Impact of a Rapid Test for Gonorrhea and Chlamydia on the Clinical Management of Urethritis and Cervicitis in a Sexual Health Clinic
Phase: NA
Conditions: Urethritis, Cervicitis, Sexually Transmitted Infections
Sponsor: Massachusetts General Hospital

 
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Impact of the binx io diagnostic platform on clinical management of urethritis and 
cervicitis compared with point-of-care gram stain in the MGH Sexual Health Clinic 
 
 
NCT05564299 
 
Document version date March 30, 2024 
 
 
 
 
 

 
 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Ingrid Bassett, MD MPH 
 
Project Title: Impact of the binx io diagnostic platform on clinical management of urethritis 
and cervicitis compared with point-of-care gram stain in the MGH Sexual Health Clinic  
 
Version Date: 
March 30, 2024 
 
 
 
1. 
 Background and Significance 
 
In recent years there has been a steady rise in the incidence of sexually transmitted 
infections (STIs), including chlamydia and gonorrhea, in the United States. New cases 
of chlamydia have increased by 19% between 2015 and 2019, while new cases of 
gonorrhea have increased by 56% in the same time period.1 This growth in new 
infections has occurred despite the availability of highly accurate diagnostic tests and 
effective antimicrobial therapies. The increase in STI rates is particularly concerning in 
light of the association between untreated STIs and HIV transmission and acquisition2,3 
and the impacts of untreated STIs on women’s reproductive health, including risks of 
ectopic pregnancy, tubal factor infertility, pelvic inflammatory disease, and adverse 
obstetric outcomes.4–6 Despite the availability of effective diagnostic tests and therapies, 
optimal management of STIs is limited, in part, by long wait times between testing and 
treatment and the resulting clinical practice of empiric therapy for symptomatic patients.  
 
Decreasing the time between testing and pathogen-directed treatment of gonorrhea and 
chlamydia with the use of point-of-care tests has the potential to decrease under- and 
over-treatment,7 to decrease forward transmission, and consequently to decrease STI 
incidence.8 Point-of-care gram stain has been recommended by the CDC for this reason 
in specialized STI clinics9, however, this procedure has several shortcomings. It can be 
labor intensive to maintain as a diagnostic modality and does not scale well to other 
clinical care settings, such as primary care, urgent care, or emergency departments. 
Importantly, it can only detect evidence of infection with Neisseria gonorrhoeae and 
does not provide any data on the presence or absence of chlamydial infection, which is 
either treated empirically or not treated until confirmatory test results are available. 
 
As rapid, molecular diagnostic tests for gonorrhea and chlamydia are becoming 
available, providing a test result within the time frame of a clinical encounter will become 
increasingly feasible in the near future. Decreasing the time from specimen collection to 
STI test result with point-of-care tests has the potential to avoid inappropriate antibiotic 
treatment, decrease forward STI transmission, and reduce costs.7,10,11 Thus, it is critical 
to understand the potential impact of rapid molecular tests on STI management in 

 
 
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specialized STI clinics, which in turn can inform the implementation of point-of-care 
molecular STI testing in other clinical settings.  
 
The binx io is an FDA-approved desktop polymerase chain reaction (PCR) platform for 
the detection of the etiologic agents of gonorrhea and chlamydia using self-contained 
cartridges. The platform is CLIA certified and can be set up at the point of care (e.g., 
within a clinic) and operated by staff without formal laboratory training. The hands-on 
time of specimen processing is approximately one minute, and qualitative 
(positive/negative/invalid) results for gonorrhea and chlamydia infection are available in 
30 minutes. The platform has demonstrated good sensitivity and specificity for the 
detection of gonorrhea and chlamydia from male urine or female vaginal swab 
specimens.12  
 
The binx io platform has the potential to inform the clinical management of urethritis and 
cervicitis beyond that of the point-of-care gram stain. The sensitivity and specificity of 
the binx io should allow for a similar detection rate of gonococcal urethritis or cervicitis 
as with the point-of-care gram stain. In addition, the binx io can detect the presence of 
chlamydia, which can have a direct impact on the antibiotics administered for immediate 
management of symptomatic urethritis or cervicitis during the clinical encounter. 
Specifically, with a negative chlamydia result on the binx io, patients may be spared 
from the empiric use of antibiotics for chlamydia. Additionally, an in-clinic diagnosis of 
chlamydia would allow patients with an indication for expedited partner therapy (EPT) to 
receive a prescription for partner therapy earlier, decreasing treatment delay among 
their partners. However, the impact of the binx io on management of urethritis and 
cervicitis has not yet been studied in a specialized STI clinic setting. 
 
