Work Should Not Hurt You: Reduction of Hazardous Exposures in Small Businesses Through a Community Health Worker Intervention
Phase: NA
Conditions: Community Health Aides, Industrial Hygiene, Volatile Organic Compounds
Sponsor: University of Arizona

Work Should Not Hurt You: Reduction of Hazardous Exposures in Small Businesses 
Through a Community Health Worker Intervention 
ClinicalTrials.gov ID NCT03455530 
PI: Professor Paloma Beamer (University of Arizona) 
Protocol 
September 8, 2017 

F200: Application for Human Research 
 
 
 
 
Page 1 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
PROJECT TITLE: 
El Trabajo no te Debe Dañar: Reduction of Hazardous Exposures in Small 
Businesses through a Community Health Worker Intervention – R01ES028250 
 
INVESTIGATOR INFORMATION 
Principal Investigator Name, 
Degree(s): 
Paloma Beamer, PhD 
Affiliation 
 UA            
 B–UMG             
Principal Investigator UA NetID 
pbeamer 
Status/Rank: 
Associate Professor 
Center: 
Community Environment & Policy 
Department: 
 
College: 
Public Health 
Contact phone:  
520-626-0006 
Official Institutional Email: 
pbeamer@email.arizona.edu 
 
 
ADVISOR CONTACT INFORMATION (REQUIRED FOR ALL STUDENTS AND RESIDENTS) 
Name, Degree(s), UA NetID: 
 
Contact phone:  
 
Official University Email: 
 
 
 
ALTERNATE/COORDINATOR or Co-PI CONTACT INFORMATION 
*THIS INDIVIDUAL WILL RECEIVE COPIES OF ALL CORRESPONDENCE ON THE STUDY 
Name, UA NetID: 
Nathan Lothrop; lothrop 
Contact phone:  
520-314-7971 
Official University Email: 
Lothrop@email.arizona.edu 

 
 
 
 
 
 
 
Page 2 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
SECTION 1: REQUIRED SIGNATURES 
1. PRINCIPAL INVESTIGATOR 
I will conduct my study according to the University of Arizona HSPP policies and procedures for research with human 
subjects. 
 
 
09/08/17 
 
Paloma Beamer 
 
 
Signature 
 
Date 
 
Print Name 
 
2. ADVISOR (FOR ALL STUDENTS AND RESIDENTS ACTING AS THE PI) 
I will oversee the student researcher according to the University of Arizona HSPP policies and procedures for research with 
human subjects. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 
 
3. SCIENTIFIC/SCHOLARLY REVIEW (SEE HSPP GUIDANCE ON REQUIREMENTS FOR SCIENTIFIC/SCHOLARLY ASSESSMENT  - INCLUDE 
DOCUMENTATION FOR OPTIONS A AND B WITH SUBMISSION MATERIALS.) 
a. 
 Nationally based, federal funding organization (NIH, NSF) subject to full peer review 
b. 
 Nationally based, non-federal funding organization (March of Dimes, Amer Academy of Pediatrics) subject to peer 
review 
c. 
 Locally constituted peer review (signature required)  
 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 
 
4. DEPARTMENT/CENTER/SECTION REVIEW 
I have reviewed this application and determined that all departmental requirements are met and that the investigator has 
adequate resources to conduct the Human Research. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name/Email 
 
5. RESPONSIBLE PHYSICIAN (PROJECTS INVOLVING MEDICAL PROCEDURES WHICH THE PI IS NOT AUTHORIZED TO CONDUCT) 
I am a physician licensed by the State of Arizona (or US license for the SAVAHCS). I will be responsible for ensuring that all 
procedures that are part of this project and that require the attendance of a licensed physician will have a suitable physician 
present during the procedures. If at any time this is not possible, I will inform the IRB before any procedures are conducted. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 
 
 
 

 
 
 
 
 
 
 
Page 3 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
SECTION 2: GENERAL INFORMATION 
1. How many Human Research studies does the PI have open? 
5 
2. How many research staff will be involved in the Human Research? 
6 
3. What is the expected length of this project?   
09/01/17-08/31/22 
4. Will the University of Arizona be the coordinating center for a multi-site study? 
  No   
 
 Yes- Complete Appendix C- Multi-Site study 
 
5. Retention of study materials before, during, and after completion of the project:  
a. Where will original signed consent and PHI Authorization documents be stored (building name 
and room)?  Location: Drachman A223 
 
b. How long will consents be maintained after conclusion of the project? 
             
 6 years (UA standard)     
 6 years after child reaches 18    
 Other (explain): 
 
6. Is or will the project be funded by an external funding source e? 
  No  
 Yes- Complete below: 
 
a. Funding PI: Paloma Beamer, PhD 
b. Proposal Title: El Trabajo no te Debe Dañar: Reduction of Hazardous Exposures in Small 
Businesses through a Community Health Worker Intervention – R01ES028250 
c. Funder Name: NIH 
d. Total funding amount OR per subject amount: $3,498,725.00 
e. UAccess Account Information  Provide one of the following below: 
i. Institutional Proposal #: 00753004 
ii. Award #: 
 
Submit complete copy, cover-to-cover, of grant or award. If you need help locating any of the UAccess 
numbers please call Sponsored Projects at 626-6000. 
 
