Cal Poly Pomona - Human Research Protections ProgramInstitutional Review Board (IRB) Protocol Application

IRB principles: respect for persons, beneficence, justice

Cal Poly Pomona (STATE UNIVERSITY) is committed both to research in the advancement of teaching and science and to the protection of the individuals involved in those efforts. Thereby, as part of the assurance filed with regulatory agencies including the federal government’s Dept. of Health and Human Services (DHHS) and according to policies and guidelines from others like the State of California, Cal Poly Pomona has designated a human subjects’ committee, called the Institutional Review Board or IRB, to review proposals where there is research involving living persons. This protocol application, when submitted to the IRB, will be evaluated in terms of its compliance with ethical standards and regulations regarding the treatment of subjects (participants) and the risk to benefit ratio. The type of review – full, expedited, or exempt – will be determined by the IRB. While individual researchers are ultimately responsible for their practices, the IRB’s review is designed to provide objective input as additional protection for the subjects. Further, it is of benefit to those who could be held accountable for the research practices, i.e., the researchers and the University. All research conducted by students, faculty, sponsored individuals, or others that involves living persons must have prior IRB approval.

THE “TYPICAL” IRB PROCESS CYCLEStep 1: Obtain training appropriate to your research (business, with minors, general IRB “101”, etc.) using the CITI “Course in

the Protection of Human Research Subjects” to understand the IRB regulations and ethical imperatives. See the IRB website, http://www.State University.edu/~research/irb/index.shtml, and https://www.citiprogram.org. You may be asked to pursue additional training appropriate to your study.

Step 2: Write/Develop your IRB protocol (you can use this Word document, but the content needs to be entered into Cayuse), which describes the goals and procedures of the research as it pertains specifically to the involvement of persons as subjects. Fill out each section in detail sufficient to explain all aspects of the research for the IRB reviewer to understand. This is where you will also attach surveys, informed consent forms, recruiting flyers, authorizations, stimuli etc. pertaining to your proposed study.

Step 3: If the protocol is to be submitted for actual review, authenticate yourself and other investigators with Cayuse. Information is available at http://www.State University.edu/~research/irb/getting-started-with-a-protocol/index.shtml.

Step 4: The Cayuse software assigns a protocol number (e.g., 16-001 for the year and the sequence) at this point. Please use this number on all correspondence with the IRB and put it on the informed consent form (ICF).

Step 5: Certify the Cayuse protocol after completing entry of all information. You as the PI (primary investigator) -- and all co-investigators -- must read and “Certify” before the review can begin. This serves as a check that the research group/team is in agreement with what has been submitted for review.

Step 6: The compliance office, doing an administrative review, reads and evaluates the materials to ensure all items for IRB member review are present and regulations and policies have been satisfied. If not, there will be communication through Cayuse for the PI(s) to address what is missing.

Step 7: When all administrative issues have been addressed, the protocol is sent out for IRB member review. Members are STATE UNIVERSITY faculty and unaffiliated individuals who will conduct an ethical review and may also contribute a research opinion.

Step 8: The reviewing member(s) can and do request changes from the PI(s) to secure approval. During this exchange, PIs should clarify their methods and subject protections with the reviewers. When those are satisfied, the IRB chair indicates approval in Cayuse, an approval memo is generated, and the study may commence. This approval is valid for one year (typically). If the research is to continue beyond, the PI must submit a renewal before the approval expires.

Step 9: Any changes or deviations to the approved protocol need to be sent to the IRB for re-review and approval, which can be done in Cayuse.

Other hints to ensure your protocol is complete and ready for IRB reviewReview these steps before you submit your application to the IRB and Cayuse IRB.

o For a more detailed checklist, go to the STATE UNIVERSITY IRB website. There you will also find sample protocols and consent forms, links to training materials, IRB policies and procedures, and other information.

o Proof-read all documents. It is highly recommended to have someone not involved in the writing of the protocol to look it over for clarity and typographical errors. Have someone test surveys and comprehend your ICF. Remember, ‘first impressions make an impression’ both to the IRB reviewer and to the subject who might (or might not) participate.

o Finalize any surveys, questionnaires, inventories, stimuli, lists of interview questions, recruiting flyers, etc. that you will be using in your research. If these materials are still being developed (for example, a translated ICF), indicate that they are “in development” in the protocol. Final approval cannot be granted until all materials are received.

o Check that all elements of the Informed Consent Form for adults (ICF) and Assent Form for minors are included as appropriate.

o Do provide documentation of your training with this application. Training in the conduct of human subject research is critical and investigators must demonstrate their knowledge and awareness through the completion of appropriate coursework.

o Once the protocol is received, and it is complete, the review and approval process usually takes 12 to 16 business days.

For other assistance, contact the Compliance Associates in the Office of Research Compliance at irb-office@State University.edu, 909.869.3713 or 909.869.4215. The office address is building 1, room 229

IRB application, version October 2016, page 1 of 15

Cal Poly Pomona - Human Research Protections ProgramInstitutional Review Board (IRB)

Investigator Information and Signature PageIRB principles: respect for persons, beneficence, justice

Primary (aka Principal) Investigator (PI)(faculty, staff, student, etc.)

Other Investigators (Team Members/Personnel) engaged in the research as applicable

(your faculty advisor, co-PIs, facilitator, sponsor, collaborators, etc.)

Your name: Joe Schmoe

Your status:(indicate faculty, staff, student, unaffiliated, or something else)

Faculty

Your affiliation:(college/dept.)

Kinesiology

Phone contact:(office or cell)

999-888-5555

Email contact:(Cal Poly address preferred)

joeschmoe@univ.edu

Title of your IRB protocol:

Supplement Study

Original date submitted:

__X_ new ___ amendment to protocol number: ___ renewal of protocol number:

Any vulnerable subjects (risks)?

___ minors ___ pregnant women ___ medically sensitive ___ prisoners___ other:

Any permissions needed? (see 5.G)

___ STATE UNIVERSITY health center ___ place of employment ___ school principal or board___ place of business ___ other:

DECLARATION BY ALL INVESTIGATORS: This proposal is guided by the ethical principles regarding research involving human subjects as set forth in the Belmont Report. I/We agree to abide by the policies and procedures of the IRB at STATE UNIVERSITY, including obtaining appropriate training in human subject research for myself and those involved in its conduct. I/We will not initiate any research associated with this proposal on or off campus until authorized by the IRB. I/We will report to the IRB about any adverse events or unanticipated problems (unexpected, possible greater risk, etc.) that occur. I/We will inform the IRB of a need to modify the study design requiring an amendment. I/We understand that approval, when granted, is valid for up to one year and will submit a renewal for its continuation if needed.

