The Effect of Smart Ambient Bright Light for Nursing Home Residents With Alzheimer's Disease and Related Dementias
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Sponsor: Penn State University

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HRP-592 - Protocol for Human Subject 
Research with Use of Test Article(s)
Protocol Title:
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu). 
The Effect of Smart Ambient Bright Light for Nursing Home Residents with Alzheimer's Disease and Related Dementias 
(Smart Lighting Study)
Principal Investigator:
Name: Ying-Ling Jao (Contact PI) 
Department: Ross and Carol Nese College of Nursing 
Telephone: (814)865-5634 
E-mail Address: yuj15@psu.edu 
Version Date:
Provide version date for this document. This date must be updated each time this document is submitted to the IRB 
office with revisions.  DO NOT revise the version date in the footer of this document. 
04/21/2023 
Clinicaltrials.gov Registration #:
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual,” under 
“ClinicalTrials.gov” for more information. 
NCT05825404
Important Instructions for Using This Protocol Template:
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the 
IRB to determine whether a study meets all applicable criteria for approval.
1.
GENERAL INSTRUCTIONS1:  

Prior to completing this protocol, ensure that you are using the most recent version by verifying the 
protocol template version date in the footer of this document with the current version provided in the 
CATS IRB Library.

Do not change the protocol template version date located in the footer of this document.

Some of the items may not be applicable to all types of research.  If an item is not applicable, please 
indicate as such or skip question(s) if indicated in any of the instructional text. 

GRAY INSTRUCTIONAL BOXES: Type your protocol responses below the gray instructional boxes of 
guidance language.  If the section or item is not applicable, indicate not applicable.
o
Do NOT delete the instructional boxes from the final version of the protocol.

The protocol should be written in lay language. Do NOT copy and paste grant proposal information into 
the protocol.
1 This template satisfies AAHRPP elements 1.7.B, I.8.B, I-9, II.2. A, II.2.I, II.3.A, II.3.B, II.3.C-II.3.C.1, II.3.D-F, II.4.A, III.1.C-F, II.2.D 
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
Add the completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic 
Information” page.  
2.
CATS IRB LIBRARY: 

Documents referenced in this protocol template (e.g. SOP’s, Worksheets, Checklists, and Templates) can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).
3.
PROTOCOL REVISIONS: 

When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in 
the guides available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes. 

Update the Version Date on page 1 each time this document is submitted to the IRB office with revisions.
If you need help…
All locations: 
Human Research Protection Program
Office for Research Protections
101 Technology Center
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
https://www.research.psu.edu/irb
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Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Number of Subjects and Statistical Plan
9.0
Data and Safety Monitoring Plan
10.0
Risks
11.0
Potential Benefits to Subjects and Others
12.0
Sharing Results with Subjects
13.0
Subject Payment and/or Travel Reimbursements
14.0
Economic Burden to Subjects
15.0
Resources Available
16.0
Other Approvals
17.0
Multi-Site Study
18.0
Adverse Event Reporting
19.0
Study Monitoring, Auditing and Inspecting
20.0
Future Undetermined Research: Data and Specimen Banking
21.0
References
22.0
Confidentiality, Privacy and Data Management
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1.0
Objectives
1.1
Study Objectives
Describe the purpose, specific aims or objectives.  State the hypotheses to be tested.
Aim 1: Pilot test the effect of Smart Ambient Bright Light (SABL) in reducing agitation in persons 
with dementia. We will also examine the effect of SABL on other Behavioral and Psychological 
Symptoms of Dementia (BPSD), affect, and sleep and side effects. We hypothesize that 
participants will show less agitation and other BPSD and improve affect and sleep during and 
after SABL compared to baseline and control periods. We will also explore the intervention effect 
on residents’ other behavioral and psychological symptoms and affect and monitor potential side 
effects. 
Aim 2: Evaluate the fidelity of the SABL delivery. We will evaluate the fidelity of SABL delivery. 
We will measure lighting intensity (lux) and circadian stimulus (CS) levels via two methods: 1) on-
site light measurements, and 2) a personal light monitor. We will compare the actual lighting 
dosage to our target lighting dosage.
Aim 3: Evaluate the feasibility of implementing the SABL. We will use convergent mixed 
methods to evaluate the acceptability, feasibility, and appropriateness of the interventions from 
perspectives of nursing home staff and administrators.
1.2
Primary Study Endpoints
State the primary endpoints to be measured in the study.  
Research typically has a primary objective or endpoint. Additional objectives and endpoints are 
secondary.  The endpoints (or outcomes), determined for each study subject, are the quantitative 
measurements required by the objectives.  Measuring the selected endpoints is the goal of a trial 
(examples: response rate and survival).
The primary outcomes of this study are 1) the effect of SABL on residents’ agitation, other 
BPSD, affect, sleep and any side effects, 2) fidelity of SABL (e.g., lighting level on site and at 
individual level), and 3) feasibility of implementing SABL (e.g., acceptability, feasibility, 
appropriateness, time, and cost of implementing and maintaining the lighting). 
1.3
Secondary Study Endpoints
State the secondary endpoints to be measured in the study.
The secondary outcomes of this study include nursing home facility characteristics and 
resident characteristics.
2.0
Background 
2.1
Scientific Background and Gaps
Describe the scientific background and gaps in current knowledge. 
For clinical research studies being conducted at Penn State Health/Penn State College of Medicine, and 
for other non-PSH locations as applicable, describe the treatment/procedure that is considered standard 
of care (i.e., indicate how patients would be treated in non-investigational setting); and if applicable, 
indicate if the treatment, drug, or device is available to patient without taking part in the study.
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Behavioral and psychological symptoms of dementia (BPSD) is significant in persons with 
dementia living in nursing homes. Evidence suggests that up to 90% of persons with dementia 
experience at least one BPSD. Agitation includes various disruptive behaviors, including verbal and 
physical, aggressive and non-aggressive behaviors, such as screaming, wandering, resisting, 
grabbing, and hitting. Among the BPSDs, agitation is the most challenging symptom. Agitation 
occurs in 90% of nursing home residents with dementia. Medications are commonly used as a 
treatment for agitation but show limited effect and have significant side effects. Non-
pharmacological interventions are recommended as the first-line treatment, but most are labor-
intensive and show mixed effects. Thus, identifying feasible and effective non-pharmacological 
interventions to reduce agitation is critical.
Researchers have tested the association between lighting and BPSD, especially agitation and 
depression. Evidence has shown that circadian disruption, short daylight exposure, and changes 
in interior daylight conditions are related to agitation. Light is the strongest external stimuli 
regulating the circadian rhythm, but older adults are at a higher risk for circadian disturbances 
and need more and brighter light to regulate their circadian rhythm because of reduced 
suprachiasmatic nuclei (SCN) activity and age-related vision deficiencies. In addition, persons 
with dementia living in nursing homes do not have sufficient daylight exposure to maintain a 
stable circadian rhythm. Evidence also shows that many nursing homes are too dim during the 
day. Therefore, ambient lighting is promising in reducing agitation in dementia, especially for 
older adults living in nursing home s. 
Lighting interventions are not invasive with minimal adverse effects and can help maintain a 
stable circadian rhythm and thus reduce agitation. Traditional light interventions are light boxes 
that require participants to sit and keep their eyes towards the light for 1-2 hours. This can lead 
to compliance issues among persons with dementia and workload issues among their 
caregivers. Interest has arisen in using ambient lighting in nursing homes. Ambient lightings 
have shown positive effects on agitation in persons with dementia when targeted at 350-400 
lux and circadian stimulus (CS) = 0.3-0.4. However, there are limitations among these studies 
that tested ambient light in persons with dementia. Window shades were closed to minimize 
daylight exposure and agitation was not the listed in the inclusion criteria. Daylight exposure 
has positive impacts on circadian rhythms, sleep quality, and depression. Yet, the daylight 
effects on other BPSD and affect have not been well evaluated.  Additionally, intervention 
fidelity and feasbility are critical but has not been addressed in prior studies.
2.2
Previous Data
Describe any relevant preliminary data.
Grounded in the theoretical basis of the impact of light on circadian rhythm and aging vision, 
high-intensity lighting and circadian stimulation during the day and low stimulation with less 
short-wavelength content at night are recommended for persons with dementia. This 24-hour 
scheme maintains a bright-dark cycle to regulate rest/activity rhythm, reduces sleep 
disturbance, and consequently reduces agitation and other behavioral symptoms. 
Most lighting studies design lighting interventions based on intensity and can range widely, 
from 350-1000 lux in the daytime for 4 to 12 hours a day. Also, the measurement method 
(e.g., horizontal, vertical, floor plane, work plane, or eye level) is often not explicitly specified. 
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Besides lux, one research group tested lighting interventions based on CS and recommended 
CS=0.3-0.4 during the daytime and CS≤0.1 during the nighttime. 
Ambient lights showed positive effects on depressive symptoms and agitation when targeted at 
approximately 350-750 lux 4500-9325 K, and/or circadian stimulus (CS) of 0.375-0.4 for 10 to 12 
hours a day for more than 4 weeks. For agitation specifically, it has shown positive effects when 
targeted at 350-400 lux and circadian stimulus (CS) = 0.3-0.4. There is also evidence on other 
BPSDs with mixed effects and no conclusion can be drawn. These BPSDs include pleasure, 
general alertness, anxious behaviors, apathy, restlessness, and disturbances of consciousness.  
It is believed that our SABL is safe with minimum adverse effects based on existing research 
evidence. A systematic review of 32 articles concludes that bright light interventions trend 
toward a positive impact and do not have significant adverse effects for persons with 
ADRD(Mitolo et al., 2018). Two studies reported negative outcomes of lighting interventions: 
one study reported deteriorated agitation and depression (Barrick et al., 2010; Hickman et al., 
2007) and another study reported increased anxiety (Van Hoof et al., 2009).  However, their light 
designs were very different from this proposed study, with much higher intensity (2000-3000 
lux) (Barrick et al., 2010; Hickman et al., 2007) or much higher color temperature (CCT=17000K, 
very bluish) (Van Hoof et al., 2009). Our proposed lighting scheme (targeted at 400 lux and 
CS=0.3 during the day and ≤40 lux, CS≤0.1during the night) follows the scientific consensus for 
persons with ADRD (Figueiro et al., 2016) and the recommendations of the American National 
Standards Institute and Illuminating Engineering Society (Illuminating Engineering Society of 
North America, 2020). Ambient light schemes similar to the proposed SABL, but without daylight 
incorporation, have also been evaluated in multiple studies and did not report any negative 
effects. (Figueiro et al., 2014; Figueiro et al., 2015; Figueiro et al., 2019; Figueiro et al., 2020)   
Additionally, the intensity and color of our SABL will be perceived similar to low-level daylight 
and does not cause any glare. Altogether, evidence suggests that our SABL is safe with minimum 
adverse effects.
However, there are limitations among these studies that tested ambient light in persons with 
dementia. Window shades were closed to minimize daylight exposure and agitation was not the 
listed in the inclusion criteria. Daylight exposure has positive impacts on circadian rhythms, sleep 
quality, and depression. Yet, the daylight effects on other BPSD and affect have not been well 
evaluated.  Additionally, intervention fidelity and feasbility are critical but has not been 
addressed in prior studies. Finally, only one study reported that there were no intervention-
related side effects, and most studies did not report any information on intervention side 
effects.
2.3
Study Rationale
Provide the scientific rationale for the research.
Our SABL is the first ambient lighting intervention that utilizes a smart lighting system to 
accommodate daylight through windows and maintain the lighting condition, without eliminating 
the daylighting benefits. This approach is more sustainable and potentially maximizes the effect 
of the ambient lighting interventions. 
This SABL is ‘smart’ in two aspects. First, designing for ambient lighting environments, compared 
with simple light boxes, makes adherence easier. Second, the new tunable LED technologies 
address implementation barriers by providing new auto-controlling of light intensity, distribution, 
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and spectra in nursing home buildings. The SABL system has a pre-programmed 24-hour control 
schedule on illuminance settings to mimic the natural bright-dark cycle. It will regularly monitor 
the lighting level using customized photosensors and automatically adjust the lights to 
accommodate the daylight effect, minimizing staff burden and maintenance efforts, while 
maximizing the LI effect. Moreover, we will work closely with the nursing homes and co-design 
the SABL and implementation protocol and obtain input from stakeholders (e.g., care providers, 
directors of maintenance, and administrators). This will be a critical foundation to implement the 
SABL on a larger scale.
Our proposed SABL will provide bright light with illuminance targeted at 400 lux and high CS of 
0.3 at the eye level, and dim light ≤40 lux and low CS ≤0.1 at night to maintain a bright-dark cycle 
to regulate activity/rest rhythm, improve sleep, and reduce agitation. This dosage selection is 
based on the current scientific consensus and research evidence.  We will measure the light 
levels received by each participant using a personal, wearable lighting measure device and will 
use the actual dosage (lux and CS levels) received by participants to analyze the intervention 
effect. We design the lighting based on lux and CS levels at the eye level in the sitting position, 
which is more in line with the surrounding surface reflexivity and the lighting the individuals 
receive.
SABL is a non-invasive, non-labor-intensive, and promising non-pharmacological intervention for 
persons with dementia and agitation. This is the first study designing an ambient LI for persons 
with dementia that incorporates daylight and testing the intervention fidelity and feasibility. 
Findings will inform intervention design, measures, and implementation protocols for future 
studies.
3.0
Inclusion and Exclusion Criteria
Create a numbered list below in sections 3.1 and 3.2 of criteria subjects must meet to be eligible for study 
enrollment (e.g., age, gender, diagnosis, etc.). 
Vulnerable Populations:
Indicate specifically whether you will include any of the following vulnerable populations in this research. You 
MAY NOT include members of these populations as subjects in your research unless you indicate this in your 
inclusion criteria because specific regulations apply to studies that involve vulnerable populations.  
The checklists referenced below outline the determinations to be made by the IRB when reviewing research 
involving these populations. Review the checklists as these will help to inform your responses throughout the 
remainder of the protocol.

Children –Review “HRP-416- Checklist - Children”

Pregnant Women – Review “HRP-412- Checklist - Pregnant Women”

Cognitively Impaired Adults- Review “HRP-417- Checklist - Cognitively Impaired Adults” 

Prisoners- Review “HRP-415- Checklist - Prisoners”

Neonates of uncertain viability or non-viable neonates- Review “HRP-413- Checklist - Non-Viable 
Neonates” or “HRP-414- Checklist - Neonates of Uncertain Viability”
[Do not type here]
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3.1
Inclusion Criteria
Create a numbered list of the inclusion criteria that define who will be included in your final study 
sample (e.g., age, gender, condition, etc.).  
Aims 1 and 2: Residents
We plan to enroll 20 residents with dementia and agitation from each nursing home (Centre 
Care and Christ the King Manor). Inclusion criteria are as follows:
1. Age≥55
2. English speaking
3. Nursing home residency ≥3 months
4. Presence of dementia. Dementia will be determined based on 1) dementia diagnosis on 
medical records, 2) a score of ≤12 on the Brief Interview for Mental State (BIMS) on MDS, 
and 3) a score of ≤22 on the Montreal Cognitive Assessment (MoCA).
5. Presence of agitation over the past week. Agitation will be determined based on 1) presence 
of agitation symptoms recorded on the most recent Minimum Dataset (MDS) section E, and 
2) a score of >45 on the Cohen-Mansfield Agitation Inventory (CMAI).
Aim 3: Staff and administrators 
We will enroll 16 staff/administrators from the two nursing homes (Rehabilitation and Skilled 
Care at Brookline and Centre Care), including three certified nursing assistants (CNAs), one 
activity staff, one nurse, one director of nursing, one director of maintenance, and one 
administrator from each nursing home. For CNAs and nurses, priority given to individuals who 
provide care for the enrolled residents.  
Participants inclusion criteria: 1) age ≥18, 2) English speaking, and 3) employed at the facility for 
≥3 months.
3.1.1
Does this research involve collecting data from individuals residing outside of the US?
  No
  Yes – identify the countries where data collection will take place
[Type protocol text here] 
3.2
Exclusion Criteria
Create a numbered list of the exclusion criteria that define who will be excluded in your study.
Aims 1 and 2: Residents
Exclusion criteria are major sleep problems, major mental illness, severe vision impairment, and 
severe acute or terminal illness. 
        Major sleep problems refer to severe sleep apnea or severe insomnia that affect individuals’ 
physical function and is documented in medical records. Major mental illness includes mental illness 
that severely impacts their daily function, including schizophrenia and bipolar disorder. Severe acute 
illness includes health conditions that result in the needs to be hospitalized or hospice care, or 
individuals being unconscious, or having life expectancy of less than 6 months. Severe vision 
impairment refers to “severely impaired vision” based on the Minimum Dataset (MDS) or diagnosis of 
blindness based on medical records. 
Aim 3: Staff and administrators 
Age < 18 years old and employed at the facility for < 3 months.
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3. 3 
E arl y  Wit h dr a w al of S u bj ects
3. 3. 1
Crit eri a f or r e m o v al fr o m  st u d y
I ns ert s u bj ect wit h dr a w al crit eri a ( e. g., s af et y r e as o ns, f ail ur e of s u bj ect t o a d h er e t o pr ot oc ol 
r e q uir e m e nts, s u bj ect c o ns e nt wit h dr a w al, dis e as e pr o gr essi o n, etc.).
Ai ms 1  a n d 2: R esi d e nts: 
P artici p a nts w h o  f ail t o a d h er e t o t h e pr ot oc ol, c o ns e nt t o wit h dr a w al, or n e w di a g n osis 
of h e alt h c o n diti o ns m e eti n g excl usi o n crit eri a m a y b e r e m ov e d fr o m t h e st u d y. 
            Ai m 3: St aff a n d a d mi nistr at ors
P artici p a nts w h o  f ail t o a d h er e t o pr ot oc ol r e q uir e m e nt or c o ns e nt wit h dr a w al m a y b e 
r e m o v e d fr o m t h e st u d y.
3. 3. 2
F oll o w- u p f or  wit h dr a w n s u bj ects
D escri b e w h e n  a n d h o w t o wit h dr a w s u bj ects fr o m t h e st u d y; t h e t y p e a n d ti mi n g of t h e d at a t o 
b e c oll ect e d f or wit h dr a w al of s u bj ects; w h et h er a n d h o w s u bj ects ar e t o b e r e pl ac e d; t h e 
f oll o w- u p f or s u bj ects wit h dr a w n fr o m i nv esti g ati o n al tr e at m e nt.
W e will c oll ect  i nf or m ati o n a b o ut r e as o ns f or wit h dr a w al u p o n t h e ti mi n g of wit h dr a w. 
  Ai ms 1 a n d 2: R esi d e nts: 
If a n y r esi d e nts w h o di d n ot c o m pl et e t h e pr oc e d ur es of t h e st u d y m a y b e r e pl ac e d wit h 
a n e w p artici p a nt. W e ai m t o r e pl ac e t h e p artici p a nt wit h a r esi d e nt fr o m t h e s a m e 
f acilit y, if p ossi bl e. All t h e d at a c oll ect e d fr o m t h e p artici p a nts pri or t o t h e wit h dr a w al 
m a y b e i ncl u d e d f or a n al ysis. T h e n e w p artici p a nts will g o t hr o u g h t h e e ntir e 1 3- w e e k 
st u d y pr oc e d ur es fr o m b as eli n e t hr o u g h p ost i nt erv e nti o n. 
Ai m 3:  St aff a n d a d mi nistr at ors
Ai m 3: A n y  p artici p a nts w h o di d n ot c o m pl et e t h e st u d y pr oc e d ur es m a y b e r e pl ac e d 
wit h a n e w st aff or a d mi nistr at ors wit h a si mil ar r ol e/ p ositi o n at t h e f acilit y. All t h e d at a 
c oll ect e d fr o m t h e p artici p a nts pri or t o t h e wit h dr a w al m a y b e i ncl u d e d f or a n al ysis.
4. 0 
R ecr uit m e nt  M et h o ds
U pl o a d  r ecr uit m e nt m at eri als f or y o ur st u d y i n C A T S I R B (htt p://ir b. ps u. e d u ).  D O N O T  i ncl u d e t h e act u al 
r ecr uit m e nt w or di n g i n t his pr ot oc ol.  
St u d y Fi n d er:   If St u d y Fi n d er (htt p://st u d yfi n d er. ps u. e d u ) is t o b e us e d f or r ecr uit m e nt p ur p os es, s e p ar at e 
r ecr uit m e nt d oc u m e nts d o n ot n e e d t o b e u pl o a d e d i n C A T S I R B. T h e n ec ess ar y i nf or m ati o n will b e c a pt ur e d 
fr o m t h e St u d y Fi n d er p a g e i n y o ur C A T S I R B st u d y.  
A n y  eli gi bilit y scr e e ni n g q u esti o ns (v er b al/ p h o n e scri pts, e m ail, etc.) us e d w h e n c o nt acti n g p ot e nti al 
p artici p a nts m ust b e u pl o a d e d t o y o ur st u d y i n C A T S I R B ( htt p://ir b. ps u. e d u ).
[ D o n ot t y p e h er e]
4. 1 
I d e ntific ati o n  of s u bj ects
D escri b e t h e  s o urc e of s u bj ects a n d t h e m et h o ds t h at will b e us e d t o i d e ntif y p ot e nti al s u bj ects ( e. g., 
or g a niz ati o n al lists ervs, est a blis h e d r ecr uit m e nt d at a b as es, s u bj ect p o ols, m e dic al or sc h o ol r ec or ds, 
i nt er acti o ns d uri n g a cli nic visit, etc.). If n ot r ecr uiti n g s u bj ects dir ectl y ( e. g., d at a b as e q u er y f or eli gi bl e 
r ec or ds or s a m pl es) st at e w h at will b e q u eri e d, h o w a n d b y w h o m.
St u d y Fi n d er:  
S T U D Y 0 0 0 2 0 2 1 6
A p pr o v al: 4/ 2 4/ 2 0 2 3