7. Is the project funded by a For-profit industry sponsor? 
  No  
 Yes- Complete required below: 
 
a. IRB Payment eDoc #: 
 
Please review HSPP Guidance, Fees for Human Research, for more information.  
 
8. Conflict of Interest (COI): 
The Principal Investigator hereby affirms that ALL individuals who meet the definition of 
investigator for this project in the current Policy on Investigator Conflict of Interest in Research 
have completed the mandatory Conflict of Interest training and Disclosure of Significant Financial 
Interests. 
 
 Yes  
 
 
 
 No (explain):      

 
 
 
 
 
 
 
Page 4 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
  
9. Additional requirements: 
Certain types of research require additional regulatory documentation. Please identify which of the 
following apply to your project. Complete the appropriate Appendix and submit as part of the 
submission materials. 
 
 Appendix A – Children (subjects under 18)  
 Appendix B – Drugs/Devices (A clinical investigation of a drug or device)  
 Appendix C – Multi-Site study (The UA IRB will review research activities for an investigator or 
research staff not affiliated with the UA who is ‘engaged in the research’ (e.g. consenting, 
collecting data, or analyzing identifiable information)  
 Appendix D – Pregnant Women/Neonates  
 Appendix E – Prisoners 
 Appendix F – Waivers of consent, waiver of a signature, or waiver or alteration of PHI 
 Appendix G – Exception From Informed Consent (EFIC)  
 Appendix H – Native American or International Indigenous populations 
 None apply to the proposed study 
 
10. Research Site: Small businesses in Tucson AZ 
 
Location (Explain): Beauty salons and auto repair shops in 7 underserved zipcodes in Tucson, 
Arizona 
 
 
If research is taking place at B–UMG or AZCC please check the appropriate boxes below: 
 
Banner – University Medicine Group: 
 Phoenix Campus 
 
 
 
 Biological specimens 
 Clinical Data 
 Tucson Campus      
 
 
 
 Biological specimens 
 Clinical Data 
 South Campus  
 
 
 
 Biological specimens 
 Clinical Data 
*Submit a copy of the UAHS Research feasibility review approval 
 
University of Arizona Cancer Center: 
 North Campus  
 
 
 
 Biological specimens 
 Clinical Data 
 Orange Grove Clinics   
 
 
 Biological specimens 
 Clinical Data 
 Phoenix 
 
 
 
 
 Biological specimens 
 Clinical Data 
*Submit a copy of the Scientific Review Committee letter 
 
 
 
SECTION 3.  PROJECT NARRATIVE 
1) Background 
This project aims to reduce negative health outcomes in small businesses that primarily employ high-
risk Latino workers by characterizing their exposures to hazardous chemicals and assessing if a 
community health worker (CHW) intervention is effective at decreasing these exposures. 
Occupational disease and injury, though preventable by definition, are leading causes of death in the 

 
 
 
 
 
 
 
Page 5 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
United States, with a disproportionate burden faced by Latinos. Small businesses pose a particular 
risk. They are more likely to employ low-wage Latino workers, and often use hazardous solvents 
containing volatile organic chemicals that can cause asthma, cancer, cardiovascular, and neurological 
disease; yet their workers lack access to culturally and linguistically appropriate occupational health 
and pollution prevention information due to economic, physical, and social barriers. CHW-led 
interventions and outreach in Latino communities have documented increased access to health care 
and health education and reduced workplace exposures among farmworkers. CHWs are an 
innovative method to bridge the gap between these small business communities and other 
stakeholders. The proposed project will capitalize on established partnerships between the 
University of Arizona, the Sonora Environmental Research Institute, Inc. and the El Rio Community 
Health Center. A community-engaged research framework will be used to complete three specific 
aims: 1) Quantify and identify exposures to hazardous chemicals in the two high risk small business 
sectors common in our target area (i.e., auto repair shops and beauty salons); 2) Work 
collaboratively with business owners, trade groups, workers and CHWs to design an industrial 
hygiene-enhanced CHW intervention tailored for each small business sector; and 3) Conduct a 
cluster randomized trial to evaluate the effectiveness of the CHW intervention at reducing workplace 
exposures to volatile organic compounds and assess which factors led to successful utilization of 
exposure control strategies in both male and female-dominated businesses. Businesses will be 
randomized to either an intervention or delayed intervention group, both of which will receive 
incentives to participate, such as worksite health screenings. CHWs will work closely with business 
owners and employees to select and implement exposure-strategies appropriate for their worksite 
using a menu of complementary strategies of varying complexity and cost. This innovative project 
has the potential to directly reduce occupational health disparities through a CHW intervention that 
moves beyond providing occupational health education. The intervention will overcome current 
barriers by helping marginalized Latino workers and small business owners who may have limited 
education, literacy, and computer skills to understand the hazards associated with their work, and 
will empower them to have greater control over their occupational exposures, with the ultimate goal 
of preventing occupational disease and reducing health disparities. 
2) Purpose 
Project Goal: Determine if an industrial hygiene-enhanced community health worker (CHW) 
intervention can significantly reduce workplace exposures to hazardous chemicals in small 
businesses that mainly employ marginalized minority workers. 
 
