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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION

 December 15, 2015

MEMORANDUM 

SUBJECT: Ethics Review of Completed Study entitled, “Field Testing of S.C. Johnson 

Personal Mosquito Repellent Products to Support their Use of the EPA 

Repellency Awareness Graphic” for MARK-8 OFF! Deep Woods Insect 

Repellent V

FROM: Maureen Lydon, Human Research Ethics Review Officer

Office of the Director

Office of Pesticide Programs 

TO: Marietta Echeverria, Chief, Invertebrate -Vertebrate Branch 1

Registration Division

Office of Pesticide Programs

REF: C. Talbert (2015) Field Testing of S.C. Johnson Personal Mosquito 

Repellent Products to Support their Use of the EPA Repellency Awareness 

Graphic, October 21, 2015. 154 pages, Test Substance MARK-8 OFF! 

Deep Woods Insect Repellent V (OFF! Insect Repellent Formula, EPA Reg. 

No. 4822-167) GLP Study No. 873E1 (MRID 49761601)

I have reviewed available information concerning the ethical conduct of the 

referenced research study, “Field Testing of S.C. Johnson Personal Mosquito Repellent 

Products to Support their Use of the EPA Repellency Awareness Graphic” for test 

substance MARK-8 OFF! Deep Woods Insect Repellent V (OFF! Insect Repellent 

Formula, EPA Reg. No. 4822-167). If the research is determined to be scientifically 

acceptable, I find no barrier in regulation to the U.S. Environmental Protection Agency’s 

(EPA’s) reliance on this study in actions under the Federal Insecticide, Fungicide, or 

Rodenticide Act (FIFRA) or the Federal Food, Drug, and Cosmetic Act (FFDCA). The 

Human Studies Review Board (HSRB) will be asked to comment on this study.

Completeness of Submission

All requirements of §26.1303 were satisfactorily addressed in the completion of this 

study as noted in the checklist in Attachment 1.
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Purpose and summary of study

The purpose of this study was to establish the complete protection time (CPT) of 

MARK-8 OFF! Deep Woods Insect Repellent V, which was previously registered and 

assessed by EPA, in the field against populations of wild mosquitoes, using human 

subjects. Testing took place at two geographically and ecologically distinct field sites 

(Wisconsin and Florida). The protocol called for 10 volunteer subjects at each test site 

with two untreated control subjects at each site. Table 7 summarizing test subject 

participation was included in each study; an updated version of this table, supplied by S.C. 

Johnson, is included in Attachment 2. As noted in the updated table 7, 24 human subjects 

were assigned to the tests and 23 completed the testing at the Wisconsin and Florida sites.

Human subjects were used because no reliable models or surrogates have been found to 

adequately predict the duration of efficacy of topically-applied insect repellents. Because

the repellent test products have all been registered by EPA, they have already been found to 

present little or no risk when used as directed on their labels. The precautions taken to 

mitigate hazards associated with the study are discussed on pages 17-19 (of 154) of the 

completed study and were consistent with the approved protocol.

Testing was completed in Wisconsin on a single day and then in Florida on a single 

day. The Study Director assembled all test subjects in an area within walking distance of 

the test site for testing preparation (limb preparation, suiting up and test substance 

application, etc.). Tent enclosure was provided to protect all personnel during this process 

from mosquitoes present at this location. Each subject was given and instructed to put on a 

bug suit pants and jacket. This suit is made of tightly woven nylon which allows air 

exchange but is impenetrable to mosquito bites. The bottoms of the pant legs and ends of 

the sleeves fit snuggly around the wearer's shoe or wrist respectively; this keeps 

mosquitoes out. There is also mesh on the sides of the jacket (under arm) for better 

breathability. The suit has drawstring band around the waist and a mesh area around the 

face (a zipper allows removal of this mesh around the face). Gloves were provided to 

protect the hands from mosquito bites. After washing their limbs, subjects put on the bug 

suit prior to treatment to help reduce any occurrence of abrading or contacting the area of 

the skin that will be treated. Each subject rolled up the sleeve of their bug suit for their 

forearm treatment.

The test substance was applied to human forearms. Starting two hours after test 

substance application, subjects exposed their treated forearms to mosquitoes in the field for 

5 minute periods at 30 minute intervals until repellent break-down occurred, or the study 

director ended the test. Duration of repellency was measured as the time between 

application of a test substance and the first confirmed landing. A “landing” occurred when 

a mosquito alighted on the treated test skin of a subject. A “First Confirmed Landing” is 

when two or more landings occurred in any five minute exposure period or, when one 

landing occurred in such an exposure period and another landing occurred in the next 

exposure period.
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The median duration for Wisconsin was 8.25 hours and for Florida was 8.0 hours. 

The duration of CPT for the repellency awareness graphic will be based on the EPA

Repellency Awareness Guidance for Skin-Applied Insect Repellent Products, EPA

Document No. 730-C-13-001, which states, "The mosquito claim should be calculated

using the most conservative (i.e., lowest) CPT from all available field studies" and "The 

number of hours of protection appearing on the repellency awareness graphic should be 

expressed as a whole number. If the most conservative calculated CPT is not a whole 

number, EPA recommends rounding down to the nearest whole number." The data support 

an 8 hour CPT for use on the repellency awareness graphic. 

Institutional Review Board Approval of Revised Final Protocol

The protocol for this study was approved by the overseeing institutional review 

board, the Schulman Associates Institutional Review Board (SAIRB), and submitted to 

EPA in draft form for review. The protocol and EPA’s review, dated March 31, 2015,

were discussed in a public meeting by the Human Studies Review Board (HSRB) on April 

22-23, 2015. Per the final HSRB meeting report, dated June 23, 2014, the HSRB 

concluded that “the amended protocol, when approved by the SAIRB, should meet all 

applicable ethical standards for the protection of human subjects of research, and all 

requirements for documentation of ethical conduct of the research. If this study is 

determined to be scientifically valid and relevant, there is no regulatory barrier to EPA’s 

reliance on it in actions under FIFRA or Section 408 of FFDAC.” 

In follow-up to the April 22-23, 2015 HSRB meeting, S.C. Johnson revised the 

protocol, telephone screening script for initial contact, script for follow-up contact, and 

consent form to address comments, including the EPA and HSRB comments described in 

Attachment 3, and submitted the revised documents to the Institutional Review Board 

(IRB) for review and approval prior to initiating the study. 

The SAIRB approvals relevant to this study and associated approval dates are listed 

below.