Signature, certifying the above Date

(PI) primary investigator: Signatures as hard copy are no longer needed by the protocol software.

IRB office use review type: full IRB (risk involved) exempt PEIP SAE expedited/designated review (minimum risk/harm) not human subject research NA

Note: This MS Word protocol application is meant to facilitate the development of a research study. It may be used as a classroom tool without the intention of actually submitting it to the protocol software (Cayuse IRB) or to the IRB for review. It may also be used by a team of investigators to draft the human study with the intention to transfer (cut-and-paste) the information into Cayuse. While both Word and Cayuse formats are similar, they are not exactly the same. The PIs are advised to review the Cayuse protocol before certification and submission.

The IRB will appreciate any suggestions to improve this protocol application as a learning tool.

IRB application, version October 2016, page 2 of 15

Answer each question in the sections below adequately enough so that ethical standards and human protection can be determined by an outside reviewer. Be sure to address all questions asked within each section, as this will

help to speed the review and approval process of your protocol.

CORE INFO - FUNDING

A. In what general discipline(s) is your proposed research with human subjects?Biological or clinical science (biomedical) (e.g. nutrition and kinesiology), Social Science, behavioral science, or education (SBER), a combination of biomedical and SBER. If other, please explain.

Kinesiology

B. What kind of funding or support do you have for this study with human subjects?Federal (NSF, NIH, DoD, DoE, DoEd, etc.), State agency such as CARB, California Dept. of Ed., etc., STATE UNIVERSITY program such as McNair, Trio, Office of Research, etc., Others (private sources).

None

C. Are you collaborating with another group such as a school, community association, government agency, etc.? If yes, please explain.

NO

RESEARCHER (PI) TRAININGBoth formal training and practical experience in research with human subjects are critical for the protection of the participants and minimization of risk that might be associated with the conduct of your study. Federal regulations require that investigators possess training. The STATE UNIVERSITY IRB adopted in 2006 the on-line CITI program as required training in human subjects research (CITI training is valid for five years). All investigators submitting applications to the IRB must complete appropriate modules of CITI as a condition of approval of a protocol. Other formal training will be considered by the IRB on an individual basis. See https://www.citiprogram.org and the training section of the STATE UNIVERSITY IRB website.

A. Describe the training possessed by you as the primary investigator. Include when it was obtained. Provide your CITI completion report number. Will you be obtaining any additional training related to this proposal? If you are a student, your advisor (faculty mentor) must possess training as well, which you are to describe in the next section.

Confirmation #, Expiration Date, Institution (of other than CPP)

B. Describe the training possessed by others involved with the study, including your co-investigators, research associates (RAs), collaborators, students, staff, faculty members, a student’s mentor or advisor, etc., from Cal Poly or elsewhere, working on this study. Include when it was obtained. Provide CITI completion report number(s). Provide a copy of this report if training was obtained from a different institution. List and identify the role of each co-investigator, e.g. Billy Bronco, RA, “research with minors” report #012345, 13 Nov 2014; Dr. Helga Schmidt, collaborator at ABC University, ethics training from ABC University attached

Name, Confirmation #, Expiration Date, Institution (of other than CPP)

1. RESEARCH FOCUS AND CONCEPTSResearch for IRB purposes is defined as “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

A. Purpose of this study – Why are you conducting this study? What are the goal(s), objective(s) and outcome(s)? What hypothesis or hypotheses are you testing or what are the research questions? Explain the rationale and impetus for your research project. Provide enough detail such that: a) the IRB member(s) reviewing your protocol will understand your research plan and b) it supports a judgment of the risks and benefits in order to approve the “use” of the research participants.

The overall purpose of the proposed study is to investigate the efficacy by which a supplementation loading phaseimproves the ergogenic benefits of dietary nitrate consumption.

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Specific AimsAim 1. To determine the effects of a two-week nitrate supplement loading period vs. a single pre-exercise dose on time trial performance in recreationally trained, college-aged male and female subjects.

Aim 2. To examine skeletal muscle oxygen kinetics via near infrared spectroscopy (NIRS) during time trial performance following a two-week loading phase vs. a single pre-exercise dose of nitrate supplementation.

HypothesisWe hypothesize that a nitrate supplementation loading phase will result in greater time trial performance and skeletal muscle oxygenation compared to a single pre-exercise dose.

B. Relevance – State specifically the relationship of your proposed research to other, previous scientific and/or scholarly investigations in the field or to existing best practices. What literature is related to your research? On what are you basing your own work, pertaining to the use of human subjects? What are you doing that builds on existing research findings/best practices? What work has come before and what have you learned from it to inform your own methods and questions? Provide full citations (APA or MLA reference styles are good).

A transient augmentation in energy efficiency in working skeletal muscle and thereby exercise performance is theFundamental basis for supplementing the diet with nitrates amongst competitive and recreational athletes alike. Recent findings support the use of dietary nitrates (e.g. beet root extract and sodium nitrate) as an effective ergogenic nutraceutical as results demonstrated enhanced skeletal muscle oxygenation, O2 and energy efficiency, and microvascular blood flow with short-term supplementation (1-4). These physiological effects likely contribute, at least to some degree, to the enhanced exercise tolerance and endurance performance frequently reported following nitrate supplementation. As with most ergogenic aids, e.g. creatine monohydrate, the optimum duration of supplementation prior to performance or competition, i.e. loading phase, remains of significant debate and question. In other words, is a short term nitrate supplementation loading phase required to optimally elicit a physiological response conducive to exercise performance? To our knowledge, researchers have yet to directly investigate this question. A controlled trial examining the effects of nitrate loading on exercise performance would conceivably improve the knowledge regarding the proper application of dietary nitrate supplementation as an ergogenic aid.