3) Lay Summary (approximately 400 words) 
Occupational exposures contribute to minority health disparities. This study will formally evaluate if 
a community health worker intervention can effectively reduce workplace exposures to hazardous 
chemicals in marginalized small businesses. Through face-to-face encounters, this study will increase 
the capacity of workers with limited education, literacy, and computer skills to understand 
workplace hazards and implement effective control options to reduce exposures and prevent 
occupational disease. 
For Aim 1, we will characterize exposure to volatile organic compounds (VOCs) in 20 local businesses 
(10 from each sector). We will measure this through two methods: 1) Summa Canisters, which are 
metal canisters to collect air that is analyzed for VOCs, will be placed in the workplace and will give 
an average air concentration over time, and 2) A small device, a photo-ionizing detector (PID) called 

 
 
 
 
 
 
 
Page 6 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
a ppbRAE3000, which records VOCs exposure levels in real-time, will be worn by workers or 
owner/managers who agree to participate. We will facilitate focus groups with workers (x4) and 
brief interviews with owner/managers (1/shop) to explore elements of the safety culture such as risk 
perception and attitudes towards health promotion and personal protection. In Aim 2, we will work 
with various business owners, trade groups, workers and CHWs to design and refine approaches that 
CHWs can take to reduce workplace VOCs exposures, specific for each business sector. In Aim 3, we 
will recruit participants from 120 businesses (60 from each sector) and evaluate how effective the 
CHW intervention is at reducing workplace exposures to VOCs by measuring total VOCs before and 
after the controls for VOC exposures recommended by CHWs are put in place. To help the CHWs 
determine the best recommendations for each shop, they will ask owners a series of questions and 
complete a shop audit. In addition, we will also ask questions of owners and employees about their 
ideas on health and wellness in the workplace and how they felt about the CHW recommendations 
in their shops. We will also conduct focus groups with ownersto investigate their ideas on the CHW 
recommendations. 
 
4) Setting of the Human Research 
Research will take place in underserved communities in Tucson, AZ in small businesses (<25 
employees) that primarily employ high-risk Latino workers. We will focus on beauty salons and auto 
repair shops. For measuring chemicals in air for Aim 1, we will work with a total of 10 of each 
business type drawn from seven zip code areas in Tucson (total of 20 businesses). For the interviews 
with owners and focus groups with workers as part of Aim 1, we will recruit owners and workers 
from these same 20 businesses. Focus groups will be held in a non-business related, neutral location 
in the general area. Interviews will be held on site.  
In Aim 3, we will measure chemicals in the same way but from 120 shops total (60 from each sector) 
from the same seven zip codes in Tucson. If it is not possible to recruit all the shops we need, we will 
amend this geographic recruitment area in the future. Surveys on health and wellness and the CHW 
recommendations for reducing exposures will be done at the workplace. Any questions asked to 
refine the exposure control recommendations will take place at work. Focus groups will be held in a 
non-business related, neutral location in the general area. 
Potential businesses will have the project fully explained to them. If a business agrees to participate 
and the owner signs the site authorization form, we will describe the project to employees and 
provide them with individual Informed Consent Forms. 
The project will capitalize on established partnerships between the University of Arizona, the Sonora 
Environmental Research Institute, Inc. and the El Rio Community Health Center. Our hope is that a 
CHW intervention will be shown to be effective at decreasing VOC exposures in these small business 
types.  
5) Resources available to conduct the Human Research  
Key personnel include: 
Paloma I. Beamer, Ph.D. Principal Investigator 
Dr. Beamer is an Associate Professor of Environmental Health Sciences in the Mel and Enid 
Zuckerman College of Public Health and Chemical & Environmental Engineering at the University of 
Arizona. 

