*List three to five keywords describing this study (separate the words with commas).  The keywords may
be used for identifying certain types of studies.
Spice, Microbiome, Healthy
3.0
* Is this study conducted or supported by HHS (e.g., the National Institutes of Health, Centers for Control
and Prevention, etc.)?
Yes
No
4.0
* Is this study regulated by the Food and Drug Administration (FDA)?
Yes
No
If yes, check all that apply:
Human Drugs
Medical Devices
Biological Products
Mobile Medical Applications
Food Additives
Color Additives
Other
ID: IRB#17-000617
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Methods/Procedures - Descriptors
Note: The items listed below are not an inclusive list of methods and procedures that may be used in research studies.
The list only includes items that will trigger additional questions related to the research or are needed for the review
process
1.0
*Indicate all that apply to this study. 
Audio, Visual or Digital Recordings
Certificate of Confidentiality for research not supported by NIH
Clinical Trial of a Drug, Biologic, Device or a Behavioral Intervention
Community Based Research
Controlled Substances (Schedule I or II)
Deception or Partial Disclosure
Devices/Diagnostics (including Humanitarian Devices - HUD)
Drugs/Biologics/Dietary Supplements
Expanded Access to Drug, Device or Biologic for Treatment Purposes (aka Compassionate Use, Treatment
Use)
Genetic Analyses/Genotyping
Human Embryonic Stem Cells and/or Induced Pluripotent Stem Cells
Human Gene Transfer/ Recombinant DNA
Infectious Agents
Non-FDA approved medical equipment used with UCLA hospital patients or research participants that
operate under the UCLA Hospital License.
Radiation (Standard of Care or Investigational Use of radioactive materials, radiation producing machines or
ionizing radiation)
Substance Abuse Research (with Medication)
Treatment in an Emergency Setting (with request to waive consent)
None of the above
2.0
*Will the study require services or resources owned/rented/operated or provided by the
UCLA Health System (e.g. clinic and/or hospital visit(s), CTRC, professional medical
services, clinical treatment, diagnostics, labs, medical supplies, etc.)?
Please direct any questions about this to The Financial Coverage & Activation Team at
coverageanalysis@mednet.ucla.edu.
Yes
No
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ID: IRB#17-000617
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Coverage Analysis
1.0
*Will all protocol-required items and services that produce data for the study be funded
by intramural or extramural funding/support?
Yes - we will not bill participants or their insurers for any protocol-required items or services
No - we will bill one or more protocol-required items or services to participants or their insurers
Not Applicable – this is a non-interventional study (e.g., observational/registry/retrospective study without
active treatment) that does not require additional visits, labs, items or services performed solely due to study
participation
Note:
If “Yes” is selected to the question above, then the corresponding “Research Only” cost language
in the guidance to the right should be included in the ICF, and an abbreviated coverage analysis
review is indicated.
If “No” is selected to the question above, then the “Mixed Cost” language in the guidance to the
right should be included in the ICF, and a full coverage analysis review is indicated.
If “Not Applicable” is selected to the question above, then coverage analysis may not be
applicable, and the corresponding “All Standard of Care” cost language in the guidance on the
right should be included in the ICF.
2.0
*Is your study any of the following?
Treatment Use (Expanded Access, Compassionate Use, or a Humanitarian Use Device)
Hematology-Oncology Clinical Research Unit Study
UCLA reliance on an external IRB review
Yes
No
Note:  If you have selected yes, then continue with question 3.0 below.
3.0
Please upload a copy of your study protocol below:
Document Name
Document Version #
Protocol CLEAN 071017
0.02
Protocol TRACKED 071017
0.03
4.0
The following item pertains to investigational drugs and devices only.
If the study participant or a third party payor (i.e., medical insurance/Medicare/Medicaid) may be billed for
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ID: IRB#17-000617
View: NEW 6.1 - Funding and Other Study Characteristics
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Funding and Other Study Characteristics
1.0
*Indicate the funding status for this study. 
Funded
Application for funding is pending
Departmental funding / Self funding / No funding
2.0
*Check all that apply:
The research will be conducted through the UCLA Clinical and Translational Research Center (CTRC)
The study will be supported by or conducted in collaboration with the U.S. Department of Defense (DOD)
The study will be supported by or conducted in collaboration with the U.S. Department of Energy (DOE)
The study will be supported by or conducted in collaboration with the U.S. Department of Justice (DOJ)
The study will be supported by or conducted in collaboration with the U.S. Department of Education (ED)
The study will be supported by or conducted in collaboration with the U.S. Department of Protection Agency
(EPA)
None of the above
If you selected DOD, DOE, DOJ, ED, and/or EPA
support/collaboration, please provide your assurances that
you will review the additional requirements for research
supported by the relevant federal agency.
Agree
Note: Please refer to the Federally-Supported Research section
of the OHRPP guidance document: Funding Considerations for
Federally-Funded and Industry-Sponsored Human Research.
ID: IRB#17-000617
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Study Design
1.0
*Check all that apply to the study design.
Direct subject contact ONLY – The research activities involve direct contact with study
participants (e.g., collection of data or specimens in person or via internet, phone, mail, etc.)
No direct subject contact – None of the research activities involve direct contact with study participants
and include only analyses of data, records and/or human biological specimens (e.g., medical record or other
record review, study of specimens left over from clinical procedures).
BOTH Direct subject contact AND No direct subject contact – Some of the research activities involve
direct contact with study participants and some of the research activities involve analyses of data, records
and/or human specimens obtained without contact with participants.
ID: IRB#17-000617
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Clinical Trial of a Behavioral Intervention, Drug, Biologic or Device
You indicated that this study includes a clinical trial (section 2.3/item 1.0). Please provide the following information
1.0
*Indicate the type of clinical trial.