P a g e 1 0  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E 
o
If y o u i nt e n d t o us e St u d y Fi n d er (htt p://st u d yfi n d er. ps u. e d u ) f or r ecr uit m e nt p ur p os es, i ncl u d e t his 
m et h o d i n  t his s ecti o n. 
o
I nf or m ati o n pr ovi d e d i n t his pr ot oc ol, i ncl u di n g t h e d escri pti o n of st u d y pr oc e d ur es, c o m p e ns ati o n, 
a n d r ecr uit m e nt, n e e ds t o b e c o nsist e nt wit h i nf or m ati o n pr ovi d e d o n t h e St u d y Fi n d er p a g e i n y o ur 
C A T S I R B st u d y.
F or P e n n  St at e H e alt h s u b missi o ns usi n g E nt er pris e I nf or m ati o n M a n a g e m e nt ( EI M) f or r ecr uit m e nt, a n d 
f or n o n- H ers h e y l oc ati o ns as a p plic a bl e, att ac h y o ur EI M D esi g n S p ecific ati o n f or m i n C A T S I R B 
(htt p://ir b. ps u. e d u ). S e e “ H R P- 1 0 3- I nv esti g at or M a n u al, St u d y R ecr uit m e nt” f or a d diti o n al i nf or m ati o n. 
D O N O T  i ncl u d e t h e act u al r ecr uit m e nt m at eri al or w or di n g i n t his pr ot oc ol.
Ai ms 1  a n d 2: R esi d e nts 
W e will c o n d uct  t his st u d y fr o m l oc al n ursi n g h o m e f aciliti es. 
W e will as k  n ursi n g h o m e a d mi nistr ativ e st aff at e ac h f acilit y t o h el p i d e ntif y p ot e nti all y eli gi bl e 
r esi d e nts w h o m e et o ur br o a d i ncl usi o n crit eri a: 1) a g e ≥5 5,  2) E n glis h s p e a ki n g, 3) l o n g-t er m 
st a y at t h e f acilit y f or at l e ast 3 m o nt hs, a n d 4) di a g n osis of d e m e nti a. 
T h e eli gi bilit y  of t h e p ot e nti al p artici p a nts i d e ntifi e d b y n ursi n g h o m e st aff will b e c o nfir m e d b y 
t h e r es e arc h t e a m aft er c o ns e nt. T h e r es e arc h t e a m will r evi e w t h e r esi d e nts’ m e dic al r ec or ds 
f or i ncl usi o n a n d excl usi o n crit eri a ( a g e≥5 5, E n glis h s p e a ki n g, n ursi n g h o m es r esi d e nc y ≥3 
m o nt hs, pr es e nc e of d e m e nti a, a n d pr es e nc e of a git ati o n ov er t h e p ast w e e k) a n d c oll ect 
i nf or m ati o n o n r esi d e nt’s c o g nitiv e f u ncti o n a n d a git ati o n t hr o u g h t h e pr ox y r e p ort of t h eir 
pri m ar y c ar e gi v ers ( C N A or n urs e) t o c o nfir m eli gi bilit y.  Eli gi bl e p artici p a nts will b e a p pr o ac h e d 
f or c o ns e nt o nc e t h eir c o nt act i nf or m ati o n is o bt ai n
Ai m 3:  St aff a n d a d mi nistr at ors
W e will as k  n ursi n g h o m e a d mi nistr ativ e st aff t o h el p i d e ntif y p ot e nti all y eli gi bl e 
st aff/ a d mi nistr at ors f or t h e crit eri a of i nt er est: a g e ≥1 8,  E n glis h s p e a ki n g, e m pl o y e d f or ≥3  
m o nt hs, a n d i n t h e p ositi o n of i nt er est at t h e f aciliti es. T h eir eli gi bilit y will b e v erifi e d b y t h e 
r es e arc h t e a m.
4. 2 
R ecr uit m e nt  pr oc ess
D escri b e h o w  p ot e nti al s u bj ects first l e ar n a b o ut t his r es e arc h o p p ort u nit y or i n dic at e ‘ n ot a p plic a bl e’ if 
s u bj ects will n ot b e pr os p ectiv el y r ecr uit e d t o p artici p at e i n t h e r es e arc h. S u bj ect r ecr uit m e nt c a n 
i n v olv e v ari o us m et h o ds ( e. g., a p pr o ac hi n g p ot e nti al s u bj ects i n p ers o n, c o nt acti n g p ot e nti al s u bj ects vi a 
e m ail, l ett ers, t el e p h o n e, R es e arc h M atc h, or a dv ertisi n g t o a g e n er al p u blic vi a fl y ers, w e bsit es, 
St u d y Fi n d er, n e ws p a p er, t el evisi o n, a n d r a di o etc.). D O N O T  i ncl u d e t h e act u al r ecr uit m e nt m at eri al or 
w or di n g i n t his pr ot oc ol.
[ D o n ot t y p e h er e]
4. 2. 1
H o w  p ot e nti al s u bj ects will b e r ecr uit e d.
Ai ms 1  a n d 2: R esi d e nts 
R ef err al of  n ursi n g st aff. O nc e t h e p ot e nti all y eli gi bl e r esi d e nts ar e i d e ntifi e d, 
r ecr uit m e nt will b e c o n d uct e d i n a f e w w a ys. 
  
First, t h e  h e n ursi n g h o m e st aff will s e n d o ut a r esi d e nt r ecr uit m e nt l ett er (s e e 
d oc u m e nt att ac h e d) t o t h e f a mil y/l e g all y a ut h oriz e d r e pr es e nt ativ e of t h e 
p ot e nti all y eli gi bl e r esi d e nts. T h e l ett er i ncl u d es t h e i nf or m ati o n a b o ut a bri ef 
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o v er vi e w of t h e  st u d y a n d t h e r es e arc h t e a m’s c o nt act i nf or m ati o n. T h e l ett er als o 
as ks t h e f a mil y/L A R t o c o nt act t h e r es e arc h t e a m if t h e y ar e i nt er est e d i n l etti n g t h e 
r esi d e nts t o p artici p ati n g i n t h e st u d y. 
N ext, t h e  r es e arc h t e a m will h ol d o n e or m or e r ecr uit m e nt m e eti n gs i n p ers o n 
a n d/ or virt u all y t o m e et wit h f a mil y, pr ovi d e a n ov ervi e w a b o ut t h e st u d y, a n d 
a ns w er a n y q u esti o ns t h e y m a y h av e. T h e r es e arc h t e a m will as k t h e f a mil y/L A R t o 
pr o vi d e t h eir c o nt act i nf or m ati o n, if t h e y ar e i nt er est e d i n l etti n g t h e r esi d e nts t o 
p artici p at e i n t h e st u d y or disc ussi n g t h e r es e arc h f urt h er. T h e St u d y Ov ervi e w Sli d es 
f or t h e r ecr uit m e nt m e eti n gs ar e att ac h e d. 
  
Fi n all y, t h e  r es e arc h t e a m will p ost r ecr uit m e nt fl y ers (s e e att ac h m e nt) at t h e f acilit y 
a n d i n vit e f a mil y/L A R t o c o nt act t h e r es e arc h t e a m or l e av e c o nt act i nf or m ati o n f or 
t h e r es e arc h t e a m t o c o nt act t h e m. 
Ai m 3:  St aff a n d a d mi nistr at ors
Fl y ers will  b e cr e at e d a n d p ost e d i n t h e f acilit y t o r ecr uit st aff. T h e r es e arc h t e a m 
will h ol d o n e or m or e r ecr uit m e nt m e eti n gs at t h e f acilit y t o i ntr o d uc e t h e st u d y, 
a ns w er q u esti o ns, a n d r ecr uit st aff p artici p a nts. T h e St u d y Ov ervi e w Sli d es f or t h e 
r ecr uit m e nt m e eti n gs ar e att ac h e d. 
4. 2. 2
W h er e  p ot e nti al s u bj ects will b e r ecr uit e d.
W e pl a n  t o r ecr uit p artici p a nts fr o m l oc al n ursi n g h o m es. T h e p ot e nti al n ursi n g 
h o m es w e pl a n t o r ecr uit ar e 1) C e ntr e C ar e a n d 2) C hrist t h e Ki n g M a n or.
4. 2. 3
W h e n  p ot e nti al s u bj ects will b e r ecr uit e d.
P artici p a nts will  b e r ecr uit e d as s o o n as w e h av e I R B a p pr ov al a n d p er missi o n fr o m 
n ursi n g h o m es. 
4. 2. 4
D escri b e  t h e eli gi bilit y scr e e ni n g pr oc ess. Scr e e ni n g b e gi ns w h e n t h e i n v esti g at or o bt ai ns 
i nf or m ati o n a b o ut or fr o m a pr os p ecti v e p artici p a nt i n or d er t o d et er mi n e t h eir eli gi bilit y.  
  Eli gi bilit y scr e e ni n g is occ urri n g b ef or e c o ns e nt * - d escri b e t h e pr oc ess b el o w 
  Eli gi bilit y scr e e ni n g is occ urri n g aft er c o ns e nt - d escri b e t h e pr oc ess b el o w
  Eli gi bilit y scr e e ni n g is occ urri n g, c o ns e nt is n ot b ei n g o bt ai n e d i n t his r es e arc h - d escri b e t h e 
pr oc ess b el o w
  N ot a p plic a bl e - Eli gi bilit y scr e e ni n g is n ot b ei n g d o n e i n t his r es e arc h
Ai ms 1  a n d 2: R esi d e nts
T h e scr e e ni n g  pr oc ess f or r esi d e nts i nv olv es t hr e e st e ps: 1) i niti al scr e e ni n g c o n d uct e d 
b y n ursi n g h o m e st aff, 2) c h art r evi e ws c o n d uct e d b y t h e r es e arc h t e a m, a n d 3) 
i nt er vi e ws wit h pri m ar y st aff/c ar e giv ers c o n d uct e d b y t h e r es e arc h t e a m.  T h e st e p 1 
scr e e ni n g will b e c o n d uct e d pri or t o t h e c o ns e nt, a n d t h e st e ps 2 a n d 3 will b e 
c o n d uct e d aft er c o ns e nt.  
F or st e p  1, t h e n ursi n g h o m e  st aff will c o n d uct a n i niti al scr e e ni n g b as e d o n o ur br o a d 
i ncl usi o n crit eri a: 1) a g e ≥5 5,  2) E n glis h s p e a ki n g, 3) l o n g-t er m st a y at t h e f acilit y f or at 
l e ast 3 m o nt hs, a n d 4) di a g n osis of d e m e nti a. 
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DO NOT ALTER OR DELETE 
For step 2, after the informed consent is obtained from LAR or resident as appropriate, 
the research team will review the residents’ medical records to verify their eligibility 
based on the  inclusion and exclusion criteria. 
If the resident is not capable to consent and does not have a LAR to provide consent, 
they will not be eligible to participate in the study.
For residents who pass the step 2 screening, the research team will proceed with the 
screening and conduct additional assessments to confirm the presence of dementia and 
agitation. Specifically, the research team will assess residents’ cognitive function by 
interviewing the residents and assess the residents’ agitation symptoms based on inputs 
from the primary staff caregivers, which includes but is not limited to certified nurse 
assistants (CNAs), licensed practical nurses (LPNs), and registered nurse (RNs). 
We will assess residents’ cognitive impairment using the Montreal Cognitive Assessment 
(MoCA). A score of ≤22 on the Montreal Cognitive Assessment (MoCA) is considered 
cognitive impairment and eligible for this research study. We will assess residents’ 
agitation symptoms using the Cohen-Mansfield Agitation Inventory (CMAI), based on 
the residents’ behaviors over the past week. A CMAI score of ≥ 45 is considered 
presence of agitation and is eligible for this study. Residents who have cognitive 
impairment (MoCA score ≤22) and agitation (CMAI score ≥ 45) are considered eligible 
and will be enrolled for the study. 
Aim 3: Staff and administrators  
The screening for staff and administrators will be conducted after consent has been 
provided. Our inclusion criteria are as below: a) nursing home employed healthcare 
workers employed for ≥ 3 months, b) age≥ 18, and c) English speaking. We will provide 
the inclusion criteria to the staff during the recruitment meeting and, if they are 
potentially eligible and interested in participating, the research team will ask them to 
provide their contact information.  Next the research team will reach out to them 
individually to obtain consent. 
In some studies, these procedures may not take place unless HIPAA Authorization is obtained OR a 
waiver of HIPAA Authorization when applicable for the screening procedures is approved by the IRB.
*Unless informed consent is waived by the IRB, screening before consent is only permitted when 
screening activities are limited to the collection of information through oral or written communication 
OR when identifiable private information or identifiable biospecimens is obtained by accessing records 
or stored identifiable biospecimens. Screening before consent is not permitted if data will be used for 
activities other than eligibility screening/recruitment (e.g., data analysis). 
  
5.0
Consent Process and Documentation 
Refer to the following materials:

The “HRP-090- SOP - Informed Consent Process for Research” outlines the process for obtaining informed 
consent.  

The “HRP-091– SOP - Written Documentation of Consent” describes how the consent process will be 
documented.
STUDY00020216
Approval: 4/24/2023

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
T h e  “ H R P- 3 1 4- W or ks h e et - Crit eri a f or A p pr ov al” s ecti o n 7 lists t h e r e q uir e d el e m e nts of c o ns e nt.

T h e  “ H R P- 3 1 2- W or ks h e et - Ex e m pti o n D et er mi n ati o n” i ncl u d es i nf or m ati o n o n r e q uir e m e nts f or t h e 
c o ns e nt pr oc ess f or ex e m pt r es e arc h.  I n a d diti o n, t h e C A T S I R B Li br ar y c o nt ai ns c o ns e nt g ui d a nc e a n d 
t e m pl at es f or ex e m pt r es e arc h.

T h e C A T S I R B li br ar y c o nt ai ns v ari o us c o ns e nt t e m pl at es f or ex p e dit e d or f ull r evi e w r es e arc h t h at ar e 
d esi g n e d t o i ncl u d e t h e r e q uir e d i nf or m ati o n.

