Novel Approaches to Identifying and Engaging Disadvantaged Patients With Alzheimer's Disease (AD) in Clinical Research
Phase: NA
Conditions: Dementia, Cognitive Dysfunction, Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia
Sponsor: University of Wisconsin, Madison

 
A Relational Research Recruitment and Engagement 
Intervention for Cognitive Aging Research 
 
Study Protocol and Statistical Analysis Plan 
 
NCT05444244 
 
October 31, 2023 
 
 

 
4.1. 
Background/Significance 
Alzheimer’s disease and related dementias (ADRD) are a major public health priority and remain 
the only of the top 10 leading causes of death for which there is no cure or disease-modifying 
treatment. Individuals with ADRD experience progressive and irreversible losses in cognitive 
functioning that eventually lead to functional impairment and dependence on others to meet their 
basic needs. In addition to negatively impacting quality of life for those affected by ADRD, the 
condition also has tremendous societal consequences due to the heavy financial costs of the 
condition and stress/burden associated with caregiving – most of which are shouldered by 
informal (i.e. family, unpaid/nonprofessional) caregivers. Estimates of ADRD diagnoses are 
projected to rise dramatically in the coming decades, highlighting the importance of research 
aimed at not only better understanding disease risk and protective factors – but also identifying 
best approaches to supporting people with ADRD and their caregivers.  
 
Our ability to address these needs is currently hampered by what is referred to by national experts 
and funders as the “Alzheimer’s recruitment crisis.” There is currently a need to screen 700,000 
individuals to recruit 70,000 people to participate in ADRD research studies.1,2 Studying people 
with ADRD is challenging for many reasons – including stigma related to the condition, public 
misconceptions regarding brain health and ADRD, challenges with informed consent, and 
difficulty identifying study participants as 50% of ADRD is not detected or diagnosed.3 Many are 
concerned that advances in ADRD discovery and care will not be made unless we are able to 
rapidly and effectively recruit, engage and retain more research participants. 
 
Because we now understand that the pathophysiologic changes that contribute to ADRD 
conditions and late-life cognitive decline occur decades (often beginning around 40 years of age) 
before clinical symptoms are observable, there is widespread recognition of the need for 
comprehensive inclusion of both adults and older adults in what is referred to as cognitive aging 
research which spans the entire pre-clinical to late-stage disease continuum.4 
 
In addition to needing to expand the numbers of individuals participating in ADRD research there 
is pressing need to also expand the representativeness of ADRD research participants. This is 
particularly important because ADRD disproportionately impacts individuals from historically 
underrepresented and disadvantaged backgrounds – including racial and ethnic minorities and 
individuals from low socioeconomic backgrounds.5,6 These groups also experience significant 
disparities in ADRD diagnosis, time to diagnosis, response to treatment, and mortality7,8—and are 
at higher risk for many other health conditions that serve as independent ADRD risk factors (i.e. 
cardiometabolic conditions). Despite these concerning disparities, these groups are significantly 
underrepresented in ADRD and cognitive aging research.9 Reasons for low rates of inclusion of 
these populations in AD research are multifaceted and include stringent inclusion/exclusion 
criteria of some studies, and mistrust due to discrimination and historical mistreatment of research 
participants.10,11 Emerging research suggests that social and economic barriers also serve as 
major barriers to research participation. Individuals from under-represented backgrounds are 
disproportionately more likely to experience these barriers including time scarcity challenges due 
to multiple jobs (lack of free time), lack of respite care or childcare (due to social or financial 
circumstances), and lack of transportation.11,12 As the ADRD field as a whole advances rapidly 
toward a new recently defined biological definition of ADRD to improve prospects for therapeutic 
targets, there are growing concerns regarding the potential inapplicability of many study findings 
to non-Caucasian individuals as emerging evidence demonstrates variable biomarker, genetic 
and risk profiles among minority populations. In short, emerging research suggests that disease 
mechanisms may vary among diverse racial, ethnic, gender and socio-economic groups. It is 
further worth noting that ADRD incidence and prevalence are highest among the demographics 
that are growing at the fastest rate in the US. Consequently, absent more advanced and 

 
successful research recruitment and retention strategies and programs that proactively tackle the 
fundamental mechanisms of disparities in research participation– local, regional, and national 
goals to address the many health and societal challenges posed by ADRD are unlikely to be met. 
 
