Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality
Phase: PHASE1
Conditions: Sleep Onset Insomnia
Sponsor: Brigham and Women's Hospital

Electronic IRB Submission Generated On April 06, 2018
Page 1 of 9
Title: Effect of continuous background noise at specific frequencies on sleep quality and
architecture.
Sponsor Name: Beth Israel Deaconess Medical Center
PI Name: Wellman, David
Protocol #: 2016P000982
Type: Continuing Review 2
Date Received: January 26, 2018
Study Staff
Name
Role
Degree
Organization
Citi Certified
Azarbarzin, Ali
Co-Investigator
Ph.D
BWH > Medicine > Sleep Medicine
2/9/2018
Calianese, Nicole
Intern/Student
BWH > Medicine > Sleep Medicine
1/2/2017
Gerard, Nathan
Intern/Student
BWH > Medicine > Sleep Medicine
1/3/2017
Hess, Lauren
Research
Coordinator/Manager
BS
BWH > Medicine > Sleep Medicine
9/6/2016
Joseph, Callie
Research
Coordinator/Manager
BWH > Other
2/3/2017
Lucey, Elizabeth
Research Assistant
BA
BWH > Other
9/13/2016
Messineo, Ludovico
Co-Investigator
BWH > Medicine > Sleep Medicine
11/17/2016
Oliveira Marques,
Melania
Co-Investigator
MD
BWH > Medicine > Sleep Medicine
5/27/2015
Pomeroy, Hayley
Research Assistant
BWH > Medicine > Rheum, Allergy
and Immuno
6/1/2016
Sands, Scott
Co-Investigator
Ph.D
BWH > Medicine > Sleep Medicine
6/23/2016
Taranto Montemurro,
Luigi
Co-Investigator
MD
BWH > Medicine > Sleep Medicine
1/16/2018
Wellman, David
Principal Investigator MD, Ph.D
BWH > Medicine > Sleep Medicine
11/28/2017
Signatures
PI Name: Wellman, David, A, MD,Ph.D
Authenticated: January 26, 2018
Continuing Review - Intervention / Interaction
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1.  Sponsor / Funding Information
 
Is the research funded at this time?
8 Yes
o
No
Check all current funding sources that apply.
R Government (Federal / State)

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Title: Effect of continuous background noise at specific frequencies on sleep quality and architecture. 
Principal Investigator: David Andrew Wellman, MD, PhD 
 
I. 
BACKGROUND AND SIGNIFICANCE 
It is known from many research studies that human performance declines with insufficient or disrupted 
sleep causing loss of cognitive and behavioral flexibility together with reduction in attention that produces 
errors on the work environment with consequences sometimes severe (1). Moreover it has been shown in 
the past years that sleep disruption may have wide-ranging effects on the cardiovascular, endocrine, 
immune, and nervous systems such as obesity, diabetes and impaired glucose tolerance, hypertension and 
other cardiovascular diseases, anxiety symptoms, depressed mood and alcohol use (2). 
According to the Sleep in America survey from the National Sleep Foundation, two of the top five issues 
associated with disrupted sleep in adults are inside and outside noise (3). Indoor and outdoor noises can 
prevent sleep consolidation by increasing the wake-after-sleep-onset (WASO) time or increasing the 
number of brief arousals (3 to 15 seconds) from sleep. 
 
One possible approach to improve sleep quality in the general population is to reduce the impact of indoor 
and outdoor noise. Stanchina and coworkers (4) recently proved in an Intensive Care Unit setting that 
application of mixed frequency sound noise (62 DB) in patients’ room reduced the numbers of arousals 
from sleep by increasing the acoustic arousal threshold. These authors also showed that the change in 
noise level from baseline is more important than the peak noise level in determining the arousal from 
sleep.  
Another study showed that application of constant noise (40 to 60 DB) during the night could increase 
stable sleep when measured with a technique called cardiopulmonary coupling. This method is designed 
to assess sleep stability using a measure derived from the ECG recording (5).  
 