Check all that apply:
Randomized
Non-randomized
Single Blinded
Double Blinded
Placebo
Sham Control
Active/Treatment Control
Open Label
Crossover
Washout Period
Dose Escalation
Other
If you indicated "other", specify.
2.0
*Indicate the type of clinical trial: 
Pilot/Feasibility
Phase I
Phase I/II
Phase II
Phase II/III
Phase III
Phase III/IV
Phase IV
Open Label Extension/Rollover
Expanded Access
Behavioral
3.0
*Indicate the status of registration of registering this trial with ClinicalTrials.gov 
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ID: IRB#17-000617
View: NEW 8.6 - Drugs/Biologics/Dietary Supplements
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Drugs/Biologics/Dietary Supplements
You indicated that this study includes drugs/biologics/dietary supplements (section 2.3/item 1.0). Please provide the
following information.
1.0
Approved Drugs or Biologics:  List any drugs or biologics that will be used in this study in accordance
with their approved labeling.
The UCLA Pharmacy will not dispense drugs that have been procured from an external pharmacy or
compounding pharmacy.  Contact the UCLA Pharmacy - Investigational Section at (310) 267-8522 if you
require a compounded drug for the study.
2.0
Enter any drugs/biologics that will be used as part of this study that do not fit in response to item 1.0
above. 
Generic name
of the
drug/biologic
Investigational Drug/Biologics Information
View Spice Blend
The trade name of the
Drug/Biologic:
No Value Entered
Indicate the manufacturer:
McCormick Scientific Institute 
Indicate the source of the
study drug/biologic:
Other 
If you indicated "Other"
and/or that the study
drug/biologic is being
provided by a pharmaceutical
company other than the
sponsor, identify the source:
McCormick Scientific Institute 
Attach the Investigator's
Brochure (IB) or package
insert
Document
Name
SPICE BLEND INGREDIENT
LIST
Document
Version #
0.01 
Indicate the regulatory status
of the drug or biologic:
Investigational Use of a Marketed Drug or Biologic:
The drug/biologic will be used off-label for an indication
not in the approved labeling. 
Investigational Use of a
Marketed Drug or Biologic:
Describe the
approved
indications for
the use of the
drug/biologic
and how the
Spices are generally used to
flavor food products. The
spice mixture in this pilot
study is intended only to
advance scientific
understanding in the area of
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ID: IRB#17-000617
View: NEW 9.2 - Information about Study Data
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Information about Study Data
This information is needed to determine how you will best protect the confidentiality of data.
1.0
*Indicate all that apply to the study data.
Check all that apply:
Obtained from a medical or clinical record
Created or collected as part of health or mental health care
Used to make healthcare or mental healthcare decisions and/or provided to other healthcare professionals
Research data will be entered into the participants' medical or clinical record
None of the above
2.0
*Is it reasonably foreseeable that the study will collect information that State or Federal law requires to be
reported to other officials (e.g., child or elder abuse), ethically requires action (e.g., suicidal ideation), or is
a reportable disease?
Yes
No
If yes, explain below and include a discussion of the
reporting requirements in the consent document:
3.0
*Indicate if any of the following are being obtained and used without any direct contact with study
participants.
Records (Not medical)
Human biological specimens
None of the Above
4.0
*Indicate all identifiers that may be accessed or included in the research records for the study:
Names
Dates
Age (if over 89 years)
Postal Address
Phone Numbers
Fax Numbers
E-Mail Address
Social Security Number
Medical Record Number
Health Plan Numbers
Account Numbers
2.1
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ID: IRB#17-000617
View: NEW 9.2a - Privacy and Confidentiality
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Privacy and Confidentiality
Important Notes:
·
Privacy is about people. Privacy refers to a person's wish to control the access of others to
themselves. 
·
Confidentiality is about data. Confidentiality refers to the researcher's plan to handle, manage,
and disseminate the participant's identifiable private information.
See OHRPP Quick Guide: Protecting Privacy and Maintaining Confidentiality
1.0
*Privacy: How will the investigator maintain privacy in the research setting(s)?
(e.g., interviewing participant in a room or area where conversations cannot be overheard by others, or
conducting medical procedures in an examination room, or behind a curtain in an emergency room).
All data files have safeguards to maintain the anonymity of participants and to bar unauthorized personnel. The
subject forms are kept in locked files according to legal requirements.
2.0
*Confidentiality:  If the protocol will collect and maintain identifiable data, explain how the planned
safeguards to maintain confidentiality of identifiable data and data security are appropriate to the degree
of risk from disclosure.
Note: Other sections of the application (e.g., Sections 9.3, 9.3a, 9.4, 9.5, and 15.3) will
request specifications such as identification of persons who will have access to code keys
or measures to comply with HIPAA requirements.
All identifiable subject data will be maintained in a private office in locked file cabinets. The research office is only
accessible to research personnel.
ID: IRB#17-000617
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Data Security
You indicated that the study team will have access to personally identifiable or coded information (Section 9.2/item 5). 
Please complete the following items.
1.0
*Do you agree to follow the OHRPP Data Security in Research guidance and procedures?
Yes
I have an alternate equally effective plan (Note: The plan must be attached to item #2.1)
2.0
*Do you have a data security plan for this study? (Note: a plan is not required for all studies; it may be
recommended in some instance).
Yes
No
If yes, attach it here:
Document Name
Document Version #
There are no items to display
3.0
*Indicate all that apply to personally identifiable information or codes during conduct of the study:
The data and/or specimens will be coded
The personal identifying information will be removed and destroyed
Personally identifying information will be maintained with the data and/or specimens
If you indicated that the personal identifying information will
be removed or destroyed or that the data/specimens will be
coded, provide the following information:
The process for removing and destroying the personal
identifying information or for coding the information, and
Indicate who will perform the task
Study coordinator will label all specimens with codes only and
processed internally through research labs. Paper records all
contain identifying information and will be maintained in the
Center for Human Nutrition under a double-locked system with
restricted access by study personnel only. Paper documents may
be maintained for up to three years after the completion of study,
after which time they will be destroyed by shredder.