Chronology of SAIRB Final Approvals after April 2015 HSRB Meeting

a) 7/10/15 – The SAIRB notified S.C. Johnson that the protocol and informed consent 

forms were approved by the SAIRB on the dates noted below. 

b) 7/9/15 – The SAIRB approved, via expedited review, the updated recruitment/phone 

script for screening candidates via an initial and follow-up call. 

c) 7/7/15 – The SAIRB full board approved the protocol dated 6/26/15 and informed 

consent form which took into account EPA and HSRB comments. 

The June 26, 2015 protocol, which includes the SAIRB-approved changes, is in 

Appendix A to the completed study. The consent form approved by the SAIRB is datestamped 7/10/15 and included in the IRB correspondence file (beginning on page 84 of 

398.)
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The emails and/or forms requesting changes and the IRB’s review and approval 

notifications are provided in the file entitled, “IRB Correspondence for Completed 

Research Submissions of Field Testing of S.C. Johnson Personal Mosquito Repellent 

Products to Support Their Use of the EPA Repellency Awareness Graphic.” The 

aforementioned SAIRB approval dates are based on page 5 (of 398) of the IRB 

correspondence file.

Subject Recruitment 

Two recruitment firms, J. Reckner Associates, Inc. in Wisconsin and Herron 

Associates, Inc. in Florida were contracted to recruit potential candidates for these studies. 

J. Reckner Associates compiled and maintained a list of subjects for Wisconsin and Herron 

Associates did the same for Florida. A total of 6950-6953 potential candidates served as 

the initial pool. Using the approved script for the initial phone call, the recruitment firms 

screened 392 - 395 subjects. Using the approved inclusion/exclusion criteria, and taking 

into account subjects’ availability and interest, the recruitment firms identified and 

scheduled 170-173 subjects for S.C. Johnson to contact and further screen. There were 

three additional subjects recruited between 9/10/15 and 9/15/15, so the studies with test 

days of 9/15/15 and later had a slightly larger pool than those studies whose latest test dates 

were 9/10/15 and before. Using the approved follow-up screening script, the interested 

subjects who met the inclusion/ exclusion criteria and were available for both the training 

and test dates were enrolled for studies. This approach was used for all five studies shared 

with the Human Studies Review Board (HSRB). 

For the Mark-8 study, 57 subjects were enrolled. As described on page 13 of the 

study, the pool of enrolled subjects generally represented the demographics of U.S. 

repellent users. S.C. Johnson indicated that they made every effort to recruit and schedule 

subjects to fit the targeted demographics per the protocol. Not all targets were met due to: 

1) availability of subjects for the training and test dates; and 2) subjects withdrawing on the 

training and test day; and 3) subjects not showing up to their scheduled training and/or test 

dates. A broad range of demographics was still represented in the study looking at the 

combined demographic data for the human subjects participating in the Florida and 

Wisconsin testing. Table 5 in the completed study provides the demographics. Table 6, 

included in Attachment 2 to this memo, summarizes figures on subject recruitment, while 

Table 7 (also in Attachment 2) summarizes subject participation.

Subject Inclusion/Exclusion Criteria

Consistent with the approved protocol, the following inclusion/exclusion criteria 

were used for subject selection:

1. Subjects were within the ages of 18-55 and provided proof of age by a driver's

license, passport, or other valid identification.
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2. Subjects could read and speak English fluently. A percentage of bilingual subjects 

(English plus another language) were recruited for each study.

3. Subjects were not employees of S.C. Johnson or immediate family members of

SC Johnson employees.

4. Subjects had a reliable form of transportation to get to and from the test and training 

locations.

5. Subjects were willing to be exposed to and potentially bitten by mosquitoes and

were not known to be hypersensitive to mosquito bites.

6. Subjects felt they were healthy enough and did not have any health conditions that 

would make them unable to sit in a chair for long periods, with breaks for limb 

stretching and movement at reasonable intervals, able to stand continuously for five 

minutes and be outdoors for several hours where high temperatures, high humidity 

and sweating were possible

7. Subjects were willing to participate in testing outdoors where high temperatures, 

high humidity and sweating were possible.

8. Subjects did not have a known sensitivity or allergy to mosquito bites, Elastikon

(or equivalent) tape, latex, insect repellents, or skin care products.

9. Subjects were free of skin disease, skin problems, such as eczema, psoriasis, or 

atopic dermatitis.

10. Subject were willing to refrain from using alcohol 12 hours before the test, and 

refrain from nicotine, and fragrance products (e.g., soap, perfume, cologne, hair 

spray, lotion, etc.) during the test.

11. Female Subjects were not pregnant or breast-feeding.

12. Mosquitoes were attracted to subjects' untreated skin.

13. Subjects were users of insect repellent products.

Consent Process

Each potential subject who expressed interest in participating in the study and met 

the inclusion/exclusion criteria met with the Study Director or Principle Investigator at the 

scheduled training session. At this session, the subjects were provided with copies of the 

informed consent document (ICD) and asked to read the entire document. In cases where 

S.C. Johnson had an email address for eligible subjects, S.C. Johnson emailed the consent 

form to the subjects in advance of the training session. During the training, after the 

subjects completed reading the consent form, the Study Director or Investigator asked the 
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subjects if they had any questions regarding the information in the consent form, the study, 

and their role in the study. S.C. Johnson answered any questions. If a subject still wished 

to enroll in the study, he or she was asked to sign their copy of the ICD and the Study 

Director or Sub Investigator witnessed the signature. S.C. Johnson gave each subject a 

copy of his or her signed ICD.

Training

The subjects were trained in the skill of aspirating blood-seeking mosquitoes prior 

to participating in the study. In Wisconsin, training took place in the lab at the S.C. Johnson 

and Son Inc. Entomology Research Center in Racine, Wisconsin. In Florida, training 

occurred in the field at Collier Seminole State Park in Naples, Florida.

In Wisconsin, lab-reared female Aedes aegypti (yellow fever mosquitoes) were 

used. These mosquitoes were from colonies which have been fed only on animal hosts, 

never on humans, for many years. These mosquitoes were free of any disease-causing 

organisms which can afflict humans. Ten mosquitoes were released in a 2' x 2' x 2' 

screened cage with two entry ports. The study staffer demonstrated how to aspirate 

mosquitoes from their own bare forearm by inserting both arms into the cage, a batterypowered aspirator held in one hand (this forearm was protected by a long sleeve). When a 

mosquito landed on the staffer's bare forearm, it was observed for the distinctive posture it 

adopts when preparing to bite. The mosquito was aspirated before it could bite. The same 

procedure was followed with additional mosquitos.