Although these and others studies showed a possible relationship between exposure to overnight constant 
noise of mixed frequency sounds and sleep quality, no study performed a complete assessment of all the 
sleep variables that determine sleep quality in the clinical setting. 
 
 
II. 
SPECIFIC AIMS 
To determine the effect of mixed frequency sound on subjective and objective sleep quality. 
We hypothesize that the exposure to sound during sleep will improve sleep quality and will reduce sleep 
onset latency.  
 
Specifically, we will test this hypothesis by assessing;  
The effect of exposure to a range of frequencies from 350 to 4000Hz at a pressure level of 40dB on 
subjective sleep quality scores, sleep onset latency, sleep architecture (time spent in rapid eye movement 
(REM) and non-REM (NREM) sleep stage 1, 2, 3), number of arousals from sleep and time of 
wakefulness after sleep onset in a group of healthy subjects. 
 
III. 
SUBJECT SELECTION 
 
We will recruit a group of 20 healthy controls aged 21 to 65 years old. Normal controls will be recruited 
from the community, as well as from our existing database of control subjects, and will be completely 
healthy and thus without medical or sleep problems. 
 

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Exclusion criteria: 
 
Individual affected by insomnia or other sleep-related diseases. 
 
Individual taking any medication known to influence sleep/arousal state 
 
 
Equal number of males and females will be recruited. We will consider all applicants regardless of sex, 
race, color, creed, or national origin. 
 
IV. 
SUBJECT ENROLLMENT 
 
Subjects will be recruited through email, telephone, newspaper, and or bulletin advertisements. Only 
subjects who have stated in the initial clinical questionnaire that they are interested in hearing about 
research studies will be contacted by phone. Should the subject be interested in the study, they can call the 
study physician or coordinator to inquire about study participation. We will also recruit from our existing 
database of research participants. 
 
Subjects who respond will be given a thorough review of the risks, discomforts, potential benefits to the 
study and their expected involvement using a prepared script approved by our Institutional Review Board. 
Subjects will be given a copy of the informed consent and allowed a minimum of 24 hours to review the 
information and make a decision on study participation. During this time, the subject will have the 
opportunity to discuss the research with his/her primary care physician or clinician. The study 
investigators will be available to answer any questions should any arise. Informed consent will be 
obtained from all subjects by the principal investigator or a co-investigator prior to commencement of any 
study procedures. Subjects will be informed that they may withdraw from the study at any point, with no 
impact on their ongoing care.  
 
 
 
Inclusion and exclusion criteria will be carefully assessed prior to enrollment. Assuming subjects meet the 
inclusion criteria, they will begin the protocol by scheduling their overnight studies in the 
clinical/physiology laboratories. Subjects will be informed that they may withdraw from the study at any 
point, with no impact on their ongoing care. We have not previously had difficulty enrolling participants 
into similar studies performed in our laboratory. 
 
 
V. 
STUDY PROCEDURES 
 
Protocol:  
The protocol will be composed by 2 overnight sleep studies (a night with no noise and a night with 
background noise) to be conducted at Brigham and Women’s Hospital. The 2 nights will be performed 
approximately one week apart in random order. Sleep will be scored by an expert sleep technologist 
blinded to the randomization order. Pittsburgh Sleep Quality Index questionnaire will be administered to 
all study participants before sleep on the first study night. Stanford Sleepiness Scale score and a 
subjective sleep quality score will be obtained from every subject after each study night. 
 
Measurements and equipment:  
Subjects will be instrumented with standard polysomnography (PSG) recording sensors. Sleep stage and 
arousals will be measured with electrodes pasted on to the scalp, face, chin and chest (EEG, EOG, EKG, 
chin EMG). Paste-on EMG electrodes will be placed over the anterior tibialis muscle to detect leg 

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movements. Respiratory effort belts will be placed around the chest and abdomen to measure breathing 
movements. Oxygen saturation will be measured continuously with a pulse oximetry probe placed on 
either the fingertip or earlobe. Snoring will be detected with a small microphone positioned over the 
suprasternal notch. Body position will be recorded with a sensor taped to the thoracic belt. Each of these 
devices is standard for diagnostic PSG and should not be uncomfortable.  
 