 
 
 
 
 
 
 
Page 7 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
Scott Carvajal, Ph.D., MPH Co-Investigator 
Dr. Carvajal is a Professor of Health Behavior and Health Promotion in the Mel and Enid Zuckerman 
College of Public Health and director of the CDC-funded Arizona Prevention Center at the University 
of Arizona. 
Dean Billheimer, Ph.D. Co-Investigator 
Dr. Billheimer is a Professor in the Department of Epidemiology and Biostatistics of the Mel and Enid 
Zuckerman College of Public Health at the University of Arizona. 
Maia Ingram, MPH. Co-Investigator 
Ms. Ingram is Program Director for Community-Based Evaluation Projects in the Health Promotion 
Sciences Department of the Mel and Enid Zuckerman College of Public Health at the University of 
Arizona. 
Community collaborators include: 
Sonora Environmental Research Institute, Inc. (SERI):  
SERI will lead the community health worker intervention. They will be responsible for recruitment of 
businesses, aid in development of the intervention, serve as a liaison and implement the 
intervention by conducting at least three visits to each business. They will also assist in training, 
workshops, and results interpretation and dissemination. 
El Rio Community Health Center: 
El Rio will conduct interviews with owner/managers and focus groups with workers in Aim 1. El Rio 
will be responsible for conducting health screenings, wellness consultations, and follow-up health 
care referrals (during Aim 3). They will also aid in development of the intervention and dissemination 
of the results in the community.  
6) Study Population 
We anticipate that we will obtain personal exposure measurements from up to 4 workers at 140 
businesses (Aim 1 n=20; Aim 3 n=120), as well as conduct focus groups with owners/managers at 
each business (n=140). Thus, we anticipate that our total subject population could be 700 small 
business workers and owners. It is possible that at some businesses with <4 workers, we may obtain 
repeat measurements on different days to ensure that 4 full-shift exposure assessments are 
conducted at each business during each assessment. This would result in a lower number of 
participants in our study. We have assumed 3 workers per business (n=420) in calculation of our 
planned enrollment, in addition to the 140 business owners. We will make every attempt to measure 
the exposure of the same workers at each assessment. However, because of timing constraints, high 
worker turnover or staffing changes in the businesses, it is possible that different workers could be 
measured at each assessment, resulting in a possible total of 1520 (20 business*4 workers+120 
businesses*4 workers*3 assessments) worker subjects, in addition to the 140 business owner 
participants.  
 
 
 

 
 
 
 
 
 
 
Page 8 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
Inclusion criteria include workers or owner/managers of small businesses over 18 years of age in the 
auto repair or beauty salon sectors in southern metropolitan Tucson, Arizona. Exclusion criteria 
include age less than 18 years or people not working in auto repair or beauty salon sectors. 
 
7) Recruitment Methods and Consenting Process 
a. Recruitment Process:  
Businesses will be recruited with the assistance of SERI CHWs and the Tucson Hispanic Chamber of 
Commerce. The project will be described to the business owner/manager and if they agree to 
participate and sign the site authorization form, workers will be told about the project’s overall goals 
of community health interventions leading to decreased exposure to potentially dangerous 
chemicals in their workplace. In Aim 1, we are recruiting 20 businesses so that we can obtain an idea 
of current baseline VOC exposure levels and work practices, as well as owner/manager and worker 
ideas about health and safety in the workplace via interviews and focus groups. These are small 
businesses and SERI CHWs typically go door-to-door and explain the project orally. In Aim 3, we will 
recruit 120 businesses using the same methods as developed in Aim 1. 
In Aim 3, once the business owner/manager agrees for their business to participate and signs the site 
authorization, the owner/manager will be recruited into the study, allowing the study team to get 
information about their shop and work practices critical for choosing effective ways of reducing 
chemical exposures (see Owner_Consent document).  
Once the business owner/manager is recruited, individual employees and the owner/manager (if 
they do similar activities as workers) will be recruited with the goal of measuring four full-shift 
exposures per business (see AirSampling_Consent document). In Aim 3, we will complete four full-
shift exposures in three different visit periods for a total of 12 full-shift exposures per business.  
If the small business does not have four workers that are willing to participate, multiple 
measurements may be taken on the same workers on multiple days. Employees and 
owner/managers will also be recruited to join focus groups and do interviews, respectively. 
However, since the shops participating in Aim 1 are not able to participate in the randomized control 
trial in Aim 3 (for statistical reasons), we will only work with businesses with enough potential 
participants to consent to complete monitoring for 4 work shifts for any part of Aim 1. 
In Aim 3, after we recruit air sampling participants, we will also recruit owners/managers and 
employees to complete a survey on health and wellness in the workplace (see 
WellnessSurvey_Consent document). Owner/managers will be recruited for focus groups discussing 
ideas about CHW recommendations on reducing workplace VOC exposures (see 
FocusGroup_Consent document). We will recruit employees to complete a survey on ideas about 
CHW recommendations on reducing VOC exposures (see PostInterventionQx_Consent document).  
 
b. Informed Consent:  
Once the business owner agrees to participate, they will be provided with a site authorization letter 
to sign. SERI CHWs will describe in the language of choice (English or Spanish) the study in general 
and the small VOC measurement device the participants will be asked to wear. They will also 
describe the survey on health and wellness in the workplace (see WellnessSurvey_Consent 
document) to owner/managers and employees; the focus groups (see FocusGroup_Consent 

 
 
 
 
 
 
 
Page 9 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
document) to owners/managers; the survey on ideas about CHW recommendations on reducing 
VOC exposures (see PostInterventionQx_Consent document) to employees.  
The Informed Consent Form (ICF) document for each study component (e.g. Air Sampling; Wellness 
Survey; Focus Group, etc.), in the language of subject’s choice – Spanish or English, will then be read 
aloud to potential subjects (ensuring low-literacy participants have the same access to information 
and chance to ask questions). If an employee or owner/manager agrees to participate, they will be 
given a written ICF document and have the chance to ask questions. The ICF may be taken home to 
discuss with family members if they wish. Please note that immigration status will not be asked, 
discussed, or recorded at any point in this project.  
 