After the subjects watched at least eight mosquitoes captured in this way by the 

study staffer, they were asked to try it themselves in the same manner. The study staffer 

observed these attempts closely and provided guidance as needed. The subjects were given 

additional mosquitoes to aspirate until the staffer felt that they were sufficiently proficient 

to participate in the field test. All mosquitoes from this training session were killed by 

exposure to compressed carbon dioxide and disposed in the trash.

In Florida, an appropriate laboratory site for training was not available. Instead, the 

subjects underwent training in the field at Collier Seminole State Park in Naples, Florida. 

This possibility and approach was described in section 8.2 of the approved protocol. The 

Study Director located an outdoor area where the mosquito landing rate was adequate to 

supply wild mosquitoes for practice, but not so heavy that trainee subjects were 

overwhelmed with mosquitoes while learning to aspirate. Both the staff members and test 

subjects wore bug suits to protect the entire body from mosquitoes and gloves over the 

hands. A study staffer demonstrated how to aspirate mosquitoes from their suit protected 

forearm with the battery powered aspirator. When a mosquito landed on the staffer's 

forearm, it was observed for the distinctive posture it adopts when preparing to bite and the 

mosquito was aspirated. The same procedure was followed with additional mosquitoes. 

After the subjects watched at least eight mosquitoes captured in this way by the study 

staffer, they were asked to try it themselves in the same manner. The study staffer observed 

these attempts closely and provided guidance as needed. The subjects practiced aspiration 
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until the staffer felt that they were sufficiently proficient to participate in the field test. No 

skin was exposed to biting mosquitoes during the training.

Exclusion of Pregnant Women

The pregnancy test was performed by the potential subject alone in a private 

bathroom. The results were verified by the subject only. After completion of the pregnancy 

test, a female member of the study staff asked in a private setting if the potential subject is 

still interested in participating in the study. If they were no longer interested, they did not 

need to explain why. If the test subject was interested in participating, the results were 

verified by a female of the study staff in a private manner. The results were kept 

confidential, were not recorded, and were not disclosed to anyone. The female staff 

member only notified the Study Director which females were and were not participating in 

the study. S.C. Johnson confirmed for EPA that pregnancy testing for each study was 

conducted on the training day in all cases. If the test day occurred more than 48 hours after 

the training day, the pregnancy test was repeated on the morning of the test day. This was 

consistent with section 2.3.12 of the approved protocol. No pregnant or nursing female 

subjects participated in the study.

Mitigation of Hazards

As described in the approved protocol and completed study, there were five types of 

hazards associated with the study, including: adverse reaction to the test substances; 

exposure to biting mosquitoes; exposure to mosquito-vectored diseases; general risks of 

being in the field; and unanticipated loss of confidentiality. Pages 17 – 20 of the completed 

study describes the precautions taken to mitigate those hazards. Some examples of these 

precautions are included in this memo and are consistent with the protocol approved in 

advance of the study. 

No subjects with known allergies to mosquito bites were allowed to participate as a 

test subject. Subjects received specific training on how to remove mosquitoes from their 

skin before they could be bitten. In addition, test subjects only exposed one forearm for 

mosquitoes to land. For untreated control subjects who were at greater risk of being bitten, 

when they received five lands within the 5-minute exposure (the minimum necessary to 

ensure adequate mosquito landing rate), they covered their exposed limbs by rolling down 

their sleeve.

In the U.S., mosquitoes can transmit various disease-causing organisms to humans,

notably the West Nile virus. All subjects were instructed as to what symptoms of these 

diseases may look like, so they could seek informed medical care in the very unlikely event 

they contracted any of these diseases and became symptomatic. To reduce the risk of 

contracting any mosquito-borne diseases, the study was conducted in areas where the 

presence of mosquito-borne disease had not been detected by county or state health staff or 

mosquito abatement district staff within one month prior to the test date. The Study 

Director continually monitored for emerging reports of mosquito borne diseases in the area 

of the test locations prior to the test date and within two weeks following the test date. The 
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Study Director consulted the USGS, CDC and State Health Department websites to 

monitor reported mosquito borne disease in areas for the county where the test location 

resided. Study staff provided food and non-alcoholic beverages on site, and encouraged 

subjects to drink regularly to keep hydrated. A tent enclosure was provided to keep subjects 

away from mosquitoes between test exposure periods and shade was also provided to 

protect them from direct sun. In addition, ample seating was provided to subjects 

participating in testing. (For the information of the HSRB, the protocol did not explicitly 

state that seating would be provided to subjects. However, the seating was a positive 

difference which provided some comfort to subjects and it was implied in protocol section 

10.5.2.6 which states that “test subjects will be instructed and reminded on how to properly 

sit and stand during study to not lean on or rest against the treated skin.” Furthermore, the 

approved inclusion/exclusion criteria referenced, in part, that a subject should be able to 

“sit in a chair for long periods, with breaks for limb stretching and movement at reasonable 

intervals, able to stand continuously for five minutes...”. In the future, EPA will suggest 

that such information be included in the section on mitigating risk if discomfort from 

testing will likely occur and the study sponsor offers a solution as S.C. Johnson did in each 

of their mosquito repellent studies.)

Staff were cognizant of the types of wildlife they may find in the areas where 

testing was conducted, and moved subjects away from areas where they found potentially 

harmful organisms, such as fire ants and wasps. Staff also encouraged subjects to perform 

frequent tick checks to remove any acquired ticks before they had opportunity to bite. No 

reports of any tick activity occurred during the test. Subjects were told that if anyone 

experienced any skin reaction, experienced an injury, or simply felt unwell, he or she was 

to inform study staff right away. Such subjects would immediately be given appropriate 

care, and could withdraw from testing. As of December 10, 2015, S.C. Johnson had not 

received any reports of adverse reactions after the test.

Subjects were advised on several occasions that they could withdraw from the study 

for any reason, without penalty. However, if they chose to withdraw early due to a nonhealth related reason, they would only be paid for the hours in which they have 

participated. Page 19 of this study notes that, “In Wisconsin, one control subject withdrew 

from the test after the fifth exposure interval (4.5 hours post treatment) feeling ill. In 

Florida, one test subject withdrew from the test prior to treatment of test subjects and an 

alternate was substituted.” S.C. Johnson will amend the latter statement in the report to 

clarify that one test subject withdrew on training day. Regarding the subject who felt ill, 

S.C. Johnson provided the following additional information. The test subject contacted the 

study director after the test day regarding other testing. When the study director asked 

about his ailments on the test day, “the test subject commented that he just felt ill and that 

he had helped a friend do work the night before until late and that he was probably over 

tired. He took some aspirin and went to sleep and felt better afterward.”