A d d  t h e c o ns e nt d oc u m e nt(s) t o y o ur st u d y i n C A T S I R B (htt p://ir b. ps u. e d u ). Li n ks t o P e n n St at e’s c o ns e nt 
t e m pl at es ar e av ail a bl e i n t h e s a m e l oc ati o n w h er e t h e y ar e u pl o a d e d. D O N O T  i ncl u d e t h e act u al c o ns e nt 
w or di n g i n t his pr ot oc ol.
[ D o n ot t y p e h er e]
5. 1 
C o ns e nt  Pr oc ess:
C h ec k all  a p plic a bl e b o x es b el o w:
 I nf or m e d c o ns e nt will b e s o u g ht a n d d oc u m e nt e d wit h a writt e n c o ns e nt f or m [ C o m pl et e S ecti o ns 
5. 2 a n d 5. 6; If t his is t h e o nly b ox c h ec k e d, m ar k S ecti o ns 5. 3, 5. 4 a n d 5. 5 as ‘ N ot a p plic a bl e’]  
 I m pli e d or v er b al c o ns e nt will b e o bt ai n e d – s u bj ects will n ot si g n a c o ns e nt f or m ( w ai v er of 
writt e n d oc u m e nt ati o n of c o ns e nt) [ C o m pl et e S ecti o ns 5. 2, 5. 3 a n d 5. 6; If t his is t h e o nly b ox 
c h ec k e d, m ar k S ecti o ns 5. 4 a n d 5. 5 as ‘ N ot a p plic a bl e’]  
  I nf or m e d c o ns e nt will b e s o u g ht b ut s o m e of t h e el e m e nts of i nf or m e d c o ns e nt will b e o mitt e d or 
alt er e d ( e. g., d ec e pti o n). [ C o m pl et e s ecti o n 5. 2, 5. 4 a n d 5. 6; If t his is t h e o nly b ox c h ec k e d, m ar k 
S ecti o n 5. 5 as ‘ N ot a p plic a bl e’]  
 I nf or m e d c o ns e nt will n ot b e o bt ai n e d – r e q u est t o c o m pl et el y w ai v e t h e i nf or m e d c o ns e nt 
r e q uir e m e nt. [ C o m pl et e S ecti o n 5. 5; If t his is t h e o nly b ox c h ec k e d, m ar k S ecti o ns 5. 2, 5. 3, 5. 4 a n d 
5. 6 as ‘ N ot a p plic a bl e’]
5. 2 
O bt ai ni n g I nf or m e d  C o ns e nt 
5. 2. 1
C o ns e nt  Pr oc ess 
D escri b e t h e  c o ns e nt pr oc ess, i ncl u di n g w h e n a n d w h er e it will t a k e pl ac e.
Ai ms 1  a n d 2: R esi d e nts 
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F or e ac h  r esi d e nt w h o is p ot e nti all y eli gi bl e, t h e i nf or m e d c o ns e nt pr oc ess will b e gi n 
pri or t o r es e arc h t e a m’s scr e e ni n g (scr e e ni n g st e ps 2 a n d 3). 
Pri or t o  c o ns e nti n g, t h e r es e arc h t e a m will ass ess t h e r esi d e nt’s c a p acit y t o c o ns e nt f or 
r es e arc h. All p ot e nti all y eli gi bl e r esi d e nt p artici p a nts will b e a p pr o ac h e d t o ass ess t h eir 
c a p a bilit y of pr o vi di n g c o ns e nt usi n g t h e Ev al u ati o n t o Si g n C o ns e nt ( E S C). T h e E S C is a 
fi v e-it e m m e as ur e a n d its ps yc h o m etrics h av e b e e n est a blis h e d i n ass essi n g ol d er 
a d ult’s c a p acit y t o c o ns e nt f or r es e arc h ( R es nic k et al., 2 0 0 7).   T h e d et ails of t his 
ass ess m e nt i nstr u m e nt ar e pr ovi d e d i n s ecti o n 5. 6. 2. 1. B as e d o n t h e ass ess m e nt, if t h e 
r esi d e nt is d et er mi n e d t o b e c a p a bl e of c o ns e nti n g, t h e r es e arc h t e a m will pr oc e e d 
wit h t h e i nf or m e d c o ns e nt pr oc ess wit h t h e r esi d e nt. R esi d e nt c o ns e nt will b e 
c o n d uct e d i n- p ers o n a n d will t a k e pl ac e at t h e f acilit y. W e will m e et wit h t h e r esi d e nt 
at t h e n ursi n g h o m e f acilit y a n d ex pl ai n t h e st u d y t o t h e r esi d e nt usi n g t h e c o ns e nt 
f or m. If t h e r esi d e nt a gr e es t o p artici p at e, w e will as k hi m/ h er t o si g n t h e c o ns e nt 
f or ms i n- p ers o n. 
F or r esi d e nts w h o  ar e n ot c a p a bl e of c o ns e nti n g a n d/ or h av e a L A R, w e will c o nt act t h e 
L A R t o pr o vi d e c o ns e nt f or t h e r esi d e nt aft er c o m pl eti n g t h e first t w o st e ps of 
scr e e ni n g.
T o o bt ai n  i nf or m e d c o ns e nt fr o m t h e L A R, t h e st u d y t e a m will c o n d uct t h e f oll o wi n g 
pr ot oc ol.  First, t h e r es e arc h t e a m will o bt ai n t h e L A R’s n a m e a n d c o nt act i nf or m ati o n 
fr o m n ursi n g h o m e st aff u n d er t h e r esi d e nts’ p er missi o n or dir ectl y fr o m t h e L A R. 
S ec o n d, w e will c o ns e nt t h e L A R i n- p ers o n or r e m ot el y vi a p h o n e . I n- p ers o n c o ns e nt 
will t a k e pl ac e eit h er at t h e f acilit y, o ur r es e arc h offic e, or l oc ati o n of t h eir c h oic e wit h 
pri v ac y. F or i n- p ers o n c o ns e nt, w e will as k t h e L A R t o si g n t h e c o ns e nt f or ms i n- p ers o n. 
F or r e m ot e c o ns e nt, w e will as k t h e L A R t o si g n t h e c o ns e nt f or ms, sc a n t h e f or ms, a n d 
t h e n eit h er s e n d b ac k t h e si g n e d c o ns e nt f or ms eit h er vi a m ail, e m ail, or i n p ers o n. 
Ai m 3:  St aff a n d a d mi nistr at ors  
 W e will pr o vi d e st aff a n d a d mi nistr at ors t h e c o ns e nt f or ms i n p ers o n or vi a m ail or 
e m ail a n d o bt ai n t h eir c o ns e nt i n p ers o n or r e m ot el y vi a p h o n e or vi d e oc o nf er e nc e 
( e. g., z o o m). I n- p ers o n c o ns e nt will t a k e pl ac e eit h er at t h e f acilit y, o ur r es e arc h offic e, 
or l oc ati o n of t h eir c h oic e wit h priv ac y a n d will as k t h e m t o si g n t h e c o ns e nt f or ms i n-
p ers o n.
5. 2. 2
C o erci o n  or U n d u e I nfl u e nc e d uri n g C o ns e nt 
D escri b e t h e  st e ps t h at will b e t a k e n t o mi ni miz e t h e p ossi bilit y of c o erci o n or u n d u e i nfl u e nc e 
i n t h e c o ns e nt pr oc ess.
F or c o ns e nt  of all r es e arc h p artici p a nts (i. e., t h e r esi d e nts, st aff, a n d a d mi nistr at ors), i n 
t h e c o urs e of ex pl ai ni n g t h e st u d y, all p artici p a nts will b e t ol d t h at p artici p ati o n i n t his 
r es e arc h st u d y is t ot all y v ol u nt ar y, a n d t h e y ar e fr e e t o wit h dr a w at a n y ti m e. T h e 
r es e arc h t e a m will e m p h asiz e t o r esi d e nts a n d f a mil y m e m b ers t h at p artici p ati o n will 
n ot i nfl u e nc e t h e q u alit y of c ar e t h e r esi d e nt r ec eiv es i n a n y w a y. W e will als o 
e m p h asiz e t o st aff t h at t h eir p artici p ati o n d ecisi o n will i n n o w a y i m p act t h eir j o b 
st at us or p erf or m a nc e r evi e w.
5. 3  
W ai v er  of Writt e n D oc u m e nt ati o n of C o ns e nt 
R e vi e w “ H R P  – 4 1 1 – C h ec klist – W aiv er of Writt e n D oc u m e nt ati o n of C o ns e nt.” 
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5. 3. 1
I n dic at e w hic h of t h e f oll o wi n g c o n diti o ns a p pli es t o t his r es e arc h:
  T h e r es e arc h pr es e nts n o m or e t h at mi ni m al ris k of h ar m t o s u bj ects a n d i nv olv es n o 
pr oc e d ur es f or w hic h writt e n c o ns e nt is n or m all y r e q uir e d o utsi d e of t h e r es e arc h c o nt ext.
O R
  T h e o nl y r ec or d li n ki n g t h e s u bj ect a n d t h e r es e arc h w o ul d b e t h e c o ns e nt d oc u m e nt a n d t h e 
pri nci p al ris k w o ul d b e p ot e nti al h ar m r es ulti n g fr o m a br e ac h of c o nfi d e nti alit y. E ac h s u bj ect 
will b e as k e d w h et h er t h e s u bj ect w a nts d oc u m e nt ati o n li n ki n g t h e s u bj ect wit h t h e r es e arc h, 
a n d t h e s u bj ect’s wis h es will g ov er n. ( N ot e: T his c o n diti o n is n ot a p plic a bl e f or F D A-r e g ul at e d 
r es e arc h. If t his c at e g ory is c h os e n, i ncl u d e c o pi es of a c o ns e nt f or m a n d / or p ar e nt al 
p er missi o n f or m f or p artici p a nts w h o w a nt writt e n d oc u m e nt ati o n li n ki n g t h e m t o t h e 
r es e arc h.)
O R
  If t h e s u bj ects or l e g all y a ut h oriz e d r e pr es e nt ativ es ar e m e m b ers of a disti nct c ult ur al gr o u p 
or c o m m u nit y i n w hic h si g ni n g f or ms is n ot t h e n or m, t h at t h e r es e arc h pr es e nts n o m or e 
t h a n mi ni m al ris k of h ar m t o s u bj ects a n d pr ovi d e d t h er e is a n a p pr o pri at e alt er n ati v e 
m ec h a nis m f or d oc u m e nti n g t h at i nf or m e d c o ns e nt w as o bt ai n e d.  ( N ot e: T his c o n diti o n is n ot 
a p plic a bl e f or F D A-r e g ul at e d r es e arc h.) 
F or disti nct c ult ur al gr o u ps  d escri b e t h e alt er n ativ e m ec h a nis m f or d oc u m e nti n g t h at 
i nf or m e d c o ns e nt w as o bt ai n e d:
N ot a p plic a bl e
5. 3. 2
I n dic at e w h at m at eri als, if a n y, will b e us e d t o i nf or m p ot e nti al s u bj ects a b o ut t h e 
r es e arc h ( e. g., a l ett er acc o m p a n yi n g a q u esti o n n air e, v er b al scri pt, or i m pli e d c o ns e nt 
f or m)
N ot a p plic a bl e
5. 4 
I nf or m e d  c o ns e nt will b e s o u g ht b ut s o m e of t h e el e m e nts of i nf or m e d c o ns e nt will b e o mitt e d or 
alt er e d ( e. g., d ec e pti o n).
R e vi e w “ H R P- 4 1 0- C h ec klist  - W aiv er or Alt er ati o n of C o ns e nt Pr oc ess” t o e ns ur e t h at y o u h a v e pr o vi d e d 
s uffici e nt i nf or m ati o n.  
5. 4. 1
I n dic at e t h e el e m e nts of i nf or m e d c o ns e nt t o b e o mitt e d or alt er e d
N ot a p plic a bl e
5. 4. 2
I n dic at e w h y t h e r es e arc h c o ul d n ot pr actic a bl y b e c arri e d o ut wit h o ut t h e o missi o n or 
alt er ati o n of c o ns e nt el e m e nts
N ot a p plic a bl e
5. 4. 3
D escri b e  w h y t h e r es e arc h i n v ol v es n o m or e t h a n mi ni m al ris k t o s u bj ects.
N ot a p plic a bl e
5. 4. 4
D escri b e  w h y t h e alt er ati o n/ o missi o n will n ot a d v ers el y aff ect t h e ri g hts a n d w elf ar e of 
s u bj ects.
N ot a p plic a bl e
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P a g e 1 6  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E 
5. 4. 5
If t h e r es e arc h i n v ol v es usi n g i d e ntifi a bl e pri v at e i nf or m ati o n or i d e ntifi a bl e 
bi os p eci m e ns, d escri b e w h y t h e r es e arc h c o ul d n ot pr actic a bl y b e c arri e d o ut wit h o ut 
usi n g s uc h i nf or m ati o n or bi os p eci m e ns i n a n i d e ntifi a bl e f or m at.
N ot a p plic a bl e
5. 4. 6
D e bri efi n g  
Ex pl ai n w h et h er  a n d h o w s u bj ects will b e d e bri ef e d aft er p artici p ati o n i n t h e st u d y. If s u bj ects 
will n ot b e d e bri ef e d, pr ovi d e a j ustific ati o n f or n ot d oi n g s o. A d d a n y d e bri efi n g m at eri als t o 
t h e st u d y i n C A T S I R B.
N ot a p plic a bl e
5. 5 
I nf or m e d  c o ns e nt will n ot b e o bt ai n e d – r e q u est t o c o m pl et el y w ai v e t h e i nf or m e d c o ns e nt 
r e q uir e m e nt
R e vi e w “ H R P- 4 1 0- C h ec klist  - W aiv er or Alt er ati o n of C o ns e nt Pr oc ess” t o e ns ur e t h at y o u h a v e pr o vi d e d 
s uffici e nt i nf or m ati o n.
5. 5. 1
I n dic at e w h y t h e r es e arc h c o ul d n ot pr actic a bl y b e c arri e d o ut wit h o ut t h e w ai v er of 
c o ns e nt
[ T y p e pr ot oc ol t ext h er e or i n dic at e as n ot a p plic a bl e]
5. 5. 2
D escri b e  w h y t h e r es e arc h i n v ol v es n o m or e t h a n mi ni m al ris k t o s u bj ects.
[ T y p e pr ot oc ol t ext h er e or i n dic at e as n ot a p plic a bl e]
5. 5. 3
D escri b e  w h y t h e alt er ati o n/ o missi o n will n ot a d v ers el y aff ect t h e ri g hts a n d w elf ar e of 
s u bj ects.
[ T y p e pr ot oc ol t ext h er e or i n dic at e as n ot a p plic a bl e]
5. 5. 4
If t h e r es e arc h i n v ol v es usi n g i d e ntifi a bl e pri v at e i nf or m ati o n or i d e ntifi a bl e 
bi os p eci m e ns, d escri b e w h y t h e r es e arc h c o ul d n ot pr actic a bl y b e c arri e d o ut wit h o ut 
usi n g s uc h i nf or m ati o n or bi os p eci m e ns i n a n i d e ntifi a bl e f or m at.
[ T y p e pr ot oc ol t ext h er e or i n dic at e as n ot a p plic a bl e]
5. 5. 5
A d diti o n al  p erti n e nt i nf or m ati o n aft er p artici p ati o n
Ex pl ai n if  s u bj ects will b e pr ovi d e d wit h a d diti o n al p erti n e nt i nf or m ati o n aft er p artici p ati o n. 
N ot a p plic a bl e
5. 6 
C o ns e nt  – Ot h er C o nsi d er ati o ns 
5. 6. 1
N o n- E n glis h- S p e a ki n g  S u bj ects
I n dic at e w h at l a n g u a g e(s) ot h er t h a n E n glis h ar e u n d erst o o d b y pr os p ectiv e s u bj ects or 
r e pr es e nt ativ es.
If s u bj ects w h o d o n ot s p e a k E n glis h will b e e nr oll e d, d escri b e t h e pr oc ess t o e ns ur e t h at t h e 
or al a n d writt e n i nf or m ati o n pr ovi d e d t o t h os e s u bj ects will b e i n t h at l a n g u a g e. I n dic at e t h e 
l a n g u a g e t h at will b e us e d b y t h os e o bt ai ni n g c o ns e nt.
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P a g e 1 7  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E 
I n dic at e w h et h er t h e c o ns e nt pr oc ess will b e d oc u m e nt e d i n writi n g wit h t h e l o n g f or m of t h e 
c o ns e nt d oc u m e nt ati o n or wit h t h e s h ort f or m of t h e c o ns e nt d oc u m e nt ati o n. R evi e w “ H R P- 0 9 1 
– S O P- Writt e n D oc u m e nt ati o n of C o ns e nt” a n d “ H R P- 1 0 3 -I nv esti g at or M a n u al” t o e ns ur e t h at 
y o u h av e pr ovi d e d s uffici e nt i nf or m ati o n. 
W e d o  n ot pl a n t o e nr oll p artici p a nts w h o d o n ot s p e a k E n glis h at t his ti m e d u e t o 
li mit e d tr a nsl ati o n r es o urc es. W e h o p e t o ex p a n d t h e st u d y p o p ul ati o n t o n o n- E n glis h-
s p e a ki n g p o p ul ati o n i n f ut ur e r es e arc h st u di es. 
5. 6. 2
C o g niti v el y  I m p air e d A d ults
R ef er “ H R P- 4 1 7  - C H E C KLI S T- C o g nitiv el y I m p air e d A d ults” f or i nf or m ati o n a b o ut r es e arc h 
i nv olvi n g c o g nitiv el y i m p air e d a d ults as s u bj ects. 
5. 6. 2. 1 C a p a bilit y  of Pr o vi di n g C o ns e nt
D escri b e t h e  pr oc ess t o d et er mi n e w h et h er a n i n divi d u al is c a p a bl e of c o ns e nt.
All p ot e nti all y  eli gi bl e r esi d e nt p artici p a nts will b e a p pr o ac h e d t o ass ess 
t h eir c a p a bilit y of pr ovi di n g c o ns e nt usi n g t h e Ev al u ati o n t o Si g n C o ns e nt 
( E S C). T h e E S C is a fiv e-it e m m e as ur e a n d its ps yc h o m etrics h av e b e e n 
est a blis h e d i n ass essi n g ol d er a d ult’s c a p acit y t o c o ns e nt f or r es e arc h 
( R es nic k et al., 2 0 0 7). T h e first it e m ev al u at es w h et h er t h e i n divi d u al is al ert 
a n d a bl e t o c o m m u nic at e. T h e ot h er f o ur it e ms ass ess t h e i n divi d u al’s 
u n d erst a n di n g of t h e r es e arc h st u d y, i ncl u di n g n a mi n g at l e ast t w o p ot e nti al 
ris ks i nc urr e d as a r es ult of p artici p ati n g i n t h e st u d y, n a mi n g t w o t hi n gs 
t h at will b e ex p ect e d of t h e m r el at e d t o p artici p ati o n, ex pl ai ni n g w h at 
h e/s h e c o ul d d o if n o l o n g er i nt er est e d i n p artici p ati n g i n t h e st u d y, a n d 
w h at h e/s h e c o ul d d o if a n y distr ess or disc o mf ort w as ex p eri e nc e d 
ass oci at e d wit h st u d y p artici p ati o n. Evi d e nc e of a bilit y t o si g n c o ns e nt is 
b as e d o n c orr ect r es p o ns es t o all fiv e it e ms o n t h e E S C.
5. 6. 2. 2
A d ults  U n a bl e t o C o ns e nt
D escri b e w h et h er  a n d h o w i nf or m e d c o ns e nt will b e o bt ai n e d fr o m t h e l e g all y 
a ut h oriz e d r e pr es e nt ativ e. D escri b e w h o will b e all o w e d t o pr ovi d e i nf or m e d 
c o ns e nt. D escri b e t h e pr oc ess us e d t o d et er mi n e t h es e i n divi d u al’s a ut h orit y t o 
c o ns e nt t o r es e arc h.
F or r es e arc h  c o n d uct e d i n t h e st at e of P e n ns ylv a ni a, r evi e w “ H R P- 0 1 3 - S O P- L e g all y 
A ut h oriz e d R e pr es e nt ativ es, C hil dr e n a n d G u ar di a ns” t o b e a w ar e of w hic h 
i n divi d u als i n t h e st at e of P e n ns ylv a ni a m e et t h e d efi niti o n of “l e g all y a ut h oriz e d 
r e pr es e nt ativ e.”
F or r es e arc h  c o n d uct e d o utsi d e of t h e st at e of P e n ns ylv a ni a, pr ovi d e i nf or m ati o n 
t h at d escri b es w hic h i n divi d u als ar e a ut h oriz e d u n d er a p plic a bl e l a w t o c o ns e nt o n 
b e h alf of a pr os p ectiv e s u bj ect t o t h eir p artici p ati o n i n t h e pr oc e d ur e(s) i n v ol v e d i n 
t his r es e arc h. O n e m et h o d of o bt ai ni n g t his i nf or m ati o n is t o h av e a l e g al c o u ns el or 
a ut h orit y r evi e w y o ur pr ot oc ol al o n g wit h t h e d efi niti o n of “c hil dr e n” i n “ H R P- 0 1 3 -
S O P- L e g all y A ut h oriz e d R e pr es e nt ativ es, C hil dr e n, a n d G u ar di a ns.”
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P a g e 1 8  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E 
F or r esi d e nts w h o  ar e ass ess e d as n ot c a p a bl e of pr ovi di n g c o ns e nt, w e 
will as k t h eir L A Rs t o pr ovi d e si g n e d i nf or m e d c o ns e nt o n t h e r esi d e nt 
p artici p a nt’s b e h alf.  O nc e w e o bt ai n t h eir c o nt act i nf or m ati o n, w e will 
r e ac h o ut t o t h e m f or c o ns e nt. T h e r es e arc h t e a m will c o nfir m wit h t h e 
L A R t h at t h e y h av e t h e l e g al a ut h oriz ati o n t o c o ns e nt f or t h e r esi d e nt. 
T h e r es e arc h t e a m will c o nfir m t h e L A R st at us b as e d o n t h e d efi niti o n of 
H R P- 0 1 3. F or r esi d e nts w h o ar e ass ess e d as c a p a bl e of pr ovi di n g 
i nf or m e d c o ns e nt f or r es e arc h a n d w h o als o h av e a d oc u m e nt e d L A R 
acc or di n g t o t h eir m e dic al r ec or ds r evi e w, w e will still o bt ai n a writt e n 
c o ns e nt fr o m t h eir L A R. F or t h e s p ecific pr oc e d ur es of t h e c o ns e nt 
pr oc ess pl e as e s e e s ecti o n 5. 2 a b ov e.
5. 6. 2. 3 Ass e nt  of A d ults U n a bl e t o C o ns e nt
D escri b e t h e  pr oc ess f or ass e nt of t h e s u bj ects. I n dic at e w h et h er ass e nt will b e 
r e q uir e d of all, s o m e, or n o n e of t h e s u bj ects. If s o m e, i n dic at e w hic h s u bj ects will 
b e r e q uir e d t o ass e nt a n d w hic h will n ot. 
If ass e nt will n ot b e o bt ai n e d fr o m s o m e or all s u bj ects, pr ovi d e a n ex pl a n ati o n of 
w h y n ot.
D escri b e w h et h er  ass e nt of t h e s u bj ects will b e d oc u m e nt e d a n d t h e pr oc ess t o 
d oc u m e nt ass e nt. T h e I R B all o ws t h e p ers o n o bt ai ni n g ass e nt t o d oc u m e nt ass e nt 
o n t h e c o ns e nt d oc u m e nt a n d d o es n ot r o uti n el y r e q uir e ass e nt d oc u m e nts a n d 
d o es n ot r o uti n el y r e q uir e s u bj ects t o si g n ass e nt d oc u m e nts.
Ass e nt will  n ot b e o bt ai n e d f or t his st u d y. I n m y ex p eri e nc e, w h e n p e o pl e 
wit h d e m e nti a ar e n ot c a p a bl e of pr ovi di n g c o ns e nt, t h at us u all y m e a ns 
t h at t h eir c o g nitiv e f u ncti o n is t o o i m p air e d t o h av e a g o o d u n d erst a n di n g 
of t h e r es e arc h ( e. g., p ur p os es a n d pr oc e d ur es). I n t h at c as e, t h e y w o ul d 
n ot b e a bl e t o pr ovi d e a m e a ni n gf ul ass e nt eit h er. T h us, i n t his st u d y, w h e n 
t h e r esi d e nts c a n n ot pr ovi d e c o ns e nt, w e will n ot as k f or t h eir ass e nt. 
Alt er n ati v el y, w h e n w e i nt er act wit h t h e m a n d c o n d uct r es e arc h 
pr oc e d ur es, s uc h as as ki n g q u esti o ns f or c o g nitiv e ass ess m e nt a n d p utti n g 
o n t h e li g hti n g m o nit or, w e will as k t h eir p er missi o n a n d o bs erv e t h eir 
v er b al r es p o ns e a n d n o n-v er b al b e h avi or al c u es. W h e n t h e r esi d e nt 
v er b all y a gr e es or d o es n ot s h o w o bs erv a bl e r esist a nc e f or t h e m o nit or. If 
t h e y ex pr ess o bs erv a bl e v er b al or n o n-v er b al r esist a nc e t o t h e pr oc e d ur es, 
s uc h as st ati n g “ g o a w a y” “I d o n’t w a nt t h at” or p us h a w a y t h e m o nit or, w e 
will n ot pr oc e e d wit h t h e pr oc e d ur es a n d m a y a p pr o ac h t h e r esi d e nt at a 
l at er ti m e.  
5. 6. 3
S u bj ects  w h o ar e n ot y et a d ults (i nf a nts, c hil dr e n, t e e n a g ers) 
5. 6. 3. 1 P ar e nt al  P er missi o n
D escri b e w h et h er  a n d h o w p ar e nt al p er missi o n will b e o bt ai n e d. If p er missi o n will 
b e o bt ai n e d fr o m i n divi d u als ot h er t h a n p ar e nts, d escri b e w h o will b e all o w e d t o 
pr ovi d e p er missi o n. D escri b e t h e pr oc ess us e d t o d et er mi n e t h es e i n divi d u al’s 
a ut h orit y t o c o ns e nt t o e ac h c hil d’s g e n er al m e dic al c ar e.
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Page 19 of 60 (IRB USE ONLY: V.02/01/2023) 
DO NOT ALTER OR DELETE 
For research conducted in the state of Pennsylvania, review “HRP-013-SOP- Legally 
Authorized Representatives, Children and Guardians” to be aware of which 
individuals in the state of Pennsylvania meet the definition of “children.” 
For research conducted outside of the state of Pennsylvania, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved in the research, under the applicable law of the 
jurisdiction in which research will be conducted. One method of obtaining this 
information is to have a legal counsel or authority review your protocol along with 
the definition of “children” in “HRP-013-SOP- Legally Authorized Representatives, 
Children, and Guardians.”
Not applicable
5.6.3.2 Assent of subjects who are not yet adults
Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be required 
to assent. When assent of children is obtained describe whether and how it will be 
documented.
Not applicable
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually 
identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted 
or maintained in any form or medium by a Covered Entity or its Business Associate. A Covered Entity is a health 
plan, a health care clearinghouse or health care provider who transmits health information in electronic form.  
See “HRP-103 -Investigator Manual” for a list of the 18 identifiers.  
If requesting a waiver/alteration of HIPAA authorization, complete sections 6.2 and 6.3 in addition to section 
6.1. The Privacy Rule permits waivers (or alterations) of authorization if the research meets certain conditions. 
Include only information that will be accessed with the waiver/alteration. 
[Do not type here]
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used, or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3]
STUDY00020216
Approval: 4/24/2023

