Engaging Patients in Colon Cancer Screening Decisions During COVID-19
Phase: NA
Conditions: Colon Cancer
Sponsor: Massachusetts General Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Karen Sepucha, PhD 
 
PROTOCOL TITLE
Promoting informed decisions about rescheduling colonoscopies delayed due 
to COVID-19 (PRIMED-2): randomized controlled trial 
 
FUNDING 
Patient Centered Outcomes Research Institute (PCORI) 
 
 
VERSION DATE 
January 6, 2021 
 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
Due to COVID-19 there has been a sharp reduction in the number of colonoscopies since Feb 2020. This 
is predicted to lead to delayed diagnosis in more than 18,000 patients across the US.i Recovery efforts 
are underway to plan for resuming these non essential health care services. However, if patients are not 
willing or able to come back to get routine cancer screening, then these testing delays may have a 
significant impact on cancer mortality rates. There is very limited data examining patients’ attitudes and 
concerns about seeking cancer screening in this environment. The aims of this study are to:  
 
Aim 1: Assess anxiety, COVID risk tolerance, cancer worry, willingness to screen, barriers to 
colonoscopy, and preference for alternative colon cancer screening options for patients aged 45-75 who 
had their screening or surveillance colonoscopy delayed due to the pandemic.   
 
Aim 2: Examine effectiveness of using a shared decision making approach with patients on the 
waitlist to decide about rescheduling their colonoscopy. We will randomly assign patients to receive 
SDM tools or usual care. We will test hypotheses that compared to the control group, patients in 
intervention arm will (a) report higher shared decision making; (b) have stronger intention to follow 
through with colon cancer screening (whether colonoscopy, stool-based test or other approach); and (c) 
have less decisional conflict.  
 
Aim 3: Follow all patients on the waitlist and examine wait times and completed colonoscopies to 
determine whether these differ by patient characteristics, including gender, age, race and ethnicity, 
adjusting for cancer risk.  
 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
COVID-19 has changed the health care landscape in profound ways in a few short months. Entire 
hospitals and practices have been refocused to screen for and treat patients with COVID-19. Routine 
visits, screening tests and elective procedures have been postponed. As the initial surge of patients with 
COVID-19 recedes, routine care will not simply be able to return to normal. One pressing issue is the 
large and growing backlog of screening tests and elective procedures at many hospitals. Nationally, data 
suggest that colonoscopies have dropped 90% since February.ii  At Massachusetts General Hospital 
(MGH) alone, the Gastroenterology (GI) department estimates that about 8,000 colonoscopies have 
been postponed, more than 5,000 of these are routine screening colonoscopies. Recovery planning 
programs have been delayed further because of the shortage of PPE and because GI nursing staff have 
been redeployed to COVID care duties. The department anticipates 2-3 months to ramp up to about 
66% of prior volume but does not anticipate getting back to 100% in the next year due to new 
requirements for infection control that will increase turnover time. To further complicate matters, 
public health officials warn that multiple waves of infection may occur over the next 12-18 months, and 
each may cause additional restrictions on capacity, increasing backlogs even more. Managing demand 
with reduced capacity while planning for additional shutdowns represents a key new challenge for 
health care systems delivering care during this crisis. Further, even if there is capacity, many patients 
may feel differently about the value of seeking healthcare, including cancer screening, during the crisis. 
A recent poll showed that the majority of patients are unlikely to visit a hospital (62%) or specialist 
(64%), regardless of whether they live in a COVID hotspot.iii There are many challenges to resuming 
healthcare during this crisis, and important research questions about how to do this in a safe, equitable 
and patient-centered manner. Some key questions include: How should patients be prioritized for 
routine screening procedures like colonoscopy? What role should patients’ preferences play in the 
prioritization process? What do health systems need to do to ensure patients are comfortable accessing 
needed care? How can systems do this without furthering disparities or disadvantaging vulnerable 
populations?    
 
The PI and co-investigators have an existing PCORI-funded project, the PRIMED study, that is examining 
the impact of training primary care physicians in shared decision making (SDM) on colorectal cancer 
screening decisions for patients aged 76-85. A PRIMED advisor, Dr. Richter, is on the task force to 
determine policies for resuming GI services at MGH and will serve as co-investigator on this study.  
Together with our stakeholders (including our patient partners and the Colon Cancer Alliance), we have 
designed two descriptive studies and a randomized controlled trial to examine whether shared decision 
making will improve colon cancer screening decisions for patients aged 45-75 who have had their 
colonoscopy delayed due to COVID-19. The findings will not only have direct implications for managing 
the backlog of colonoscopies, but will also help inform policies for other screening tests and elective 
procedures. 
 
