DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
Phase: NA
Conditions: Vehicular Environment
Sponsor: Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Page 1 of 45 
 
 
Approval date: 20-Dec-2017 
DRIIVE (Data and Research on Interventions to Improve the V 
MSKCC NON THERAPEUTIC PROTOCO 
Principal Investigator/Department: 
Jennifer Leng, M.D., M.P.H. 
ehicular Environment) 
L 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Co-Principal 
Francesca Gany, M.D., M.S. 
Investigator(s)/Department: 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Investigator(s)/Department: 
Emily Tonorezos, M.D., M.P.H. 
Yuelin Li, PhD 
Jedd Wolchok, M.D.,PhD 
Medicine 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Medicine 
Consenting 
Professional(s)/Department: 
Francesca Gany, M.D., M.S 
Jennifer Leng, M.D., M.P.H. 
Nicole Roberts, M.P.H. 
Redwane Gatarny 
Shu Fang Lei 
Rehan Mehmood 
Bharat Narang, M.P.H. 
Xiaoxiao Huang, M.A. 
Anuradha Hashemi, M.P.H. 
Munia Islam 
Emily McNeil 
Anna Claire Fernandez 
Julia Smith 
Luke Paolantonio 
Devika Jutagir 
Minlun Wu 
Sabrina Pan 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
 

Page 2 of 45 
Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
 
 
 
 
 
Irina Melnic 
Victor Luna 
Nujbat Meraji 
Jacqueline Weng 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Psychiatry/ Immigrant Health & 
Cancer Disparities 
Please Note: A Consenting Professional must have completed the mandatory Human 
Subjects Education and Certification Program. 
 
Participating Institutions – If multicenter 
study coordinated by MSKCC: 
PI's Name 
Site's Role 
New York University 
Judith Zelikoff, PhD 
Specimen Analysis 
The City College of New York 
Pengfei Zhang, PhD 
Specimen Analysis 
Memorial Sloan-Kettering Cancer Center 
1275 York Avenue 
New York, New York 10065 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 3 of 45 
 
 
 
 
Table of Contents 
1.0 
PROTOCOL SUMMARY AND/OR SCHEMA ....................................................................... 4 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS ................................................................................ 4 
3.0 
BACKGROUND AND RATIONALE ..................................................................................... 5 
4.0 
OVERVIEW OF STUDY DESIGN/INTERVENTION ................................................................. 10 
4.1 
Design................................................................................................................................. 10 
4.2 
Intervention .............................................................................................................................. 11 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY ............................................................................... 13 
5.1 
Subject Inclusion Criteria ..................................................................................................... 14 
5.2 
Subject Exclusion Criteria ................................................................................................... 14 
6.0 
RECRUITMENT PLAN .................................................................................................................... 15 
7.0 
ASSESSMENT/EVALUATION PLAN ................................................................................. 16 
8.0 
TOXICITIES/SIDE EFFECTS .................................................................................................... 22 
9.0 
PRIMARY OUTCOMES ..................................................................................................... 23 
10.0 
CRITERIA FOR REMOVAL FROM STUDY ....................................................................... 23 
11.0 
BIOSTATISTICS ............................................................................................................... 23 
12.0 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
25 
12.1 
Research Participant Registration ....................................................................................... 25 
Confirm eligibility as defined in the section entitled Criteria for Patient/Subject Eligibility .............. 25 
12.2 
Randomization .................................................................................................................... 25 
13.0 
DAT A M ANAGEMENT ISSUES ........................................................................................ 25 
13.1 
Quality Assurance............................................................................................................... 26 
13.2 
Data and Safety Monitoring .................................................................................................... 26 
14.0 
PROTECTION OF HUMAN SUBJECTS ............................................................................ 27 
14.1 
Privacy ................................................................................................................................ 28 
14.2 
Serious Adverse Event (SAE) Reporting ................................................................................ 28 
14.2.1  ........................................................................................................................................  29 
15.0 
INFORMED CONSENT PROCEDURES................................................................................... 30 
16.0 
REFERENCES ....................................................................................................................... 30 
17.0 
APPENDICES ................................................................................................................... 45 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 4 of 45 
 
 
 
 
 
 
1.0 
PROTOCOL SUMMARY AND/OR SCHEMA 
 
New York City (NYC) is home to 100,000 taxi drivers, of whom 92% are immigrants. The 
overwhelming majority are men. This large, male taxi driver population faces poor health 
outcomes that can be mitigated through scalable, targeted interventions. NYC taxi drivers 
work long hours (10-12 h/d shifts, ~6d/wk), most often in heavy traffic. Exposure to high 
levels of particulate matter (PM) and air pollution are closely linked to lung cancer and 
cardiovascular disease (CVD). 
 
DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment) is a 
community-engaged translational pilot project that will utilize a two parallel arm design to 
obtain preliminary data on associations between Particulate Matter (PM)/air pollution and 
physiologic measurements and biomarkers in taxi drivers, and to determine the impact of 
a HEPA filter (to remove PM  and volatile organic compounds) intervention on such 
physiologic measurements and biomarkers. DRIIVE is funded by the New York State 
Department of Health Empire Clinical Research Investigator  Program  (ECRIP),  which 
trains physicians in clinical research in New York. Drivers will be randomized to one of two 
groups: Intervention or Wait-list Control. In total, two groups of 14 participants in each 
group will be recruited: 1) Wait List Control group, who will receive a HEPA filter at the end 
of the 1 month participation period and 2) Intervention group, who will receive a HEPA 
filter two weeks into their participation period. The project will be completed within a 2 year 
timeframe. 
 
 
 
 
 
 
= PM and biological measurements 
 
 
TIME 
Baseline 
2 -weeks 
1-month 
*The HEPA filter intervention depicted above by “…” will be introduced after 2 weeks in the Intervention group, 
and at the end of the study for the Wait-list control group. PM and biological measurements will be conducted 
throughout the study in all 2 groups and is depicted above by “ 
” 
 
 
 
 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS 
Non-smoking taxi drivers; 
n=28 
Control; n=14 
HEPA filter intervention; n=14 
HEPA 
Randomization 
HEPA 
= HEPA filter interv ention 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 5 of 45 
 
 
 
 
1a) To collect preliminary data on in-vehicle excess PM exposure, including size 
distribution, mass concentration, and chemical composition among taxi drivers (measured 
during work shifts and at home). 
 
1b) To conduct a preliminary assessment of the correlation between PM exposure and 
physiologic and biochemical markers associated with increased risk of lung cancer and/or 
CVD. Physiologic and biochemical markers will include pro/anti-inflammatory cytokines, 
epigenetic changes (associated with cancer and/or inflammation), and high-sensitivity C- 
reactive protein, blood pressure, and reduced heart rate variability (associated with CVD). 
 
2) To use a randomized wait-list controlled design to conduct a pilot study of whether a 
targeted intervention, installation of a portable car high-efficiency particulate air (HEPA) 
filter (to remove PM), results in a reduction of in-vehicle PM exposure and associated 
physiologic and biochemical markers among taxi drivers. 
 
3) To collect data on the feasibility of conducting a larger RO-1 type (NIH granting 
mechanism) randomized wait-list controlled pilot study among New York City taxi drivers. 
 
 
3.0 
BACKGROUND AND RATIONALE 
 
There are approximately 240,000 taxi/limousine drivers in the U.S. (1). By  2020,  this 
number is expected to increase by 20% (1). New York City (NYC) is home to 100,000 taxi 
drivers, among whom 92% are immigrants (2, 155). Forty percent of those are South 
Asian (originating from India, Pakistan, Bangladesh, Nepal, and Sri Lanka) (2), followed by 
large numbers of drivers from the Dominican Republic, Mexico, former USSR,  Haiti, 
Nigeria, Ethiopia, Columbia, Ecuador, and Jamaica (2). The overwhelming majority of taxi 
drivers are minority men. They are at great risk for increased cancer risk and poor 
cardiovascular health due to a number of occupation-related factors, including stress, diet, 
sedentary lifestyle, and poor health care access (18-21). 
They work long hours (10-12 h/d shifts, ~6d/wk (2)), most often in heavy traffic, and are 
exposed to environmental contaminants. This exposure, including to ambient particulate 
matter (PM) (even low-level exposure to fine airborne PM [PM smaller than 2.5 
micrometers (PM2.5)]), increases health risk (13, 22, 23). Even short-term exposure (i.e., 
while driving) to peak particle concentrations appears to be linked with adverse health 
effects (24-27). A vehicle cabin is a relatively confined space where drivers are exposed to 
high concentrations of PM. In comparison to outdoor/indoor microenvironments, in-vehicle 
PM levels are often very high, originate from external sources, including road traffic (28), 
and can be 3-5 times that of outdoor PM values (29). In a study examining PM levels in 
private cars, values in moving vehicles exceeded those in parked cars by 9.2 times for 
PM10 (PM smaller than 10 micrometers) and 3.8 times for PM2.5 (28). These conditions can 
potentially be improved at very low cost, with a HEPA filter, with a resultant diminution of 
lung cancer and cardiovascular disease (CVD) risk in this vulnerable group of minority 
men. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 6 of 45 
 
 
 