In addition to its test characteristics, the binx io has additional properties, such as ease 
of use and rapid specimen processing time, that may be advantageous over the point-
of-care gram stain and could ultimately inform CDC recommendations for point-of-care 
diagnostics in specialized sexual health clinic settings. Furthermore, understanding the 
implementation process of the binx io in specialized STI care settings could inform wider 
uptake of similar rapid molecular diagnostic tests in other clinical settings where STIs 
are managed.  
 
 
2. 
Specific Aims and Objectives  
 
Aim 1. To evaluate the impact of the binx io platform, compared to point-of-care 
gram stain, on antibiotic use in the clinical management of patients with 
symptomatic urethritis and cervicitis presenting to the Massachusetts General 
Hospital Sexual Health Clinic (SHC). We will conduct a randomized controlled pilot 
trial comparing the mean number of antibiotic courses administered per patient when 
evaluated with either point of care gram stain (current standard of care in MGH SHC) or 
the binx io platform. Secondary outcomes include concordance of binx io and point-of-
care gram stain results for gonorrhea, concordance of binx io and nucleic acid 
amplification test (NAAT) results for gonorrhea and chlamydia, and time to provision of 

 
 
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Expedited Partner Therapy (EPT) for eligible patients with chlamydia.  
Hypothesis: Clinical management based on the results of the binx io will decrease the 
mean number of antibiotic courses administered per patient by 10%.  
 
Aim 2. To evaluate the implementation of the binx io platform in a specialized 
sexual health clinic using mixed methods. Quantitative analysis will assess process 
measures including rate of invalid results, equipment errors, processing time, and 
patient visit duration. We will conduct a focus group discussion with MGH SHC staff to 
assess impressions of use of the testing platform and other potential uses of point-of-
care testing in the STI management pathway.  
 
 
 
3. 
General Description of Study Design 
 
This study is a pilot randomized controlled trial evaluating the use of either a) the binx io 
or b) point-of-care gram stain (current standard of care) to guide clinical management of 
patients with symptomatic urethritis or cervicitis evaluated in the MGH Sexual Health 
Clinic. Patients presenting with symptoms of urethritis or cervicitis and meeting inclusion 
criteria will be randomized to have diagnostic specimens tested during the clinical 
encounter using either the binx io platform or point-of-care gram stain. Patients 
randomized to the intervention arm of the study will also have a gram stain slide 
created, which will be held for later interpretation following the clinical encounter. 
Participants will not be followed longitudinally. Towards the end of the study, we will 
conduct a focus group discussion with Sexual Health Clinic staff to explore their 
impressions of use of a rapid STI test in the clinic and other potential uses of rapid STI 
testing in STI clinical management.   
 
A detailed study schema is attached. 
 
 
 
4. 
Subject Selection 
 
The study will take place in the Massachusetts General Hospital Sexual Health Clinic 
(SHC), a specialized sexually transmitted infection (STI) clinic operated in partnership 
with the Massachusetts Department of Public Health. The clinic is staffed by nurse 
practitioners and physicians, who see patients for scheduled and urgent care visits.  
 
Potential participants will be identified for recruitment by the Sexual Health Clinic staff 
upon review of the reasons given for scheduled or urgent care appointments for the 
day. Additionally, any patient who reports symptoms of urethritis or cervicitis during the 
clinic encounter, regardless of the reported chief complaint for the visit, will be assessed 
for eligibility by the clinician. Participants will be approached by a research assistant to 
introduce the study and obtain informed consent. Consenting participants will be 

 
 
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randomized to either the intervention or control group using a randomization function in 
RedCap.  
 
