Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
Phase: NA
Conditions: Dementia
Sponsor: Brown University

Protocol Title: 
Home-delivered Meals for Persons With 
Dementia: Which 
Model Delays Nursing Home Placement? 
 
 
 
NCT04850781 
 
 
 
 
Document Date: 
11/12/2023 

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Application for Expedited / Full Board IRB Review
PART 1: Name(s) and Contact Information.
Protocol Title: Home-delivered meals for persons with dementia: Which model delays nursing home
placement?
Principal Investigator: Kali Thomas, PhD
For more information on who may serve as a PI, see Brown’s guidance and PI Eligibility Policy.
Department: Health Services, Policy and Practice
Phone number: 401-863-9036
Email address: kali_thomas@brown.edu
Is this a graduate student project?* տYes ցNo
If student PI, please provide the following:
Advisor:
Department:
Phone number:
Email address:
Is this an undergraduate student project?* տYes ցNo Ifyes,
name of undergraduate student:
PART 2: Education Affirmation.
Human Subjects CITI training is complete (PI, advisor (if student PI)): ցYes տNo
Good Clinical Practice (GCP) training is complete (clinical trials only): ցYes տNo տN/A
HIPAA training is complete (if using PHI): ցYes տNo տN/A
PART 3: Collaboration Information.
Are there multiple sites involved with this study? ցYes տNo
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If yes, list the site(s) involved: Meals on Wheels of America
●
If “yes,” review the Application for IRB Authorization Agreement
PART 4: Funding Information.
Funding Source(s):
▪
If externally funded, provide the following:
Sponsor: National Institute on Aging
Project title: Home-delivered meals for persons with dementia: Which model delays nursing home
placement?
Grant / Contract #: R61AG070170
▪
If funded by a specific Brown program (e.g., Mellon Mays Fellowship, Royce Fellowship, UTRA,
OVPR Seed funds, etc.) please specify:
▪
If there is no funding for the study, write "Brown"
Expedited / Full Board studies must meet the federal definition of “Human Subjects Research.” Answer the following
questions to determine if your proposed study meets the federal definitions of both “Research” and “Human subjects.”
ցYes տNo
Is this study a systematic investigation?
ցYes տNo
Is the primary design intent of this study to contribute to generalizable knowledge?
ցYes տNo
Is the information being obtained about living individuals?
ցYes տNo
Will you collect information through some type of intervention or interaction? OR
Will you have access to individually identifiable information? OR
Will you have access to private information?
If you answered “no” to any of the above questions, your study does not meet the definition of “Human
Subjects Research.” You are not required to submit an Application for IRB review to the Brown HRPP.
1. Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical
or psychological examination or tests.
Using this definition, do you believe this research presents:
ցGreater
than
minimal risk
(Full Board)
Briefly justify this selection (and proceed to Part III):
Grace Ayers at the HRPP indicated our request for a waiver of informed consent for randomization and our
receipt of administrative data means this project requires full board review
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PART I. HUMAN SUBJECTS RESEARCH SCREENING
PART II. RISK ASSESSMENT & EXPEDITED ELIGIBILITY SCREENER
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տNo greater than
minimal risk
(Expedited)
Briefly justify this selection (and proceed to Question 2):
Click or tap here to enter text.
2. Below are Research Categories eligible for Expedited Review. Select one or more of the categories that are applicable to
your proposed research, if any.
տCategory 1
Clinical studies of drugs and medical devices only when condition (a) or (b) is met (please select one):
տ(a) research on drugs for which an IND application is not required. (Note: Research on marketed drugs
that significantly increases the risks or decreases the acceptability of the risks associated with the use of the
product is not eligible for expedited review); OR
տ(b) research on medical devices for which (i) an IDE exemption application is not required; or (ii) the
medical device is cleared/approved for marketing and the medical device is being used in accordance with
its cleared/approved labeling.
տCategory 2
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
տ(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these participants, the
amounts drawn must not exceed 550 ml in an 8-week period and collection may not occur more frequently
than 2 times per week; OR
տ(b) from other adults and children, considering the age, weight, and health of the participants, the
collection procedure, the amount of blood to be collected, and the frequency with which it will be
collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an8-
week period and collection may not occur more frequently than 2 times per week.
տCategory 3
Prospective collection of biological specimens for research purposes by noninvasive means. Examples may
include:
(a) hair and nail clippings in a non-disfiguring manner;
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
(c) permanent teeth if routine patient care indicated a need for extraction;
(d) excreta and external secretions (including sweat);
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or
wax or by applying a dilute citric solution to the tongue;
(f) placenta removal at delivery;
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more
invasive than routing prophylactic scaling of the teeth and the process is accomplished in accordance with
accepted prophylactic techniques;
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
(j) sputum collected after saline mist nebulization.
տCategory 4
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely
employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical
devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the
safety and effectiveness of the medical device are not generally eligible for expedited review, including
studies of cleared medical devices for new indications.)
Examples may include:
(a) physical sensors that are applied either to the surface of the body or at a distance and
do not involve input of significant amounts of energy into the subject or an invasion of
the subject's privacy;
(b) weighing or testing sensory acuity;
(c) magnetic resonance imaging;
(d) electrocardiography, electroencephalography, thermography, detection of naturally
occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging,
doppler blood flow, and echocardiography;
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(e) moderate exercise, muscular strength testing, body composition assessment, and
flexibility testing where appropriate given the age, weight, and health of the individual.
ցCategory 5
Research involving materials (data, documents, records, or specimens) that have been collected, or will be
collected solely for non-research purposes (such as medical treatment or diagnosis). NOTE: Some research in
this category may be Exempt. Review the categories for Exemption before selecting this option.
տCategory 6
Collection of data from voice, video, digital, or image recordings made for research purposes.
ցCategory 7
Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies. NOTE: Some research in this category may
be Exempt. Review the categories for Exemption before selecting this option.
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1. Introduction and Background. In reviewing the protocol, the IRB must consider the rationale for the
study and the importance of the knowledge that may reasonably be expected to result.
Food insecurity among older adults is a critical health and healthcare issue with
implications for families, the healthcare system, and society. In 2017, an estimated 5.5
million older adults (7.7%) in the United States were food insecure. Food insecurity, defined as a
lack of consistent access to enough food for an active, healthy life, disproportionately affects
older adults who are racial or ethnic minorities, those with lower incomes, those who are
disabled, and those living in non-metropolitan areas. Food is a basic human need, and among
many food- insecure older adults, the need for food competes with other basic necessities such as
medication, housing, utilities, and transportation. While food-insecure older adults sometimes
have enough money to purchase food, they may not have the resources to access or prepare food
due to lack of transportation, functional limitations, or health problems.
Individuals with Alzheimer’s disease and related dementias (ADRD) are at increased risk
of food insecurity. Many individuals with ADRD living in the community are characterized as
being low income, with close to one- quarter living under the Federal Poverty Level and almost
one-third enrolled in Medicaid. In early stages of ADRD, when the ability to perform complex
tasks is declining, difficulties in shopping, preparing meals, and eating may regularly arise,
especially among persons living alone, which may mark the entry into a vicious circle of food
insecurity and health instability. Estimates of the percent of persons with dementia (PWD) living
in the community who need assistance shopping for and preparing meals range from 50% to
90%. Caregivers play a central role in recognizing these difficulties and providing support.
However, between 25% and 30% of PWD in the community live alone, and approximately one
quarter of PWD who live alone have limited social support and report not visiting with family or
friends in the last month. Therefore, PWD in the community, particularly those who live alone,
are at increased risk of food insecurity.
Among older adults, food insecurity is associated with poor health status and health
outcomes, and accounts for an estimated $130 billion annually in healthcare expenses.
Previous research suggests that addressing food insecurity is associated with reduced odds of
hospitalization, emergency department use, and nursing home admission, including shorter
lengths of nursing home stays. In addition, evidence, much of which our team has helped
generate, continues to suggest that home-delivered meals, specifically, have an impact on the
health and healthcare utilization of a highly vulnerable population of homebound older adults
experiencing food insecurity. Recognizing the link between food insecurity, health, and
healthcare utilization, healthcare entities (e.g., payers, systems, providers) are increasingly
interested in addressing food insecurity with home-delivered meals for older patients.
While home-delivered meals have traditionally been provided daily to clients’ homes by a
volunteer or paid driver, mailed frozen meals have emerged in recent years as a lower-cost
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PART III. RESEARCH DESIGN & METHODS
THE BLUE TEXT IN THE FOLLOWING SECTIONS IS A GUIDE TO ENSURE ALL
RELEVANT INFORMATION IS INCLUDED IN YOUR APPLICATION. YOU MAY DELETE
THE BLUE TEXT BEFORE SUBMISSION
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alternative. In this model, participants are provided one to two weeks’ worth of meals in one
bulk delivery via postal courier. While these meals have the same nutritional standards as daily-
delivered meals (⅓of older adults’ Dietary Reference Intake), there is limited evidence on how
satisfaction with, and the benefit of, these meals may differ from the traditional daily- delivered
meal. Our pilot research suggests that clients who receive daily-delivered meals (including
socialization and a wellness check) have lower rates of loneliness and falls than clients who
receive frozen, weekly delivered meals. These findings are particularly salient given the
relationship between these two measures and older adults’ health and healthcare utilization.
However, overall differences in health and healthcare utilization, including the ability for
meals to enable PWD to remain in the community, attributable to the two meal delivery
methods remain unknown.
The healthcare sector has a growing interest and motivation to address food insecurity in
order to achieve better patient health outcomes and reduce costs. Increasingly, providers and
health systems are addressing food insecurity and its impact on health through the direct
provision of meals. Medicare Advantage (MA) plans, which currently enroll over one-third of all
Medicare beneficiaries, were given new flexibility to address chronically ill enrollees’ social
needs, including enrollees with ADRD, through the, “Creating High-Quality Results and
Outcomes Necessary to Improve Chronic (CHRONIC) Care Act,” of 2018. Interviews that our
team conducted with MA plans across the country indicate that they are examining new
opportunities to meet the needs of chronically ill enrollees through the provision of home-
delivered meals in response to CHRONIC. In fact, our preliminary work using MA plan benefit
data suggests that 1,979 MA plans (47.4%) are offering a meal benefit to their 9.4+ million
enrollees in 2020. In addition, many local communities offer meal and nutrition services to
eligible individuals through Medicaid waivers or other government-funded programs. The
Centers for Medicare and Medicaid Services (CMS) through their Accountable Health
Communities Model are testing how identifying and addressing patients’ social needs, like food
insecurity, impacts healthcare costs and reduces utilization. Despite the increased focus on
addressing social needs like food insecurity through home-delivered meals, healthcare entities
have little information guiding them about what mode of meal delivery (meals delivered by the
MOW program multiple times a week with socialization vs. frozen, drop-shipped meals)
promotes community independence among PWD and benefits their caregivers.
It is particularly important to examine the differences in experiences between the two
modes of meal delivery and how they impact community residence among PWD, who
comprise approximately 30% of Meals on Wheels (MOW) clients. There are several reasons
why examining differences in the two modes of meal delivery among PWD is of great interest.
For example, frozen, drop-shipped meals require the client to transport the heavy box of frozen
meals to the kitchen, put them in the freezer, microwave them, open the meal containers, etc., all
of which may be particularly challenging for PWD. However, the hot/chilled meals delivered
multiple times a week by the MOW program are brought directly to the client. Interviews we
have conducted with MOW drivers found that it is common for drivers to bring the meal to the
kitchen/table and set up the meal for the client (e.g., open containers). Further, PWD may
benefit greatly from physical check-ins by a meal delivery driver because PWD may not always
accurately self- report or request help if thereare issues. Better understanding of the process of
meal delivery and its impacts on the lives of PWD can improve services to meet clients’ needs
and provide evidence to guide decision- making around what type of meals to provide and to
whom.
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The proposed research will address key knowledge gaps identified by a multitude of
stakeholders. Two recently released reports by the National Academies of Science, Engineering,
and Medicine called for rigorous research to understand effective and efficient ways for the
healthcare sector to reduce food insecurity and other health-related social needs. Our proposed
research addresses the need to identify, “how interventions affect health, for which patients, via
what mechanisms, and in what contexts,” put forward by the committee, and works toward their
recommended goal to “Fund, Conduct, and Translate Research and Evaluation on the
Effectiveness and Implementation of Social Care Practices in Health Care Settings.” Also, this
work meets the needs of other stakeholders, including MA plans and Medicaid managed care
organizations, both of which indicated the need for evidence around program effectiveness to
guide decision-making. Our proposed research is significant because it will provide evidence
to guide stakeholders’ decisions and ultimately improve PWDs’ health outcomes and
quality of life.
Specific Aims and Study Objectives. The IRB must evaluate the objectives of the research in order to
determine whether the risks to participants are reasonable in relation to the importance of the knowledge that
may be gained.
The Specific Aim of the R61 is to:
1. Test and validate procedures to recruit individuals with ADRD and evaluate their outcomes in
partnership with Meals on Wheels programs. The goal of this aim is to test and validate the vital
elements and procedures for conducting a pragmatic effectiveness trial: specifically, 1) enrolling persons
with ADRD on MOW programs’ waiting lists to receive one of the two types of meals; 2) recruiting a
subsample of participants and caregivers to participate in telephone interviews; 3) extracting and
transferring program data to Brown University; 4) linking participant data with Medicare and nursing
home assessment data.
2. Materials, Methods and Analysis. The study design, methods and procedures must be adequately
described in order for the IRB to understand all activities in which human subjects will participate. The
IRB must also be able to differentiate those procedures that are performed for research purposes from
those that are performed for routine care or evaluation.
This application is a pragmatic randomized controlled trial comparing outcomes among two
approaches for delivering meals to food insecure older adults with Alzheimer’s disease and related
dementias (ADRD). Research procedures include assignment to one of the two predominant modes
of meal delivery in standard practice, primary data collection, and secondary data analysis.
We propose a two-arm, parallel, randomized control trial. The initial phase of this project will be a
pilot phase with one aim.
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If your study ONLY involves the use of identifiable secondary data / biospecimens,
including coded data from which you may be able to ascertain participant identity, skip to
PART V. Otherwise, please continue to next page.
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Brown UniveresistyeIaRrBchOrtigeinaam
l Apwpirollvaal:ls1o2/1s0e/2n0d20participants from the third site (MOW-SA) an opt-out letter. This opt-
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Aim 1. Test and validate procedures to recruit participants with ADRD and evaluate their
outcomes in partnership with MOW programs. The goal of this aim is to test and validate the
vital elements and procedures for conducting the pragmatic effectiveness trial: specifically, 1)
enrolling persons with ADRD on MOW programs’ waiting lists to receive one of the two types of
meals; 2) recruiting a subsample of participants and caregivers to participate in telephoneinterviews;
3) extracting and transferring program data to Brown University; 4) linking participant data with
Medicare and nursing home assessment data
Enrolling Persons with ADRD on MOW Programs’ Waiting Lists to Receive One of the Two
Types of Meals. We will work with programs during this pilot research award to test the
procedures for enrolling persons with ADRD who are on programs’ waiting lists to receive one of
the two types of meals that are currently provided by home-delivered meals programs (i.e., meals
delivered multiple times a week by the MOW programs versus frozen, drop-shipped meals) As a
note: we have been informed by the MOW programs that the frequency of the daily delivered meals
has been shifted to multiple times a week due to the COVID-19 pandemic. These meal recipients
are still receiving the same number of meals, but delivery may occur multiple times a week instead
of daily. Daily meal delivery may resume when the MOW programs are able to safely do so. Both
types of meals are regularly provided to individuals with dementia. To do this, the MOW program
will identify individuals who are already on their waiting list and during the initial intake indicated
that a doctor or other healthcare professional had indicated that they suffer from memory loss,
cognitive impairment, any type of dementia, or Alzheimer’s disease (this could be self-reported or
by the person making the referral). This information is available in the programs’ intake records and
therefore will not require any additional data collection or screening procedures. Brown University
will randomize those individuals into one of the two groups (meals delivered multiple times a week
by the MOW programs or frozen meals) and notify the MOW program. The MOW programs will
reach out to individuals and offer them the delivery type. If an individual agrees to come off of the
waiting list, they will begin receiving meals. If not, they will remain on the waiting list (i.e., there is
no penalty for declining). The MOW program will inform theindividual that their decision to come
off the waiting list will not influence their place on the waitinglist -- that is, if (for whatever reason)
decide not to continue to receive their randomly-assigned mealtype, the individual will be returned
to the waiting list and will not lose their spot. We are requestinga waiver of informed consent for
this portion of the study, as we believe this study meets the five criteria for a waiver as described in
45 CFR §46.116 f 3 (i-v) and detailed below. For those who have agreed to receiving one of the two
types of meals, MOW will send client intake information that they regularly collect (e.g., name,
address, phone number, date of birth, last four of SSN, race, gender, living arrangement) to Brown
University through secure methods. Brown University researchers will randomize the participants
and will communicate assignments back to the MOW programs. Upon receiving the assignment, the
MOW program will begin service for clients and continue to serve the assigned meals for six
months. Following the six-month study period, individuals may continue to receive their assigned
meals or roll onto the MOW programs’ usual service (i.e., meals delivered multiple times a week by
the MOW program). Importantly, the three programs who are participating have agreed to continue
to serve meals to interested individuals after the study period ends.
Recruiting a Subsample of Participants to Take Part in Telephone Interviews. To obtain rich
information about the context, implementation, and mechanisms of impact associated with receiving
meals, a subset of PWD who accepted the intervention will be interviewed by Brown researchers. To
do this, the MOW program will send an invitation letter and informed consent sheet to participants
from the first two programs (VNA Texas and Neighborly) approximately one month after the first
meal delivery. This letter will include an invitation to participate in an in-depth, semi-structured
pilot phone interview with Brown University researchers. Interested individuals will “opt-in” to
participate by contacting the research team with the information included in the initial invitation
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l Apwpirollvaal:ls1o2/1s0e/2n0d20participants from the third site (MOW-SA) an opt-out letter. This opt-
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letter. Additionally, if any of the participants from the first two programs (VNA Texas and
Neighborly) do not respond to the initial letter, the Brown University research team will send a
second letter, reminding participants about the opportunity to participate in a phone interview. To
test out a different recruitment protocol in hopes of increasing participation, the Brown University
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out letter will
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describe the study and will let them know that a member from the research team will contact them
unless they “opt-out” of the study.
Within this introductory letter, we will provide our contact information and will also include a
refusal to participate postcard that participants will be asked to complete and return if they
do not wish to participate in the study. For participants for whom we do not receive a refusal
postcard, telephone call, or email indicating that they are not interested in participating, we will
make no more than 3 attempts to contact them between the hours of 10am and 7pm, in their
representative time zones.
The Brown University research team will call the interested participants, complete an informed
consent process over the telephone, and conduct the interview. Pilot interview questions will be
guided by the Medical Research Council’s Process Evaluation Framework. We will include
questions focused on implementation (e.g., participants’ interaction, if any, with the driver/mail
carrier who delivers their meals), mechanisms of impact (e.g., participants’ experiences receiving,
preparing, and eating meals); and outcomes (e.g., participants’ satisfaction with the meal services).
We will also administer the Telephone Interview for Cognitive Status (TICS-M) to assess
participants’ cognitive abilities. We will test our procedures for recruiting and conducting the
interviews with 2-10 participants at each program. While we initially proposed to conduct in-person
interviews, because of COVID-19, we will pursue telephone interviews and should conditions
change, we will seek IRB approval to conduct in-home interviews. Nonetheless, telephone
interviewsare efficient, cost-saving, and allow for the greatest amount of privacy for participants.
Recruiting a Sample of Caregivers to Take Part in Telephone Interviews. We will conduct
semi-structured telephone interviews with a subset of caregivers of PWD who accepted the
intervention to better understand the process of receiving meals and potential mechanisms behind
outcomes observed. We will test our procedures and pilot the interview guide with 2-10 caregivers
at each program with separate methods at the three programs (i.e., VNA Texas, Neighborly Senior
Services, and MOW-San Antonio). In the first site, VNA Texas, MOW programs will mail the
invitation letter to the emergency contact listed in the clients’ records approximately three months
after the participant begins receiving meals. Interested caregivers will “opt-in” to the study by
contacting Brown University researchers who will describe the study, obtain verbal consent to
participate over the telephone, and conduct the telephone interview. In the second and third sites,
Neighborly Senior Services and MOW-San Antonio, researchers will ask participants who are
interviewed if they would share the contact information of an informal caregiver. Brown University
researchers will mail a welcome letter approximately three months after the participant begins
receiving meals, which will describe the study and that a member from the research team will
contact them to schedule the interview unless they “opt-out” of the study. Within this introductory
letter, we will include a refusal to participate postcard that caregivers will be asked to complete and
return if they do not wish to participate in the study. For caregivers from whom we do not receive a
refusal postcard, telephone call, or email indicating that they are not interested in participating, we
make no more than 3 attempts to contact them between the hours of 10am and 7pm, in their
representative time zones. The Brown University research team will be responsible for calling
caregivers, conducting an informed consent process over the telephone, and completing the
interview. These interviews, also guided by the Medical Research Council’s Process Evaluation
Framework, will focus on caregivers’ experiences and caregivers' perceptions of participants'
experiences receiving meals, their interactions, if any, with the person who delivers their meals (i.e.,
driver or mail carrier), how the meal service may have impacted their lives (e.g., responsibilities,
stress, burden), and their satisfaction with the meal services. We have chosen to conduct telephone
interviews because they are an efficient, cost-saving, and effective way to ensure a diverse set of
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participants and allow for the greatest amount of privacy and convenience of caregivers.
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Extracting and Transferring Program Data to Brown University. During this pilot study, in
addition to developing our data sharing platform and testing data transfer with our pilot sites, we
will test data transfers at least twice per participating program. We will ask MOW programs to
shareenrollment and programmatic data that is regularly collected from current clients who have a
self- reported diagnosis of dementia/cognitive impairment. This is information that is routinely
collected and available in MOW programs’ records. While we have confidence in our ability to
obtain and link MOW program data to CMS data given our work in a previously funded study, the
goal of this activity is to test the data sharing platform and refine instructions provided to programs.
Brown staffhave considerable experience receiving data directly from a variety of sources (e.g.,
nursing home corporations) in various formats for pragmatic trials. Our IT director will work with
MOW staff around data transfer options. Options will include transfer by physical media or through
electronic submission. By either method, data will be encrypted to at least AES-256 standards prior
to transmission. Passwords will be transmitted out of band, either verbally or via email, or an SMS
textmessage.
Linking Participant Data with Medicare and Nursing Home Assessment Data. Participant data
(i.e., first and last name, phone number, date of birth, race/ethnicity, gender, address, last four of
SSN) will be shared with Brown investigators by MOW programs via secure methods and
downloaded to a secure Brown server. Participant information will be shared securely with
HealthAPT to obtain identifiers (i.e., bene_id) to link across the Medicare enrollment record, nursing
home MDS, and claims. Our team has access to 100% national data through our Program Project and
the PI and co-investigators on this proposal are intimately familiar with the data and adept in linking
files in this way. We will assess the match rate with these unique identifiers to determine the best
combination of data needed for linkage in the full trial. Further, we will use the current enrollment
data to estimate the probabilities of linkages for our non-matches using our previously derived
algorithm that we used to link MOW client data with Medicare enrollment records without unique
identifiers. Finally, we will conduct initial exploratory analyses to determine if nursing home
placement differs between the two groups of participants in the pilot.
3. Participant Population. In order to approve research, the IRB must determine that the
selection of participants is equitable and reasonably related to the purpose and aims of the
research. The IRB must also consider whether adequate safeguards are in place to minimize
any risks that are unique to vulnerable populations. To make this determination, the IRB must
review all methods and materials used to contact and recruit potential participants, including
letters, flyers, emails, etc.
During this pilot phase, we will work with three programs who will deliver meals to 235 participants. This
willallow us to refine the process for enrolling and randomizing PWD to receive meals. To do this, we will 
pilot the procedures with three MOW programs: Neighborly Senior Services in Clearwater, Florida; VNA 
Texas inDallas, Texas; and Meals on Wheels – San Antonio in San Antonio, Texas.
The inclusion criteria for receiving meals include being on the waiting list, 66 years of age or older (to allow
for Medicare enrollment and a one-year baseline lookback) and self-reporting a diagnosis of dementia or
cognitive impairment. Age and self-reported diagnosis come from the MOW programs’ intake records and
therefore no additional screening or data collection is required for receiving meals (i.e., enrollment in the
study).
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There is no requirement that participants be English-speaking in order to receive meals. MOW programs
during their usual intake procedures confirm that individuals have working refrigerators, microwaves, etc.
necessary to store and heat the food. Both participating programs, like many MOWA-member programs, have
procedures in place for supplying this equipment if it is determined that a client is in need. MOW programs
may have a limited ability to assess individuals' cognitive abilities to store, heat, or prepare food. Furthermore,
there are many MOW programs in which frozen meals are the only option - these programs do not withhold
meals for individuals with diminished cognitive abilities.
The goal is to test, on a very small scale, procedures that we will use later on a not-yet-funded R33. The R33 is
designed to be pragmatic and will be scaled up to the anticipated goal sample of 2300. We selected 235
participants for this pilot because we want to ensure we will reach the goal we had set out in the short time
period of the pilot project.
For the interviews, we will recruit a subsample of 2-10 persons with dementia receiving meals and 2-10
caregivers at each program to pilot the procedures and interview guides. For persons with dementia, inclusion
criteria consists of receiving meals, being English-speaking, and having capacity to consent at the time of the
consent discussion and interview. Members of the research team have previous experience conducting research
with individuals with impaired decision-making capacity. Although participants can end the interview at any
time, the research team members conducting the interview will continue the interview even if the reliability of
the information provided is suspected to be incomplete or not pertinent to the question asked. As a pilot of this
procedure for the larger trial, the quality of the data reported by participants with dementia is of interest to the
study team.
The research team members conducting the interviews (i.e., Dr. Gadbois, Dr. Shield, Dr. McAuliff) will
identify and make note when the content provided by the participant does not contain information pertinent to
the questions being asked. As long as the person with dementia participating in the interview is not distressed
and wants to continue, then the interview will be completed as planned. In our experience, a participant may
understand a question later in the interview and be able to provide relevant information even in cases where
they had a less reliable response to an earlier item / interview question. However, if the participant is not able
to meaningfully respond to a series of questions such that a lack of data integrity is clear the interviewer can
end the interview early. If that occurs, the research team member will end the interview by thanking the
participants for their contribution (e.g., “Thank you for sharing that with me. That is all of the questions that I
have for you today. I really appreciate you taking this phone call. Is there anything else that you want me to
know?”). It is not necessary to tell participants the interview is being discontinued, in all cases empathy and
dignity will be prioritized.
For caregivers, interview inclusion criteria consist of being an informal caregiver of a PWD who is receiving
home-delivered meals and English-speaking.
4. Recruitment Methods
Randomization to Meal Group: MOW program staff will identify individuals on their existing waiting lists who 
are age 66+ years and have a self-reported memory impairment or diagnosis of dementia. This information is 
available in the programs’ intake records and therefore will not require any additional data collection or screening
procedures.
Brown University will randomize individuals into one of the two groups (meals delivered multiple times a week by the
MOW program or frozen meals) and notify the MOW program. The MOW programs will reach out to individuals and offer
them the delivery type, allowing them to come off the waiting list. However, participation is voluntary and if individuals do
not want to come off of the waiting list, they willretain their place on the waiting list. The MOW program will inform the
individual that their decision to come off the waitinglist will not influence their place on the waiting list - meaning, if they
decide not to continue to receive their assigned meal type, they will be returned to the waiting list and will not lose their spot.
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The average time that clients spend on a waiting list at these three programs is between 3-5 months;
individuals who decline to participate or who decide to leave the study and return to the waiting list
will keep their original place on the waiting list (i.e., their accrued waiting time). The client
information will be shared with the research team at Brown University who will be responsible for
randomizing the client to meals delivered multiple times a week by the MOW program or bi-
weekly, drop-shipped meals, and communicatingthe assignment back to the MOW program. We
will consult with participating programs, our expert ethicist consultant, Emily Largent, PhD, RN,
JD, and the Brown IRB on the process (e.g., general barriers to enrollment, reasons for refusal).
Based on this feedback, we will make refinements to the implementation strategy and training
materials for the larger trial.
Brown has an established collaborative relationship with MOWA, which represents over 5000 home-
delivered meals programs. In partnership with MOWA, we have already recruited 2 MOWA member
programs to participate in this pilot (please see letter of support from MOWA). MOWA’s member
programs have agreed to collectively enroll clients with ADRD, to devote staff to implement the
intervention, and to work with the Brown research team to develop and execute secure data transfer
protocols. MOWA has ensured their support of recruiting additional programs to participate, if
needed.
Telephone Interviews with Participants: We will recruit 2-10 participants receiving meals at each program to pilot
the telephone interview protocol. The MOW program will send an invitation letter and informed consent sheet to the
first two MOW programs (VNA Texas and Neighborly) approximately one month after the first meal delivery. This letter
will include an invitation to participate in an in-depth, semi-structured pilot phone interview with Brown University
researchers. The invitation letter will describe the study and include the contact information for Brown University researchers
who the participant can call to express interest in participating. Interested individuals will “opt-in” to participate by
contacting the research team with the information included in the initial invitation letter. If any of the participants from the
first two programs (VNA Texas and Neighborly) do not respond to the initial letter, the Brown University research team
will send a second letter, reminding participants about the opportunity to participate in a phone interview. To test out a
different recruitment protocol in hopes of increasing participation, the Brown University research team will also send
participants from the third site (MOW-SA) an opt-out letter. This opt-out letter will describe the study and will let them
know that a member from the research team will contact them unless they “opt-out” of the study.
Within this introductory opt-out letter, we will provide our contact information and will also include
a refusal to participate postcard that participants will be asked to complete and return if they
do not wish to participate in the study. For participants for whom we do not receive a refusal
postcard, telephone call, or email indicating that they are not interested in participating, we will
make no more than 3 attempts to contact them between the hours of 10am and 7pm, in their
representative time zones.
A trained Brown University research team member will call the interested participants, screen participants, complete
an informed consent process, and complete the interview all over the telephone. The interviews will be scheduled at
a time of each participant’s choosing to ensure privacy and convenience. Interviews will be designed to collect
information about participants’ experiences receiving, preparing, and eating meals; their interaction, if any, with
the person who delivers their meals (i.e., driver or mail carrier); and their satisfaction with the meal services. Interviews
will be tailored around the needs of older adults with AD/ADRD. If the interviewee loses his or her train of thought,
the interviewer will repeat the last topic or sentence. If participants are too impaired to correctly or effectively
answer specific questions, the interviewer will use examples rather than open-ended questions.
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In addition to the interview questions, we will conduct a brief cognitive assessment (i.e., Telephone
Interview of Cognitive Status (TICS-M)) to estimate the participant’s level of cognitive
impairment. The TICS-M will be conducted after the interview questions, and the score will be
used to understand how experiences may differ for clients with differing levels of cognitive
impairment. There is no cut-off score on the TICS-M for conducting the interview and it will not
affect eligibility. Scores on cognitive screeners, like the TICS-M, do not consistently predict
capacity to consent to research and clinical interview is considered the gold standard for capacity
assessment. That is why we are using a study-specific capacity to consent assessment and not the
score on the TICS-M.
Telephone Interviews with Caregivers: We will test our procedures and pilot the interview guide
with 2-10 caregivers at each program using two different methods at the three programs (one
program will use one method, the other two programs will use a different method). In the first site,
MOW programs will mail the invitation letter to the emergency contact listed in the clients’ records