The mixed frequencies noise background will be delivered by four speakers included in two wall mount 
modules powered by A/C and will include a range of frequencies from 350 to 4000Hz at a pressure level 
of 40dB (Nightingale, Cambridge Sound Management). The system will be activated at “lights off” time 
via computer by a co-investigator or a trained student who will monitor patients and data 
recordings overnight.  
 
Data Analysis: 
Sleep will be scored by an expert sleep technologist blinded to the randomization order following 
American Academy of Sleep Medicine rules. 
If the data collected will be considered insufficient, the subject will be asked to repeat the whole 
study or a part of it without signing a new informed consent form. 
 
 
Reimbursement  
Subjects will receive $100/night for participation in each overnight study (TOTAL = $200). 
Reimbursement for parking expenses will be provided. 
If the subjects will repeat a part or the entire protocol because of insufficient data collection, 
they will be reimbursed $100 for any extra night. 
 
 
 
VI. 
BIOSTATISTICAL ANALYSIS 
In this protocol we want to collect pilot data to measure the possible size effect of this 
intervention. Variables of interest will be compared using a Student T-test with p<0.05 
considered as statistically significant. 
 
 
VII. 
RISKS AND DISCOMFORTS 
 
We believe that the risks associated with participation in this study are minimal. All study 
procedures have been conducted in our laboratory without serious incident. Anticipated risks and 
discomforts are listed below: 
 
1. The equipment used for assessing sleep (paste on electrodes) is standard and poses no risk. 
The electrodes may be mildly uncomfortable and could cause some sleep interruption. Thus 
subjects may feel somewhat tired the day following this study. 
 
2. The background noise could cause sleep disruption and mild discomfort at wake-to-sleep 
transition. In case the subject will not tolerate the noise we will reduce the intensity or stop 
the noisy signal.  

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VIII. 
POTENTIAL BENEFITS 
 
Although it is unlikely that there will be any direct physical benefit to the subjects from participating in 
this study, we will make known to each subject, if requested, some of the information we have gathered 
from this physiologic testing. This study provides a unique opportunity to gain insight into the specific 
mechanisms by which continuous background noise may improve sleep quality. The results may, in the 
future, lead to improved strategies for the treatment of insomnia. However, if previously unknown 
abnormalities of sleep are encountered, this information will be passed onto the subject. Results can be 
forwarded to the primary care physician or clinician at the request of the subject. 
 
 
IX. 
MONITORING AND QUALITY ASSURANCE 
 
As this study is a physiological investigation and not clinical trial, a formal Data and Safety Monitoring 
Board will not be implemented. The PI will be responsible for monitoring safety and quality assurance. 
Additionally, the ongoing results, problems, and limitations of the study will be presented on a regular 
basis to the investigators in the Division of Sleep Medicine. Any adverse events will be promptly reported 
to the Human Research Committee for review according to HRC guidelines.  
 
Adequacy of Protection Against Risks 
 
All of our laboratory personnel involved in the research of human subjects have completed the required 
institutional program for education in the protection of human research participants and their 
confidentiality.   The institutional educational program consists of the review of regulatory and 
informational documents pertaining to human-subject research, passing a test demonstrating knowledge 
of the ethical principles and regulations governing human-subject research and signing a statement of 
commitment to the protection of human subjects.   
 
All electronic data will be stored on secure computers under password protection with no access allowed 
to individuals outside of our research team.  All paper data will be stored under lock and key with access 
only given to the study staff.                        
 
Protection Against Risks 
 
We believe that all possible safeguards are in place to minimize the risk.  However, several steps will be 
taken to insure patient comfort and safety.  We will work with our IRB to come up with a safety 
monitoring plan to minimize risk and discomfort.  This will include: 
 
Reporting any complications of our studies immediately to the IRB. 
 
Appoint a safety officer (David Wellman, MD) who will work with our physicians and 
technicians to maximize safety and comfort.  
 
