January 3rd, 2018
EPA-HSRB-18-1
Dr. Jennifer Orme-Zavaleta
EPA Science Advisor
Office of the Science Advisor
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Subject: October EPA Human Studies Review Board Meeting Report
Dear Dr. Orme-Zavaleta,
The United States Environmental Protection Agency (EPA or Agency) requested that the
Human Studies Review Board (HSRB) provide scientific and ethics review of one item titled
Protocol for a Study for Measurement of Potential Dermal and Inhalation Exposure during
the Application of Paint Containing an Antimicrobial using an Airless Sprayer. The
Board's responses to the charge questions and detailed rationale and recommendations are
provided in the enclosed final meeting report.
Signed,
Liza Dawson, PhD
Chair
EPA Human Studies Review Board
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INTRODUCTION
On October 25, 2017, the United States Environmental Protection Agency's (EPA or Agency)
Human Studies Review Board (HSRB or Board) met to address the scientific and ethical charge
questions related to a Protocol for a Study for Measurement of Potential Dermal and
Inhalation Exposure during the Application of Paint Containing an Antimicrobial using an
Airless Sprayer
REVIEW PROCESS
The Board conducted a public meeting on October 25, 2017. Advance notice of the meeting was
published in the Federal Register as "Human Studies Review Board; Notification of a Public
Meeting" (EPA, October 11, 2017, Pages 47204 and 47205).
Following welcoming remarks from Agency officials, the Board began its review of the study,
Protocol for a Study for Measurement of Potential Dermal and Inhalation Exposure during
the Application of Paint Containing an Antimicrobial using an Airless Sprayer.
The Board heard two presentations from EPA for this study protocol, consisting of the Agency's
review of scientific and ethical aspects of the proposed study. This Final Report of the meeting
describes the HSRB's discussion, recommendations, rationale and consensus in response to each
charge question for the study.
At the meeting, Agency staff first presented their review of the science and the Board asked the
Agency presenters clarifying questions. The staff then described their review of the ethical
aspects and the Board asked clarifying questions about those. The HSRB solicited public
comments and next asked Agency staff to read the Charge Questions under consideration. The
Board discussed the science question first and then the ethics question. The Chair called for a
vote to confirm concurrence on a summary statement in response to each charge question.
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For their evaluation and discussion, the Board considered materials presented by EPA staff at the
meeting, related materials and documents provided by the study sponsors, the Agency's science
and ethics reviews of the studies, and oral responses from Agency staff and from study
investigators in attendance at the meeting.
Scientific Review: Charge to Board:
Is the protocol "A Study for Measurement of Potential Dermal and Inhalation Exposure During
the Application of Paint Containing an Antimicrobial using an Airless Sprayer" likely to
generate scientifically reliable data, useful for assessing the exposure of those who apply
products containing antimicrobial pesticides as preservatives using an airless sprayer?
Board Response
The Board concludes that the protocol as presented is likely to generate scientific reliable data,
useful for assessing the exposure of those who apply products containing antimicrobial pesticides
as preservatives using an airless sprayer, provided the changes requested by EPA and the
changes requested by the HSRB below are implemented. The Board also has specific
recommendations and clarifications to be made in the study protocol, as described below.
HSRB Detailed Recommendations and Rationale:
HSRB reviewed information provided in advance of the meeting, as well as the EPA scientific
and ethics presentations provided at the meeting. The Board noted and agreed with the changes
in the protocol document, both major and minor, that were recommended by EPA reviewers. In
addition, the Board identified further details that need to be clarified or modified in the protocol.
The HSRB requests that these changes be made and submitted for EPA review prior to
submission to the reviewing IRB. The Board's detailed recommendations are discussed below.
1) Clarification of rationale for paint volumes in the study protocol
The study sponsor is asked to revise the justification of the volumes of paint used within the
protocol. The protocol currently states that subjects will use 10, 15, and 30 gallons as target
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paint volumes during the different scenarios, indicating that the 30 gallon limit is driven by
typical use patterns. This reasoning is not supported by the survey of professional painters that
was performed and provided by the study sponsors, in which some respondents used volumes as
high as 50 gallons. It was clarified that the upper volume of 30 gallons is needed based on
feasibility, given that this volume may take 6 hours to spray and the sponsors wanted to
minimize the total time of subjects in each scenario given the additional tasks required during the
study day. The Board recognizes the rationale for a 3-point reference of exposure based on the
10, 15, and 30 gallon usage that will allow extrapolation to 50 gallons. At the same time, the
Board notes that the study may not be capturing exposure for high risk groups (i.e., large
companies) that either use higher amount of paint volumes and work longer hours, or have
multiple painters working at the same time that could increase exposures. This potential high risk
group is indicated on the survey. The Board recommends that this potential higher exposure be
acknowledged in the protocol, as well as noting that the survey is based on a small sample size.