4.0
*Will coded or personally identifiable data be collected, transmitted or stored via the internet?
Yes
No
If
i di
t
ll th t
l
2.1
3.1
4 1
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ID: IRB#17-000617
View: NEW 9.4 - Data Security Plan - During the Study
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Data Security Plan - During the Study
You indicated that data and/or specimens for this study will be coded (Section 9.3/item 3).  Please complete the following
information.
1.0
During the study indicate how data will be stored and secured including paper records, electronic files,
audio/video tapes, specimens.  Specify how the code key will be securely maintained, as applicable.
Check all that apply:
*Electronic Data
Encryption or password protection software will be used
Secure network server will be used to store data
Stand alone desktop computer will be used to store data
(not connected to server/internet)
A contracted outside vendor will store the code key. The
vendor will have a business associate agreement with
UCLA.
Other
Not Applicable
*Hardcopy Data, Recordings and Specimens
Locked file cabinet or locked room with limited access
by authorized personnel
Locked lab/refrigerator/freezer with limited access by
authorized personnel
The code key will be kept in a locked file in a locked room
The coded data and/or specimens will be maintained in
a different room
Other
Not Applicable
If you indicated "Other" in item 1.1 or 1.2 above, describe
here.
2.0
*By checking this box, I provide my assurance that all the person(s) who will have access to the code key
have been identified in section 1.1 or section 1.1a.
Agree
ID: IRB#17-000617
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1.1
1.2
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Data Security Plan
You indicated that the study will have access to personally identifiable or coded information (Section 9.2/item 5).  Please
complete the following items:
1.0
*After the study is completed, indicate how the data codes and/or personal identifying
information will be handled. 
Check all that apply:
All data files will be stripped of personal identifiers and/or the key to the code destroyed.
All specimens will be stripped of personal identifiers and/or the key to the code destroyed.
Personal identifiers and/or codes linking the data and/or specimens to personal identifiers will be maintained
for future research.
Audio or Video recordings will be transcribed and then destroyed or modified to eliminate the possibility that
study participants could be identified.
Photos or Images will be modified to eliminate the possibility that study participants could be identified.
Restricted use data will be destroyed or returned to the source.
If you indicated that personal identifiers will be maintained
for future research, provide the following information:
  a) How the information will be securely handled and stored
  b) assure confidentiality, and
  c) who will have access to the identifiers and/or codes.
2.0
Describe any additional steps, if any, to be taken to assure that the subjects' identities and any personal
identifying information are kept confidential.
ID: IRB#17-000617
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Study Summary - Research Study
1.0
Study Materials:  As applicable to this study, attach the following:
Protocol, Dissertation Proposal or Study Plan
Preliminary Data 
Surveys, Questionnaires or other instruments to be used with study participants
References
Document Name
Document Version #
Bristol Srool Chair
0.01
BSQ
0.01
Protocol Clean Copy 071017
0.02
Protocol Tracked 071017
0.03
SF-36
0.01
2.0
*Specific Aims: Indicate the purpose of the research, specifying the problems and/or
hypotheses to be addressed.
Primary outcome measures:
Intestinal microbiome composition
Secondary outcome measure:
1. Fecal short chain fatty acids
2. Blood rosmarinic acid and cinnamaldehyde
3. Urine malondialdehyde (MDA)
4. Digestive Health and General Wellness questionnaires
3.0
*Background and Significance: Provide a summary of the background for this study and
explain how it will contribute to existing knowledge. 
For greater than minimal risk biomedical studies, include preliminary data.  If
necessary, attach in Item 1.0 graphs or tables used to convey information.  If there no
preliminary data are available, briefly indicate why this proposed study is a reasonable
starting point.
The bacterial composition of the intestinal microbiome has been linked to the development of chronic diseases
including obesity, metabolic syndrome, type II diabetes and heart disease. Spices are a rich source of
polyphenols and fiber. It has been demonstrated in animal studies that fruits and vegetable with high polyphenol
content and fiber exhibit prebiotic effects leading to changes in the gut microbiome, decrease in symptoms of
metabolic syndrome, improvement in insulin resistance and decrease in intestinal and systemic inflammation.
Several human intervention studies have also been performed that demonstrated beneficial effects of high
polyphenol fruits and vegetable on the intestinal microbiome. No information is available about the effect of spice
consumption on the gut microbiome.
4 0
*Research Design and Methods: Describe in detail the design and methodology of the
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ID: IRB#17-000617
View: NEW 11.1 - Characteristics of the Study Population
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Characteristics of the Study Population
1.0
*Is this an observational or ethnographic study for which the number of participants observed or
interviewed cannot be determined in advance.
Yes
No
2.0
If you answered "no" to item 1.0, indicate the maximum number of study participants
you hope to enroll: 
30 subjects
3.0
How many participants do you expect you will need to recruit, consent and/or screen to meet the target
number above?
35 subjects
4.0
*Indicate the specific inclusion criteria for enrollment of each of the groups of research participants in
this study. 
If there are any inclusion criteria based on gender, pregnancy/childbearing potential, race, ethnicity or
language spoken, explain the nature of and scientific rationale for the inclusions.
• Healthy human adults age 18-65 years old
• Typically consume low fiber/polyphenol diet (beige diet)
5.0
*Indicate the specific exclusion criteria for each of the groups of research participants
in this study.