 
The association between mortality with PM2.5, sulfate particles, and sulfur dioxide (SO2) 
was illustrated in a study that demonstrated their role in increasing all-cause, 
cardiopulmonary, and lung cancer mortality (4, 49). Several additional studies have linked 
PM exposure to lung cancer (14, 15, 50). A 26-year prospective study found that each 10 
µg/m3 increase in PM2.5 exposure concentration was associated with a 15-27% increase in 
lung cancer mortality among never-smokers (14). Another study found that each 10 µg/m3 
increase in PM2.5 was associated with an adjusted increased risk of all-cause mortality of 
14% (95% CI: 7, 22%), and with a 37% (95%CI: 7, 75%) increase in lung cancer mortality 
(15). Many studies (although none in the U.S. to date) have demonstrated a high 
prevalence of lung cancer among taxi drivers, suggesting a possible association with PM 
(16, 17). In a large population-based study of Danish male drivers, the odds ratio (OR) for 
lung  cancer  among  taxi  drivers  was  1.6  (95%  CI  1.2  –  2.2)  after  adjusting  for 
socioeconomic status (16). As the duration of driver employment  increased,  the  lung 
cancer risk also increased significantly: the highest risk was found among long term taxi 
drivers with 10 years of lag time between lung cancer diagnosis and first employment (OR 
3.0; 95% CI 1.2 – 6.8) (16). A prospective study of drivers in Geneva found that 
professional drivers, including taxi drivers, had significant excess risk compared to the 
general population for all causes of death (standardized mortality ratio (SMR) 115, 90% CI 
1.07-1.23) and for all cancers (SMR 125, 90% CI 1.12-1.40) (51). Cause-specific analysis 
showed significant excesses for lung cancer (SMR 150, 90% CI 1.23-1.81)  (51).  In 
DRIIVE, we will collect data on biomarkers associated with lung cancer, including cytokine 
levels, changes  in white blood cell profiles, and changes  in the epigenome to further 
elucidate the possible mechanisms underlying increased lung cancer risk (52-55). 
The health effects of PM are related to both particle size and chemical composition (56, 
57). Fine particles, PM2.5, produced mostly by vehicle emissions, can penetrate more 
deeply into the airways than PM10. Lung airways and alveoli retain mostly PM2.5 rather 
than PM10; 96% of the effectively retained particles are PM2.5, of which 5% are ultrafine 
particles (<0.1 μm) (58, 59). Fine and ultrafine particles are also more likely than coarse 
particles to induce inflammation and oxidative damage. Elemental and organic carbon 
together make up a significant fraction of ambient particles. In  particular,  elemental 
carbon, a pseudo-marker of traffic pollution such as that caused by diesel engines, has 
been found to be significantly correlated with cardiopulmonary morbidity and mortality, and 
thus important to assess (144, 145). 
 
There are data showing that increased levels of inflammatory cytokines (e.g. TNF-α, 
interleukin-6, interleukin-8) and bronchoalveolar lavage fluid are correlated with lung 
cancer. The interleukin-1 family of cytokines, including IL1-beta, is a key pro-inflammatory 
cytokine which regulates the expression of several genes involved in the inflammatory 
process. There is ample evidence, moreover, that PM stimulates alveolar macrophages 
and human bronchial epithelial cells to release proinflammatory cytokines, including IL-6 
and Il-1beta. 
 
There is a growing understanding of the role of epigenetics in complex human diseases, 
especially respiratory diseases including lung cancer and asthma. Exposure to 
environmental  carcinogens,  including  particulate  air  pollution,  traffic  particles,  cigarette 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 7 of 45 
 
 
 
 
smoke, and cadmium, has been reported to alter normal DNA methylation patterns. 
Importantly, Palmisano et al. found that alterations to p16 and MGMT methylation can be 
identified in 100% of patients with squamous cell lung carcinoma up to 3 years before 
clinical diagnosis. Suitable biosamples for lung disease biomarker studies include DNA 
obtained from buccal cells, which will be used here. 
The Harvard Six Cities Study was the first large, prospective cohort study that 
demonstrated that chronic exposure to air pollutants is independently related to 
cardiovascular mortality (3). It showed that elevations of PM2.5 and sulfates demonstrated 
the strongest associations with CVD. Fine particulate air pollution is a risk factor for CVD 
via mechanisms that likely include altered cardiovascular autonomic function (associations 
have been seen between elevations in PM2.5 and increases in systolic blood pressure (30) 
and reduced heart rate variability (31-38), inflammation, and accelerated atherosclerosis 
(5, 39-41). Short-term exposure to PM has been associated with elevated proinflammatory 
markers, including interleukin 1-beta (IL-1β), interleukin 6  (IL-6),  tumor-necrosis-factor 
alpha (TNF-α), and high sensitivity C-reactive protein (hs-CRP), which may potentially 
mediate harmful subclinical cardiovascular effects (30, 42-45). There is epidemiologic 
evidence that CRP is a strong predictor of future CVD risk (46) and that elevated hs-CRP 
is highly associated with poor cardiovascular prognosis (47, 48). DRIIVE will contribute to 
the understanding of the associations between these mechanisms and increased CVD 
risk. 
 
Products of diesel combustion, such as polycyclic aromatic hydrocarbons (PAHs), are also 
relevant to drivers (164, 165).Many individual PAHs are genotoxic carcinogens (165). One 
of the parent PAHs, pyrene, is metabolized to 1-hydroxypyrene and excreted in the urine, 
has been widely used as a biomarker for PAH exposure, and has been shown to be 
elevated in studies including taxi drivers (166-168). Increased incidences of cancer have 
been associated with occupational PAH exposure, including lung cancer (169). PAHs may 
also contribute to the atherosclerotic process and inflammation, increasing cardiovascular 
disease risk (170). 
 
Various reviews have shown that 1 hydroxy pyrene (1-OHP) is a biomarker of exposure to 
poly-cyclic aromatic hydrocarbons from traffic related air pollution  (161, 162). 1 hydroxy 
pyrene is a major metabolite of pyrene and it is used to estimate overall exposure to PAH. 
Work specifically on taxi drivers has shown that urinary 1 OHP levels were increased in 
drivers compared with non-occupationally exposed subjects.  Elevated 1-OHP levels were 
also shown to be associated with elevated levels of pro-inflammatory cytokines and were 
negatively associated with levels of antioxidants in exposed taxi drivers. (163).  In DRIIVE 
we look to show the impact of use of a HEPA filter on 1 OHP levels in drivers by sampling 
levels pre-and post implementation of filter. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 8 of 45 
 
 
 
 
PRELIMINARY STUDIES 
 
Immigrant Health and Cancer Disparities Service (IHCD) 
One of IHCD‘s long-standing community based participatory research programs (CBPR) is 
the South  Asian  Health  Initiative  (SAHI), founded  in 2004. Dr.  Gany has led  SAHI in 
several projects on cardiovascular disease (CVD) and cancer risk reduction (104): South 
Asians Engaging in Hypertension Awareness and Treatment, an NIH-funded RCT of the 
impact of linguistically and culturally appropriate educational materials  on hypertension 
(105); Smokeless  Tobacco Oral Pathology Prevention and Awareness  Network (STOP 
PAAN) (103); and the Health Camp Project (106). In Gany‘s ―Drive By R eadings ‖ s tudy, 
over 100 taxi drivers were followed through their tuberculosis screening and treatment, 
with the results impacting TB policy in NYC (107). Additional taxi driver initiatives include: 
STEP I (Supporting Taxi Drivers to Exercise through Pedometers), funded by the NYS 
Department  of  Health  Empire  Clinical  Research  Investigator  Program   (ECRIP),  to 
investigate the health knowledge, attitudes, and beliefs of South Asian taxi drivers. Drivers 
described high work-related stress, health risk, and poor health care access (21). STEP II, 
also funded by ECRIP, was  a randomized controlled trial to evaluate  the efficacy of a 
culturally responsive pedometer/motivational interviewing exercise intervention among taxi 
drivers  (108).  74  male  South  Asian  taxi  drivers  participated.  15%  of  the  drivers  who 
completed the study improved > 2000 steps from their baseline (108). Step On It! is a 
cancer and CVD risk reduction case management project for NYC taxi drivers at John F. 
Kennedy airport, and a parallel effort in San Francisco in partnership with the Palo Alto 
Medical Foundation Research Institute (109). Airport holding lots are places where the taxi 
driver community can congregate to eat, talk, play games, walk/exercise, and pray. We 
have been successful in engaging the taxi driver community at airport holding lots in our 
risk reduction interventions. 480 taxi driver participants at JFK were enrolled in Step On It!, 
50% of the taxi drivers did not have a primary care provider and 51% did not have health 
insurance prior to the intervention. 51% more are now engaged in ongoing care. 33% of 
the drivers were subsequently diagnosed with diabetes or  hypertension and prescribed 
medication   (109).   CICHD   facilitated   the   formation   of   the   Taxi   CAB   (Community 
Advisory/Action Board) in 2010 to help further develop, implement, provide feedback to 
and context for results, and disseminate the taxi driver research program. The CAB has 
identified exposure to air pollution, and its  impact on health, as  an important issue for 
drivers.  In  Gany  protocol  X12-025,  a  p ilot  s urvey s tudy  to  as s es s  NYC  taxi  drivers ‘   
knowledge, beliefs and awareness of health risks associated with air pollution , 100 NYC 
drivers, including both yellow taxi (N=77) and livery (N=23) cab drivers, were surveyed. 
Sixty-seven percent of respondents had worked as drivers for at least three years, with 
17% having worked more than 15 years. Drivers were evenly dispersed in age, with 17% 
between 18 and 30 years old, 24% between 31 and 40 years old, 26% between 41 and 50 
years old and 32% over 50. Eighty-eight percent of all drivers were foreign-born. Over half 
of all surveyed drivers (56%) believed that they are exposed to more air pollution than 
those who are not taxi drivers, while 25% did not believe as such, and 19% were unsure. 
Most drivers thought that air pollution in general causes health problems (81%), while 19% 
did not  agree  or were unsure. A belief that air  pollution  causes health problems  was 
significantly associated (p<0.05) with drivers  who had at least 10 years  of taxi driving 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 9 of 45 
 