P a g e 2 0  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E 
Alt er ati o n is r e q u est e d  t o w ai v e r e q uir e m e nt f or writt e n d oc u m e nt ati o n of a ut h oriz ati o n 
( v er b al or i m pli e d a ut h oriz ati o n will b e o bt ai n e d). [ C o m pl et e all p arts of s ecti o ns 6. 2 a n d 6. 3]
6. 2  
W ai v er  or Alt er ati o n of A ut h oriz ati o n f or t h e Us es a n d Discl os ur es of P HI
6. 2. 1
Acc ess,  us e or discl os ur e of P HI r e pr es e nti n g n o m or e t h a n a mi ni m al ris k t o t h e pri v ac y of 
t h e i n di vi d u al
6. 2 . 1. 1
Pl a n  t o pr ot ect P HI fr o m i m pr o p er us e or discl os ur e
I ncl u d e t h e f oll o wi n g st at e m e nt as writt e n – D O N O T AL T E R O R D EL E T E 
u nl ess t his s ecti o n is n ot a p plic a bl e b ec a us e t h e r es e arc h d o es n ot i n v ol v e a 
w aiv er of a ut h oriz ati o n. If t h e s ecti o n is n ot a p plic a bl e, r e m o v e t h e 
st at e m e nt a n d i n dic at e as n ot a p plic a bl e. 
I nf or m ati o n is i ncl u d e d i n t h e “ C o nfi d e nti ality, Priv acy a n d D at a 
M a n a g e m e nt” s ecti o n of t his pr ot oc ol or i n “ H R P- 5 9 8 – R es e arc h D at a Pl a n 
R evi e w F or m”.
6. 2 . 1. 2
Pl a n  t o d estr o y i d e ntifi ers or a j ustific ati o n f or r et ai ni n g i d e ntifi ers 
D escri b e t h e  pl a n t o d estr o y t h e i d e ntifi ers at t h e e arli est o p p ort u nit y 
c o nsist e nt wit h t h e c o n d uct of t h e r es e arc h. I ncl u d e w h e n a n d h o w 
i d e ntifi ers will b e d estr o y e d. If i d e ntifi ers will b e r et ai n e d, pr ovi d e t h e l e g al, 
h e alt h or r es e arc h j ustific ati o n f or r et ai ni n g t h e i d e ntifi ers.
W e ar e  r e q u esti n g a p arti al w aiv er of c o ns e nt f or n ursi n g h o m e st aff 
t o scr e e n r esi d e nts’ m e dic al r ec or ds f or t h e p ur p os e of i d e ntif yi n g 
p ot e nti al r esi d e nts’ eli gi bilit y t o p artici p at e i n t his st u d y a n d f or 
r ecr uit m e nt. 
6. 2. 2
E x pl a n ati o n f or  w h y t h e r es e arc h c o ul d n ot pr actic a bl y b e c o n d uct e d wit h o ut acc ess t o 
a n d us e of P HI
Pr ovi d e r e as o ns  w h y t his r es e arc h c o ul d n ot pr actic a bl y b e c arri e d o ut wit h o ut acc ess t o a n d us e 
of P HI.
T h e r es e arc h t e a m  n e e ds t h e n ursi n g h o m e st aff t o r evi e w t h e m e dic al r ec or ds t o 
scr e e n t h e p artici p a nts f or eli gi bilit y t o p artici p at e i n t h e st u d y. T his r es e arc h st u d y 
c o ul d n ot pr actic a bl y b e c o n d uct e d wit h o ut t h e n ursi n g h o m e st aff t o acc ess t o t h e 
r esi d e nts’ P HI i nf or m ati o n f or r ecr uit m e nt a n d scr e e ni n g f or s ev er al r e as o ns. First, t h e 
i ncl usi o n a n d excl usi o n crit eri a ar e s p ecific ( e. g., d e m e nti a di a g n osis) a n d r e q uir e cli nic al 
j u d g e m e nt f or scr e e ni n g.  S ec o n d, o nc e t h e r esi d e nt p ass es t h e i niti al scr e e ni n g, n ursi n g 
h o m e st aff will n e e d t o c h ec k if t h e r esi d e nt h as a L A R a n d, if s o, t h e n ursi n g h o m e st aff 
will n e e d t o h a v e t h e L A R’s n a m e a n d c o nt act i nf or m ati o n t o s e n d t h e r esi d e nt 
r ecr uit m e nt l ett er f or r ecr uit m e nt. T h us, w e n e e d t o h av e HI P P A w aiv er t o c o n d uct t h e 
scr e e ni n g a n d r ecr uit m e nt. 
6. 2. 3
E x pl a n ati o n f or  w h y t h e r es e arc h c o ul d n ot pr actic a bl y b e c o n d uct e d wit h o ut t h e w ai v er 
or alt er ati o n of a ut h oriz ati o n
Pr ovi d e r e as o ns  w h y t his r es e arc h c o ul d n ot pr actic a bl y b e c arri e d o ut wit h o ut t h e w ai v er or 
alt er n ati o n of a ut h oriz ati o n.
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We are requesting partial waiver of consent for recruitment and screening purposes.  
This research study could not practicably be conducted without the waiver of 
authorization for two  main reasons. First, we need the nursing home staff to review the 
PHI information to initially screen the resident’s eligibility for the study. The inclusion 
and exclusion criteria are very specific and clinical judgement for screening. Moreover, it 
is estimated that less than 50% of nursing home residents will meet the criteria for the 
study, it is not practical to consent all residents prior to screening. Especially, the 
consent process for nursing home residents with dementia and their LARs are very time 
consuming. Consenting prior to the nursing home staff’s initial screening will require 
considerable time and could cause too much unnecessary burden for the nursing home 
staff, the residents, and their LARs. Third, once the resident passes the initial screening, 
the nursing home staff  will need to check if the resident has a LAR and, if so, they  will 
need to have the LAR’s name and contact information to contact them and send the 
resident recruitment letter to facilitate the recruitment and consent. .
6.3
Waiver or alteration of authorization statements of agreement
By submitting this study for review with a waiver of authorization, you agree to the following statement – 
DO NOT ALTER OR DELETE unless this section is not applicable because the research does not involve a 
waiver or alteration of authorization. If the section is not applicable, remove the statement and indicate 
as not applicable.
Protected health information obtained as part of this research will not be reused or disclosed to any other 
person or entity, except as required by law, for authorized oversight of the research study, or for other 
permitted uses and disclosures according to federal regulations. 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) per 
federal regulations. 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented.
7.0
Study Design and Procedures
Data collection materials that will be seen or used by subjects in your study must be uploaded to CATS IRB 
(http://irb.psu.edu). DO NOT include any actual data collection materials in this protocol (e.g., actual survey or 
interview questions).
[Do not type here]
7.1
Study Design
Describe and explain the study design.
Aim 1: Pilot test the effect of SABL in reducing agitation in persons with dementia. This is a 
crossover, cluster randomized control trial to pilot test the effect of SABL in   NHs. This design 
includes a 4-week intervention period and 2-week washout period. This design will allow for 
participants to act as their own control and thus reduce the needed sample size and strengthen 
the research rigor. The study procedures include five phases over 13 weeks. We will recruit a 
total sample of 40 nursing home residents with dementia and agitation from the 2 nursing 
homes, 20 residents from each nursing home. The two NHs will be randomly assigned into 
different sequences for intervention and control. Otherwise, the same study procedures will be 
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conducted simultaneously at the two NHs. During the daytime, participants will be guided and 
encouraged to spend time in the designated areas in the dining room and activity room for 
their meals and daily activities. For blinding prior to control period, we will perform installation 
procedures with non-SABL light bulbs. We will evaluate the effect of SABL on agitation, other 
BPSD, affect, and sleep, based on the actual lighting levels participants receive measured by 
personal light monitors. The study procedures include five phases: 1) baseline, 2) intervention, 
3) post intervention/washout, 4) control, and 5) post control/washout. The sequence of 
intervention and control differs between the two NHs based on randomized assignment. 
Agitation and lighting will be measured at baseline and then once every two weeks throughout 
the study. We hypothesize that participants will show less agitation during and after SABL 
compared to baseline and control periods. We will also explore the intervention effect on other 
BPSD and affect and monitor adverse effects. Aim 2: Evaluate the fidelity of the SABL delivery. 
We will evaluate the fidelity of SABL delivery by measuring lighting intensity (lux) and CS levels 
in two ways: 1) on-site light measurements, and 2) a personal light monitor. The actual lighting 
data will be compared to the intended SABL design.
Four strategies will be implemented to ensure the actual lighting condition the SABL 
delivers is as designed. First, SABL system has a pre-programmed 24-hour control schedule on 
illuminance settings to automatically maintain the target lighting dosage. The SABL include 
photosensors to measure the lighting every 10 minutes and will automatically adjust tunable 
LED lights through wireless communication to accommodate the daylight effect. Second, the 
wall-mounted photosensors can detect any problematic lighting events (e.g., <400lux or CS<0.3 
during the day) in real-time and will trigger alerts to the research team for trouble shooting. 
Third, a comprehensive in field lighting measurement will be performed by the research team 
twice a week during the intervention and control periods to confirm the designed conditions 
and address any lighting system issues. Fourth, we will remotely monitor the lighting data from 
the personal light monitors and then analyze the daily data during the data collection week to 
detect any individual compliance issues and potential device or lighting problems.
                    
                    The following will describe the installation of SABL system. 
First, the SABL system will be installed in resident participants' bedrooms, and 
designated areas in the hallways, dining rooms, and activity rooms to cover areas that 
resident participants usually spend time with. Specifically, in the dining room and activity 
room, the lighting system will only cover the participating residents’ tables and areas where 
they sit. Note that residents and staff typically only spend minimal time in hallways. As a 
check, prior to installation, the SABL system will be verified via the computer simulation in a 
lab setting to ensure it only covers the designed areas for participants. 
Second, prior to the study, we will announce the general timeline of the study period 
and will post signs in the dining rooms and activity rooms to notify people that lighting 
interventions are taking place. While nonparticipants and staff are not restricted from 
entering the rooms with SABL lighting, they can opt out of the specific areas in the rooms 
with SABL if they prefer. Non-participating residents will be informed the research areas and 
the priority of the areas will be given to participants.
Third, in bedrooms with two occupants, the SABL will be limited to the participants’ 
bed area and will not be in common areas in the room (e.g., bathrooms). This will minimize 
potential impact of the SABL on the other resident and minimize the interference with their 
daily routine. Privacy curtains can be kept closed between the two sleeping areas to reduce 
SABL spill-over.
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Finally, our proposed lighting scheme of the SABL (targeted at 400 lux and CS=0.3 
during the day and ≤40 lux, CS≤0.1during the night), follows the scientific consensus for 
persons with dementia (Figueiro et al., 2016) and the recommendations of the American 
National Standards Institute and Illuminating Engineering Society (Illuminating Engineering 
Society of North America, 2020). Also, the intensity and color of our SABL will be perceived 
like low-level daylight and does not cause any glare. In addition, the lighting scheme will 
meet the state requirement of minimum lighting levels for long-term care facilities in 
Pennsylvania (Commonwealth of Pennsylvania, 2022). Thus, even if the non-participant 
residents and staff are exposed to the lights, we believe the lighting is safe with minimal 
risk.
Aim 3: Evaluate the feasibility of implementing the SABL. We will use convergent mixed 
methods to evaluate the acceptability, feasibility, and appropriateness of the intervention. We 
will enroll at least 16 NH employees, including certified nursing assistants, activity staff, nurses, 
directors of nursing, director of maintenance, and NH administrators. We will survey and 
individually interview participants to collect quantitative and qualitative data on their 
experiences. Also, we will calculate the total hours and cost of installing and maintaining the 
SABL.
7.2
Study Procedures
Provide a step-by-step description of all research procedures being conducted (broken down by visit, if 
applicable) including such information as below (where and when applicable); describe the following:

HOW: (e.g., data collection via interviews, focus groups, forms such as surveys and questionnaires, 
medical/school records, audio/video/digital recordings, photographs, EKG procedures, MRI, mobile 
devices such as electronic tablets/cell phones, observations, collection of specimens, experimental 
drug/device testing, manipulation of behavior/use of deception, computer games, etc.) For surveys, 
indicate if subjects are able to skip questions that they don’t want to answer.

WHERE: (e.g., classrooms, labs, internet/online, places of business, medical settings, public spaces, 
etc.)
The intervention testing procedures (aims 1 and 2) are summarized in table 1. Data collection 
procedures (for all three aims) are summarized in Table 2.
Aims 1 and 2: Residents
Aim 1: We will evaluate the effect of SABL on agitation, other BPSD, affect, sleep, and adverse 
effect.  
After the informed consent is obtained, we will conduct steps 2 and 3 screening procedures. 
For step 2, the research team will review the residents’ medical records to verify their eligibility 
based on the inclusion and exclusion criteria. To evaluate the resident’s eligibility, we need the 
resident’s name and medical record number to access their medical records. We will review 
medical records to extract information about whether the residents speak English, are a long-
term resident who have lived in the facility for at least 3 months, have a diagnosis of dementia, 
and presence of dementia and agitation based on the MDS to meet the inclusion criteria. 
For residents who pass the step 2 screening, the research team will proceed with the step 3 
screening and conduct additional assessments to confirm the presence of dementia and 
agitation. Specifically, the research team will assess residents’ cognitive function by 
interviewing the residents and assess the residents’ agitation symptoms based on inputs from 
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the primary staff caregivers, which includes but is not limited to certified nurse assistants 
(CNAs), licensed practical nurses (LPNs), and registered nurse (RNs). 
We will assess residents’ cognitive impairment using the Montreal Cognitive Assessment 
(MoCA). A score of ≤22 on the Montreal Cognitive Assessment (MoCA) is considered cognitive 
impairment and eligible for this research study. We will assess residents’ agitation symptoms 
using the Cohen-Mansfield Agitation Inventory (CMAI), based on the residents’ behaviors over 
the past week as reported by the staff. A CMAI score of ≥ 45 is considered presence of agitation 
and is eligible for this study. Residents who have cognitive impairment (MoCA score ≤22) and 
agitation (CMAI score ≥ 45) are considered eligible and will be enrolled for the study. 
Only residents who past all three steps of screening will continue study participation in the 
study visits for the lighting intervention procedures. 
Data collection procedures will include
1) Data extraction from CMS Nursing Home Compare Website 
(https://www.medicare.gov/care-compare/): Data on facility characteristics, including 
number of certified beds, ownership, quality rating, participation in Medicaid, staffing, 
COVID-related data is publicly available and can be accessed through the link provided 
above.
2) Chart reviews: Data on resident characteristics, including age, race, sex, diagnoses, level of 
cognitive impairment, current medication use, current listed comorbidity and physical 
function, BPSD in the past two weeks, pain in the past two weeks, current vision status, 
current hearing status, and other clinical conditions. 
3) Surveys based on staff caregivers’ reports: The surveys will be conducted on paper and in-
person with researcher administering the survey to the staff caregiver for proxy report of 
residents’ dementia stage, agitation, other BPSD, affect, and side effects. 
4) Personal light monitor, LYS button, placed on individual resident participants to measure 
lighting intensity (lux) and CS levels participants receive. 
There will be seven visits for data collection throughout the 13-week of the study: baseline visit 
(week 1) and six follow-up visits, every other week (weeks 3, 5, 7, 9, 11, 13). The procedures for 
each visit are as followings:
Baseline visit: Procedures 1 through 4. 
Follow-up visits: Procedures 3 and 4. 
For the procedure 4, the light monitor will be worn 7 days a week during the data collection 
weeks (week 1, 3, 5, 7, 9, 11, & 13). 
Aim 2: We will evaluate the fidelity of SABL delivery by measuring lighting intensity (lux) and CS 
levels. 
Data collection procedures s will include the following: 
1) on-site manual light measurements
2) personal light monitor, LYS button, placed on individual resident participants (same as 
the procedure 4 in aim 1).   
The procedures will be conducted primarily on site at the nursing home facilities. 
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The procedure 1 will be conducted twice a week throughout the 13-week study period. 
For the procedure 2, as mentioned in aim 1, the light monitor will be worn 7 days a week during 
the data collection weeks (week 1, 3, 5, 7, 9, 11, & 13). 
Aim 3: Staff and Administrators 
Data collection methods include the following:
1) Surveys: Surveys will be administered to staff in-person and on paper to collect their 
characteristics (e.g., age, race, gender, education, & professional experiences) and their 
evaluation on the acceptability, feasibility, and appropriateness of the SABL lighting 
intervention. 
2) Qualitative interviews: Staff’s and administrators’ inputs on the acceptability, feasibility, 
and appropriateness of the SABL lighting intervention. 
3) We will also calculate the total hours and cost of installing and maintaining the SABL.
                          The procedures can be conducted either in person at the facility or via virtual conference (e.g., 
zoom). The procedure will be conducted in one visit scheduled in week 13. 
Table 1. Intervention testing procedures and timeline. 
Week 
1
2
3
4
5
6
7
8
9
10
11
12 
13
NH A
Intervention
Post 
intervention/washout 
Control 
Post control
Study 
phases  
NH B
Baseline
Control
Post control/washout
Intervention
Post 
intervention
Lighting 
Usual light
 I: SABL 
C: Usual light
Usual light
C: Usual light 
 I: SABL 
Usual light
Data collection
Baseline, L&E
L&E
L&E
L&E
L&E
L&E
L&E
L=lighting measured via individual light monitor, E=effect outcomes (e.g., agitation, BPSD, affect, and sleep) and adverse effects
Table 2 Summary of Variables, Measures, and Data Collection. 
Aim
Variables
Measures
Data collection methods 
Timing 
Facility characteristics 
# of certified beds, ownership, quality 
rating, participation in Medicaid, staffing, 
COVID-related data. 
CMS Medicare NH Compare Rating 
System.
Resident characteristics
Age, race, sex, diagnoses, medication 
use, comorbidity, physical function, pain, 
vision, and dementia stage based on 
CDR.
Data extraction from medical 
records and MDS. CDR ratings will 
be measured via inputs from staff 
caregivers (e.g., nurse or CNAs).
Baseline.
Aim 1
Agitation, BPSD, affect, 
sleep & adverse effects
CMAI, NPI-NH, ARS, sleep & adverse 
events checklist.
Inputs from staff caregivers (e.g., 
nurse or CNAs) based on 
participants’ conditions in past 
week.
Aims 
1 & 2
Light level (lux & CS).
Lighting level each participant receives. 
Personal light monitor, LYS button, 
every 10 minutes, 24 hours/day, 7 
days/week. 
Baseline & 
every two 
weeks. 
Aim 2
Light level (lux & CS).
Lighting level SABL delivers.
Manual on-site measurements.
Baseline & 
twice a 
week. 
NH employee 
characteristics 
Age, race, gender, education, & 
professional experiences.
Surveys. 
Acceptability, 
feasibility, & 
appropriateness
AIM, FIM, & IAM.60
Surveys & qualitative interviews 
with staff & administrators.
Aim 3 
Time & cost 
Time & cost for implementing SABL.
Calculate by the research team.
Week 13.
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D O N O T  AL T E R O R D EL E T E
AI M = Acc e pt a bilit y  of I nt er v e nti o n M e as ur e
A R S = P hil a d el p hi a G eri atric C e nt er  Aff ect R ati n g Sc al e 
B P S D = B e h a vi or al a n d  ps yc h ol o gic al s y m pt o ms of d e m e nti a. 
C D R = Cli nic al D e m e nti a  R ati n g
C M AI = C o h e n- M a nsfi el d A git ati o n  I n v e nt or y 
C M S = C e nt ers f or M e dic ar e  a n d M e dic ai d S er vic es 
C N A =c ertifi e d n urs e  assist a nt
FI M = F e asi bilit y  of I nt er v e nti o n M e as ur e
I A M = I nt er v e nti o n A p pr o pri at e n ess M e as ur e
M D S- Mi ni m u m D at a  S et
N PI- N H = N e ur o ps yc hi atric I n v e nt or y- N ursi n g  H o m e v ersi o n 
P S QI = Pitts b ur g h Sl e e p  Q u alit y I n d ex 
7. 2. 1
Visit  1 or D a y 1 or Pr e-t est, etc. 
Pr ovi d e a  d escri pti o n of w h at pr oc e d ur es will b e p erf or m e d o n visit 1 or d a y 1 or pr e-t est i n 
or d er of h o w t h es e will b e d o n e.  If y o ur st u d y o nl y i nv olv es o n e s essi o n or visit, us e t his s ecti o n 
o nl y a n d d el et e 7. 2. 2. 
Ai ms 1  a n d 2: R esi d e nts 
B as eli n e visit/ visit 1:  W e will c oll ect d at a o n 1) f acilit y c h ar act eristics, 2) r esi d e nt b as eli n e 
c h ar act eristics, a n d 3) r esi d e nt b as eli n e a git ati o n, B P S D, aff ect, a n d sl e e p, 4) li g hti n g 
l e v els.
F or f acilit y c h ar act eristics,  w e will extr act d at a fr o m t h e w e bsit e of t h e C e nt ers f or 
M e dic ar e a n d M e dic ai d S ervic es ( C M S). I nf or m ati o n extr act e d i ncl u d e n u m b er of 
c ertifi e d b e ds, o w n ers hi p, q u alit y r ati n g, p artici p ati o n i n M e dic ai d, st affi n g, C O VI D-
r el at e d i nf or m ati o n, h e alt h i ns p ecti o ns, fir e s af et y i ns p ecti o ns a n d e m er g e nc y 
pr e p ar e d n ess, p e n alti es, a n d av ail a bl e of r esi d e nt a n d f a mil y c o u ncil.. 
F or r esi d e nt c h ar act eristics, w e  will r evi e w r esi d e nts’ m e dic al r ec or ds a n d mi ni m u m 
d at as et ( M D S) t o c oll ect d at a o n r esi d e nt c h ar act eristics, i ncl u di n g a g e, r ac e, s ex, 
di a g n os es, m e dic ati o n us e, c o m or bi dit y, p h ysic al f u ncti o n, p ai n, visi o n, a n d ot h er 
m e dic al c o n diti o ns, s y m pt o ms, a n d f u ncti o n al l ev els. A d diti o n all y, w e will ev al u at e 
r esi d e nt p artici p a nts’ d e m e nti a st a g e, b as e d o n t h e r esi d e nts’ st aff c ar e giv ers’ i n p uts a n d 
o bs er v ati o ns of t h e r esi d e nts usi n g t h e Cli nic al D e m e nti a R ati n g ( C D R). 
W e will e v al u at e  r esi d e nt p artici p a nts’ b as eli n e a git ati o n, B P S D, aff ect, a n d sl e e p, b as e d 
o n t h e r esi d e nts’ st aff c ar e giv ers’ i n p uts a n d o bs erv ati o ns of t h e r esi d e nts. W e will ass ess 
a git ati o n, B P S D, aff ect, a n d sl e e p usi n g t h e C o h e n- M a nsfi el d A git ati o n I nv e nt or y ( C M AI), 
N e ur o ps yc hi atric I n v e nt or y- N ursi n g H o m e v ersi o n ( N PI- N H), P hil a d el p hi a G eri atric C e nt er 
Aff ect R ati n g Sc al e ( A R S), a n d Pitts b ur g h Sl e e p Q u alit y I n d ex ( P S QI), r es p ectiv el y, 
W e will m e as ur e  li g hti n g l ev el b y 1) o n-sit e m a n u al li g ht, a n d 2) a p ers o n al li g ht m o nit or, 
L Y S b utt o n d uri n g t h e b as eli n e w e e k. T h e L Y S b utt o n is s m all ( 1 i nc h), li g ht w ei g ht e d ( 4 g), 
a n d us er fri e n dl y. It h as a cli p at t h e b ac k of t h e b utt o n a n d c a n b e e asil y cli p p e d o n 
cl ot h es. F or a r esi d e nt w h o d o es n ot mi n d h avi n g t h e s e ns or pl ac e d o n cl ot hi n g, w e m a y 
pl ac e it o n t h e s hirt c oll ar or s h o ul d er. W e will c o m m u nic at e wit h t h eir c ar e giv ers s o t h at 
S T U D Y 0 0 0 2 0 2 1 6
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D O N O T  AL T E R O R D EL E T E
t h e y ar e a w ar e of t h e b utt o n w h e n cl ot h es ar e b ei n g c h a n g e d a n d m a k e s ur e t h e b utt o n 
is cli p p e d b ac k o n. W e will c h ec k t h e d evic e o n sit e at l e ast t wic e p er w e e k a n d will 
r etri e v e d at a aft er e ac h w e e k of d at a c oll ecti o n. W e will pr e-s et a s eri es of al g orit h ms 
d et er mi ni n g t h e d e vic e us e st at us.  If t h e d evic e a p p e ars n ot t o b e pl ac e d or f u ncti o ni n g 
pr o p erl y, t h e s yst e m will s e n d a w ar ni n g m ess a g e t o t h e t e a m a n d w e will m a k e all 
att e m pts t o c h ec k t h e d evic e o n sit e. W e will m a n u all y m e as ur e li g ht l ev el t wic e a w e e k 
d uri n g t h e b as eli n e w e e k. I n a d diti o n, w e will pl ac e a p ers o n al li g ht m o nit or, L Y S b utt o n, 
o n p artici p a nts, all d a y, 7 d a ys a w e e k, d uri n g t h e b as eli n e w e e k. 
Ai m 3:  St aff a n d a d mi nistr at ors
1.
Scr e e ni n g  s ur v e y: W e will as k p artici p a nts t o fill o ut t h e s urv e y t o c o nfir m t h eir 
eli gi bilit y. If t h e y ar e eli gi bl e, w e will c o nti n u e t o t h e n ext st e ps. 
2.
B as eli n e  s ur v e y: w e will as k p artici p a nts t o fill o ut a s urv e y t o c oll ect d at a a b o ut t h eir 
d e m o gr a p hics a n d r el ev a nt w or k ex p eri e nc es ( e. g., a g e, r ac e, g e n d er, e d uc ati o n, a n d 
pr of essi o n al ex p eri e nc es). 
3.
F e asi bilit y  s ur v e ys: w e will as k p artici p a nts t o fill o ut t h e Acc e pt a bilit y of I nt erv e nti o n 
M e as ur e ( AI M), F e asi bilit y of I nt erv e nti o n M e as ur e ( FI M), a n d I nt erv e nti o n 
A p pr o pri at e n ess M e as ur e ( AI M) t o ev al u at e t h e acc e pt a bilit y, a p pr o pri at e n ess, a n d 
a p pr o pri at e n ess of t h e S A BL i nt erv e nti o n. 
4.
Q u alit ati v e  i nt er vi e w: t h eir ev al u ati o n o n t h e acc e pt a bilit y, f e asi bilit y, a n d 
a p pr o pri at e n ess of t h e S A BL li g hti n g i nt erv e nti o n. 
5.
W e  will als o c alc ul at e t h e t ot al h o urs a n d c ost of i nst alli n g a n d m ai nt ai ni n g t h e S A BL.
W e ex p ect t h at i n  m ost c as es, t h e st u d y pr oc e d ur es c a n b e c o m pl et e d i n o n e visit. I n t h e 
c as e t h at o n e visit is i ns uffici e nt t o c o m pl et e all pr oc e d ur es, o n e a d diti o n al visit m a y b e 
c o n d uct e d t o c o m pl et e t h e pr oc e d ur es.
7. 2. 2
Visit  2 or D a y 2 or P ost-t est, etc. (If a p plic a bl e) 
Pr ovi d e a  d escri pti o n of w h at pr oc e d ur es will b e p erf or m e d o n visit 2 or d a y 2 or p ost-t est i n 
or d er of h o w t h es e will b e d o n e.  If y o ur st u d y i nv olv es m or e t h a n t w o s essi o ns or visits 
r e plic at e t his s ecti o n f or e ac h a d diti o n al s essi o n or visit ( e. g., 7. 2. 3, 7. 2. 4, etc.). If y o ur st u d y 
i nv olv es o nl y o n e s essi o n or visit, d el et e t his s ecti o n.
Ai m 1 : 
Visits 2- 6 : Aft er t h e i nt erv e nti o n st arts, w e will m e as ur e a git ati o n, B P S D, aff ect, a n d 
sl e e p, a n d i nt er v e nti o n-r el at e d a dv ers e eff ects usi n g t h e C M AI, N PI- N H, A R S, P S QI, a n d 
a d v ers e eff ect c h ec klist o nc e ev er y t w o w e e ks. 
Ai m 2 : 
Visits 2- 6 : Aft er li g ht is i nst all e d, w e will m o nit or t h e li g hti n g b y 1) o n-sit e m a n u al li g ht 
m e as ur e m e nts t wic e a w e e k f or 1 3 w e e ks, a n d 2) a p ers o n al li g ht m o nit or, L Y S b utt o n, 
pl ac e d o n p artici p a nts, all d a y, 7 d a ys a w e e k, ev er y t w o w e e ks f or 1 3 w e e ks.
7. 3 
D ur ati o n  of P artici p ati o n
D escri b e h o w  l o n g s u bj ects will b e i nv olv e d i n t his r es e arc h st u d y.  I ncl u d e t h e n u m b er of s essi o ns a n d 
t h e d ur ati o n of e ac h s essi o n - c o nsi d er t h e t ot al n u m b er of mi n ut es, h o urs, d a ys, m o nt hs, y e ars, etc.  
S T U D Y 0 0 0 2 0 2 1 6
A p pr o v al: 4/ 2 4/ 2 0 2 3