If there are any exclusion criteria based on gender, pregnancy/childbearing potential,
race, ethnicity or language spoken, explain the nature of and scientific rationale for the
exclusions.
• Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the
absorption of polyphenols.
• History of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatic
or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction,
coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled
hypertension (defined as systolic BP >160mmHg, diastolic BP > 95mmHg), active or chronic gastrointestinal
disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication)
as indicated by medical history or routine physical examination.
• Pregnant or breastfeeding
• Currently uses tobacco products.
• Is unable or unwilling to comply with the study protocol.
• Frequently using prebiotics, probiotics, yogurt, and/or any fiber supplements
• Allergy or sensitivity to spices. Subjects will be excluded if there is a prior history of such sensitivity. Since these
foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the
study. To determine this, a positive history of spices ingestion without incident will be requested. In addition, any
subject with a history of allergy or anaphylaxis of any kind will be excluded
• Taking antibiotics or laxatives within the past 3 months
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ID: IRB#17-000617
View: NEW 11.2 - Characteristics of Study Population
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Characteristics of Study Population
1.0
*Indicate the age range of the study participants.
Check all that apply:
0 to 6 years
7 to 11 years
12 to 17 years
17 or younger in California who can consent for themselves - see note below
17 or younger outside California who can consent for themselves - see note below
18 years or older
NOTE:
For additional information on minors in California who are permitted to consent for themselves please
refer to the section "Legal Exceptions Permitting Certain Minors to Consent" in the OHRPP Guidance
document, Child Assent and Permission by Parents or Guardians
For additional information on minors outside of California who are permitted to consent for themselves
please refer to the section "Exceptions Outside of California" in the OHRPP Guidance document, Child
Assent and Permission by Parents or Guardians
2.0
*Indicate if any of the following populations/specimens will be specifically recruited/obtained for the
study.
Adults who are competent to give informed consent
Adults unable to give informed consent
Adults with diminished capacity to consent
Fetal Tissue
Neonates
Participants Unable to Read, Speak, or understand English
Pregnant Women/Fetuses
Prisoners
UCLA Faculty/Staff
UCLA Students
Wards
Unknown/Not Applicable
3.0
* Is it possible that there may be non-English speakers enrolled in this study or children whose parents
are non-English speaking?
Yes
No
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ID: IRB#17-000617
View: NEW 14.1 - Risks & Benefits
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Risks & Benefits
Benefits
1.0
*Are there any potential direct benefits (physical, psychological, social or other) to
study participants? 
Yes
No
If yes, describe.
2.0
*Describe the potential benefits to society including the importance of the knowledge to
be gained.
A possible benefit to society is the development of a better understanding of the role of spices and gut health.
The results of this study may lead to larger studies.
Risks
3.0
*Indicate the potential risks/discomforts, if any, associated with each intervention or
research procedure.
Additionally discuss any measures that will be taken to minimize risks.  If data are
available, estimate (a) the probability that a given harm may occur, (b) its severity, and
(c) its potential reversibility.  The information provided should be reflected in risks
section of the informed consent documents.
If this is an exempt study and there are no risks, indicate N/A.  Otherwise, please see
the help text.  
Mixed spice blend:
Black pepper and oregano are safe when consumed in food amounts. Cinnamon is likely safe in food amounts.
Possible known side effects for consumption of ginger include heartburn, general stomach discomfort and/or
diarrhea. Cayenne pepper may cause side effects such as stomach irritation and upset, sweating, flushing and
runny nose. There may be unknown side effects of consumption of a blend of these spices. Subjects who are
allergic to cinnamon, oregano, ginger, black pepper or cayenne pepper, should not participate in this research.
Placebo capsules:
There are no known side effects with consuming maltodextrin.
Blood Draw:
There are possible side effects associated with blood collection. These include pain, small bruises, bleeding,
infection, or rarely anemia and fainting.
Unknown risks and discomforts:
The experimental treatments may have side effects that no one knows about yet. The researchers will let
1.1
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ID: IRB#17-000617
View: NEW 15.1 - Data & Safety Monitoring Plan
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Data & Safety Monitoring Plan
1.0
*Is a Data and Safety Monitoring Plan (DSMP) required by the funding agency or other
entity? 
Yes
No
ID: IRB#17-000617
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Data & Safety Monitoring Plan (continued)
Important Note:
All interventional studies involving more than minimal risk must include a Data and Safety Monitoring Plan (DSMP).  A
DSMP is a plan established to assure that each research study has a mechanism for appropriate oversight and
monitoring of the conduct of the study to ensure the safety of participants and the validity and integrity of the data.  The
DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB) or Data
Monitoring Committee (DMC).
Most, but not all studies (i.e., non-interventional studies) undergoing full board review will require a DSMP.  You will need
a DSMP if any of the following apply:
1.  This is a Phase I, II or III clinical trial 
2.  This is an investigator initiated trial (Section 2.1/item 3.0)
3.  This study involves treatment in an emergency setting (Section 2.3/item 1.0)
4.  A Data/Safety Monitoring Plan is required by the funding agency (Section 15.1/item 1.0)
5.  This study is greater than minimal risk (Section 1.1b/item 1.0)
1.0
*Indicate who will be responsible for overseeing the study safety. Check all that apply.
The Principal Investigator
Designee of the Principal Investigator
The DSMP includes at least one person who is not associated with the study
A formally constituted Data and Safety Monitoring Board (DSMB)
Medical monitor designated by the sponsor
Other
If you indicated that a designee would be responsible for
overseeing the study safety, or that the DSMP would include
at least one person not associated with the study, provide
the name(s) of this individual (s). Also, provide a brief
explanation of why this person(s) would be appropriate in
this role(s).
If you indicated "other," describe or indicate where the
information can be found in the attached protocol.