 
 
 
experience. Thirty-four percent of respondents stated they were ―not worried‖ about being 
exposed to air pollution while driving, while another 40% said they were ―a little or 
somewhat worried‖. Nineteen percent reported that they believed they had a  health 
problem attributable to air pollution exposure. In Gany protocol X12-021, a pilot 
investigation of particulate matter concentrations in NYC taxi cabs , we measured levels of 
in-vehicle Particulate Matter (PM) concentration in a convenience sample of 7 NYC Taxi 
Cabs. In-vehicle PM levels were measured through Personal DataRams(pDR) and 
Microaethalometers, which were placed on the passenger seat or console area of the 
taxicab for the full 6-hour shift. Near-roadway outdoor air monitoring of PM and BC 
concentrations was also conducted using aerosol monitors . Compared with previously 
published results of personal exposure studies conducted in NYC (156, 157), taxicab PM 
and BC concentrations were elevated. Average concentrations of PM per  15-minute 
interval for all seven shifts indicated large intra- and inter-car variability. Per shift average 
PM concentrations ranged from 4 µg/m3 to 49 µg/m3 and 1-minute peak levels measured 
up to 452 µg/m3. Black carbon levels were also elevated, and reached over 10 µg/m 3. 
Peak in-vehicle PM levels were short and sporadic, and may have been influenced by 
external events, such as passenger smoking, as recalled by  drivers after their shift. 
Roadside air monitoring was conducted at three large taxi passenger pick-up stands in 
midtown Manhattan, all located at traffic hubs and mass transport terminals. Monitoring 
during morning and evening rush hours revealed ambient PM levels to be near or greater 
than the EPA 24 hour NAAQS of 35 µg/m3  for PM2.5. Average levels at each taxi stand 
were 44 µg/m
3 (SD ± 32), 58 µg/m
3  (SD ± 10), and 76 µg/m
3, (SD ± 43) and peak levels 
were as high as 434 µg/m3, mirroring peak in-vehicle values. Levels of black carbon were 
also found to be high; peak levels at one taxi stand were as high as 12 µg/m 3. Average 
taxi stand BC and PM levels were significantly higher than levels recorded at the closest 
New York State Department of Environmental Conservation‘s air monitoring site (Division 
Street) (158). As a sedentary occupational group with a disproportionate prevalence of 
disease, taxi drivers are likely at greater risk from air pollutant exposure  than  those 
working away from roadways. Community-engaged interventions are needed to limit their 
exposure to high levels of PM and BC. The proposed DRIIVE project will move the 
preliminary data a step forward and the CAB will continue to play a central role  in 
planning, implementation, and dissemination. 
 
NYU Department of Environmental Medicine's NIEHS P30 Center of Excellence 
The NYU/NIEHS Center develops programs around community environmental risks, with 
a focus on NYC taxi drivers. Dr. Gany is the MSKCC Co-PI with Dr. Zelikoff of the NIEHS 
Center Community Core. Community initiatives are developed through town hall meetings, 
workshops/educational forums, health fairs, and/or provider education developed with the 
community, and guided by community-based focus groups and interviews with community 
leaders and other stakeholders. Dr. Zelikoff is also an active toxicology researcher in 
reproductive- and immune-toxicology associated with inhaled environmental/occupational 
pollutants (110-124). She has worked with Dr. Gany on maternal exposure studies with 
gutka, a smokeless tobacco product (115, 125). 
 
Drs. Gordon and Zelikoff have collaborated on a number of studies on the adverse effects 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 10 of 45 
 
 
 
 
of inhaled particles. In the COARSE PM study, size-segregated ambient PM was collected 
during 2 seasons at several urban and rural sites in the NYC metropolitan area and in 
central California. The toxicity of extracted PM was tested both in vitro and in vivo and the 
findings were correlated with PM components. In general, coars e  PM10- 2.5  and  heavy 
metals produced the greatest toxicity. Importantly, PM composition was a more important 
indicator of toxicity than PM mass concentration alone, a finding with potentially significant 
regulatory policy impact in the U.S. (manuscript in preparation). In a collaborative study, 
by CIHCD and the NYU/NIEHS Center, of ambient PM, real time DataRam monitors found 
that at taxi stands PM levels were near or greater than the EPA 24 hour National Ambient 
Air Quality Standards (NAAQS) of 35 µg/m3  for PM2.5. Peak levels were as high as 140 
µg/m
3  PM (133). Dr. Gordon is currently completing the GW B (George W ashington Bridge) 
Study, which investigates the contribution of traffic-related air pollutants to CVD. Healthy 
volunteers walked for two hours along traffic at three NYC sites which differ significantly in 
traffic-related pollution. Ambient PM exposure assessment and several similar health 
endpoints (e.g., inflammatory cytokines in the blood, and ECG, heart rate, pulmonary 
function) were evaluated. Results showed significant changes in blood  pressure,  and 
serum interleukin (IL)-1 levels associated with exercise along the diesel-laden GWB traffic 
(manuscript in preparation). In the proposed application, we will use similar techniques to 
monitor adverse physiologic/biochemical changes in drivers while monitoring in-vehicle 
PM exposures. 
 
 
4.1 
OVERVIEW OF STUDY DESIGN/INTERVENTION 
 
4.2 
Design 
 
This study is proposed to be carried out across a two year period including an intervention 
period and dissemination of results to the Taxi Network community. Twenty eight non- 
smoking male NYC cab drivers will be recruited and randomized to one of two study arms, 
an Intervention Group (to receive the HEPA filter 2 weeks into their 4 week period of 
participation) and a Wait-list Control Group (to receive the HEPA filter at the end of their 4 
weeks of participation). For the Intervention and Wait-list Control Group drivers, during the 
first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken 
under usual conditions. At the end of the initial two weeks, portable HEPA air purifiers 
(136) will be placed in the Intervention Group drivers‘ cars and the air monitoring and 
biological parameters will be repeated for another 2-week period, to determine changes in 
PM levels and physiological measurements as a result of this targeted intervention. The 
Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also 
have the air monitoring and biological parameters repeated for another 2 weeks. At the 
end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers 
will then receive a HEPA air purifier, so that they may also potentially benefit from the 
intervention being tested in this study, but no further measurements will be taken. Drivers 
will serve as their own controls before/after work and before and after the intervention. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 11 of 45 
 
 
 
 
Our taxi network CAB (Community Advisory/Action Board) will be engaged in the 
implementation and dissemination of the proposed study. This Taxi CAB represents the 
full range of the taxi driver experience, including varied shifts, income, education, age, 
ownership/lease arrangements, and countries of origin. The Taxi CAB will be instrumental 
in study recruitment and dissemination of results. The CAB will meet quarterly, with 
additional meetings as needed. This study is conducted in collaboration with Drs. Gordon 
and Zelikoff‘s research teams at New York University Department of Environmental 
Medicine, and Dr. Pengfei Zhang, working from the City College of New York (CCNY). 
Biological specimens collected will be immediately transported to MSK BAIC Core facilities 
for temporary storage and will be shipped later to either NYU or CCNY (outlined in the 
assessment and evaluation-section 7). 
 
4.3 
Intervention 
 
Over the course of the study, we will monitor several biological and physiological markers 
associated with lung cancer and CVD risk, along with ongoing air monitoring of work-sites 
and residences of all study participants. HEPA filters were selected as the intervention 
because of their effectiveness in removing PM and volatile organic compounds (VOCs), 
ease of use, relatively low-cost, small size, light weight, and lack of interference with 
drivers‘ normal practices (136). In a previous study by Pui et al., placing the air 
recirculation mode on (and with a cabin air filter in place already installed by the car 
manufacturer, not all cars have cabin air filters), was successful at substantially removing 
ultrafine particles, although was still relatively inefficient (45.5% particle removal efficiency) 
compared to a HEPA filter (137). 
 
The study will require 4 weeks of participation. Drivers will be recruited and randomized to 
either the control condition or the HEPA filter intervention condition. The in-vehicle (for all 
drivers PM exposure levels and physiologic and biochemical markers will be measured 
over the course of 1 month. For the first two weeks of the 1-month period, measurements 
will be taken under usual conditions ( without HEPA filters) for all participants. 
 
Particulate matter concentrations will be measured/monitored through Personal DataRams 
(pDR) (personalDataRam™ model pDR-1200). The DataRam measures particulate matter 
through optical impedance, and produces per-minute averages. Therefore, the time that 
the DataRam is ―on‖ will be directly reflected in the data that is produced. The pDR is 24 
ounces, 6.3 inches in height, 8.1 inches in width, and 2.4 inches in depth, and is thus very 
portable. One pDR will be provided to each enrolled participant.  All  participants  will 
monitor PM at their homes in the room in which they spend most of their off work hours; 
the DataRam will then be moved to the bedroom at night (or during sleeping hours). For 
drivers, the pDR will record PM levels throughout the work shift while the vehicle is in 
motion, momentarily stopped, or parked. 
Black carbon exposures will be measured/monitored through BGI 400 Personal Sampler 
Pump. The BGI pump is a constant air flow sampler that has broad applications in industry 
hygiene and environmental testing. It is compact, 6.75 inches in height, 3.1 inches in width 
and 2.3 inches in depth, which is ideal for mobile projects. It is attached to an external 

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Page 12 of 45 
 
 
 
 
Nickel Metal Hydride battery, which is 5.75 inches in height, 3.60 inches in width and 1.10 
inches in depth. BGI pump connects with a Tygon or ID tubing, ¼ inch in diameter, which 
is attached to a plastic cassette on the other end, where the pre baked quartz filter is 
placed. The BGI pump and filter will be placed in the vehicle of the participant at the 
beginning of their work shift and picked up at the end of their shift. All participants will 
monitor black carbon exposures at minimum for one work shifts on week 1 and week 4 of 
the study, or a maximum of three work shifts every week. 
 