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Across all of the aims, we anticipate enrolling 645 participants study-wide. (Aim 1, n=195 patients 
completing a survey; Aim 2, n=450 patients completing a survey in the study).  
 
For Aim 1 we will conduct a cross-sectional survey study targeting patients aged 45-75 who had their 
screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. We will survey 
a random subsample of these patients. Table 1 includes information on eligibility for the patient sample. 
We anticipate inviting 300 patients and estimate receiving 195 completed surveys.   
 
Eligible patients will be sent a survey packet in the mail that will include a cover letter signed by the GI 
Director of Quality and Safety inviting their participation, an information sheet describing the study, an 
incentive ($10), and the survey. The cover letter will include information for participants to opt-out if 
they desire. Patients will be asked to complete the survey and return it back to study staff. Consent is 
implied with return of the survey. 
 
For Aim 2, we will conduct a randomized controlled trial that will enroll patients who have to reschedule 
colonoscopies. We will randomly assign about 900 patients who are on the waitlist to either 
intervention or control arm. The intervention arm will receive a shared decision making worksheet that 
will cover (a) presenting pros and cons of three screening options (first available colonoscopy (wait time 
estimated to be ~6 months), stool-based test (with consideration that if positive, a follow-up 
colonoscopy may still be delayed ~3 months), and delay colonoscopy one year); (b) contact information 
for rescheduling their colonoscopy; and (c) contact information to connect with staff if they have 
questions or need more information. GI clinicians will be recruited and complete an online SDM training 
prior to their visit with patients who have more questions and request a GI visit. The control group will 
receive the standard department guidance and policies on scheduling. We will invite patients to 
complete a survey to track SDM, decisional conflict, overall anxiety and cancer worry, preference for 
colonoscopy, concerns about accessing health care and we will also track any testing received within 6 
months. We estimate sending a survey to about 700 patients across both arms and receiving 450 
completed surveys.  
 
For Aim 3, we will follow all MGH patients who had their screening or surveillance colonoscopy delayed 
for 12 months and will document receipt of colonoscopy or other colon cancer screening test, and if 
they got a colonoscopy, will calculate the wait time for colonoscopy for all of the patients on the waitlist. 
We will track demographic information, age, gender, race and ethnicity, primary language, zip code. We 
estimate that there are about 5,000 patients who have had their colonoscopy delayed that will be 
followed in this chart review portion of the study.        
 
 
Table 1: Eligibility for patient participants  
 
Eligible 
Ineligible 
 • 
Adults, age 45-75  
• 
Had screening or surveillance 
colonoscopy delayed due to COVID-19 
• 
Either due for first screening 
colonoscopy or a routine screening or 
surveillance colonoscopy for low to 
moderate risk patients (as indicated by 
3-10 year recommended follow up 
frequency on prior test) 
• 
Diagnostic colonoscopy 
• 
High risk for colorectal cancer as indicated 
by 1 year follow up schedule 
• 
Prior history of colon cancer 
• 
Unable to read or write in English or 
Spanish (Aim 1 and 2 only) 
• 
Have not already rescheduled or 
completed their colonoscopy 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
Working closely with co-investigators and staff in GI department, study staff will create a master waitlist 
of patients who had a previously scheduled colonoscopy postponed, who had a referral for a 
colonoscopy that has not been processed, and/or who should have been contacted by the GI 
department to schedule a colonoscopy but were not due to COVID-19 restrictions. Study staff will 
confirm that they meet the eligibility criteria as outlined in Table 1. Study staff will also use RDPR and 
Epic to confirm eligibility if needed.   
 
For the patient surveyed in both the cross-sectional study and the randomized trial, study staff will send 
each subject a packet that includes a cover letter signed by the Director of Quality and Safety for the 
department inviting their participation and providing information to opt-out of the study, an 
information sheet describing the study, an incentive ($10), and the survey. Patients will also be given 
option to complete the survey via RedCap. Patients will indicate consent by returning the survey. Survey 
responses will be entered into RedCap and analyzed by the study team. On the survey, patients will be 
able to indicate if they are interested in participating in an optional short interview to follow-up on their 
survey responses. Staff will contact a selected subset of patients who agreed to set up the short 
interview.  
 
The research staff will track the number of participants screened, reason for ineligibility, the number 
sent invitation by mail, the number who opted out or otherwise declined participation and any reasons 
given for the refusal to participate. Limited information collected during the eligibility screening process 
will be kept for non-responders to examine non response bias.  
 