approximately three months after the participant begins receiving emails. Interested caregivers will
“opt-in” to the study by contacting Brown University researchers. A trained member of the Brown
University research team will describe the study, obtain verbal consent to participate over the
telephone, and conduct the telephone interview. In the second and third sites, researchers will ask
participants who are interviewed if they would share the contact information of an informal
caregiver. Brown University researchers will mail a welcome letter approximately three months after
the participant begins receiving meals, which will describe the study and that a member from the
research team will contact them to schedule the interview unless they “opt-out” of the study. Within
this introductory letter, we will include a refusal to participate postcard that caregivers will be asked
to complete and return if they do not wish to participate in the study. For caregivers from whom we
do not receive a refusal postcard, telephone call, or email indicating that they are not interested in
participating, we make no more than 3 attempts to contact them between the hours of 10am and 7
pm, in their representative time zones.
A trained Brown University research team member will be responsible for calling caregivers,
conducting an informed consent process over the telephone, and completing the interview.
Recruitment will continue with replacement until we achieve our target total sample size of 2-10
caregivers at each program. Interviews aim to understand participants’ and caregivers’ experiences
receiving meals, their interactions, if any, with the person who delivers meals (i.e., driver or mail
carrier), how the meal service may have impacted their lives (e.g., responsibilities, stress, burden),
and their satisfaction with the meal services.
5. Compensation / Reimbursement
Participant incentives are included for persons with dementia and caregivers who are participating
in the telephone interviews in the study. Persons with dementia will be mailed a $50 pharmacy
gift card for a 30-minute telephone interview, an amount that is typically offered for interview studies
in populations with, or at risk for AD/ADRD. Caregivers will be mailed a $50 pharmacy gift card
for a 30-45-minute telephone interview.
6. Potential Research Risks / Discomforts to Participants. In order to approve the research, the IRB
must consider the risks posed to participants by the research and any efforts to mitigate those risks.
The IRB needs to determine that the risks have been both minimized and are reasonable in relation to
the anticipated benefits to participants, as well as to the importance of the knowledge that may be
gained. The IRB will also consider whether the informed consent process provides potential
participants with an accurate and fair description of the risks or discomforts.
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The pilot is considered a minimal risk study. Potential risks to individuals receiving meals
include mild distress due to not receiving the preferred type of meal. While both options (i.e.,
meals delivered multiple times a week by the MOW program vs. frozen, mailed meals) are
preferable to no meals at all, some participants may have a strong preference for one over the
other and experience disappointmentif randomized to the non-preferred option. However, given
that participants will have expressedan interest in receiving meals and are on the waiting list,
receiving any meals will be preferableto receiving none.
There is also a risk of breach of confidentiality to individuals receiving meals and those
participating in interviews. The risk of breach of confidentiality will be minimized to the
greatest extent possible by the stipulations set forth in the Data Use Agreement with CMS, as
well as by the measures described below.
Protecting Participant Data
One risk of the study is a breach of confidentiality with the use of identifiable data. All research
staff involved in the study will receive training in the protection of human subjects. The
procedures described here address our efforts to minimize the risk of breach of confidentiality.
All data management and analyses will be conducted by the Brown Center for Gerontology &
Healthcare Research, leveraging its administration and computing infrastructure. Researchers
and staff have many years of experience working with identifiable data files on a large scale and
have numerous security measures in place to ensure the integrity and confidentiality of the data.
CMS data will be covered under the strict terms of a data use agreement (DUA). At the
conclusion of this study, or by the date of retention identified in the DUA, a CMS “Certificate
of Disposition” certifying the proper destruction of all data obtained from CMS will be sent to
CMS. All non- CMS data will be handled in a similarly restrictive manner. In addition, all
output containing individual identifiable information is treated as confidential data. This
information is never transferred electronically via email.
Identifiable information will not be attached to any research documents, and all data will be
identifiable only using the unique identifier specific to this study. All members of the research
team have experience collecting data from participants and using secondary data that contains
private health information. None of the study team members have had a breach of
confidentiality associated with their research.
For participants with dementia and caregivers taking part in the interviews, they may experience
some discomfort in responding to the interview questions as they may bring up unpleasant
feelings or memories (for example, what things were like before they began receiving meals).
However, these risks do not exceed those of topics considered in everyday life and are minimal.
In order to protect against these risks, the researchers will remind participants that they are free
to stop the interview and recording at any time and it will not impact the receipt of meals. The
interviewers will also offer participants to take a break during the interview if there is any
indication that the interview becomes too difficult or uncomfortable.
The justification for including persons with dementia and their caregivers in this study is the
scientific value of understanding how home-delivered meals help people with dementia, who
make up approximately 30% of all MOW clients. Given this population’s unique needs, it is not
possible to conduct informative research for this research with other populations (i.e., we have
selected this population for scientific reasons; it is not a convenience population). In sum, this
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population is being enrolled because the findings of the research will directly inform the
delivery of services to people with dementia in the future – and is needed to improve service
quality for this population in support of their goal of living independently in the community.
7. Potential Benefits of the Research. NOTE: Compensation for participation is not a benefit and
should not be included in this section. In order to approve this research, the IRB must determine that
the potential benefits to research participants are reasonable in relation to the potential risks. Very
often, research at Brown does not include potential direct benefits to participants, but may only benefit
society as a whole by helping researchers.
Older adults with dementia on MOW waiting lists who agree to participate will receive meals, as
opposed to remaining on the waiting list to receive meals. Further, this study would provide
information that would assist healthcare systems, providers, payers, programs, persons with
dementia, and their caregivers. The minimal risks to subjects are reasonable for the importance
of the information that will help understand the comparative effectiveness of the two
predominant forms of meal delivery for persons with dementia.
For individuals participating in interviews, they will not directly benefit from being interviewed.
However, their participation will help us better understand the experiences of older adults with
dementia who receive home-delivered meals.
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1. Describe the informed consent process
Telephone Interviews with Participants: One day prior to the scheduled telephone interview, the project
coordinator will confirm the appointment with the participant via phone call, email, or text message according
to the participant’s preference. At the beginning of the telephone interview, co-investigators Dr. Emily Gadbois
Dr. Renee Shield, and/or Dr. Katie McAuliff will review the study procedures and will go over the consent
form with study participants, reviewing the form with them and periodically asking them questions about the
consent process to be sure that they understand what they are consenting to. (Please see the interview guide for
additional information.) Dr. Gadbois, Dr. Shield, and Dr. McAuliff have years of experience conducting
research interviews, including interviews with vulnerable populations such as those with cognitive impairment.
Nonetheless, Dr. Gadbois, Dr. Shield, and Dr. McAuliff will participate in training by Dr. Michelle Hilgeman, a
study Co-I and geriatric psychologist, who has extensive research experience consenting and conducting
research interviews with individuals with memory impairment. Dr. Gadbois, Dr. Shield and Dr. McAuliff will
answer any questions the participant might have and remind them that they may opt out of the interview at any
time. If a participant agrees to be interviewed, they will give verbal consent to participate that will be recorded
by the Brown researcher. The consent forms will address audio recording consent. Participants who decline
audio recording may still participate in the interview. In their case, a research team member will take notes
during the interview. While the informed consent document will be sent with the welcome letter, a second blank
copy of the informed consent form will be mailed to the participant within one week if they request. The
consent form will have contact information for both the study PI and the Brown University IRB if they have
any questions or concerns. Because interviews will be conducted by telephone rather than in-person, we will
seek a waiver of documentation of informed consent.
Telephone Interviews with Caregivers: One day prior to the scheduled telephone interview, the project
coordinator will confirm the appointment with the caregiver via phone call, email, or text message according to
the caregiver’s preference. At the beginning of the telephone interview, the trained research team member will
review the study procedures and will go over the consent form with caregivers, reviewing the form with them
and periodically asking them questions about the consent process to be sure that they understand what they are
consenting to. (Please see the interview guide for additional information.) This research team member will also
answer any questions the caregiver might have and remind them that they may opt out of the interview at any
time. If a caregiver agrees to be interviewed, they will give verbal consent to participate that will be recorded
by the Brown researcher. The consent forms will address audio recording consent. Caregivers who decline
audio recording may still participate in the interview. In their case, the research team member will take notes
during the interview. While the informed consent document will be sent with the welcome letter, a second
informed consent form will be mailed to the caregiver within one week of the interview if they request. The
consent form will have contact information for both the study PI and the Brown University IRB if they have
any questions or concerns. Because interviews will be conducted by telephone rather than in-person, we will
seek a waiver of documentation of informed consent for the caregiver interviews, as well.
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PART IV. INFORMED CONSENT
Informed consent is a process, not just a form. The IRB must ensure the informed consent process clearly
discloses and facilitates the understanding of all information needed to make an informed decision to
participate while promoting the voluntariness of participation.
Please use the Brown consent / assent templates and related guidance on the HRPP Forms & Templates page
to develop your consent forms.
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2. Facilitate Understanding
Telephone Interviews with Participants: A trained co-investigator on the research team (Dr. Emily Gadbois
Dr. Renee Shield, and/or Dr. Katie McAuliff) will assess the participant’s ability to understand and to express a
reasoned choice concerning the purpose of the study and the information relevant to their participation and
consequences of participation for the subject’s own situation. Dr. Gadbois, Dr. Shield, and/or Dr. McAuliff will
determine if all of the following standards are met: Did the participant "make a clear choice"? Did the
participant show "understanding"? Did the participant show "reasoning/rational reasons"? Did the participant
show an appreciation of the personal risks/benefits of participation in the study? This determination will be
accomplished through a four-item informed consent understanding checklist included as an attachment. For
individuals who do not pass the 4-item consent capacity checklist, they will be informed that they are ineligible
to participate in the interviews. If this event occurs, Dr. Gadbois, Dr. Shield, or Dr. McAuliff will allow as
much time as needed to allow the expression of any concerns. While Dr. Gadbois, Dr. Shield, and Dr. McAuliff
have years of experience conducting research interviews, including vulnerable populations such as those
experiencing cognitive impairment, they will receive training on ensuring understanding by Dr. Michelle
Hilgeman, a geriatric psychologist with extensive research experience consenting and interviewing individuals
with dementia and their caregivers. In addition, Dr. Hilgeman and the PI will regularly meet with Dr. Gadbois,
Dr. Shield, and Dr. McAuliff to review their responses on the consent understanding checklist, answer any
questions, and discuss any challenges.
Telephone Interviews with Caregivers: A trained research team member will conduct the informed consent
process with the Caregiver. There is no reason to believe that the Caregiver will experience any challenges
comprehending the informed consent form as they are the person listed as the emergency contact for the MOW
participant. Therefore, the research team member will assess the Caregiver’s understanding of the consent
process through encouraging them to ask questions during the review of the consent form. Dr. Hilgeman and the
PI will regularly meet with the research team member conducting the interviews and consent process to answer
any questions and discuss any challenges.
3. Documentation
Please see below for a request for a waiver of documentation of informed consent for interviews.
4. Additional Considerations
We request a waiver of documentation of informed consent for the telephone interviews with caregivers and
participants. We believe that we meet the criteria for a waiver as described in 45 CFR 46.117(c)(ii):
The research presents no more than minimal risk of harm to subjects and involves no procedures for which
written consent is normally required outside of the research context.
The interviews will be conducted over the phone and ask minimal risk questions where we anticipate little to no
distress as a result of the interviews. Consent would not normally be required for a telephone conversation of this
nature, and it would not be practicable to obtain signatures because the interviews are being conducted over the
telephone. We request a waiver of informed consent for initial enrollment to be randomized to receive one of the
Two types of meals (meals delivered by the MOW programs multiple times a week vs frozen, mailed meals). We
believe enrollment in the two types of meal deliveries and analysis using routinely collected data meets the five
criteria for a waiver as described in 45 CFR §46.116 f 3 (i-v)and below:
(i) The research involves no more than minimal risk to the subjects;
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Our study proposes to provide meals via the two predominant modes of meal delivery currently used by home-
delivered meals programs and contracted for by healthcare entities to food insecure, homebound, community-
dwelling older adults with ADRD. Because we are recruiting from an existing MOW waitlist, these individuals
have already expressed a desire to receive meals and shared their information with MOW, but they are not
currently receiving meals because of limitations in program capacity (i.e., inadequate funding to meet demand
for meals). The primary outcome analysis for the trial is through secondary data analysis of routinely collected
administrative data; therefore, no additional data collection is required or burden will be placed on the enrolled
sample. Enrollment and receipt of meals puts these individuals at no greater risk than everyday life.
(ii) The research could not practicably be carried out without the requested waiver or alteration;
Because we are interested in understanding the impact of receiving meals on the time spent in the community
among individuals living with dementia, we need to enroll individuals with varying levels of dementia severity.
While some individuals with dementia may retain capacity to consent to research (a diagnosis, especially a self-
reported diagnosis one, is not determinative), restricting the study to only those able to provide consent would
limit the generalizability of our findings, as we would likely only be able to enroll those with less-severe ADRD.
If we were to conduct a capacity assessment and sought to include people who lacked capacity to consent to
research, we would need to identify a legally authorized representative (LAR). Most individuals with ADRD
living in the community do not have a LAR appointed. Some studies have found rates as low as 0% of
individualswith mild dementia and only 11-23% of those with moderate to severe dementia have legal
documents in place such as guardianship, trusteeship, proxy, or power of attorney (Ruggieri & Piccoli, 2003).
Furthermore, LAR rates vary by race and socioeconomic status and are lowest among racial minorities and those
with less education(AARP, 2000). Our prior work has found that MOW clients are more likely to be racial and
ethnic minorities and low-income than the general population of older adults. In addition, MOW programs do not
collect information about clients’ LARs. Therefore, there is no mechanism for identifying LARs for potential
participants in this study. Finally, MOW programs do not collect information to identify possible surrogates for
consent. In addition,surrogate consent laws for research participation vary by state, and it would not be possible
to identify a consent process that is consistent across the programs that will participate in the follow-on
pragmatic trial and located
in 5 states. Taken together, requiring consent would result in bias through differential selection into the study
and comprise the validity and overall scientific value of the study findings.
Waiving the informed consent process allows us to include individuals who may not have capacity to give
consent, the very group who is most at risk of nursing home placement and whom we hypothesize would
experience the greatest effect of this low-risk intervention that they have already signed up to receive but are
currently unable to access because of program limitations. Notably, we are not asking for a waiver of consent
because we assume that no participants can consent; rather, we are asking for a waiver because including only those
individuals for whom consent can be obtained (either directly from the participant or from a LAR) would prohibit
conclusions to be drawn or bias the sample such that our conclusions would be skewed. In addition, there are two
other considerations. First, a goal of this pilot is to test the feasibility of the procedures for enrolling individuals with
ADRD in a study of the effects of receiving meals from MOW on time in the community. Our team will use the
experience from this pilot study to inform enrollment procedures in a follow-on pragmatic trial. While we are only
including 235 individuals in this study, the larger follow-on pragmatic study will include 2300 individuals with
ADRD. In that case, the sample size is so large that it would be impracticable to conduct capacity assessments with
each individual. Thus, it will be informative to test waivers here.
Second, our power calculations to derive our needed sample size for our larger trial were based on our prior
observational study that included the population of MOW clients with varying degrees of dementia severity. We are
unable to conduct a power analysis and derive a needed sample size for our follow-on trial only among those who
have capacity to consent/less severe impairment; this information is simply not available. Therefore, by excluding
individuals who may not have capacity to consent, we may be underpowered to detect an effect for our primary
outcome, time to nursing home placement, in the larger trial.
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(iii)
If the research involves using identifiable private information or identifiable biospecimens, the
research could not practicably be carried out without using such information or biospecimens in an identifiable
format;
We are proposing to use routinely collected administrative data for the analysis of the primary and secondary
study outcomes. We require the data in identifiable format in order to link data received from the MOW
program to data received from the Centers for Medicare and Medicaid Services (CMS) at the client level and
could not conduct the study without the link. A waiver of consent is regularly sought out for analyses that are
conducted using linked CMS data. Measures to protect the confidentiality of the information are described
below.
(iv)
The waiver or alteration will not adversely affect the rights and welfare of the subjects;
This study population with dementia is unique. While some individuals with dementia could successfully
complete a consent process over the telephone, we would likely lose the ability to enroll those most likely to be
impacted by meal delivery type (i.e., individuals with more than mild cognitive impairment or mild AD)
confounding our ability to address the primary aims of this study. The level of understanding necessary to
comprehend the study design during a telephone conversation with someone they have not met (i.e., consenting
to receive meals, which they have already requested) may introduce added burden and distress. In addition, for
those who have previously requested meals but do not have capacity to consent to receive meals through this
study, resulting in a return to the MOW waiting list, could be distressing. Some people may worry that
individuals on the MOW waiting list would feel they had no reasonable alternative to agree to participate in
research in order to receive meals or worry that they will not keep their place on the waiting list if they decline
to participate. By waiving the consent process (as we have done in previously funded studies), providing meals
to individuals, and linking MOW program data with claims data addresses these concerns and is consistent with
the pragmatic trial design.
(v)
Whenever appropriate, the subjects or legally authorized representatives will be provided with
additional pertinent information after participation.
Finally, we will ensure that participants are provided information about the study upon completion of the study.
We will do this through including a description of the study and results in the MOW programs’ newsletters,
which is shared with all clients and caregivers. Included will be the contact information of who to call for
additional information. In addition, we will mail a study summary to all participants and caregivers who took
part in the interviews.
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For research that involves the use of identifiable secondary data / biospecimens, including coded data
from which you may be able to ascertain participant identity.
If your research does not involve identifiable secondary data / biospecimens, proceed to PART VI.
DATA SECURITY ASSESSMENT
1. From what source(s) will you acquire or access the data / biospecimens?
Secondary data sources will include participant data from MOW programs as well as CMS data.
We will utilize research identifiable (RIF) claims, enrollment, assessment, data from the Centers for
Medicare and Medicaid Services (CMS). We will acquire these data through the strict terms of a data use
agreement (DUA) that we will enter into with CMS.
MOW participant data (e.g., first and last name, telephone number, date of birth, race/ethnicity, gender,
address,
SSN,
client
ID,
emergency
contact
information,
living
arrangement,
participant
dementia/cognitive impairment, diagnoses, functional status) as well as programmatic data (e.g., meal
delivery start date, meal delivery end date, breaks in service for meal delivery (including reasons for
break in meal delivery service, issues/complaints/satisfaction from participant, caregiver, or delivery
person, and total number of meals delivered to participant) will be shared with Brown investigators via
secure methods and downloaded to a secure Brown University server.
As part of this March 2020 amendment we are adding two new data sources (both secondary data from
MOWA):
- Data from a 2013 pilot conducted by MOWA
This pilot was a programmatic evaluation conducted by MOWA and was not considered a research
study
- Programmatic data from 13 MOW programs.
Both of these datasets have already been disclosed to us without a DUA as part of a pervious project,
and MOW is aware we will be reusing these datasets for this project.
Client information is covered by a Non-Disclosure Agreement executed between Brown and MOWA. We
will explore obtaining individual Data Use Agreements with participating programs if necessitated by the
programs, and will file IRB amendments as needed to reflect the need for DUAs if MOW requires them.
2. Describe the type(s) of data and date range(s) of the data you will use and the characteristics of the study
research population (e.g., age range, sex, and any other pertinent demographic information.)
The inclusion criteria for the current pilot include being on the waiting list, 66 years of age or older (to allow
for Medicare enrollment and a one-year baseline lookback, so anyone over the age of 65 will be included) and
self-reporting a diagnosis of dementia or cognitive impairment. Age and self-reported diagnosis come from the
MOW programs’ intake records.
Additionally, to determine the efficacy of two different modes of meal delivery (frozen vs. meals delivered
by MOW programs multiple times a week), we will leverage a previous pilot trial that was completed in
2013 with 626 participants randomized to three arms: 1)daily delivered meals, 2) frozen, weekly delivered
meals, and 3) remain on the waiting list. From the
PART V. USE OF SECONDARY DATA / BIOSPECIMENS
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2013 pilot, we have SSNs for 302 participants (123 participants in the daily-delivered meal arm; 79
participants in the frozen, weekly delivered meals; and 100 participants who remained on the waiting list) that
we are requesting linkage for CMS data to examine their characteristics, healthcare utilization, and time to
nursing home placement. Eligibility criteria for the 2013 pilot data include being enrolled in the pilot. We will
also leverage data from 13 MOW programs (which includes 14,000 MOW participants) that we previously
linked to CMS claims using probabilistic methods under a previous DUA. Criteria for inclusion forthis cohort
include MOW recipients ages 66 and older receiving meals from one of the 13 MOW programs.
For each cohort, we will track their healthcare utilization, including time to nursing home placement.
Additionally, for each cohort, we are also requesting from CMS a year of data prior to them entering the
cohort in order to compare their characteristics leading up to the receipt of MOW to see how similar they are
to one another. For the 2013 pilot data, this will entail using data starting from February 6, 2012, and for the
13 MOW programs, starting on January 1, 2009 (with lookback to 2007 in order to characterize MOW clients'
healthcare utilization prior to enrollment in MOW as well as their diagnoses and functional status changes
leading up to enrollment).
For the current pilot, this will entail using data starting from April 2020.
Inclusion of Women. Women will not be oversampled but will be included as they appear naturally in the
populations described above.
Inclusion of Minorities. All races and socio-economic statuses will be represented in the data as they appear
naturally in the target data populations.
Inclusion of Children. Not applicable - Our study examines the population of MOW clients age 66 and over.
3. We request a waiver of informed consent for the release of the MOW and CMS data under theCommon
Rule. We acknowledge that:
(1)
The research involves no more than minimal risk to the subjects; the only risk is the
breach of confidentiality of the use of the data. Our safeguards are detailed in the application.
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; No contact with
individuals is necessary for the completion of this project since all data will have been previously collected for
non-research purposes. Results will be reported in aggregate and no published reports will include information
on specific individuals.
(3) The research could not practicably be carried out without the waiver or alteration; We are
proposing to use routinely collected administrative data for the analysis of the primary and
secondary study outcomes. We require the data in identifiable format in order to link data received
from the MOW program to data received from the Centers for Medicare and Medicaid Services
(CMS) at the client level and could not conduct the study without the link. A waiver of consent is
regularly sought out for analyses that are conducted using linked CMS data. Measures to protect the
confidentiality of the information are described below
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after
participation. We will not have direct access to any individuals not enrolled in the
randomization portion of the study. Therefore, we will include a study summary and results in
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MOW programs’ newsletters. There we will also include information about who to contact to
learn more about the study. For those we do have direct access to (i.e., participating in the
interviews), we will directly mail a summary of study results at the completion of the study.
4. HIPAA and Protected Health Information (PHI):
At the individual level, this project will use secondary data sources from the Centers for Medicare and
Medicaid Services (CMS), and Meals on Wheels (MOW). Direct identifiers such as social security
number, first and last name, telephone number, and address will be present in the MOW data (not in
the CMS data), but other identifiers will be present in both data. The data contain personal health
information (PHI), and the CMS data will be disclosed to the research team by the CMS under the
strict terms of a Data Use Agreement (DUA). Shells of the DUA form and executive summary (which
includes a drafted data management section) are included with this request.)
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As part of the CMS DUA, we request that a HIPAA waiver of authorization be granted by the Brown
IRB in order to allow CMS to release the PHI to us. MOW may also require a DUA for their data, we
are not yet sure about that and will update the IRB and the Brown DUA office before we pursue a
DUA.
We acknowledge that:
The PHI use or disclosure involves no more than minimal risk to the privacy of individuals.
Part VI (3) and Part VI (6), as well as the Protections Against Risk section below outlines how we
will accomplish protecting identifiers from improper use and disclosure, as well as our plan to
destroy identifiers at the earliest opportunity consistent with research. In addition, we confirm that
the PHI will not be reused or disclosed to any other person or entity except (a) as required by law, (b)
for authorized oversight of the research study, or (c) for other research for which the use or
disclosure of the PHI is permitted by the Privacy Rule.
The research could not practicably be conducted without the requested waiver or alteration.
The CMS data used for this project have been previously collected for non-research purposes.
Depending on the cohort as described above, we will use data from 2007-2021. No contact with
individuals is necessary or desired for this study. It would be impossible for us to obtain individual
permission from these individuals.
The research could not practically be conducted without access to and use of the PHI.
The research could not be conducted without access to these individually identifiable data since CMS
does not release assessment data (i.e., MDS) in less restricted form. We need the PHI in the MOW
data to link to their CMS data, perform the randomization, and for follow-up. Additionally, we need
the PHI in order to determine the efficacy of the two different modes of delivery on time to nursing
home placement (primary outcome) as well as days in community and hospital transfers (secondary
outcomes) among food insecure older adults with ADRD.
Protections Against Risk
Dr. Kali Thomas will ensure that systems are in place to minimize the risk of breach of
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confidentiality for all data in this trial. Brown maintains numerous confidential databases, including
MDS and Medicare files, and has a high level of security built into its computing systems. Dr.
Thomas will work closely with MOWA leadership to develop protocols to maintain a high level of
data confidentiality for extracting and merging data from their programs’ records. She will also work
with our DUA manager (Dr. Julie Lima) and our IT Director (Jeffrey Hiris).
All data transfers will be managed by the IT Director. Those between MOW programs and Brown
University will be done by secured methods, likely via a secure stfp server. Data will be encrypted
with an Advanced Encryption Standard (AES) of at least 256-bit encryption algorithm. This is a
block cipher adopted as an encryption standard by the U.S. government. The National Security
Agency (NSA) has deemed the use of 256- bit AES encryption algorithm as secure enough for U.S.
government top secret information. Passwords will be transmitted out of band, either verbally, email,
or via an SMS text message. Identifiers for MOW clients will be shipped to HealthApt to pull their
Medicare and assessment data from the Centers for Medicare and Medicaid Services. To maintain
and assure the security of identifiable information shipped to HealthApt, all finder files containing
secure information will, again, be encrypted to at least AES-256 standards. The files will be
password protected with a password no less than 10 digits in length and must contain a combination
of letters and numbers. The data shipment will be sent by a courier service with tracking capabilities,
such as FedEx, UPS, DHL, or Registered Mail options. The password and the DUA# to which the
finder file belongs will be emailed to HealthAPT at CMSdata@gdit.com.
As mentioned above, The Center for Gerontology and Health Care Research maintains numerous
confidential databases and has a high level of security built into its computing system. The
computing infrastructure consists of a VMScluster, which houses all substantial data, a group of
Windows servers that provide computer services and infrastructure support for client systems, and
client Windows PCs through which all Gerontology users access our systems. Network security is
provided by a combination of University firewalls, local network access controls, and continuous
auditing and monitoring for security breaches. All access from systems external to the local area
network (LAN) is limited to encrypted channels, e.g., Secure Sockets Layer (SSL) for Virtual
Memory System (VMS) terminal sessions, or Virtual Private Network (VPN) connections for LAN
file-sharing access. (Unencrypted access is provided for the Center's external website and general
email support functions.) The VMScluster acts as a file server for 186 Windows clients, and file
access controls are consistently applied whether access is from the VMS or Windows environment.
Security within the system is applied via Access Controlled Entry (ACE) attached to all files on all
systems. Security is applied uniformly to all files within a subtree of any file system, with the general
rule that groups of users sharing a common task may read each other’s files but, in most cases, not
write to each other’s files. VMS provides a highly-secure programming environment with ACEs
applied to all objects and extremely controlled access to the larger system for individual users, as
well as a versioning file system, secure batch queues and distributed processing, and efficient backup
and recovery procedures. Windows clients are limited to a subset of these services (e.g., there is no
way for file version information to be shown to Windows clients), but otherwise access is secured as
for any other method of accessing data.
Personally-identified data, as well as partially de-identified data, are housed in files that are
restricted to systems management or to programmers who have been identified as custodians. No
data are ever moved to more "public" spaces without identification information being stripped or
non-reversibly encoded. Encoding is generally done via fairly large Roman cyphers applied
iteratively to the original character string. No reverse encoding is ever generated nor maintained.
Any matching between personally-identified data sources is done within a secured area prior to any
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data being exported. Windows servers that house partially de-identified data have matching ACEs
applied so that access restrictions are applied consistently with VMS-based data. It should be noted
that since we use demographic covariates for many of our analyses, even the encoded data are best
considered partially de-identified. ACEs restrict access to all data, such that access to any data
elements on the servers is limited to those staff authorized to make such access. Authorizations are,
in turn, granted by the core system's support staff upon request from a PI or other appropriate data
owner. All users authorized to access systems have access to some storage, which is considered
"general file sharing," but, by convention and policy, all individual or otherwise restricted data are
prohibited from being stored on such space. Desktop systems are authorized to specific users, and it
is assumed that they will store data that they have been authorized to work with on such local
systems. The LAN is switched, yielding a reasonable amount of security between clients and
servers within the LAN. Desktop systems are required to run current anti-virus software and are
prohibited from running local file-sharing software. External analyses are run periodically to verify
the security of the systems within the LAN.
Similarly, the Windows servers that support the LAN are configured as a local, isolated, secure,
collapsed Active Directory (AD) forest local to our LAN, Domain Name System (DNS), and
Dynamic Host Configuration Protocol (DHCP); other critical services are secured within the
context of the local forest and are not accessible externally with the exception, of course, of VPN or
Remote Desktop Protocol (RDP) access from authorized client systems. Extensive monitoring is
done from the VMS cluster to ensure the health and stability of the Windows forest structure and
the individual servers within it.
In summary, the VMS computer system is highly secure and accessible only to authorized users.
Within the group of authorized users, access to project data is restricted to individuals who are
authorized to work on that specific research project. Access to identifiers is further restricted to only
the systems manager and any person designated to do raw data merges across files. Furthermore,
Gerontology employees have signed an oath of confidentiality, and its violation is sufficient
grounds for immediate termination. Results of this research will be presented for large groups so
that individuals cannot be identified. We will suppress the reporting of any data where the number
of individuals is less than 11.
5. Do any of the source(s) require a Data Use Agreement (DUA) or other Agreement that requires institutional
signature to obtain, access or use the data / biospecimens? ցYes տNo
If “yes,” please include a copy of the Agreement(s) with this submission and also follow the Data Use
Agreement review and signature processes.
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Brown
PART VI. DATA SECURITY ASSESSMENT
1. Will you be collecting biospecimens?
տYes ցNo
If “yes,” please review the Institutional Biosafety Committee (IBC) webpage. A
supplemental IBC review may be required.
2. Do the study data / biospecimens include identifiers? Video and audio recordings are considered
identifiable.
տNo
If “no,” I affirm that I have read and will abide by the Level 1 Risk Minimum Security
Standards: տYes տNo
Proceed to Question #3.
ցYes
University IRB Original App
If “yes,” answer the following questions.
A. Describe the identifiers associated with the data / biospecimens.
For the MOW data: first and last name, telephone number, date of birth,
race/ethnicity, gender, address, SSN, Medicare   ID   number,   MOW
client ID, marital status, emergency contact information, living arrangement,
participant dementia/cognitive impairment, diagnoses, functional status) as