PAH exposure will be measured through portable passive Polyurethane Foam Filter (PUF) 
sampler sized 10 cm by 2.2 cm diameter (171). The PUF filter will be place in the vehicle 
of the drivers at the beginning of their work shift and picked up at the end of their shift. 
Drivers will monitor PAH through PUF sampler one day every week. 
 
The intervention of HEPA air filters will be introd uced after 2 weeks of participation in the 
Driver Intervention group (but not in those of the control drivers‘ cars. The HEPA air 
purifier is 7.5‘‘x 8.5‘‘, 6 lb, and covers up to 150 sq feet. An accompanying auto adapter kit 
contains a cigarette lighter adapter, 7 foot cord, and a seatbelt clip to secure the filter 
(159). Air monitoring and measurements of PM exposure levels and physiologic and 
biochemical markers will be continued for another 2-week period to assess the extent of 
risk reduction achieved by this targeted intervention. Two weeks should be more than 
sufficient to measure risk reduction by the HEPA filter intervention, as the study by Pui et 
al. showed that with the air recirculation mode on and a cabin filter in place, in-cabin 
aerosol concentration was reduced to below typical office air concentrations  in 
approximately 3 minutes (137). HEPA filters will be given to drivers in the Wait-list Control 
Group at the end of the 4 weeks of participation. 
 
 
Physiologic and biochemical markers will be measured by trained study staff twice per 
week and twice per day on 1 work day and 1 non-working day per week, for a total of four 
measurements per week (see section 7 for details). Physiologic and biochemical markers 
to be measured include:  high-sensitivity C-reactive protein, blood pressure, and reduced 
heart rate variability – data to be downloaded via a smart phone (associated with CVD), 
and pro/anti-inflammatory cytokines (i.e., interleukin (IL)-1b, -6, -8, -10, tumor necrosis 
factor (TNF)-α, and interferon (IFN)-γ), and epigenetic changes associated with cancer 
and/or inflammation (see Figure 1 below and section 7 for details). 

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Polycyclic aromatic hydrocarbon (PAH) exposures will also be assessed through 
measurements of the urinary metabolite 1 hydroxy pyrene. Drivers will be asked to give a 
urinary sample in the morning after several days of work. They will be provided with a 100 
cc sterilized polypropylene container. (Urinalysis Cup Kit). This will be collected by the 
study team, protected from sunlight and transported to BAIC for storage in a -20 degree 
freezer. Samples will ultimately be analyzed using liquid chromatography-tandem mass 
spectrometry (LC-MS-MS) by collaborating facility City College of New York. PAH 
exposures will also be measured through PUF sampler sized 10 cm by 2.2 cm diameter 
(171). Drivers will monitor PAH through PUF sampler one work day every week. The PUF 
filter will be place in the vehicle of the drivers at the beginning of their work shift and 
picked up at the end of their shift. The study team will transport the sampler to the 
collaborating facility City College of New York for analysis. 
 
The study team will be trained on screening and recruitment procedures, downloading 
DataRam results on PM measurements, on fingerstick blood, salivary, and buccal swab 
sampling procedures, and on storage/handling of samples (e.g. shipping dangerous goods 
training). Samples collected will be transported immediately by study staff to NYU for 
storage and analysis. If any critical abnormal/irregular health measurements are identified 
in the process of data collection, study staff will be trained to refer participant to low-cost 
health services. 
 
Prior to study implementation, the study team will conduct a series of validation testing 
along with necessary calibration checks for all study equipment  (including  pDRs,  air 
pumps and HEPA filters). Taxi Network CAB members will assist in trial runs to ensure all 
equipment and logistical concerns are optimized before equipment is provided to study 
participants. 
 
 
 
 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY 
 
Describe the characteristics of the subject population. 

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5.1 
Subject Inclusion Criteria 
 
Drivers: 
• 
Full-time New York City cab drivers; 
• 
Non Smokers  (assessed by modified BRFSS smoking question within screening 
tool) 
• 
Male; 
• 
Between the ages of 21 and 90; 
• 
No immediate plans (within the next 3 months) to leave the City for vacation or for 
trips back to their home country,; 
• 
Driver for at least 3 years;* 
• 
Driving schedule does not include overnight shifts, nor does driver have an 
additional job overnight; 
• 
Own a smart phone (in order to collect heart rate variability data) 
• 
Should self-report ―Very well‖ or ―Well‖ level of English fluency (according to the 
standard US census question). 
• 
Have working cigarette lighter receptacle/socket inside taxi cab 
 
 
*The requirement to have worked at least 3 years in the U.S. should minimize any 
acute health effects/disease due to high levels of contaminants associated with 
country of origin. 
5.2 
Subject Exclusion Criteria 
Drivers: 
• 
Smoker or uses smokeless tobacco products; 
• 
Resides in a smoking household (where 1 or more household members smoke); 
• 
Has a sleep disorder (including insomnia, delayed sleep phase syndrome (DSPS), 
narcolepsy, night terror, sleep apnea, sleep walking); 
• 
Has a current or previous diagnosis of any type of cancer; 
• 
Has a diagnosis of an inflammatory, autoimmune, or chronic infectious disease 
(including rheumatoid arthritis, lupus, chronic liver disease, multiple sclerosis, 
fibromyalgia, inflammatory bowel disease, psoriasis, HIV); 
• 
Has a serious cardiopulmonary medical condition (including cardiovascular 
disease, congestive heart failure (CHF), chronic obstructive pulmonary disease 
(COPD), restrictive lung disease, interstitial lung disease, asthma, acute or chronic 
bronchitis, cystic fibrosis, pneumonia, tuberculosis, pneumoconiosis, pulmonary 
hypertension, pulmonary embolism, pleural effusion, pneumothorax, obesity 
hypoventilation syndrome, neuromuscular lung disease). 
• 
Self reports ―well‖ level of English fluency and indicates a preference for an 
interpreter. 

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IRB Number: 14-247 A(9) 
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Page 15 of 45 
 
 
 
 
 
 
 
6.0 
RECRUITMENT PLAN 
 
Study staff will work in collaboration with the previously established IHCD Taxi Network 
Community Advisory Board and community partners such as South Asian Council for 
Social Services (SACSS) to recruit participants for this study. SACSS is our subcontracted 
community partner in the IHCD Taxi Network initiative and the Co-Director or the IHCD 
South Asian Health Initiative. Under the direction of Ms. Sudha Acharya, SACSS provides 
various community services including health care access counseling and insurance 
enrollment. Members of SACCS were previously on-boarded as MSKCC non-employee 
affiliates and will be a part of the study team to assist with identifying potential study 
candidates through their previous relationships with the taxi driver community. Study staff 
will enroll a convenience sample of drivers by approaching potential participants at driver- 
frequented sites across NYC- including taxi garages, taxi bases, parking stands, taxi relief 
and shift change stands, gas stations, restaurants, and religious and community 
organizations. Study staff will approach drivers who are present at these locations 
including drivers who are waiting in their parked and stationary vehicles. Staff will also 
utilize partnerships with CBOs and local and ethnic newspapers, radio stations and media 
outlets such as the Union Fouta and Murid Islamic Community of America radio station 
and newspaper to accrue study participants. Flyers (Appendices F) for Drivers will be 
distributed in the community setting for recruitment as well. The flyers will be posted in 
various community locations drivers frequent including garages, taxi bases, parking 
stands, gas stations, restaurants, religious and community organizations to garner interest 
in the study. A screening tool (see Appendix A) will be used to identify eligible participants 
(drivers). All those who meet inclusion/exclusion criteria will be informed of the risks and 
benefits of study participation and, if willing to participate, asked to read and sign a written 
informed consent document. Consenting professionals will use general teach-back 
method in which we will ask drivers if they understand what participation entails to ensure 
they are informed of the study procedures. 
 
Following informed consent, participants will be assigned a participant number and 
administered the Intake Assessment (Appendix B). Participant drivers will also be 
randomized to either the Intervention or Wait-list Control Groups, as described above. A 
convenient time and place will then be arranged to complete the informed consent and 
Intake. Driver pairs will participate in the study in approximately the same time frame to 
avoid seasonal differences in PM levels. 
 
During consent procedures, participants will be informed that they will receive a $200 
incentive over the course of the study for their participation to account for the time 
commitment required of participants. This will be distributed as 4 weekly incentives totaling 
$50.00 each, which can be viewed as compensating study participants $7 each day for 
carrying around monitors throughout their daily lives and allowing us to conduct biologic 
assessments 2 days a week. All participants will also be informed that they will receive a 
HEPA air  purifier.  Given  the  intensity  of  the  proposed  study  measurements  and  the 

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Page 16 of 45 
 
 
 
 
associated time required of participants, for which drivers could result in lost earnings, the 
$200 incentive is commensurate with the degree of commitment demanded. 
 
Consenting professionals will emphasize the need to meet with participants 2 days a week 
to conduct study testing, and will discuss and compile a list of 2-3 future meeting locations 
for data collection. Convenient locations may include enclosed taxi garages, taxi relief 
stands, semi-private spaces within public venues, MSKCC offices or our  community 
partner locations. Staff will not conduct any assessments at a participant‘s home. 
 