2.0
*Provide your assurance that information about serious, unanticipated problems related to the study
(e.g., adverse events, incidents and violations) will be reported to the IRB within the time frames
specified by the Summary Sheet of Reporting Requirements.
Agree
Provide the following information as appropriate to the study:
1.1
1.2
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ID: IRB#17-000617
View: NEW 16.1 - Payment, Costs, and Injury
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Payment, Costs, and Injury
1.0
*Indicate what the participants will receive for their participation in the study. 
Check all that apply.
No payment will be provided
University check
Course Credit
Cash
Gift Cards/Bruincard Deposit
Non-Monetary Gifts or Services
Other (including vouchers for parking)
If you selected Non-Monetary Gifts or Services or Other,
describe:
If you selected Cash and/or Gift Cards/Bruincard Deposit
please specify the estimated total amount of money you will
require to pay all participants during the length of the entire
study.  This information is required by UCLA Business and
Finance Services (BFS), the office that will provide the
cash/gift cards for payment.
2.0
If study participants will receive financial or other payment for their participation
in the study, please provide the following information:
-
If applicable, the amount each participant will receive and the payment schedule to
be followed including whether partial payment will be provided when the participant
does not complete the study.
-
If there are different plans for different populations or sub-studies, specify the
groups and describe the plans.
-
If families or children will be involved in the research, clarify how the payments,
items or services will be apportioned.
Subjects will receive $50 for completion of baseline and week 2 for a compensation up to $100 for the
completion of the study in full. Subjects will not be paid for participation in the screening phase of the
study.
3.0
*Will subjects incur any financial obligations from participation in the study? 
Yes
No
If yes describe:
1.1
1.2
3 1
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ID: IRB#17-000617
View: NEW 17.1 - HIPAA Authorization
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HIPAA Authorization
According to your responses to section 9.2/item 1.0, this study uses protected health information. Please provide the
following information.
1.0
*Indicate all that apply to use of or disclosure of PHI in this study: 
All UC participants will sign a UC HIPAA Research Authorization for Release of Personal Health
Information for Research.
Another Institutions' Healthcare Authorization for Release of Health Information will be used or a
waiver for release of health information will be granted from another Institution.
A Waiver of HIPAA Research Authorization is requested for screening using UC medical records. I
assure that the PHI collected for this study will not be reused or disclosed, except as indicated in this
application.
A Total Waiver of HIPAA Research Authorization is requested for the entire study. I assure that the PHI
collected for this study from UC records will not be reused or disclosed, except as indicated in this
application.
Limited Data Set with a Data Use Agreement will be obtained from UC medical records. I assure that I
will follow the data security plan outlined in this application to protect the identifiers from improper use or
disclosure.
None of the above. This study will be conducted outside the United States
2.0
*Indicate to whom or where you will grant access to personal identifying information (including PHI) as
part of the study process:
There is no plan to share identifiers outside the study team
The study sponsor; on site only (if there is more than one study sponsor, specify below).
A foreign country or countries
Other
If you checked "other", "a foreign country or countries", or if
"there is more than one sponsor", specify.
3.0
*The investigator's agreement is needed to the following: 
- The protected health information requested is the minimum necessary to meet the research
objectives
- The protected health information that is obtained as part of this study will not be used or
disclosed to any other person other than study personnel or to the parties listed in item Section
17.1/item 2, except as required by law.
- Study Sponsors will not be provided with personal identifying information (including PHI) to take
from the study site at any time, including the end of the study.
- Data and specimens shared with outside entities, such as study sponsors, will be coded or de-
identified.
2.1
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ID: IRB#17-000617
View: NEW 18.1 - Identification/Recruitment Methods
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Identification/Recruitment Methods
1.0
*How will you identify and/or recruit participants for this study. 
Check all that apply:
Advertisements/Flyers/Information Sheet/Internet Postings
Direct recruitment of potential study participants (e.g., physicians talking with their own or clinic
patients about the study, contact between the study team and potential subjects in person, on the
phone or on the internet, etc.)
Random or Other Probability Sampling
Recruitment Letters/Emails
Referrals (e.g., referrals from non-investigator healthcare providers, snowball sampling, participants
referring other participants, etc.)
Review of medical records to identify potential research participants
Review of publicly available records
Review of other records
Participant pool for which potential research participants have given permission for future contact
Potential Study Participants are identified from another IRB approved study or IRB approved screening
protocol
Other
ID: IRB#17-000617
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Recruitment Methods
1.0
Please upload copies of your recruitment materials below. This includes advertisements, flyers, internet
postings, recruitment scripts and letters/emails.
Document Name
Document Version #
Flyer 071017
0.02
Flyer CLEAN 071017
0.01
Ads/Flyers/Info Sheets/Internet Postings
2.0
If you have indicated that study participants will be recruited with advertisements/flyers (Section 18.1/Item
1.0), please indicate the type of media that will be used (e.g., newspaper, radio, internet, etc.) and/or where
information will be posted or distributed.
IRB-approved flyers will also be posted around campus and a separate newspaper advertisement will be run if
additional recruitment is necessary.
Direct Recruitment
3.0
If you have indicated that participants will be recruited through direct contact (Section 18.1/Item 1.0),
please provide the following information: 
-
A description of how, when, and where initial contact would be made (e.g. in a
public setting, in a waiting room, via a phone call, via a letter, via the internet, etc.)
-
If applicable to the study, indicate how the potential research participant’s privacy
will be maintained.
-
Who will make the contact (e.g. the investigator, a patient’s physician, etc.)
 If one of the investigators encounters a potential participant in clinical practice, during the course of
conducting another study, or in events of daily professional or private life, the investigator will give the
participant the information of the study coordinator and if appropriate, provide the potential participant
with printed information and/or the informed consent form. The participant will be given time to read the
materials and discuss with their friends, family or outside healthcare providers if desired.