well as programmatic data (e.g., meal delivery start date, meal delivery end
date, breaks in service for meal delivery (including reasons for break in meal
delivery service, issues/complaints/satisfaction from participant, caregiver, or
delivery person, and total number of meals delivered to participant)
For the CMS data: dates directly related to an individual such as birth, death, dates
of service, enrollment, assessment, hospital admission, discharge (as found in
claims, assessment, and enrollment Research Identifiable Files (RIF) from the
Centers for Medicare and Medicaid Services), age information for those above 89,
gender, race/ethnicity, medical conditions, that in combination with these other
items may be considered uniquely identifying.
B. Justify why identifiers are required to conduct the research.
CMS does not release many of these files in less restricted form, and those that are
available in less restricted Limited Data Set (LDS) form are not sufficient for our
purposes because they do now allow us to follow an individual. We must be able to
follow individuals over time and through the health care system, requiring consistent
identifiers.
MOW data with identifiers is needed for the randomization, and to link to the CMS data.
C. Described the proposed research use of the identifiable data / biospecimens.
We require the data in identifiable format in order to link data received from the MOW
program to data received from the Centers for Medicare and Medicaid Services
(CMS) at the client level and could not conduct the study without the link
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D. Self-classify the Risk Level of these data / biospecimens (select the highest level of risk
for all data / biospecimens being collected).
տLevel 2 Risk
ցLevel 3 Risk
3. How will study data / biospecimens be collected?
տBrown desktop
տLaptop
տDepartmental server
տCIS managed server
տBrown Qualtrics
տREDCap; Please describe what instance of REDCap is being used (Brown does not have an instance of
REDCap): Click or tap here to enter text.
տAmazon Mechanical Turk (MTurk)
տText messaging ೦You must complete the Text messaging section after completing Qs 3 – 5.
տMobile App (on tablet, iPad, Phone) ೦You must complete the Mobile App section after completing Qs 3-
5.
տZoom
տDigital records (audio / videoconferencing tools, digital photographs); please describe the tool: Click or
tap here to enter text.
տPaper records (including physical photographs). Please describe, including how you will securely store
the paper records: Click or tap here to enter text.
տWeb-based site / survey/ other tool not listed above ೦You must complete the Web-based Other section
after completing Qs 3 – 5.
ցOther; please describe:
CMS and MOW data will already have been collected for non-research purposes. Much of the CMS data
will already be in-house, anything not in house will be sent to us on discs. The MOW data transfer will be
done by secured methods, likely via a secure stfp server. See “protections against risk” above for more
information.
Interviews will be conducted over the telephone and recorded. Recorded responses will be collected,
stored, and examined at Brown University and will be kept in a secured area in password-protected server
files. Any transcribed interviews will be kept in locked cabinets in the Principal Investigator’s office. All
interviews will be given a unique identifier (e.g., 001, 002) and will not contain nor be linked to any
identifiable information.
4. Who will have access to the study data / biospecimens?
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տA. Brown PI only. How will unauthorized access by others be prevented?
Click or tap here to enter text.
ցB. Brown PI and other Brown research team members. How will unauthorized access by others be
prevented?
Personally-identified as well as partially de-identified data is housed in files which are restricted to the
systems manager or to programmers who have been identified as Custodians or project staff for a
specific data collection process which requires use of personal identifiers. No data is ever moved to
more “public” spaces without personal identifying information being stripped and replaced by unique
and non-informative person IDs. Insofar as CMS provides such IDs (e.g., a study-specific beneficiary
ID) we have used them. Any matching between personally-identified data sources is done within a
secured area prior to any data being exported.
It should be noted that since the Center uses demographic covariates and provider IDs for many of our
analyses, even the encoded data is best considered partially de-identified. ACEs restrict access to all
data housed by the Center, such that access to any data elements on the servers is limited to those staff
authorized to make such access. Authorizations are in turn granted by the core system’s support staff,
upon request from a PI or other appropriate data owner. All users authorized to access Center systems
have access to some storage which is considered “general file sharing,” but by convention and policy
all individual or otherwise restricted data is prohibited from being stored on such space.
Desktop systems are authorized to specific users and it is assumed that they will store data that they are
authorized to work with on such local systems. The Center’s LAN is switched, yielding a reasonable
amount of security between clients and servers within the LAN. Desktop systems are required to run
current anti-virus software and are prohibited from running local file-sharing software. External
network scans are run periodically to verify the security of the systems within the LAN.
Similarly, the Windows servers which support the LAN are configured as a local, isolated, secure,
collapsed AD forest local to our LAN. DNS, DHCP and other critical services are secured within the
context of the local forest and are not accessible externally (with the exception, of course, of VPN
access from authorized client systems.) Extensive monitoring is done from a small VMScluster to
ensure the health and stability of the Windows forest structure, and the individual servers within it.
տC. Data will be shared with research collaborators external to Brown. This data sharing intent must be
described as part of your consent process / form. Please describe how you will securely share / transfer
the data outside of Brown:
Click or tap here to enter text.
Note that an Outgoing Data Use Agreement is required when sharing identifiable data external to
Brown. Please follow the procedures outlined here. You do not need to submit a copy of a DUA to the
HRPP. This will be linked by the ORI administratively.
5. Where will the study data / biospecimens be stored?
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ցDepartmental server
տCIS managed server
տStronghold
տCampus file storage
տREDCap
ցOther. Please describe: Transcripts and tapes will be kept in locked cabinets in the Principal Investigator's
office
6. If traveling with your data, describe how your data will be secured.
N/A
7. For how long will you retain identifiable data / biospecimens? How will you destroy identifiers when
no longer required?
Some data for this project do contain names, social security numbers and other direct identifiers. Additionally,
PHI including dates of birth, death, health services utilization, and geographic information smaller than the
state will remain on the analytic files, making the data potentially identifiable. These data will be housed in a
project space that is specific to the project and accessible only to anyone with permission to access the data
according to our DUA and relevant agreements with MOW (more on the specifics of the environment the data
are stored in can be found in part 3, above.)
At the end of the study, the project space will be deleted, all analytic files containing identifiable information
will be destroyed, and a Certificate of Disposition will be signed and sent to CMS certifying the proper
destruction of all applicable data.
Interview tapes, transcripts, and any related study materials will be destroyed after three years from
publication of the findings and/or three years from the submission of the final report to NIA, whichever event
is later.
8. Text Messaging (only complete if instructed above.)
A. Are you using the current text messaging service available on the device?
տYes տNo
If “no,” you must also complete the Mobile App section.
B. Whose device will be used? տParticipant’s personal phone տBrown-issued phone
C. Content of messaging: (If brief, insert here; otherwise, please provide as an attachment)
D. Is the communication one-way or two-way? տOne-way տTwo-way
9. Mobile App (only complete if instructed above.)
A. Name of the mobile app: Click or tap here to enter text.
B. Has this site / tool been reviewed by CIS IT Security?
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տYes տNo
If “no,” answer the following:
a)
Who created the site / tool (vendor name or off the-shelf app creatorname)?
Click or tap here to enter text.
b)
Where is it hosted?
Click or tap here to enter text.
c)
Is the site / tool scanned for security vulnerabilities? տYes տNo
d)
What version of software is being used, if applicable: տN/Aor
Click or tap here to enter text.
e)
How are the data encrypted?
Click or tap here to enter text.
C. Whose device will be used? տParticipant’s personal phone տBrown-issued phone If
Participant’s person phone:
a.How is the app downloaded to the device?
Click or tap here to enter text.
b. Is a password or PIN required for the app? տYes տNo
D. Will data be stored on the device for any period of time?
տYes տNo
a.If “yes,” please describe (i.e., queue on phone and then transmitted to server):
Click or tap here to enter text.
b. Is the app data encrypted on the device? տYes տNo
E. Device features mobile app can access տN/A
տDevice ID and call information
տIdentity
տContacts
տCamera
տSMS or chat
տStorage
տDevice and application history
տPhone
տPhoto / media / files
տMicrophone
տLocation
տOther; please describe: Click or tap here to enter text.
F. Will a third-party have access to research data through this app? տYes տNo
G. Is data transmitted by the device?
տYes տNo
If “yes,” how is it encrypted in transit?
Click or tap here to enter text.
H. Are phone numbers or mobile identification numbers stored with the data? տYes տNo
10. Web-based Other (only complete if instructed above.)
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A. Name of the site / tool: Click or tap here to enter text.
B. Has this site / tool been reviewed by CIS IT Security?
տYes տNo
If “no,” answer the following:
a.Who created the site / tool (vendor name or off the-shelf app creator name)?
Click or tap here to enter text.
b. Where is it hosted?
Click or tap here to enter text.
c. Is the site / tool scanned for security vulnerabilities? տYes տNo
d. What version of software is being used, if applicable: տN/A or Click
or tap here to enter text.
e. How are the data encrypted?
Click or tap here to enter text.
C. Is informed consent being obtained via this site / tool?
տYes տNo
If “yes,” how is re-identification prevented?
Click or tap here to enter text.
D. Does the technology allow for the explicit exclusion of the collection of IP address of the participant’s
connection?
տYes տNo
If “yes,” will you use this option to exclude the collection of IP address?
տYes տNo
Brown Qualtrics: CIS has pre-vetted Brown Qualtrics for collection/storage of up to Risk Level III data. Qualtrics is the preferred
survey tool for all Brown research data collection.
REDCap: Brown does not currently have its own instance of REDCap. Access to REDCap through a Lifespan collaborator must be
explicitly identified.
Data collection: The expectation is that data collection devices will only store data during active data collection. Data must then be
transitioned to more secure long-term storage solutions.
Departmental/CIS managed servers: If data are collected/entered directly onto a Departmental or CIS managed server, you must
ensure that the server meets the security standards described in the Minimum Security Standards for Servers based on the Risk Level
of the data identified in 1D.
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Please complete & attach the following Appendices to this Application, as applicable.
Incl.
N/A
տ ց
Appendix A. Children as Subjects
To be attached when minors are included as participants [please be aware of the age of
majority for your specific research site(s)]
տ ց
Appendix B. Prisoners as Subjects
To be attached when prisoners are included as participants.
տ ց
Appendix C. Use of Drugs
To be attached when the research includes the use of FDA-regulated or unregulated drugs.
տ ց
Appendix D. Use of Devices
To be attached when the research includes the use of FDA-regulated or unregulated devices.
տ ց Appendix E. Prescription Drug / Medication Management
To be attached when study procedures include administering prescription medications to study
participants
տ ց
Appendix F. Mental Health Safety Plan
To be attached when participants may experience significant emotional distress, or be at risk of
themselves or others.
ց տ
Appendix G. Use of Protected Health Information (PHI) for Research
To be attached when study procedures include a plan to access, use or disclose Protected Health
Information (PHI) of participants.
տ ց Appendix H. International Research
To be attached when study involves human subjects research outside the United States.
տ ց Appendix I. Advisor Appendix
To be attached when a graduate or medical student is the Principal Investigator.
PART VII. APPENDICES
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Please attach the following materials to this Application for Expedited / Full Board IRB Review, as
applicable.
Incl.
N/A
ց
տ Additional Investigator COI
տ ց Application for IRB Authorization Agreement (IAA)
ց
տ Data collection materials (questionnaires, surveys, interview scripts, etc.)
ց
տ Data Safety Monitoring Plan
ց
տ Data Use Agreement from data provider(s)
տ
ց DSMB Charter Template
տ ց HIPAA Authorization
ց
տ Informed consent documents / scripts
ց
տ Permissions, approval documents, and/or support letters
ց
տ Recruitment materials (emails, flyers, letters, scripts, posters, brochures, etc.)
տ
ց Request for Approval to Serve as Principal Investigator on a Human Subjects Research
Application
ց
տ Other: Consent Understanding Checklist, Study Cohort Table
տ
I am affiliated with Rhode Island School of Design and will abide by policies and
procedures set forth by my institution.
1. Have you completed a conflict of interest disclosure (i.e. COI Reporting Form) within the past 12 months
and is it accurate and up-to-date as of the time of this submission, as required by Brown’s COI Policy? (If
you have not completed this disclosure, access the InfoEd system here.)
PART VIII. ATTACHMENTS
PART IX. CONFLICT OF INTEREST
The Brown University Conflict of Interest Policy for Officers of Instruction and Research (“COI Policy”) defines the term
“Investigator” as “the project director or principal investigator and any other person, regardless of title or position (e.g., full or part-
time faculty member, staff member, student, trainee, collaborator, or consultant), who is responsible for the design, conduct, or
reporting of sponsored research.”
Using this definition of “Investigator,” please ensure that all Investigators on this protocol answer questions
(1) and (2) below. Attach additional sheets for any Investigators who are not the PI; additional sheets are
available on the HRPP website.
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ցYes տNo
If “no,” please do so before submitting this Application
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2. Do you have a significant financial interest (SFI) that is related to this research protocol?
“Related” could mean the research involves products, technology, intellectual property, or services made,
owned, or provided by the entity/ies in which you have an SFI. It could also mean that the SFI could be
affected by the proposed research or its results.
տYesցNo
If “yes,” please identify the SFI and explain the relatedness:
Click or tap here to enter text.
3. Do you have a faculty advisor or other Brown investigators working on this study?
ցYes տNo
Additional COI sheets for Investigators are attached to this Application.
A. Conduct of the Research
1. I accept responsibility for the ethical conduct of this research and protection of participants as set
forth in the Belmont Report, Common Rule, and Brown University policies.
2. I accept responsibility for ensuring this research is conducted in accordance with:
a) Sound research design and methods;
b) The parameters of the research plan and activities described in this Application;
c) The applicable terms of the grant, contract, or other signed funding agreements;
d) Applicable laws and regulations, including those protecting the rights, safety and welfare of
human subjects.
3. I certify that I am, or my faculty advisor is, sufficiently qualified by education, training and
experience to assume responsibility for the proper conduct of this research. I accept
responsibility for ensuring that all member of the research team have or will complete human
4. subjects CITI training before any work with participants or identifiable data / biospecimens
begins.
5. I accept responsibility to personally conduct and/or directly supervise this research. I certify that
I have sufficient time and resources to properly conduct and/or supervise this research.
6.
B. Ensuring and Maintaining Compliance
1. I will comply with relevant regulatory and institutional reporting requirements, including Brown
University’s Reportable Events Policy.
2. I understand that it is my responsibility to ensure that any research personnel, including myself,
responsible for the design, conduct or reporting of the research declares any conflicts of interest
related to this research. I will ensure that any changes that impact my or other research
personnel’s answers to the questions in PART IX. Conflict of Interest, are reported promptly to
Brown’s HRPP.
3. I will ensure that prospective agreement and/or informed consent is obtained and a copy is
provided to participants, when appropriate.
4. If there are changes to the research described in this Application for Expedited / Full Board IRB
Review that may impact the study’s classification as Full Board or Expedited research, I will
promptly notify the Brown HRPP of such changes.
5. I will notify the Brown HRPP when I have completed all activities involving human subjects or
PART X. PRINCIPAL INVESTIGATOR AGREEMENTS &
RESPONSIBILITIES
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identifiable participant data or identifiable biospecimens.
6. I will maintain approval, as applicable, with collaborative parties, including approvals from other
countries or jurisdictions.
7. I will cooperate with any post-approval monitoring or auditing of study activities and/or study
records as requested and/or required by the Brown ORI, the Brown IRB, funding entities,
sponsors, and/or any federal or state regulatory agencies.
C. Study records, Reports and Documentation
1. I will comply by Brown’s Research Data and Research Materials Management, Sharing and
Retention Policy.
2. I will maintain all research protocol materials and consent materials for the duration of this
study.
3. I will maintain research records for at least three years following the end of this research, or for a
longer length of time if specified in applicable regulations or sponsor requirements. I will take
measures to prevent accidental or premature destruction of these records.
4. I will abide by all terms of any Data Use Agreement (or equivalent agreement) related to this
study, including those agreed to electronically (through an online attestation).
5. I will ensure that the data security measures for acquisition, collection, transfer and use of study
data described in PART VI. of this Application are adhered to by all members of the research
team.
By my signature below, I certify that I have read and agree to uphold all of the Agreements and
Responsibilities in PART X.
Principal Investigator signature:
Date: 12/02/2020
===============================================================================
For IRB Use Only
Signature of the IRB:
Date of IRB approval: 12/10/2020
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0 IPAA Authorization, by Subject Group
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Pilot Research Activities and
Research Activity
Subject Group
Informed Consent Requirement
HIPAA Authorization
Requirement
Linking MOW client data to CMS
administrative data
All MOW clients at 3 MOW program
sites at time of data request.
Request waiver of Informed
Consent
Request waiver of HIPAA
authorization requirement
Clients from MOW program
waitlist enroll to receive either
drop-shipped meals or meals
delivered by the MOW 
program multiple times a 
week. Those who enroll are 
randomly assigned meal type
delivery.
Those who do not enroll remain
on the MOW waitlist. Client
data will beshared with the
research team.
We will enroll 235 clients at 3
MOW program sites
(Including a range of 45-60 clients
in Florida, 75-80 in Dallas, Texas,
and 100-115 at MOW-
SanAntonio, for a grand total of 
235 participants) who meet the
following eligibility:
●
Age 66 years or older
●
Currently on MOW waitlist
●
Self-report dementia diagnosis
or cognitive impairment
Request waiver of Informed
Consent
Request waiver of HIPAA
authorization requirement
Client telephone interviews
(recorded)30minutes
Sub-group of enrolled clients
participating in the Pilot.
Total number interviews: 6-30 clients
from 3 MOW program sites (2-10
clients per site)
1.
Requesting a waiver of
documentation of Informed
Consent
2.
Participant Welcome Letter,
Participant Consent Form and
Consent Checklist (including
consent to audio recording)
will be used for consent
discussion
n/a (no protected health
information is collected)
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0 IPAA Authorization, by Subject Group
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Caregiver/Emergency Contact
interviews (recorded) 30-45
minutes
Sub-group of caregivers or emergency
contacts of enrolled clients
participating in the Pilot.
Total number interviews: 6-30
caregivers/emergency contacts from 3
MOW program sites (2-10 interviews
per site)
1.
Requesting a waiver of
documentation of Informed
Consent
2.
Caregiver Welcome Letter
and Caregiver Consent Form
(including consent to audio
recording) will be used for
consent discussion
n/a (no protected health
information is collected)
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ID:
Date:
Research Staff Initials:
Home-delivered meals for persons with dementia: Which model delays nursing home
placement?
CONSENT CHECKLIST
Instructions: Complete this checklist as you review the informed consent with the potential participant.
Explain to the participant that:
“We are going to go over “Informed Consent” summary sheet that you received with your welcome letter. This
summary sheet will explain everything you are being asked to do as part of the study. Feel free to stop me at
any time to ask questions. We are going to go slow and review parts of the document as we go to make sure
you understand all the pieces of the project. Are you ready? OK…”
1) Does the participant understand the nature of the research and of his/her participation?
Check #1: After reviewing the PURPOSE on the consent form, say to the participant:
In your own words tell me what this study is about.
If the participant has difficulty, provide simple prompts such as:
•
This study is people’s experiences receiving home-delivered meals, can you tell memore
about it?
Notes:
Check #2: After reviewing the section, PROCEDURES, say to the participant:
In your own words, tell me some of the things you will be
asked to do as part of this study.
If the participant has difficulty, provide simple prompts such as:
•
We will contact you by phone, what will we ask you to do?
Notes:
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ID:
Date:
Research Staff Initials:
CONSENT CHECKLIST cont.
2) Does the participant appreciate the consequences of the participation, including personal consequences?
Check #1: After reviewing the section, RISKS, say:
If the participant is unable to spontaneously provide risks that might come from participation in
the study, make note of any prompts that are used or sections that are repeated.
Notes:
Check #2: After reviewing the section on BENEFITS of being in the study say:
If the participant is unable to spontaneously provide benefits that might come from
participation in the study, make note of any prompts that are used or sections that are
repeated.
Notes:
In your own words, tell me some of the risks that might
come from being in the study?
In your own words, tell me some of the benefits that
might come from being in the study?
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ID:
Date:
Research Staff Initials:
CONSENT CHECKLIST cont.
3) After reviewing the section, VOLUNTARY, does the participant understand participation is voluntary and are
they consistently interested in doing the study? For example:
Check #1: Say: “Your participation is voluntary, what does that mean
to you?”
Check #2: And “If you change your mind about being in the study, what
can you do?”
Notes:
4) Does the participant show the ability to make a reasoned and consistent choice?
Check #1: After reviewing the entire consent form, say: Do you have any final questions
about the study? Does this sound like something you would be
willing to take part in?
Notes:
Check #2: Make note throughout the informed consent process and the initial assessment (Baseline)
regarding the consistency of their choice to take part in the study.
Notes:
Based on your Capacity to Consent Training: If the participant is unable to perform any of these tasks to your
satisfaction, proceed to discontinuing the interview.
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Attachment: Caregiver Welcome Letter - “Opt In” - Site 1
Date
Dear Care Partner of an Older Adult Receiving Home-Delivered Meals,
You are invited to take part in a telephone interview as part of a Brown University
research study. We are asking you to take part because you are listed as an emergency
contact for a person who is receiving home-delivered meals.
The goal of this study is to learn about what it is like for care partners of people who
receive meals delivered to their homes.
The phone call will take about 30 to 45 minutes. We will ask about what it is like to be a
care partner for a person receiving meals at their home. We want to know more about
your experience and how the service has impacted your life. We will also ask about any
interactions with the person who delivers the meals and how satisfied you are with the
services.
This study is paid for by the National Institute on Aging. In this envelope, there is also
an Informed Consent Summary Sheet. This sheet gives details on the study. The sheet
also has information about the possible risks and benefits of choosing to take part.
To thank you for helping us, we will mail you a $50 pharmacy (for example, CVS or
Walgreens) gift card. You will get this giftcard after the telephone interview is done.
If you would like to take part in the study, please call us at xxx-xxx-xxxx. We will tell you
about the study and may ask you some questions to see if you qualify.
If you would like more information or to verify this study, please call xxx, Project
Coordinator, at xxx-xxx-xxxx. You may also call the Principal Investigator, Dr. Kali
Thomas at xxx-xxx-xxxx
Sincerely,
Kali Thomas, PhD
Principal Investigator
Brown University
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Attachment: Caregiver Welcome Letter - “Opt Out” - Site 2
Date
Dear Care Partner of an Older Adult Receiving Home-Delivered Meals,
You are invited to take part in a telephone interview as part of a Brown University
research study. We are asking you to take part because a client receiving home-
delivered meals told us that you were their care partner.
The goal of this study is to learn about what it is like for care partners of people who
receive meals delivered to their homes.
The phone call will take about 30 to 45 minutes. We will ask about what it is like to be a
care partner for a person receiving meals at their home. We want to know more about
your experience and how the service has impacted your life. We will also ask about any
interactions with the person who delivers the meals and how satisfied you are with the
services.
This study is paid for by the National Institute on Aging. In this envelope, there is also
an Informed Consent Summary Sheet. This sheet gives details on the study. The sheet
also has information about the possible risks and benefits of choosing to take part.
To thank you for helping us, we will mail you a $50 pharmacy (for example, CVS or
Walgreens) gift card. You will get this giftcard after the telephone interview is done.
We are asking you to do one of the following:
1. If you would like to be considered for participation in the study or you would like
to know more about this study, please contact us at xxx-xxx-xxxx. We will tell
you about the study and may ask you some questions to see if you qualify.
2. If you do not wish to be considered for participation in the study, please return
the pre-addressed, postage-paid postcard or call the phone number indicated
below.
If we don’t hear from you, we will contact you by telephone in 2-4 weeks from the
postmarked date of this letter.
If you would like more information or to verify this study, please call xxx, Project
Coordinator, at xxx-xxx-xxxx. You may also call the Principal Investigator, Dr. Kali
Thomas at xxx-xxx-xxxx
Sincerely,
Kali Thomas, PhD
Principal Investigator
Brown University
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Attachment: Participant Welcome Letter - Reminder
Date
Dear [Name of Program] Client,
We previously reached out to you to see if you were interested in taking part in a
telephone interview as part of a Brown University research study.
We are asking you to take part because you are receiving home-delivered meals.
The goal of this study is to learn what it is like for you to receive meals delivered to your
home. This study consists of a telephone interview that will take about 30 minutes. We
willask you about your experience receiving meals.
This study is paid for by the National Institute on Aging. In this envelope, there is also
an Informed Consent Summary Sheet. This sheet gives details on the study. The sheet
also has information about the possible risks and benefits of choosing to take part.
To thank you for helping us, we will mail you a $50 pharmacy (for example, CVS or
Walgreens) gift card. You will get this giftcard after the telephone interview is done.
If you would like to take part in the study, please contact us at xxx-xxx-xxxx. We will tell
you about the study and may ask you some questions to see if you qualify.
If you would like more information or to verify this study, please call xxx, Project
Coordinator, at xxx-xxx-xxxx. You may also call the Principal Investigator, Dr. Kali
Thomas at xxx-xxx-xxxx.
Sincerely,
Kali Thomas, PhD
Principal Investigator
Brown University
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Attachment: Participant Welcome Letter - “Opt Out” - Site 3
Date
Dear [Name of Program] Client,
We are reaching out to you to see if you are interested in taking part in a telephone
interview as part of a Brown University research study.
We are asking you to take part because you are receiving home-delivered meals.
The goal of this study is to learn what it is like for you to receive meals delivered to your
home. This study consists of a telephone interview that will take about 30 minutes. We
willask you about your experience receiving meals.
This study is paid for by the National Institute on Aging. In this envelope, there is also
an Informed Consent Summary Sheet. This sheet gives details on the study. The sheet
also has information about the possible risks and benefits of choosing to take part.
To thank you for helping us, we will mail you a $50 pharmacy (for example, CVS or
Walgreens) gift card. You will get this giftcard after the telephone interview is done.
We are asking you to do one of the following:
1. If you would like to be considered for participation in the study or you would like
to know more about this study, please contact us at xxx-xxx-xxxx. We will tell
you about the study and may ask you some questions to see if you qualify.
2. If you do not wish to be considered for participation in the study, please return
the pre-addressed, postage-paid postcard or call the phone number indicated
below.
If we don’t hear from you, we will contact you by telephone in 2-4 weeks from the
postmarked date of this letter.
If you would like more information or to verify this study, please call xxx, Project
Coordinator, at xxx-xxx-xxxx. You may also call the Principal Investigator, Dr. Kali
Thomas at xxx-xxx-xxxx.
Sincerely,
Kali Thomas, PhD
Principal Investigator
Brown University
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Attachment: Interview Guide for Caregivers
1) REVIEW CONSENT SHEET WITH PARTICIPANT
As the consent summary sheet stated, the goal of this interview is to understand your experience as a
caregiver of an older adult who receives meals delivered to their home. This interview should take no more
than 30-45 minutes and you will be given a $50 pharmacy (for example, CVS or Walgreens) gift card for your
time. This interview is confidential andnothing you say will be connected with your name, your loved one
receiving meals, or the meals that they receive. You have the right to stop the interview at any time.
Do you have any questions about the study procedures as described?
YES.................................................. ANSWER QUESTIONS AND CONTINUE BELOW
NO.................................................... CONTINUE BELOW
Do you agree to participate in this interview?
YES…....................DOCUMENT CONSENT and then PROCEED WITH INTERVIEW
NO........................ CAPTURE REASON(S) for REFUSAL (see below) and READ REFUSAL SCRIPT
REFUSAL SCRIPT - We want to thank you for considering the interview. We will remove your name from our
list of potential participants. As helpful feedback to the investigators conducting this research study, would you
be willing to share the reasons you declined participation?
[WRITE DOWN REASONS FOR REFUSAL VERBATIM]
2) PERMISSION TO RECORD INTERVIEW
Great, I would like to record our conversation so that I can listen closely to what you are telling me. As we
discussed earlier, everything that you say will be confidential in that it will not be connected with your name or
meal program. The recording will be saved in a secure location and will be destroyed after the completion of
this study. [START RECORDER UNLESS PARTICIPANT OBJECTS]
3) CONDUCT INTERVIEW QUESTIONS
1.
Tell me what it’s like for [enter name of participant] to get mealdeliveries.
Probes:
If someone helps, who is it and how?
What do they think about the person who brings the meals?
Does [name of participant] look forward to receiving the meals?
What does [name of participant] like/not like about receiving the meals?
What else?
2.
Tell me about when and how the meals are prepared and eaten.
Probes:
How much of the meal is eaten. What more can you say about that?
How the participant prepares meals.
When [name of participant] does not receive meals, how do they get their food? For example,
on weekends? Or other times?
What else?
3.
Think about before meals were coming to [name of participant’s] home and then what it was like after
they started to get meals:
Probes:
How do the meals compare to what [name of participant] used to eat?
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Brown University IRB Original Approval: 12/10/2020
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How do you think [name of participant’s] health has changed since receiving meals?
Tell me more about this.
4.
We’ve heard about how meals affected [name of participant], and now I’d like to know whether and how
receiving meals has affected YOUR life. Tell me how you feel your situation may have changed since
the [name of participant] is receiving meals.
Probe about worry, health, stress, mood, isolation.
Probe about any positive effects (follow-up prompts could be: conversation, feedback about
participant’s general well-being, feeling connected, a bright spot in the day, anything else?)
5.
What suggestions do you have for how the meal program could be improved or better tailored to those
with dementia?
Probe about communication with participant, communication with caregiver, assistance.
6.
Would you recommend that a friend or relative with dementia sign up for these meals, if offered?
Probes:
What makes you want to recommend these meal deliveries?
What things make you feel like not recommending these meals?
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Attachment: Interview Guide for Participants
(This interview will be conducted over the telephone approximately one month after initiation of meals. Prior to
the start of the interview, participants will be administered the Telephone Interview of Cognitive Status (TICS -
M) to assess the participant’s level of cognitive impairment. Following that, the interview questions below will
be asked. The interview guide may be altered and refined during piloting. We understand that IRB
amendments will need to be filed should any changes or the process change.)
1) Review Consent Sheet with Participant (use the attached Capacity to Consent Checklist when reviewing
the form)
“We are going to go over “Informed Consent” summary sheet that you received with your welcome
letter. This summary sheet will explain everything you are being asked to do as part of the study.
Feel free to stop me at any time to ask questions. We are going to go slow and review parts of the
document as we go to make sure you understand all the pieces of the project. Are you ready? OK…”
●
Does the participant understand the nature of the research and of his/herparticipation?
○
Check #1. After reviewing the PURPOSE on the consent form, say to the participant: “In
your own words tell me what this study is about.”
■
If the participant has difficulty, provide simple prompts such as:
○
Check #2: After reviewing the section, PROCEDURES, say to the participant: “In your
own words, tell me some of the things you will be asked to do as part of this study.”
●
Does the participant appreciate the consequences of the participation, includingpersonal
consequences?
○
Check #1: After reviewing the section, RISKS, say: In your own words, tell me some of
the risks that might come from being in the study?
■
If the participant is unable to spontaneously provide risks that might come from
participation in the study, make note of any prompts that are used or sections
that are repeated.
○
Check #2: After reviewing the section on BENEFITS of being in the study say: Inyour
own words, tell me some of the benefits that might come from being in the study?
●
After reviewing the section, VOLUNTARY, does the participant understand participation is
voluntary and are they consistently interested in doing the study? Forexample:
○
Check #1: Say: Do you understand that your participation is voluntary, it is your
decision?
○
Check #2: And “If you change your mind about being in the study, what can you do?
●
Does the participant show the ability to make a reasoned and consistent choice?
○
Check #1: After reviewing the entire consent form, say: Do you have any final questions
about the study? Does this sound like something you would be willing to take part in?
○
Check #2: Make note throughout the informed consent process and the initial
assessment (Baseline) regarding the consistency of their choice to take part in the
study.
Do you agree to participate in this interview?
YES........................DOCUMENT CONSENT and then PROCEED WITH INTERVIEW
NO........................ CAPTURE REASON(S) for REFUSAL (see below) and READ REFUSAL SCRIPT
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REFUSAL SCRIPT - We want to thank you for considering the interview. We will remove your name from our
list of potential participants. As helpful feedback to the investigators conducting this research study, would you
be willing to share the reasons you declined participation?
[WRITE DOWN REASONS FOR REFUSAL VERBATIM]
2) PERMISSION TO RECORD INTERVIEW
Great, I would like to record our conversation so that I can listen closely to what you are telling me. As we
discussed earlier, everything that you say will be confidential in that it will not be connected with your name or
meal program. The recording will be saved in a secure location and will be destroyed after the completion of
this study. [START RECORDER UNLESS PARTICIPANT OBJECTS]
3) COMPLETE TELEPHONE INTERVIEW FOR COGNITIVE STATUS (TICS-M)
Telephone Interview for Cognitive Status (TICS-M)
Orientation
1.
(i) What day of the week is it?
Day
೦ 
(ii) What is today’s date?
Date
೦ 
Month
೦ 
Year
೦ 
(iii) What season are we in?
Season
೦ 
2.
What is your age?
Age:
೦ 
3.
What is your telephone number? (Code+ number)
೦ 
Registration/Free Recall
4.
(i)I’m going to read you a list of 10 words. Please
Cabin
೦ 
listen carefully and try to remember them. When I am
Pipe
೦ 
done, tell me as many as you can in any order. Ready?
Elephant
೦ 
Chest
೦ 
Now, tell me all the words you can remember
Silk
೦ 
Theatre
೦ 
Watch
೦ 
Whip
೦ 
Pillow
೦ 
Giant
೦ 
Attention/Calculation
5.
(i) Please take 7 away from 100
93
೦ 
(ii) Now continue to take 7 away from what
you have left over until I ask you to stop.
86
೦ 
79
೦ 
72
೦ 
6.
Please count backwards from 20 to 1
65
No mistakes
೦ 
೦ 
Brown UCniovemrspityreIRhBeOnrsiigoinna,l ASpepm
roavanl:t1ic2/a10n/d20R
20ecent Memory
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7. What do people usually use to cut paper?
Scissors
೦
8. What is the prickly green plant found in the desert?
Cactus
೦
9. Who is the president now?
Correct surname ೦
10. Who is the vice president now?
Correct surname ೦
11. What is the opposite of east?
West
೦
Language/Repetition
12. Please say this ‘Methodist Episcopal’
Exactly right
೦
 