4.2. 
Study Objectives 
The Brain Health Community Registry will identify adults over age 40 and ADRD caregivers that 
may be interested in receiving information about current or future research opportunities related 
to brain health and/or caregiving, and will proactively employ strategies to reduce fundamental 
mechanisms that contribute to disparities in research participation. 
 
Through the Brain Health Community Registry, participants: (1) receive information about 
research studies they may be eligible to participate in and (2) receive information about relevant 
resources and services through comprehensive retention strategies (i.e. wraparound services) in 
an effort to eliminate barriers to research participation that result from unmet needs. The Brain 
Health Community Registry is not time limited and will remain active indefinitely. The long-term 
goals of the Registry are to facilitate connections to research opportunities and reduce barriers to 
research participation through comprehensive retention strategies, and to establish a network of 
participants and caregivers who may be able to participate in future research studies. 
 
4.3. 
Methods 
 
ELIGIBILITY  
The Brain Health Community Registry will enroll individuals in 3 categories: (1) Caregivers to 
people with ADRD who are 18 years or older, (2) Adults ages 40 and over interested in brain 
health and (3) Adults ages 40 and over experiencing changes in memory such as ADRD, 
 
Inclusion Criteria for Caregiver Participants Ages 18+  
• 
English-speaking  
• 
Has had previous or current contact with a person with ADRD at least monthly (can be 
phone/virtual or in-person contact) and provides unpaid support to the individual which 
can be health, financial, social, or logistical in nature 
• 
Interested in learning about research opportunities related to aging and brain health, 
particularly related to care for people living with ADRD 
 
Inclusion Criteria for Participants Ages 40+ Not Experiencing Changes in Memory Interested in 
Brain Health 
• 
English-speaking  
• 
Interested in learning about research opportunities related to aging, brain health and 
caregiving 
 
Inclusion Criteria for Participants Ages 40+ Experiencing Changes in Memory Interested in 
Brain Health 
• 
English-speaking 
• 
Interested in learning about research opportunities related to aging, brain health and 
caregiving 
• 
If evidence of a lack of decision-making capacity is present, presence and consent from 
a legally authorized representative (LAR) in addition to assent from the participant with 
cognitive challenges (further detail regarding informed consent, assent, and LARs is 
noted in Step 3).  
 
Exclusion Criteria for Caregiver Participants Ages 18+ 

 
• 
Frequency of contact with the person with ADRD is or has been less than monthly 
• 
Nature of contact does not involve providing supports for person with ADRD, or 
caregiver is paid for supports 
• 
Person they are providing care for is not experiencing any changes in memory 
• 
Under 18 years of age 
• 
Does not speak English 
 
Exclusion Criteria for Participants Ages 40+ Not Experiencing Changes in Memory Interested in 
Brain Health 
• 
Is not interested in learning about research opportunities related to aging and brain 
health 
• 
Under than 40 years of age 
Does not speak English  
 
Exclusion Criteria for Participants Ages 40+ Experiencing Changes in Memory Interested in 
Brain Health 
• 
Is not interested in learning about research opportunities related to aging and brain 
health 
• 
Under 40 years of age 
• 
Evidence of a lack of decision-making capacity and LAR cannot be found or contacted 
• 
Does not speak English 
 
RECRUITMENT PROCEDURES  
Information about the study, eligibility for participation, and how to get involved will be 
distributed through community organizations’ regularly scheduled newsletters (online or print) 
and/or posted flyers. The study team members will follow organizational guidelines for 
submission and a pre-written advertisement will be submitted to agencies for publication.   
 
Newspaper, radio and social media advertisements will contain Information about the study, 
eligibility for details on how interested participants can contact the study team members.  
 
When making first contact with potential participants, study team members will explain the study 
and assess interest and eligibility based upon the inclusion category the participant best aligns 
with (e.g. Adult over the age of 40, or Caregiver over the age of 18).  
 
Contact can take place in-person or over the phone, or through a secure online REDCap 
survey. All formal capacity to consent assessments and contact with LARs will still be done by 
phone or in person.  For caregivers, there will simply be two questions on 1) status as caregiver 
of someone with a dementia diagnosis, and 2) nature and frequency of contact with the care 
recipient, in addition to the requirements on age and ability to speak English. Throughout all 
steps of over the phone and in person interviews, lack of decision-making capacity will be 
determined by members of the study team with training and prior experience in making formal 
capacity assessments. For the online survey, participants will be asked if they are experiencing 
memory changes. If they select yes, they will be asked if these changes affect their daily life. If 
they select yes to both questions, they will be redirected to complete the remainder of the 
survey over the phone or in person, so that the research team may complete an accurate formal 
capacity screen.   
 