If you will be directly recruiting potential participants who are
your patients, students, laboratory workers or any others
with whom you have a relationship of authority or unequal
power, describe what measures you will put in place to avoid
those approached from feeling pressured or unduly
influenced to participate in the study.
Researchers will make clear in conversation that the decision to
participate in the study is optional and will not adversely affect
any relationship the patient may have with UCLA, another
employer, the researcher, or any mutual affiliation the participant
may share with the researchers.
3.1
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ID: IRB#17-000617
View: NEW 19.1 - Eligibility Screening
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Eligibility Screening
1.0
*Will you be conducting a preliminary assessment with potential research participants to determine
study eligibility during the recruitment process? 
Yes
No
You indicated that eligibility screening will be conducted during the recruitment process (Section 19.1/item 1.0). Please
provide the following information.
2.0
*Will private identifiable information be collected during the screening? 
Yes
No
If private identifiable information is collected during
screening, are there plans to retain data from participants
found to be ineligible for the study?
Yes
No
If private identifiable data will be collected during the
screening, indicate your plans for retaining the data.
The data will be retained with identifiers
The data will be retained without identifiers
The data will be destroyed
If you chose more than one response above, explain.
For participants who qualify to participate, the information will be
retained and become part of their records for contact and
payment purposes. For participants who do not qualify, the
information will be destroyed.
3.0
Describe how screening will be performed.
Out of consideration for the participant's time, and to avoid unnecessary use of research team resources, a
telephone screening interview will be done prior to scheduling the participant for a screening visit. During the
visit, the informed consent process will be completed prior to the conduct of any further study procedures.
4.0
Attach screening script(s), if applicable.
Document Name
Document Version #
Screening Script CLEAN 071017
0.01
Screening Script Tracked 071017
0.02
2.1
2.2
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ID: IRB#17-000617
View: NEW 20.1 - Informed Consent Process
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Informed Consent Process
You indicated that adults (and/or minors who are permitted to consent for themselves) are participating in the study
(Section 11.2/item 1.0 or Section 12.2/item 1.0).
For additional information on minors who are permitted to consent for themselves please refer to the
section "Legal Exceptions Permitting Certain Minors to Consent" in the OHRPP Guidance document, Child
Assent and Permission by Parents or Guardians. 
1.0
*Indicate your plans for obtaining informed consent for this study. 
Check all that apply:
Signed consent will be obtained from the research participant or Legally Authorized
Representative.
Signed consent means research participants will be asked to sign and date a written
consent form.
A waiver of signed consent is requested for the entire study. One of the following procedures will be
conducted:
A written information sheet will be used. Signed consent will not be obtained from research
participants.
Oral consent will be obtained from the research participant or Legally Authorized Representative
(LAR)
This option should be selected if the study involves consenting participants via the internet.
A waiver of consent is being requested.
Research participants will not be asked to sign a consent form or give oral consent
Consent will be obtained by a collaborating institution.
-  If you checked more than one plan above, list the study
groups and the plan that you will use for each.
-  If you checked "Consent will be obtained by a
collaborating institution", explain the consent process and
upload a copy of the most recent approved consent
document in item 1.2.
If applicable, attach the consent document(s) from
collaborating institution(s).
Document Name
Document Version #
There are no items to display
1.1
1.2
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ID: IRB#17-000617
View: NEW 20.3 - Description of the Consent Process
This view has been locked by amendment(s)
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Description of the Consent Process
1.0
*Indicate the type of setting(s) in which the consent process will be conducted.
Check all that apply.
In a private home
In a private room
In a waiting room
In a public setting
In a group setting
On the internet
Over the telephone
Other
If you checked more than one response, or indicated other,
describe.
If the setting is not private, describe the measures to protect
confidentiality or indicate "not applicable."
2.0
*Indicate the measures that will be taken to provide prospective research participants with sufficient
opportunity to consider whether or not to participate in the study.
Check all that apply.
Member(s) of the study staff will meet with the prospective participants/families to review the consent
document(s) and/or provide an oral explanation of the study. Individuals will be given a chance to ask
questions before making a considered decision about whether or not to participate in the study.
Prospective participants/families will have the opportunity to take the consent form(s) home and
may discuss the documents with others prior to deciding whether or not to participate in the study.
Prospective participants will self-administer the consent and send it back if they decide to participate in the
study.
Other
If you indicated other, describe.
3.0
*Indicate the length of time subjects are given to decide whether they wish to participate in the study.
Subjects will be allowed as much time as needed.
4.0
*How will you assess whether subjects understand the information conveyed during the consent
process?
1.1
1.2
2.1
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ID: IRB#17-000617
View: NEW 22.1 - Cultural Considerations
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Cultural Considerations
The following items are designed to acquaint the IRB with cultural features of the population that you are studying that
may require procedures to ensure truly informed consent.
1.0
*Check all that apply to the population(s) with which this study will be conducted.
Participants may be illiterate or insufficiently literate to be able to comprehend a conventional written
informed consent form.
The participants may be reluctant or unwilling to sign a written informed consent form.
The husbands make decisions for their wives.
Elders make decisions for younger adult family members.
Elders make decisions for their community.
It is considered impolite to refuse a request.
People are fearful of refusing requests that they regard as coming from authorities.
None of the above are applicable to this study.
If any of the above items are applicable to this study, indicate
the steps that you will take to ensure voluntary participation
after providing the study information, and if applicable, any
planned involvement with the community regarding the
consent process.
ID: IRB#17-000617
View: NEW 22.2 - Non-English Speaking Study Participants
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1.1
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Non-English Speaking Study Participants
You indicated that you would involve non-English speaking participants in the study (Section 11.2/Item 2.0) and/or that
there is a possibility that non-English speaking participants may be enrolled in the study (Section 11.2/Item 3.0). Please
provide the following information.