Delayed Recall
13. Please repeat the list of 10 words I read earlier
Cabin
೦
Pipe
೦ 
Elephant
೦ 
Chest
೦ 
Silk
೦ 
Theatre
೦ 
Watch
೦ 
Whip
೦ 
Pillow
೦ 
Giant
೦ 
□maximum of 39
4. QUESTIONS ABOUT MEAL DELIVERIES
We would like to ask some questions about your meals and want you to know that there are no right or wrong
answers.
1.
First of all, tell me if meals are delivered to your home or not.
a.
If no, ask how they get their food at home. (This response will cue the interviewer on howto
approach the interview)
2.
What is it like to get meal deliveries?
a.
Tell me a little about it: What usually happens? How does the meal get inside your home?
i.
(Probe about preparation, assistance, if any)
b.
What do you think about the person who brings the meals?
i.
(Probe about whether they look forward to seeing that person, what they do to receive it)
ii.
What is the person like? (if all negative or positive, ask about the opposite. For example,
you’ve mentioned a lot of nice things about the person; is there anything you don’t like
so much about them?)
c.
How much of the meal do you eat?
i.
(Probe for more information)
d.
What do you like about the food/meals you receive?
i.
(Probe about smell, appearance, taste, variety, anything else?)
e.
Tell me about what you don’t like so much about these meals. Remember, there are no right or
wrong answers and your answers help us know how people feel about the meals.
f.
How could the meals be improved?
3.
When you don’t receive meals, how do you get your food?
i.
(Probe about weekends, other times of the day)
4.
Think about before meals were coming to your home and then what it was like after you started to get
meals:
a.
How are these meals different or the same from what you used to eat?
b.
How do you think your health has changed?
Brown University IRB Ocri.ginaTl eApllpm
rovealh: 1o2w
/10y/2o0u20think your mood may be different since receiving meals.
Brown University IRB Amendment Approval 10/06/2021