Documentation of site and work factors: The success of the study in capturing representative
exposure monitoring data relies on the study identifying and varying the most relevant factors
influencing dermal and air exposures during airless spraying. In attempt to generate
representative exposure monitoring data, the protocol includes variations in paint volume,
propiconazole concentration and subjects between monitoring events, and room size and features
(horizontal and vertical surfaces) within monitoring events. In addition, subjects are allowed to
vary the spray gun nozzles and wands, the ventilation (through use of fans and windows), and the
use of wipe cloths ("painters rags"). HSRB suggests the careful documentation of the site factors
[ventilation sources (windows, fans), fixtures, surface areas and orientation (vertical vs.
horizontal), as well as behavioral factors (use of rags, wiping of dermal areas, choice of nozzle
and wands] that influence air and dermal exposures to aid in data interpretation. When
appropriate, both the frequency and duration of the factors influencing exposure should be
captured. The Board recommends creating a field collection report form that includes all the
work-practice and environmental factors (i.e., field variables) that will be collected and the time
over which these factors will be collected (e.g., every 15 minutes, as they change).
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2. Provide exposure information and rationale for respirator use choice.
The Board recommends that the use of respirators during the study be more thoroughly
addressed in the protocol. In order to identify whether respirator use should be mandatory and if
so, the appropriate respirator type, the study sponsor should clearly identify the potential hazards
(contaminants) based on the type of paint and sprayers used, and determine the
level/concentration of the contaminant(s) in the air. First, the study sponsor should provide an
updated Safety Data Sheet (SDS) for the Sherman Williams Superpaint. The SDS provided
includes discrepancies, indicating a respirable dust/total dust hazard, yet suggesting the use of a
combination organic vapor/particulate respirator. If the only hazard is dust/total dust, then a
particulate respirator is adequate. Should a volatile organic compound (VOC) be present and an
organic vapor respirator be required, details on the VOC should be listed within the
Composition/Information on the Ingredients Section of the SDS. In addition, the study sponsor
should provide data on the concentration of the hazard during the task, either by performing
sampling or by providing an industry accepted concentration. Once the concentration is
determined, the study sponsor can use the United States Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limit (PEL) for each of the identified hazards to
guide respirator selection. Respirators should be required if concentration of the contaminant is
above OSHA PEL and can be voluntary if the concentration during activity is below OSHA PEL.
Based on the protection factor and hazard characteristics (particle versus VOC) the correct type
of respirator should be chosen. Based on whether respirators are required or voluntary, different
requirements are specified under OSHA.1 Training may be achieved by providing appendix d1 or
showing a video.2 If respirator use is required, then, fit testing and medical clearance is also
needed. Fit testing is suggested rather than required, if the study sponsor is going to provide N95
respirators for voluntary use. OSHA provides a protocol for qualitative fit testing which requires
a kit and equipment, and can be performed by following the protocol (i.e., by study personnel).
The respirator fit testing can likely be performed within 30 minutes.3 The study sponsors should
1 See: https://www.osha.gov/video/respiratorv protection/voluntarvuse transcript.html Workers wearing
respirators, regardless of voluntary versus required need training. Specifically the content of Appendix D from the
OSHA standard
(https://www.osha.gov/pls/oshaweb/owadisp.show document?p table=STANDARDS&p id=9784).
2 https://www.osha.gov/video/respiratorv protection/voluntarvuse.html
3 see protocol - https://www.osha.gov/pls/oshaweb/owadisp.show document?p table=standards&p id=9780 .
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provide a range of N95 respirators to account for different face types. The study sponsor should
allow, but not require workers to bring their own respirators. Allowing for the use of a study
supplied respirator or for subjects to bring their own respirator, would allow for a wider and
potentially more representative sample of painters in the area. Furthermore, should respirator use
be deemed to be voluntary, subject selection can proceed without requiring that subjects be
willing to wear a respirator.