Follow-up Action by EPA

S.C. Johnson adhered to the protocol with regard to the subject who felt ill. In 

future draft protocols, EPA will ensure that the protocol indicates that if a subject 
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feels ill and withdraws from a study, the study sponsor will contact the subject the 

next day to determine his/her health status.

Confidentiality

The identity of each subject was protected in the following ways consistent with the 

approved protocol:

• Each subject was assigned a code number;

• Only subjects' code numbers appear on data sheets and in the reports;

• Study records were maintained in locked cabinets and electronic files kept on a 

password-protected computer server; and

• No one outside of the study sponsor, study staff, the recruitment firm, the IRB, or 

certain governmental agencies (such as U.S. EPA) will have access to subjects' 

personal information.

Compensation

Subjects were paid $60 for participating in an approximately 3-4 hour training 

session conducted prior to the field testing. Test subjects that chose to withdraw or were 

asked to withdraw from the training session were still paid $60 for attending all or part of 

the training session. For each field test day, subjects were paid $15 per hour for the test 

day. If a test day exceeded 8 hours, subjects were paid $18 for each additional hour beyond

the first 8 hours, rounded up to the nearest hour. Test subjects who chose to withdraw or 

were asked to withdraw on the test day were still paid for the hours they participated. All 

subjects were paid for the hours in which they participated, from the time they arrived on 

site until the time they departed. The alternates, if they were not needed on the test day to 

replace an absent or withdrawn test subject, were paid $50.

Protocol Amendments

There was no amendments to the protocol. 

Protocol Deviations 

Appendix B to the study documents six protocol deviations on pages 112-117 (of 

154). EPA identified follow-up actions associated with deviations 1, 4 and 6.

Deviation 1

Section 2.2.3 of the protocol called for the recruitment firm to make initial contact 

with the potential subjects. A male subject who was used in the study was not 

initially contacted by the recruitment firm. He was referred to the Study Director by 

another test subject used in the study. The male recruit was treated the same as if 

he were recruited via by the recruitment agency. The subject was interviewed via 

telephone, and completed the consent form and required pre-test training. The late 
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addition of the male subject allowed for the appropriate number of male to female 

test subjects.

Follow-up Action by EPA

It’s reasonable to expect that subjects might be referred by other test subjects who 

participate in studies. For that reason, in future draft protocols for repellent studies, 

EPA should address this in the recruitment or other appropriate section.

Deviation 4

Page 115 of the completed study describes deviation 4 as follows:

“Test Substance Application Rate Data Sheets:

a. Subject 207: The measurement for the upper left arm is 28.5 cm, and 

subsequent calculated dose was 0.83g. The measured value from original 

raw data sheet looks like 23.5 cm and not 28.5. Using this value (23.5) in 

the dose calculation, the target dose amount would have calculated out to be 

0.78g.

b. Subject 219: The measurement for the lower arm is 16 cm. and subsequent 

calculated dose was 1.05g. The measured value from original raw data sheet 

is 18 cm. Using this value (18) in the dose calculation, the target dose 

amount would have calculated out to be 1.07g.”

Follow-up Action by EPA

OPP scientists confirmed that the incorrect dose would not have affected the health 

and safety of the subjects. However, EPA will follow-up with the study sponsor to 

reiterate the importance of ensuring that correct arm measurements are clearly and 

accurately documented in future studies so that correct doses are calculated and 

administered to subjects. EPA will ask the study sponsor to identify safeguards that 

can be put in place to address this. 

Deviation 6

Page 117 of the study describes deviation 6 as follows:

“Section 10.6.6 called for the first exposure to be 3 hours post treatment for DEET 

formulas with an active ingredient amount of 16.0% and above. There was only a 2 hour 

post treatment delay before the first exposure for this study.” Subsequent to their study

submittal to EPA, S.C. Johnson corrected their section on “impact on the study/results” to 

read: “There was no negative impact on the results of the study by having two extra data 

collections added to the start of the exposures.” 
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Follow-up Action by EPA

The subjects were exposed to mosquitos during two extra data collections. This did 

not negatively impact the subjects’ health or safety. However, for future studies, 

EPA will request that the study sponsor ensure adherence to the appropriate start 

time for first exposures consistent with the protocol.

The deviations listed in the report did not negatively affect participants’ rights or 

their health or safety. However, EPA has identified follow-up actions in response to each 

deviation. S.C. Johnson adhered to the IRB instructions and protocol regarding 

documentation of deviations. As stated in section 13 of the protocol, “The amendments, 

deviations, as well as any adverse events will be documented in the Study Director's final 

report. Documentation will include a description of the change, the reason for the change 

and the effect of the change on the conduct and outcome of the study.”

Regulatory and Statutory Standards 

The following provisions of 40 CFR 26 Subpart Q, as amended, define the 

applicable ethical standards, which read in pertinent part: 

§26.1703: Except as provided in §26.1706, EPA must not rely on data from 

any research subject to this subpart involving intentional exposure of any 

human subject who is a pregnant woman (and therefore her fetus), a nursing 

woman, or a child. 

§26.1705: Except as provided in §26.1706, EPA must not rely on data from 

any research subject to this section unless EPA determines that the research 

was conducted in substantial compliance with all applicable provisions of 

subparts A through L of this part. 

In addition, §12(a)(2)(P) of the Federal Insecticide, Fungicide and Rodenticide Act 

(FIFRA) applies. This passage reads: 

In general, [i]t shall be unlawful for any person . . . to use any pesticide in 

tests on human beings unless such human beings (i) are fully informed of 

the nature and purposes of the test and of any physical and mental health 

consequences which are reasonably foreseeable therefrom, and (ii) freely 

volunteer to participate in the test. 

Findings 

Prior HSRB and EPA Review

Because this study was initiated after April 7, 2006, prior submission of the 

protocol and supporting materials to EPA was required by 40 CFR §26.1125. The 

requirements of 40 CFR §26.1125 for prior submission of the protocol to EPA and of 
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§26.1606 for HSRB review of the protocol were satisfied. The study protocol was 

approved by the SAIRB prior to submittal to EPA. The HSRB discussed the protocol at its 

April 22-23, 2014 meeting, and concurred with EPA’s assessment that the protocol, if 

revised as suggested by the Agency and the HSRB, would meet the applicable 

requirements of 40 CFR part 26, subparts K and L. 