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d. In general, how do you feel getting meals delivered to your home?
5.
Would you recommend that a friend or relative sign up for these meals, if offered?
a.
What makes you want to recommend these meal deliveries?
b.
What things make you feel like not recommending these meals?
c.
What else do you think we need to know about what receiving meals is like for you?
Brown University IRB Amendment Approval 10/06/2021

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KThomas R61AG070170|11/02/2020
BROWN UNIVERSITY
PARTICIPANT CONSENT FOR RESEARCH PARTICIPATION
Home-delivered meals for persons with dementia:
Which model delays nursing home placement?
Version 2, August 18, 2021
KEY INFORMATION:
You are invited to take part in a Brown University study. Your participation is voluntary.
●
PURPOSE: The study is about people’s experiences receiving home-delivered meals.
●
PROCEDURES: You will be asked to participate in a telephone interview aboutyour
experiences receiving meals delivered to your home.
●
TIME INVOLVED: The study will take about 30 minutes of your time.
●
COMPENSATION: You will receive a $50 pharmacy (for example, CVS or Walgreens) gift card
for your time.
●
RISKS: We will ask you questions about your experience receivinghome-delivered
meals. Some of these questions may make you feel uncomfortable, or bring up
unpleasant feelings or memories.
●
BENEFITS: While you may not directly benefit from being in this study, your
experiences will help us better understand older adults’ experiences receiving home-
delivered meals.
1. Researcher(s):
Kali Thomas, Principal Investigator; xxx-xxx-xxxx; xx_xxx@brown.edu
2. What is this study about?
The purpose of the study is to understand the experiences of people receiving home-delivered
meals. We also want to understand what helps people who receive home-delivered meals stay
living in the community.
You are being asked to be in this study because you receive meals delivered to your home.
3. What will I be asked to do?
You are being asked to participate in a telephone interview about your experiences receiving
meals delivered to your home. You will be asked questions like: “What is it like to get meal
deliveries?” “When you don’t receive meals, how do you get your food?” “In general, how do
you feel getting meals delivered to your home?”
The interview also includes a brief memory exercise.
Brown University IRB Amendment Approval 10/06/2021

1
Brown University IRB Original Approval: 12/10/2020
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Brown University IRB Amendment Approval 08/19/2021
KThomas R61AG070170|11/02/2020
We will be recording our conversation during the interview. We will use a notebook for notes
and a digital recorder.
Your participation in this study should take about 30 minutes.
4. Will I be paid?
A $50 pharmacy (for example, CVS or Walgreens) gift card willbemailedtoyourhomewithinoneweek
ofcompleting the interview.
5. What are the risks?
We will ask you questions about your experience receiving home-delivered meals. Some of
these questions may make you feel uncomfortable, or bring up unpleasant feelings or
memories. If there are any questions that you are uncomfortable answering, you do not need
to answer them. You are free to stop the interview and recording at any time.
6. What are the benefits?
While you may not directly benefit from being in this study, your participation will help us
better understand older adults’ experiences receiving home-delivered meals.
7. How will my information be protected?
Any information we collect that can be used to identify you will be carefully protected. Our
research staff are trained in protecting confidential information, and we have security
measures in place to ensure the integrity and confidentiality of all data.
All data we collect (such as recordings or notes we take) will be stored in a locked filing
cabinet in the researcher’s locked office. All electronic files we create using the data will be
secured with passcodes for protection.
We will be recording our conversation during the interview. We will use a notebook for notes
and a digital recorder. We will keep this information confidential. Only researchers working
on this study will have access to the data. We will destroy the recording after the study isover.
Brown University staff sometimes review studies like this one to make sure they are being
done safely and correctly. If a review of this study takes place, your records may be examined.
The reviewers will protect your confidentiality.
Certification of Confidentiality: To help us protect your privacy, we have obtained a Certificate
of Confidentiality from the National Institutes of Health. The researchers can use this
Certificate to legally refuse to disclose information that may identify you in any federal, state,
or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is
a court subpoena. The researchers will use the Certificate to resist any demands for
information that would identify you, except as explained below.
Brown University IRB Amendment Approval 10/06/2021

1
Brown University IRB Original Approval: 12/10/2020
Brown University IRB OAm
rigeinadlmAepnptroAvpaplr:o1v2a/l102/2/2052/02021 
Brown University IRB Amendment Approval 05/11/2021
Brown University IRB Amendment Approval 08/19/2021
KThomas R61AG070170|11/02/2020
The Certificate cannot be used to resist a demand for information from personnel of the United
States federal or state government agency sponsoring the project and that will be used for
auditing or program evaluation of agency funded projects or for information that must be
disclosed in order to meet the requirements of the federal Food and Drug Administration
(FDA). You should understand that a Certificate of Confidentiality does not prevent you or a
member of your family from voluntarily releasing information about yourself or your
involvement in this research. If an insurer, medical care provider, or other person obtains your
written consent to receive research information, then the researchers will not use the
Certificate to withhold that information.
The Certificate of Confidentiality will not be used to prevent disclosure to state or local
authorities of such as child abuse and neglect, or harm to self or others.
8. What if I want to stop?
You do not have to be in this study if you do not want to be. Even if you decide to be
interviewed, you can change your mind and stop at any time.
If you refuse to participate or leave the study, your current or future relationship with Brown
University and your meals program will not be affected.
9. Who can I talk to if I have questions about this study?
If you have any questions about your participation in this study, you can call XXX, Project
Coordinator, at xxx-xxx-xxxx or by email at xxxx@brown.edu or Dr. Kali Thomas, Principal
Investigator, xxx-xxx-xxxx or xx_xxx@brown.edu
10. Who can I talk to if I have questions about my rights as a participant?
If you have questions about your rights as a research participant, you can contact Brown
University’s Human Research Protection Program at 401-863-3050 or email them at
IRB@Brown.edu.
Brown University IRB Amendment Approval 10/06/2021

Brown University IRB OAm
rigeinadlmAepnptroAvpaplr:o1v2a/l102/2/2052/02021 
Brown University IRB Amendment Approval 05/11/2021
Brown University IRB Amendment Approval 08/19/2021
Brown University IRB Amendment Approval 02/25/2021
Brown University IRB Amendment Approval 05/11/2021
BROWN UNIVERSITY
CAREGIVER CONSENT FOR RESEARCH PARTICIPATION
Home-delivered meals for persons with dementia:
Which model delays nursing home placement?
Version 2, August 18, 2021
KEY INFORMATION:
You are invited to take part in a Brown University study. Your participation is voluntary.
●
PURPOSE: The study is about people’s experiences receiving home-delivered meals
●
PROCEDURES: You will be asked to participate in a telephone interview
●
TIME INVOLVED: The study will take 30-45 minutes of your time.
●
COMPENSATION: You will receive a $50 pharmacy (for example, CVS or Walgreens) gift card
compensation for your time.
●
RISKS: In this study, we will ask you questions about your experience as a care partner
of someone who receives home-delivered meals. Some of these questions may make
you feel uncomfortable, or bring up unpleasant feelings or memories.
●
BENEFITS: While you may not directly benefit from being in this study, your
experiences will help us better understand older adults’ experiences receiving home-
delivered meals.
1. Researcher(s):
Kali Thomas, Principal Investigator; xxx-xxx-xxxx; xx_xxx@brown.edu
2. What is this study about?
The purpose of the study is to understand the experiences of people receiving home-delivered
meals. We also want to understand the experiences of care partners of people who receive
meals delivered to their homes.
You are being asked to be in this study because you are listed as an emergency contact of a
person who receives home-delivered meals.
3. What will I be asked to do?
You are being asked to participate in a telephone interview about your experience as a care
partner of a person who is receiving meals delivered to their home. We will also ask questions
about your interactions (if any) with the person who delivers meals, how meal service impacts
your life, and your satisfaction, or dissatisfaction, with meal services.
We will be recording our conversation during the interview. We will use a notebook for notes
Brown UniverasintydIRaBdOiriggiintaal lAprpercovoarl:d1e2/r1.0/2020
Brown University IRB Amendment Approval 10/06/2021

Brown University IRB Original Approval: 12/10/2020
Brown University IRB OAm
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Brown University IRB Amendment Approval 05/11/2021
Brown University IRB Amendment Approval 08/19/2021
Your participation in this study may last up to 45 minutes.
4. Will I be paid?
A $50 pharmacy (for example, CVS or Walgreens) gift card will be mailed to your home within one
week of completing the interview.
5. What are the risks?
We will ask you questions about your experience as a care partner for a person who receives
home-delivered meals. Some of these questions may make you feel uncomfortable, or bring up
unpleasant feelings or memories. If there are any questions that you are uncomfortable
answering, you do not need to answer them. You can stop the interview and recording at any
time.
6. What are the benefits?
While you may not directly benefit from being in this research study, your experiences will
help us better understand older adults’ experiences receiving home-delivered meals.
7. How will my information be protected?
Any information we collect that can be used to identify you will be carefully protected. Our
research staff are trained in protecting confidential information, and we have security
measures in place to ensure the integrity and confidentiality of all data.
All data we collect (such as recordings or notes we take) will be stored in a locked filing
cabinet in the researcher’s locked office. All electronic files we create using the data will be
secured with passcodes for protection.
We will be recording our conversation during the interview. We will use a notebook for notes
and a digital recorder. We will keep this information confidential. Only researchers working
on this study will have access to the data. Any results published using this data will not
include your name or any other identifiable information. We will destroy the recording of our
interview after the study is over.
Brown University staff sometimes review studies like this one to make sure they are being
done safely and correctly. If a review of this study takes place, your records may be examined.
The reviewers will protect your confidentiality.
Certification of Confidentiality: To help us protect your privacy, we have obtained a Certificate
of Confidentiality from the National Institutes of Health. The researchers can use this
Certificate to legally refuse to disclose information that may identify you in any federal, state,
or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is
a court subpoena. The researchers will use the Certificate to resist any demands for
information that would identify you, except as explained below.
2
KThomas R61AG070170 |11/02/2020
Brown University IRB Amendment Approval 10/06/2021

Brown University IRB Original Approval: 12/10/2020
Brown University IRB OAm
rigeinadlmAepnptroAvpaplr:o1v2a/l102/2/2052/02021 
Brown University IRB Amendment Approval 05/11/2021
Brown University IRB Amendment Approval 08/19/2021
The Certificate cannot be used to resist a demand for information from personnel of the United
States federal or state government agency sponsoring the project and that will be used for
auditing or program evaluation of agency funded projects or for information that must be
disclosed in order to meet the requirements of the federal Food and Drug Administration
(FDA). You should understand that a Certificate of Confidentiality does not prevent you or a
member of your family from voluntarily releasing information about yourself or your
involvement in this research. If an insurer, medical care provider, or other person obtains your
written consent to receive research information, then the researchers will not use the
Certificate to withhold that information.
The Certificate of Confidentiality will not be used to prevent disclosure to state or local
authorities of such as child abuse and neglect, or harm to self or others.
8. What if I want to stop?
You do not have to be in this study if you do not want to be. Even if you decide to be
interviewed, you can change your mind and stop at any time.
If you refuse to participate or leave the study, your current or future relationship with Brown
University and the meals program will not be affected.
9. Who can I talk to if I have questions about this study?
If you have any questions about your participation in this study, you can call XXX, Project
Coordinator, at xxx-xxx-xxxx or by email at xxxx@brown.edu or Dr. Kali Thomas, Principal
Investigator, xxx-xxx-xxxx or xx_xxx@brown.edu
10. Who can I talk to if I have questions about my rights as a participant?
If you have questions about your rights as a research participant, you can contact Brown
University’s Human Research Protection Program at 401-863-3050 or email them at
IRB@Brown.edu.
3
KThomas R61AG070170 |11/02/2020
Brown University IRB Amendment Approval 10/06/2021

Brown University IRB Amendment Approval 08/19/2021
RB
Kali S. Thomas, PhD, MA
Associate Professor of Health Services, Policy and Practice
Center for Gerontology and Health Care Research
Brown University School of Public Health
Box G-S121(6)
Providence, RI 02912
Dear Dr. Thomas,
Trusted Senior Services Provider
since 1966
Meals on Wheels Pinellas County (Neighborly Care Network) is pleased to write this letter of
strong organizational support to partner with you and Brown University for your proposed
research entitled "Home-delivered meals for persons with dementia: Which model delays
nursing home placement?"
We understand the overall goal of this research is to evaluate two types of meal delivery and
assess which type of meal is best for our homebound clients with dementia by allowing them to
live longer in their communities. The project will be conducted with Meals on Wheels America
and include multiple member programs across the United States; one of these program sites
will be Meals on Wheels Pinellas County.
Our program serves 2900 clients per year and currently has a waiting list of 900 individuals, 26%
of whom have been told by a healthcare professional that they suffer from memory loss,
cognitive impairment, any type of dementia, or Alzheimer’s disease. We are eager to serve this
project as the research will have a direct impact on our operations, the healthcare system and
ultimately, the lives of our clients. We are increasingly contracting with healthcare providers
and payers who are interested in offering nutrition services to their homebound, food insecure
patients, many of whom have dementia. Having the evidence from this project will inform
those discussions. We are familiar with the previous research conducted by Brown University
under your direction and are excited to participate in this study. We are confident this project
will be greatly beneficial to our services and our clients.
We are writing to confirm our institutional support for your research. My team and I have
already provided feedback on the initial study design and look forward to providing additional
input that reflects the most important issues to our clients, families, drivers, and our program.
We appreciate the resources provided by the grant to support our efforts, and we are
committed to providing the necessary support to accomplish the aims of this proposal,
including access to our long and growing waiting list to recruit participants. We look forward to
working with you over the five years, during the pilot and full trial phases. We will participate in
13945 Evergreen Ave,. Clearwater, FL 33762
Phone: (727) 573-9444
Brown University I
OAmrigeinadlmAepnptrAovpaplr:o1v2a/l102/2/2052/02021 
Brown University IRB Amendment Approval 05/11/2021
Brown University IRB Amendment Approval 10/06/2021

Brown University IRB OAmrigeinadlmAepnptrAovpaplr:o1v2a/l102/2/2052/02021 
Brown University IRB Amendment Approval 05/11/2021
Brown University IRB Amendment Approval 08/19/2021
wn University IRB N
OrEigIiG
naHl ABpOprRovLaYl: 1S2/E10N/2IO
02R0 CARE
NEIGHBORLY_CARE
WWW.NEIGHBORLY.ORG
Brown University IRB Amendment Approval 10/06/2021

Brown University IRB OAmrigeinadlmAepnptrAovpaplr:o1v2a/l102/2/2052/02021 
Brown University IRB Amendment Approval 05/11/2021
Brown University IRB Amendment Approval 08/19/2021
the initial training designed for our program, participate in monthly meetings, host the research
team on their site visits and identify one client and one client caregiver to serve on the
Stakeholder Advisory Panel. In addition, we will identify a staff member to provide
administrative support, enroll participants, track relevant data, and coordinate data access to
your research team for project implementation. Our staff are looking forward to working with
you and your team at Brown University and Meals on Wheels America during the pilot, active
phase of project implementation, as well as the preparation of presentations and informational
materials resulting from this project.
We are confident that this research will positively impact our clients with dementia and inform
the conversations we and other home-delivered meals programs are having with healthcare.
Thank you for the opportunity to be part of this important work aimed at advancing the
evidence around home-delivered meals in an effort to improve the lives of our nation’s older
adult population.
Sincerely,
Anita Frankhauser, MS, RDN, LDN
Director of Nutrition and Licensed Dietitian
Neighborly Care Network
13945 Evergreen Ave
Clearwater, FL 33762
13945 Evergreen Ave,. Clearwater, FL 33762    Phone: (727) 573-9444
wn University IRB N
OrEigIiG
naHl ABpOprRovLaYl: 1S2/E10N/2IO
02R0 CARE
NEIGHBORLY_CARE
WWW.NEIGHBORLY.ORG
Brown University IRB Amendment Approval 10/06/2021