The study coordinator will meet with the safety officer and PI monthly (and as needed) to go over any 
complaints or problems. The safety officer will call the patients with problems directly to verify important 
issues.  If problems are identified, the protocol will be adjusted as needed.  Based on conversations with 
the NIH and the NHLBI policy (http://www.nhlbi.nih.gov/funding/ethics.htm), we will not require a 

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formal data safety monitoring board. However, we do have a thorough data safety monitoring plan 
whereby our safety officer will review all adverse events in order to classify them as serious adverse 
events, minor adverse events, and whether they are anticipated or unanticipated, and study related or 
unrelated as per our IRB rules and the NHLBI policy. The medical monitor will be an academic physician 
with considerable experience in clinical research but not involved in our research program or a co-
investigator in any of our studies.  The medical monitor will strictly adhere to the following definitions: 
 
Definitions 
Definitions are per January 2007 OHRP  Guidance on Reviewing and Reporting Unanticipated Problems 
Involving Risks to Subjects or Others and Adverse Events, OHRP Guidance,  
http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm  
Adverse Event (AE):  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 event (SAE):  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  
 
Is another condition which investigators judge to represent significant hazards 
 
Unanticipated Problem (UP): any incident, experience, or outcome that meets all of the following 
criteria:  
 
unexpected, in terms of nature, severity, or frequency, given the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and the characteristics of the subject population being studied;  
 
related or possibly related to participation in the research, in this guidance document, possibly 
related means there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research;  
 
suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
Adverse Events (FDA) versus Unanticipated Problems (OHRP)  
 
All adverse events are not necessarily unanticipated problems  
 
All unanticipated problems are not necessarily adverse events  
 
Some events may be both 
 
 
 
 
 

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REFERENCES 
 
1. 
Williamson AM, Feyer AM. Moderate sleep deprivation produces impairments in 
cognitive and motor performance equivalent to legally prescribed levels of alcohol intoxication. 
Occup Environ Med. 2000 Oct;57(10):649-55. 
2. 
Institute of Medicine. Committee on Sleep Medicine and Research BoHSP. Extent and 
health consequences of chronic sleep loss and sleep disorders.  Sleep disorders and sleep 
deprivation: and unmet public health problem Washington, D.C.: The National Academies Press; 
2006. p. 55-135. 
3. 
Buxton OM, Chang AM, Spilsbury JC, Bos T, Emsellem H, Knutson KL. Sleep in the 
modern family: protective family routines for child and adolescent sleep. Sleep Health. 2015 
May 1;1(1):15-27. 
4. 
Stanchina ML, Abu-Hijleh M, Chaudhry BK, Carlisle CC, Millman RP. The influence of 
white noise on sleep in subjects exposed to ICU noise. Sleep Med. 2005 Sep;6(5):423-8. 
5. 
Zhou J, Liu D, Li X, Ma J, Zhang J, Fang J. Pink noise: effect on complexity 
synchronization of brain activity and sleep consolidation. J Theor Biol. 2012 Aug 7;306:68-72. 
 
 

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
Page 1 of 9 
 
Subject Identification 
Protocol Title: Effect of continuous background noise at specific frequencies 
on sleep quality and architecture. 
 
Principal Investigator: D. Andrew Wellman, MD 
 
Site Principal Investigator: BWH 
 
Description of Subject Population: Healthy Adults 
 
About this consent form 
 
Please read this form carefully.  It tells you important information about a research study.  A 
member of our research team will also talk to you about taking part in this research study.  
People who agree to take part in research studies are called “subjects.”  This term will be used 
throughout this consent form. 
 
Partners HealthCare System is made up of Partners hospitals, health care providers, and 
researchers.  In the rest of this consent form, we refer to the Partners system simply as 
“Partners.” 
 
If you have any questions about the research or about this form, please ask us.  Taking part in 
this research study is up to you.  If you decide to take part in this research study, you must sign 
this form to show that you want to take part.  We will give you a signed copy of this form to 
keep. 
 
 
Why is this research study being done? 
 