P a g e 2 8  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E
Ai ms 1  a n d 2: R esi d e nts
T h e st u d y  l asts 1 3 w e e ks wit h b as eli n e d at a c oll ecti o n: o n e w e e k f or b as eli n e, f o ur w e e ks f or 
i nt er v e nti o n ( S A BL), t w o w e e ks f or p ost i nt erv e nti o n/ w as h o ut p eri o d, f o ur w e e ks f or c o ntr ol, 
a n d t w o w e e ks f or p ost c o ntr ol. T h e b as eli n e s urv e y of t h e r esi d e nts r e g ar di n g c o g nitiv e 
f u ncti o n a n d a git ati o n m a y t a k e 1 0 mi n ut es t o c o m pl et e. 
Ai m 3:  St aff a n d a d mi nistr at ors 1- 2 visits f or a t ot al of 1- 2 h o urs. T h e s urv e ys will t a k e 
a p pr oxi m at el y 1 0- 1 5 mi n ut es t o c o m pl et e, a n d t h e i nt ervi e w will t a k e a b o ut 1 h o ur.
7. 4 
T est  Articl e(s) ( St u d y Dr u g(s) a n d/ or St u d y D e vic e(s))
7. 4. 1
D escri pti o n
Pr ovi d e a  bri ef d escri pti o n of all t est articl es ( dr u gs (i ncl u di n g a n y f o o ds a n d di et ar y 
s u p pl e m e nts), d evic es a n d/ or bi ol o gics) us e d i n t h e r es e arc h i ncl u di n g t h e p ur p os e of t h eir us e 
a n d t h eir a p pr ov al st at us wit h t h e F o o d a n d Dr u g A d mi nistr ati o n ( F D A). I ncl u d e i nf or m ati o n 
a b o ut t h e f or m of t h e dr u g pr o d uct ( e. g., t a bl ets, c a ps ul es, li q ui d).
T h e S A BL s yst e m  h as a pr e- pr o gr a m m e d 2 4- h o ur c o ntr ol sc h e d ul e o n ill u mi n a nc e 
s etti n gs t o mi mic t h e n at ur al bri g ht- d ar k c ycl e. W hil e r es e arc h evi d e nc e s u g g ests t h e 
p ot e nti al p ositiv e eff ect of t h e li g hti n g i nt erv e nti o n o n p e o pl e wit h d e m e nti a, t h e li g hti n g d e vic e 
b ei n g us e d i n t his r es e arc h is n ot c urr e ntl y F D A a p pr ov e d f or t h e us e of i m pr ovi n g b e h a vi or al 
s y m pt o ms of d e m e nti a. It will r e g ul arl y m o nit or t h e li g hti n g l ev el usi n g c ust o miz e d 
p h ot os e ns ors a n d a ut o m atic all y a dj ust t h e li g hts t o acc o m m o d at e t h e d a yli g ht eff ect, 
mi ni mizi n g st aff b ur d e n a n d m ai nt e n a nc e eff orts, w hil e m axi mizi n g t h e LI eff ect.  O ur 
pr o p os e d S A BL will pr o vi d e bri g ht li g ht wit h ill u mi n a nc e t ar g et e d at 4 0 0 l ux a n d C S ≥ 0. 3 
at t h e e y e l e v el, a n d di m li g ht ≤4 0  l ux a n d l o w C S ≤0. 1  at ni g ht t o m ai nt ai n a bri g ht- d ar k 
c ycl e t o r e g ul at e acti vit y/r est r h yt h m, i m pr ov e sl e e p, a n d r e d uc e a git ati o n. W e will 
m e as ur e t h e li g ht l e v els r ec eiv e d b y e ac h p artici p a nt usi n g a p ers o n al, w e ar a bl e li g hti n g 
m e as ur e d e vic e, L Y S b utt o n, a n d will us e t h e act u al d os a g e (l ux a n d C S l ev els) r ec eiv e d 
b y p artici p a nts t o a n al yz e t h e i nt erv e nti o n eff ect. 
T h e li g hti n g i nt er v e nti o n,  S A BL, d esi g n a n d i nst all ati o n will i nv olv e fiv e p h as es: 
1) D e v el o pi n g  a n i m pl e m e nt ati o n pr ot oc ol. PIs J a o a n d W a n g will s et u p a n a dvis or y 
b o ar d at e ac h N H t h at i ncl u d es a c ertifi e d n ursi n g assist a nt ( C N A), a n urs e, t h e dir ect or of 
n ursi n g ( D O N), t h e dir ect or of m ai nt e n a nc e ( D O M), a n d t h e a d mi nistr at or ( N H A). T hr o u g h 
t h e a d vis or y b o ar d, w e will o bt ai n i n p ut fr o m N H st a k e h ol d ers a b o ut i m pl e m e nt ati o n 
pr oc e d ur es. N ext, w e will d ev el o p a pr ot oc ol t h at lists t h e w or kfl o w, k e y st e ps, a n d 
ass oci at e d p ers o n n el c ust o miz e d t o e ac h f acilit y. Dr. J uli a n W a n g will w or k wit h t h e D O M 
at e ac h f acilit y t o fi n aliz e t h e pl a n f or S A BL i nst all ati o n a n d m ai nt e n a nc e a n d t o e ns ur e 
t h e i nst all ati o n f oll o ws N H r e g ul ati o ns. 
2) O bs er vi n g  r esi d e nt r o uti n es a n d pr ef er e nc e t o t ail or S A BL d esi g n. W e will o bs erv e 
e ac h p artici p a nt, i n t er ms of t h eir d ail y r o uti n e, activiti es, a n d h a bit u al b e h avi ors o n 2 
w e e k d a ys a n d 1 w e e k e n d d a y a n d fi n e t u n e t h e li g hti n g i nt erv e nti o n d esi g n. I n a d diti o n, 
s witc h es a n d wir el ess di m m ers will b e s u p pli e d i n c as e r esi d e nts or st aff n e e d t o m a n u all y 
o v erri d e t h e li g hti n g c o n diti o ns. T h e pr e- pr o gr a m m e d s etti n gs will b e a ut o-r es u m e d aft er 
S T U D Y 0 0 0 2 0 2 1 6
A p pr o v al: 4/ 2 4/ 2 0 2 3

P a g e 2 9  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E
1 h o ur.  
3) M e as uri n g  a n d si m ul ati n g t h e e xisti n g d a yli g hti n g. Usi n g li g hti n g si m ul ati o n s oft w ar e, 
PI W a n g will d e v el o p a di git al m o d el, i ncl u di n g acc ur at e b uil di n g m o d els, l oc al w e at h er 
fil es, a n d i nt eri or d esi g n t o pr e dict t h e i n d o or d a yli g ht distri b uti o n. 
4) D esi g ni n g  a n d si m ul ati n g t h e S A BL. Li g hti n g distri b uti o n, wit h s el ect e d s o urc es a n d 
s hi el ds, will b e d esi g n e d b y c o n d ucti n g a s eri es of c o m p ut ati o n al si m ul ati o ns t o av oi d 
u n w a nt e d li g hti n g p e n etr ati o n t o n o n- p artici p a nts’ us e ar e as.  
5) I nst alli n g t h e S A BL s yst e m. T h e s yst e m will b e i nt e gr at e d i nt o t h e existi n g el ectric al 
s yst e ms b y r e pl aci n g existi n g li g ht s o urc es ( e. g., b ul bs, t u b es) wit h o ut i nc urri n g l a b or 
c osts f or i nst all ati o n, disr u pti o n t o t h e f acilit y’s o p er ati o n, or i nc o nv e ni e nc e t o r esi d e nts 
a n d st aff. N e w st a bl e fl o or-st a n di n g l u mi n air es m a y b e a d d e d o nl y if t h e li g ht s o urc e 
r e pl ac e m e nts o n existi n g l u mi n ari es ar e n ot a bl e t o m e et t h e d esi g n l ev els.
7. 4. 2
Tr e at m e nt  R e gi m e n
D escri b e d os e,  r o ut e of a d mi nistr ati o n a n d tr e at m e nt d ur ati o n. I ncl u d e i nf or m ati o n a b o ut d os e 
a dj ust m e nts.
T h e S A BL s yst e m  i ncl u d es t u n a bl e L E D li g hts, p h ot os e ns ors, a n d c o ntr oll ers a n d will b e 
i nst all e d b y r e pl aci n g t h e b ul bs of t h e existi n g fixt ur es. T h e S A BL will pr ovi d e bri g ht li g ht 
t ar g et e d at 4 0 0 l ux a n d C S≥0. 3 i n p artici p a nt b e dr o o ms a n d d esi g n at e d ar e as i n t h e 
di ni n g r o o m a n d acti vit y r o o m d uri n g t h e d a y a n d pr ovi d e di m li g ht ≤4 0  l ux a n d C S ≤0. 1  
i n p artici p a nt b e dr o o ms at ni g ht. T h e i nt e nsit y a n d c ol or of o ur S A BL will b e p erc eiv e d 
li k e l o w-l e v el d a yli g ht a n d d o es n ot c a us e gl ar e. 
W e esti m at e e ac h  r esi d e nt will b e ex p os e d t o t h e bri g ht li g ht f or at l e ast 4 h o urs p er d a y 
( 2 h o urs d uri n g t hr e e m e alti m es a n d 2 h o urs d uri n g ot h er d ail y activiti es). T h e 
p h ot os e ns ors will c o nti n u o usl y m o nit or d a yli g ht sit u ati o ns a n d a dj ust acc or di n gl y. It is 
p ossi bl e t h at p artici p a nts m a y r ec eiv e > 4 0 0l ux a n d C S > 0. 3 fr o m d a yli g ht. H o w ev er, 
b as e d o n t h e o n-sit e m e as ur e m e nts a n d o bs erv ati o ns, it is u nli k el y p artici p a nts will 
r ec ei v e o v erl y hi g h li g hti n g c o n diti o ns.
7. 4. 3
M et h o d f or  Assi g ni n g S u bj ect t o Tr e at m e nt Gr o u ps
D escri b e t h e  r a n d o miz ati o n pr oc ess a n d h o w t h e ass oci at e d tr e at m e nt assi g n m e nt will b e 
m a d e.
T h e st u d y  d esi g n is a cr oss ov er, cl ust er r a n d o miz e d c o ntr oll e d tri al. W e pl a n t o c o n d uct 
t h e st u d y i n t w o n ursi n g h o m es. T h e st u d y pr oc e d ur es i ncl u d e fiv e p h as es ov er 1 3 
w e e ks ( T a bl e). T h e t w o N Hs will b e r a n d o ml y assi g n e d i nt o diff er e nt s e q u e nc es f or 
i nt er v e nti o n a n d c o ntr ol. Ot h er wis e, t h e s a m e st u d y pr oc e d ur es will b e c o n d uct e d 
si m ult a n e o usl y at t h e t w o n ursi n g h o m es. D uri n g t h e d a yti m e, p artici p a nts will b e 
g ui d e d a n d e nc o ur a g e d t o s p e n d ti m e i n t h e d esi g n at e d ar e as i n t h e di ni n g r o o m a n d 
acti vit y r o o m f or t h eir m e als a n d d ail y activiti es. 
T a bl e. I nt er v e nti o n  t esti n g pr oc e d ur es a n d ti m eli n e. 
W e e k 
1
2
3
4
5
6
7
8
9
1 0
1 1
1 2 
1 3
S T U D Y 0 0 0 2 0 2 1 6
A p pr o v al: 4/ 2 4/ 2 0 2 3

P a g e 3 0  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E
Fi g ur e . Li g ht M o nit or  L Y S B utt o n
7. 4. 4
S u bj ect  C o m pli a nc e M o nit ori n g
I ns ert t h e pr oc e d ur es f or m o nit ori n g s u bj ect c o m pli a nc e.
E ac h p artici p a nt  will w e ar t h e p ers o n al li g ht m o nit or, L Y S B utt o n ( Fi g ur e) t o m e as ur e 
li g hti n g i nt e nsit y (l ux) a n d C S l ev el r ec eiv e d. T h e d at a will b e us e d t o f urt h er c alc ul at e 
p artici p a nts’ h o urs of i nt erv e nti o n ex p os ur e p er d a y. 
Li g hti n g will b e m e as ur e d o nc e ev er y 1 0 mi n ut es, all d a y, 7 
d a ys a w e e k, e v er y ot h er w e e k ov er t h e 1 3- w e e k st u d y 
p eri o d. T h e m o nit or is s m all ( 1 i nc h), li g ht w ei g ht ( 4 g), a n d 
us er-fri e n dl y a n d will b e pl ac e d o n p artici p a nts’ s hirt c oll ar 
or s h o ul d er. 
I n a d diti o n, t h e li g ht m o nit or e n a bl es r e al-ti m e r e m ot e c h ec ki n g. W a n g will pr e-s et a 
s eri es of al g orit h ms d et er mi ni n g t h e d evic e us e st at us. If t h e d evic e a p p e ars n ot t o b e 
pl ac e d or f u ncti o ni n g pr o p erl y ( e. g., li g hti n g d at a r e m ai ns c o m pl et el y u nc h a n g e d f or 
o v er 1 h o ur d uri n g d a yti m e), t h e s yst e m will s e n d a w ar ni n g m ess a g e t o t h e t e a m 
(i ncl u di n g J a o a n d W a n g).  W e will m a k e all att e m pts t o c h ec k t h e d evic e o n sit e.
7. 4. 5
Bli n di n g  of t h e T est Articl e
D escri b e h o w  t h e t est articl e is bli n d e d.
F or bli n di n g p ur p os es,  pri or t o t h e c o ntr ol p eri o d, w e will p erf or m t h e li g hti n g 
i nst all ati o n pr oc e d ur e, si mil ar t o t h e i nt erv e nti o n p eri o d, t h o u g h wit h b as eli n e/ n o n-
S A BL li g ht b ul bs, t o bli n d t h e r es e arc h assist a nts w h o c oll ect d at a, p artici p a nts, a n d 
n ursi n g h o m e st aff. Als o, w e will pr ovi d e mi ni m al d et ails a b o ut t h e st u d y d esi g n a n d 
li g hti n g c o n diti o n s e q u e nc e. I n st atistic al a n al ysis, di a g n ostic a n al ys es will b e c arri e d o ut 
t o ex a mi n e u n d erl yi n g ass u m pti o ns, d et ect a n y vi ol ati o ns, a n d i d e ntif y t h e m ost 
a p pr o pri at e m o d eli n g a p pr o ac h.
7. 4. 6
R ec ei vi n g,  St or a g e, Dis p e nsi n g a n d R et ur n 
7. 4 . 6. 1
R ec ei pt  of T est Articl e 
D escri b e h o w  t h e t est articl e will b e o bt ai n e d a n d fr o m w h at s o urc e. 
D escri b e h o w t h e st u d y t est articl e will b e p ac k a g e d al o n g wit h a m o u nts 
( e. g., n u m b er of t a bl ets/c a ps ul es or v ol u m e of li q ui d) a n d l a b eli n g. If dr u g 
kits ar e us e d, d escri b e all t h e c o nt e nts of t h e kit a n d ass oci at e d l a b eli n g.
Dr. J uli a n  W a n g will p urc h as e a n d d esi g n t h e li g hti n g s yst e m, i ncl u di n g 
N H A
I nt er v e nti o n
P ost 
i nt er v e nti o n/ w as h o ut 
C o ntr ol 
P ost c o ntr ol
St u d y 
p h as es   
N H B
B as eli n e
C o ntr ol
P ost c o ntr ol/ w as h o ut
I nt er v e nti o n
P ost 
i nt er v e nti o n
Li g hti n g 
Us u al li g ht
 I: S A BL 
C: Us u al  li g ht
Us u al li g ht
C: Us u al  li g ht 
 I: S A BL 
Us u al li g ht
D at a c oll ecti o n
B as eli n e, L & E
L & E
L & E
L & E
L & E
L & E
L & E
L =li g hti n g m e as ur e d vi a i n divi d u al li g ht m o nit or, E = eff ect o utc o m es ( e. g., a git ati o n, B P S D, aff ect, a n d sl e e p) a n d a dv ers e eff ects
S T U D Y 0 0 0 2 0 2 1 6
A p pr o v al: 4/ 2 4/ 2 0 2 3

P a g e 3 1  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E
t h e t u n a bl e L E D li g hts, p h ot os e ns ors, a n d c o ntr oll ers. T h e S A BL s yst e m 
will b e i nt e gr at e d i nt o t h e existi n g el ectric al s yst e ms b y r e pl aci n g 
existi n g li g ht s o urc es ( e. g., b ul bs, t u b es). N e w st a bl e fl o or-st a n di n g 
l u mi n air es m a y b e a d d e d o nl y if t h e li g ht s o urc e r e pl ac e m e nts o n 
existi n g l u mi n ari es ar e n ot a bl e t o m e et t h e d esi g n l ev els. W a n g will 
w or k wit h t h e n ursi n g h o m e dir ect or of m ai nt e n a nc e ( D O M) t o i nst all 
t h e li g hti n g s yst e m. 
T h e li g hti n g d os a g e  will t ar g et at 4 0 0 l ux a n d C S = 0. 3 d uri n g t h e d a y 
a n d pr ovi d e di m li g ht ≤4 0  l ux a n d C S ≤0. 1  i n p artici p a nt b e dr o o ms at 
ni g ht. T h e i nt e nsit y a n d c ol or of o ur S A BL will b e p erc eiv e d li k e l o w-
l e v el d a yli g ht a n d d o es n ot c a us e a n y gl ar e. W e esti m at e e ac h 
r esi d e nt will b e ex p os e d t o t h e bri g ht li g ht f or at l e ast 4 h o urs p er 
d a y ( 2 h o urs d uri n g t hr e e m e alti m es a n d 2 h o urs d uri n g ot h er d ail y 
acti viti es). T h e p h ot os e ns ors will c o nti n u o usl y m o nit or d a yli g ht 
sit u ati o ns a n d a dj ust acc or di n gl y. It is p ossi bl e t h at p artici p a nts m a y 
r ec eiv e > 4 0 0l ux a n d C S > 0. 3 fr o m d a yli g ht.
7. 4 . 6. 2
St or a g e
D escri b e t h e  pl a ns t o st or e, h a n dl e t h e t est articl e s o t h e y will b e us e d o nl y 
o n s u bj ects a n d o nl y b y a ut h oriz e d i nv esti g at ors. D escri b e st or a g e 
t e m p er at ur e r e q uir e m e nts a n d h o w t e m p er at ur e will b e m o nit or e d a n d 
r ec or d e d.
W a n g will  b e r es p o nsi bl e f or st ori n g a n d h a n dli n g t h e li g hti n g r el at e d 
e q ui p m e nt. H e m a y w or k wit h n ursi n g h o m e dir ect or of 
m ai nt e n a nc e ( D O M) a n d d esi g n at e d r es e arc h t e a m m e m b er t o 
h a n dl e t h e li g hti n g s yst e m.  O nl y a ut h oriz e d r es e arc h ers will h a n dl e 
t h e li g hti n g s yst e m, i ncl u di n g tr a ns p orti n g a n d i nst alli n g it i n t h e sit e.
7. 4 . 6. 3
Pr e p ar ati o n  a n d Dis p e nsi n g
D escri b e h o w  t h e t est articl e will b e assi g n e d t o e ac h s u bj ect a n d 
dis p e ns e d. D escri b e t h e st e ps n ec ess ar y t o pr e p ar e t h e t est articl e. I ncl u d e 
w h er e t h e t est articl e pr e p ar ati o n will b e d o n e a n d b y w h o m. F ull y 
d escri b e h o w t h e st u d y tr e at m e nt is t o b e a d mi nist er e d a n d b y w h o m.
I n pr eli mi n ar y m e as ur es, t h e av er a g e n ursi n g h o m e li g hti n g is 2 5 0 
( ± 1 0 5) l ux i n b e dr o o m, 1 9 3 ( ± 1 2 2) l ux at c orri d or, 1 7 0- 2 8 8 ( ± 1 0 6-
1 2 3) l ux at t h e di ni n g r o o m, a n d 2 8 5 ( ± 9 1) l ux. T h e m e as ur es ar e 
c o nsist e nt wit h a pri or st u d y s h o wi n g t h at t h e li g hti n g i n n ursi n g 
h o m es is l ar g el y i ns uffici e nt t o m e et t h e vis u al n e e ds t o ol d er a d ults 
( D e L e p el eir e et al., 2 0 0 7).  
I n t his st u d y, t h e li g hti n g d os a g e will t ar g et at 4 0 0 l ux a n d C S = 0. 3 
d uri n g t h e d a y a n d pr ovi d e di m li g ht ≤4 0  l ux a n d C S ≤0. 1  i n 
p artici p a nt b e dr o o ms  at ni g ht. T h e i nt e nsit y a n d c ol or of o ur S A BL 
will b e  p erc eiv e d li k e l o w-l ev el d a yli g ht a n d d o es n ot c a us e a n y 
S T U D Y 0 0 0 2 0 2 1 6
A p pr o v al: 4/ 2 4/ 2 0 2 3