Brown University IRB(A8m0e0n)dm22en5t-A5p8p6ro2vaIl 1024/2250/2W
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m
Meals on Wheels
Hospice & Palliative Care
I!
Association
OFFICERS
Mary Frances Bellma n, Chairman
Eugenia King , Chairman Elect
Max Lamont, Treasurer
Uzzie Routman , Secretary
DIRECTORS
Haftda Baad
Jay Barlow
Bob Best
Jan Hart Black
Jordan Brainerd
Cathy Bryan, RN
Rebecca P Casey
Michelle Chase
Julie D. Clark
Cat her ine A. Corrigan
Levi H. Davis
Daniel DeMarco, MD
Effie Dennison
Kevin Eden
Betsy Eiseman
Kathleen Gibson
Benjamin Isgur
Zakiyah A. Johnson
Kirsten Kerrigan
Bob Krakow
Alison Draper Lolley
Louise Marsh
Pressley H. Peters
Carolyn Rathjen
Kersten Rettig
Camisha L. Simmons
Denice Swift
Alok Vaish
Andres Villareal
Jim Walton, DO
CiCi Weinmann
Paula Will s
HONORARY BOARD TRUSTEES
Deborah Cannon
Sara Fraser Crismon
Robert Ted Enloe, Ill
Philip C. Henderson
Lyda Hill
Jerry P Knippa
Lynn McBee
Jan Mcclendon
Teresa Haggerty Parravano
Daniel Polter, MD
Lucy S. Polter
Ru st E. Reid
Shirley Tobolowsky (Mrs. Edwin)
Joe Nathan Wright
PRESIDENT AND CEO
Katherine Krause
Kali S. Thomas, PhD, MA
Associate Professor of Health Services, Policy and
Practice Brown University School of Public Health Box
G-Sl21(6)
Providence, RI 02912
Dear Dr. Thomas,
The Visiting Nurses Association of Texas is pleased to write this letter of
strong organizational support to partner with you   and Brown   University
for your funded research study entitled "Home-delivered meals for
persons with dementia: Which model delays nursing home placement?"
We understand the overall goal of this research is to evaluate two types of
meal delivery and assess which type of meal is best for our homebound
senior clients with dementia by allowing them to live longer in their
communities. The project will be conducted with Meals on Wheels America
and we will participate as a pilot site for this study.
Our program served 6,363 unduplicated clients this past year and currently
has a waiting list of 289 seniors. We are eager to serve on this project as the
research will have a direct impact on our operations, the healthcare system
and ultimately, the lives of our clients. We are increasingly contracting with
healthcare providers and payers who are interested in offering nutrition
services to their homebound, food insecure patients, many of whom have
dementia. Having the evidence from   this project will inform   those
discussions. We have worked closely with you and your research team on
previous projects and are excited to work with you on this new endeavor.
We are confident this project will be greatly beneficial to our services and
our clients.
We are writing to confirm our institutional support for your research and
willingness to serve on your stakeholder advisory panel. My team  and I have
already provided feedback on the initial study design and look forward to
providing additional input that reflect the most important issues to our clients,
families, drivers, and our program. We appreciate the resources   provided   by
the grant to support our efforts, and we are committed to providing the
necessary support to accomplish the aims of this   project, including access   to
our long and growing waiting list to recruit participants.
October 22, 2020
Brown University IRB Amendment Approval 10/06/2021