CONSENT PROCEDURES 
Consistent with best practice for obtaining informed consent, study team members regularly 
check for questions and understanding of study details throughout the consent process. If 

 
during initial and later contact, a potential participant expresses memory concerns or 
demonstrates challenges remembering key study details, the study team members will complete 
a formal capacity assessment. Formal capacity assessment will be triggered by disclosed 
concerns about memory or cognition, observed challenges following the consent process, 
and/or demonstrated lack of recollection or comprehension of key study details. In the formal 
capacity assessment process, study team members first explain the purpose of a formal 
capacity assessment to interested participants and their family members as a tool to check 
whether participants can independently and safely weigh benefits and risks of research or 
whether they may need support from someone they trust. A question gauging presence of 
concerns about memory or cognition that impact daily life is built into the online eligibility, 
informed consent & intake tool. If the potential participant indicates they are experiencing 
changes in memory or cognition that impact daily life, the online process will be stopped and a 
study team member will contact them for a formal capacity assessment.  
 
Formal capacity assessment will follow the Evaluation to Consent measure – a widely used 
reliable/valid procedure designed for this purpose that study team members have applied to 
previous research. The study team member will clearly explain the study and will use the teach-
back method to confirm understanding of the Registry procedures. This method utilizes a series 
of open-ended questions throughout the process to confirm that the participant understands the 
Registry and their involvement. These questions include:  
1. What is the potential risk of your participation?  
2. What will happen in this study?  
3. What if you don't want to continue the intake interview?  
4. What if you experience discomfort during the intake interview?  
 
If the participant demonstrates understanding of the Registry and their voluntary rights and risk 
regarding participation, and is interested in participating, a study team member will perform 
informed consent procedures as outlined in this protocol. If the individual is interested in 
participating but does not demonstrate capacity to consent, the study team member will 
determine whether a LAR who meets criteria listed below is present, following the order for 
LARs as outlined. The study team member will enroll the participant by having the LAR provide 
informed consent on their behalf.  
 
If the individual is interested in participating but does not demonstrate capacity to consent and 
has no LAR, or the LAR cannot be identified, the study team member will thank them for their 
time and interest, end the recruitment process, and destroy any identifiable information about 
the person. In addition, the study team member will provide resources for the interested 
participant on LARs and ensure they have the study team member’s contact information for any 
follow-up questions. Persons without decision-making capacity will be as involved in the consent 
process as possible through evaluation of assent by research team members. A participant's 
preference not to participate in the study will operate as a veto to their participation, even if their 
representative consents to the research. 
 
Study team members will make contact with the designated Legally Authorized Representative 
(LAR) according to the criteria and hierarchy detailed below, in accordance with institutional 
policy and state law. If the study team members feel it is necessary to deviate from the criteria 
and hierarchy below they will consult with UW Legal Counsel prior to enrollment.  
 
1) A research power of attorney may consent to a potential participant's participation in 
research, if the agent’s decision is not inconsistent with the wishes and preferences of the 
potential participant expressed in the power of attorney instrument. 

 
2) A court-appointed guardian of the person may consent to a ward’s participation in research 
if the court order includes the power to consent to research. NOTE: A guardian of the estate 
or guardian ad litem cannot provide surrogate consent. 
3) A power of attorney for healthcare may consent to a potential participant's participation in 
research, if the agent’s decision is not inconsistent with the wishes and preferences of the 
potential participant expressed in the power of attorney for health care instrument. 
4) If the potential participant has no research power of attorney, guardian, or healthcare power 
of attorney, then the potential participant's “next of kin” may consent on behalf of the 
potential participant. 
 
"Next of kin” can provide surrogate consent in the following order: the spouse or registered 
domestic partner, adult child, parent, adult sibling, grandparent, adult grandchild, or a close 
friend of the potential participant.” The study team members will again confirm the inclusion 
category the participant best aligns with (e.g. Adult over the age of 40 not experiencing changes 
in memory, Adult over the age of 40 experiencing changes in memory, or Caregiver over the 
age of 18) and conduct informed consent with HIPAA authorization.  Signatures have been 
waived for both the informed consent and HIPAA authorization. 
 