Responsiveness to HSRB and EPA reviews

EPA’s and the HSRB’s ethics comments on the protocol were addressed before the 

research was conducted. Please see Attachment 3 for details. 

Prohibition of research involving intentional exposure of pregnant or nursing 

women or of children 

All enrolled subjects were at least 18 years old and there were no pregnant or 

nursing female subjects. The prohibition in 40 CFR §26.1703 of research involving 

intentional exposure of pregnant or nursing women or of children under age 18 was 

satisfied. 

Substantial compliance with 40 CFR 26 subparts A through L 

40 CFR §26.1705 requires that EPA not rely on data from any research subject to 

this section unless EPA determines that the research was conducted in substantial 

compliance with all applicable provisions of subparts A through L of this part. Within this 

range, only subparts K and L are directly applicable to the conduct of third-party research

such as this. The study documents substantial compliance with subparts K and L. 

Compliance with 40 CFR 26 subpart M 

As documented in Attachment 1 to this review, the central requirements of 40 CFR 

26 subpart M, §26.1303 to document the ethical conduct of the research were satisfactorily 

addressed. 

Compliance with FIFRA §12(a)(2)(P) 

The requirement of FIFRA §12(a)(2)(P) that human subjects of research be “fully 

informed of the nature and purposes of the test and of any physical and mental health 

consequences reasonably foreseeable therefrom,” and “freely volunteer to participate in the 

test,” was met for this study. 

EPA Conclusion 

The study entitled, “Field Testing of S.C. Johnson Personal Mosquito Repellent 

Products to Support their Use of the EPA Repellency Awareness Graphic” for test 

substance MARK-8 describes research conducted in substantial compliance with the 

applicable requirements of 40 CFR 26, subparts K and L. The conduct of the study met all 
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applicable ethical standards for the protection of human subjects of research, and 

requirements for documentation of ethical conduct of the research were satisfied. 

With regard to lessons learned, in future draft protocols, EPA will ensure that the 

protocol indicates that if a subject feels ill and withdraws from a study, the study sponsor 

will contact the subject the next day to determine his/her health status. Also, it’s 

reasonable to expect that subjects might be referred by other test subjects who participate in 

studies. For that reason, in future draft protocols for repellent studies, EPA should address 

this possibility in the recruitment or other appropriate section. EPA will also follow-up 

with the study sponsor to reiterate the importance of ensuring that correct measurements of 

forearms are clearly and accurately documented in future studies so that correct doses are 

calculated and administered to subjects. EPA will ask the study sponsor to identify 

safeguards that can be put in place to address this in future studies. Finally, for future 

studies, EPA will request that the study sponsor ensure adherence to the appropriate start 

time for first exposures consistent with the protocol.

If this study is determined to be scientifically valid and relevant, there is no 

regulatory barrier to EPA reliance on it in actions under FIFRA or §408 of FFDCA. 

Attachment 1: §26.1303 Completeness Checklist

Attachment 2: Tables 6 and 7 from Completed Study

Attachment 3: Responsiveness to EPA and HSRB Ethics Comments on Draft Protocol
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Attachment 1

§ 26.1303 Checklist for Completeness of Reports of Human Research Submitted for EPA Review

Any person who submits to EPA data derived from human research covered by this subpart shall provide at the time of submission 

information concerning the ethical conduct of such research. To the extent available to the submitter and not previously provided to 

EPA, such information should include:

Requirement Y/N Comments/Page References

(a) Copies of all of the records relevant to the research specified by §26.1115(a) to be prepared and maintained by an IRB

§1115(a)(1): Copies of 

• all research proposals reviewed, 

• scientific evaluations, if any, that accompany the proposals, 

• approved sample consent documents, 

• progress reports submitted by investigators, and reports of injuries to 

subjects.

Y

n/a

Y

n/a

The IRB-approved protocol and 

consent form were previously 

reviewed and commented on by 

the Human Studies Review Board 

(HSRB).

§1115(a)(2): Minutes of IRB meetings which shall be in sufficient detail to show 

• attendance at the meetings; 

• actions taken by the IRB; 

• the vote on these actions including the number of members voting

for, against, and abstaining; 

• the basis for requiring changes in or disapproving research; 

• a written summary of the discussion of controverted issues and their 

resolution.

Y

Minutes were previously provided 

to EPA and HSRB members when 

the protocol was submitted for 

review. Minutes for IRB meetings 

on 2/3/15 and 7/7/15 are provided 

in Volume 2- IRB Correspondence 

for Completed Research 

Submissions of Field Testing of 

S.C. Johnson Personal Mosquito 

Repellent Products to Support 

Their Use of the EPA Repellency 

Awareness Graphic, D. Hollas, 

Sept. 28, 2015, 398 pages.

§1115(a)(3): Records of continuing review (CR) activities. n/a According to the SAIRB, the CR 

will occur in February 2016.

§1115(a)(4): Copies of all correspondence between the IRB and the 

investigators. Y

WIRB correspondence provided in 

a separate file to the HSRB.

Please see Volume 2 –IRB 

Correspondence for Completed 

Research Submissions of Field 

Testing of S.C. Johnson (SCJ) 

Personal Mosquito Repellent 

Products to Support Their Use of 

the EPA Repellency Awareness 

Graphic, D. Hollas, Sept. 28, 

2015, 398 pages. Note that this

Volume 2 was submitted along 

with the completed study for Test 

Substance MARK-2, GLP study 

864E1. However, Volume 2 

applies to all SCJ studies which 

followed protocol no. 90017040.

Relevant pages in Volume 2: 5, 

102-105, 117-121, 124-137, 161-

180, 373-398.

§1115(a)(5): 

• A list of IRB members identified by name; earned degrees; 

representative capacity; indications of experience such as board 

certifications, licenses, etc., sufficient to describe each member’s chief 

anticipated contributions to IRB deliberations; 

• any employment or other relationship between each member and the 

institution

Y

Y

Previously provided to HSRB 

members with the protocol. 

Updated information was included 

in a separate file provided to 

HSRB members with the 

completed study. See Volume 2 

(with title identified in cell above).

Please see pages 373-374.