Patients presenting to the Sexual Health Clinic will be eligible to participate in the study 
based on the following criteria:  
 
Inclusion criteria  
18 years of age or older; of any gender identity; presenting with symptoms 
of acute (<14 days) urethritis (urethral discharge, dysuria) or cervicitis 
(dyspareunia, intermenstrual or postcoital bleeding, vaginal discharge); 
and willing to provide urine or an additional vaginal swab specimen in 
addition to the routinely collected clinical specimens.  
 
 
Exclusion criteria 
Younger than 18 years old; presenting with symptoms not consistent with 
urethritis or cervicitis; unable or unwilling to provide a urine or vaginal 
swab specimen; known to be pregnant; contact of index patients with 
gonorrhea or chlamydia; known to have been exposed to gonorrhea or 
chlamydia; reporting concurrent symptoms at a non-genital site that are 
felt by the clinician to be concerning for extragenital STI; persons under 
investigation for, suspected of having, or confirmed to have monkeypox 
(this designation will be made by MGH Sexual Health Clinic clinicians; 
persons whose primary language is other than English, Spanish, or 
Portuguese; refusing point-of-care gram stain. 
 
Based on historical data from the Sexual Health Clinic, approximately 270 patients were 
seen for symptoms of urethritis or cervicitis in calendar year 2020. Thus, we anticipate 
that it will take approximately 6 months to enroll 100 participants. We anticipate that the 
demographics of the recruited participants will reflect the demographics of the Sexual 
Health Clinic patient population in terms of gender identity, race, and ethnicity. For 
individuals whose primary language is other than English, Spanish, or Portuguese, 
providing a translated version of the consent form is not practicable. These persons will 
therefore be excluded from this pilot study. 
 
For the focus group discussion, all regular clinical staff (nurse practitioners and nurses) 
of the MGH sexual health clinic who have experience using the binx io instrument 
through the study and provide informed consent will be eligible.  
 
5. 
Subject Enrollment 
 
The study will be introduced to potential participants by a trained research assistant. 
The research assistant will obtain written informed consent in a private space in a clinic 
exam room. For Spanish-speaking or Portuguese-speaking participants, informed 
consent will be obtained with the assistance of either a trained medical interpreter 
through MGH Interpreter services or Sexual Health Clinic providers who are qualified to 
provide care in Spanish or Portuguese. The use of Interpreter Services will be prioritized 
over clinicians from the Sexual Health Clinic. Informed consent will be obtained using 

 
 
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fully translated consent forms and will be documented using the MGB consent process. 
Consent procedures will follow MGB IRB policy on Obtaining and Documenting 
Informed Consent of Subjects who do not Speak English and participants who speak 
Spanish or Portuguese will be provided with translated informed consent documents.  
 
The patient will be provided a copy of the consent form and ample opportunity to ask 
questions. Participants who enroll in the study will be provided a $25 gift card.  
 
For the focus group discussion, sexual health clinic staff will be informed about the 
focus group discussion at a staff meeting. Staff who express interest will be invited to 
the focus group.   
 
6. 
STUDY PROCEDURES 
 
All study procedures will take place during the patient’s index clinic visit. All participants 
will undergo routine evaluation and specimen collection per current clinic protocols. This 
includes a pelvic exam and self-collected or clinician-collected endocervical  swabs for 
female participants; or a genital exam and clinician-collected urethral discharge 
specimen for male participants per standard clinic collection protocols. For participants 
randomized to the intervention arm, either one vaginal swab (female participants) or 
urine sample (male participants) will be collected for testing by the binx platform.  
 
The endocervical and urethral specimens collected for use in this study will be 
processed immediately for point-of-care gram stain and additional specimen plated for 
gonorrhea culture as per current clinic protocols; to be sent to the Massachusetts 
Department of Public Health (DPH). Additional specimens will be sent to the DPH for 
nucleic acid amplification testing (NAAT) for gonorrhea and chlamydia, as per current 
clinic protocols. Participants in both the control and intervention arm of the study will 
have a point-of-care gram stain created, from either vaginal or endocervical swab (for 
female participants) or urethral swab (for male participants). All point-of-care gram 
stains will be performed by staff up to date with proficiency testing as per the MGH point 
of care testing committee. The point-of-care gram stain requires approximately 5-10 
minutes for specimen processing/creation of the gram stained slide and reading of the 
slide. The point-of-care gram stain will be processed and read in the Sexual Health 
Clinic laboratory space on Cox 5 (room #572). Participants in the control arm will be 
administered antibiotic therapy in the clinic based on the results of the point-of-care 
gram stain. Point-of-care gram stain slides for intervention arm participants will be held 
for later interpretation following the clinical encounter. The gram stain slides from 
intervention arm participants each week will be labelled with the participant’s study 
number and read at the end of the week. Results will be recorded in the study record.  
 