During the initial conversation between the investigator/research staff and the potential 
study participant, the potential participant may be asked to provide certain health 
information that is necessary to the recruitment and enrollment process. They will use the 
information provided by to confirm that the potential participant is eligible and to contact 
the participant regarding study enrollment. If the person turns out to be ineligible for the 
research study, the research staff will destroy all information collected on the patient 
during the initial conversation, except for any information that must be maintained for 
screening log purposes. 
 
In most cases, the initial contact with the prospective subject will be conducted either by 
the investigator or the research staff. The recruitment process outlined presents no more 
than minimal risk to the privacy of the patients who are screened and minimal PHI will be 
maintained as part of a screening log. For these reasons, we seek a (partial) limited 
waiver of authorization for the purposes of (1) reviewing medical records to identify 
potential research subjects and obtain information relevant to the enrollment process; (2) 
conversing with patients regarding possible enrollment; (3) handling of PHI contained 
within those records and provided by the potential subjects; and (4) maintaining 
information in a screening log of patients approached (if applicable). 
 
 
7.1 
ASSESSMENT/EVALUATION PLAN 
 
All potentially eligible participants will be required to complete a study screening tool to 
confirm eligibility. Participants that undergo informed consent procedures will be required 
to complete an intake assessment to gather details on personal demographics and health 
information that may relate to study outcomes. Enrolled drivers will be provided a log to 
compile a detail account of vehicle air-flow conditions while driving during study 
participation. 
 
Screening tool (Appendix A), a brief questionnaire administered to potential to assess if 
study eligibility requirements are met. Includes questions on age, residence, country of 
origin, previous travel and travel intentions, modified BRFSS tobacco use classification 
questions (160); English proficiency, smoking status, cab driving experience, current 
occupation(s), and status of pre-existing conditions relevant to study (e.g. sleep disorders, 
autoimmune conditions). (5 min to complete) 

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Intake assessment (Appendix B) administered to all study participants includes 3 
sections of questions: (1) demographic and health access information, (2) medical history 
and (3) physical activity and nutrition. (10-15 min to complete) 
 
Log-book (Appendix C), given to drivers to record environmental manipulations within the 
area they are driving or their vehicle. This includes air exchange levels within the cab 
(documenting whether the DataRam is used, HEPA filter and air conditioning is on, vents 
and windows are open, the vehicle make or model of taxi cab or the neighborhoods driven 
in during shift). This also includes documenting neighborhoods travelled thru, whether they 
were in high traffic jams, or travelled thru tunnels. In our preliminary work (X12-021), we 
have succeeded in encouraging drivers to complete a similar log-book. When we meet 
with drivers to conduct biological measurements, or contact them for any other reason, we 
will remind them to complete their log-books using the text reminder system described 
below. 
 
During biological assessments (2 days per week), the make and model of the vehicle used 
by driver participants  will be logged by study staff to account for variances within the 
current air filtration systems of the cab, because taxi drivers may rent different vehicles 
each day. 
 
Environmental Measurements, Physiologic and biochemical markers 
For all participants, measurements for environmental, physiologic and biochemical 
markers will taken twice a week, and twice per day for a total of four data collection time 
points per week. This will include one work day per week (on the last work day of their 
work week) and on 1 day per week off from work. On work days measurements will be 
taken both immediately before (to establish pre-work biological parameters)  and 
immediately after their work shift, and on non-work days measurement will be taken at 
approximately the same times during their day(s) off. In addition, blood pressure will be 
measured, data on heart rate variability will be downloaded, and a blood sample will be 
taken from each participant via finger stick to provide for measures of  inflammatory 
markers and changes in white blood cell profiles. Salivary cotinine levels will also be 
measured twice (once at Intake and at the halfway point) for all participants to assess any 
exposure to smoking or smokeless tobacco products. High sensitivity C-reactive protein 
will be measured once during Intake and again at end of the 1 month period of 
participation. Buccal swabs will also be taken once during Intake for all participants, to 
measure epigenetic changes associated with inflammation, cancer and heart disease. 
Measurements will take place at locations most convenient for participants. Locations may 
include enclosed taxi garages, taxi relief stands, semi-private spaces within public venues, 
MSKCC offices or our community  partner locations. Staff will  not  conduct  any 
assessments at a participant‘s home. All measurements will be collected by trained study 
staff including both IHCD research and outreach personnel. Samples will be collected and 
transported immediately to MSKCC Core facilities, located on the 4th floor of the Breast 
and Imaging Center for storage. Samples will be shipped to NYU facilities for processing 
by Dr(s) Gordon and Zelikoff (see Lab Manual for shipping details). Trained study 
research and outreach personnel will be handling the specimens. 
*Please see Appendix 4 RSA guide/lab manual for full details on all procedures. 

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1. PM values (measured daily): 
In-vehicle and residence PM will be measured using calibrated, personal DataRam 
monitors (Thermo Scientific) that measure real-time PM levels (measured range = 1 µg 
to 400 µg/m
3). For drivers, the DataRam will be placed inside the cab on the island 
between driver and front passenger seat during workshifts. All participants will monitor 
PM at their homes in the room in which they spend most of their off work hours; the 
DataRam will then be moved to the bedroom at night (all participants will receive daily 
text messages as reminders to do this). The DataRam will be zeroed prior to use and 
all data internally logged and displayed on an LCD monitor.  DataRam  PM 
measurement files (hourly averages) will be downloaded every week at the same time 
as blood/ salivary samples are taken. To maximize efficiency in the field, gravimetric 
calibration will be performed by comparison with a filter sampler and programming of a 
calibration constant. Teflon and quartz filters will be used to capture PM (a time- 
averaged sample) for subsequent gravimetric and trace element analyses, including 
sulfur and organic and elemental carbon analyses (micro-balance/XRF instrumentation 
available at NYU‘s NIEHS Center of Excellence Facility Core). A portion of the glass- 
fiber filter will be cut for organic analysis. This portion of the filter will be extracted via 
pressurized liquid extraction (ASE 100 system, Dionex) with hexane: dichloromethane 
(1:1, v/v) at 90C and 1500 psi (140). The extracts will be concentrated  using  a 
Turbovap and cleaned before analysis. BFRs polybrominated diphenyl ethers (PBDEs) 
will be analyzed via gas chromatography-mass spectrometry with negative chemical 
ionization (GC-NCI-MS) (141). Parent PAHs will be analyzed with GC-MS in electron 
impact ion (EI) mode and selected ion monitoring (SIM), whereas nitro-PAHs and oxy- 
PAHs (quinones) will be analyzed via GC-NCI-MS and SIM (142). Another portion of 
the glass-fiber filter will be cut for metal analysis. This portion of the filter will be 
extracted via microwave digestion and trace metals will be analyzed via inductively 
coupled plasma-mass spectrometry (ICP-MS) according to the method of Kulkarni et 
al.(143). 
DataRam data downloads will be sent to study collaborators Drs. Gordon and Zelikoff 
at NYU for analysis. 
 
 
2. Black carbon exposure (measured at minimum after 1 work shifts during week 1 and 
week 4, at maximum will be measured after 3 work shifts every week) 
In-vehicular black carbon concentrations will be measured using calibrated BGI 
Personal Sample Pumps (BGI Inc.) (provided by NYU) and pre baked quartz filters . 
Using the constant air flow, the quartz filter is able to trap black carbon levels in real 
time. For drivers, research staff will meet them at the beginning of their work shift with 
the BGI pump fully charged and the flow rate pre-set to 4L/min. The filter, sealed in 
aluminum foil, will be unwrapped immediately before the sampling,  placed  in  the 
plastic cassette using a tweezer or forceps that is attached to the BGI pump via Tygon 
tubing. Staff will turn on the BGI pump and steadily place at the floor of the vehicle 
away from foot traffic with the Tygon tubing coming up to the island in between the 
driver and the passenger seat, where the cassette with the filter would  rest  in  a 
secured position. Staff will record the start flow rate, start sampling time, and 
environmental condition in a log book. 
At the end of the shift, the staff will meet the driver to collect both USP and the filter. 
Staff will also record the end flow rate, end sampling time and changes in 
environmental conditions. The filter will be removed from the plastic cassette using a 
tweezer or forceps and immediately wrapped in aluminum foil and placed in ice packs 
within a cooler. Sampled filters will be transported in coolers with ice packs to BAIC 

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Core Lab Facility for storage in -80F freezers. This process will be repeated each time 
black carbon exposure is sampled during this study. 
 
Following sampling, using standard flow rates (typically 2-4 liters per minute) and 
measurement time base (10 to 300 seconds), the filter will be removed from the 
sampling frame, wrapped in aluminum foil, and transported to the NYU NIEHS 
laboratory for analysis by NYU study collaborators Drs. Gordon and Zelikoff. There, a 
standard punch of the filter will be used for sample analysis. The filter sample is 
inserted into the analyzer, with a replicate sample as needed for quality control. EC 
and OC mass will be determined via calculation using the analyzer results and the 
sample portion (typically 1.5cm2), i.e. the area of the standard punch.  The  entire 
NIOSH Method 5040, including how to make accommodations for changes in sample 
punch 
size 
and 
other 
quality 
control 
procedures, 
will 
be 
followed 
(http://www.cdc.gov/niosh/docs/2003-154/pdfs/5040.pdf). 
 