Consent procedures will occur before any study procedures, like intake, happen. Consent 
procedures conducted in person or over the phone will occur in a private location of the person's 
choice, over the phone or by secure, UW-approved videoconferencing platform (WebEx) in a 
private location.  Consent obtained through the online survey is completed within the secure 
REDCap survey. The informed consent document within the REDCap survey reminds 
participants of the importance of protecting personal information and encourages participants to 
complete the survey in a private location if possible. Participants will receive a copy of the 
informed consent document for their records, sent to their preferred contact method. The study 
has a waiver of consent with the IRB. After reviewing the informed consent document, 
participants will be asked to indicate whether or not they agree to participate in the study.  
 
We will provide potential participants who decline to participate with the option to speak with the 
research team about their decision not to participate. Individuals who decide not to participate 
will be given the study team’s phone number as well as email address. If the individual reaches 
out to the study team, the study team will answer any questions and the information given by 
the individual will be used to better understand perceptions of the registry, barriers to 
participation in the registry, and potential improvements. Contact information and any other 
identifiable information given by the participant will be deleted immediately after the individual 
makes contact with the study team.  
 
INTAKE PROCESS 
For participants completing enrollment over the phone or in person: Following informed consent, 
Registry participants will complete an intake visit. During the intake visit, participants will provide 
demographic information as well as information necessary for identifying potential research 
studies participants may be eligible for and successfully engaging retention strategies through 
identification of potentially relevant resources. Specifically, information pertaining to participant’s 
health, safety, financial, and caregiving situation will be collected. Participants will also be given 
the opportunity to opt in/out of a semi-annual newsletter or similar informational flyer provided 
by the Brain Health Community. They may select to have the newsletter sent via e-mail or 
postal mail. Participants will be informed that deciding whether or not to receive in the 
newsletter does not impact their participation in the Brain Health Community in any way 
 

 
For participants completing enrollment online: Following informed consent, participants will be 
directed to two questionnaires. In these questionnaires, participants will provide demographic 
information as well as information necessary for identifying potential research studies 
participants may be eligible for and successfully engaging retention strategies through 
identification of potentially relevant resources. Specifically, information pertaining to participant’s 
health, safety, financial, and caregiving situation will be collected. Participants will also be given 
the opportunity to opt in/out of a semi-annual newsletter or similar informational flyer provided 
by the Brain Health Community. They may select to have the newsletter sent via e-mail or 
postal mail. Participants will be informed that deciding whether or not to receive the newsletter 
does not impact their participation in the Brain Health Community in any way. 
 
The intake visit will take 45-90 minutes and can also be completed via phone, in person, or 
through the secure, online, REDCap survey. It can also be completed just after informed 
consent or scheduled at a later time, depending on the participant’s preference. For participants 
completing the survey online, they will have an option to save and return later to the survey, 
allowing them to complete enrollment in multiple sessions if they wish. In-person visits will occur 
in a private location convenient to the individual, including their home, a private room in a 
community center or library, or the patient’s room in a community-based or acute care facility. 
Phone calls will take place from a private room 
For participants with a LAR, intake meetings will take place with the LAR, or a proxy informant 
(as the LAR is sometimes court appointed and may not always be the individual with the most 
detailed, relevant information about the person with dementia) as designated by the LAR. For in 
person and phone enrollment, prior to meeting the participant, the researcher will ensure they 
have the necessary materials—including the intake intro script, intake form, and thank-you card 
with $10. These materials will be in the study binder.  
 
The study team member conducting the intake visit will greet the participant, introducing 
themselves and thanking them for their time and interest. The study team member will remind 
participants the purpose of the Registry and that participation is voluntary. The study team 
member will ask participant if they have any questions. The study team member will explain the 
purpose of the intake form, answers questions as needed, and provide necessary breaks during 
completion of intake visit. The intake form will be completed by the study participant with 
assistance from the study team member as needed. 
 
For online enrollment, all information participants will need to complete enrollment is built in to 
the secure online REDCap survey. Participants will select how they would like to receive their 
payment at the end of the survey. The research team’s contact information is listed throughout 
the survey in case participants have any questions, or would prefer to complete enrollment in 
person or over the phone instead.  
 