3. Clarify the margin of exposure (MOE) calculations used in the study The Board requests
that the study sponsor review and clarify the dermal absorption value for propiconazole that was
used in the MOE calculations by EPA. The initial value used in the 2006 re-registration
document appears to be 40%, but 100% was referred to in a correspondence by EPA to Janssen
Pharma. Subsequent study data provided by Janssen and accepted by EPA placed that value at
1% for paints. Based on the discussion at the meeting, the Board's view is that this is an
accurate representation of how the value of 1% was selected in the MOEs that are in effect for
this proposed study.
The Board's second concern regarding MOEs was the apparent lack of harmonization in the
MOEs that EPA has presented and those that appear in an EU document from 2015.4 The Board
requests that the Agency comment on the possible source(s) of lack of harmonization between
the EPA and the EU assessments of MOEs for propiconazole.
5. Limitations with respect to using professional painters versus consumer users
AEATF II suggests enrolling subjects who are professional painters as they best represent the
typical user of airless paint spraying equipment. Professional painters may represent the worst
case exposure scenario as they have higher exposures due to the higher volume of paint that they
use as compared to consumer painters. However, dermal exposure may be higher among
4 Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Evaluation of active substances. Assessment Report: Propiconazole; Product-type 7; (Film preservatives); January
2015; Finland.
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consumers (non-professional painters) due to inexperience with operating the equipment and the
resulting direct contact and splashing with the paint. Therefore, the results under a study
conducted according to this protocol may underestimate dermal exposure to antimicrobials
among inexperienced consumer users using an airless sprayer. Additional detail on the risk
assessment assumptions when extrapolating to consumers who use airless paint spraying
equipment may be warranted. These limitations should be discussed in the protocol.
6. Statistical issues
Given the practical and ethical constraints associated with the protocol, the design that utilizes
three volumes of paint sprayed, the same two propiconazole concentrations for each volume, and
three randomly assigned subjects (monitoring events) to each of the six combinations is
reasonable.
As noted above, the proposed protocol randomization plan restricts subject selection to
professional painters, which means that the data cannot be used to draw conclusions about
homeowners and other non-professional painters without assumptions supported by objective
evidence that it is reasonable to do so. The homeowner and other non-professional painter
population may have much different personal characteristics than the professional painter
population, which may impact the transfer of the study conclusions.
Since the AEATF II task force will not provide any statistical analysis of the data, the following
comments are directed to EPA's proposed analysis as described in Section C.5 (pagel2) of the
EPA Memorandum titled "Science and Ethics Review of AEATF II Airless Sprayer Paper
Scenario Design and Protocol for Exposure Monitoring" dated September 27, 2017. The Board
agrees with EPA's overall regression modeling approach that considers the logarithm of the
exposure as a function of the logarithm of the amount of active ingredient. The Board did find it
somewhat unusual that the presentation appeared to initially state somewhat unequivocally that
the main model would be a single straight line for all spray-propiconazole combinations with an
assumed slope of one.
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EPA does go on to indicate that several very reasonable alternative models would be investigated
both statistically and graphically if the assumed single straight line was not adequate. From a
statistical modeling perspective, it is common practice to begin by fitting more complex models
and eliminating non-significant terms to reach a final model that then would be checked for
consistency with the data.
For analysis of any of the initial regression models, it would be important to consider the
inclusion of other potentially important predictors; e.g., temperature, relative humidity, actual
painting time, actual amount of paint used, actual surface area painted, and ceiling height, against
which studentized residuals could be graphed to check for patterns. Characteristics of potentially
useful non-quantitative variables such as nozzle type should be recorded and used for color (or
symbol) coding of the observations in studentized residual plots to identify potential biases that
they may cause.
The Board had one final comment on Attachment 2, Section 2.1 (i) on pages 40 and 41 of the
EPA Memorandum. The idea that under several simplifications and other assumptions the
statistical power for dermal or inhalation exposure could be 100% does not seem at all
reasonable. A power of 100% would appear to guarantee a sample size that would provide a zero
probability of an incorrect conclusion from the study.
7. Additional recommendations
The Board recommends clarifying the following issues in the study protocol.
Formulation type: EPA's scientific review of the protocol included a slide of the formulation
types (e.g., powder, liquid) that are targeted for study. Please include the information on that
slide as a reference in the protocol for understanding the matrix and the definition of formulation
as used in this study. This also adds context to the need for the study in the special category of
"airless paint spraying".