 
3. Blood pressure (measured before and after work shift 1 work-day per week and at 
approximately same times on 1 non-work day per week): Blood pressure will be 
measured using a 9002 E-Sphyg 2 Digital LCD Desk Unit Sphygmomanometer 
(American Diagnostic Corporation; Hauppauge, NY). This will be performed by study 
staff. In the event that study staff are unable to coordinate a date and time to meet 
participants for BP measures, study participants will have the option to self monitor 
blood pressure using a portable MDS3001PLUS blood pressure unit (Medline, 
Mundelein, Illinois), which is given to the participant to keep at their home during the 
study.  A log will be provided (see Lab Manual) and study staff will contact participants 
to obtain the BP recording after the scheduled BP collection time point. 
 
4. Heart Rate Variability (measurements to be downloaded once a week): Heart rate 
variability (HRV) describes the time intervals between heartbeats that vary as an 
individual breathes in and out (inhalation and exhalation), during a rest state. The heart 
speeds up when you inhale and slows down when you exhale. Reduced heart rate 
variability has been reported in several cardiological and non-cardiological diseases. 
Participants will be required on every day of study participation, to wear Ithlete strap 
when they wake up and before going to bed and sync the chest strap monitor to their 
smart phone. Participants will then follow breathing instructions provided by the smart 
phone app to measure HRV. The ithelete will download small changes in the heartbeat 
and the variance will be analyzed. HRV will be measured over time via an Ithlete ECG 
receiver, a small piece of hardware that picks up the signal from a heart rate monitor 
chest strap. The chest strap, ECG receiver, and Ithlete app will be supplied to each 
taxi driver being tested. Data are downloaded via a smart phone. (See HRV test 
procedure in appendix 4 for further details) 
 
5. Serum cytokines and white blood cell profiles (measured before and after work 
shift 1 work-day per week on week 1 and week 4): Serum cytokines (i.e., interleukin 
(IL)-1, -6, -8, -10, tumor necrosis factor (TNF)-, and interferon (IFN)-) will be 
measured using dried blood spot sampling and MesoScale Discovery (MSD) 
immunoassay system (www.mesoscale.com). As done previously in collaboration with 
the EPA, a drop of blood will be spotted onto a  commercial  sampling  paper  and 
allowed to dry. The sampling paper will be labeled with study ID, date, and the initials 
of the person conducting the collection. The paper, along with other study samples, will 
be transported immediately to the BAIC Core facilities, 4th  floor storage at -80 Freezer, 
until shipped on ice to our EPA collaborator, , for analyses. Blood samples for testing 

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Page 20 of 45 
 
 
 
 
will be obtained by punching a disc from the center of the spot, followed by a simple 
liquid extraction of the sample. MSD assays employ a sandwich immunoassay format 
whereby captured antibodies are coated in a single spot on the wells  of a MULTI- 
SPOT plate. Multiplex assays can measure 1-10 cytokines in a 96-well MULTI SPOT 
plate; each sample will be analyzed in duplicate. A second blood drop from the finger 
stick will be placed onto a glass slide, air-dried, stored in a locked box for later H&E 
staining and used for differential counts of white blood cell profiles as a systemic 
marker of inflammation. Slides will be shipped to Dr. Zelikoff at NYU for analysis. (See 
blood prick test procedures in appendix 4 for details). 
 
 
 
6. High sensitivity C-reactive protein hs-CRP: Similar to the processes described 
above, the blood sample for hs-CRP analysis will be a drop of blood spotted onto a 
commercial sampling paper and allowed to dry. The sampling paper will be labeled 
with study ID, date, and the initials of the person conducting the collection. The paper, 
along with other study samples, will be transported immediately to the BAIC Core 
facilities, 4th floor storage at -80 Freezer, for analyses. (See blood prick test 
procedures in appendix 4 for details). 
 
7. Salivary cotinine (measured at Intake and at the half-way point): Participants will be 
directed to use a saliva collection aid with a cryovial for collection of 1ml saliva sample. 
Saliva sample can only be collected at least one half hour after eating or drinking. 
Saliva samples will be frozen at -20°C. Cotinine will be measured with an EIA 
(Enzyme-immunoassay) (148). (See salivary cotinine test procedures in appendix 4 for 
details). Saliva samples will be transported to MSK BAIC Core facilities for temporary 
storage, until shipped to Drs. Zelikoff and Gordon at NYU for analysis. 
 
8. Epigenetic changes (at Intake): We will use the minimally invasive buccal cell 
approach to identify traffic pollution-related epigenetic biomarkers in taxi drivers, 
because gene expression changes induced by inhaled pollutants in human subjects in 
buccal and/or nasal cells reflect those in bronchial epithelium (76, 149, 150). Buccal 
cells will be collected from study participants by gently scraping both left and right 
inner cheeks using special collection brushes (Gentra Puregene Buccal Cell Kit, 
Qiagen, Valencia CA). Methylation-specific PCR (MSP)  (151) will be performed as 
routinely (134), using HotStar Taq DNA Polymerase kit (Qiagen), using MSP primers 
identified from the literature. Methylated (M) or unmethylated (U) status will be denoted 
per gene per participant. Buccal samples will be transported to MSK  BAIC  Core 
facilities for temporary storage and later shipped to collaborators at NYU for analysis. 
(See buccal swab test procedures in appendix 4 for details) 
 
PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample 
collection of Urinary 1 hydroxy pyrene and particulate matter collected via 
Polyurethane Foam Filter (PUF) sampler: 
 
9. PAH via Urinary 1 hydroxy pyrene: Drivers will be asked to give a urinary 
sample twice during the study. The first urine sample will be collected on the 
morning at the end of the first or second work week of study. The second 
sample will be collected from drivers on the morning of the end of the fourth 
week of study participation. Drivers will be provided with a 100 cc sterilized 

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polypropylene container (Urinalysis Cup Kit). This will be collected by the  
study team, protected from sunlight and transported directly to BAIC for 
storage in a -20 degree freezer. Samples will ultimately be analyzed using 
liquid chromatography-tandem mass spectrometry (LC-MS-MS).  This analysis 
will be carried out at the collaborating facility City College of New York. 
 
10. PAH via PUF sampler (measured at one work day each week): Drivers‘ PAH 
exposure will be measured through portable passive PUF sampler sized 10  
cm by 2.2 cm diameter (171). Drivers will monitor PAH through PUF sampler 
one day every week. The PUF filter will be place in the vehicle of the drivers at 
the beginning of their work shift and picked up at the end of their shift. Sampler 
will be tranported to collaborating facility City College of New York for 
extraction and analysis. The PUF filter will be extracted using dichloromethane 
according to the method of Jaward et al. (172). The extracts will be 
concentrated using a Turbovap and cleaned before analysis. Parent PAHs will 
be analyzed with GC-MS in electron impact ion (EI) mode and selected ion 
monitoring (SIM), and nitro-PAHs and oxy-PAHs (quinones) will be analyzed 
via GC-NCI-MS and SIM (173). 
 
Genes in the epigenetics reference panel for this study include ten (10) genes that have 
been informative as epigenetic biomarkers in air pollution or lung cancer studies (69). 
These are: p16- tumor suppressor, cell cycle regulator; hMLH1- mismatch DNA repair 
gene; E-cadherin- cell-cell adhesion molecule associated with epithelial to mesenchymal 
transition; RARβ2- binds retinoic acid, regulates cell growth/differentiation genes; DAPK- 
serine/threonine kinase involved in gamma-interferon induced apoptosis; RASSF1A- 
interacts with DNA repair protein XPA, inhibits cell cycle arrest; RUNX3, regulator  of 
alveolar differentiation, frequently hypermethylated in lung adenocarcinomas; and FHIT, 
the most common gene inactivated in lung cancer besides p53. We also include a few 
inflammatory response genes: IL-4, whose promoter methylation decreased in mice 
exposed to diesel exhaust (DEP) and fungus (152) and IFNg, interferon gene whose 
methylation increased in DEP/fungus exposed mice. 
 
Pyrosequencing to detect global genome methylation levels (approximated  by  LINE-1 
repeat methylation) will be performed per Colella (153) using a PSQ96MA System 
(Biotage/Qiagen). Recent studies show decreased LINE-1 methylation following exposure 
to traffic particulates, PM2.5 and carbon black (71). Because pyrosequencing quantifies 
percent methylation of individual CpG sites, we can also use it for quantitative analysis of 
percent methylation of genes in the reference panel above, to supplement the qualitative 
M/U calls made by MSP. While the gene choices in a candidate gene approach are vast, 
support for the particular genes chosen here is evident in a recent study of non-small cell 
lung cancer in Asians (China) showing good correlation for RASSF1A, RARB, hMLH1, 
p16, RUNX3 and DAPK with lung cancer (154). 
Due to the nature of the study, staff will handle and transport biological specimens that are 
categorized as potential toxic and infectious substances (dangerous goods-class 6, 
category b) To ensure good clinical practice procedures are followed, before study 
activation, all staff will complete the Dangerous Goods Shipping training and complete any 
additional MSKCC courses on handling biologic materials.  Additional  biospecimen 
collection training procedures will be provided by New York University. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 22 of 45 
 
 
 
 
 
 
A reminder system will be set up to increase study adherence. To remind participants to 
carry dataRAMs to work we will have daily text messages sent to mobile phones. We will 
provide participants with a friendly door knob sign to take home and place on bedroom 
doors as an additional reminder to carry their portable dataRAM monitors to bed and as a 
visual cue to remind them to make sure to take it with them when they leave for work. 
 
Feasibility Data 
 
Feasibility data will be collected to inform the conduct of a large scale randomized 
controlled trial assessing the impact of the HEPA filter intervention on reducing PM 
exposure and associated physiologic and biochemical markers. We will document the 
number of individuals approached for participation, the number refusing and reasons for 
refusal. We will document the time spent and the number of attempts to contact 
participants by phone and to meet in person. We will document adherence with study 
protocol, i.e. taking the dataRAMS to and from home and work, completing the multiple 
biological measurements. We will document the time spent conducting the study 
measurements. We will document dropout rates and reasons for drop out. 
 