All study staff are Collaborative Institutional Training Initiative (CITI) certified and will receive training 
from the PI and program manager in the study protocol. We will hold regular meetings to review 
screening, enrollment and completion data, to discuss protocol and standard operating procedures, and 
to identify and mitigate any issues that arise.    
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
No tests or treatments will be administered as part of this study.  
For Aim 2, the standard of care is that patients may call the GI scheduling group to reschedule their 
colonoscopy or GI schedulers may reach out to patients to reschedule a cancelled or postponed 
procedure. In the intervention arm, patients may still call the GI scheduling group to reschedule their 
colonoscopy or GI schedulers may reach out to patients. In addition, patients will receive information 
about their options. The materials will direct patients who are interested in colonoscopy to call the GI 
scheduling group. Patients who are unsure or who would like to learn about other options will be 

Partners Human Subjects Research Application Form 
  
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Version Date:  October 15, 2014 
 
  
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offered the opportunity to talk with staff from Health Decision Sciences Center who will then connect 
patients with the participating GI clinicians to obtain stool-based tests or to discuss other concerns.  
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
There are minimal risks to participating individuals associated with or attributable to this study. The 
main risks are associated with loss of privacy of their health information. To minimize risks, all electronic 
data files that include patient identifiers will be kept in a Partners protected server and only members of 
the research team will have access to the files. Files with PHI will only be accessed from Partners 
computers or encrypted laptops that are protected with SafeBoot. To ensure confidentiality, all paper 
surveys will be identified by study code number only and kept in a locked file cabinet. All paper surveys 
will be scanned and electronic files will be stored on password protected Partners server. Study papers 
(e.g. eligibility screeners, surveys) that have been scanned or entered into a database will be disposed of 
in the confidential shredder. To address issues of psychological discomfort, research assistants will 
inform patients that they may refuse to answer any question and may withdraw from the study at any 
time. To address privacy and confidentiality issues, analytic database with outcomes data will not 
contain any identifying information and will be coded by unique study ID number only. 
 
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
Although there are no written informed consent forms, Drs. Simmons and Sepucha are responsible for 
assuring that patient participants are adequately informed prior to engaging in any research procedures, 
that all subjects meet eligibility criteria, and that the study is conducted according to the IRB-approved 
research plan.  
 
There are no formal stopping rules for this minimal risk study.  
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
There are minimal risks to individuals participating in this project. The main risks are the time and effort 
involved in participating (for patients estimated to be about 20 minutes for survey and about 30 minutes 
for the optional short follow-up interview) and the potential loss of privacy.  
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 

Partners Human Subjects Research Application Form 
  
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treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
There are no direct benefits to patients from completing the surveys. The potential benefit to society is 
that the study will help inform policies for how to incorporate patient’s preferences into prioritization 
process for resuming procedures and services once it is safe to do so.      
 
Shared decision making (SDM) has been shown to increase patient knowledge, reduce decisional conflict 
and improve the match between patients’ preferences and their choices. Those patients randomized to 
the intervention arm may benefit as having knowledge of other screening options may help them get 
the care that they prefer.  
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
The patient recruitment is limited to men and women 45 to 75 years of age as clinical guidelines 
recommend this age group to get routine colorectal cancer screening. We will target patients whose 
colonoscopy has been postponed or delayed due to COVID-19. Routine colon cancer screening is not 
recommended for adults younger than 45 or those older than 75.   
 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
Patient survey materials will be available in English and Spanish. Most patients seen by MGH GI speak 
either English or Spanish (>97%). 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Non-English-Speaking-Subjects.pdf 
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 

Partners Human Subjects Research Application Form 
  
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participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
 
Patient recruitment, Aim 1:  
• 
Study staff will work with the GI department to identify patients whose colonoscopy has been 
delayed due to COVID-19 and meet the eligibility criteria in Table 1.  
• 
Staff will randomly select 300 eligible patients from the wait list to invite into the cross-sectional 
survey study. Study staff will also use RDPR and Epic to confirm eligibility if needed.  
• 
The research coordinator will send a survey packet that includes: a cover letter signed by the GI 
Director of Quality and Safety inviting their participation, an information sheet describing the 
study, an incentive ($10), and the survey. The cover letter will have information for participants 
who wish to opt out of the survey. Patients will be given the option to complete the survey by 
RedCap and a link will be included in the cover letter. Patient consent for the study will be 
implied by return of the completed survey.  
• 
Staff will make up to three reminder phone calls. Study staff will send all non responders, who 
did not opt out, one reminder paper survey packet about four weeks after the initial packet. 
Study staff will then make up to 3 additional reminder calls to non-responders.   
• 
All participants who complete a survey will receive a thank you note. 
 