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Visiting Nurse
Association
Meals on
Wheels
Hospice & Palliat ive Care
We will participate in developing training materials and Manual of Operating
Procedures, participate in team meetings, and identify one client and one
client family member to serve on the stakeholder advisory panel.-In addition ,
we will identify a staff member to provide administrative support, enroll
clients in one of two types of meal programs, assist with identification of
possible participants for interviews, and coordinate data access to your
research team for project implementation. Our staff are looking forward to
working with you and your team at Brown University and Meals on Wheels
America during this pilot project.
We are confident that this research and that which will follow will positively
impact our clients with dementia and inform the conversations we and other
home-delivered meals programs are having with healthcare. Thank you   for
the opportunity to be part of this important work aimed at advancing the
evidence around home-delivered meals in an effort to improve the lives of
our nation' s older adult population.
With gratitude,
Katherine Krause
President and Chief Executive Officer
Brown Univer(s8ity0I0R)B2O2ri5gi-n5al8A6pp2roIva1l:4122/010W
/202e0st Mockingbir d Ln., Suit e 700 I Dallas, Texas 75247 I vn a texas.o rg
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1550 Crystal Drive, Suite 1004, Arlington, VA 22202 • 888.998.6325
www.mealsonwheelsamerica.org
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October 23, 2020
Kali S. Thomas, PhD, MA
Associate Professor, Health Services, Policy and Practice
Brown University School of Public Health
Box G-S121(6)
Providence, RI 02912
Dear Dr. Thomas,
On behalf of Meals on Wheels America, it is with great pleasure that I am committing to our
continued partnership with Brown University in support of the proposed pilot research, "Home-
delivered meals for persons with dementia: Which model delays nursing home placement?”
Meals on Wheels America has been committed to building the evidence base that
demonstrates the impact and value of home-delivered meals for a long time. Brown
University has been a critical partner in that endeavor.
The need for home-delivered meals is great and growing but the resources to meet this need
are woefully inadequate and millions of seniors are  going  without these  basic  services
leading to decline in health and well-being and  often,  institutionalization.  As  Meals  on
Wheels America has identified healthcare partnerships as its core strategic priority in order
to drive resources to the provision of Meals on Wheels services to a far greater number of
seniors who can benefit from our services, including those with dementia, the abilityto
demonstrate impact in terms of both healthcare outcomes and need for high-cost healthcare
services is essential.
The proposed pilot study will provide a much-needed opportunity to build out this evidence base
in areas that are of greatest interest to prospective healthcare partners, including what mode of
meal delivery works best for patients with dementia.
Meals on Wheels America is the leading national voice for the nation's estimated 5,000
community-based Meals on Wheels providers that are committed to serving seniors
struggling with hunger and isolation. As a national organization, we advocate, provide
education and training, serve as a convener, conduct research, and much more  to
support the ability of the network to extend its reach and impact. In its continuing
partnership with Brown University, Meals on Wheels America wiII provide the following
organizational support:
•
Meals on Wheels America has secured support from two programs located in
Florida and Texas (with waiting lists that include individuals with dementia) to
participate in this pilot project. These programs have collectively agreed to enroll 40
clients and to serve on the Stakeholder Advisory Panel. We are committed to
recruiting additional programs, if needed, depending on what is learned during the
pilot phase of the project.
•
Meals on Wheels America will contract with and manage our partnership with TRIO
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1550 Crystal Drive, Suite 1004, Arlington, VA 22202 • 888.998.6325
www.mealsonwheelsamerica.org
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Community Meals to bi-weekly deliver the ten frozen meals to 20 clients randomly
assigned to that intervention group.
•
We will work with Meals on Wheels programs to recruit clients with dementia and
one family members to serve on the Stakeholder Advisory Panel
•
Meals on Wheels America will provide project management to our participating
member programs and will work with them directly throughout the pilot study
project to ensure its success.
•
We will co-host training of programs and monthly conference calls with programs
and research team.
•
We will leverage our communications team and channels to disseminate
information about this important study and its findings.
Throughout the development of this pilot project, the MOW program directors and I have been
involved in the study design and provided important feedback about feasibility and outcomes. I
look forward to continuing to work with you and your team in this capacity and engage with you
throughout the award by sharing Meals on Wheels experiences and perspectives from working
with our clientele.
I am writing to confirm our institutional support of the proposed pilot project and to leverage the
resources of Meals on Wheels America to fulfill our obligations as described above. In my role
as Chief Strategy and Impact Officer, I will serve as the primary point of contact for this mission-
critical work to ensure that our responsibilities are executed in accordance with our agreement
with Brown University. In addition to my role as an integral member of the research team, I will
also serve on the Stakeholder Advisory Panel alongside Uche Akobundu, PhD. We have
established a strong partnership and have worked closely together in the development of this
proposed research project.
I am confident that this research will be essential in our efforts to partner with healthcare for the
delivery of Meals on Wheels services. As a result, we will be better positioned to ensure that no
senior in this country is hungry or isolated.
Sincerely,
Lucy Theilheimer
Chief Strategy and Impact Officer
Direct: 571.339.1601 Cell:  703.850.3865
1550 Crystal Drive, Suite 1004
Arlington, VA 22202
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
INSTRUCTIONS FOR COMPLETING THE DATA USE AGREEMENT (DUA) FORM CMS-R-0235
(AGREEMENT FOR USE OF CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)
DATA CONTAINING INDIVIDUAL IDENTIFIERS)
This agreement must be executed prior to the disclosure of data from CMS’ Systems of Records to ensure that
the disclosure will comply with the requirements of the Privacy Act, the Privacy Rule and CMS data release
policies. It must be completed prior to the release of, or access to, specified data files containing protected
health information and individual identifiers.
Directions for the completion of the agreement follow:
Before completing the DUA, please note the language contained in this agreement cannot be altered in
any form.
• First paragraph, enter the Requestor’s Organization Name.
• Section #1, enter the Requestor’s Organization Name.
• Section #4 enter the Study and/or Project Name and CMS contract number if applicable for which the
file(s) will be used.
• Section #5 should delineate the files and years the Requestor is requesting. Specific file names should be
completed. If these are unknown, you may contact a CMS representative to obtain the correct names
The System of Record (SOR) should be completed by the CMS contact or Project Officer. The SOR is
the source system the data came from.
• Section #6, complete by entering the Study/Project’s anticipated date of completion.
• Section #12 will be completed by the User.
• Section #16 is to be completed by Requestor.
• Section #17, enter the Custodian Name, Company/Organization, Address, Phone Number (including area
code), and E-Mail Address (if applicable). The Custodian of files is defined as that person who will have
actual possession of and responsibility for the data files. This section should be completed even if the
Custodian and Requestor are the same. This section will be completed by Custodian.
• Section #18 will be completed by a CMS representative.
• Section #19 should be completed if your study is funded by one or more other Federal Agencies. The
Federal Agency name (other than CMS) should be entered in the blank. The Federal Project Officer
should complete and sign the remaining portions of this section. If this does not apply, leave blank.
• Sections #20a AND 20b will be completed by a CMS representative.
• Addendum, CMS-R-0235A, should be completed when additional custodians outside the requesting
organization will be accessing CMS identifiable data.
Once the DUA is received and reviewed for privacy and policy issues, a completed and signed copy will be
sent to the Requestor and CMS Project Officer, if applicable, for their files.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
DATA USE AGREEMENT
Form Approved
OMB No. 0938-0734
DUA #
(AGREEMENT FOR USE OF CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)
DATA CONTAINING INDIVIDUAL IDENTIFIERS)
CMS agrees to provide the User with data that reside in a CMS Privacy Act System of Records as identified in this
Agreement. In exchange, the User agrees to pay any applicable fees; the User agrees to use the data only for purposes
that support the User’s study, research or project referenced in this Agreement, which has been determined by CMS to
provide assistance to CMS in monitoring, managing and improving the Medicare and Medicaid programs or the services
provided to beneficiaries; and the User agrees to ensure the integrity, security, and confidentiality of the data by complying
with the terms of this Agreement and applicable law, including the Privacy Act and the Health Insurance Portability and
Accountability Act. In order to secure data that reside in a CMS Privacy Act System of Records; in order to ensure the
integrity, security, and confidentiality of information maintained by the CMS; and to permit appropriate disclosure and use
of such data as permitted by law, CMS and
Brown University
enter into this
agreement to comply with the following specific paragraphs.
(Requestor)
1. This Agreement is by and between the Centers for Medicare & Medicaid Services (CMS), a component of the
U.S. Department of Health and Human Services (HHS), and
Brown University
,
hereinafter termed “User.”
(Requestor)
2. This Agreement addresses the conditions under which CMS will disclose and the User will obtain, use, reuse
and disclose the CMS data file(s) specified in section 5 and/or any derivative file(s) that contain direct individual
identifiers or elements that can be used in concert with other information to identify individuals. This Agreement
supersedes any and all agreements between the parties with respect to the use of data from the files specified
in section 5 and preempts and overrides any instructions, directions, agreements, or other understanding in or
pertaining to any grant award or other prior communication from the Department of Health and Human Services
or any of its components with respect to the data specified herein. Further, the terms of this Agreement can be
changed only by a written modification to this Agreement or by the parties adopting a new agreement. The parties
agree further that instructions or interpretations issued to the User concerning this Agreement or the data specified
herein, shall not be valid unless issued in writing by the CMS point-of-contact or the CMS signatory to this
Agreement shown in section 20.
3. The parties mutuallyagree that CMS retains all ownershiprights to the data file(s) referred to in this Agreement, and that
the User does not obtain any right, title, or interest in any of the data furnished by CMS.
4. The User represents, and in furnishing the data file(s) specified in section 5 CMS relies upon such
representation, that such data file(s) will be used solely for the following purpose(s).
Name of Study/Project
Home-delivered meals for persons with dementia: Which model delays nursing home placement?
CMS Contract No. (If applicable)
The User represents further that the facts and statements made in any study or research protocol or project plan
submitted to CMS for each purpose are complete and accurate. Further, the User represents that said study
protocol(s) or project plans, that have been approved by CMS or other appropriate entity as CMS may determine,
represent the total use(s) to which the data file(s) specified in section 5 will be put.
The User agrees not to disclose, use or reuse the data covered by this agreement except as specified in an
Attachment to this Agreement or except as CMS shall authorize in writing or as otherwise required by law, sell,
wn UniversitryeInRtB, Oleraigsinea,llAopapnro, voarl:o1t2h/1e0r/w
20i2s0e grant access to the data covered by this Agreement. The User affirms that the
wn UniversitryeIqRuBeAsmteednddmaetantiAsptphreovm
ali0n2i/m
25u/2m
021necessary to achieve the purposes stated in this section. The User agrees that,
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l Aspeprroovragl:a1n2i/1z0a/t2i0o2n0and the organizations of its agents, access to the data covered by this Agreement
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shall be limited to the minimum amount of data and minimum number of individuals necessary to achieve the
purpose stated in this section (i.e., individual’s access to the data will be on a need-to-know basis).
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5. The following CMS data file(s) is/are covered under this Agreement.
File
Years(s)
System of Record
6. The parties mutually agree that the aforesaid files(s) (and/or any derivative file(s)), including those files that
directly identify individuals or that directly identify bidding firms and/or such firms’ proprietary, confidential
or specific bidding information, and those files that can be used in concert with other information to identify
individuals, may be retained by the User until
1 year
, hereinafter known as the “Retention Date.”
The User agrees to notify CMS within 30 days of the completion of the purpose specified in section 4 if the
purpose is completed before the aforementioned retention date. Upon such notice or retention date, whichever
occurs sooner, the User agrees to destroy such data. The User agrees to destroy and send written certification of
the destruction of the files to CMS within 30 days. The User agrees not to retain CMS files or any parts thereof,
after the aforementioned file(s) are destroyed unless the appropriate Systems Manager or the person designated in
section 20 of this Agreement grants written authorization. The User acknowledges that the date is not contingent
upon action by CMS.
The Agreement may be terminated by either party at any time for any reason upon 30 days written notice. Upon
notice of termination by User, CMS will cease releasing data from the file(s) to the User under this Agreement
and will notify the User to destroy such data file(s). Sections 3, 4, 6, 8, 9, 10, 11, 13, 14 and 15 shall survive
termination of this Agreement.
7. The User agrees to establish appropriate administrative, technical, and physical safeguards to protect the
confidentiality of the data and to prevent unauthorized use or access to it.The safeguards shall provide a level
and scope of security that is not less than the level and scope of security requirements established by the Office
of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III--Security of Federal Automated
Information Systems (http://www.whitehouse.gov/omb/circulars/a130/a130.html) as well as Federal
Information Processing Standard 200 entitled “Minimum Security Requirements for Federal Information and
Information Systems” (http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf); and, Special
Publication 800-53 “Recommended Security Controls for Federal Information Systems” (http://csrc.nist.gov/
publications/nistpubs/800-53-Rev2/sp800-53-rev2-final.pdf). The User acknowledges that the use of unsecured
telecommunications, including the Internet, to transmit individually identifiable, bidder identifiable or deducible
information derived from the file(s) specified in section 5 is prohibited. Further, the User agrees that the data must
not be physically moved, transmitted or disclosed in any way from or by the site indicated in section 17 without
written approval from CMS unless such movement, transmission or disclosure is required by a law.
8. The User agrees to grant access to the data to the authorized representatives of CMS or DHHS Office of the
Inspector General at the site indicated in section 17 for the purpose of inspecting to confirm compliance with
the terms of this agreement.
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9. The User agrees not to disclose direct findings, listings, or information derived from the file(s) specified in section 5,
with or without direct identifiers, if such findings, listings, or information can, by themselves or in combination with
other data, be used to deduce an individual’s identity. Examples of such data elements include, but are not limited to
geographic location, age if > 89, sex, diagnosis and procedure, admission/discharge date(s), or date of death.
The User agrees that any use of CMS data in the creation of any document (manuscript, table, chart, study, report,
etc.) concerning the purpose specified in section 4 (regardless of whether the report or other writing expressly
refers to such purpose, to CMS, or to the files specified in section 5 or any data derived from such files) must
adhere to CMS’ current cell size suppression policy. This policy stipulates that no cell (e.g. admittances,
discharges, patients, services) 10 or less may be displayed. Also, no use of percentages or other mathematical
formulas may be used if they result in the display of a cell 10 or less. By signing this Agreement you hereby agree
to abide by these rules and, therefore, will not be required to submit any written documents for CMS review. If
you are unsure if you meet the above criteria, you may submit your written products for CMS review. CMS agrees
to make a determination about approval and to notify the user within 4 to 6 weeks after receipt of findings. CMS
may withhold approval for publication only if it determines that the format in which data are presented may result
in identification of individual beneficiaries.
10. The User agrees that, absent express written authorization from the appropriate System Manager or the person
designated in section 20 of this Agreement to do so, the User shall not attempt to link records included in the
file(s) specified in section 5 to any other individually identifiable source of information. This includes attempts to
link the data to other CMS data file(s). A protocol that includes the linkage of specific files that has been approved
in accordance with section 4 constitutes express authorization from CMS to link files as described in the protocol.
11. The User understands and agrees that they may not reuse original or derivative data file(s) without prior written
approval from the appropriate System Manager or the person designated in section 20 of this Agreement.
12. The parties mutually agree that the following specified Attachments are part of this Agreement:
Signature addenda, DUA Attachment B
13. The User agrees that in the event CMS determines or has a reasonable belief that the User has made or may have
made a use, reuse or disclosure of the aforesaid file(s) that is not authorized by this Agreement or another written
authorization from the appropriate System Manager or the person designated in section 20 of this Agreement,
CMS, at its sole discretion, may require the User to: (a) promptly investigate and report to CMS the User’s
determinations regarding any alleged or actual unauthorized use, reuse or disclosure, (b) promptly resolve any problems
identified by the investigation; (c) if requested by CMS, submit a formal response to an allegation of unauthorized
use, reuse or disclosure; (d) if requested by CMS, submit a corrective action plan with steps designed to  prevent
any future unauthorized uses, reuses or disclosures; and (e) if requested by CMS, return data files to CMS or
destroy the data files it received from CMS under this agreement. The User understands that as a result of CMS’s
determination or reasonable belief that unauthorized uses, reuses or disclosures have taken place, CMS may refuse
to release further CMS data to the User for a period of time to be determined by CMS.
The User agrees to report any breach of personally identifiable information (PII) from the CMS data file(s), loss of
these data or disclosure to any unauthorized persons to the CMS Action Desk by telephone at (410) 786 -2580 or
by e-mail notification at cms_it_service_desk@cms.hhs.gov within one hour and to cooperate fully in the federal
security incident process. While CMS retains all ownership rights to the data file(s), as outlined above, the User
shall bear the cost and liability for any breaches of PII from the data file(s) while they are entrusted to the User.
Furthermore, if CMS determines that the risk of harm requires notification of affected individual persons of the
security breach and/or other remedies, the User agrees to carry out these remedies without cost to CMS.
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14. The User hereby acknowledges that criminal penalties under §1106(a) of the Social Security Act (42 U.S.C.
§ 1306(a)), including a fine not exceeding $10,000 or imprisonment not exceeding 5 years, or both, may apply to
disclosures of information that are covered by § 1106 and that are not authorized by regulation or by Federal law.
The User further acknowledges that criminal penalties under the Privacy Act (5 U.S.C. § 552a(i) (3)) may apply if
it is determined that the Requestor or Custodian, or any individual employed or affiliated therewith, knowingly and
willfully obtained the file(s) under false pretenses. Any person found to have violated sec. (i)(3) of the Privacy Act
shall be guilty of a misdemeanor and fined not more than $5,000. Finally, the User acknowledges that criminal
penalties may be imposed under 18 U.S.C. § 641 if it is determined that the User, or any individual employed or
affiliated therewith, has taken or converted to his own use data file(s), or received the file(s) knowing that they
were stolen or converted. Under such circumstances, they shall be fined under Title 18 or imprisoned not more
than 10 years, or both; but if the value of such property does not exceed the sum of $1,000, they shall be fined
under Title 18 or imprisoned not more than 1 year, or both.
15. By signing this Agreement, the User agrees to abide by all provisions set out in this Agreement and acknowledges
having received notice of potential criminal or administrative penalties for violation of the terms of the Agreement.
16. On behalf of the User the undersigned individual hereby attests that he or she is authorized to legally bind the User
to the terms this Agreement and agrees to all the terms specified herein.
Name and Title of User (typed or printed)
David A. Savitz, PhD, Professor and Chair of Epidemiology, School of Public Health
Company/Organization
Brown University
Street Address
121 S. Main Street, 2nd floor, Box G-S121-2
City
Providence
State
RI
ZIP Code
02912
Office Telephone (Include Area Code)
401-863-9060
E-Mail Address (If applicable)
cgchr@brown.edu
Signature
Date
17. The parties mutually agree that the following named individual is designated as Custodian of the file(s) on behalf
of the User and will be the person responsible for the observance of all conditions of use and for establishment and
maintenance of security arrangements as specified in this Agreement to prevent unauthorized use. The User agrees
to notify CMS within fifteen (15) days of any change of custodianship. The parties mutually agree that CMS may
disapprove the appointment of a custodian or may require the appointment of a new custodian at any time.
The Custodian hereby acknowledges his/her appointment as Custodian of the aforesaid file(s) on behalf of the
User, and agrees to comply with all of the provisions of this Agreement on behalf of the User.
Name of Custodian (typed or printed)
Jeffrey Hiris, MA
Company/Organization
Brown University
Street Address
121 S. Main Street, 6th floor, Box G-S121-6
City
Providence
State
RI
ZIP Code
02912
Office Telephone (Include Area Code)
401-863-3317
E-Mail Address (If applicable)
Jeffrey_Hiris@brown.edu
Signature
Date
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18. The disclosure provision(s) that allows the discretionary release of CMS data for the purpose(s) stated in section 4
follow(s). (To be completed by CMS staff.)
19. On behalf of
the undersigned individual hereby acknowledges that the
aforesaid Federal agency sponsors or otherwise supports the User’s request for and use of CMS data, agrees to
support CMS in ensuring that the User maintains and uses CMS’s data in accordance with the terms of this
Agreement, and agrees further to make no statement to the User concerning the interpretation of the terms of this
Agreement and to refer all questions of such interpretation or compliance with the terms of this Agreement to the
CMS official named in section 20 (or to his or her successor).
Typed or Printed Name
Title of Federal Representative
Signature
Date
Office Telephone (Include Area Code)
E-Mail Address (If applicable)
20. The parties mutually agree that the following named individual will be designated as point-of-contact for the
Agreement on behalf of CMS.
On behalf of CMS the undersigned individual hereby attests that he or she is authorized to enter into this
Agreement and agrees to all the terms specified herein.
Name of CMS Representative (typed or printed)
Title/Component
Street Address
Mail Stop
City
State
ZIP Code
Office Telephone (Include Area Code)
E-Mail Address (If applicable)
A. Signature of CMS Representative
Date
B. Concur/Nonconcur — Signature of CMS System Manager or Business Owner
Date
Concur/Nonconcur — Signature of CMS System Manager or Business Owner
Date
Concur/Nonconcur — Signature of CMS System Manager or Business Owner
Date
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
The valid OMB control number for this information collection is 0938-0734. The time required to complete this information collection is estimated to average 30 minutes
per response, including the time to review instructions, search existing data resources, gather the data nee ded, and complete and review the information collection. If
wn UynoivuehrasviteyaIRnyBcO
omrimgiennatlsAcpopncroevrnailn:g1t2h/e10a/c2c0u2ra0cy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn:
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ApepnrtoAvaplp: r1o2v/a1l00/220/205/2021 
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Research Identifiable Files
DUA #:
Attachment B
This attachment supplements the above-referenced Data Use Agreement (DUA) between the Centers
for Medicare and Medicaid Services and the User (as set forth in the DUA). Upon execution by both
parties, to the extent this Attachment is inconsistent with any terms in the DUA, this Attachment
modifies and overrides the DUA.
A-1. Use of Data: Users may disseminate research findings on providers or suppliers (including individual
physicians) using original or derived information from the files specified in Section 5 of the DUA
provided all findings are limited to patient de-identified data that conform with the HIPAA Privacy Rule’s
definition of de-identified data at 45 CFR 164.514(b).
A-2. Disclosure of Findings: Nothing in the DUA, including but not limited to Section 9, prohibits Users
from discussing or reporting on specific providers or suppliers (including individual physicians) in a
manner consistent with A-1.
For: Centers for Medicare & Medicaid Services
For: DUA Data Requestor
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Centers for Medicare & Medicaid Services
Executive Summary for Research Identifiable Data
Version 4/2015
DUA User name and title
(see Item 16 of DUA)
David A. Savitz, PhD, Professor and Chair of Epidemiology, School of Public Health
Requesting
Organization1
(see Item 1 of DUA)
Brown University
Type of Organization
Academic
Study PI (if different from DUA User)
Kali Thomas, PhD
Study Title
Home-delivered meals for persons with dementia: Which model delays nursing home
placement?
Funding Source
NIA, R61AG070170
Executive Summary| Dissemination and Reporting of Findings |Data Management Plan | Project Staff| Collaborator Checklist
EXECUTIVE SUMMARY
1.
Study Overview
Please describe your study objectives and aims.
Click here to enter text.
2.
How have you ensured that your data request includes the minimum amount of data necessary to achieve your
research objectives?
2.1. Please describe how this cohort will meet minimum data necessary. (Include estimated cohort size. Refer to
your cost invoice.)
Click here to enter text.
2.2. List the CMS data files and years being requested at this time and provide justification for how each will be
used in the analysis. If requesting reuse of data, include the DUA # to be reused. The list of files should match
Item #5 of DUA.
2.2.1. Medicare (claims and enrollment) or Medicaid (claims and enrollment)
Click here to enter text.
2.2.2. Part D event data (if using in study)
Click here to enter text.
2.2.3. Part D characteristics files (if using in study)
Click here to enter text.
2.2.4. Assessment data (if using in study)
Click here to enter text.
2.3. If this study will require further years of CMS data that are not yet available for request, please list those
CMS data files and years that will be required for the entire scope of your study (Note: Approval of data files
for years that are not yet available will NOT be granted at this time, the information included here will simply
provide CMS with an overview of your study).
Click here to enter text.
1 Throughout this document, “organization” can be interpreted as the company, agency, or group or team within a company,
depending on which makes more sense in context with the research study for which CMS data files are being used. For example,
large companies may defer to a CMS data file inventory for just their team; whereas smaller companies may keep a single CMS data
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For CMS Use Only
Privacy Board Approval Date:
Part D Approval Date:
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Executive Summary for Research Identifiable Data
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2.4. Please list any non-identifiable or non-CMS files you are planning to use in conjunction with the above files
for your analysis. (e.g. Provider of Services (POS) file, AMA Physician Master file, etc.)
Click here to enter text.
3.
You are requesting Research Identifiable Files (RIF). Why can’t Limited Data Set (LDS) files be used for this study?
Assessment data are not available as LDS.
4.
Is it feasible to obtain individual level authorization from Medicare/Medicaid beneficiaries for your research?
Explain.
No, all of the data were previously collected for non-research purposes. We will not have contact with individuals.
5.
If you intend on requesting the National Death Index segment of the Master Beneficiary Summary File, please
complete the NDI Supplement.
□YES, I’ve included the NDI Supplement
□NO, I’m not requesting theNDI
6.
If this research project is funded by a commercial entity, the (primary) lead investigator attests that they will limit
data sharing with the funding entity to aggregated analytic results and will retain the right to independently
prepare publications of the study results.
□I attest
Signature of (Primary) Lead Investigator
Date
DISSEMINATION AND REPORTING OF FINDINGS
From the CMS DUA, “The User agrees that any use of CMS data in the creation of any document (manuscript, table,
chart, study, report, etc.) concerning the purpose specified in section 4 (regardless of whether the report or other
writing expressly refers to such purpose, to CMS, or to the files specified in section 5 or any data derived from such files)
must adhere to CMS’ current cell size suppression policy. This policy stipulates that no cell (e.g. admittances,
discharges, patients, services) 10 or less may be displayed. Also, no use of percentages or other mathematical formulas
may be used if they result in the display of a cell 10 or less.“
□I agree.
Please describe your plans for disseminating the findings from your analysis, including specific media through which you
will report results.
We will disseminate findings through peer-reviewed venues such as abstracts for presentations at national meetings
(i.e., conferences at the Gerontological Society of America and AcademyHealth’s annual meetings) and manuscripts
for publication in journals such as the Journal of the American Geriatrics Society, and Health Services Research. We
intend to use this DUA to support preliminary work for future studies and doctoral theses, in turn leading to peer-
reviewed publications. If doctoral work formalizes, the student will request his/her own DUA.
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Executive Summary for Research Identifiable Data
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PROJECT STAFF
This section specifically identifies the project staff, organization, and the role of individuals in this project. The requestor
and custodian should be named in this section at a minimum.
1.Name & Title of Requestor /User
Bess Marcus, PhD, Dean, School of Public Health
Organization
Brown University
Role in this Study
Requestor, University Signatory
Will this individual have access to raw
data, analytic files, or output with cell
sizes less than 11?
NO.
□
YES, this individual will be directly supervised by DUA signatory, [Name] .
□
YES, this individual has signed the DUA.
2.Name & Title of Custodian
Jeff Hiris, MA, IT Director
Organization
Brown University
Role in this Study
Data Custodian
Will this individual have access to raw
data, analytic files, or output with cell
sizes less than 11?
□
NO.
□
YES, this individual will be directly supervised by DUA signatory, [Name] .
YES, this individual has signed the DUA.
3.Name & Title
Julie Lima, PhD, Investigator
Organization
Brown University
Role in this Study
Data acquisition and compliance
Will this individual have access to raw
data, analytic files, or output with cell
sizes less than 11?
□
NO.
□
YES, this individual will be directly supervised by DUA signatory, [Name] .
YES, this individual has signed the DUA or signature addendum.
4.Name & Title
Organization
Role in this Study
Will this individual have access to raw
data, analytic files, or output with cell
sizes less than 11?
□
NO.
□
YES, this individual will be directly supervised by DUA signatory, [Name] .
□
YES, this individual has signed the DUA or signature addendum.
** If more individuals need to be added to this section, please copy and paste above fields.
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DATA MANAGEMENT PLAN2
Please reference the Data Management Plan Guidelines, Data Management Plan Evaluation Guide, Collaborator
Checklist, and/or the FAQ document for more information on completing this section. These materials are found under
the Executive Summary section of the New Study Requesting Data page of the website.
For research studies involving researchers from another organization that will have access to RIF or non-identifiable
files, please refer to the Collaborator Checklist for guidance and considerations to include in the Data Management
Plan.
For collaborating organizations that will be receiving a physical copy of the CMS data files, a full Data Management Plan
should be completed by the collaborating organization.
1.
PHYSICAL POSSESSION AND STORAGE OF CMS DATA FILES
1.1. Who will have the main responsibility for organizing, storing, and archiving the data? Please provide name(s)
and job title(s).
Jeffrey R Hiris, IT Director
1.2. Describe how your organization maintains a current inventory of CMS datafiles.
An Excel spreadsheet is used to track all incoming and outgoing media. It records the media identity insofar as
it is labeled, date and direction of transfer, file system location of the files copied from the media, and briefly
describes the data. Decrypted versions of the raw data are stored in the same file system location, or below it.
Raw data is stored in directories with a regular naming convention which clear identifies the source of the data.
No master inventory is maintained of all derivative datasets, however all CMS data is processed in a similar
fashion. 1) Raw data is read using whatever accompanying code or formatting is provided by a program stored
in a single standard location by the Custodian; 2) one of a small number of programmers then applies code to
standardize this raw data, such code being stored in a small number of protected locations; and 3) all
standardized datasets are then stored in a small number of specific file system locations. Analytic datasets built
pursuant to a specific DUA are then stored in a DUA-specific analysis location within the file system. Programs
which manipulate that data clearly identify the DUA, EDGN, and/or any other identifying information provided
when the data us received. Second stage programs which further standardize the data clearing identify the
source data upon which they operate.
1.3. Describe how your organization binds all members (i.e., organizations, individual staff) of research teams to
specific privacy and security rules in using CMS datafiles.
All staff and organizations which handle CMS data covered by a DUA are identified on that DUA and if required
have signed the appropriate amendment which binds them to CMS requirements. Center staff and any other
data users are required to sign internal confidentiality agreements covering all Center work with sensitive data.
This internal confidentiality agreement is found at the back of the Center’s Handbook of Computing and
Research Manual and is signed by all Brown and non-Brown personnel working on data stored at the Center. It
includes the following information:
2 Note that CMS is specifically asking for reference to written policies and procedures related to your organization’s administrative,
technical and physical safeguards. If policies and procedures have not been developed, please explain any ongoing activities your
organization is taking to document and make them available to staff. Organizations selected for DPSP reviews will be asked to
provide copies of written policies and procedures. Please note that an explanation of the process is not sufficient.
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Executive Summary for Research Identifiable Data
Version 4/2015
Data Protection & Security Agreement
I,
, through my involvement with and work on approved
research projects at the Center for Gerontology and Health Care Research (the Center) will have access to
sensitive data. While Brown University and the Center have taken every precaution to ensure the security of
these data, I understand it is my responsibility to comply with the Center’s data security protocol. I understand
that access to project data is restricted to individuals who are authorized to work on specific research projects
and I agree to fulfill my responsibilities in accordance with the followingguidelines:
1) All data to which any user is granted access by the Center remain the property of Brown, insofar as Brown
can assert ownership.
2) Data will be used on Brown equipment only, except as displayed by supported remote access mechanisms on
equipment operated in accordance with Centerpolicy.
3) Onlyfully de-identified non-CMS person-level data is permitted to be removed from the Center’s protected
network, physical perimeter, and local systems. Partially-identified data, which has been appropriately
encrypted, can be removed only when authorized in advance in writing by the data owner [as determined by an
approved Data Use Agreement (DUA)] and datacustodian.
4) Partially-identified data may only be moved to a Brown-owned desktop system for processing purposes. Data
are not to be stored on local harddrives.
5) No attempt will be made to correlate any Brown data with “real” individuals except as approved in advance
by the Brown IRB.
6) Any security breach which occurs on any hardware or software under the control of any user shall be
reported to the Center’s Director of Operations, the data owner (as determined by an approved DUA), and the
system manager as soon as the user becomes aware of it. The user may request any of the above to contact the
others, but it remains the user’s responsibility to ensure that each of the above arenotified.
7) All datasets built using data covered by a Data Use Agreement will be erased when such Data Use Agreement
terminates, upon notification by the PI for a project or the data custodian that such termination has occurred.
Output which displays substantial parts of such data will likewise beerased.
I understand that violation of these guidelines may result in disciplinary and/or legal action.
1.4. Provide details about whom and how your organization will notify CMS of any project staffing changes.
Principal Investigators will notify relevant staff changes to our DUA Manager and Project Contact (presently
Julie Lima) as soon as they become aware of staff additions or terminations in the scope of this DUA. Dr. Lima
will then notify CMS of the removal or addition of personnel through the procedures currently outlined at
https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-
Agreements/DUA_-_Contact_Changes.html
For example, a contact update request will be filed in a timely manner reflecting the change and for personnel
additions (as opposed to removals), will be accompanied by any necessary signatures. Directly supervised staff
are not required to be reported to CMS, although the PI is required to approve any access to CMS data for use
under a particular DUA Similarly, we are not required to notify CMS of staffing changes not involved with the
handling of sensitive data.
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Executive Summary for Research Identifiable Data
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1.5. Describe your organization’s training programs that are used to educate staff on how to protect CMS data files.
Brown staff are trained under the Brown CITI certification system in the handling of human subjects data. CMS
data is not considered different from other sensitive human subjects data. The Center is small enough that
staff handling sensitive data are trained internally and informally on the proper handling of CMS data files.
Staff handling sensitive data are required to read our Center’s Handbook of Computing and Research and sign a
confidentiality agreement which indicates they understand the need to protect sensitive data, and the technical
requirements of maintaining such protections. In addition, our DUA Manager and Project Contact (currently
Julie Lima) gives a Center-wide talk 2-3 times yearly to outline ongoing policies and procedures for working with
confidential data at the Center.
1.6. Explain the infrastructure (facilities, hardware, software, other) that will secure the CMS datafiles.
a. Physical security for the servers housing sensitive data is provided by a combination of Brown card-access controls
and physically secured space within a common server room. The network switching infrastructure is maintained by
Brown and our network is protected by ACLs which limit external access to services and protocols which are
unencrypted or otherwise too sensitive to traverse an external network. Power and cooling integrity is provided
by Brown facilities management, including generator power in the event of a loss of external power. Hardware
support for the Center’s servers is provided by the Center and by Brown central IT(CIS).
b.
Data is currently stored on file servers and is protected by ACLs leveraging group membership to provide an
effective baseline security model. Access by client Windows systems is controlled by the user’s membership in this
group structure. While the underlying security model is DAC, users are not granted Control access to any files nor
directories. Data is routinely moved between file servers as a part of routine systems support activities, and ACLs