PARAMETERS-TIME 
POINTS* 
At Intake 
At Half-Way 
Point 
1 Work Day 
per Week 
1 Non- 
Work Day 
per week 
1 work day 
(wk 1 & wk 4) 
Every Day 
Epigenetic Changes 
X 
Hs-CRP 
X 
Salivary Cotinine 
X 
X 
Serum Cytokines 
X 
White blood cell profile 
X 
Blood Pressure 
X 
X 
Heart rate variability 
X 
PM/Air Pollution 
X 
1-hydroxypyrene 
X 
Black carbon 
X 
PUF sample 
X 
* Study Period = 28 Days 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.0 
TOXICITIES/SIDE EFFECTS 
 
There  are  minimal  risks  associated  with  participation  in  this  study.  Participants  may 
experience pain undergoing fingerstick blood draw (e.g. soreness at puncture site) and 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 23 of 45 
 
 
 
 
may experience dizziness or light-headedness. Staff will be trained to conduct fingerstick 
procedures and trained to identify participant‘s signs of distress during and after 
procedures. Participants may on occasion recognize problems or identify unmet clinical 
needs as a result of participating in a study such as this. If patients do report concerns of 
study burden, distress or mention specific medical concerns he will be informed to report 
this concerns to research staff who will be trained to alert study investigators  who will 
make referrals to low cost community health services as appropriate. 
 
9.1 
PRIMARY OUTCOMES 
 
The primary outcomes are: 
 
• 
To collect preliminary data on in-vehicle excess PM exposure the personal 
DataRam will monitor/report the PM levels as time-averaged sample (hourly 
averages) that will be monitored at work site and at homes across all groups 
 
• 
To conduct a preliminary assessment of the correlation between PM exposure and 
physiologic and biochemical markers associated with increased risk of lung cancer 
and CVD the personal DataRam will monitor/report PM levels (hourly averages) 
that will be analyzed in comparison to increased systolic blood pressure, reduced 
heart rate variability, and presence of biological markers related to lung cancer and 
CVD risk. 
 
10.0 
CRITERIA FOR REMOVAL FROM STUDY 
 
Participants may be removed from the study protocol based on the following 
circumstances: 1) if they choose to voluntarily withdraw; 2) they are determined to be 
ineligible for the study; 3) they express significant distress related to completion of the 
study (the study staff will refer the participant to counseling and support services  if 
needed); or 4) if the PI believes it is in the participant‘s best interest to do so. 
11.0 
BIOSTATISTICS 
 
Overview. This pilot study follows a two parallel arm design. Drivers will be randomized to 
one of two groups, an Intervention Group (an in-vehicle HEPA filter will be provided) and a 
Wait-list Control Group (HEPA filter will be provided at the end of wait-list period). We plan 
to recruit a sample of n=14 participants in each group (n=11 per arm with analyzable (non- 
missing) data, assuming a 25% drop-out rate as described below). 
 
General analytic strategies. The general data analytic paradigm for this pilot study will 
be descriptive statistics only. The aim is to collect pilot data to help guide a future 
randomized intervention study. Descriptive statistics and assessments of correlations will 
be sought to address the aims (see below). The sample size of 14 per condition was 
primarily determined by resources limitations. A sample of 14 per condition was deemed 
possible within the funding resources of no more than 2 years. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
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Page 24 of 45 
 
 
 
 
Analytic plans for the Specific Aims. 
 
Aim 1a: The primary aim will be to collect preliminary data on in-vehicle excess PM 
exposure. 
 
Descriptive statistics (means and standard deviations) will be sought on: 1) PM size 
distribution 2) mass concentration, and 3) chemical composition  for  all  three  groups. 
These observations will be used to evaluate to what extent the two groups were exposed 
to these environmental hazards. For each study participant,  an  area-under-the-curve 
(AUC) summary will be sought for each of the three PM measurements over appropriate 
time periods. Generally, a daily average will be calculated from the hourly PM 
assessments. Then the AUC of the 28 daily averages will be calculated per person to 
represent the summary of PM exposures during study participation. 
Aim 1b: To conduct a preliminary assessment of the correlation between PM exposure 
and physiologic and biochemical markers associated with increased risk of lung cancer 
and/or CVD. 
 
For each group, a correlation matrix will be constructed between the three components of 
the AUC outcomes described in Aim 1a and a set of physiologic and biochemical markers. 
Generally, Pearsons‘ correlation coefficients will be sought. If preliminary analyses found 
the variables to be skewed, then Spearman‘s rank correlation coefficients will be 
calculated instead. The purpose of these correlation coefficients are to examine the 
associations between the environmental exposure to air pollutants and physiologic and 
biochemical markers. Point-biserial correlation coefficients will be sought between the 
continuous AUC summaries of PM data and other binary variables of interest (e.g., 
methylation). These correlation coefficients can be sorted in descending order to help 
identify the top candidates of physiologic and biochemical markers that are most likely to 
be associated with PM exposure. Care will be taken to match the variables by time, using 
the time stamps from the PM measurements and the date of biomarker serum collection. 
For example, the AUC of PM in the first week will be associated with serum cytokines 
measured during the first week. This work will have to be done in a post-hoc manner, 
after we have all data sources. Then we will evaluate the best strategies to link them 
together by time. It helps to have automatic time  stamps  by the  PM measurement 
devices, which is likely to minimize coding errors and missing data. 
 
Aim 2: To use a randomized wait-list controlled design to conduct a pilot study of whether 
a targeted intervention, installation of a portable car high-efficiency particulate air (HEPA) 
filter (to remove PM), results in a reduction of in-vehicle PM exposure and associated 
physiologic and biochemical markers among taxi drivers.. 
 
We 
will 
calculate 
the 
difference 
in 
the 
three 
PM 
components 
and 
in 
physiologic/biochemical markers between the HEPA intervention condition and the Wait- 
List Control condition to obtain the pilot data needed for a future, larger study with the 
potential to provide remediation to potential harmful exposures to air pollution among NYC 
taxi drivers. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 25 of 45 
 
 
 
 
Aim 3: To collect feasibility data on conducting the proposed randomized wait-list 
controlled pilot study among New York City taxi drivers. 
 
We will perform descriptive statistics to describe the feasibility data collected in this study 
(number of participants approached, number refused, number  dropping  out,  time  and 
effort required to conduct the study, adherence with the study protocol including carrying 
dataRAMS to and from home and work and completion of the multiple biological 
measurements, etc.). These data will inform a future, large-scale randomized controlled 
study. 
 
 
12.1 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
 
12.2 
Research Participant Registration 
 
Confirm eligibility as defined in the section entitled Criteria for Patient/Subject Eligibility. 
 
Obtain informed consent, by following procedures defined in section entitled Informed 
Consent Procedures. 
During the registration process registering individuals will be required to complete a 
protocol specific Eligibility Checklist. 
 
The individual signing the Eligibility Checklist is confirming whether or not the participant is 
eligible to enroll in the study. Study staff are responsible for ensuring that all institutional 
requirements necessary to enroll a participant to the study have been completed. See 
related Clinical Research Policy and Procedure #401 (Protocol Participant Registration). 
12.3 
Randomization 
 
Drivers will be randomized to one of the two arms: 1) Driver Wait list control arm or 2) 
Driver Intervention. After eligibility is confirmed and after consent is obtained, participants 
will be registered, and then randomized using the MSKCC Clinical Research Database 
(CRDB) or by calling the MSKCC Clinical Research Administration at 646-735-8000 
between the hours of 8:30 am and 5:30 pm, Monday - Friday. 
 
 
13.1 
DAT A M ANAGEMENT ISSUES 
 
The PI and research staff will be responsible for project compliance, data collection, data 
reporting, regulatory monitoring, problem resolution and prioritization and coordinating the 
activities of the protocol study team. An RSA will be assigned to the study. The 
responsibilities of the RSA include project compliance, data collection, abstraction and 
entry, data reporting, regulatory monitoring, problem resolution and prioritization, and 
coordination of the activities of the protocol study team. 
The data collected for this study will be entered into UNITY Web database, the 
Department of Psychiatry and Behavioral Sciences secure web-based  database 
application, to be accessed by study staff. The hard copies of the study materials will be 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 26 of 45 
 
 
 
 
kept in a locked, secured location and will only be accessible to study staff. Participants 
will be assigned unique identification numbers upon study entry which will be used to 
identify all the data. Questionnaire may be completed directly online by study staff using 
tablets, otherwise they will be entered into UNITY Web by research staff on site from hard 
copy surveys. All hard copy questionnaire data completed by participants will be identified 
only with a study code number. All data to be analyzed for reporting purposes will continue 
to be stripped of any identifying information. A list, matching participants‘ name and 
case numbers will also be kept in a secure area at MSKCC. All questionnaire data 
completed by participants will be identified only with a study code number. 
The data collected for this study will be managed through UNITY Web Database, 
questionnaire and screening data will be entered into the research study web based 
database UNITY maintained by MSKCC. UNITY Web is a secure web based research 
database application that was developed and being  maintained  by  the  MSKCC 
Department of Psychiatry and Behavioral Sciences. The primary goal of UNITY Web is to 
streamline research data collection via the Internet and the ease of survey creation. 
Data collection in UNITY Web can be accomplished directly over the Internet without 
establishing a VPN connection. Eliminating the VPN connection requirement can  be 
crucial when conducting multi-site research studies with Institutions outside of MSKCC 
locations. UNITY Web was developed using the latest Microsoft .Net Framework with C# 
and JQuery. The application is being hosted by Microsoft IIS and the backend database is 
on Microsoft SQL Server. A number of various encryption methods were used from the 
user interface to the servers and as well as the communications between servers. All 
encryption methods used have either met or exceeded the requirements described in the 
standard HIPAA web application security guideline. 
 