Choice of paint: Please include the rationale for choosing this particular product for study. In
discussion, it was mentioned that this paint was used in the previous study with consumers and
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commonly used with airless paint sprayers and this clarification could be included in the
protocol.
Documentation of personnel training: The protocol does not mention training of personnel. A
training protocol would be appropriate to prepare and train study staff on data collection
procedures. The training protocol could be referenced or included as an appendix.
Protocol for dermal samplers: Please include a wait time to allow drying of the paint on the
dosimeters for removal, and also add further details on how the dosimeters will be handled with
care. In addition, please provide the rationale for not including the researchers' gloves in the
testing after they handle the dosimeters. In Volume 4 of 4 in the SOPs (page 83) there is a
procedure for taking off the dosimeters which mentions that the gloves from the researcher
should be discarded, but the rationale for this is not provided.
Handwashing: Page 42-43 of protocol, please clarify if the subjects wash their hands on site,
before starting to paint. This is mentioned on the consent form on page 4 but not in the protocol.
Use of ladder: Please clarify if a ladder over 6 feet will be used, and when or if fall protection
will be used, as fall protection is required by OSHA at 6 feet and above. Slipping on tarps is also
a possibility.
Videotaping: Videotaping is first mentioned on page 48 and then 60 (AEATF II Project ID:
AEA10). The protocol should elaborate on this videotaping (i.e., is the videotaping done
throughout the exposure period; is taping stationary or following the subject; focused on the
spraying activities, or on all activities).
Alternate location: Page 37 of protocol should clarify if alternates are brought to the site on the
day of testing, or if an alternate is only contacted if they are needed, and is brought to the site on
another day.
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Snacks: Page 45 mentions that the subjects may choose to eat or use tobacco. Please clarify if
the subjects bring their own food.
Ethics Review: Charge to the Board
• Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K
and L?
Board Response
HSRB Recommendation
The HSRB concludes that the research presented in the protocol "A Study for Measurement of
Potential Dermal and Inhalation Exposure During the Application of Paint Containing an
Antimicrobial Using an Airless Sprayer" (AEA10) is likely to meet the applicable requirements
of 40 CFR part 26, subparts K and L, if modified in the ways detailed below.
HSRB Detailed Recommendations and Rationale
The Agency's rules at 40 CFR part 26, subpart K detail the practical and ethical requirements for
IRB review and approval of third-party research that the Agency intends to consider in
connections with its actions. The rules at 40 CFR part 26, subpart L prohibit the Agency from
relying on third-party research for such consideration if that research involves intentional
exposure to a pesticide of human subjects who are children or pregnant or nursing women. These
regulatory requirements are sufficiently satisfied in the ways described below.
1. IRB Information
This study has been reviewed and approved by Schulman IRB, a commercial IRB that has been
accredited by the Association for the Accreditation of Human Research Protection Programs
(AAHRPP) since June 2008. They are registered with the Office for Human Research
Protections (IRB Registration #00000971) and indicate on their website that they have
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undergone six consecutive audits by the U.S. Food and Drug Administration (FDA) with no
findings, the most recent of which took place in November 2016.
The Schulman IRB panel roster provided by AEATF II in Volume 3 of their supplied
documentation demonstrates that the panel that reviewed and approved this study in August 2017
satisfies the IRB membership requirements set forth in subpart K, paragraph 1107. A Schulman
IRB panel will also review any changes made to the study in light of HSRB and EPA
recommendations prior to their implementation.
2. Minimization of Risks
Risks associated with research procedures will be minimized in the following ways:
As noted on page 18 of the protocol and detailed in its supplementary materials, the surrogate
test substance used in this study—propiconazole—has been selected due in part to its low
toxicity level in mammals. It is an antimicrobial pesticide and fungicide commonly used in
agriculture and is commercially available with a maximum concentration of 12,000 ppm. Its
concentration in this study, either 1,200 ppm or 12,000 ppm, is consistent with what is already
commercially available. As a result, the amount of test substance to which subjects are exposed
should not be drastically dissimilar to what one may be exposed in the course of daily work
activities. Further, individuals with known allergies or sensitivities to propiconazole or any
triazole fungicide, as well as individuals with skin issues (such as psoriasis, eczema, or visible
cuts) will be excluded from study participation.
Subjects will also have multiple physical barriers to protect them from the test substance.