This research study is being done to learn whether the presence of a noise produced at specific 
frequencies can help people sleeping better. 
 
In this research study, you will be exposed to a continuous noise produced by four speakers 
positioned in the wall of the hospital bedroom for the entire night. While the ultimate goal of this 
project is to treat people with insomnia, we are testing in this protocol the effect of background 
noise in healthy subject.  
 
Our hypothesis is that the background noise will improve the quality of your sleep, will reduce 
the time required to fall asleep and the awakenings during the night.   
The side effects of these background noise are listed below under the Risks section.   

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
 
Page 2 of 9 
 
Subject Identification 
 
In this study we will recruit 20 subjects at Brigham and Women’s Hospital (BWH). 
 
Dr. D. Andrew Wellman is paying for this research to be done thanks to philanthropic donations 
to our laboratory. 
 
How long will I take part in this research study? 
 
It will take you two nights to complete this research study.  During this time, we will ask you to 
visit the Harvard Catalyst Clinical Research Center (HCCRC) at BWH.  
On one night you will be exposed to the background noise and on the other night you will sleep 
in the same room without noise. The two overnight sleep studies will take about 12 hours each.  
 
 
 
What will happen in this research study? 
 
If you choose to take part in this study, we will ask you to sign this consent form before we do 
any study procedures.   
 
You will have two research sleep studies, which are explained in detail below.  During one 
study, you will sleep in a room where a noise will be generated from four speakers plugged into 
the wall. The noise will be similar to the one produced by a fan. 
 
You cannot have any alcohol for at least 24 hours before this study visit, as alcohol may affect 
your sleep.  
 
Research overnight sleep study: 
This visit will take about 12 hours. We will ask you to arrive at the HCCRC at about 8:00 pm.   
 
When you arrive we will: 
 Ask you about your medical history 
 Ask you to answer one questionnaire about our sleep quality and about your sleepiness in 
the previous month. 
 Do a physical examination to make sure that you are healthy enough to take part in this 
study 
 Do a urine pregnancy test, if you are a woman who is able to become pregnant. You 
cannot take part in this study if you are pregnant. 
 

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
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Subject Identification 
We will then attach several pieces of equipment to you, which you will wear while you sleep to 
measure your sleep and breathing. We will: 
 Attach electrodes (thin wires) to your scalp, face, chin, and chest to measure your brain 
activity, eye movements, muscle tone (how contracted or tense your muscles are), and 
heartbeat. These electrodes will be attached with paste and/or tape to your body. We will 
also attach electrodes to your legs so we can measure how much your legs move while 
you are sleeping.  
 Put a small probe on your fingertip or earlobe to monitor how much oxygen is in your 
blood. This probe does not puncture your skin and will not hurt.  
 
Once all of this equipment is placed on you and you are comfortable, you will be asked to look in 
several directions, blink, wriggle your feet, and make chewing movements so that we can check 
that all of our equipment is working.   
 
After that, we will turn off the light and let you go to sleep. We will record your breathing and 
sleep until approximately 6:00 am, when we will wake you up and remove all the study 
equipment, electrodes, and sensors.   
 
The investigator will ask you some question about the quality of your sleep and about your level 
of vigilance. We will ask you to stay until you feel rested enough to return home. You should not 
drive your car, especially if you are feeling sleepy. We can help you get public transportation or 
a taxi if you do not have a responsible adult that can drive you home. 
 
 
What are the risks and possible discomforts from being in this research 
study? 
 
Risks of Sleep Study Procedure  
Due to the extent of the equipment we use to monitor you when you sleep, and to the background 
noise, you may not sleep well and may be tired the next day.  
 
You should not drive or take part in other potentially dangerous activities while you are feeling 
sleepy. If you plan to drive, you will have to stay in the laboratory until you have rested enough 
to drive safely.   
 
What are the possible benefits from being in this research study? 
 
You will not benefit from taking part in this study. Others with insomnia may benefit in the 
future from what we learn in this study. We hope that the results of this study will lead to 
improved treatments for insomnia. 