 
 
 
 
 
13.2 
Quality Assurance 
 
Registration reports will be generated regularly to monitor patient accruals and 
completeness of registration data. Routine data quality reports will be generated to assess 
missing and inconsistent data. Accrual rates and extent and accuracy of evaluations and 
follow-up will be monitored periodically throughout the study period and potential problems 
will be brought to the attention of the study team  for discussion and action. Random- 
sample data quality and protocol compliance audits will be conducted by the study team. 
 
13.3 
Data and Safety Monitoring 
 
The Data and Safety Monitoring (DSM) Plans at Memorial Sloan-Kettering Cancer Center 
were approved by the National Cancer Institute in September 2001. The plans address the 
new policies set forth by the NCI in the document entitled ―Policy of the National Cancer 
Institute for Data and Safety Monitoring of Clinical Trials‖ which can be found at: 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 27 of 45 
 
 
 
 
http://cancertrials.nci.nih.gov/researchers/dsm/index.html. 
 
The DSM Plans at MSKCC were established and are monitored by Clinical Research 
Administration. The MSKCC Data and Safety Monitoring Plans can be found  on  the 
MSKCC Intranet at 
https://one.mskcc.org/sites/pub/clinresearch/Documents/MSKCC%20Data%20and%20Saf 
ety%20Monitoring%20Plans.pdf There are several different mechanisms by which clinical 
trials are monitored for data, safety and quality. There are institutional processes in place 
for quality assurance (e.g., protocol monitoring, compliance and data verification audits, 
therapeutic response, and staff education on clinical research QA) and departmental 
procedures for quality control, plus there are two institutional committees that are 
responsible for monitoring the activities of our clinical trials programs. The committees: 
Data and Safety Monitoring Committee (DSMC) for Phase I and II clinical trials, and the 
Data and Safety Monitoring Board (DSMB) for Phase III clinical trials, report  to  the 
Center‘s Research Council and Institutional Review Board. 
 
During the protocol development and review process, each protocol will be assessed for 
its level of risk and degree of monitoring required. Every type of protocol (e.g., NIH 
sponsored, in-house sponsored, industrial sponsored, NCI cooperative group, etc.) will be 
addressed and the monitoring procedures will be established at the time of protocol 
activation. 
13.4 
Regulatory Documentation 
 
Participating sites that are consulting and/or conducting specimen or data analysis should 
submit this protocol to their IRB according to local guidelines. Copies of any site IRB 
correspondence should be forwarded to MSK. 
 
 
14.1 
PROTECTION OF HUMAN SUBJECTS 
 
Participants will be informed that participation is voluntary and that they have the right to 
withdraw at any time and/or leave any question blank if they do not feel comfortable 
answering. Confidentiality of each subject‘s self-report information and each patient‘s 
medical information will be protected with the utmost care. Each study subject will be 
given a unique numeric identifier upon study  entry. Data sheets collected  from  each 
subject will be identified solely by a code number. A list matching subject names and code 
numbers will be maintained separately and kept in a secure area. This will preserve the 
anonymity of participants. All data will be used only for research purposes. IRB and HIPAA 
regulations concerning confidentiality will be strictly enforced. Hardcopies of the original 
questionnaires will be stored in locked file cabinets. Through the use of password security 
measures, restrictions will be applied to each user commensurate with their needs to 
access the data. Confidential information will not be routinely available to all members of 
the research team but rather on a ―need to know‖ basis. All study personnel will be 
instructed in the ethics of electronic data access, as well as receive training in both HIPAA 
issues and human subjects training. Similarly, all biological samples will be labeled only 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
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Page 28 of 45 
 
 
 
 
with the unique subject number. Study staff will be trained on procedures for  data 
collection and handling/storage of all biological samples and will follow standard 
procedures to minimize pain and bleeding. Staff will observe and record any signs of 
distress during fingerstick procedures. In the event that any abnormal or irregular health 
measures are identified, staff will be trained to alert study investigators and research 
manager, participant will be referred to low cost community health services. During weekly 
assessments, staff will be trained to check in with participants to identify if study 
participation has impacted their working environment (unintended consequences, such as 
passengers and others asking them about equipment despite its small size). In the event 
that a concern is reported staff will inform participants of their right to withdraw from the 
study and the study team will work them to mitigate problems. 
 
14.2 
Privacy 
 
MSKCC‘s Privacy Office may allow the use and disclosure of protected health information 
pursuant to a completed and signed Research Authorization form. The use and disclosure 
of protected health information will be limited to the individuals described in the Research 
Authorization form. A Research Authorization form must be completed by the Principal 
Investigator and approved by the IRB and Privacy Board (IRB/PB). 
 
 
14.3 
Serious Adverse Event (SAE) Reporting 
 
An adverse event is considered serious if it results in ANY of the following outcomes: 
• 
Death 
• 
A life-threatening adverse event 
• 
An adverse event that results in inpatient hospitalization or prolongation of existing 
hospitalization 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
• 
A congenital anomaly/birth defect 
• 
Important Medical Events (IME) that may not result in death, be life threatening, or 
require hospitalization may be considered serious when, based upon medical 
judgment, they may jeopardize the patient or subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition 
Note: Hospital admission for a planned procedure/disease treatment is not considered an 
SAE. 
 
As this is a minimal risk study, we will only report SAEs (including deaths) that are 
believed to be at least possibly related to the protocol intervention. 
 
SAE reporting is required as soon as the participant signs consent.  SAE reporting is 
required for 30-days after the participant‘s last investigational treatment or intervention. 
Any events that occur after the 30-day period and that are at least possibly related to 
protocol treatment must be reported. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 29 of 45 
 
 
 
 
 
 
If an SAE requires submission to the IRB office per IRB SOP RR-408 ‗Reporting of Serious 
Adverse Events‘, the SAE report must be sent to the IRB within 5 calendar days of          
the event. The IRB requires a Clinical Research Database (CRDB) SAE report be 
submitted electronically to the SAE Office as follows: 
For IND/IDE trials: Reports that include a Grade 5 SAE should be sent to  
saegrade5@mskcc.org.  All other reports should be sent to saemskind@mskcc.org. 
 
For all other trials: Reports that include a Grade 5 SAE should be sent to  
saegrade5@mskcc.org.  All other reports should be sent to sae@mskcc.org. 
The report should contain the following information: 
 
 
 
Fields populated from CRDB: 
 
• 
Subject‘s initials 
• 
Medical record number 
• 
Disease/histology (if applicable) 
• 
Protocol number and title 
Data needing to be entered: 
• 
The date the adverse event occurred 
• 
The adverse event 
• 
The grade of the event 
• 
Relationship of the adverse event to the treatment (drug, device, or intervention) 
• 
If the AE was expected 
• 
The severity of the AE 
• 
The intervention 
• 
Detailed text that includes the following 
o A explanation of how the AE was handled 
o A description of the subject‘s condition 
o Indication if the subject remains on the study 
• 
If an amendment will need to be made to the protocol and/or consent form 
• 
If the SAE is an Unanticipated Problem 
The PI‘s signature and the date it was signed are required on the completed report. 
For IND/IDE protocols: 
The CRDB SAE report should be completed as per above instructions.  If appropriate, the 
report will be forwarded to the FDA by the SAE staff through the IND Office. 
14.2.1 

Memorial Sloan Kettering Cancer Center 
IRB Number: 14-247 A(9) 
Approval date: 20-Dec-2017 
Page 30 of 45 
 
 
 
 
N/A 
 
15.1 
INFORMED CONSENT PROCEDURES 
 
Before protocol-specified procedures are carried out, consenting professionals will explain 
full details of the protocol and study procedures as well as the risks involved to 
participants prior to their inclusion in the study. Participants will also be informed that they 
are free to withdraw from the study at any time. All participants must sign an IRB/PB- 
approved consent form indicating their consent to participate. This consent form meets the 
requirements of the Code of Federal Regulations and the Institutional Review 
Board/Privacy Board of this Center. The consent form will include the following: 
 
1. The nature and objectives, potential risks and benefits of the intended study. 
2. The length of study and the likely follow-up required. 
3. Alternatives to the proposed study. (This will include available standard and 
investigational therapies. In addition, patients will be offered an option of 
supportive care for therapeutic studies.) 
4. The name of the investigator(s) responsible for the protocol. 
5. The right of the participant to accept or refuse study interventions/interactions and 
to withdraw from participation at any time. 
 
Before any protocol-specific procedures can be carried out, the consenting professional 
will fully explain the aspects of patient privacy concerning research specific information.  In 
addition to signing the IRB Informed Consent, all patients must agree to the Research 
Authorization component of the informed consent form. 
 
Each participant and consenting professional will sign the consent form. The participant 
must receive a copy of the signed informed consent form. 
16.0 
REFERENCES 
 
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2. 
Consulting S. The changing face of taxi and limousine drivers, U.S., large states and 
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Page 33 of 45 
 
 
 
 
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17.0 
APPENDICES 
 
Appendix A. Screening Tool 
Appendix B. Intake 
Appendix C. Driver Log Book 
Appendix D. RSA guide/Lab Manual 
Appendix E. Data Collection log 
Appendix F. Driver Recruitment Flyer