8) Research procedures involved in the Human Research 
During Aim 3, owner/managers will answer questions about their workplace and practices and 
complete a survey on ideas about CHW recommendations on reducing exposures (see 
Owner_Consent document). Owner/managers and employees will have the option to consent into 
any of the following: wearing an air sampler during their work shift (see AirSampling_Consent 
document); and/or a survey on health and wellness in the workplace (see WellnessSurvey_Consent 
document). Owner/managers also have the option to consent to a focus group on ideas about the 
CHW recommendations on reducing VOC exposures (see FocusGroup_Consent document). 
Employees will also have the option to consent to answering questions in survey format on ideas 
about CHW recommendations on reducing VOC exposures (see PostInterventionQx_Consent 
document). 
For the business owner/manager completing the Owner_Consent document, they will be asked 
questions on: their background and demographics; their workplace and practices so as to help 
inform the VOC control recommendations; and their ideas about the CHW recommendations on 
reducing VOC exposures that were recommended in their shop.  
For the owner/manager or employee completing the AirSampling_Consent document, they will be 
asked questions on their background and demographics. Participants of air monitoring will wear a 
small device called a photo-ionization detector (PID) attached to their clothing during the work shift. 
The PID can only obtain total VOC exposure levels, and it is not possible to distinguish exposures to 
individual VOCs if multiple VOCs are present. The PIDs will record at the parts per billion level and 
will record the total VOC level every 60 seconds. Please see device information included with this 
submission for more information on the PID. Results of the sampling will be returned to participants 
individually by a CHW, and then they will be asked a brief survey on how it went to get their results 
returned to them. 
For the owner/manager or employee completing the WellnessSurvey_Consent document, they will 
be asked questions on their background and demographics and on health and wellness in the 
workplace. This will take place at the health screening visit. 
For the owner/manager completing the FocusGroup_Consent document, they will be asked 
questions on their background and demographics and ideas about the CHW recommendations on 
reducing VOC exposures in their business. This focus group will be held outside of work hours at a 
non-work location. Conversations during focus groups and interviews will be audio recorded and 
notes will be taken on the dialogue. 

 
 
 
 
 
 
 
Page 10 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
For the employee completing the PostInterventionQx_Consent document, they will be asked 
questions on their background and demographics and ideas about the CHW recommendations on 
reducing VOC exposures in their business. This questionnaire will be done at work during work 
hours.  
 
All shops will receive a different printed postcard every 1-2 months throughout the study in the 
preferred language of the owner/manager. These postcards will address what is a VOC; a thank you 
for signing up for the study; and then series of reminders about focus groups for owner/managers. 
 
 
9) Cost to subjects  
There will be no direct cost to subjects. The air monitoring portion in this study will not take any 
extra time, since the participant will only participate during their regular work shift. It may take a few 
minutes to put the equipment on (this was approved as part of Aim 1 and has not changed for Aim 
3). These pieces of equipment are designed to be worn by workers with minimum interference of 
their work. 
The wellness surveys, focus groups, and post-intervention questionnaire portions will take up 
approximately 10 minutes, 1.5 hours, and 10 minutes of each participant’s time, respectively. This 
includes travel to an off-site location for a focus group.  
Questions for the owner/manager that will help inform how to better reduce VOCs will take 
approximately 1 hour of the participant’s time.  
For owner/managers who participate in both wellness surveys, a focus group, and questions about 
the shop come up with more appropriate methods of reducing VOC exposures in the shop, it will 
take a total 3 hours. 
For employees who participate in both wellness surveys and the post-intervention questionnaire, 
and it will take a total of 30 minutes. 
 
 
10) Risks to subjects 
There is no known risk involved with wearing the PID. If the subject finds its presence annoying or 
uncomfortable in any way, they may simply take it off. There are no anticipated risks to subjects 
from participating other than the risks they encounter daily completing their normal job tasks.  
There is no known risk involved with participating in focus groups or any surveys/questionnaires. 
Potential subjects may refuse to be enrolled in the research study even if the small business 
owner/manager that employs them has agreed to participate by signing the site authorization letter. 
This will be explained to both owners/managers and employees at the onset. 
Within the worksite, workers will know which of the other workers are participating in the study 
because they will be wearing the monitors and the monitors will be visible. Owner/managers will not 
know if their workers participate in focus groups as these will be held off-site outside of work hours 
(Aim 1). 