For participants randomized to the intervention arm, the aliquot of urine (male 
participants) or the vaginal swab (female participants) will be processed immediately for 
testing on the binx io platform. All point-of-care testing will be conducted in the Sexual 
Health Clinic laboratory space on Cox 5 (room #572). The MGH Point of Care testing 
committee will guide the process of quality control for the binx io platform. 

 
 
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Participants will be administered antibiotic therapy in the clinic based on results of the 
point-of-care gram stain in the control arm and according to the binx io results in the 
intervention arm. A positive gram stain for gonorrhea will be defined using standardized 
clinical criteria, consisting of >4 polymorphonuclear leukocytes (PMNs) per high power 
field for male specimens and >10 PMNs per high power field for female specimens, 
along with the presence of intracellular gram-negative diplococci. Treatment for 
chlamydia, which cannot be detected specifically by the point-of-care gram stain, will be 
administered per routine clinical practice (either treated empirically or deferred pending 
confirmatory testing at the Massachusetts DPH) per the discretion of the clinical 
provider per routine clinical procedures. Results on the binx io are qualitative, indicating 
either the presence or absence (positive or negative result) separately for gonorrhea 
and chlamydia. For participants with positive test results for chlamydia on the binx io 
platform, the participant will be counseled on the availability of Expedited Partner 
Therapy (EPT) as per standard clinical guidelines. The results of binx io testing and 
treatment administered will be recorded in the medical record. For participants who are 
unwilling or unable to wait for the results of the binx io, clinical management will be at 
the discretion of the treating clinician and can involve the interpretation of the prepared 
and stored gram stain if elected by the treating clinician.  
 
Per standard clinic procedures, participants will be contacted by phone with results of 
NAAT gonorrhea and chlamydia testing from MA DPH if these results require additional 
treatment that was not provided during the initial clinic visit. Participant contact and 
treatment will be provided according to standard clinical procedures of the Sexual 
Health Clinic. After one week following the visit, the study team will review the 
participant’s chart to record DPH test results and any resulting additional treatment. 30 
days following the initial visit, the study team will record additional antibiotics prescribed 
for participants with unresolved symptoms.  
  
In addition to specimens collected for immediate clinical use, all participants in both the 
intervention and control groups will be asked to provide an additional vaginal or urethral 
swab for storage. These specimens may be used in future studies of STI diagnostics. 
Any extra unused urine specimens may also be stored for use in future studies of STI 
diagnostic tests. Participants will be asked to consent to the collection and use of these 
additional vaginal, urethral, or urine specimens for future research. These specimens 
may be cultured in an incubator prior to storage in a freezer in the laboratory space on 
Jackson 7. Stored specimen will be labelled with a unique identification number. 
Following the conclusion of this study, each new use of these samples will be submitted 
in a secondary use protocol for MGB IRB approval. Specimen collection is summarized 
in the table below.  
 
 
 
Table 1: Specimen Collection 
 
 
Control Arm 
Intervention Arm 

 
 
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Consented to 
research 
specimen 
collection? 
No 
Yes 
No 
Yes 
Male 
1) 1 or 2 
urethral swabs  
1) 1 or 2 
urethral swabs  
2) Urine 
sample 
1) 1 or 2 
urethral swabs  
2) Urine 
sample 
1) 1 or 2 
urethral swabs  
2) Urine 
sample 
Female 
1) 2 cervical 
swabs 
1) 2 cervical 
swabs  
2) One vaginal 
swab 
1) 2 cervical 
swabs 
2) 1 vaginal 
swab 
1) 2 cervical 
swabs  
2) 2 vaginal 
swabs 
 