P a g e 3 2  of 6 0 (I R B U S E O NL Y: V. 0 2/ 0 1/ 2 0 2 3) 
D O N O T  AL T E R O R D EL E T E
gl ar e. W e  esti m at e e ac h r esi d e nt will b e ex p os e d t o t h e bri g ht li g ht 
f or at l e ast 4 h o urs p er d a y ( 2 h o urs d uri n g t hr e e m e alti m es a n d 2 
h o urs d uri n g ot h er d ail y activiti es). T h e p h ot os e ns ors will 
c o nti n u o usl y m o nit or d a yli g ht sit u ati o ns a n d a dj ust acc or di n gl y. It is 
p ossi bl e t h at p artici p a nts m a y r ec eiv e > 4 0 0l ux a n d C S > 0. 3 fr o m 
d a yli g ht.
7. 4 . 6. 4
R et ur n  or D estr ucti o n of t h e T est Articl e
D escri b e t h e  pr oc e d ur es f or fi n al r ec o ncili ati o n of t h e t est articl e s u p pl y at 
t h e e n d of t h e st u d y a n d w h et h er t h e t est articl e is t o b e s hi p p e d b ac k t o a 
s o urc e or d estr o y e d o n sit e.
Dr. J uli a n  W a n g a n d his d esi g n at e d r es e arc h assist a nt will c oll ect t h e 
li g hti n g s yst e m at t h e e n d of t h e st u d y a n d bri n g it b ac k t o t h e l a b.
7. 4 . 6. 5
Pri or  a n d C o nc o mit a nt T h er a p y
D escri b e w h at  pri or a n d/ or c o nc o mit a nt m e dic al t h er a p y will b e c oll ect e d. 
D escri b e w hic h c o nc o mit a nt m e dici n es/t h er a pi es ar e p er mitt e d d uri n g t h e 
st u d y. D escri b e w hic h c o nc o mit a nt m e dici n es ar e n ot p er mitt e d d uri n g t h e 
st u d y.
N o pri or  or c o nc o mit a nt m e dic al t h er a p y will b e pr ovi d e d or 
pr o hi bit e d.
8. 0 
N u m b er  of S u bj ects a n d St atistic al Pl a n
8. 1 
N u m b er  of S u bj ects
I n dic at e t h e m axi m u m n u m b er of s u bj ects t o b e accr u e d/ e nr oll e d, t o i ncl u d e all p ers o ns w h o si g n 
c o ns e nt f or t h e st u d y. If a p plic a bl e, disti n g uis h b et w e e n t h e n u m b er of s u bj ects w h o ar e ex p ect e d t o b e 
e nr oll e d a n d scr e e n e d, a n d t h e n u m b er of s u bj ects n e e d e d t o c o m pl et e t h e r es e arc h pr oc e d ur es (i. e., 
n u m b ers of s u bj ects excl u di n g scr e e n f ail ur es.)
Ai ms 1  a n d 2: R esi d e nts
R esi d e nt: T h e  t ar g et s a m pl e siz e is 4 0 n ursi n g h o m e r esi d e nts. W e ex p ect t o scr e e n 8 0 p ot e nti al 
r esi d e nts t o i d e ntif y a n d e nr oll 4 0 eli gi bl e r esi d e nts. 
Ai m 3:  St aff a n d A d mi nistr at ors
St aff: W e  pl a n t o e nr oll 1 6 N H st aff/ a d mi nistr at ors, i ncl u di n g t hr e e C N As, o n e activit y st aff, o n e 
n urs e, o n e D O N, o n e D O M, a n d o n e N H A.
8. 2 
S a m pl e  Siz e D et er mi n ati o n
If a p plic a bl e, pr ovi d e a j ustific ati o n of t h e s a m pl e siz e o utli n e d i n s ecti o n 8. 1 t o i ncl u d e r efl ecti o ns o n, or 
c alc ul ati o ns of, t h e p o w er of t h e st u d y.
Ai ms 1  a n d 2: R esi d e nts
W e will r ecr uit  4 0 r esi d e nts wit h A D R D a n d a git ati o n, 2 0 fr o m e ac h N H. T h e t w o N Hs h av e at 
l e ast a fl o or or a wi n g t h at is pri m aril y d e dic at e d t o r esi d e nts wit h A D R D, w h er e w e pl a n t o 
S T U D Y 0 0 0 2 0 2 1 6
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install the lighting and carry out the study. As attrition is expected to be around 10%, based on 
prior studies with a similar population, this will result in a final sample size of 36. This sample 
size was calculated based on a significance level of α=.05, medium effect size Cohen’s d=0.53, 
reported in previous studies, power=0.92.
Aim 3: Staff and Administrators
CNAs, activity staff, and nurses provide the most direct care. Priority will be given to individuals 
who provide care for resident participants. DONs, DOMs, and NHAs are decision makers for 
intervention implementation. The DOMs can provide feedback on the feasibility of installing 
and maintaining the lighting system and ensure the installation follows NH regulations. 
Potential participants will be initially identified by NH staff and confirmed by the research team. 
Sample size may be increased to reach data saturation.
8.3
Statistical or Analytic Methods
Describe the statistical methods (or non-statistical methods of analysis) that will be employed.
Aim 1
All data will initially be assessed with descriptive techniques to determine distributions and 
identify outliers. Baseline to post-intervention changes in participants’ CMAI, NPI-NH, and ARS 
scores will be used as the outcomes in all subsequent analyses. To conduct the group analysis, 
each participant will serve as their own control, which allows minimal use of control variables. The 
effect of the intervention will be analyzed using multi-level modeling to adjust for clustering of 
participants at the facility level. We will use the daytime and nighttime average of lighting dosages 
(lux and CS) from the personal light monitors as the independent variable to analyze the effect of 
SABL on changes in CMAI, NPI, and ARS. Although not powered for a detailed analysis, we will 
explore the impact of participant characteristics (sex, age, race, ethnicity, ADRD stage, and 
daylight exposure) on the intervention effect by adding them as covariates to the regression 
model.
Aim 2
All data will initially be assessed using descriptive techniques to examine underlying assumptions 
and detect any violations. To assess the intervention fidelity, the lux and CS data measured via 
manual measurements will be analyzed using one sample t-tests to analyze lighting levels during 
the day and nighttime, compared to the target levels. The data from personal light monitors will 
be analyzed similarly at individual level. Although not powered for a detailed analysis, we will 
explore the impact of participant characteristics (e.g., sex, age, race, dementia stage, co-
morbidity, facility, and daylight conditions) on the lighting received based on the personal light 
monitor. 
Aim 3
Quantitative Analysis: The data include ratings of acceptability, feasibility, appropriateness, time, 
and cost of installing and maintaining the intervention. All data will be analyzed using descriptive 
analyses. Although not powered for a detailed analysis, we will explore differences in perceptions 
of intervention feasibility and acceptability between sexes as well as the difference across 
professional roles and between facilities.
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Qualitative Analysis: The data include statements about SABL’s acceptability, feasibility, and 
appropriateness by NH employees. All interviews will be analyzed to identify patterns of feedback 
in implementation outcomes. We will use the five phases of thematic analysis in an iterative 
process: 1) transcripts and field notes will be read and reread, 2) building on the notes and ideas 
generated, the analysis will be coded, 3) identifying themes or patterns in the data that are 
relevant to the research question, 4) naming and defining each theme, 5) extracting analytic 
narrative and exemplar data to illustrate the themes. This approach will reveal themes related to 
the acceptability, feasibility, and appropriateness of the intervention.
Mixed Methods Analysis: After quantitative and qualitative data are analyzed, the data will be 
merged by PI Jao and Co-I Boltz, using the spiraled analysis to compare and contrast the results. 
The data will be evaluated for convergence, divergence, relationships, contradictions, and new 
findings. Merged results will be reported in a joint display.
9.0
Data and Safety Monitoring Plan
This section is required when research involves more than Minimal Risk to subjects as defined in “HRP-001 
SOP- Definitions.”
Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the research that 
are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests. For research involving prisoners, Minimal Risk is the 
probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in 
the routine medical, dental, or psychological examination of healthy persons. 
Please complete each section below if the research involves more than minimal risk to subjects or indicate not 
applicable. 
[Do not type here]
9.1
Periodic evaluation of data
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe.
Not applicable.
9.2
Data that are reviewed
Describe the data that are reviewed, including safety data, untoward events, and efficacy data.
Not applicable.
9.3
Method of collection of safety information
Describe the method by which the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls and with subjects).
Not applicable.
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9.4
Frequency of data collection
Describe the frequency of data collection, including when safety data collection starts.
Not applicable.
9.5
Individuals reviewing the data
Identify the individuals who will review the data. The plan might include establishing a data and safety 
monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the 
sponsor.
Not applicable.
9.6
Frequency of review of cumulative data
Describe the frequency or periodicity of review of cumulative data.
Not applicable.
9.7
Statistical tests
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring.
Not applicable.
9.8
Suspension of research
Describe any conditions that trigger an immediate suspension of research.
Not applicable.
10.0
Risks
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the 
subjects’ participation in the research. Include as may be useful for the IRB’s consideration, a description of the 
probability, magnitude, duration, and reversibility of the risks. Consider all types of risk including physical, 
psychological, social, legal, and economic risks. Note: Loss of confidentiality is a potential risk when conducting 
human subject research and must be listed here.

If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable.

If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or 
become pregnant.

If applicable, describe risks to others who are not subjects.
Aims 1 and 2: Residents
It is believed our SABL is safe with minimum adverse effects based on existing research evidence. Our 
proposed lighting scheme follows the scientific consensus for persons with dementia and the 
recommendations of the American National Standards Institute and Illuminating Engineering Society. 
Ambient light schemes similar to the proposed SABL have also been evaluated in a few studies and did 
not report any negative effects. Additionally, the intensity and color of our SABL will be perceived similar 
to low-level daylight and does not cause any glare. Also, for lighting installation, Dr. Julian Wang will work 
with the director of maintenance (DOM) at each facility to ensure the installation follows NH regulations. 
Altogether, evidence suggests that our SABL is safe with minimum adverse effects.
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Potential but rare risks of exposure to the SABL may include increased agitation, skin rash, eye irritation, 
dizziness, and nausea. Another potential risk for participating in this study is loss of identifiable 
information. Because the smart lighting system will operate automatically, we anticipate the burden on 
supporting the operation of the intervention will be very minimal. 
It is believed our SABL is safe, and we do not expect any risks occur caused by our proposed SABL 
based on current research evidence. The list of rare risks listed in this study was based on the adverse 
effect checklist used in other studies and we plan to monitor unexpected but possible risks to be extra 
cautious in this study despite that we do not expect any side effects.
A systematic review of 32 articles concludes that bright light interventions trend toward a positive 
impact and do not have significant adverse effects for persons with dementia (Mitolo et al., 2018). 
Currently, to our knowledge, only two prior studies reported adverse effects: one study reported 
deteriorated agitation and depression (Barrick et al., 2010; Hickman et al., 2007) and one study 
reported increased anxiety (Van Hoof et al., 2009). However, their light designs were very different 
from this proposed study, with much higher intensity (2000-3000 lux) (Barrick et al., 2010; Hickman 
et al., 2007), or much higher color temperature (CCT=17000K, very bluish) (Van Hoof et al., 2009). 
Our proposed lighting scheme follows the scientific consensus for persons with dementia (Figueiro et 
al., 2016), and the recommendations of the American National Standards Institute and Illuminating 
Engineering Society (Illuminating Engineering Society of North America, 2020). Moreover, the 
ambient light schemes and schedule similar to our proposed SABL, but without daylight incorporation, 
have also been evaluated in a few studies and did not report any negative effects (Figueiro et al., 
2014; Figueiro et al., 2015; Figueiro et al., 2019; Figueiro et al., 2020). Additionally, the intensity 
and color of our SABL will be perceived similar to low-level daylight and does not cause any glare. 
Altogether, evidence suggests that our SABL is safe with minimum adverse effects.
            Aim 3: Staff and administrators
The risks to participants are very minimal. There is a potential of increased burden for staff and 
administrators from completing the surveys and participating in the interviews. We anticipate the study 
procedures will not take more than 2 hours to complete.  We will make every attempt to work around 
their schedule and will conduct the interview during times that work best for them, including evenings 
and weekends.
11.0
Potential Benefits to Subjects and Others 
11.1
Potential Benefits to Subjects
Describe the potential benefits that individual subjects may experience from taking part in the research. 
If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. 
Compensation should be addressed in section 13.0.
Aims 1 and 2: Residents
There is no guarantee that residents will benefit from this research study. The possible benefits 
residents may experience include improvement with their mood, behaviors, and sleep due to 
the exposure to the SABL lighting intervention.       
Aim 3: Staff and Administrators
Participants will not benefit from this research study.
11.2
Potential Benefits to Others
Describe the potential benefits to society or others. 
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The results of this research study may benefit other people in the future by helping us learn 
more about the use of lighting interventions in residents with dementia. The results may help 
further refine the lighting intervention to be more effective and practical to use for residents 
with dementia in nursing homes improved BPSD, sleep, quality of life, and health outcomes.
12.0
Sharing Results with Subjects
Describe whether results (study results or individual subject results, such as results of investigational diagnostic 
tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care 
physicians) and if so, describe how information will be shared. 
This study will not share individual participant results with the participating nursing homes, 
participants, staff caregivers, residents, and family. However, we can share the aggregate results of the 
study with the participating facilities, participants, or family, if they are interested.
13.0
Subject Payment and/or Travel Reimbursements
Describe the amount, type (cash, check, gift card, other) and timing of any subject payment or travel 
reimbursement. If there is no subject payment or travel reimbursement, indicate as not applicable. 
Extra or Course Credit:  Describe the amount of credit and the available alternatives. Alternatives should be 
equal in time and effort to the amount of course or extra credit offered. It is not acceptable to indicate that the 
amount of credit is to be determined or at the discretion of the instructor of the course. 
Approved Subject Pool: Indicate which approved subject pool will be used; include in response below that 
course credit will be given and alternatives will be offered as per the approved subject pool procedures. 
For resident, we will not provide any reimbursement. 
For staff and administrators, we will provide an honorarium for individuals who help with resident 
assessment for aim 1 or intervention feasibility assessment for aim 3. For staff caregivers who provide 
information for one resident assessment, including assessment on  agitation, other BPSD, affect, sleep, 
and intervention side effects, we will provide a gift card of $15for each assessment visits for each 
resident. For staffs and interviews to evaluate intervention feasibility,we will provide a gift card of $15 . 
There is no limit of the number of assessments that an individual staff member will help with. If an 
individual staff member earns more than $300 over the course of one calendar year, the study team 
will need to pay the reimbursement by check.  Use of small financial honoraria is reasonable to convey 
respect to staff caregivers’ participation in the research in exchange for their time and associated 
workload burden and has been found to enhance participation.
14.0
Economic Burden to Subjects
14.1
Costs
Describe any costs that subjects may be responsible for because of participation in the research.
Participants will not have any research-related costs.
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14.2
Compensation for research-related injury
If the research involves more than Minimal Risk to subjects, describe the available compensation in 
the event of research related injury.
If there is no sponsor agreement that addresses compensation for medical care for research subjects 
with a research-related injury, include the following text as written - DO NOT ALTER OR DELETE:
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers. 
For sponsored research studies with a research agreement with the sponsor that addresses 
compensation for medical care for research-related injuries, include the following text as written - DO 
NOT ALTER OR DELETE:
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Such charges may be paid by the study sponsor as 
outlined in the research agreement and explained in the consent form.
It is the policy of the institution to provide neither financial compensation nor free medical 
treatment for research-related injury. In the event of injury resulting from this research, 
medical treatment is available but will be provided at the usual charge. Costs for the treatment 
of research-related injuries will be charged to subjects or their insurance carriers.
15.0
Resources Available 
15.1
Facilities and locations
Identify and describe the facilities, sites, and locations where recruitment and study procedures will be 
performed. 
If research will be conducted outside the United States, describe site-specific regulations or customs 
affecting the research, and describe the process for obtaining local ethical review. Also, describe the 
principal investigator’s experience conducting research at these locations and familiarity with local 
culture.
The study will be conducted in nursing homes in local central Pennsylvania: 1) Christ the King 
Manor and 2) Centre Care. These two facilities have agreed to be the clinical sites for this study 
and the administrator has provided a letter of support. Additional nursing homes may be 
identified as needed.  The PI has established research relationships with these two sites and 
other long-term care facilities in central PA.
15.2
Feasibility of recruiting the required number of subjects
Indicate the number of potential subjects to which the study team has access. Indicate the percentage 
of those potential subjects needed for recruitment.
Christ the King Manor has the capacity to house 160 residents and approximately 70% of 
residents are living with dementia. 
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Centre Care has the capacity to house 240 residents and approximately 65% of the residents 
have dementia.
15.3
PI Time devoted to conducting the research
Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and 
completing the research. Consider outside responsibilities as well as other on-going research for which 
the PI is responsible. Please only provide a response for the principal investigator – do not include 
information about any other study team members.
The PI Jao has secured at least 15% of her time and Wang has secured at least 8% of his time to 
be devoted to conducting and completing this research study.
15.4
Availability of medical or psychological resources
Describe the availability of medical or psychological resources that subjects might need as a result of 
their participation in the study.
Not applicable.
15.5
Process for informing Study Team
Describe the training plans to ensure members of the research team are informed about the protocol 
and their duties.
All research team members will be trained by the PI Jao and/or Wang prior to the start of the 
study. Additionally, PI Jao and Wang will conduct weekly meetings with the research team who 
are directly involved in data collection and study procedures and monthly meetings with all 
study team members.
16.0
Other Approvals
16.1
Other Approvals from External Entities
Describe any approvals that will be obtained prior to commencing the research (e.g., from engaged 
cooperating institutions IRBs who are also reviewing the research and other required review 
committees, community leaders, schools, research locations where research is to be conducted by the 
Penn State investigator, funding agencies, etc.).
The clinical facilities have provided a letter of support for conducting the study at the site.
16.2
Internal PSU Ancillary Reviews
DO NOT ALTER OR DELETE: 
Ancillary reviews are reviewed by other compliance groups or individuals within Penn State that inform 
the IRB’s review of a new study or a modification to an existing study.
PSU IRB may set applicable ancillary reviews for your study. Please refer to the HRP-309 Worksheet – 
Ancillary Review Matrix for more information (found in the CATS Library).
[Do not type here]
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17.0
Multi-Site Study
If this is a multi-site study (i.e., a study in which two or more institutions coordinate, with each institution 
completing all research activities outlined in a specific protocol) and the Penn State PI is the lead investigator, 
describe the processes to ensure communication among sites in the sections below.
[Do not type here]
17.1
Other sites 
List the name and location of all other participating sites. Provide the name, qualifications and contact 
information for the principal investigator at each site and indicate which IRB will be reviewing the study 
at each site.
Not applicable.
17.2
Communication Plans
Describe the plan for regular communication between the overall study director and the other sites to 
ensure that all sites have the most current version of the protocol, consent document, etc. Describe the 
process to ensure all modifications have been communicated to sites. Describe the process to ensure 
that all required approvals have been obtained at each site (including approval by the site’s IRB of 
record). Describe the process for communication of problems with the research, interim results, and 
closure of the study.
Not applicable.
17.3
Data Submission and Security Plan
Describe the process and schedule for data submission and provide the data security plan for data 
collected from other sites. Describe the process to ensure all engaged participating sites will safeguard 
data as required by local information security policies.
Not applicable.
17.4
Subject Enrollment
Describe the procedures for coordination of subject enrollment and randomization for the overall 
project.
Not applicable.
17.5
Reporting of Adverse Events and New Information
Describe how adverse events and other information will be reported from the clinical sites to the overall 
study director. Provide the timeframe for this reporting.
Not applicable.
17.6
Audit and Monitoring Plans
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any 
on-site auditing and monitoring plans for the study.
Not applicable.
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18.0
Adverse Event Reporting
18.1
Adverse Event Definitions
For drug studies, incorporate the following definitions into the below responses, as written:
Adverse event
Any untoward medical occurrence associated with the use of the drug in 
humans, whether or not considered drug related
Adverse reaction
Any adverse event caused by a drug
Suspected adverse 
reaction
Any adverse event for which there is a reasonable possibility that the drug 
caused the adverse event.  Suspected adverse reaction implies a lesser degree 
of certainty about causality than “adverse reaction”.