 
 
 
 
 
 
 
Page 11 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
It is possible that participants may be concerned about participating in our study because of their 
legal immigration status or concern about compliance with occupational regulations.  
Business owners may be concerned about letting their workers participate because of economic 
risks, potential liability, or possible reputational harm.  
Study staff may also be exposed to VOCs while collecting data in the small businesses. 
Our team has substantial experience conducting studies with Latino populations of mixed 
immigration status, and with utilizing protocols that effectively minimize risks while working with 
these populations. This includes: 1) not asking about immigration status; 2) obtaining a Certificate of 
Confidentiality from NIH; 3) orally reading Informed Consent Forms to participants in their preferred 
language; and 4) minimizing collection of identifiable and private data as much as possible. Further, 
to protect any potential economic risk or harm to the businesses, we will maintain confidentiality of 
the participating business and will not link exposure data with a business in any public setting. 
 
11) Potential benefits to subjects and/or society 
Potential direct benefits to the subjects include knowledge of their personal VOC exposures and 
reduced exposures to hazardous chemicals in the workplace. As VOCs emitted from small businesses 
are one of the primary sources of hazardous air pollutants in urban air, particularly in minority 
neighborhoods, by reducing exposures in these workplaces, we may also reduce neighborhood 
exposures to these chemicals. This could benefit workers and their families if they live nearby. In our 
previous work, we have demonstrated that regions of metropolitan Tucson that have the highest 
levels of hazardous air pollution and emissions from small businesses have higher than expected 
cases of childhood wheezing illnesses. 
 
12) Provisions to protect the privacy of subjects and the confidentiality of data 
a. Protection of subject privacy: There will be no personal identifiers (including business name) 
on any written materials used for exposure assessments, surveys, questionnaires, or other 
data collection instruments. Businesses will receive an alphanumeric code. During focus 
groups, participants will be asked to NOT use their names when speaking. We will not discuss 
or inquire about immigration status at any point during the study. Consent forms and the link 
between personal identifiers and subject codes will be kept separately from all other study 
material, in hardcopy form only, within a locked cabinet in Drachman Hall, room A223 at the 
University of Arizona. All contact information will be kept there until the study is complete. In 
order to facilitate scheduling of previously consented individuals for air sampling between 
the three organizations, we will store the link between the participant/business 
alphanumeric code and identifying information temporarily on UA Box Health, a HIPAA-
compliant data storage system, until all visits for the business and its participants are 
completed (estimated 9 months).  
b. Protection of data confidentiality: The primary protection against potential risks is a data 
security plan that includes physical, administrative, and technical aspects for confidentiality 
and privacy of the data, including personal identifiers. Of particular importance will be the 
appropriate training of CHWs, interviewers, and program evaluators in maintaining 
confidentiality and privacy of all data, in addition to their formal training from Collaborative 
Institutional Training Initiative (CITI). To assure total anonymity of businesses and subjects, 
alphanumeric codes will be used. Digitized data will be de-identified and stored in a HIPAA-

 
 
 
 
 
 
 
Page 12 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
grade encrypted file storage system (e.g., REDCap). This will include audio recordings of 
interviews and focus groups, which will be uploaded directly in REDCap. During focus groups, 
we will ask subjects NOT to use their names. Transcribing of any sort will be completed in a 
sound-proof room (Medical Research Building, room 113i), with any transcriptions or audio 
files being uploaded directly into REDCap. Only study personnel as indicated on the VOTF will 
have access to this information, including audio recordings and transcriptions. Participants 
are free to withdraw from the study at any time with no penalties. This right will be explained 
to each participant as part of the informed consent procedure.   
These protections should provide confidentiality to the businesses and reduce the risk of economic 
harm. Ultimately, we anticipate that businesses will participate because they value the health and 
wellbeing of their workers and would like to reduce their occupational exposures and help them 
improve their health. Other businesses are likely to self-select out and are not likely to agree to 
participate in the study.  
 
13) Access to Private Information  
c. Access to medical records (HIPAA): N/A – medical records will not be accessed 
d. Access to educational records (FERPA): N/A – educational records will not be accessed     
e. Access to employee records: N/A – employee records will not be accessed 
 
14) Subject compensation 
Subjects in the air monitoring portion of Aim 1 will not be compensated for participation. Subjects in 
the focus groups portion and interviews of Aim 1 will be paid $25 cash for their participation.  
In Aim 3, owner/managers participating in air sampling will be paid $10/shift, up to 3 shifts (a total of 
$30); owner/managers participating in focus groups will be paid $15. An owner/manager could be 
compensated up to $45 over the course of the study. Employees participating in air sampling will be 
$10/shift up to 5 shifts (a total of $50). An employee can be compensated up to $50 over the course 
of the study. 
 
 
15) Medical care and compensation for injury  
No risk of injury is anticipated due to study participation. However, in case of an injury, we do not 
have any monetary compensation to cover any possible costs related to the injury. Workers will be 
provided with referral to appropriate community health clinics for follow up if they are concerned 
about their exposures or any related findings. 
 