Clinician recruitment, Aim 2: 
• 
The department chair will send out an email notifying clinicians about the study and may share 
study information at regular faculty meetings.  
• 
Dr. Richter will follow up on the Chief’s communication and will reach out individually to 
clinicians via email and/or during regular meetings to describe the study and invite clinicians to 
join. The email will contain an information sheet for clinicians.  
• 
Clinicians will indicate consent by sending an email to Dr. Simmons and/or Sepucha indicating 
their interest to join the study.   
• 
Interested clinicians will complete a ~1 hour online shared decision making training session with 
study investigators and send availability for ~1 hour per week they may be available to meet 
with study participants who request a GI visit via the intervention. 
• 
All clinician participants will complete a short phone debrief after the intervention is complete 
and receive a thank you email. 
 
Patient recruitment, Aim 2:  
• 
Study staff will work with the GI department to identify patients whose colonoscopy has been 
delayed due to COVID-19 and meet the eligibility criteria in Table 1.  
• 
Study statistician will randomly assign patients on the waiting list to either the intervention or 
control group. Patients in the intervention group will receive information in the mail that 
describes available options for colon cancer screening and directions on who to call depending 
on patients’ preference for screening. The usual care group will not receive the information.  
• 
About 6-8 weeks after the mailing, the research coordinator will send a survey packet that 
includes: a cover letter signed by the Director of Quality and Safety for the department inviting 
their participation, an information sheet describing the study, an incentive ($10), and the 
survey. The cover letter will have information for participants who wish to opt out of the survey. 
Patients will be given the option to complete the survey by RedCap and a link will be included in 
the cover letter. Patient consent for the study will be implied by return of the completed survey.  

Partners Human Subjects Research Application Form 
  
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Version Date:  October 15, 2014 
 
  
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• 
Staff will make up to three reminder phone calls. Study staff will send all non responders, who 
did not opt-out, one reminder paper survey packet about four weeks after the initial packet. 
Study staff will then make up to 3 additional reminder calls to non-responders.  
• 
All participants who complete a survey will receive a thank you note. 
 
All study staff are CITI certified and will receive training from the PI and program manager in the study 
protocol. We will hold regular meetings to review screening, enrollment and completion data.    
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
Patients will receive $10 with the initial survey packet. Patients who participate in the optional short 
interview will receive $20. Clinicians will receive $50 gift card for each completed survey and $50 gift 
card for completing the intervention. A Partners Corporate Card will be used to purchase the gift 
cards. 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Recruitment-Of-Research-Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Guidelines-for-Advertisements.pdf 
 
          Remuneration for Research Subjects
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-Research/Remuneration-for-
Research-Subjects.pdf 
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
There are no formal written consent procedures in this project for patients or clinicians. The research 
presents no more than minimal risk of harm to subjects and involves no procedures for which written 
consent is normally required. 
 
Eligible patient participants will be sent a cover letter signed by the Director of Quality and Safety for the 
GI department inviting them to participate in the survey and an information sheet that describes the 
risks and benefits of the study. Consent will be implied by the return of the completed survey. 

Partners Human Subjects Research Application Form 
  
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The principal investigator’s and study staff’s names and contact information will be available on the 
cover letter, information sheet and survey if participants have any questions or concerns about the 
study. The study staff will be available by phone or email to discuss the study and answer any questions.  
 
Study materials will emphasize that whether or not patients participate will have no effect on the health 
care they receive. 
 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Partners policy: 
     Informed Consent of Research Subjects:
     https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Informed-Consent-of-Research-Subjects.pdf
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
Study staff will protect the privacy of research study participants as described in the Privacy and 
Confidentiality section. It is possible that participants may be upset by a question in the survey, and 
survey instructions will emphasize that subjects may skip any question they do not wish to answer. 
Study staff will review completed surveys weekly and if any complaints or concerns are raised, will flag 
those and send to the PI and clinician co-investigators to address.    
 
Study data will be accessible at all times for the PIs to review. The project manager and PIs will examine 
study conduct including enrollment, accrual, drop-outs, and protocol deviations on a weekly or every 
other week basis with the staff at each site. Study staff will review study related data including reminder 
phone calls to participants, participant surveys and will notify the PI about any serious or moderate 
potential adverse events (AEs) immediately and any minor or potential ones at regular meetings. No 
SAEs are expected based on the minimal risk trial. However, the co-investigators will review potentially 

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serious adverse events (SAEs), as soon as they are discovered. The PIs will ensure all protocol deviations, 
AEs, and SAEs are reported to the IRB within required time frame based on severity, and will file an HRC 
AE Form within 10 working days as needed. 
 