1.Bailey SJ, Winyard P, Vanhatalo A, et al. Dietary nitrate supplementation reduces the O2 cost of low-intensity exerciseand enhances tolerance to high-intensity exercise in humans. J Appl Physiol (1985) 2009;107:1144-55.2.Bailey SJ, Fulford J, Vanhatalo A, et al. Dietary nitrate supplementation enhances muscle contractile efficiency duringknee-extensor exercise in humans. J Appl Physiol (1985) 2010;109:135-48.3.Gladwin MT, Shelhamer JH, Schechter AN, et al. Role of circulating nitrite and S-nitrosohemoglobin in the regulation ofregional blood flow in humans. Proc Natl Acad Sci U S A 2000;97:11482-7.4.Breese BC, McNarry MA, Marwood S, Blackwell JR, Bailey SJ, Jones AM. Beetroot juice supplementation speeds O2uptake kinetics and improves exercise tolerance during severe-intensity exercise initiated from an elevated metabolicrate. Am J Physiol Regul Integr Comp Physiol 2013;305:R1441-50.5.Zafeiridis A, Kounoupis A, Dipla K, et al. Oxygen Delivery and Muscle Deoxygenation during Continuous, Long- andShort-Interval Exercise. Int J Sports Med 2015.6.Jones AM, Berger NJ, Wilkerson DP, Roberts CL. Effects of "priming" exercise on pulmonary O2 uptake and muscledeoxygenation kinetics during heavy-intensity cycle exercise in the supine and upright positions. J Appl Physiol (1985)2006;101:1432-41.7.Jones B, Hamilton DK, Cooper CE. Muscle oxygen changes following Sprint Interval Cycling training in elite fieldhockey players. PLoS One 2015;10:e0120338.

2. METHODSIt is important that the procedures to be applied – some might call these treatments - to the human subjects are thoroughly

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explained and outlined. Those who will review and approve your study must fully understand what will take place during its conduct. Once approved, it is necessary that the procedures be carried out in the way they are officially described in this protocol.

A. Summarize the overall design of your proposed study. Is it qualitative, Quantitative? Will you use an experimental, quasi-experimental, or correlational design? Will you be modeling after the Delphi Study, Snowball Sampling, etc. What are the independent variables, interventions, treatments, etc.?

Experimental Design

We will implement a randomized, double blind, placebo-controlled experiment for the proposed study. Subjects will visit the Kinesiology Laboratory (KL) at State University on three separate occasions. During the first laboratory visit, subjects will first undergo assessment for exercise and health history, anthropometric measures, and body composition via dual energy x-ray absorptiometry (DXA). Afterwards, subjects will be familiarized with physiological testing and cycling time trial procedures (details below) to minimize potential learning effects during subsequent experimental trials.

Approximately 48 hours following the first visit, subjects will return to the laboratory for baseline physiological andperformance testing (i.e. baseline testing). During the baseline visit, subjects will rest for the initial 30 minutes during which time investigators will apply the NIRS sensor to the subject’s dominant leg and prepare the cycle ergometer and software for time trial testing. Subsequently, resting blood pressure, heart rate, and muscle oxygenation levels will be measured. Afterwards, subjects will be provided 10 minutes for self-selected stretching exercises and an additional 10 minutes for a submaximal cycling warm-up at a constant workload of 60W. Subsequently, subjects will perform the time trial protocol (procedures described below).

Following the second visit, subjects will be randomly allocated to one of the following groups: 1) Nitrate Loading Group (EXP) or 2) Non-Loading Control Group (CTL). EXP and CTL will undergo 2 weeks of nitrate and placebo supplementation, respectively. Following the 2 week supplementation period, subjects will return to the laboratory for repeat testing. Both EXP and CTL will consume 1 dose of the experimental nitrate supplement 2 hours prior to their scheduled testing. Subjects will then repeat the testing procedures implemented during visit 2. Performance outcome variables include, time to completion, average power output, peak power output, and final average power output; hemodynamic measures include, heart rate (HR), percent hemoglobin+myoglobin saturation or muscle oxygenation (SmO2), total hemoglobin (tHb), deoxyhemoglobin + deoxymyoglobin (HHb+Mb), and oxyhemoglobin + oxymyoglobin (O2Hb+Mb). Each subject will undergo protocols administered by the same investigators for all their laboratory visits.

B. Provide a step-by step outline of the activities included in this study. What events will occur and in what order? How will the information about the study be presented to the participants? Please note you are asked to describe the specific measures and data to be collected in Section 4 below.

VISIT 1. Subjects will visit the Kinesiology Lab (KL) at STATE UNIVERSITY. Subjects will be read the informed consent form and asked to review, ask any questions, and sign and

date. Assessment of exercise and health history via questionnaire. Height and weight measurement using standard medical stadiometer and scale, respectively Body composition measurement via Dual Energy X-ray Absorptiometry or DXA. Subjects will perform cycling time trial for familiarization Subjects will be asked to revisit the lab 48 hours later

VISIT 2. Subjects will visit the KL and initially rest for 30 minutes in a seated position Investigators will apply the NIRS sensor device on the subjects dominant leg Subjects will perform warm-up activities for 10 minutes, e.g. stretching. Subjects will perfrom an additional task specific warm-up on the cycle ergometer for 10 minutes at a

constant workload of 60W Subjects will perform the cycling time trial (5 miles) Investigators will randomly allocated subject to either nitrate loading group (EXP) or Non-loading control

group (CTL).

2 WEEKS AFTER VISIT 2. Subjects will ingest 1 dose daily of either a nitrate or placebo supplement after the first meal. VISIT 3.

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Subjects will return to the KL and consume a single dose of nitrate supplement. 2 hours later subjects will repeat time trial and NIRS testing.

3. SUBJECTS AND RECRUITMENTThe terms subjects and participants are often interchangeable. A human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.” (Dept. of Health and Human Services, 45CFR46)

A. Describe the characteristics of the subject group(s). Who in a population, from which you will sample, are you trying to study? What are you looking for in your subjects? What will you use to qualify them (e.g., age, gender, being a student or faculty member, being able to do a specific task, belonging to a certain group, etc.)?

A total of thirty healthy male and female subjects will be recruited to participate in this study. Each volunteer will initially complete a pre-participation exercise and health history questionnaire and sign an informed consent form. Subjects must meet the following inclusion criteria to participate in this research study: 1) Age= 18-29 years and 2) recreationally active (i.e. within the past 6 months: at least 3 hours/week of aerobic exercise). Subjects will be excluded from participation if they report or exhibit: 1) a history of medical or surgical events in which the study protocols would be contraindicated or confound the interpretation of results. These include, but are not restricted to, cardiovascular, metabolic, pulmonary, renal, or kidney diseases, hypertension, or musculoskeletal impediments; 2) use of any medication including those with cardiovascular, pulmonary, thyroid, hyperlipidemic, hypoglycemic, hypertensive, endocrinologic, psychotropic, neuromuscular, neurological, or androgenic implications; 3) pregnancy; 4) daily use of ergogenic aids or dietary sports supplements within 6 weeks prior to the study (use of nutritive supplements, e.g. whey protein, will be permissible). Subjects will be asked to maintain normal physical activity/exercise levels during participation. Subjects will be asked to maintain their normal dietary intake throughout the course of the study and wil be monitored via an online-based dietary tracker (MyFitnessPal Calorie Counter). The dietary tracker is a mobile and computer based application where the subject can record the foods consumed throughout the day. The application will then compute the subject's daily dietary intake (i.e. caloric and nutrient intake). Average dietary intake will be assessed by the investigators on a weekly basis and in the event there are any significant deviations (+/- 20%) from the average week 1 caloric intake, the subject will be instructed to revert back to their normal caloric intake as assessed during week 1. Careful instructions on how to utilize the application will be provided during the first visit. The subject will have the choice of using their mobile device or computer to utilize the application. Mobile or computer devices will not beprovided to the subject.