Subjects will be wearing two layers of clothing (long sleeved shirt and long pants over the
dosimeters) to further minimize unnecessary dermal exposure. The protocol states that they will
be provided with safety glasses with side-shields or goggles and must use their own half-face
respirator when painting. The issue of respirators was a major point of discussion by the HSRB
as noted above and the final plan regarding respirator use should be based on level and type of
contaminants and OSHA standards for respirator use associated with those exposures.
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To minimize the risk of allergic reactions to the latex materials and isopropyl alcohol used in the
study, persons with known allergies or sensitivities to these materials will be excluded from
study participation.
To minimize the risk of heat stress, the study will take place in winter in Florida, where the
researchers report that average high temperatures are rarely above 80 degrees Fahrenheit. The
duration of actual paint spraying during a subject's participation will be approximately two to six
hours, which seems consistent (if not slightly below) with what a typical day of painting would
be for a professional painter. The study will also follow AEATF II SOP 1 IB. 1 (Heat Stress),
which provides ample guidance for researchers to monitor environmental conditions that may
contribute to heat-related stress, including hourly checks of the heat index if the ambient
temperature reaches at least 70 degrees Fahrenheit. If necessary, researchers will open doors and
windows to lower ambient temperature and will make floor fans or blowers available to subjects.
Water and sports drinks will also be made available to subjects, who are encouraged to take
breaks whenever they feel the need. Researcher personnel are trained to recognize symptoms of
heat stress and will be present to monitor subjects. The SOP also indicates that the research team
will "make arrangements to provide access to local emergency medical assistance if it becomes
necessary" (SOP 1 IB. 1, Section 4.6.a) and the protocol states that "a physician, nurse,
emergency medical technician (EMT), or physician's assistant unaffiliated with the researchers
will be hired for the study and will be on site for each monitoring event and will provide medical
support if needed" (p. 33). Lastly, an informational poster titled "Controlling Heat Stress Made
Simple" will be posted in both English and Spanish at the test site.
Risks associated with moving multiple five-gallon buckets of paint are also minimal, but further
minimized by enrolling only professional painters who already perform such activities and are
healthy enough to do so.
There are minor psychological risks associated with the study participation, given that female
subjects must take a urine pregnancy test in order to participate and subjects will need to disrobe
in front of researchers when donning and doffing their dosimeters. These activities and the
potential risks are clearly delineated in the informed consent document. The process for
minimizing psychological risks associated with a pregnancy test is described below. To
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minimize psychological discomfort associated with dressing and undressing, subjects will do so
only in front of a researcher of the same gender and in a private area.
There may also be minor confidentiality risks in the event that study data is unexpectedly
released or accessed. However, this risk is very minor given that none of the data collected about
subjects are of an especially sensitive nature. SOP 11J.1 (Obtaining Informed Consent) describes
appropriate methods to keep study data secure and accessible only to qualified research
personnel, and those methods adhere to Good Laboratory Practice guidelines at 40 CFR part 160.
Any photos included in the study's final report will omit subject faces and identifying tattoos. In
the event that the study data is published, those data will be de-identified before publication. As
noted below, the results of pregnancy tests will not be recorded. As a result, there are no
significant confidentiality concerns related to this study.
Lastly, subject compensation does not appear coercive or extravagant, given the study
procedures and the time subjects will spend participating in the study. Interested persons who
attend an informed consent meeting but elect not to participate will receive $20, while subjects
who enroll in the study and participate or serve as an alternate will receive $200. Since subjects
will either spend a full working day participating in the study or block off a full working day for
their participation, this amount seems appropriate.
3. Subject Selection
Subjects who enroll in the study must be professional painters with a minimum of three months
experience using an airless sprayer to apply architectural paint within the last five years
(protocol, p. 17). As described in the scientific review, the inclusion of only professional
painters is because professionals are more likely to use airless sprayers than non-professional
(consumer) painters and because professionals generally use higher volumes of paint than non-
professionals. Further, professionals are more likely to have the appropriate knowledge and
experience to be able to operate an airless sprayer and repeatedly handle large buckets of paint,
thereby minimizing the risks associated with those study activities.
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The study's inclusion and exclusion criteria are clearly defined in both the study protocol and
informed consent document and are appropriate for minimizing risks associated with study
participation, as noted above. Any employees or the spouse of any employee of companies
represented by AEATF, Sherwin-Williams, the American Chemistry Council, or Lange Research
and Consulting will be excluded in order to minimize the risks of bias or coerced participation.