 
The focus group discussion will be led by a trained research assistant. All participants 
will be asked to provide written informed consent, including consent for the session to 
be recorded. A focus group guide will be used to moderate the focus group discussion; 
questions will focus on staff impressions of using a rapid PCR test for STI diagnosis in 
the SHC and impressions of other uses of rapid STI testing in the MGH sexual health 
clinic or in other clinical settings. A second member of the study team will be present to 
take notes during the session. The session will be audio recorded; the recording will be 
transcribed following the focus group discussion and the audio recording will be deleted 
or destroyed. All participants of the focus group will remain anonymous, no names or 
identifying information will be included in the audio recording. Informed consent forms 
will be scanned and uploaded to a secure MGB business dropbox folder and paper 
copies will be securely disposed. The focus group discussion transcript will be analyzed 
using content analysis to identify emergent themes.  
 
 
 
7. 
Risks and Discomforts 
 
Physical risks 
The study procedures do not differ significantly from routine clinical practice in the 
Sexual Health Clinic and thus we do not anticipate any substantial risks beyond those 
associated with routine clinical care. We will collect an additional vaginal swab from 
female participants (which will be self-collected or clinician-collected, by participant 
preference), which may result in mild discomfort, although vaginal swab collection is 
generally well-tolerated. There is a theoretical risk that a participant randomized to the 
intervention arm will have a false negative gonorrhea result on the binx io platform that 
would have been detected by the standard of care point-of-care gram stain, however, 
the sensitivity of the binx io platform for gonorrhea is similar to higher than for the point-
of-care gram stain (sensitivity for gonorrhea detection, female specimens: 100%, male 
specimens: 97.3%). Thus, the risk that a participant in the intervention arm would have 
a delayed gonorrhea diagnosis that would have otherwise been detected is very small. 
All participants will have specimens sent to the Massachusetts Department of Public 

 
 
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Health as per standard clinic procedures for additional polymerase chain reaction 
testing for gonorrhea and chlamydia. We do not anticipate any physical risks related to 
the focus group discussion.  
 
Psychosocial risks 
The study does not incorporate additional questionnaires or instruments beyond the 
data already collected during the course of routine clinical evaluation in the Sexual 
Health Clinic, thus we do not anticipate any psychosocial risks related to the study 
procedures. As the focus group discussion will be asking participants about clinical 
pathways in the sexual health clinic and not about their personal health or any other 
sensitive personal information, we do not anticipate psychosocial risks associated with 
participation in the focus group discussion.  
 
Privacy risks  
Conducting all discussions in a private space will minimize social risks during the interactions 
with participants. Privacy risks will be further minimized by handling all research data in a 
confidential and secure manner. Data collected during the course of the study will be entered 
either into the existing Sexual Health Clinic RedCap database or into the medical record (results 
of point of care gram stain and binx io tests). RedCap will be accessed on password-protected 
workstations or an encrypted, password-protected tablet. Informed consent forms will be kept in 
a locked office and stored for 7 years as per MGB IRB requirements. To assure confidentiality, 
each participant will receive a unique identification number. Research data will be labeled only 
with this number.  
The focus group discussion will be conducted anonymously; no identifying information will be 
collected about the participants except for informed consent forms which will be stored securely 
on a MGB business dropbox folder and accessed only from password-protected Partners 
desktop or encrypted laptop computers.  
 
 
8. 
Benefits 
 
Participants in the intervention arm have the potential for direct benefit from this study 
by receiving test results for chlamydia during the clinical encounter and thus access to 
immediate treatment for chlamydia if positive, or avoidance of unnecessary empiric 
treatment for chlamydia if negative. No direct benefit is expected for participants in the 
control arm. The study may benefit society as it will provide data on the utility of a new 
point-of-care test for gonorrhea and chlamydia when used for patients with symptoms of 
sexually transmitted infections in a specialized STI clinic.  
 
Participants in the focus group discussion may benefit by improving understanding of 
effective ways to incorporate rapid testing into specialized STI care, thus potentially 
improving their work experience and ability to care for patients in the future.  
 