B. What is the study’s expected sample size?How many subjects (or participants) will be involved in the research project? How did you determine your sample size? It is acceptable to have a range, but it must be a close approximation. For projects with surveys (e.g., electronic, phone, written, door-to-door canvassing), indicate the number to be recruited, the anticipated response rate, and thus the estimated final number of actual participants.

With α=0.05 and 1-β=0.80, a sample size of 15 participants per gender cohort (N=30) is required to detect changes in time trial performance which is our primary outcome measure.

C. Will the subjects be compensated? Will they be given something? If yes, in what way (token of appreciation, money, gift, cash card, course credit, food, lottery ticket, etc.)? This information – summarized – must be included in the consent (and/or assent) form as well. If there is no compensation, then state that clearly.

The benefits of participating in this study is as follows:1. Receiving assessments for body composition and performance free of charge2. Learning about their body's physiology and "fitness" level.

D. What are the benefits, if any, to the subjects from their participation in the study? Most studies have some kind of benefit, even if they are purely educational. Will the subjects personally gain something through the research by being a subject? This information – summarized – must be included in the consent (and/or assent) form as well. If there is no direct benefit to the subject, this needs to be stated here.

Subjects will not be compensated for participation

E. How will you recruit your potential subjects to participate in the study? From where will you

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recruit them? (For example, will you recruit subjects using e-mails or flyers?) Include any recruitment materials you will be using with your application. As applicable, attach copies of flyers, e-mail or blog text, advertisements, etc., to be used for the recruitment of subjects. Review by the IRB is necessary for approval of your protocol. Include the statement as follows: The Cal Poly Pomona Institutional Review Board has reviewed and approved for conduct this research involving human subjects under protocol YY - #### (meaning year and sequence number).

Word of mouth and classroom announcements will be the primary forms of recruitment. However, a recruitment flyer and "Facebook" post will be used to facilitate recruitment of subjects. Word of mouth recruitment will be executed by the PI and research assistants via word-of-mouth. The following is a script to guide investigators during the recruitment process: “Hello, my name is ________ and I am a researcher for an exercise science research study currently approved by the State University Institutional Review Board. The study is examining the effects of nitrate supplementation on cycling time trial performance and muscle oxygenation.Participation in this study require 3 visits to the Kinesiology Laboratory. The total duration of thestudy is approximately 3 and a half weeks. During each visit you will be required to perform a cycling time trial whileinvestigators conduct physiological testing procedures on you. Between visits 2 and 3, you will be required to consume either a nitrate or placebo supplement each day for 2 weeks.If you are interested or have any questions, you can contact Dr. Joe Schmoe 999-888-5555

F. Are you collaborating with another group such as a school, community association, government agency, etc.?

Not applicable

G. Will translation of materials be necessary to other languages or to a different reading and comprehension level for recruiting purposes? Consider that children often need simplified language. Studies show that the average adult reads at a 5th to 8th grade level.

Not applicable

H. Describe your procedures for the recruitment of a representative sample of the population. Is your recruitment based upon race, ethnicity, gender, health status, or other characteristic? If this is not the case, discuss the reasons for not having such a balanced sample (such as, the research is focused on a certain subject group or it’s a case study).

Recruitment is not based on race, ethnicity, or gender. The PI or research assistants will announce criteria forParticipation (section 3.A) through various forums, i.e. classrooms of Kinesiology courses, Kinesiology and HealthPromotion Club meetings, and provide interested individuals with the PI’s contact information. Complete eligibility will be determined by a preliminary exercise and health history questionnaire, which addresses both inclusion and exclusion criteria indicated in 3.A.

4. DATA COLLECTION AND PROCEDURESCollection methodologies include, but are not limited to: surveys, interviews, focus groups, oral histories, participant observation, observations of public behavior, research in public schools, and the analysis of existing data. Data include: survey sheets and questionnaires, biological samples, audio and video tapes, transcripts of verbal communication, photographs, paper and electronic records, previously collected (existing) information, etc. Personal and private data deemed by the IRB to be a risk to subjects if revealed include: gender, income, number of children, age, religion, ethnicity, e-mail addresses, and more. Even when labeled as demographic data, it is still personal and private and could potentially identify an individual. This is not to say such data should not be collected, but mechanisms must be described in this protocol to protect the interests of the subjects should they be (somehow) identified.

The HIPAA Privacy Rule regulations [45 CFR 164.514(b)] list specific elements that are considered to be personal identifiers. These include: name and initials; street address, city, county, precinct, zip code, or equivalent geocodes; elements of dates (except year) directly related to an individual (date of birth, admission date, discharge date, date of death); elements of date including year for persons 90 or older; telephone and/or fax number; e-mail address; social security number; medical record or health plan identification number; account number; certificate and license number; vehicle identifier and serial number including license plate number; device identifier and serial number; web address (URL), internet IP address; biometric identifier including finger and voice print, full face photographic image and comparable image; other unique identifying number, characteristic, or code.

A. Describe the type of data you will collect. For example, the variables/responses to questions from surveys and interviews, the information extracted after making audio and video recordings, data collected when reviewing

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medical histories, blood samples, treadmill running times, income, performance measures.1. Anthropometric data: Height and bodyweight measures will be collected and hand recorded on a paper data sheet2. Body composition data: Body composition data which includes fat mass, lean body mass, body fat percentage, and total mass, will be acquired via DXA data acquisition software. DXA scan results will be obtained in a standardized DXA print-out.3. Cycling time trial performance data: Data will be acquired via acquisition software specific to the cycle ergometersystem and time trial program. Data will be exported and recorded to a Microsoft Excel spreadsheet.4. Health and exercise history data: This data will be obtained via questionnaire responses from the subject and will not be used for statistical analysis or reported5. Dietary Record: Data will be collected utilizing a mobile app described earlier. Investigators will have access to each subject's log and record data onto Microsoft Excel spreadsheet.