§1115(a)(6): Written procedures for the IRB in the same detail as described in § 

26.1108(a) and § 26.1108(b). Y Previously provided to EPA.

§1115(a)(7): Statements of significant new findings provided to subjects, as 

required by § 26.1116(b)(5).

n/a
Page 15 of 25

Requirement Y/N Comments/Page References

(b) Copies of all of the records relevant to the information identified in 

§26.1125(a)-(f)

§1125(a)

A discussion of:

(1) The potential risks to human subjects; Y

Discussed in consent form and 

section 2.8 of revised protocol. 

Please note that the revised 

protocol is attached to and 

submitted with each completed 

study.

(2) The measures proposed to minimize risks to the human subjects; Y Discussed in consent form and 

section 2.8 of revised protocol.

(3): The nature and magnitude of all expected benefits of such research, 

and to whom they would accrue; Y Discussed in consent form and section 2.9 of revised protocol.

(4) Alternative means of obtaining information comparable to what would 

be collected through the proposed research; and Y

Discussed in consent form and 

section 2.1 of revised protocol

discusses rationale for human 

subjects.

(5) The balance of risks and benefits of the proposed research. Y Discussed in revised protocol 

including section 2.9.

§1125(b): All information for subjects and written informed consent agreements 

as originally provided to the IRB, and as approved by the IRB. Y Provided in separate file to EPA and HSRB.

§1125(c): Information about how subjects will be recruited, including any 

advertisements proposed to be used. Y Section 2 of revised protocol.

§1125(d): A description of the circumstances and methods proposed for 

presenting information to potential human subjects for the purpose of obtaining 

their informed consent.

Y Revised consent form, and section 

2.4 of revised protocol.

§1125(e): All correspondence between the IRB and the investigators or 

sponsors.

Y

Separate file provided to HSRB 

with requests sent to IRB and 

responses.

§1125(f): Official notification to the sponsor or investigator, in accordance with 

the requirements of this subpart, that research involving human subjects has 

been reviewed and approved by an IRB.

Y See Volume 2 provided to HSRB.

(c) Copies of sample records used to document informed consent as specified by 

§26.1117, but not identifying any subjects of the research Y Revised consent form approved by IRB was provided to HSRB.

(d) If any of the information listed in paragraphs (a) through (c) of this section is not 

provided, the person shall describe the efforts made to obtain the information. n/a
Page 16 of 25

Attachment 2 – Table 6 –Subject Recruitment Summary (as of 9/18/15)

Number of subjects initially contacted by recruitment firms 6950

Number of subjects interviewed by recruitment firms 392

Number of subjects screened by SCJ study staff 170

Table 7 Summary of Test Participation in GLP Study 873E1

At EPA’s request, S.C. Johnson provided an updated Table 7 including the state-specific information and any corrections to total 

figures. New information is provided in red type.

GLP 873E1 - 4822-167 Wisconsin Florida Total

Number of Subjects Enrolled 22 35 57

Number of No-Shows to training 

and/or testing

No-shows for training: 2

No-shows for testing: 0

No-shows for training: 18

No-shows for testing: 0 20

Number Assigned as Test Subjects 12 12 24

Number Assigned as Alternates or 

Extras

4 alternates

4 extras

4 alternates

0 extras

12

(Note to HSRB: In the study, the table 

cited 11.)

Number of Test Subjects 

Withdrawn Voluntarily

1 on test day

(post-treatment) 1 on training day

 2

** (Note to HSRB: In the study, the 

table cited 1 as a typo. However, it 

should be 2, 1 on training day and 1 

post-treatment on test day.)

Number of Test Subjects 

Withdrawn Involuntarily 0 0 0

Number of Test Subjects 

Completed Research 11 12

23 **

(Note to HSRB: In the study, the table 

cited 24**.) 

In Wisconsin: 12 test subjects (10 

treated and 2 controls) and 4 

alternates were randomly selected 

as described in the report out of 

the pool of 20 trained participants.

In Florida: Only 16 trained participants 

were available on this test day. 12 test 

subjects (10 treated and 2 controls) and 

4 alternates were selected as described 

in the report out of the pool of 16

trained participants.
Page 17 of 25

**post-treatment withdrawal was previously considered as 'completing research' instead of 'withdrawn'

Notes for HSRB: 

Table 6

The numbers listed in Table 6 in each of the ethics and science review memos are accurate for each of the studies.

S.C. Johnson highlighted for EPA that there were 3 additional test subjects recruited between 9/10 and 9/15, so the studies with test 

days of 9/15 and later had a slightly larger pool than those studies whose test dates were 9/10 and before.

Test Subject who Withdrew Voluntarily

As discussed on page 19 of the study, one test subject withdrew 4.5 hours post treatment. S.C. Johnson provided additional 

explanation regarding this as follows: “This test subject did contact the study director after the test day regarding other testing. The 

study director did ask about his ailments on the test day. The test subject commented that he just felt ill and that he had helped a friend 

do work the night before until late and that he was probably over tired. He took some aspirin and went to sleep and felt better 

afterward.”

Table 7

Table 7 includes a reference to “number assigned as alternates or extras.” 

At EPA’s request, S.C. Johnson provided the following explanation of “extras.” 

“’Extras’ was the term we used for individuals who attended training but were not randomly selected as a treated subject, 

untreated control, or alternate. If we had more than 16 people complete training, there would be extra individuals not needed

for the test. The extras would have signed the consent form and would have been paid for their attendance at the training 

session, the same as all other participants attending training. Extras were not requested to show up on test day.”

Error on page 19 of MARK-8 Study that’s corrected in Table 7
Page 18 of 25

Also, there is a statement on page 19 of the report that “In Florida, one test subject withdrew from the test prior to treatment of test 

subjects and an alternate was substituted.”

S.C. Johnson noted that this was a “transcription error.” The test had four alternates and all were female. The participant in question 

withdrew from training before being assigned as a treatment, control, or Alternate subject. S.C. Johnson will amend the report to state 

that in Florida one test subject withdrew on training day. This is noted in table 7.
Page 19 of 25

Attachment 3 – S.C. Johnson Mosquito Repellent Completed Studies -

Responsiveness to EPA and HSRB Ethics Comments on Draft Protocol 

Comment from EPA and/or HSRB Action taken by Study Sponsor

1. Please revise the benefits section of the 

Informed Consent Form as follows: “You 

will not personally benefit from this study, 

other than the financial compensation.” The 

proposed payment to subjects is considered 

compensation for lost time and 

inconvenience, not a benefit of participating 

in the research. This study provides no 

direct benefits to subjects. 