1.0
*Indicate the method that you use to conduct the consent process1 with participants who do not speak
English.
Check all that apply.
The consent form and other study documents will be available in the participants' primary language.
Study personnel (or qualified translators) able to discuss the participation in the patients' language
will be present for the consent process.
Study staff or qualified translators will discuss the study in the participants' language.
An oral consent process will be used. Study personnel (or qualified translators) able to discuss the
participation in the participants' language will be present for the consent process.
The short form or another method will be used to conduct the consent process.
Important Note: The short form may be used in very limited circumstances. For additional information
please refer to the " 'Short Form' Method" section of the OHRPP guidance document, Research Involving
Non-English Speaking Research Participants.
If you checked "short form or another method", provide
additional details.
2.0
*How will you maintain the ability to communicate with non-English speakers throughout their
participation in the study?
Indicate "N/A" if not applicable to your study.
A translation service will be used if appropriate staff is not available.
3.0
*If you are conducting research for which there is a real or foreseeable risk of biomedical harm in the state
of California, indicate your agreement that you will provide the participants who do not read, speak, or
understand English a copy of the Research Participants Bill of Rights in a language in which they are
fluent.  Translations into the most common languages in the greater Los Angeles area are available for
download on the OHRPP website.
Agree
Not Applicable
1 If minors are involved in the study, this would also include the processes of obtaining parental permission and
assent, as applicable.
ID: IRB#17-000617
View: NEW 24.0 - Additional Information and/or Attachments
1.1
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Warning: Save your work at least every 15 minutes by clicking “Save” or “Continue.”
Additional Information and/or Attachments 
1.0
Attach any other documents that have not been specifically requested in previous items, but are needed
for IRB Review.
Document Name
Document Version #
There are no items to display
2.0
If there is any additional information that you want to communicate about this study, include it in the area
provided.  Note: this section should not be used instead of the standard application items.
ID: IRB#17-000617
View: NEW 100.0 - Instructions for Study Submission
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Instructions for Study Submission
You have completed your application, but it has not yet been submitted.
FOLLOW THESE STEPS TO SUBMIT THE APPLICATION TO THE IRB FOR REVIEW:
1. Click the Finish button to return to exit the SmartForm and return to the study
workspace.
2. Use the View SmartForm Progress function to make sure that the application is
complete.
3. If you are the PI or PI Proxy, click Submit Study under My Activities. If you are a
member of the study team, you can let the PI know that the study is ready to submit by
clicking Send Ready Notification.
4. Once the study is submitted, the state indicator at the top of the page will no longer
display Pre-Submission.
5. After submission of the study, the PI Assurances activity will immediately become
available under My Activities. The PI should provide his/her assurances at that time. If
the PI is not available, the study can be submitted by a PI Proxy and the assurances
provided at a later time. The study will be reviewed by the IRB while the PI
Assurances are pending; however, it will not be approved until the PI assurances are
completed.
6. If there is a Faculty Sponsor for the study: The study can not be submitted to the
IRB until the Faculty Sponsor provides his/her assurances through FS Assurances
activity.
ID: IRB#17-000617
View: Display - Method Description
Audio, Visual or Digital Recordings
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Certificate of Confidentiality for research not supported by NIH
The Certificate of Confidentiality button in this section is only if your study is NOT supported or conducted by
NIH but you will obtain a Certificate of Confidentiality (for example, for studies collecting information about
illegal drug use).
If you previously checked this box for an NIH-supported study before the policy change, you do
not need to change your response here.
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Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect the privacy of
research subjects by protecting investigators and institutions from being compelled to release information that
could be used to identify subjects with a research project. Certificates of Confidentiality are issued to
institutions or universities where the research is conducted. They allow the investigator and others who have
access to research records to refuse to disclose identifying information in any civil, criminal, administrative,
legislative, or other proceeding, whether at the federal, state, or local level.
Effective October 1, 2017, NIH has updated its policy for issuing Certificates of Confidentiality for NIH-funded
and conducted research. For information about the policy change or about obtaining Certificates for research
supported by other agencies, please see https://humansubjects.nih.gov/coc/index.
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Clinical Trial of a Drug, Biologic, Device or a Behavioral Intervention
A clinical trial is a research study designed to answer specific questions about medical or behavioral
treatments. The trial may be interventional or observational. Interventional studies are those in which the
research participants are assigned by the investigator to a treatment or other intervention, and the outcomes
measured. Observational studies are those in which individuals are observed and the outcomes are measured
by the investigators.
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Community Based Research
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Controlled Substances (Schedule I or II)
Check here only if you are using a Schedule I or II Controlled substance in this study. Research using
Schedule I or Schedule II controlled Substances must be submitted to the Research Advisory Panel of
California for review and approval prior to initiation. Research using Schedule III, IV, or V Controlled
Substances as a study drug do not require review by the Research Advisory Panel. For further information see:
http://ag.ca.gov/research/guide.php o Schedule I Controlled Substances are drugs or substances with a high
potential for abuse, that have no currently accepted medical use in treatment in the United States. Examples
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of Schedule I Controlled Substances are: heroin, lysergic acid diethylamide (LSD), methylenedioxy-
methamphetamine (MDMA), marijuana, and psilocybin. o Schedule II Controlled Substances are drugs or
substances with a high potential for abuse, that have a currently accepted medical use in treatment in the
United States, or a currently accepted medical use with severe restrictions. Examples of Schedule II Controlled
Substances are: fentanyl, methadone, methylphenidate, morphine, and oxycodone. For further information
see: http://www.deadiversion.usdoj.gov/schedules/index.html
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Deception or Partial Disclosure
Deception includes withholding information about the real purpose of the study or purposely giving subjects
false information about some aspect of the research to prevent bias. Some professions, such as the American
Psychological Association (APA) have ethical codes regarding the use of deception in research. ( See sections
8.07 and 8.08 at http://www.apa.org/ethics/code/index.aspx#807 ) If deception is included in the study, you must
also apply for approval of a waiver of the informed consent process (Section 20.1) in addition to selecting the
other consent procedures planned for the study (e.g., written or oral consent).