The study is minimal risk and the DSMP is commensurate with the potential risk level. There are no 
formal stopping rules for this minimal risk study. 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
No serious adverse events are expected. The name and contact information for the principal investigator 
will be included on study information sheet as well as contact for study staff and Partners IRB in case 
participants have a problem. We will have a clinical co-investigator for each topic who will be able to 
consult on any clinical issues that arise during the course of the interviews or surveys. However, if a 
serious adverse event occurs relating to the study, then the principal investigator will report the event 
to the IRB within 24 hours and will file an HRC Adverse Event Form within 10 working days. If a mild or 
moderate adverse event occurs, the principal investigator will summarize the event in the progress 
report at continuing review. 
 
Study staff will be instructed to review surveys within a week of receipt and to notify the PI about any 
potentially serious events immediately and all other events at regularly scheduled meetings. Study staff 
will keep records of any feedback, questions, concerns and/or complaints that are received and we will 
address them with the co-investigators and staff as needed. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The study staff and the principal investigator will have routine meetings during the study period to 
ensure the project proceeds as intended per the protocol. All participant screening and enrollment will 
be tracked on password protected servers using an Access or RedCap database. The information is 

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stored behind a firewall and only study staff will have access to it as needed. We will track recruitment 
rates and response rates weekly and identify issues as they come up. The study staff will complete all 
required documents for the study binder and this will be reviewed quarterly by the project manager and 
one of the principal investigators. 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
         https://www.partners.org/Assets/Documents/Medical-Research/Clinical-Research/DSMP-in-
Human-Subjects-Research.pdf 
 
          Reporting Unanticipated Problems (including Adverse Events)
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Reporting-Unanticipated-Problems-including-Adverse-Events.pdf
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
 
Special efforts will be made to protect the privacy of subjects. We will have names and addresses of 
eligible participants and this information will be kept separate from the study data (e.g. survey 
responses). All patient participants will receive a code number and the surveys will only be identified by 
code number. A separate password-protected electronic file will contain the codes linked to identifying 
information. Only the study staff and investigators will have access to this file. These will be kept as long 
as required by the research project. After the study has been completed the personal contact 
information of all eligible participants will be destroyed.   
 
The last page of the patient surveys for Aim 1 and Aim 2 will ask patients if they are interested in being 
recontacted to participate in future research studies with the MGH HDSC study team. Responses from 
these questions, whether from the paper survey, or from the online survey, will be kept in a separate 
database from survey responses.  
 
All files (e.g. eligibility screeners) that contain PHI will be kept in a locked file cabinet or in a secure 
offsite file storage location or on a password protected Partners shared drive.  
 
Patient confidentiality will be maintained as is routine for all patient care privacy guidelines. All research 
staff are CITI certified and will be trained on the importance of data confidentiality. 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
12 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
To promote research replicability, transparency and future use of the data, de-identified data sets will 
be created and will be available, by request, to outside researchers. After the study results have been 
published, de-identified data sets will also be deposited in an open access service such as, ICPSR 
(https://www.icpsr.umich.edu/icpsrweb/). On ICPSR, individuals must register and agree to ICPSR’s 
Responsible Use statement prior to accessing datasets. Additionally, before a dataset is made available 
for access, ICPSR completes a detailed review of all datasets to assess disclosure risk. If necessary, ICPSR 
modifies data to reduce disclosure risk or limits access to datasets for which modifying the data would 
substantially limit their utility or the risk of disclosure remains high. No information that contains 
identifiers or that could be used to link an individual to the data will be included in the de-identified data 
set.  The information sheets will contain the following language:  After the study is completed, all 
identifiable information will be removed from the data and after removal, the de-identified information 
will be deposited in an open access service to promote use of the data by other researchers.   
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
 
No identifiable data on Partners patients will be stored outside MGH
 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
N/A 
 
 
 
i Institute for Human Data Science. Shifts in healthcare Demand, Delivery and Care During the COVID-19 
Era: Tracking the impact in the United States. 2020 IQVIA. [https://www.iqvia.com/insights/the-iqvia-
institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era ] Accessed 
May 7, 2020. 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
13 
 
ii Institute for Human Data Science. Shifts in healthcare Demand, Delivery and Care During the COVID-19 
Era: Tracking the impact in the United States. 2020 IQVIA. [https://www.iqvia.com/insights/the-iqvia-
institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era ] Accessed 
May 7, 2020. 
 
iii Franki, Richard. Pandemic Effect: All Other Healthcare Visits Can Wait. Medscape. May 5, 2020. 
(Accessed May 10, 2020 https://www.medscape.com/viewarticle/930036).