 
9. 
Statistical Analysis 
 
Sample size calculation  

 
 
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We hypothesize that the use of the binx io platform will decrease the mean number of 
antibiotic courses per patient by 10%. Based on data from 2020, symptomatic patients 
would receive approximately 1.13 courses of antibiotics per patient. With an alpha of 
0.05, we would have a power >90% to detect a decrease of 10% (to 1.017 per patient) 
with sample size of 100 (50 per arm). 
 
Analysis plan  
The primary outcomes for Aim 1 will be compared between patients randomized to 
clinical management based on the binx io and patients randomized to clinical 
management based on point-of-care gram stain. Demographic and clinical data for both 
cohorts will be obtained from the SHC RedCap database and supplemented with chart 
review as necessary.  
 
Standard descriptive statistics will be used to report primary and secondary clinical 
outcomes, reported as proportions, means with standard deviation, or median with 
interquartile range as appropriate. Unadjusted and adjusted ordinal logistic regression 
models will be used to compare the total antibiotics administered between patients for 
whom the binx io vs point of care gram stain was used for clinical management. 
Adjusted models will incorporate predictors felt clinically to affect likelihood of antibiotic 
administration as well as those found to be significant in unadjusted analyses, including 
gender, age, race/ethnicity, and insurance status.  
 
Transcripts from the focus group discussion will be transcribed, coded, and analyzed for 
key themes deductively and inductively using content analysis.  
 
 
10.   Monitoring and Quality Assurance 
 
Jana Jarolimova, MD MPH and Kevin Ard, MD MPH will be responsible for monitoring 
and reporting any adverse events in collaboration with the MGB IRB. In order to ensure 
patient safety, data and safety monitoring will include PI review of all adverse events, 
enrollment, and protocol deviations recorded by the study staff. Study staff will be 
responsible for reporting unanticipated problems, adverse events, including breach of 
participant confidentiality, and serious adverse events to the Principal Investigator and 
co-investigators. Adverse events are defined as any untoward or unfavorable medical 
occurrence in a human subject, including any abnormal sign (for example, abnormal 
physical exam or laboratory finding), symptom, or disease, temporally associated with 
the subject’s participation in the research, whether or not considered related to the 
subject’s participation in the research. Serious adverse events are considered any 
adverse event that results in death, is life threatening or places the subject at immediate 
risk of death from the event as it occurred, requires or prolongs hospitalization, causes 
persistent or significant disability or incapacity, results in congenital anomalies or birth 
defects, or is another condition which investigators judge to represent significant 
hazards.  
 

 
 
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The Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) report will 
be completed detailing the problem, actions taken, and follow-up steps performed and 
the form will  be submitted to the MGB IRB within 5 working days or 7 calendar days of 
the date the investigator first becomes aware of the problem, consistent with MBG IRB 
policy.. Specifically, the following will be reported writing: 1) all serious adverse events 
associated with the study procedures, and/or 2) any incidents or problems involving the 
conduct of the study or participation, including problems with the recruitment and/or 
consent processes. Any action recommended by the IRB will be undertaken. The 
Principal Investigator and co-investigators will log all adverse events and deviations in a 
REDCap Adverse Events module included within the study REDCap database. 
 
Data monitoring and quality assurance will be done on an ongoing basis. The principal 
investigator and co-investigators will monitor study data every month to ensure the 
completeness of consent forms and other study questionnaires. Data entered into 
databases will be monitored on a routine basis (at least monthly but likely more 
frequently depending on the volume of data) using standard data management 
techniques (e.g., range and validation checks for individual variables; appropriate cross-
checks for two variables in the same form or across forms). Given the design of 
REDCap which has limited data checking capabilities, data checking will primarily be 
done in Stata® using batch procedures that will automatically generate query reports 
which will be provided to the site for resolution. Summaries of these reports will be 
reviewed by Drs. Ard and Jarolimova on a routine basis. 
 
 
11.   Privacy and Confidentiality 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas) 
☒ Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and 
procedures for maintaining appropriate confidentiality of research data and specimens 

 
 
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☒ The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research 
☐ Additional privacy and/or confidentiality protections 
 
 
 
 
 
12.   References 
 
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