Reasonable possibility.  For the purpose of IND safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal 
relationship between the drug and the adverse event.
Serious adverse 
event or Serious 
suspected adverse 
reaction
Serious adverse event or Serious suspected adverse reaction: An adverse event 
or suspected adverse reaction that in the view of either the investigator or 
sponsor, it results in any of the following outcomes: Death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption 
of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered serious when, based 
upon appropriate medical judgment, they may jeopardize the patient or 
subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
Life-threatening 
adverse event or 
life-threatening 
suspected adverse 
reaction
An adverse event or suspected adverse reaction is considered “life-
threatening” if, in the view of either the Investigator (i.e., the study site 
principal investigator) or Sponsor, its occurrence places the patient or research 
subject at immediate risk of death. It does not include an adverse event or 
suspected adverse reaction that had it occurred in a more severe form, might 
have caused death.
Unexpected 
adverse event or 
Unexpected 
suspected adverse 
reaction.  
An adverse event or suspected adverse reaction is considered “unexpected” if 
it is not listed in the investigator brochure, general investigational plan, clinical 
protocol, or elsewhere in the current IND application; or is not listed at the 
specificity or severity that has been previously observed and/or specified.
For device studies, incorporate the following definitions into the below responses, as written:
Unanticipated 
adverse device 
effect
Any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or IDE application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.
18.2
Recording of Adverse Events
Address the frequency and process for eliciting adverse event information from research subject, e.g., 
“Research subjects will be routinely questioned about adverse events at study visits.”
STUDY00020216
Approval: 4/24/2023

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In the response, incorporate the following as written:
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or 
its sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the 
investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria 
are met:

The test finding is accompanied by clinical symptoms

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical 
intervention; including significant additional concomitant drug treatment or other therapy
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does 
not constitute an adverse event.

The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study

The test finding is considered an adverse event by the investigator.
All adverse events (serious or non-serious) and abnormal test findings observed or reported to 
study team believed to be associated with the lighting intervention will be followed until the 
event (or its sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to 
the investigator. Research team members will visit the site biweekly during the 13 weeks of 
study period to monitor any adverse events. 
An abnormal test finding will be classified as an adverse event if one or more of the following 
criteria are met:

The test finding is accompanied by clinical symptoms. We will not be able to completely 
distinguish whether a clinical symptom is resulted from dementia or other 
comorbidities, or it is resulted from the SABL treatment. We will assess dementia-
related symptoms, including behavioral and psychological symptoms at baseline and 
every other week throughout the 13-week study period. Also, during the 13-week 
study period, the SABL will only be provided for 4 weeks. When a clinical symptom 
occurs during those 4 weeks, we will compare the participant’s symptoms with the 
baseline and non-intervention period to examine if the symptoms are possibly SABL-
related. In addition, we will examine other comorbidities that may contribute to the 
clinical symptoms, such as delirium, urinary tract infection, and a new medical 
condition/procedure that may cause pain (e.g., tooth extraction, fall). We will collect 
all relevant information and document it and will observe if the same symptom occurs 
to other participants.

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical 
intervention; including significant additional concomitant drug treatment or other 
therapy.
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does 
not constitute an adverse event.

The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study
The test finding is considered an adverse event by the investigator.
STUDY00020216
Approval: 4/24/2023

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1 8. 3 
C a us alit y  a n d S e v erit y Ass ess m e nts
B y s u b mitti n g  t his st u d y f or r evi e w, y o u a gr e e t o t h e f oll o wi n g st at e m e nt – D O N O T AL T E R O R D EL E T E: 
T h e i nv esti g at or  will pr o m ptly r evi e w d oc u m e nt e d a dv ers e ev e nts a n d a b n or m al t est fi n di n gs t o 
d et er mi n e 1) if t h e a b n or m al t est fi n di n g s h o ul d b e cl assifi e d as a n a dv ers e ev e nt; 2) if t h er e is a 
r e as o n a bl e p ossi bility t h at t h e a dv ers e ev e nt w as c a us e d by t h e st u dy dr u g(s) or d evic e(s); a n d 3) if t h e 
a dv ers e ev e nt m e ets t h e crit eri a f or a s eri o us a dv ers e ev e nt.
If t h e i nv esti g at or’s fi n al d et er mi n ati o n of c a us ality is “ u n k n o w n a n d of q u esti o n a bl e r el ati o ns hi p t o t h e 
st u dy dr u g(s) or d evic e(s)”, t h e a dv ers e ev e nt will b e cl assifi e d as ass oci at e d wit h t h e us e of t h e st u dy 
dr u g(s) or d evic e(s) f or r e p orti n g p ur p os es.  If t h e i nv esti g at or’s fi n al d et er mi n ati o n of c a us ality is 
“ u n k n o w n b ut n ot r el at e d t o t h e st u dy dr u g(s) or d evic e(s)”, t his d et er mi n ati o n a n d t h e r ati o n al e f or t h e 
d et er mi n ati o n will b e d oc u m e nt e d i n t h e r es p ectiv e s u bj ect’s c as e hist ory.
1 8. 4 
R e p orti n g  of A d v ers e R e acti o ns a n d U n a ntici p at e d Pr o bl e ms t o t h e F D A  
1 8. 4. 1 Writt e n I N D/I D E  S af et y R e p orts
F or a  dr u g st u d y u n d er a n I N D, i nc or p or at e t h e f oll o wi n g fr o m 2 1 C F R 3 1 2. 3 2 as writt e n – D O 
N O T AL T E R O R D EL E T E: 
T h e S p o ns or-I nv esti g at or  will s u b mit a writt e n I N D S af et y R e p ort (i. e., c o m pl et e d F D A F or m 
3 5 0 0 A) t o t h e r es p o nsi bl e n e w dr u g r evi e w divisi o n of t h e F D A f or a n y o bs erv e d or v ol u nt e er e d 
a dv ers e ev e nt t h at is d et er mi n e d t o b e a s eri o us a n d u n ex p ect e d, s us p ect e d a dv ers e r e acti o n.  
E ac h I N D S af et y R e p ort will b e pr o mi n e ntl y l a b el e d, “I N D S af et y R e p ort”, a n d a c o p y will b e 
pr ovi d e d t o all p artici p ati n g i nv esti g at ors (if a p plic a bl e) a n d s u b-i nv esti g at ors.
Writt e n I N D  S af et y R e p orts will b e s u b mitt e d t o t h e F D A as s o o n as p ossi bl e a n d, i n n o e v e nt, 
l at er t h a n 1 5 c al e n d ar d a ys f oll o wi n g t h e S p o ns or-I nv esti g at or’s r ec ei pt of t h e r es p ecti v e 
a dv ers e ev e nt i nf or m ati o n a n d d et er mi n ati o n t h at it m e ets t h e r es p ectiv e crit eri a f or r e p orti n g.
F or e ac h  writt e n I N D S af et y R e p ort, t h e S p o ns or-I nv esti g at or will i d e ntif y all pr evi o usl y 
s u b mitt e d I N D S af et y R e p orts t h at a d dr ess e d a si mil ar s us p ect e d a dv ers e r e acti o n ex p eri e nc e 
a n d will pr ovi d e a n a n al ysis of t h e si g nific a nc e of n e wl y r e p ort e d, s us p ect e d a dv ers e r e acti o n i n 
li g ht of t h e pr evi o us, si mil ar r e p ort(s) or a n y ot h er r el ev a nt i nf or m ati o n.
R el ev a nt f oll o w- u p  i nf or m ati o n t o a n I N D S af et y R e p ort will b e s u b mitt e d t o t h e a p plic a bl e 
r evi e w divisi o n of t h e F D A as s o o n as t h e i nf or m ati o n is av ail a bl e a n d will b e i d e ntifi e d as s uc h 
(i. e., “ F oll o w- u p I N D S af et y R e p ort”).
If t h e r es ults of t h e S p o ns or-I nv esti g at or’s f oll o w- u p i nv esti g ati o n s h o w t h at a n a d v ers e e v e nt 
t h at w as i niti all y d et er mi n e d t o n ot r e q uir e a writt e n I N D S af et y R e p ort d o es, i n f act, m e et t h e 
r e q uir e m e nts f or r e p orti n g; t h e S p o ns or-I nv esti g at or will s u b mit a writt e n I N D S af et y R e p ort as 
s o o n as p ossi bl e, b ut i n n o ev e nt l at er t h a n 1 5 c al e n d ar d a ys, aft er t h e d et er mi n ati o n w as m a d e.
F or a  d e vic e st u d y u n d er a n I D E, i nc or p or at e t h e f oll o wi n g fr o m 2 1 C F R 8 1 2. 1 5 0 as writt e n – 
D O N O T AL T E R O R D EL E T E:  
T h e S p o ns or-I nv esti g at or  will s u b mit a c o m pl et e d F D A F or m 3 5 0 0 At o t h e F D A’s C e nt er f or 
D evic es a n d R a di ol o gic al H e alt h f or a n y o bs erv e d or v ol u nt e er e d a dv ers e eff ect t h at is 
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determined to be an unanticipated adverse device effect. A copy of this completed form will be 
provided to all participating sub-investigators.
The completed FDA Form 3500Awill be submitted to the FDA as soon as possible and, in no 
event, later than 10 working days after the Sponsor-Investigator first receives notice of the 
adverse effect.
If the results of the Sponsor-Investigator’s follow-up evaluation show that an adverse effect that 
was initially determined to not constitute an unanticipated adverse device effect does, in fact, 
meet the requirements for reporting; the Sponsor-Investigator will submit a completed FDA 
Form 3500Aas soon as possible, but in no event later than 10 working days, after the 
determination was made.
For each submitted FDA Form 3500A, the Sponsor-Investigator will identify all previously 
submitted reports that that addressed a similar adverse effect experience and will provide an 
analysis of the significance of newly reported adverse effect in light of the previous, similar 
report(s). 
Subsequent to the initial submission of a completed FDA Form 3500A, the Sponsor-Investigator 
will submit additional information concerning the reported adverse effect as requested by the 
FDA.
The Sponsor-Investigator will submit a completed FDA Form 3500Ato the FDA’s Center 
for Devices and Radiological Health for any observed or volunteered adverse effect that 
is determined to be an unanticipated adverse device effect. A copy of this completed 
form will be provided to all participating sub-investigators.
The completed FDA Form 3500Awill be submitted to the FDA as soon as possible and, in 
no event, later than 10 working days after the Sponsor-Investigator first receives notice 
of the adverse effect.
If the results of the Sponsor-Investigator’s follow-up evaluation show that an adverse 
effect that was initially determined to not constitute an unanticipated adverse device 
effect does, in fact, meet the requirements for reporting; the Sponsor-Investigator will 
submit a completed FDA Form 3500Aas soon as possible, but in no event later than 10 
working days, after the determination was made.
For each submitted FDA Form 3500A, the Sponsor-Investigator will identify all previously 
submitted reports that that addressed a similar adverse effect experience and will 
provide an analysis of the significance of newly reported adverse effect in light of the 
previous, similar report(s). 
Subsequent to the initial submission of a completed FDA Form 3500A, the Sponsor-Investigator 
will submit additional information concerning the reported adverse effect as requested by the 
FDA.
STUDY00020216
Approval: 4/24/2023

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1 8. 4. 2 T el e p h o n e d I N D  S af et y R e p orts – F at al or Lif e-t hr e at e ni n g S us p ect e d A d v ers e R e acti o ns
F or a  dr u g st u d y u n d er a n I N D, i nc or p or at e t h e f oll o wi n g fr o m 2 1 C F R 3 1 2. 3 2 i nt o t h e 
r es p o ns e, as writt e n:
I n a d diti o n t o t h e s u bs e q u e nt s u b missi o n of a writt e n I N D S af et y R e p ort (i. e., c o m pl et e d F D A 
F or m 3 5 0 0 A), t h e S p o ns or-I nv esti g at or will n otif y t h e r es p o nsi bl e r evi e w divisi o n of t h e F D A b y 
t el e p h o n e or f acsi mil e tr a ns missi o n of a n y u n ex p ect e d, f at al, or lif e-t hr e at e ni n g s us p ect e d 
a dv ers e r e acti o n. 
T h e t el e p h o n e  or f acsi mil e tr a ns missi o n of a p plic a bl e I N D S af et y R e p orts will b e m a d e as s o o n 
as p ossi bl e b ut i n n o ev e nt l at er t h a n 7 c al e n d ar d a ys aft er t h e S p o ns or-I nv esti g at or’s r ec ei pt of 
t h e r es p ectiv e a dv ers e ev e nt i nf or m ati o n a n d d et er mi n ati o n t h at it m e ets t h e r es p ecti v e crit eri a 
f or r e p orti n g.
 N ot a p plic a bl e.
1 8. 5 
R e p orti n g  A d v ers e R e acti o ns a n d U n a ntici p at e d Pr o bl e ms t o t h e R es p o nsi bl e I R B
B y s u b mitti n g  t his st u d y f or r evi e w, y o u a gr e e t o t h e f oll o wi n g st at e m e nt – D O N O T AL T E R O R D EL E T E: 
I n acc or d a nc e wit h a p plic a bl e p olici es of T h e P e n nsylv a ni a St at e U niv ersity I nstit uti o n al R evi e w B o ar d 
(I R B), t h e i nv esti g at or will r e p ort, t o t h e I R B, a ny o bs erv e d or r e p ort e d h ar m ( a dv ers e ev e nt) ex p eri e nc e d 
by a s u bj ect or ot h er i n divi d u al, w hic h i n t h e o pi ni o n of t h e i nv esti g at or is d et er mi n e d t o b e ( 1) 
u n ex p ect e d; a n d ( 2) pr o b a bly r el at e d t o t h e r es e arc h pr oc e d ur es. H ar ms ( a dv ers e ev e nts) will b e 
s u b mitt e d t o t h e I R B i n acc or d a nc e wit h t h e I R B p olici es a n d pr oc e d ur es.
1 8. 6 
U n bli n di n g  Pr oc e d ur es
D escri b e t h e  pr oc e d ur es f or u n bli n di n g st u d y t h er a p y o n a s u bj ect, i ncl u di n g d oc u m e nt ati o n of t his i n 
t h e s u bj ect’s s o urc e d oc u m e nt. I ncl u d e ex a m pl e(s) h er e w h y s o m e o n e mi g ht u n bli n d a st u d y. I n m ost 
c as es, t h e u n bli n di n g will b e p art of m a n a gi n g a s eri o us a dv ers e r e acti o n a n d will b e r e p ort e d wit h t h e 
s eri o us a dv ers e ev e nt. H o w ev er, i n c as es w h er e u n bli n di n g w as n ot ass oci at e d wit h a s eri o us a d v ers e 
e v e nt, s uc h acti o ns s h o ul d b e r e p ort e d i n a ti m el y m a n n er.
I n r ar e c as es, if a n y r esi d e nt p artici p a nts ar e d et er mi n e d b y t h e r es e arc h t e a m t o h av e a s eri o us 
a d v ers e r e acti o n dir ectl y r el at e d t o t h e li g hti n g i nt erv e nti o n, w e will u n bli n d t h e p artici p a nts’ 
li g hti n g c o n diti o ns.
1 8. 7 
St o p pi n g  R ul es
I n st u di es wit h a pri m ar y s af et y e n d p oi nt or st u di es wit h hi g h ris k t o st u d y s u bj ects, pr ovi d e t h e r ul es 
t h at d efi n e t h e circ u mst a nc es a n d pr oc e d ur es f or i nt err u pti n g or st o p pi n g t h e st u d y. If a n i n d e p e n d e nt 
D at a a n d S af et y M o nit ori n g ( D S M B) or C o m mitt e e ( D S M C) is s et u p f or t h e st u d y, t h e s a m e st o p pi n g 
r ul es s h o ul d b e i nc or p or at e d i nt o t h e s af et y a n al ysis pl a n as w ell.
N ot a p plic a bl e.
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1 9. 0 
St u d y  M o nit ori n g, A u diti n g a n d I ns p ecti n g
1 9. 1 
St u d y  M o nit ori n g Pl a n
1 9. 1. 1 Q u alit y  Ass ur a nc e a n d Q u alit y C o ntr ol
I ncl u d e t his s ecti o n if F D A r e g ul ati o ns a p pl y t o t his st u d y (s e e “ W O R K S H E E T: Dr u gs ( H R P- 3 0 6)” 
a n d “ W O R K S H E E T: D evic es ( H R P- 3 0 7)”. H R P- 3 0 6 a n d H R P- 3 0 7 c a n b e acc ess e d b y clic ki n g t h e 
Li br ar y li n k i n C A T S I R B (htt p://ir b. ps u. e d u ). 
D escri b e h o w  y o u will e ns ur e t h at t his st u d y is c o n d uct e d, a n d t h at t h e d at a ar e g e n er at e d, 
d oc u m e nt e d (r ec or d e d) a n d r e p ort e d i n c o m pli a nc e wit h t his pr ot oc ol, wit h i nstit uti o n al a n d 
I R B p olici es, wit h G o o d Cli nic al Pr actic e g ui d eli n es a n d a n y ot h er a p plic a bl e r e g ul at or y 
r e q uir e m e nts.
I n dic at e w h o is r es p o nsi bl e f or m o nit ori n g t h e c o n d uct of t h e st u d y a n d s p ecif y h o w oft e n t h e 
st u d y will b e m o nit or e d. 
F or si n gl e-sit e st u di es  wit h l o w ris k, it m a y b e a p pr o pri at e f or t h e pri nci p al i nv esti g at or t o 
m o nit or t h e st u d y.
F or m ulti-c e nt er  st u di es or si n gl e sit e st u di es i nv olvi n g si g nific a nt ris k, a n i n d e p e n d e nt m o nit or 
m a y b e r e q uir e d ( e. g., m o nit ori n g b y t h e st aff of t h e P S U q u alit y ass ur a nc e pr o gr a m offic e(s) or 
b y a cli nic al r es e arc h or g a niz ati o n).
PI J a o a n d  Dr. J uli a n W a n g ar e r es p o nsi bl e f or m o nit ori n g t h e c o n d uct of t h e st u d y 
w e e kl y d uri n g t h e 1 3 w e e ks of t h e st u d y. PI J a o will e ns ur e t h at all s urv e ys, li g hti n g d at a, 
a n d ass ess m e nts c oll ect e d fr o m t h e r es e arc h t e a m f oll o ws pr ot oc ols a n d s ec ur el y 
l oc k e d i n t h e offic e t hr o u g h w e e kl y r evi e w of c oll ect e d d at a. A d diti o n all y, w e will h av e 
Exc el s h e ets t o k e e p tr ac k of t h e pr o gr ess of d at a c oll ecti o n t o e ns ur e all n ec ess ar y d at a 
ar e c oll ect e d.
1 9. 1. 2 S af et y  M o nit ori n g
I ncl u d e t his s ecti o n if F D A r e g ul ati o ns a p pl y t o t his st u d y (s e e “ W O R K S H E E T: Dr u gs ( H R P- 3 0 6)” 
a n d “ W O R K S H E E T: D evic es ( H R P- 3 0 7)”. H R P- 3 0 6 a n d H R P- 3 0 7 c a n b e acc ess e d b y clic ki n g t h e 
Li br ar y li n k i n C A T S I R B (htt p://ir b. ps u. e d u ). 
I n dic at e t h e pr oc ess f or i d e ntif yi n g, r ec or di n g, a n d r e p orti n g a dv ers e ev e nts.
S p ecif y r ol es  f or a dv ers e ev e nt r ec or di n g a n d m o nit ori n g. I n dic at e e ac h st aff m e m b er’s r ol e i n 
t h e a dv ers e ev e nt r e p orti n g pr oc ess. I ncl u d e t h e f oll o wi n g if a p plic a bl e:
T h e Pri nci p al  I n v esti g at or will c o nfir m t h at all a dv ers e ev e nts ( A E) ar e c orr ectl y e nt er e d i nt o t h e 
A E c as e r e p ort f or ms b y t h e c o or di n at or; b e av ail a bl e t o a ns w er a n y q u esti o ns t h at t h e 
c o or di n at ors m a y h av e c o nc er ni n g A Es; a n d will n otif y t h e I R B, F D A, s p o ns or a n d/ or D S M B of all 
a p plic a bl e A Es as a p pr o pri at e. All ass ess m e nts of A Es will b e m a d e b y a lic e ns e d m e dic al 
pr of essi o n al w h o is a n i nv esti g at or o n t h e r es e arc h.
T h e R es e arc h C o or di n at or  will c o m pl et e t h e a p pr o pri at e r e p ort f or m a n d l o gs; assist t h e PI t o 
pr e p ar e r e p orts a n d n otif y t h e I R B, F D A a n d/ or D S M B of all U n a ntici p at e d Pr o bl e ms/ S A E’s.
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The Monitor will confirm that the AEs are correctly entered into the case report forms. The 
Monitor will also confirm that the adverse events are consistent with the source documents and 
are reported to the appropriate regulatory bodies as required.
During the 13 weeks of lighting intervention, the research team will identify adverse 
events through interviews with CNAs using a checklist, which includes deteriorated 
BPSDs, skin rash, eye irritation, dizziness, nausea, or any other reactions. Data will be 
collected routinely once every two weeks throughout the study period or as needed by 
staff reporting. If there is a report of adverse events, PI Jao will ensure that these 
adverse events are correctly logged and entered into the AE case report forms and 
notify the IRB, FDA, and NIH. The research coordinator will keep track of the adverse 
event and assist PO Jao to prepare reports to notify IRB, FDA, and NIH.
20.0
Future Undetermined Research: Data and Specimen Banking
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined 
research, please describe this process in the sections below.  This information should not conflict with 
information provided in section 22 below OR the “HRP-598 – Research Data Plan Review Form” regarding 
whether or not data and/or specimens will be associated with identifiers (directly or indirectly).  If there are no 
plans to use identifiable data/specimens for future, undetermined research, then this section is NOT applicable.
[Do not type here]
20.1
Data and/or specimens being stored
Identify what data and/or specimens will be stored, and the data associated with each specimen.
Not applicable.
20.2
Location of storage
Identify the location where the data and/or specimens will be stored.
Not applicable.
20.3
Duration of storage
Identify how long the data and/or specimens will be stored. If data and/or specimens will be stored 
indefinitely, indicate such. 
Not applicable.
20.4
Access to data and/or specimens
Identify who will have access to the data and/or specimens.
Not applicable.
20.5
Procedures to release data or specimens
Describe the procedures to release the data and/or specimens, including: the process to request a 
release, approvals required for release, who can obtain data and/or specimens, and the data to be 
provided with the specimens.
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Not applicable.
20.6
Process for returning results
Describe the process for returning results about the use of the data and/or specimens.
Not applicable.
21.0
References
List relevant references in the literature which highlight methods, controversies, and study outcomes.
1. Barrick, A. L., Sloane, P. D., Williams, C. S., Mitchell, C. N., Connell, B. R., Wood, W., Hickman, 
S. E., Preisser, J. S., & Zimmerman, S. (2010). Impact of ambient bright light on agitation in 
dementia. International Journal of Geriatric Psychiatry, 25, 1013-1021. doi: 10.1002/gps.2453.
2. Campamà Pizarro, R. (2020). Daylighting and Electric Lighting Integration in the Retail Sector: 
A Case Study of the IKEA Kaarst Store. Lund University.
3. Czunyi, L., & Craib, D. (2016). Lighting the way to independent living: Preventative methods 
for senior health inspired by daylight. (pp. 339-348). Springer International Publishing. 
https://doi.org/10.1007/978-3-319-41661-8_33
4. Cerejeira, J., Lagarto, L., & Mukaetova-Ladinska, E. B. (2012). Behavioral and psychological 
symptoms of dementia, Frontiers in Neurology, 3, 73, 1-21.
5. Canevelli, M., Valletta, M., Trebbastoni, A., Sarli, G., D'Antonio, F., Tariciotti, L., de Lena, C., & 
Bruno, G. (2016). Sundowning in dementia: Clinical relevance, pathophysiological 
determinants, and therapeutic approaches. Frontiers in Medicine, 3, 
73. https://doi.org/10.3389/fmed.2016.00073
de Oliveira, A. M., Radanovic, M., de Mello, P. C. M., Buchain, P. C., Vizzotto, A. D. B., Celestino, 
D. L., Stella, F., Piersol, C. V., & Forlenza, O. V. (2015).  Nonpharmacological interventions to 
reduce behavioral and psychological symptoms of dementia: A systematic review. BioMed 
Research International. http://dx.doi.org/10.1155/2015/218980. 
6. De Lepeleire, J., Bouwen, A., De Coninck, L. & Buntinx, F. (2007). Insufficient lighting in nursing homes. 
Journal of the American Medical Directors Association, 8(5), 314-317.
7. Figueiro, M. G. (2017). Light, sleep and circadian rhythms in older adults with Alzheimer's 
disease and related dementias. Neurodegenerative Disease Management, 7(2), 119-145.
8. Figueiro, M. G., Gonzales, K., & Pedler, D. (2016). Designing with circadian stimulus. LD+A, 8, 
30-34.
9. Figueiro, M. G. (2020). Future directions for lighting environments. In Circadian Rhythm Sleep-
Wake Disorders (pp. 221-240). Springer, Cham.
10. Figueiro, M. G., Hunter, C. M., Higgins, P. A., Hornick, T. R., Jones, G. E., Plitnick, B., Brons, J., 
& Rea, M. S. (2015). Tailored lighting intervention for persons with dementia and caregivers 
living at home. Sleep Health, 1(4), 322-330. doi: 10.1016/j.sleh.2015.09.003.
11. Figueiro, M. G., Nagare, R., & Price, L. L. A. (2018). Non-visual effects of light: How to use 
light to promote circadian entrainment and elicit alertness. Lighting Research & 
Technology, 50(1), 38-62.
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12. Figueiro, M. G., Plitnick, B. A., Lok, A., Jones, G. E., Higgins, P., Hornick, T. R., & Rea, M. S. 
(2014). Tailored lighting intervention improves measures of sleep, depression, and agitation 
in persons with Alzheimer’s disease and related dementia living in long-term care 
facilities. Clinical Interventions in Aging, 9, 1527-1537. doi: 10.2147/CIA.S68557.
13. Figueiro. M. G., Plitnick, B., Roohan. C., Sahin, L., Kalsher, M., & Rea, M. S. (2019). Effects of 
a tailored lighting intervention on sleep quality, rest-activity, mood, and behavior in older 
adults with Alzheimer disease and related dementias: a randomized clinical trial. Journal of 
Clinical Sleep Medicine, 15(12), 1757-1767. doi: 10.5664/jcsm.8078.
14. Figueiro, M.G., Page, E., & Rea, M. (2020). Measuring dose in a tailored lighting intervention 
to improve sleep and mood in Alzheimer’s disease patients. The Journal of the Alzheimer’s 
Association, 16(Suppl.7). https://doi.org/10.1002/alz.037168
15. Figueiro, M. G., Steverson, B., Heerwagen, J., Kampschroer, K., Hunter, C. M., Gonzales, K., 
Plitnick, B., & Rea, M. S. (2017). The impact of daytime light exposures on sleep and mood in 
office workers. Sleep Health, 3(3), 204-215. 
16. Figueiro, M. G., Sahina, L., Kalsherb, M., Plitnicka, B., & Rea, M. S. (2020). Long-term, all-day 
exposure to circadian-effective light improves sleep, mood, and behavior in persons with 
dementia. Journal of Alzheimer’s Disease Reports, 4, 297-312. doi 10.3233/ADR-200212.
17. Hanford, N., & Figueiro, M. (2013). Light therapy and Alzheimer’s disease and related 
dementia: Past, present and future. Journal of Alzheimer’s Disease, 33(4), 913-922.
18. Hickman, S. E., Barrick, A. L., Williams, C. S., Zimmerman, S., Connell, B. R., Preisser, J. S., 
Mitchell, M., & Sloane, P. D. (2007). The effect of ambient bright light therapy on depressive 
symptoms in persons with dementia. The American Geriatrics Society, 55, 1817-1824. doi: 
10.1111/j.1532-5415.2007.01428. x.
19. Illuminating Engineering Society of North America. (2020). Recommended practice: Lighting 
hospital and healthcare facilities. Illuminating Engineering Society.
20. Konis, K., Mack, W. J., & Schneider, E. L. (2018). Pilot study to examine the effects of indoor 
daylight exposure on depression and other neuropsychiatric symptoms in people living with 
dementia in long-term care communities. Clinical Interventions in Aging, 13, 1071-1077.
21. Ringman, J. M., & Schneider, L. (2019). Treatment options for agitation in dementia. Current 
Treatment Options for Neurology, 21(30), 1-14. 
22. Mitolo, M., Tonon, C., Morgia, X. L., Testa, C., Caelli, V., & Lodi, R. (2018). Effects of light 
treatment on sleep, cognition, mood and behavior in Alzheimer’s disease: A systematic 
review. Dementia and Geriatric Cognitive Disorders, 46(5-6), 371-384.
23. Missotten, P., Faraq, L., Delve, S., Muller, A., Gortz, C., & Adam, S. (2019). Role of “light 
therapy” among older adults with dementia: An overview and future perspectives. Geriatric 
Psychology Neuropsychiatric De Vieillissement, 17(1), 83-91.
24. Jao, Y.-L., Wang, J., Liao, Y-J, Parajuli, J., Berish, D., Boltz, M., Van Haitsma, K., Wang, N., 
McNally, L., & Calkin, M. (2022). Effect of Ambient Bright Light on Behavioral and 
Psychological Symptoms in People with Dementia: A Systematic Review. Innovation in 
Aging, 6 (3), 10.1093/geroni/igac018
25. Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., Boynton, M. H., 
& Halko, H. (2017). Psychometric assessment of three newly developed implementation 
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outcome measures. Implementation Science: IS, 12(1), 108-108. doi: 10.1186/s13012-017-
0635-3
26. Wahnschaffe, A., Nowozin, C., Haedel, S., Rath, A., Appelhoff, S., Münch, M., & Kunz, D. 
(2017). Implementation of dynamic lighting in a nursing home: Impact on agitation but not 
on rest-activity patterns. Current Alzheimer Research, 14, 1076-1083. Doi:  
10.2174/1567205014666170608092411.
27. Werner, O., & Myrta, G-M. (2020). IEA SHC Task 61/EBC Annex 77 Integrated solutions for 
daylighting and electric lighting-Subtask Wearable Light Sensors in Case Study Evaluations. 
ISES Conference
Van Hoof, J., Schoutens, A. M. C., & Aarts, M. P. J. (2009). High colour temperature lighting for institutionalized older people 
with dementia. Building and Environment, 44, 1969-1969. doi: 10.1016/j.buildenv.2009.01.009.
22.0
Confidentiality, Privacy and Data Management 
IMPORTANT: The following section is required for all locations EXCEPT Penn State Health and the College of 
Medicine. Penn State Health and College of Medicine should skip this section and complete “HRP-598 
Research Data Plan Review Form.” In order to avoid redundancy, for this section state “See the Research Data 
Plan Review Form” if you are conducting Penn State Health research. Delete all other sub-sections of section 
22.
For research being conducted at Penn State Health or by Penn State Health researchers only: The research 
data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form Application 
Supplement.”  
In order to avoid redundancy, for this section state “See the Research Data Plan Review Form” if you are 
conducting Penn State Health research. Delete all sub-sections of section 22. 
For all other research: Complete the following section.  Please refer to PSU Policy AD95 for information 
regarding information classification and security standards and requirements. It is recommended that you work 
with local IT staff when planning to store, process, or access data electronically to ensure that your plan can be 
carried out locally and meets applicable requirements. If you have questions about Penn State’s Policy AD95 or 
standards or need a consultation regarding data security, please contact Penn State IT – Information Security at 
security@psu.edu. 
22.1
Which of the following identifiers will be recorded for the research project? Check all that apply. If none of 
the following identifiers will be recorded, do not check any of the boxes.
Hard 
Copy 
Data
Electronic 
Stored 
Data 
Names and/or initials (including on signed consent documents)
 