B. Describe the method(s) you will utilize in the study to obtain the data. For example, on-line survey, focus group, whole body scanner, observation, tissue biopsy.

Physiological and Performance TestingAnthropometric and Body Composition Testing. During the first visit, the investigators will initially assess the subject’s height (m) and bodyweight (kg) using a standard medical grade stadiometer and scale. Body composition will be measured by dual-energy x-ray absorptiometry (DXA) (Hologic Discovery-QDR Series Densitometer, Bedford, MA). DXA scans are typically 7-10 minutes in duration and non-invasive with marginal radiation exposure. The effective dose for a whole body scan using the Hologic Discovery system is <5 uSV, which is less than half a day of natural background exposure and less than half the dose of a standard x-ray scan. Total body mass (TBM) will be quantified through the scan. A 3-compartment model of body composition will be applied through which FM (kg) and non-bone LBM (i.e. fat free mass – bone mineral content) (kg) will be analyzed for the whole body. Data for body fat percentage (%BF) will also be acquired from DXA measurements. The DXA machine will be calibrated before each scan using a manufacturer provided phantom. All DXA measurements and analyses will be conducted by a single certified technologist (Dr. Joe Schmoe).

Skeletal Muscle Oxygenation. During the cycling time trial, muscle oxygenation of the vastus lateralis muscle of thesubject’s dominant leg will be continuously monitored using a wireless 4-wavelength near-infrared spectroscopy (NIRS) apparatus (Fortiori Design LLC, Spicer, Minnesota, USA). The NIRS device comprises of 2 probes: 4 light emitting diodes (LEDs) and 2 detectors and uses a modified Beer-Lambert Law to analyze the changes in light absorbed between 650 to 850nm. The device will be placed at the lower third of the vastus lateralis muscle (~12cm above patella and 5cm lateral to the midline) on the subject’s dominant leg. The anatomical landmark will be cleaned with isopropyl wipes and shaved. The device will then be secured using strong adhesive tape to the subject’s skin. A solid colored bandage will be used to cover the device to preclude any external light intrusion and to secure the device in place during movement. NIRS data will be collected at a frequency of 0.5Hz to measure absolute concentrations (μM) of O2Hb+Mb (oxyhemoglobin + oxymyoglobin), HHb+Mb (deoxyhemoglobin + deoxymyoglobin), and tHb (total hemoglobin + total myoglobin) as well as SmO2 (% of tHb). HHb+Mb and SmO2 reflect the balance of O2 delivery and consumption and have been previously used as a proxy indicator of microvascular O2 extraction5-7.

Cardiovascular Testing. Resting heart rate (HR) as well as systolic (SBP) and diastolic (DBP) blood pressure will bemeasured before the time trial test following a 30 minute period of rest. HR will be continuously measured throughout the time trial.

Exercise Performance Assessment. The 8km (~5mi) cycling time trial test will be performed on a computer-integrated cycle ergometer (Velotron, RacerMate, Inc., Seattle, WA, USA). Initially, subjects will perform a submaximal warm-up at 60W for 10 minutes. Following the warm-up and an addition 5 minutes of seated rest, subjects will begin the time trial. The time trial will be implemented using a manufacturer cycling ergometer computer program (RacerMate, Inc., Seattle,WA, USA). Subjects will be asked to complete a 16.1 km time trial at a self-selected pace (i.e. revolutions per minute). Computerized gear configurations will be held constant. Investigators will provide distance cues every 2km while performance feedback from the computer program will be blinded to the subject. Following the time trial, the subjects will be instructed to cool-down at a self-selected pace.

Dietary SupplementationEXP and CTL will receive 14 single servings of a nitrate supplement and placebo, respectively. Both groups willconsume 1 serving of the nitrate supplement 2 hours prior to their last laboratory visit. This serving will be provided by the investigator during the day of the last visit. The loading phase supplements will be administered in a double-blind manner. Both supplements will be administered in capsule form and matched for caloric value and

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appearance. An outside member naive to the nature of this study will prepackage each serving of the assigned supplement in a packet labeled “A” or “B” representing either EXP or CTL conditions. Information indicating the content of packets “A” or “B” will be sealed in an enveloped and opened once data collection has been completed. During the 2-week loading phase, subjects will be instructed to consume a single serving of their assigned supplement immediately following their first meal of the day.

Each serving of the experimental nitrate supplement (Shaklee Corporation, Pleasanton, CA, USA) contains 1g ofcarbohydrate, 100mg of vitamin C, 200mg of magnesium, and 1300mg blend of potassium nitrate, quercetin, beetpowder, grape extract, and spinach powder.

Analysis of DataA 2 (time) x 2 (group) repeated measures ANOVA will be used to detect main effects and/or interaction. In the event of a significant F-ratio, a Tukey’s post hoc test will be used for pairwise comparisons. All statistical analyses will be performed using Statistica12 for Windows (StatSoft; Tulsa, OK, USA) with significance set at p<0.05.

C. Where will the research be conducted?For example, a laboratory, a classroom, a hospital, field work. Will you be conducting any experiments in a lab or classroom or collecting data in the field? The IRB needs evidence that you are permitted to conduct the research in other venues for the protection of you, your subjects, and institutions. For example, a signed letter or email authorizing a study at your work or in a business, or from a school principal or school board, or to use the STATE UNIVERSITY student health center will be required for protocol approval. Provide information about the human subjects procedures that apply for your international studies (see the STATE UNIVERSITY IRB Policies and Procedures document).

In the Kinesiology research laboratory at State University

D. Will your research take place in another country?If yes, please provide an explanation and provide proof of authorization.

Not Applicable

E. Will you be using any study measures, data collection tools/apparatus, and data collection procedures?Please explain all study measures. Does not refer to surveys/questionnaires

Not Applicable

F. Will the study utilize a survey/questionnaire? If yes, please explain the form of the survey (paper copy, electronic) and provide the pdf version and the electronic link (if applicable). Provide the name of any third party online websites you will use to collect data (if applicable)This would include SurveyMonkey or other professional internet-based data collection survey mechanism or social media sites.