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
 
Page 4 of 9 
 
Subject Identification 
 
 
 
 
Can I still get medical care within Partners if I don’t take part in this 
research study, or if I stop taking part?  
 
Yes.  Your decision won’t change the medical care you get within Partners now or in the future.  
There will be no penalty, and you won’t lose any benefits you receive now or have a right to 
receive. 
 
Taking part in this research study is up to you.  You can decide not to take part.  If you decide to 
take part now, you can change your mind and drop out later.  We will tell you if we learn new 
information that could make you change your mind about taking part in this research study. 
 
 
What should I do if I want to stop taking part in the study? 
 
If you take part in this research study, and want to drop out, you should tell us.  We will make 
sure that you stop the study safely.  We will also talk to you about follow-up care, if needed. 
 
Also, it is possible that we will have to ask you to drop out of the study before you finish it.  If 
this happens, we will tell you why.  We will also help arrange other care for you, if needed. 
 
 
 
Will I be paid to take part in this research study? 
 
You will receive $100 for each overnight visit. We will also pay for parking your car at the 
Brigham and Women’s Hospital during the overnight sleep studies. 
 
 
What will I have to pay for if I take part in this research study? 
 
You will not have to pay anything to participate in this study. 
 
 
What happens if I am injured as a result of taking part in this research 
study?

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
Page 5 of 9 
 
Subject Identification 
 
We will offer you the care needed to treat any injury that directly results from taking part in this 
research study.  We reserve the right to bill your insurance company or other third parties, if 
appropriate, for the care you get for the injury.  We will try to have these costs paid for, but you 
may be responsible for some of them.  For example, if the care is billed to your insurer, you will 
be responsible for payment of any deductibles and co-payments required by your insurer. 
 
Injuries sometimes happen in research even when no one is at fault.  There are no plans to pay 
you or give you other compensation for an injury, should one occur.  However, you are not 
giving up any of your legal rights by signing this form. 
 
If you think you have been injured or have experienced a medical problem as a result of taking 
part in this research study, tell the person in charge of this study as soon as possible.  The 
researcher's name and phone number are listed in the next section of this consent form. 
 
 
If I have questions or concerns about this research study, whom can I 
call? 
 
You can call us with your questions or concerns.  Our telephone numbers are listed below.  Ask 
questions as often as you want.  
 
Andrew Wellman, MD, PhD is the person in charge of this research study.  You can call him/her 
at 508-982-7401 Monday-Friday 9am-5pm.  You can also call Luigi Taranto-Montemurro at 
617-732-6541 Monday-Friday 9am-5pm or 617-407-8645 24/7 with questions about this 
research study. 
 
If you have questions about the scheduling of appointments or study visits, call  Lauren Hess at 
617-732-8976.
 
If you want to speak with someone not directly involved in this research study, please contact 
the Partners Human Research Committee office.  You can call them at 617-424-4100. 
 
You can talk to them about: 
 Your rights as a research subject 
 Your concerns about the research 
 A complaint about the research 
 
Also, if you feel pressured to take part in this research study, or to continue with it, they want to 
know and can help. 
 

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
 
Page 6 of 9 
 
Subject Identification 
 
If I take part in this research study, how will you protect my privacy? 
 
During this research, identifiable information about your health will be collected.  In the rest of 
this section, we refer to this information simply as “health information.”  In general, under 
federal law, health information is private.  However, there are exceptions to this rule, and you 
should know who may be able to see, use, and share your health information for research and 
why they may need to do so.    
 