The study sponsor addressed this comment and 

deleted the requested language on page 9 of the 

IRB-approved final consent form (dated July 

10, 2015). 

(Volume 2 to the study for test substance 

MARK-2 provides the IRB correspondence 

that impacts all of the completed studies based 

on the same protocol. The final consent form 

can be found in Volume 2, on pages 84-94 of 

398. Volume 2 is entitled IRB Correspondence 

for Completed Research Submissions of Field 

Testing of S.C. Johnson (SCJ) Personal 

Mosquito Repellent Products to Support Their 

Use of the EPA Repellency Awareness 

Graphic, D. Hollas, Sept. 28, 2015, 398 pages.) 

2. Johnson should inquire with the recruiting 

firm about the demographics of the 

volunteer pool from which subjects will be 

recruited, and provide additional details in 

the protocol to support the statement that 

the pool of subjects will be demographically 

and ethnically representative of the 

population in the area where the field 

testing will be conducted. The pool of 

subjects should also be representative of the 

overall population of concern, which is 

repellent users in the United States.

The study sponsor addressed this comment in 

the expanded section 2.2.3 of the protocol 

which includes additional details. 

3. The protocol excludes Johnson employees 

from becoming subjects. Please amend the 

protocol and consent form to also exclude 

immediate family members of Johnson 

employees. 

As requested, the study sponsor excluded 

family members on page 3 of the final IRBapproved consent form (dated July 10, 2015).

4. Johnson should consider whether additional 

stopping rules should be added to the 

protocol. Examples of conditions which 

The study sponsor expanded the language in 

protocol section 11.2.6 to address this 

comment. The sponsor added the following 
Page 20 of 25

may be appropriate to trigger a stop to the 

research (either for an individual participant 

or for the whole study) include: mosquito 

landing rate falls below threshold needed to 

challenge test material, wind speeds exceed 

a certain level, subject asks to withdraw, 

subject exhibits hypersensitivity to insect 

bites, subject exhibits sensitivity to the test 

material, medical management is invoked. 

The first two examples would apply to the 

entire study; the other examples would 

apply to an individual subject. 

language: “If the test subjects asks to 

withdraw, if any adverse reactions or 

sensitivity such as redness, edema, itching, or 

pain to the test substance are observed or 

reported, subjects exhibit hypersensitivity to 

insect bites and/or any medical management is 

needed, the test subject will be removed from 

the test immediately.”

5. The protocol and consent form must explain 

how compensation will be handled if a 

potential subject participates in the consent 

meeting, the training meeting, and/or the 

pregnancy testing, but then ultimately 

decides not to participate in the research.

The study sponsor addressed this comment. In 

section 2.2.6 of the protocol, the sponsor added 

the following language: “Test subjects that 

choose to withdraw or asked to withdraw from 

the training session will still be paid $60.00 for 

attending all or part of the training session.” In 

section 2.2.7 of the protocol, the sponsor 

added, “Test subjects that choose to withdraw 

or are asked to withdraw from the study on the 

test day will still be paid for the hours which 

they participated on that test day (however, this 

will not affect payment for any previous test

days in which the subject may have already 

participated).” The same topics were 

addressed in the compensation section in the 

final consent form. Finally, these topics were 

also addressed in sections 12.2.5 and 12.2.6 of 

the final study.

6. The protocol and consent form should be 

revised to include details about whether 

subjects will be transported by the 

researchers to and from the testing site. If 

the testing site is remote, and if Johnson 

intends to transport the subjects to the 

testing site, then Johnson should make 

arrangements to transport any subjects who 

withdraw back to the starting location

within a short period of time after that 

subject indicates his or her desire to 

withdraw. If Johnson cannot make such 

arrangements, then a subject who withdraws 

should be paid for all of the time spent at 

the study site, even if he or she has chosen 

The final consent form was updated to state: 

“You must have a reliable form of 

transportation to get to and from the test and 

training locations. You are responsible for 

your own transportation to the [and] from the 

training and test site locations.”

Section 2.3.4 of the final protocol was 

expanded to state, “Subjects are responsible for 

their own transportation to and from the 

training and test site locations.” 
Page 21 of 25

to withdraw early. Not compensating a 

subject for this type of time and 

inconvenience could unduly influence him 

or her to continue participating. 

7. The protocol provides that the entire 

consent document will be read aloud to 

potential subjects during the consent 

meeting. Given that the ability to read 

English is a requirement to participate, 

Johnson should offer subjects the option of 

reading the consent form themselves. If 

Johnson wishes to confirm understanding of 

the consent form, Johnson should draft 

several questions to be asked of each 

potential subject prior to them signing the 

consent form, and those questions should be 

included in the revised materials that are 

reviewed by SAIRB before the study is 

initiated.

The study sponsor revised section 2.4.1 of the 

protocol to include the new language 

underlined below: “Prior to participating in any 

aspect of the test, each potential subject who 

has expressed interest in participating in the 

study and has met the inclusion/exclusion 

criteria will meet with the Study Director or 

Principle Investigator at the scheduled training 

session. At this session, the subjects will be 

provided with copies of the Informed Consent 

Document and will then be asked to read the 

entire document.” 

In addition to the revision to section 2.4.1 

noted above, section 2.4.2 was also revised to 

state ”After the potential subjects have 

completed reading the consent, The Study 

Director or Principle Investigator will ask the 

subjects if they have any questions regarding the 

information in the consent form, the study and 

their role in the study. Any questions will be 

answered.” 

In addition, the screening document was 

revised to make it clear that the subjects could 

request a copy of the consent document in 

advance for their review. S.C. Johnson 

confirmed that, since most of the test subjects 

asked for a copy of the consent document at 

this point, their practice was to send the 

consent form via email to all eligible test 

subjects. 

Given the changes above, it was determined 

that additional questions to confirm 

understanding of the informed consent 

document were not necessary; all test subjects 

could read and speak English, all test subjects

were given ample time and opportunity to read 

the consent form and ask questions about it, 

and study staff asked each test subject if they 
Page 22 of 25

had any questions about the consent document. 

Any questions were answered.

8.

The protocol should discuss whether the 

number of repeat tests per person should be 

limited. There should be some plan to 

follow-up with subjects after their 

participation in the study has ended to check 

for any delayed consequences of study 

participation. This could consist of a phone 

call to check on health status. 