Not Applicable

G. Will the research take place in another country? The IRB must receive authorization/permission verification prior to the approval of your protocol. The IRB needs evidence that you are permitted to conduct the research in other venues for the protection of you, your subjects, and institutions. Provide information about the human subjects procedures that apply for your international studies (see the STATE UNIVERSITY IRB Policies and Procedures document).

Not Applicable

H. For studies involving medical records, explain compliance with the HIPAA privacy rule (Health Insurance Portability and Accountability Act) and disclosure of protected health information (PHI). See http://www.State University.edu/~research/irb/Hints_help_examples.shtml for the “Experimental subject’s bill of rights – Medical research“ consent form if any invasive procedures are to be performed. x not applicable comment:

IRB application, version October 2016, page 9 of 15

I. What is the estimated start and end date of the study?Start date includes the beginning of the recruitment process. Think about the time it will take to collect all of your data from your participants. All STATE UNIVERSITY IRB approved studies (except exempt) expire in one (1) year. Will you need to continue the study after the expiration date?

September 30, 2015- January 31, 2016All data collection will be conducted at California State Polytechnic University, Pomona

5. VULNERABLE SUBJECTSWhen a subject has limitations, is coerced or manipulated, there is a loss of capability to volunteer, and the subject may be vulnerable. According to regulations, vulnerable subjects include prisoners, pregnant women, minors and fetuses. The IRB considers other kinds of vulnerability, for example, the possibility that bosses can coerce at the workplace and teachers can manipulate in the classroom. Research conducted with regulated vulnerable subjects requires demonstration of your training and experience with that specific population (include in the training section).

A. Minors – Will children, minors, or wards be recruited for this research? Children in most circumstances are those less than 18 years of age. Research with children involving no greater than minimal risk requires the permission of one parent and the assent of the child (45 CFR 46.404). Please note: Research involving minors is typically subject to full IRB review.

Not applicable

B. Other kinds – Explain research which involves other vulnerable subjects such as prisoners, pregnant women, or culturally or medically vulnerable groups? Consider the circumstances, too. For example, a pregnant woman answering a survey about being a teacher may not be vulnerable, but she could be if it’s a study about baby furniture.

Not applicable

6. DATA SECURITY PROCEDURESPer California law, CC 1798.24, the researcher must provide a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.

A. Is the study anonymous or confidential?Please justify your answer.

Confidential. Identifiers will be collected throughout the study however, all participants will be assigned a study ID number in order to keep identifiers separate from study data. All data will be recorded on a formatted data collection sheet or digital spreadsheet exported from data acquisition software. All documents with recorded data will be immediately maintained and locked in a safety cabinet located in a secure work office with direct access restricted to the PI. Digital data will be kept on the computer and flash drive of the PI under password protection. Only the PI will have access to the files on the computer. The flash drive will be kept in the PI's locked office. Identifiers will not be indicated on any paper or electronic data sheets. Each subject will be assigned a numbered code and data will only be recorded by subject code. Therefore all data sheets will not be linked to the subject identifiers. As such, the only subject information that will be revealed will be the subject code. Identifier information and subject code number will be documented on an electronic Microsoft Excel template and filed on a computer that is password protected and located in a locked office with direct access restricted to the PI. Informedconsent forms will be will be stored in a separate and locked file cabinet which is only accessible by the PI. Data will be properly destroyed in 3 years.

B. Will personally identifiable information (PII) be collected/used? Please describe what information you will be collecting. Keep in mind that some demographic data are considered to be identifiers. If you are collecting data online, know that an IP address is considered to be an identifier. If data like audio and video tapes are kept for any reason (such as archiving for publication), the subject must be told of the purpose (e.g., conference presentations) and for how long, as part of the informed consent process. Also, if you are going to be using audio and video tapes there must be a section on the ICF for the subject to initial that they agree to being recorded. The subject has the option, after the study is over, to contact the researcher to withdraw permission for continued use. This information, summarized, must be included in the consent form.

IRB application, version October 2016, page 10 of 15

Yes. Demographic information, name, contact information. Every participant will be assigned a study ID number in order to keep identifiers separate from study data.

C. Who will have access to and use the data? Describe who else will be involved in this research. What will their responsibilities be within the study? Will you have research assistants? All others involved and engaged in the research - including research assistants and associates - must complete CITI training before they may work with subjects. For example, a person who hands out ICFs to participants is considered to be engaged in research, while a statistician who analyzes the data is not engaged. Their CITI completion record must be included in the section on Researcher/PI Training.

Dr. Joe Schmoe (PI) will have access to the data. Only the PI will use the data for analyses. The responsibilities of the research assistants include, recruitment of subjects, distributing and obtaining ICFs to and from subjects, respectively, and collecting data during experimental trials.

D. How will the raw data be kept protected and secure? How will it be coded or identified? Will social security numbers or other personally identifiable information be used? What will become of the data at the end of the study (returned, destroyed, archived? Keep in mind that some demographic data are considered to be identifiers. If you are collecting data online, know that an IP address is considered to be an identifier. If data like audio and video tapes are kept for any reason (such as archiving for publication), the subject must be told of the purpose (e.g., conference presentations) and for how long, as part of the informed consent process. Also, if you are going to be using audio and video tapes there must be a section on the ICF for the subject to initial that they agree to being recorded. The subject has the option, after the study is over, to contact the researcher to withdraw permission for continued use. This information – summarized – must be included in the consent form.

All data will be recorded on a formatted data collection sheet or digital spreadsheet exported from data acquisitionsoftware. All documents with recorded data will be immediately maintained and locked in a safety cabinet located in a secure work office with direct access restricted to the PI. Digital data will be kept on the computer and flash drive of the PI under password protection. Only the PI will have access to the files on the computer. The flash drive will be kept in the PI's locked office. Identifiers will not be indicated on any paper or electronic data sheets. Each subject will be assigned a numbered code and data will only be recorded by subject code. Therefore all data sheets will not be linked to the subject identifiers. As such, the only subject information that will be revealed will be the subject code. Identifier information and subject code number will be documented on an electronic Microsoft Excel template and filed on a computer that is password protected and located in a locked office with direct access restricted to the PI. Data will be properly destroyed in 3 years.

E. What will become of the data at the end of the study? Will the data be returned, destroyed, archived, etc.?Data will be archived for three years and kept locked in the PIs office.

F. How will the data, results, and conclusions be utilized? Will the data be shared with any other researchers or funding agencies? Will these data appear in a published thesis or journal publication? This information, summarized, must be included in the consent form.