16) Monitoring for subject safety  
This research does not involve more than minimal risk to subjects. However, because our CHW 
intervention meets the NIH definition of a clinical trial, we have developed a Data and Safety 
Monitoring Plan. Data will be monitored by UA investigators not involved in the research, who have 
substantial experience in human exposure studies. Each data collector will complete a daily log 

 
 
 
 
 
 
 
Page 13 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
during the assessment periods, which will include reporting of any breaches of the interviewing 
process or exposure assessment or any adverse events as well as document instrument calibration. 
At least two of the following three investigators below will meet to review reports and logs on a 
quarterly basis to monitor data quality, recruitment, accrual, retention, VOC exposures, and 
maintaining data security. Data and safety monitoring meetings will be held in a conference room, 
adjacent to where the hard copies of the data and logs are maintained in locked storage. They will 
report any data or safety issues immediately to the project investigators and appropriate entities. 
The following UA investigators have agreed to provide oversight on data and safety monitoring for 
this study:  
• Jeff Burgess, MD, MS, MPH; Associate Dean of Research, Mel and Enid Zuckerman College of 
Public Health; Professor, Environmental Health Sciences, Mel and Enid Zuckerman College of 
Public Health 
• Walter Klimecki, DVM, PhD; Interim Department Head and Associate Professor, Pharmacology & 
Toxicology, College of Pharmacy  
• Philip Harber, MD, MPH; Professor, Environmental Health Sciences, Mel and Enid Zuckerman 
College of Public Health  
 
In addition to these protections, project investigators will establish a set of exposure criteria that will 
be provided to research staff to determine if a workplace presents immediate, severe risk to workers 
and themselves. Research staff will be trained to call project investigators immediately, and together 
they will work with the business owners to resolve the issues with the appropriate regulatory and 
health agencies.  
 
17) Withdrawal of subjects 
Subjects may withdraw themselves from the study at any time they wish. Any data collected about 
chemicals in the air or the subject’s views on safety and health in the workplace from focus groups or 
interviews to that point may be used in this study. The voluntary nature of their participation will be 
made clear during the consenting process. 
Subjects would be withdrawn from the study if it were deemed by any expert on the study team to 
be in the participant’s best interest to withdraw.  
18) Sharing of results with subjects  
Air monitoring participants will be provided with the results of their exposure assessments and an 
interpretation of these exposures with respect to activities at the business, as well as any relevant 
recommendations on how to reduce their exposures. Participants will be referred to appropriate 
community health clinics for follow up if they are concerned about their exposures.  
Owner/managers will be provided the same results materials as given to all air monitoring 
participants. In doing so, we realize that owner/managers may be able to identify which results 
correspond to which worker; however, this will be a condition that air monitoring participants will 
agree to during consenting. 
These results will be provided by the CHWs in person, so subjects can ask questions. CHWs will be 
provided with a list of experts, including the PI and co-investigators, who will be able to provide on-
site technical advice to businesses seeking assistance with designing and implementing their control 

 
 
 
 
 
 
 
Page 14 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
plans. These experts will be assembled from five UA colleges and include industrial hygienists, 
engineers, toxicologists, and occupational doctors. 
19) Future use and long-term storage of data or specimens 
Personal information we get from Aim 3 will not be stored for future research. We will use the data 
(not personal information) from this study for future research. 
 
20) Information management  
N/A 
 
21) Clinical Trials.gov Information 
 
 
ClinicalTrials.gov "NCT" number for this trial (provide): 
NCT03455530 
 Registration pending 
 Clinical trial does not require registration (explain): 
22) Gases 
N/A 
 
SECTION 4: LIST OF ATTACHMENTS FOR THIS SUBMISSION (REQUIRED) (Items listed here are 
expected to be attached as separate documents. These documents will appear in the UA HSPP IRB 
approval letter as 'documents submitted concurrently' with the review.) 
Document Name 
Version Date 
1. Research_Personnel_List_10 
2. SiteAuthorization 
3. RecruitmentPoster 
4. ParticipantInfoForm 
5. ParticipantBackgroundDemographics 
6. SERI_PreAssessment_SPN 
7. SERI_PreAssessment_ENG 
8. SERI_Assessment_SPN 
9. SERI_Assessment_ENG 
10. Site_Authorization_ENG 
11. PostInterventionQx_ENG 
12. PostInterventionQx_SPN 
13. FocusGroup_Questions_ENG 
14. FocusGroup_Questions_SPN 
15. WellnessSurvey_ENG 
16. WellnessSurvey_SPN 
17. AirSampling_Consent_ENG 
18. AirSampling_Consent_SPN 
19. WellnessSurvey_Consent_ENG 
20. WellnessSurvey_Consent_SPN 
1. 10/17/19 
2. 10/17/19 
3. 11/11/19 
4. 10/17/19 
5. 10/17/19 
6. 10/17/19 
7. 10/17/19 
8. 10/17/19 
9. 10/17/19 
10. 10/17/19 
11. 10/17/19 
12. 10/17/19 
13. 11/11/19 
14. 11/11/19 
15. 10/17/19 
16. 10/17/19 
17. 11/11/19 
18. 11/11/19 
19. 10/17/19 
20. 10/17/19 