The protocol did not limit the number of repeat 

tests per person. S.C. Johnson provided the 

following explanations: 

a. All products which are subject to 

this protocol are registered by EPA 

and have been previously evaluated 

for safety. 

b. There were and are no anticipated 

hazards from repeated use.

c. Since the protocol dictated that a 

minimum of two full calendar days 

would occur between treatments, it 

was not expected that residual 

active ingredient would be present 

in a later study.

d. The protocol called for exposure to 

be controlled by exposing the test 

subjects to no more than the typical 

use rate. 

e. Exposure was further minimized 

by instructing each participant to 

wash their treated limb at the 

conclusion of the study.

f. Test subjects were monitored 

during the study, so if an adverse 

reaction was noted, they could be 

removed from the study and avoid

subsequent exposure.

As of December 10, 2015, S.C. Johnson had 

not received any reports of adverse reactions 

after the test.

The study sponsor expanded protocol section 

11.2.4 to state, “The Study Director and 

recruitment firm will keep on file the phone 

numbers and addresses for each study 

participant as a means to contact them if 

needed.” This statement follows the preexisting language that, “Subjects will be 

informed both verbally and in writing of any 

significant new findings, such as detection of 
Page 23 of 25

mosquito borne disease in the area or product 

contamination, discovered during the course of 

the testing which may influence their continued 

participation.” 

Section 11.2.8 was expanded to state, “Study 

staff will monitor and contact test participants 

if any mosquito borne disease cases are 

reported in the test area within two weeks 

following the test date.” 

Language was already included in protocol 

section 11.2.9 and in the consent form 

providing a 24 hour contact number that test 

subjects could use for any research-related 

issues or concerns.

Follow-up was deemed necessary only if S.C. 

Johnson came into possession of new 

information about which the test subjects 

should be notified consistent with the protocol. 

On the topic of following up with subjects, 

prior to S.C. Johnson finalizing the protocol, 

OPP told S.C. Johnson that the expanded 

information described above was sufficient.

9.

The protocol team should provide a process 

to contact subjects in the unlikely event that 

new information is developed or discovered 

as a result of the study, for example, if 

mosquitoes were discovered with vectorborne disease or if a contaminated product

was identified. 

The study sponsor expanded protocol section 

11.2.4 to state, “The Study Director and 

recruitment firm will keep on file the phone 

numbers and addresses for each study 

participant as a means to contact them if 

needed.” This statement follows the preexisting language that, “Subjects will be 

informed both verbally and in writing of any 

significant new findings, such as detection of 

mosquito borne disease in the area or product 

contamination, discovered during the course of

the testing which may influence their continued 

participation.” 

Section 11.2.8 was expanded to state, “Study 

staff will monitor and contact test participants 

if any mosquito borne disease cases are 

reported in the test area within two weeks 

following the test date.” 
Page 24 of 25

Protocol section 2.8.2.5 was also expanded to 

further reduce the risk of contracting any 

mosquito-borne disease and include the 

following language: “The study director will 

consult USGS, CDC and State health 

department websites that provide data on 

occurrences of mosquito borne disease by state 

and by county in each state. The study director 

will contact local State Health Departments to 

inquire about cases of mosquito borne disease 

if information cannot be found on the website 

and will contact Mosquito Control Districts to 

inquire about cases of mosquito borne disease 

if available in the county of the test location. 

In the event that testing occurs outside of the 

U.S., similar resources for determining the 

presence of mosquito borne disease, such as 

the Queensland health Website, will be 

consulted prior to any international testing.”

10. The protocol team should provide a 

justification, in the protocol or IRB 

documents, for excluding non-English 

speakers, especially at the Florida site 

where Spanish-speakers are a significant 

proportion of the population; or if no 

justification for exclusion is provided, the 

protocol should be amended to include 

Spanish speakers. In order to assess the 

representativeness of the study population, 

the protocol team should provide to EPA 

general information on population 

demographics of subject pool at each site, 

and some information about recruitment 

strategies. This is particularly important if 

alternate sites located outside of the U.S. are 

used. 

The revised protocol addressed this comment. 

The original section 2.2.3 of the protocol did 

not provide details on the demographic targets. 

The revised section 2.2.3 provides details on 

the demographic targets. 

With regard to the requested justification 

language, the protocol was revised to state: 

“This pool will generally represent the 

demographics of US repellent users. Current 

repellent product labels are in English, so to 

target users familiar with and that understand 

the product labels, we will be recruiting 

English speaking subjects. This research does 

not offer benefits to the subjects, so limiting 

recruitment to English speakers does not result 

in equity-of-access issues. In addition, the 

language that someone speaks does not directly 

affect attractiveness to mosquitos. SCJ will 

target recruiting a minimum of 10% bilingual 

(English and another language) to help not 

restrict recruitment to only English speakers.” 

After this language, the revised protocol 

includes 2015 Neilson data related to U.S. 

repellent users.
Page 25 of 25

11. The Board discussed two additional aspects 

of the study that could benefit from 

clarification. The Board expressed concern 

regarding the statement in the consent 

document that care and compensation for 

injury would be handled similar to a 

workers compensation claim. It was not 

clear if this was an appropriate mechanism 

for care and compensation in a research 

study. The consent form states “This study 

is considered confidential.” The Board 

questioned whether this is intended to refer 

to data collected on individual subjects or 

whether the details of the study should not 

be disclosed or discussed with others.

In the consent form, the study sponsor deleted 

the worker compensation claim language that 

concerned the HSRB and revised the 

applicable section to read as follows: 

“Compensation for Injury: In the unlikely 

event that you are injured as a result of your 

participation in this study, medical care will be 

made immediately available. The sponsor will 

reimburse you for the costs of this care. If you

believe you may have suffered any physical or 

mental side effects as a result of your 

participation, please contact the Study 

Investigator using the phone number on page 1 

of this document. All adverse effects will be 

followed until resolution is reached. There are 

no plans to provide other compensation beyond 

that which is listed in this informed consent 

document. You will not lose any of your legal 

rights or release the Sponsor, the study doctor, 

the study staff, or study site from liability for 

mistakes or intentional misconduct by signing 

this consent document.”

Regarding confidentiality, the study sponsor 

clarified the consent form in response to the 

comment. The sentence in question stated that, 

“This study is considered confidential.” After 

this sentence, the study sponsor clarified that 

“The details of the study should not be 

discussed or disclosed with others not involved 

with the study. All data collected on individual 

subjects is also confidential.” (This is included 

on page 93 of 398 in Volume 2.)