RETENTION STRATEGIES 
If any potential barriers to participation in the Registry or subsequent research studies are 
identified during the intake visit (e.g. lack of respite care, lack of reliable transportation, housing 
or food insecurity concerns), researchers will offer Registry participants (or their LAR) a list of 
potential resources and services based on their identified unmet needs (includes contact 
information, eligibility requirements, steps for getting connected). During the intake process, 
situations may arise where participants (or their LAR) need to gather personal information 
before being provided with a list of relevant resources. For example, information about 
insurance eligibility may affect which types of community support groups or respite services 
would be appropriate resources. In these instances, the researcher will arrange follow up with 
participants via phone as needed until connection to appropriate resources and services are 

 
made. All contact will be scheduled at a time and frequency desired by and convenient for the 
participant. 
 
Participants will be offered an additional follow-up call following connection to resources and 
services. This follow-up call is optional. The purpose of this call is to help identify “real time” 
barriers the participants encounter and sufficiency of services. Participants who have opted in 
for the Brain Health Community newsletter will receive periodic information classes or events of 
interest, information related to brain health, and additional ongoing studies. Some participants 
may not be interested in engaging in retention activities, as they may feel they do not have 
unmet needs or would like to use other mechanisms to address their needs. In these situations, 
participants that are not interested in receiving information and/or support connecting to 
supports and services can opt out and/or deny with no effect on their participation in the 
Registry.  
 
ANNUAL UPDATE VISIT 
Researchers will contact participants every 12 months following their entry into the Registry. 
Participants will have the option to complete the annual update via phone, in person at a 
convenient location of their choosing, or through the secure, online REDCap survey. Prior to 
meeting the participant, the researcher will ensure they have the necessary materials—including 
the annual intake intro script, annual intake form, and thank-you card with $5. These materials 
will be in the study binder.  
 
These visits, calls, or online questionnaires will last approximately 20-30 minutes and will ask 
participants to: a) update their contact information, b) complete brief annual update interview to 
identify any significant changes, c) provide feedback on any research studies they participated 
in that they would like to share with the study team member, d) provide feedback on the 
usefulness of retention efforts including any resources or services engaged and their utility, and 
e) share general feedback on the Registry. This information will be used to facilitate continual 
improvement in cultivating useful resources, processes for engaging referring participants to 
research studies and the Registry itself. Resource and service needs will be reassessed on a 
yearly basis or if a participant demonstrates or expresses problems with participating in the 
Registry or subsequent studies due to unmet needs. Standard study team member procedures 
for working with a LAR and/or triggering and completing capacity assessment will apply during 
the annual update visit.  
 
TERMINATING PARTICIPATION 
Participation in the Registry and retention strategies is voluntary; participants may choose to 
terminate their participation at any time by contacting the study team members. Upon receiving 
a request, the Registry staff will unenroll the participant from the Registry within 3 business 
days.   
 
If during the Annual Review process study team members cannot reach a participant, they will 
make attempts to re-contact the participant every two months for up to six months. If the study 
team is unable to reach the participant within that time frame, the study team will attempt to 
contact the participants’ alternative contact every two months for up to six months, if participants 
listed an emergency contact. If no contact is made, the study team will contact the participant 
and alternative contact (if listed) at one year from the missed annual update and a final contact 
at two years from the missed annual update. The study team will unenroll the participant from 
the Registry after two years of no contact with the participant. The study team members will 
review death records to determine whether the reason for unenrollment is death. It will be the 
study team member’s responsibility to periodically evaluate and update their participant pools 

 
and manage the data they have collected from unenrolled participants. Prior data from 
unenrolled participants may be retained indefinitely as indicated in the informed consent to allow 
the study team members to analyze Registry procedures.  
 
SPECIAL PROCEDURES TO MINIMIZE STUDY RISKS 
To minimize risk of stress or burden during intake and annual update procedures, participants 
will be informed and reminded that they may take a break at any time, and may choose to end 
any assessment at any time. They may opt out of answering questions that are upsetting. 
Resources will be provided as needed. Study team members are trained to evaluate participant 
stress during interviews and assessments, and will address challenges as they occur. The 
informed consent process will be conducted in a private location. Subsequent contact by the 
research staff of enrolled participants will be done via telephone calls or conducted in a private 
location. 
 