controlling access are automatically rewritten to their baseline state as a part of any suchcopying.
c.
While the Center does host a variety of modern services in support of its mission, including Web servers, users
are strictly limited in how they can interact with such services. The casual dissemination of Web content to the
public in particular is notpossible.
Access to the Center’s internal networks is protected by multiple layers of firewalls and network access control
lists. The University as a whole is committed to a multi-year plan to improve network security by moving
sensitive data resources into non-routable internal networks. Given the complexity of all the Center’s
operations and the need to maintain a coherent network infrastructure this is a multi-year process.
Remote access to any data, regardless of sensitivity, is in general limited to remote access via Windows
terminal servers. (Trusted staff are permitted to make VPN connections using Center-owned and maintained
client systems.) Such servers are housed in the same data center as the Windows servers and operate in the
same security context. Some few staff handling less sensitive data do make remote connections to their usual
desktop systems, which is permitted but discouraged.
1.7. Describe the policies and procedures regarding the physical possession and storage of CMS datafiles.
The Brown CIS Acceptable Use Policy (defined in http://www.brown.edu/cis/policy/aup.php) requires that all
users of Brown computing resources are limited to those resources for which they have appropriate
authorization and are to use those resources in a manner consistent with their authorization. CMS identifiable
data files fall into the category of PIHI data and their appropriate use is defined by general by the Policies and
Procedures Relating to Research Privacy of the Office of the Provost
(http://www.brown.edu/Administration/Provost/policies/rpp.html). In a general sense, CMS data files may be
broken into three classes, namely identifiable data, Limited Data Sets (as defined in the context of the above
Policy), and de-identified data with small cell suppression applied. Functionally, CMS data may be classified as
media received from CMS and local computer files built from the data contained on such media. All received
CMS data file are stored in the Center’s locked section of the machine room. Normally, they are either in that
secure location or in the physical possession of the data custodian, for example when received from a courier
service. Similarly, working copies of data files containing PIHI or LDS data are only stored on servers within that
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secure locked location. LDS datasets may be analyzed locally on workstations within our firewalled network,
but are not stored on such local systems. All data acquired under a DUA which is identifiable, protected,
embargoed, or otherwise sensitive is never stored on user-controlled removable media of any type. As a
standard Disaster Recovery procedure such data is stored in an encrypted form on removable backup media.
As outlined in the accompanying justification letter to this DUA request, one complete set of tapes will be held
externally for Disaster Recovery (DR) purposes in a secure vault maintained by Iron Mountain at their Rhode
Island offsite facility located in Chepachet, RI, 02814. Others are maintained in the same secure environment
as our servers and secured in the same fashion (that is, with limited access by systems staff, behind two locked
doors, and with card access controls).
Why: in the event of a catastrophic failure of the Center's computing infrastructure it is essential that a
reasonably recent backup copy of all data and software systems be maintained. Note that internally we
maintain multiple copies of basically all data and systems on non-removable media, replicated between various
storage systems. Such replication is secured by the use of local disks, firewalls, and/or encryption. However, in
the event of a catastrophic environmental failure (e.g. a water leak leading to a roof collapse over the server
room near in time to a similar disaster in the DR replicate server room), or a malicious software attack leading
to data loss (e.g., a ransomware attack), an offline backup would be essential to ensure recovery.
Physical safeguards: all backup tapes except for those stored offsite for DR purposes are stored within the same
physical environment as the Center's main servers. Any retired media are physically crushed before being
removed from the server room before being shipped out as e-waste for shredding and recycling. (Our current
media are Linear Tape Open (LTO) tapes which cannot be effectively de-gaussed). The one offsite copy will be
picked up by an Iron Mountain courier for storage in their facility, such copy to consist of a box of tapes in a
container secured with a locking tag. After the first copy has been transferred a monthly swap will occur via
the Iron Mountain courier. Given the media are encrypted there seems minimal operational risk in allowing
staff working for our Director of Operations to hold the monthly box of media in an external safe for the brief
times between removal from the server room and acceptance by/receipt from the Iron Mountaincourier.
1.8. Explain your organization’s system or process to track the status and roles of the researchteam.
As each PI is individually responsible for their research project, as matter of Center Policy each PI is required to
track their staff allocations and responsibilities. Staff are required to sign a certification of their percent effort
on each project. From a computer operations perspective, each PI is required to identify any unique security
groups or contexts within their research, and to identify team members who should be granted access to
specific resources. (For example, any project with PIHI and LDS data would have a more secure location and
more restricted group for PIHI access, a separate space and group for LDS access.) Given the small number of
PIs within the Center, this has been controlled informally using e-mail as the control system and the local
authorization databases as the system of record, but given CMS’s requirement of auditable controls, we are
developing a paper records system to document rights granted to staff members. Note that as a matter of cost
control much of the CMS data provided to the Center is handled by a small number of programmers who work
across all CMS projects on initial data preparation and removal of PHI identifiers. (Thus, the role of these core
programmers with respect to the CMS PIHI data for any individual research project is not specifically tracked
since they have the same duties with respect to all projects.) Research team members who are not a member
of this small group of programmers will be granted limited access to data as needed for their duties, or to
project-specific location for project-specific PIHI.
1.9. Describe your organization’s physical and technical safeguards used to protect CMS data files (including physical
access and logical access to the files).
As mentioned above, physical access to sensitive systems is controlled by physical locks behind Brown card-
access controls. Access is limited to systems management staff, and as a part of University operations Brown
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life safety personnel and other necessary University exceptions. Technical safeguards are primarily provided by
the use of access controls on data stored on the core servers. Software interfaces which can access the data
are limited in number, scope, and connectivity to other systems, and tightly controlled by the Center. In
particular, unencrypted transmission of any Center data outside the secure internal networks is blocked insofar
as technically possible. Ultimately, the security and integrity of all Center data depends upon the diligence and
integrity of the staff handling the data.
Physical security for the servers housing sensitive data is provided by a combination of Brown card-access controls
and physically secured space within a common server room. The network switching infrastructure is maintained
by Brown and our network is protected by ACLs which limit external access to services and protocols which are
unencrypted or otherwise too sensitive to traverse an external network. Power and cooling integrity is provided
by Brown facilities management, including generator power in the event of a loss of external power. Hardware
support for the Center’s servers is provided by the Center in concert with Central IT. The Center is exploring the
feasibility of utilizing hosted servers in Brown secure central data center to augment servers in our local machine
room in order to better leverage central IT resources, such servers and services to remain under the technical
ownership of the Center.
Physical safeguards for disaster recovery copies on removable media: all backup tapes except for those stored
offsite for DR purposes are stored within the same physical environment as the Center's main servers. Any
retired media are physically crushed before being removed from the server room before being shipped out as e-
waste for shredding and recycling. (Our current media are Linear Tape Open (LTO) tapes which cannot be
effectively de-gaussed). The one offsite copy will be picked up by an Iron Mountain courier for storage in their
facility, such copy to consist of a box of tapes in a container secured with a locking tag. After the first copy has
been transferred a monthly swap will occur via the Iron Mountain courier. Given the media are encrypted there
seems minimal operational risk in allowing staff working for our Director of Operations to hold the monthly box
of media in an external safe for the brief times between removal from the server room and acceptance
by/receipt from the Iron Mountain courier.
2.
DATA
SHARING,
ELECTRONIC
TRANSMISSION,
DISTRIBUTION
2.1. Describe your organization’s policies and procedures regarding the sharing, transmission, and distribution of
CMS data files.
It is our policy that data is received under a data use agreement with CMS and cooperatively the PI acts as local
functional data owner and the Center as technical data owner. Any sharing, transmission, or distribution is
strictly controlled by the requirements of the Data use Agreement signed with CMS.
It is a violation of Brown Policy to move PIHI or LDS data out from the secure systems to any less secure system,
and as a matter of Center Policy no portable systems nor removable media are authorized for the storage of
identifiable data except as part of our Disaster Recovery plan as outlined in sections 1.7 and 1.8 above and in
the accompanying justification letter.
In the exceedingly rare case of the transfer of non-identifiable data, the encrypted data file may be transferred
using encrypted network protocols, notably https, with password protection for the transfer. Note that
separate passwords are used for encryption and transfer, and both are shipped via other media and methods.
General Brown Policies regarding appropriate data use are binding upon all faculty and staff of Brown
University. In particular:
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Ultimately the “Policy on the Handling of Brown Restricted Information” (https://it.brown.edu/computing-
policies/policy-handling-brown-restricted-information) defines in general terms the need to protect human
subjects data, which would include any data received from CMS under aDUA.
That in turn references “Policies and Procedures Relating to Research Privacy”
(http://www.brown.edu/Administration/Provost/policies/rpp.html) which defines in general terms the
requirements for defining and controlling access to PHI data.
Somewhat tangentially, data received from CMS under a DUA may be viewed as the property of CMS, even if
not personal health information. The use of such data is covered in general terms by the “Acceptable Use
Policy” (http://www.brown.edu/cis/policy/aup.php) which requires compliance with the requirements of the
data’s owner.
Within the Center’s context, we have a Handbook of Computing and Research that articulates procedures for
the handling of CMS data. However, note that ultimately a DUA is an agreement between the PI and CMS; the
Center is a component of Brown and cannot change Brown Policy nor make new Policy. It can augment Brown
Policy regarding internal operations, such as the mechanics of data transfers.
At present, all external data transfers of sensitive data are handled by the Data Custodian for the Center.
2.2. If your organization employs a data tracking system, pleasedescribe.
There is no industry definition for this term, but insofar as it is commonly used, we do not employ a data
tracking system. It is a violation of Brown Policy to move PIHI or LDS data out from the secure systems to any
less secure system and as a matter of Center Policy no portable systems nor removable media are authorized
for the storage of identifiable data except as part of our Disaster Recovery plan as outlined in sections 1.7 and
1.8 above and in the accompanying justification letter. Note that following best practices, Center computer
security is implemented in a concentric fashion with all access to secured locations where PIHI data should be
stored limited to a small number of staff persons. Most research team members have no access right to PIHI
data, and limited access to LDS data as appropriate to their role.
The Center has undertaken internal discussion in this regard, and is in the process of determining how best to
track CMS (and other sensitive data) within our systems. Given current limits to technical controls that can be
applied when Investigators and staff are working on numerous projects with different DUAs, ultimately any
such process is dependent upon staff adhering to Policy requiring such tracking. It is therefore unclear whether
tracking individual data items is useful; we currently employ an implicit classification scheme that aligns
security descriptors with storage locations. Aligning that scheme with DUA requirements and in turn requiring
that files covered by a DUA be stored in the place that classifies them as belonging to that DUA may thus be a
more scalable approach than inventorying and tracking datasets individually.
The Center is working on a documented version of these procedures. This is therefore explanatory, not
required procedure.
In general, note that the Center’s computer operations are generally based within Windows, based on access to
individual files. No database technology is used to store CMS data for general use. Files are organized into
trees and read access to a tree from a specific root downwards is granted to specific groups of users. Write
access is granted to a subset of those users at and below certain nodes in the file tree. Given the needs to users
to create their own files and the need for consistent security, it is considered neither feasible nor supportable
to manage access to individual files within the file tree except asabove.
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Informally, all incoming data is stored by the Custodian within a set of locations to which only a subset of the
professional programming staff. Specific code is responsible for removing primary identifiers from incoming
data, and otherwise cleaning it and standardizing it, before it is placed into different “base file” locations. Read
access to this partially de-identified data is then granted to additional analysts, PIs, and staff, upon receipt of an
appropriate confidentiality form.
Finally, each DUA (or other type of project, e.g. contract) has one or more file trees dedicated to its work.
Access to these is granted by systems management staff upon receipt of a request from the PI. Note that such
requests also inform the grant of access to base files, e.g. claims data.
Therefore, ultimately the classification system is based upon location of a file within the file trees; essentially,
the top-level directory identifies the classification of the files within. DUA-specific analytic files are clearly
identified as being part of that project. Incoming and base files of various types, e.g. claims and MDS
assessments, are identified as such, but their creation and destruction is the responsibility of the Custodian
and, rarely, core programming staff under the direction of a PI.
Since data is stored within files, access could be tracked via various audit and alarm mechanisms. To date we
have no requirement to provide such tracking, and to be honest, it would be hard to effectively track access in
the sense of reduce and analyze access patterns given funding limits.
Note that it is a matter of Center policy that all data be stored in accordance with the above guidelines, at least
for current research. We do know, from the inception of a DUA or other project, which spaces users are
required to store files for that project in.We do not centrally track the name, size, or other specifics of the files
that are developed in the course of a project, any more than we centrally track the names of documents and
spreadsheets produced. The PI has complete visibility over all files within the space for a given DUA and is
responsible for certifying the destruction of all datasets within said space as part of DUA termination.
2.3. Describe the policies and procedures your organization has developed for the physical removal, transport and
transmission of CMS data files.
The Policy Relating to Research Privacy from the Office of the Provost, referenced above, covers all handling of
PIHI, and requires that it be kept confidential. Within our Center, in all cases, whether data is inbound or
outbound, no sensitive data in transmitted nor received unless encrypted. Encryption is generally applied
which includes the AES-256 standard, although other strong encryption may be applied under specific
circumstances. (For example, while not relevant to the handling of CMS data, SSL encryption is commonly
employed for websites which must display PIHI or other PII.) Encryption keys are transmitted separately, if
possible using alternative media and/or channel.
2.4. Explain how your organization will tailor and restrict data access privileges based on an individual’s role on the
research team.
Depending upon the needs of the research team, one or more security project groupings are used. Each project
grouping allows for staff to be assigned read-only or read-write access to project files, although read-write
access is further limited to specific directories in a regular and well-defined fashion. Projects handling PHI or PII
will in general need access to at least two project spaces, one for datasets including sensitive identifiers, one for
datasets stripped of such identifiers. Given the level of CMS data re-use and staffing constraints it is not
uncommon to have three to five levels of project groups associated with a given research team, some spanning
research teams to support the development of common data resources.
2.5. Explain the use of technical safeguards for data access (which may include password protocols, log-on/log-off
protocols, session time out protocols, and encryption for data in motion and data atrest).
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Passwords are required to be reasonably long and complex, striking a balance between recall limits and
technical requirements. Passwords must be changed frequently, and a common password is used across all
interactive systems. Some systems used by junior staff do enforce session timeout limits, but in general staff are
permitted to work after hours and thus systems are operational 24 x 7. Encryption within the protected systems
would provide no additional security and is notused.
The standard interface for most users is expected, but not required, to be a Windows system, either a local
desktop or a remote desktop session on a central server. All Center owned machines are joined into a Windows
Domain, specific to the Center and locally managed. Idle session screen locks are provided by GPO, but users
are able to change limits if they wish. Idle sessions are never terminated since some software becomes “idle”
without saving intermediate results, and thus any form of automatic session termination would cause lost work
product. Similarly, which the terminal servers will lock the remote desktop session when idle, they do not
disconnect the session.
By policy, any confidential data, of which all CMS acquired under a DUA is a subset, shall not be stored on a local
system. This includes laptops, desktops, mobile devices of other sorts, external storage devices, etc. The central
servers are secured by multiple layers of physical security. Similarly the Center’s network is isolated behind
multiple layers of switches and firewalls. Data at rest on server disks is not encrypted except insofar as it may be
prepared for a data transfer. Recognizing our poor disaster recovery posture since unencrypted tapes cannot be
securely exported from the server room, we’re engaged in a process of adding encryption to our backup system.
Data transfers within the Center’s local network are not encrypted, partly due to speed concerns, partly as a
matter of platform compatibility. The Center’s local network is blocked from allowing Windows or Unix native
file sharing method using standard ports. Data transfers for confidential data outside of the network are
prohibited, but terminal server traffic is always natively encrypted. All network traffic beyond the Brown
campus network boundary requires further encryption, generally involving an SSL channel.
2.6. Are additional organizations involved in analyzing the data files provided by CMS? No
If so, please review the Collaborator Checklist for guidance and considerations to include in the Data
Management Plan, and indicate below how these organizations’ analysts will access the data files:
□
VPN connection
□
Will travel to physical location of data files at requestingorganization
□
Request that a copy of the data files be housed at second location
□
Other: Click here to enter text.
2.7. If an additional copy of the data will be housed in a separate location, please describe how the data will be
transferred to this location. (Also, please ensure you have included information on this organization’s database
management under the appropriate subsections of the database management plan.)
One complete set of tapes will be held externally for Disaster Recovery purposes in a secure vault maintained by
Iron Mountain at their Rhode Island offsite facility located in Chepachet, RI, 02814. The one offsite copy will be
picked up by an Iron Mountain courier for storage in their facility, such copy to consist of a box of tapes in a
container secured with a locking tag. After the first copy has been transferred a monthly swap will occur via the Iron
Mountain courier. Given the media are encrypted there seems minimal operational risk in allowing staff working for
our Director of Operations to hold the monthly box of media in an external safe for the brief times between removal
from the server room and acceptance by/receipt from the Iron Mountain courier.
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3.
DATA REPORTING AND PUBLICATION
3.1. Who will have the main responsibility for notifying CMS of any suspected incidents wherein the security and
privacy of the CMS data may have been compromised? Please describe and identify your organization’s policies
and procedures for responding to potential breaches in the security and privacy of the CMS data.
Brown’s Computing Information Services: Policy on the Handling of Brown Restricted Information /computing-
policies/policy-handling-brown-restricted-information and the Human Research Protection Program Policy and
Procedure Manual (https://www.brown.edu/research/conducting-research-brown/preparing-proposal/research-
integrity/hrppirb-home-page/brown-univ-pol-proc) require the User to notify any or all of the CIS ISIRT team, the
Brown IRB, and CMS of known or likely exposure of CMS PII data, and conversely CIS may notify the User of a
suspected security breach (https://it.brown.edu/information-security/protect-university-data/brown-university-
cybersecurity-program). Specific notification to CMS per the requirements of this DUA falls to Center systems
management as technical owner of the data. It is assumed that this would occur via the CMS incident reporting
hotline. Notification will be made within 1 hour of the discovery of any security breach. Note, however, that the
term “potential” above is disturbing; we will report any and all breaches where there is a reasonable likelihood that
any specific CMS data, covered by this or any other DUA, has been exposed to unauthorized users, and in particular
to unknown or known but non-Center users. Brown maintains extensive network and systems monitoring systems
and we routinely update and improve our security posture.
3.2. Explain how your organization’s data management plans are reviewed andapproved.
Approval is granted by Center senior management to the systems manager to select, develop, and maintain the
security infrastructure for the core systems, as well as other technical and functional supporting systems. PIs,
acting as functional data owners, work with systems and programming staff, as technical data owners, to
manage project data. No Center formal review and approval process has been implemented, nor would one be
appropriate. The Brown IRB does review and approve research proposal involving PHI or PII with respect to
data security and confidentiality safeguards in the context of each specific research project, as does each data
owner with which a PI holds a DUA for a specificproject.
3.3. Explain whether and how your organization’s data management plans are subjected to periodic updates during
the DUA period.
Data management plans are updated by PIs in response to changing conditions and competing priorities. The
Center does not assert ownership of this process although we have instituted a limited annual review for each
project with the PI, aligned with yearly CMS expiration dates to confirm the personnel and data approved under
a particular DUA. In addition, certain types of DUA amendment requests require a re-review of the data
management plan by CMS.
3.4. Please attest to the CMS cell suppression policy of not publishing or presenting tables with cell sizes lessthan
11. (see Item 9 of the DUA)
I agree.
4.
COMPLETION OF RESEARCH TASKS AND DATA DESTRUCTION
4.1. Describe your organization’s process to complete the Certificate of Disposition form and policies and
procedures to dispose of data files upon completion of its research.
The Certificate of Disposition is filled out in accordance with CMS procedures. Data transfer media are
mechanically destroyed locally (e.g., CD-ROM media are shredded), shredded by a bonded data destruction
contractor managed by Brown, or sanitized by writing random data multiple times (in the case of removable
and reusable disk drives). All copies of primary data containing PHI or PII is erased from all active systems. PIs
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are responsible for the destruction of any derivative data files, which should have been stored in specific
project spaces associated with their DUA or other project scope, in compliance with CMS policies.
Ultimately, the Custodian is responsible for certifying the disposition of CMS data, in accordance with our
standard business practices. Once signed, the form is handed over to our DUA Manager, Julie Lima, who
submits the formal request for DUA closure to CMS or the appropriate federal project officer or DUA Requester
with instructions to submit to CMS following current CMS policy found at https://www.cms.gov/Research-
Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-
_Extensions_Closures.htmlNote that all Center staff are covered by Brown Policy on the handling of sensitive
data, and such Policies are written and maintained under the auspices of the office of the Provost. In particular,
such policies imply and require that staff not undertake to circumvent data destruction mechanisms. Such
Policy is freely available for review by all staff at any time. The Center is undertaking to amplify that Policy with
details internal to our business practices, in order to clarify the procedure requirements for adhering to those
policies. To a first approximation, that means diligently erasing any all data covered by a DUA or IRB agreement
at the termination of such agreement, except for such retentions as allowed by suchagreements.
4.2. Describe your organization’s policies and procedures used to protect CMS data files when individual staff
members of research teams (as well as collaborating organizations) terminate their participation in research
projects (which may include staff exit interviews and immediate accesstermination).
The Policy Relating to Research Privacy of the Office of the Provost, referenced above, in concert with the Brown
Acceptable Use Policy for computing resources, requires that no use be made of any CMS data files after a staff
person’s association with a research project is terminated. As a matter of Center Policy, as being developed to
meets CMS’s requirements for auditable staff allocations all research staff will have signed a confidentiality
agreement covering their use of CMS data. Our Center is currently considering putting a time limit on such
agreements and requiring regular renewal. Staff access to sensitive data is terminated as soon as systems
management staff is notified by the PI that a staff member’s participation in a project has terminated. Note that
no work product destruction is ever undertaken by system staff, and thus access termination is a relatively light-
weight process, should a staff member’s participation in a project resume. Language has been added to the
Center User’s Guide reinforcing these points.
Note that we do not currently have a policy which requires an exit interview relevant to data security. Staff have
no physical devices with any security significance and it would be a violation of policy to have a local copy of any
confidential dataset, including a CMS dataset. Conveniently, the Custodian is also the senior system
administrator, so as soon as he is notified by the PI or other staff (eg. HR admin), access is terminated as soon as
possible. Practically, this means within minutes of notification. PIs and other Investigators may of course
require exit interviews as a part of other business processes; the security plan does not encompass workflow
management. Note that revoking staff access to a protected project space can be accomplished without
removing them from all access to Center systems. Such removals are made in the same manner as terminations,
that is, upon receipt of a request for such removal by a PI to theCustodian.
4.3. Describe policies and procedures your organization uses to inform CMS of project staffing changes, including
when individual staff member’s participation in research projects is terminated,voluntarily or involuntarily.
The Policy Relating to Research Privacy of the Office of the Provost requires, through its reference of the IRB
approval process, that changes to the Principal Investigator (PI) be reported to the IRB. Separately, each DUA
between CMS and a researcher requires that CMS be informed of staffing changes relating to those staff
members with direct and unsupervised access to CMS data. Procedurally, our Center PIs normally directly
contact our DUA coordinator, currently Julie Lima, about staff changes and appropriate signature addenda are
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filed with CMS either directly or via a federal project officer as applicable. She will then contact CMS in a timely
manner via e-mail to notify them of the staffing change.
4.4. Describe your organization’s policies and procedures to ensure original data files are not used following the
completion of the project.
General Brown Policies regarding appropriate data use are binding upon all faculty and staff of Brown
University. In particular:
Ultimately the “Policy on the Handling of Brown Restricted Information” (https://it.brown.edu/computing-
policies/policy-handling-brown-restricted-information) defines in general terms the need to protect human
subjects data, which would include any data received from CMS under aDUA.
That in turn references “Policies and Procedures Relating to Research Privacy”
(http://www.brown.edu/Administration/Provost/policies/rpp.html) which defines in general terms the
requirements for defining and controlling access to PHI data.
Somewhat tangentially, data received from CMS under a DUA may be viewed as the property of CMS, even if not
personal health information. The use of such data is covered in general terms by the “Acceptable Use Policy”
(http://www.brown.edu/cis/policy/aup.php) which requires compliance with the requirements of the data’s
owner.
The Policy Relating to Research Privacy of the Office of the Provost, referenced above, in concert with the
Brown Acceptable Use Policy for computing resources, requires that no use be made of any data acquired
under control of this or any other CMS DUA beyond the termination of that DUA. Therefore, by Brown Policy,
there is no authorized access to data files beyond completion of their project. The Center’s User’s Guide
emphasizes these points. (Note that in all cases data is authorized for use in a specific fashion in the context of
a specific project. If CMS authorized re-use of data in an additional project within the Center, access to that
data is tracked separately in the context of each project.) Procedurally, data is erased from all systems as part
of the destruction process. Since the same staff receive, process, and destroy the data, no technical controls
are applied beyond employing safety features such as disk high water marking. Similarly, PIs and staff are
responsible for storing derivative datasets in project-specific locations secured to limit access to only project
staff, and to erase any sensitive datasets as part of study termination unless the entire project space is being
erased. (This latter is not normally done, but rather the project space is “dehydrated” so that it only contains
residual work product such as program code. Such derivative files often need to be referenced for years after
the termination of all Data Use Agreements.)
PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information
unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-
XXXX . The time required to complete this information collection is estimated to average two hours per response,
including the time to review instructions, search existing data resources, gather the data needed, and complete and
review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions
for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop
C4-26-05, Baltimore, Maryland 21244-1850.
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COLLABORATOR
CHECKLIST
Please note –This checklist is for guidance purposes only and for organizations that are involving an additional
organization as part of their research study. The checklist identifies data safeguard practices and considerations of the
collaborating organization that should be indicated in the data requestor’s Data Management Plan. All questions may
not apply but are dependent upon the data sharing arrangement between the organizations involved in the research
study.
(* Information that should be indicated for each collaborating organization that will have access to RIF or non-
identifiable files.)
A. Access to Identifiable and De-identifiable Files
1.
What is the name of the collaborating organization?*
Click here to enter text.
2.
How will the collaborating organization access the CMS data (secure VPN, a physical copy on site at the
collaborating organization, traveling to the DUA holder’s site,etc.)?*
Click here to enter text.
3.
Who are the researchers from the collaborating organization? Indicate if each researcher will have access to
raw data, analytic files, or output with cell sizes less than 11. (Please ensure that these individuals and data
access rights are listed in the Project Stafflist.)*
Click here to enter text.
4.
What binding agreements are required of the researchers from the collaborating organization?*
Click here to enter text.
5.
What training is required of researchers from the collaboratingorganization?*
Click here to enter text.
6.
How will the collaborating organization notify the DUA holder of changes in staff who are participating on the
research team?*
Click here to enter text.
7.
Will the researchers from the collaborating organization abide by the DUA holder’s project rules or the policies
of their employing organization?*
Click here to enter text.
B. Access to RIF
1.
Will the collaborating organization have access to RIF?*
Click here to enter text.
If yes, please provide the following required details:
a.
Will the collaborating organization have the ability to download and store a copy of the CMS data?
Click here to enter text.
b.
Does the collaborating organization intend to backup the data? If so, has the collaborating organization
developed a backup arrangement and are the back-up copies maintained at a secondlocation?
Click here to enter text.
c.
Who is responsible for maintaining the security and distribution of the CMS data at thecollaborating
organization?
Click here to enter text.
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d.
Does the collaborating organization maintain an inventory of the CMS data files that are maintained by
the collaborating organization?
Click here to enter text.
e.
How will the collaborating organization tailor and restrict dataaccess?
Click here to enter text.
f.
Please describe the collaborating organization’s physical and technical safeguards used to protect CMS
data files (including physical access and logical access to the files).
Click here to enter text.
g.
Please describe the collaborating organization’s infrastructure, operating systems, and hardware that
will be used to secure the CMS data.
Click here to enter text.
h.
How will the collaborating organization dispose of electronic copies of thedata?
Click here to enter text.
C. Physical Copies of RIF
Please note - if the collaborating organization will maintain a separate copy of the CMS data, the collaborating organization is
required to complete a full Data Management Plan.
1.
Will a separate copy of the CMS data be housed at the collaborating organization’s location?
Click here to enter text.
2.
How will the collaborating organization receive the CMS data (shipment from the DUA holder, collaborating
organization will request an additional copy directly from CMS, POC from the collaborating organization will
transport the data, etc.)?
Click here to enter text.
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COLLABORATOR
CHECKLIST
Please note –This checklist is for guidance purposes only and for organizations that are involving an additional
organization as part of their research study. The checklist identifies data safeguard practices and considerations of the
collaborating organization that should be indicated in the data requestor’s Data Management Plan. All questions may
not apply but are dependent upon the data sharing arrangement between the organizations involved in the research
study.
(* Information that should be indicated for each collaborating organization that will have access to RIF or non-
identifiable files.)
A. Access to Identifiable and De-identifiable Files
8.
What is the name of the collaborating organization?*
9.
How will the collaborating organization access the CMS data (secure VPN, a physical copy on site at the
collaborating organization, traveling to the DUA holder’s site,etc.)?*
Secure VPN
10. Who are the researchers from the collaborating organization? Indicate if each researcher will have access to
raw data, analytic files, or output with cell sizes less than 11. (Please ensure that these individuals and data
access rights are listed in the Project Stafflist.)*
Dr.
11. What binding agreements are required of the researchers from the collaboratingorganization?*
has signed the Data Protection and Security Agreement as detailed in section 1.3 of the data management plan.
12. What training is required of researchers from the collaboratingorganization?*
Dr. is up to date on their CITI training.
13. How will the collaborating organization notify the DUA holder of changes in staff who are participating on the
research team?*
Dr. will inform the PI by email or phone of any changes in staff as soon as they becomes aware of such changes.
14. Will the researchers from the collaborating organization abide by the DUA holder’s project rules or the policies
of their employing organization?*
Yes, Dr. will abide by the DUA holder’s project rules and policies.
B. Access to RIF
2.
Will the collaborating organization have access to RIF?*
No – they will not have access to the RIF. Dr. will access to RIF by VPN-ing into Brown’s secure network. They
will NOT copy or otherwise transfer any data from that network to the University of
If yes, please provide the following required details:
a.
Will the collaborating organization have the ability to download and store a copy of the CMS data?
Click here to enter text.
b.
Does the collaborating organization intend to backup the data? If so, has the collaborating organization
developed a backup arrangement and are the back-up copies maintained at a secondlocation?
Click here to enter text.
c.
Who is responsible for maintaining the security and distribution of the CMS data at thecollaborating
organization?
Click here to enter text.
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d.
Does the collaborating organization maintain an inventory of the CMS data files that are maintained by
the collaborating organization?
Click here to enter text.
e.
How will the collaborating organization tailor and restrict dataaccess?
Click here to enter text.
f.
Please describe the collaborating organization’s physical and technical safeguards used to protect CMS
data files (including physical access and logical access to thefiles).
Click here to enter text.
g.
Please describe the collaborating organization’s infrastructure, operating systems, and hardware that
will be used to secure the CMS data.
Click here to enter text.
h.
How will the collaborating organization dispose of electronic copies of thedata?
Click here to enter text.
C. Physical Copies of RIF
Please note - if the collaborating organization will maintain a separate copy of the CMS data, the collaborating organization is
required to complete a full Data Management Plan.
3.
Will a separate copy of the CMS data be housed at the collaborating organization’s location?
No, a separate copy of the CMS data will not be housed at the collaborating organization’s location.
4.
How will the collaborating organization receive the CMS data (shipment from the DUA holder, collaborating
organization will request an additional copy directly from CMS, POC from the collaborating organization will
transport the data, etc.)?
Click here to enter text.
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Office of Research Integrity
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Email: IRB@Brown.edu
FWA# 00004460
IRB# 00000556
IRB Amendment Approval
To:
Kali Thomas, Box G-S121-6
From:
Human Research Protection Program
Date:
October 06, 2021
Protocol:
Home-delivered meals for persons with dementia: Which model delays
nursing home placement?
Protocol #:
2008002788
Amendment #:
5
Approval Date: October 06, 2021
This amendment was approved by expedited procedures in accordance with 45 CFR 46.111.
Approval of this amendment (memo dated:10/01/2021) includes:
1. modify the language in the protocol to reflect that participants are receiving meals delivered
 multiple times a week by the MOW program, rather than daily-delivered meals. 
2. Revise one error in the protocol, where it should read biweekly frozen meal delivery rather than
 weekly frozen meal delivery. Participants are still receiving the same amount of meals in both
 arms. 
3. Modify the recruitment targets for two sites - Neighborly and MOW-San Antonio. We would like
 to modify the target goals from 60 to Neighborly to 45-60, and MOW-SA from 100 to 100-115.
Any changes to this research protocol must be submitted to the IRB for review and approval
prior to implementation. While this study is active, compliance with any post-approval monitoring
activities and all Brown University HRPP policies and procedures, including the Reportable Events
Policy, are required.
All study staff must successfully complete CITI training in human subjects research prior to
beginning work on this project.