There is an upper age limit of 65 for subjects, which the protocol notes is because the "study
requires some physical activities." The Board recommends that this upper age limit be removed
to allow healthy subjects older than 65 to participate, if they choose to do so, unless there is a
clear rationale and justification for the age limit.
4. Informed Consent
Informed consent discussions will be conducted in a one-on-one setting unless potential subjects
want their family member(s) to attend. Potential subjects will be given two copies of the
informed consent document—one to keep and one to sign—and those persons will have the
opportunity to take a copy of the consent document home with them to discuss the study with
family or friends prior to agreeing to participate. The informed consent document is clearly
written, contains all required elements of informed consent detailed in subpart K, and gives
potential subjects a helpful overview of what study participation will entail.
A bilingual member of the research team who is able to communicate in both English and
Spanish will be available for consent discussions when potential subjects indicate a preference
for speaking in Spanish. That team member will also be present during monitoring events that
involve subjects who prefer to speak Spanish. Certified Spanish-language translations of the
informed consent document and recruitment materials have also been included with the materials
the Board has reviewed (certification provided by WeLocalize Life Sciences).
Lastly, AEATF II SOP 11J.1 (Obtaining Informed Consent) provides an overview of the
measures researchers will take to ensure that subjects comprehend what study participation
entails, including the study's risks and benefits (or lack thereof). There is also a "Subject Study
Comprehension" verification worksheet attached to that SOP, which includes a series of open-
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ended questions that researchers will pose to subjects that they must successfully answer before
being able to participate in this study (Volume 4, p. 159).
Exclusion of Children and Pregnant or Nursing Women
This study intends to enroll subjects between the ages of 18 and 65, so no minors will participate
in the research. As noted in the protocol (p. 16), subject ages will be verified by a government
issued photo ID when potential subjects meet with a member of the research staff for the
informed consent discussion.
AEATF II Standard Operating Procedure (SOP) 11 A. 1 (Human Subject Management Pregnancy
Testing and Nursing Status) clearly details steps taken to ensure that pregnant or lactating
women do not participate in the study. First, researchers will review the study's exclusion
criteria—including the exclusion of pregnant or nursing women—with potential subjects during
the initial consent discussion. At that time, interested women will also be informed that they
must take an over-the-counter urine pregnancy test when arriving to the test site on the day of
their participation. These pregnancy tests will be provided to female subjects by the study team
at no cost to subjects. Female subjects will self-administer the test in a private bathroom. After
taking the test and viewing her results, a female subject will be asked if she wants to continue
study participation. If she declines, her participation in the study is discontinued though she will
still receive compensation for her time and inconvenience. She will not be asked why she wishes
to discontinue participation and her test result will not be recorded. If she wishes to continue, the
results of the pregnancy test will be verified by a female researcher to ensure that the test result is
negative. In this case, researchers will record that a pregnancy test was performed in compliance
with SOP 11 A. 1. In both cases, the pregnancy tests will then be discarded in an opaque bag.
These measures appear appropriate and do not introduce unnecessary risks or burdens on the
women who wish to participate in this study.
HSRB Recommendations
The HSRB recommends the study team implement the following changes in order to further
ensure protection of the rights and welfare of research subjects:
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1. As noted above, remove the upper age limit on study participation so that adults of any
age who otherwise satisfy the study's inclusion and exclusion criteria are able to
participate in the study, unless a clear justification is provided for the age limit.
2. Please revise recruitment materials to indicate that a government-issued photo ID is
required for study participation.
3. The Occupational Safety and Health Administration (OSHA) recommends a minimum of
two hearing protection device options be provided to allow workers with a variety of ear
types and preferences to be protected. Please revise the study protocol accordingly to
provide at least two types of hearing protection options.
4. Revise the informed consent document to include risks associated with using a small
ladder.
5. Revise the informed consent document to describe the videotaping that will take place
during the study, and give subjects the option of indicating if they do not wish to be
videotaped.
6. In the study's subject screening materials, subjects are currently asked if they are allergic
to the test product, propiconazole. To promote subject understanding, please revise this
question to ask whether subjects have ever had an allergic response to paint products.
7. Please address the concern regarding respiratory protection as detailed elsewhere in this
Report.
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