Data will be presented as mean values and will not be identified to any particular subject. The results and conclusion of the study will be used in journal publication and conference presentation. Individual data or other identifying information will not be disclosed under any circumstance.

7. POTENTIAL RISKS AND THEIR ASSESSMENTDefinition of risk: A potential harm, discomfort, or inconvenience associated with your research that a reasonable volunteer would be likely to consider significant in deciding whether or not to participate. Risks include legal, social, emotional, or psychological issues, physical or biological hazards, revealing an identity, damage to reputation, exposure of behavior or medical character, illness, injury, side effects of applied or consumed products, revealing or a loss of private information, etc. Risk comes at various orders of magnitude, ranging from mere inconvenience to perceptible bodily pain.

A. What are the risks? Describe any potential harm, discomfort, or inconvenience, however minimal, as you would explain them to the subjects. It can be said that everything has a risk. Think carefully about what may potentially happen during your research. This information – summarized – must be included in the consent form.

The risks associated with the procedures are minimal and the selected protocol has been implemented in previous

IRB application, version October 2016, page 11 of 15

research studies. There is a possibility that muscle soreness will occur from the exercise protocol. The risk of soreness will be minimized by implementing proper warm-up and adequate recovery periods. The exercise testing protocol will also be supervised and administered by a certified strength and conditioning specialist (CSCS) who is qualified to ensure proper and safe exercise conditions for the participant. There is a minimal risk of hypoglycemia and/or cardiac complications during the protocol. To minimize this risk, researchers will 1) exclude participants who demonstrate or report cardiovascular/pulmonary and metabolic health conditions during pre-screening procedures, 2) monitor heart rate (HR) and blood pressure before exercise to ensure that it is within safe parameters to begin exercise and 3) have glucose incorporated drinks (Gatorade) available in the event hypoglycemic symptoms are observed. All researchers will be cognizant of overt signs of pain and discomfort that is unusual to normal levels elicited by the protocol. There are no notable risks associated with any laboratory testing procedures; although, DXA testing will involve exposure to radiation. However, the amount of radiation averaged over the entire human body is equivalent to 1/30 of the amount of natural background radiation and is too small to measure. It is of little consequence when compared to other everyday exposure risks. Participation is voluntary and you can withdraw at any time without penalty. The nitrate supplement contains blood pressure lowering ingredients. However this effect has not been shown to be potent enough to elicit a harmful drop in blood pressure. To minimize the risk of dangerously low blood pressure, hypotensive individuals will be excluded from participation. The ingredients of both the nitrate supplement and placebo will be disclosed in the ICF, and if the subject reports any adverse reaction to the supplement they will not be excluded from the study. The researchers and the University will not be responsible for medical care in the unlikely event of injury. It is strongly advised that the participant have health insurance to cover the cost of medical care if needed. The adhesive tape used to attach the muscle oxygenation sensor may cause discomfort when removing it or the participant may have an adverse reaction (i.e. allergic reaction) to the adhesive material.

B. Describe your procedures for protecting against or minimizing the potential risks. Is a debriefing statement needed? Contact information for Counseling and Psychological Services (CAPS at STATE UNIVERSITY) might be necessary. Do you have procedures and contacts with medical emergency services for treadmill exercises or phlebotomy? Could someone else not affiliated with the study obtain the personal and private data that you collect? Should an adverse event like these occur – something you don’t anticipate or didn’t plan on – the IRB web site has a reporting form for this purpose.

The exercise protocol will be supervised and administered by a certified strength and conditioning specialist (CSCS) who is qualified to ensure proper and safe exercise conditions for the participant. There is a minimal risk ofHypoglycemia and/or cardiac complications during the protocol. To minimize this risk, researchers will 1) excludeParticipants who demonstrate or report cardiovascular/pulmonary and metabolic health conditions during pre-screening procedures, and 2) monitor heart rate (HR) and blood pressure before exercise to ensure that it is within safe parameters to begin exercise. All researchers will be cognizant of overt signs of pain and discomfort that is unusual to normal levels elicited by the protocol. In the event of a medical emergency, investigators will call 911 for medical attention. To minimize the risk of dangerously low blood pressure associated with nitrate supplementation, hypotensive individuals will be excluded from participation. The participants will be informed about the potential discomfort and adverse reaction associated with the adhesive tape used to attach the sensor. In terms of mitigating discomfort, the site will be shaved and the tape will have adhesive material used by most medical devices. The participant may withdraw from the study at any moment during the protocol.

C. Explain why these risks should be determined as reasonable in relation to the anticipated benefits, if any, while conducting research with the subjects. Include in your response the importance of the expected gain in generalizable knowledge, when evaluated against the risks.

These risks are minimal and highly unlikely given the precautionary measures stated above, therefore, the potential benefits of the study outweigh the possible risks.

D. Will your study utilize a debriefing statement, counseling and psychological services (SHCS at STATE UNIVERSITY), adverse event protocol (medical emergency services contact)? If yes, please explain and provide copies of the documents.

no

8. AFFILIATIONSThese questions ask about how you are related to the institution and subjects where the research project is to be conducted. As examples: you are a teacher using your students in a classroom setting as your subjects, or you work for the company where a marketing survey is to be conducted, or you have a financial interest in a product being tested, or you are working with a colleague in another country. Each of these examples presents an element of risk. IRB reviewers will evaluate whether these risks are reasonable and whether they are sufficiently controlled, minimized, or eliminated by your procedures.

IRB application, version October 2016, page 12 of 15

A. Do you have any kind of pre-existing relationships with the subjects (participants) or institutions involved in conducting this study?Is there a possibility that collection of data from either the participant or institution may be seen as a favor and/or coercive when they are being asked to volunteer information? State any type of relationship apart from the study itself. If you work for an off-campus organization or entity and need to keep its identity confidential, note that here. See the following guidelines at the STATE UNIVERSITY IRB website.- Collecting data in classroom situations - Undue Influence and Coercion in Consenting

None

B. As an investigator involved with the project, do you or any of your family members (e.g. spouse, child) have a financial or other “self” interest in this study? If yes, describe. For example: an MBA student may conduct a consumer survey about establishing a business (restaurant) she herself wants to open. In this case, there could be a need for disclosure of that fact in the informed consent form.

None

C. Though there may not be one, could there be the perception of a conflict of interest for either you, as the investigator, or for the subjects in this study?If so, how will you manage that?