In this study, we may collect health information about you from: 
 Past, present, and future medical records 
 Research procedures, including research office visits, tests, interviews, and 
questionnaires 
 
Who may see, use, and share your identifiable health information and why they may 
need to do so: 
 Partners research staff involved in this study 
 The sponsor(s) of this study, and the people or groups it hires to help perform this 
research 
 Other researchers and medical centers that are part of this study and their ethics boards 
 A group that oversees the data (study information) and safety of this research 
 Non-research staff within Partners who need this information to do their jobs (such as for 
treatment, payment (billing), or health care operations) 
 The Partners ethics board that oversees the research and the Partners research quality 
improvement programs. 
 People from organizations that provide independent accreditation and oversight of 
hospitals and research 
 People or groups that we hire to do work for us, such as data storage companies, insurers, 
and lawyers 
 Federal and state agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health, and other US or foreign 
government bodies that oversee or review research)  
 Public health and safety authorities (for example, if we learn information that could mean 
harm to you or others, we may need to report this, as required by law) 
 Other:        
 
Some people or groups who get your health information might not have to follow the same 
privacy rules that we follow and might use or share your health information without your 

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
 
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Subject Identification 
permission in ways that are not described in this form.  For example, we understand that the 
sponsor of this study may use your health information to perform additional research on various 
products or conditions, to obtain regulatory approval of its products, to propose new products, 
and to oversee and improve its products’ performance.  We share your health information only 
when we must, and we ask anyone who receives it from us to take measures to protect your 
privacy.  The sponsor has agreed that it will not contact you without your permission and will not 
use or share your information for any mailing or marketing list.  However, once your information 
is shared outside Partners, we cannot control all the ways that others use or share it and cannot 
promise that it will remain private. 
 
Because research is an ongoing process, we cannot give you an exact date when we will either 
destroy or stop using or sharing your health information. 
 
The results of this research study may be published in a medical book or journal, or used to teach 
others.  However, your name or other identifying information will not be used for these purposes 
without your specific permission. 
 
Your Privacy Rights 
 
You have the right not to sign this form that allows us to use and share your health information 
for research; however, if you don’t sign it, you can’t take part in this research study.    
 
You have the right to withdraw your permission for us to use or share your health information 
for this research study.  If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing.  Once permission is withdrawn, you cannot continue to 
take part in the study. 
 
If you withdraw your permission, we will not be able to take back information that has already 
been used or shared with others. 
 
You have the right to see and get a copy of your health information that is used or shared for 
treatment or for payment.  To ask for this information, please contact the person in charge of this 
research study.  You may only get such information after the research is finished.  
 
 
Informed Consent and Authorization 
 
Statement of Person Giving Informed Consent and Authorization 
 
 I have read this consent form. 

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
 
Page 8 of 9 
 
Subject Identification 
 This research study has been explained to me, including risks and possible benefits (if 
any), other possible treatments or procedures, and other important things about the study. 
 I have had the opportunity to ask questions. 
 I understand the information given to me. 
 
Signature of Subject: 
 
I give my consent to take part in this research study and agree to allow my health information to 
be used and shared as described above. 
 
 
 
 
 
 
 
 
Subject 
Date 
Time (optional) 
 
 
Signature of Study Doctor or Person Obtaining Consent: 
 
Statement of Study Doctor or Person Obtaining Consent 
 
 I have explained the research to the study subject. 
 I have answered all questions about this research study to the best of my ability. 
 
 
 
 
 
 
 
 
Study Doctor or Person Obtaining Consent 
Date 
Time (optional) 
 
Consent of Non-English Speaking Subjects Using the “Short Form” in the 
Subject’s Spoken Language 
 
 
Statement of Hospital Medical Interpreter 
 
As someone who understands both English and the language spoken by the subject, I interpreted, 
in the subject's language, the researcher's presentation of the English consent form.  The subject 
was given the opportunity to ask questions. 
 
 
 
 
 
 
 
 
Hospital Medical Interpreter 
Date 
Time (optional) 

Partners HealthCare System 
Research Consent Form 
 
 
 
General Template 
Version Date:  October 2014 
 
 
 
 
Page 9 of 9 
 
Subject Identification 
 
Statement of Other Individual (Non-Interpreter) 
 
As someone who understands both English and the language spoken by the subject, I represent 
that the English version of the consent form was presented orally to the subject in the subject’s 
own language, and that the subject was given the opportunity to ask questions. 
 
 
 
 
 
 
 
 
Name 
Date 
Time (optional) 
Consent Form Version:  May 27, 2016