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Devices/Diagnostics (including Humanitarian Devices - HUD)
A medical device is defined, in part, as any health care product that does not achieve its primary intended
purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical
lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical
devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and
other medical conditions such as pregnancy. For further information see: http://www.fda.gov/oc/ohrt
/irbs/irbreview.pdf
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ID: IRB#17-000617
View: Display - Method Description
Drugs/Biologics/Dietary Supplements
Drug: The term "drug" means: articles recognized in the official United States Pharmacopoeia, official
Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to
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any of them; and articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease in man or other animals; and articles (other than food) intended to affect the structure or
any function of the body of man or other animals.
Biologics vs. Drugs: Most drugs consist of pure chemical substances and their structures are known.
Most biologics, however, are complex mixtures that are not easily identified or characterized. Biological
products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to
microbial contamination. This requires sterile processes to be applied from initial manufacturing steps.
For more information see: http://www.fda.gov/consumer/updates/biologics062608.html#drugs
Dietary Supplements are products that are intended to supplement the diet and have one of the
following ingredients:
 A vitamin
 A mineral
 An herb or other botanical
 An amino acid
 A dietary substance for use by man to supplement the diet by increasing the total daily intake
 A concentrate, metabolite, constituents, or an extract of combinations of these ingredients.
For additional information see: http://www.foodsafety.gov/~dms/supplmnt.html
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ID: IRB#17-000617
View: Display - Method Description
Expanded Access to Drug, Device or Biologic for Treatment Purposes (aka Compassionate Use, Treatment Use)
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Genetic Analyses/Genotyping
Genetic analyses/genotyping include, but are not limited to, studies of inheritable conditions or traits, gene
markers or mutations, and pedigrees.
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ID: IRB#17-000617
View: Display - Method Description
Human Embryonic Stem Cells and/or Induced Pluripotent Stem Cells
Research with human embryonic stem cells (hESC) and related lines requires IRB review under the following
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conditions: o Clinical research in which human subjects are given hESCs or related products. o When the UCLA
research team will have a research related direct interaction or intervention with the cell donors, including
donation of blastocysts or gametes for the purpose of creating hESCs,. o Cells provided to the UCLA research
team that have identifiers or codes that can be linked back to the donor. Research involving hESC requires
review and approval by the ESCRO Committee. For further information see: http://www.stemcell.ucla.edu/research
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Human Gene Transfer/ Recombinant DNA
Studies involving gene transfer and/or recombinant DNA require approval of the UCLA Institutional Biosafety
Committee ( IBC) and the NIH Recombinant DNA Advisory Committee (RAC) . Human gene transfer is an
investigational method for correcting defective genes responsible for disease development through one of the
following techniques: o A normal gene may be inserted into a nonspecific location within the genome to
replace a nonfunctional gene. o An abnormal gene could be swapped for a normal gene. o The abnormal gene
could be repaired through selective reverse mutation, which returns the gene to its normal function. o The
regulation of a particular gene could be altered. Recombinant DNA molecules, according to the NIH Guidelines,
are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA
segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication
of those described in (i) above.
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ID: IRB#17-000617
View: Display - Method Description
Infectious Agents
Studies involving the use of Risk Group 2 or 3 infectious agents (such as bacteria, fungi, parasites, prions,
rickettsia, viruses, etc.) require approval of the UCLA Institutional Biosafety Committee (IBC).
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ID: IRB#17-000617
View: Display - Method Description
Non-FDA approved medical equipment used with UCLA hospital patients or research participants that operate under the UCLA
Hospital License.
Clinical Engineering is responsible for completing incoming inspections on investigational devices that are used
to diagnose, treat or monitor a patient and that are used in the patient care area on site at UCLA, but not in
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other hospitals such as Cedars Sinai, CHLA, or Drew. If a device is FDA and/or testing - laboratory approved
for the purpose it was designed, then evaluation is not required of the device. If you have a copy of an
inspection report from Clinical Engineering, please attach here. As appropriate, please contact Clinical
Engineering at 310-267-9000 to arrange an inspection.
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ID: IRB#17-000617
View: Display - Method Description
Radiation (Standard of Care or Investigational Use of radioactive materials, radiation producing machines or ionizing radiation)
Note: This includes CT-guided biopsy, fluoroscopy use, etc.; MRI is not included. The radiological procedures
included in this study must be described in the SafetyNet system. Please create a new SafetyNet application
after submitting this webIRB application to the IRB for review.
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Substance Abuse Research (with Medication)
Research for the treatment of controlled substance addiction or abuse that uses any drug (scheduled or not)
as treatment, requires the review and approval of the Research Advisory Panel of California prior to initiation.
For further information see: For further information see: http://ag.ca.gov/research/guide.php
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000617
View: Display - Method Description
Treatment in an Emergency Setting (with request to waive consent)
Federal regulations allow certain research activities to be conducted in emergency settings with waiver of
informed consent - in the interest of facilitating potentially life-saving and life-enhancing research with
protecting the rights and welfare of participants. For further information see: o OHRP Guidance:
http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc97-01.htm o FDA Guidance: http://www.fda.gov/oc/ohrt
/irbs/except.html
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ID: IRB#17-000617
View: Display - Method Description
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None of the above
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