 
 
 
 
 
 
 
Page 15 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
21. FocusGroup_Consent_ENG 
22. FocusGroup_Consent_SPN 
23. Owner_Consent_ENG 
24. Owner_Consent_SPN 
25. PostInterventionQx_Consent_ENG 
26. PostInterventionQx_Consent_SPN 
27. Postcards 
28. HealthScreeningFlyer 
29. UA_SiteAudit_Auto 
30. UA_SiteAudit_Beauty 
31. F200 
32. AirSampling_Script_ENG 
33. AirSampling_Script_SPN 
34. FocusGroup_Script_ENG 
35. FocusGroup_Script_SPN 
36. PostInterventionQx_ENG 
37. PostInterventionQx_SPN 
38. WellnessSurvey_Script_ENG 
39. WellnessSurvey_Script_SPN 
 
21. 11/11/19 
22. 11/11/19 
23. 10/17/19 
24. 10/17/19 
25. 10/17/19 
26. 10/17/19 
27. 10/17/19 
28. 11/11/19 
29. 10/17/19 
30. 10/17/19 
31. 11/11/19 
32. 11/11/19 
33. 11/11/19 
34. 11/11/19 
35. 11/11/19 
36. 11/11/19 
37. 11/11/19 
38. 11/11/19 
39. 11/11/19 
See HSPP website for submission requirements. 
Items needed for approval: 
• 
Word Versions of Application, Consents, Recruitment and Data Collection  
• 
F107: Verification of Training Form 
• 
Current PI/Co-PI CVs or biosketch, if not included with copy of grant application 
• 
Informed Consent/Permission/Assent Form(s) – including study specific release of information documents, DHHS 
approved sample consent forms.  If consent will not be documented in writing, a script of information to be provided 
orally to subjects 
 
Other Items as applicable: 
• 
Appendix A - Children 
• 
Appendix B - Drug/Device 
• 
Appendix C- Multi Site Research 
• 
Appendix D- Pregnant Women and Neonates 
• 
Appendix E- Prisoners 
• 
Appendix F- Waiver of Consent/ PHI 
• 
Appendix G- Exception from Informed Consent (EFIC) 
• 
Appendix H- Native American 
• 
Biosafety Review letter (for UA - Institutional Biosafety Committee) 
• 
Certificate of Confidentiality 
• 
Compressed Gases Review letter (for UA – Research Instrumentation) 
• 
Contract – complete or draft copy of contract including budget 
• 
Data Collection Tools – surveys, questionnaires, diaries not included in the protocol, data abstraction form for 
records review 
• 
Data Monitoring Charter and Plan  
• 
Drug/Device information – Investigator's Brochure, drug product sheet, device manual, user's manual, instructions 
for use, package insert, IND/IDE documentation, FDA 1572 form, 510k indication, FDA exemption, sponsor 
determination of device risk, etc. 
• 
Export Control Review 

 
 
 
 
 
 
 
Page 16 of 16 
 
HSPP Use Only: 
Form 200 v 2016-07 
• 
Grant Application(s) – cover-to-cover copy of grant, regardless of home institution or funding agency, and a copy of 
the Notice of Grant Award.   
• 
Multi-site information (for sites engaged in research where the UA is the IRB of record)  
o 
Copy of any approvals granted from that site (including determinations if this site has an IRB of its own) 
o 
Site-specific F107 
o 
Copy of the site's human subjects training policy 
o 
CV and medical license (if applicable) of site PI 
• 
Other Approval letters (e.g., school districts, Tribal, other IRB approvals) 
• 
Participant Materials – written materials to be provided to or meant to be seen or heard by subjects (e.g. study 
newsletter, physician to participant letter, wallet cards, incentive items, holiday/birthday cards, certificates, 
instructional videos/written guides, calendars, certification of achievement, etc.) 
• 
Payer coverage analysis 
• 
PHI Authorization Form(s) 
• 
Protocol – including all amendments/revisions, sub- or extension-studies 
• 
Radiation Safety Review letter- needed regardless if the radiation device is approved and used standard of care 
• 
Recruitment Materials – telephone scripts, flyers, brochures, websites, email texts, radio/television spots, 
newspaper advertisements, press releases, etc. 
• 
Scientific Review Committee letter (for cancer related projects – AZCC SRC; other units as applicable if the unit has a 
scientific review committee) 
• 
Site Authorizations for research purposes and/or access to administrative records/samples 
o 
External sites (such as schools, other hospitals or campuses, etc.) 
o 
UAHS Research Portal feasibility review approval 
• 
Travel Authorization documentation (for UA – Office of Global Initiatives) 
• 
Use of retrospective research samples and/or data – IRB approval letter, original consent under which 
samples/data were collected, letter allowing access to samples