None

9. INFORMED CONSENT FORM FOR ADULTS AND ASSENT FOR MINORS The informed consent form (ICF) is the means by which you as the PI convey not only the research, but also the principles of human subjects protections to your subjects: respect, beneficence, and justice. There are examples on the IRB website at http://www.State University.edu/~research/irb/forms-and-links/index.shtml. Toward the top of this web page is the Word protocol document which contains the elements for the ICFs and the required header in English and Spanish: "blank IRB protocol application for training, classroom exercise, and development."

To test your ICFs for appropriate reading levels, submit your ICF to this software: http://www.readabilityformulas.com/flesch-grade-level-readability-formula.php

A. What type of Informed Consent Form will you utilize?The three most common types of consent are: informed consent, informed consent (electronic), and waiver of informed consent. For certain types of research methods, like anonymous on-line surveys, it is possible to obtain a waiver of documentation of consent (implied or passive) from the subjects. Contact the IRB for a determination and the requirements. A justification must be provided to obtain the waiver during the IRB member review. Note that you should add the current IRB protocol number obtained when you created this protocol in Cayuse to your ICF(s) before you upload it to this site. Be sure to check the list of required elements and that the domain csupomona has been changed to State University in email addresses and websites.

Informed consent, in person, paper copy.

B. How will you obtain and document informed consent (for adults) or assent (for children)? Which study personnel will be involved in obtaining consent and/or assent? For certain types of research methods, like anonymous on-line surveys, it is possible to obtain a waiver of documentation of consent (implied or passive) from the subjects. Contact the IRB for a determination and the requirements. A justification must be provided to obtain the waiver during the IRB member review.

Participants will provide written informed consent on a form approved by the IRB. The PI will verbally describe all the elements contained in the consent form and give the participant an opportunity to read the consent form and ask questions before signing it. If the individual agrees to participate, he or she will be instructed to sign and date the consent form.

C. Will there be recruitment of subjects who cannot themselves provide informed consent? If so, how will informed consent be documented for this population? For example, the ability of minors to assent could be dependent upon their age and/or their circumstance. Persons in vulnerable situations could be impaired in their ability to understand the study and may not be able to consent.

IRB application, version October 2016, page 13 of 15

No, there will be no recruitment of participants who cannot provide informed consent for themselves.

D. Which study personnel will be involved in obtaining consent?Know that makes such personnel engaged with the potential study subjects/participants.

The PI, Joe Schmoe

E. Describe how you will maintain the consent forms received from the subjects? Where (the location) will they be kept? For how long/until when? Will they be kept separate from subject data and specimens? For anonymous studies, it is crucial to keep identifiers separated from the actual data.

The signed informed consent forms will be stored in a locked file cabinet in the PI’s office, separated from other rawdata records.

Informed Consent Form Checklist Title of the protocol (same as on the front page of this application). Protocol number as assigned by the Cayuse IRB software (it will be provided when the protocol is started); it must appear

distinctly (e.g., bolded, its own line). A telephone number and/or e-mail address of all primary investigator(s) of this proposal, including faculty members and

students, who would be the point(s) of contact for the subjects. Affiliations (professional and institution) of the contacts and investigators; use full names, thus don’t write Cal Poly Pomona

- use California State Polytechnic University, Pomona. Clarification of the contacts in research projects which involve multiple sites (there can be multiple offices of research for

example). A statement that the study you are conducting involves research. An explanation of the purpose(s) of the research; why it’s being conducted by you. A description of what the subject must do as part of the research, what data will be collected, what will happen to the data

after the “active” phase of interaction with the subject is completed. (It has been found useful to include blocks in the ICF for subjects to initial when audio- or video-taping, so as to further document that these methods will be conducted.)

The expected duration of the subject's participation on the study (e.g., 50 mins in one day, four visits between May 1 and June 30).

The information about the procedures must be presented in layman's terms (at the 5th grade reading level); it must fully explain to the subjects what they are expected to do.

The entire consent and/or assent form may need to be translated into the subject’s language of fluency. Identification of any procedures or methods which are experimental. A description of any reasonable and foreseeable risks or discomforts to the subject. Changes of pronoun as appropriate to the subjects (e.g., you will be asked …; your child will do …). A description of any benefits to the subject or others which may reasonably be expected (or not) from the research. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the

subject. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to

whether any medical treatments would be available if injury occurs and, if so, what that would consist of and where further information may be obtained.

California law, under Health & Safety Code Section 24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the Experimental Research Subject’s Bill of Rights written in the language in which the person is fluent.

An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and - as appropriate - to contact in the case of a research-related injury to the subject.

A statement that participation is voluntary, that declining to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled.

Printed name and signature lines for the subject/participation and the date signed. Printed name and signature lines for the primary investigators (e.g., faculty member or the student conducting the research)

and perhaps research associates; and the date signed. A statement that the subject is entitled to receive a copy of the completed informed consent (or assent) form.

IRB application, version October 2016, page 14 of 15

California State Polytechnic University, PomonaInformed Consent Form for Research Involving Human Subjects

You are being invited to participate in a research study, which the Cal Poly Pomona Institutional Review Board (IRB) has reviewed and approved for conduct by [the investigators named here]. This form is designed to provide you - as a human subject/participant - with information about this study. The investigator or his/her representative will describe this study to you and answer any of your questions. You are entitled to an Experimental Research Subject’s Bill of Rights and a copy of this form. If you have any questions about your rights as a subject or participant, complaints about the informed consent process of this research study, or experience an adverse event (something goes wrong), please contact the Research Compliance Office within Cal Poly Pomona’s Office of Research at 909.869.4215. More information is available at the IRB website, http://www.State University.edu/~research/irb/index.shtml.

Below is this header in Spanish:

Forma de Consentimiento Informada para Investigación que Implica Sujetos HumanosUsted está invitado a participar en un estudio de investigación que el Comité Examinador Institucional (CEI) de

Cal Poly Pomona ha revisado y aprobado para ser conducido por los investigadores nombrados aquí. Esta forma está diseñada para proporcionarle información acerca de este estudio en su calidad de sujeto humano. El investigador o su representante le describirán este estudio y le contestarán cualquier pregunta que tenga. Usted tiene derecho a la Declaración de Derechos del Sujeto que participe en una Investigación Experimental y a recibir una copia de este documento. Si tiene alguna pregunta o quejas acerca del proceso descrito en dicho documento, por favor llame a la Oficina de la Conformidad que forma parte de la Oficina de Investigación de la Universidad de Cal Poly Pomona al 909.869.4215. Más información esa disponible en sitio web del CEI en el http://www.State University.edu/~research/irb/index.shtml.