USE OF THE REGISTRY  
Individuals requesting use of the Registry, for the purposes of recruiting Registry participants 
into a research study, should demonstrate adequate preparation and training in the conduct of 
Human Subjects Research and must hold Principal Investigator status, or its equivalent, at an 
academic, community or health-systems institution. Individuals requesting use of the Registry 
must provide documentation of their study’s Institutional Review Board (IRB) approval along 
with their IRB-approved protocol and documentation of human subjects training for any study 
team members who will collaborate on study contacts. This information will be stored by the 
study team on our Department of Medicine folders.  
 
Any member of the study team that will have direct contact with Registry participants will 
complete standard HIPAA and Human Subject Research training courses offered through the 
CITI Program and the UW-Madison Office of Talent Management, or if external to UW-Madison, 
the equivalent HIPAA and human subjects training. This training must be completed every three 
years. In order to access the Registry, the study team requires a consultation with the PI or 
study team designee both before and after the completion of the project. During the meeting 
researchers can expect feedback on recruitment and stakeholder engagement plans as well as 
research materials. This will be a chance for researchers to apply the training described above.  
 
SHARING PARTICIPANT EXPERIENCES 
As part of the Annual Update, the study team members will solicit feedback from participants 
regarding research projects in which they enrolled. This feedback will be presented to the PIs of 
studies using the Registry in an aggregated, de-identified fashion by the study team members 
once the project has been completed. This feedback will also be part of the general close-out 
procedure by the study team, which is a meeting between the PI or another member of the 
study team and the PI of the external research study. 
 
4.4. 
Statistical Analysis Plan 
Participant demographics and characteristics will be summarized for the Brain Health 
Community Registry enrollment, using frequencies and percentages for categorical variables, 
and using mean, standard deviation, and quartiles for continuous variables.  
 
The BHC Registry Intervention Arm will be evaluated using qualitative feedback from 
participants collected at annual reviews. Analyses of qualitative data will not use statistical 
approaches.  
 

 
We will conduct descriptive statistics to detail feasibility of the BHC Registry including statistics 
regarding:  
• 
refusal rate and reason (%, n) 
• 
enrollment rate, stratified by enrollment mechanism (%, n) 
• 
retention rate (%, n) 
• 
attrition rate (%, n) 
 
4.5. 
Data Protection, Storage, And Sharing 
Paper study materials will be stored under double lock and key Paper intake and retention 
strategy materials will be stored in a locked filing cabinet located within the study team 
member’s locked office. Only persons directly involved in the research evaluation will have 
access to these materials. This study waives signed informed consent, and therefore paper 
informed consent documents are not stored. 
 
Electronic data will be stored and accessed on secure servers (REDCap, Department of 
Medicine secure folders, and SecureBox) During recruitment, contact information for interested 
participants will be stored securely on the Department of Medicine’s instance of REDCap and 
on the Department of Medicine secure folders. Contact information will be destroyed if a 
potential participant denies interest, does not meet eligibility criteria, or is lost to follow-up.  Data 
for enrolled participants will also be stored securely on the Department of Medicine’s instance of 
REDCap and the Department of Medicine secure folders and linked to their intake, retention, 
and annual update data to as the purpose of the Registry is to facilitate matching participants 
with research opportunities and resources. Contact lists for research studies recruiting through 
the Registry will be stored on a Department of Medicine secure folder or on a SecureBox folder, 
specific to that participating study. 
 
All electronic data will be safeguarded through storage on REDCap, SecureBox, and the 
Department of Medicine secure folders which are hosted on secure servers which are 
maintained in locked, secure, limited-access server storage rooms. The servers are secured 
with robust firewalls that are maintained by UW-Madison School of Medicine and Public Health 
network staff.  Access to the servers and REDCap will be restricted to team members with 
special training on data safety. Access is audited every 6 months, and removed if determined no 
longer necessary. Computers used to access the servers and REDCap have an additional layer 
of password protection. Access to identifiable data is restricted to specific study team members, 
including the project PI and data programmers, by limiting REDCap and folder directory access 
permissions to just those individuals. REDCap and the server are protected physically by 
passkey and electronically by the restriction of access to data to only selected project-specific 
individuals (need-to-know). Access to contact lists for research studies recruiting through the 
Registry will be restricted to study team members from that research study provided 
documentation of their IRB approval, their IRB protocol, and each individual’s human subjects 
training. The datasets used for analysis of Brain Health Community Registry accrual, retention, 
etc. will be deidentified and aggregated. Data will be reported as group data so that no 
individual could ever be identified. 
 
 

 
4.6. 
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