All geographic subdivisions smaller than a State, including street address, city, county, 
precinct, zip code, and their equivalent geocodes,
 
All elements of dates (except year) for dates directly related to an individual, including 
birth date, admission date, discharge date, date of death; and all ages over 89 and all 
elements of dates (including year) indicative of such age, except that such ages and 
elements may be aggregated into a single category of age 90 or older
 
Telephone numbers
 
Fax numbers
 
Electronic mail addresses
 
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S oci al s ec urit y  n u m b ers
 
M e dic al r ec or d  n u m b ers
 
H e alt h pl a n b e n efici ar y  n u m b ers
 
Acc o u nt n u m b ers
 
C ertific at e/lic e ns e n u m b ers
 
V e hicl e i d e ntifi ers a n d  s eri al n u m b ers, i ncl u di n g lic e ns e pl at e n u m b ers
 
D evic e i d e ntifi ers a n d s eri al  n u m b ers
 
W e b U ni v ers al  R es o urc e L oc at ors ( U RLs)
 
I nt er n et Pr ot oc ol (I P) a d dr ess n u m b ers
 
Bi o m etric i d e ntifi ers,  i ncl u di n g fi n g er a n d v oic e pri nts
 
F ull f ac e  p h ot o gr a p hic i m a g es a n d a n y c o m p ar a bl e i m a g es
 
A n y ot h er  u ni q u e i d e ntif yi n g n u m b er, c h ar act eristic, or c o d e (s uc h as t h e p at h ol o g y 
n u m b er)
 
St u d y c o d e n u m b er  wit h li n ki n g list
 
G e n o mic s e q u e nc e  d at a
St at e I D  n u m b ers
P ass p ort n u m b ers
Dri v er’s lic e ns e  n u m b ers
2 2. 2 
If st ori n g  p a p er r ec or ds of r es e arc h d at a, a ns w er t h e f oll o wi n g q u esti o ns:
2 2. 2. 1 W h er e  will t h e p a p er r ec or ds, i ncl u di n g c o pi es of si g n e d c o ns e nt f or ms, ass oci at e d wit h 
t his r es e arc h st u d y will b e st or e d ?
All h ar dc o p y  d oc u m e nts wit h i d e ntifi a bl e i nf or m ati o n will b e st or e d i n l oc k e d, 
s ec ur e c a bi n ets t o w hic h o nl y I R B- a p pr ov e d r es e arc h t e a m m e m b ers will h av e 
acc ess. T h e l oc ati o n of t h e c a bi n et is i n PI J a o’s offic e.
2 2. 2. 2 H o w  will t h e p a p er r ec or ds b e s ec ur e d ? 
All h ar dc o p y  d oc u m e nts wit h i d e ntifi a bl e i nf or m ati o n will b e st or e d i n l oc k e d, 
s ec ur e c a bi n ets t o w hic h o nl y I R B- a p pr ov e d r es e arc h t e a m m e m b ers will h av e 
acc ess.
2 2. 2. 3 H o w  will acc ess t o t h e p a p er r ec or ds b e r estrict e d t o a ut h oriz e d pr oj ect p ers o n n el ?
All h ar dc o p y  d oc u m e nts wit h i d e ntifi a bl e i nf or m ati o n will b e st or e d i n l oc k e d, 
s ec ur e c a bi n ets t o w hic h o nl y I R B- a p pr ov e d r es e arc h t e a m m e m b ers will h av e 
acc ess t o t h e k e y t o u nl oc k t h e c a bi n ets.
2 2. 3 
If st ori n g  el ectr o nic r ec or ds of r es e arc h d at a, i n dic at e w h er e t h e el ectr o nic d at a ass oci at e d wit h t his 
r es e arc h st u d y will b e st or e d. C h ec k all t h at a p pl y.       
 P e n n St at e- pr ovi d e d d at a b as e a p plic ati o n.  C h ec k w hic h of t h e f oll o wi n g d at a b as e a p plic ati o ns ar e 
b ei n g us e d (c h ec k all t h at a p pl y):
  P e n n St at e R E D C a p  
  Ot h er – S p ecif y - pr o vi d e d a n d a p pr ov e d d at a b as e a p plic ati o n: 
[ T y p e pr ot oc ol t ext h er e if b ox c h ec k e d]
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  Penn State, College, or Department IT file server 
  Penn State OneDrive or SharePoint      
  Penn State GoogleDrive
  Web-based system provided by the sponsor or cooperative group - Specify URL and contact 
information: 
[Type protocol text here if box checked]
       
  Other – Specify the database application or server:
[Type protocol text here if box checked]
Provide details about the data security features or attach security documentation provided by 
sponsor or group:
[Type protocol text here if box checked]
Please visit datastoragefinder.psu.edu for assistance with identifying appropriate data storage 
options. If the software to be used does not appear on that site, a software request form must be 
completed. 
If there is a list/key that links indirect identifiers (code numbers, participant IDs, etc.) to direct identifiers, that list 
must not be comingled (i.e., stored in the same location) as the identifiable data, including copies of signed 
informed consent forms. Additionally, access to that list/key must be restricted to authorized project personnel.
22.4
Is there a list/key that links code numbers to identifiers? 
  Yes - explain how the list that links the code to identifiers is stored separately from coded data:
1. The hardcopy list will be stored in a locked, secure cabinet, separate from other hard 
copy documents. Only the PI and PI designated team members will have access to 
the list. The cabinet is located in PI Jao’s office.
The electronic file will be stored electronically in a secure research drive at Penn State 
(e.g., OneDrive). The file will be stored in a password-protected folder separate from the 
folder for other research data. Only the PI and PI designated team members will have 
access to the list.
 Not applicable, there is no list that links code numbers to identifiers. Skip to section 22.6.
22.5
Is there a list of people who have access to the list/key?
  Yes – explain how access to that list is restricted and why certain persons require access.
[Type protocol text here if box checked]
  No – explain why not:
[Type protocol text here if box checked]
22.6
Describe the mechanism in place to ensure only approved research personnel have access to the 
stored research data (electronic and paper).
  Password-protected files
  Role-based security 
  Specify all other mechanisms used to ensure only permitted users have access to the stored 
research data.
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T h e h ar dc o py d oc u m e nts will b e st or e d i n a l ock e d, s ec ur e d c a bi n et. F or el ectr o nic fil es, o nly 
r es e arc h t e a m m e m b ers will b e gr a nt e d acc ess t o t h e fil es. T h e  c a bi n et is l oc at e d i n PI J a o’s 
offic e .
T h e us e  of m o bil e d evic es or wir el ess activit y tr ac k ers t o c oll ect i d e ntifi a bl e r es e arc h d at a m a y h av e t o b e a p pr o v e d b y 
P e n n St at e I T - I nf or m ati o n S ec urit y. 
2 2. 7  
Will r es e arc h d at a  b e c oll ect e d a n d/ or st or e d o n a wir el ess acti vit y tr ac k er or m o bil e a p plic ati o n or 
will t h e st u d y t e a m e nt er r es e arc h d at a o n a m o bil e d e vic e, s uc h as a n el ectr o nic t a bl et or c ell p h o n e ? 
 N o – s ki p t o 2 2. 8
 Y es - a ns w er t h e f oll o wi n g q u esti o ns:
2 2. 7. 1 S p ecif y t h e  pr o vi d er of t h e tr ac k er or m o bil e d e vic es(s)/ a p plic ati o n
 S u p pli e d b y t h e s p o ns or
 P e n n St at e o w n e d d evic e
 A p ers o n al d evic e
 Ot h er – Pl e as e s p ecif y s o urc e: [ T y p e pr ot oc ol t ext h er e if b ox is c h ec k e d]
2 2. 7. 2 S p ecif y t h e  t y p e(s) of tr ac k er or m o bil e d e vic e(s)/ a p plic ati o n t h at will b e us e d t o c a pt ur e 
d at a a n d all i d e ntifi ers c a pt ur e d o n t h e m o bil e d e vic e(s)/ a p plic ati o n. Pl e as e list all 
d e vic es, a n d if m or e t h a n o n e, t h e i d e ntifi ers t o b e c oll ect e d o n e ac h.
[ T y p e pr ot oc ol t ext h er e]
2 2. 7. 3 S p ecif y t h e  t y p e of d at a c oll ect e d o n t h e tr ac k er or m o bil e d e vic es(s)/ a p plic ati o n. 
[ T y p e pr ot oc ol t ext h er e]
2 2. 7. 4 S p ecif y t h e  a p plic ati o n or w e bsit e us e d t o c oll ect t h e d at a fr o m t h e tr ac k er or m o bil e 
d e vic e, if a p plic a bl e.
[ T y p e pr ot oc ol t ext h er e]
2 2. 7. 5 D escri b e  t h e m e as ur es t a k e n t o pr ot ect t h e c o nfi d e nti alit y of t h e d at a c oll ect e d o n t h e 
tr ac k er or m o bil e d e vic e(s)/ a p plic ati o n. Pl e as e a d dr ess p h ysic al s ec urit y of t h e d e vic e(s), 
el ectr o nic s ec urit y, a n d s ec ur e tr a nsf er of d at a fr o m d e vic e(s) t o t h e pr e vi o usl y i n dic at e d 
d at a/fil e st or a g e l oc ati o n pr o vi d e d i n s ecti o n 2 2. 3 .
[ T y p e pr ot oc ol t ext h er e]
T h e us e  of o nli n e s urv e y t o ols a n d e m ail t o c oll ect or s e n d r es e arc h d at a c o nt ai ni n g i d e ntifi ers t h at r e pr es e nt m or e 
t h a n mi ni m al ris k t o s u bj ects m a y h av e t o b e a p pr ov e d b y P e n n St at e I T - I nf or m ati o n S ec urit y. 
2 2. 8  
Will a n y r es e arc h d at a  b e dir ectl y e nt er e d/s e nt b y s u bj ects o v er t h e i nt er n et or vi a e m ail ( e. g., d at a 
c a pt ur e usi n g o n-li n e s ur v e ys/ q u esti o n n air es, s ur v e ys vi a e m ail, o bs er v ati o n of c h at r o o ms or bl o gs) ?
 N o – s ki p t o 2 2. 9
 Y es - a ns w er t h e f oll o wi n g q u esti o ns:
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2 2. 8. 1 S p ecif y t h e  i d e ntifi ers c oll ect e d o v er t h e i nt er n et or vi a e m ail (I ncl u di n g I P a d dr ess es if I P 
a d dr ess es will b e c oll ect e d).
 [ T y p e pr ot oc ol t ext h er e]
2 2. 8. 2 S p ecif y t h e  t y p e of d at a c oll ect e d o v er t h e i nt er n et or vi a e m ail.
 [ T y p e pr ot oc ol t ext h er e]
2 2. 8. 3 D escri b e  t h e m e as ur es t a k e n t o pr ot ect t h e c o nfi d e nti alit y of t h e d at a c oll ect e d ?
 [ T y p e pr ot oc ol t ext h er e]
2 2. 8. 4 D escri b e  h o w t h e r es e arc h t e a m will acc ess t h e d at a o nc e d at a c oll ecti o n is c o m pl et e.
 [ T y p e pr ot oc ol t ext h er e]
2 2. 8. 5 If t h e r es e arc h i n v ol v es o nli n e s ur v e ys, list t h e n a m e(s) of t h e s er vic e pr o vi d er(s) t h at will 
b e us e d f or t h e s ur v e y(s) ( e. g., R E D C a p, P e n n St at e lic e ns e d Q u altrics, S ur v e y M o n k e y, 
Z o o m er a n g) ? ( N ot e: T h e I R B str o n gl y r ec o m m e n ds t h e us e of R E D C a p f or o nli n e s ur v e ys 
t h at o bt ai n s e nsiti v e i d e ntifi a bl e h u m a n s u bj ects d at a.)
 P e n n St at e R E D C a p
 P e n n St at e Q u altrics 
 P e n n St at e Micr os oft F or ms
 P e n n  St at e G o o gl e F or ms
 Ot h er - Pl e as e s p ecif y:
A p plic ati o n: [ T y p e pr ot oc ol  t ext h er e]
U RL (If a p plic a bl e):  [ T y p e pr ot oc ol t ext h er e]
2 2. 8. 6 If t h e a ns w er a b o v e is “ Ot h er” c o nt act s ec urit y @ ps u. e d u f or a p pr o v al of a n alt er n ati v e 
d at a c a pt ur e  m et h o d
[ T y p e pr ot oc ol t ext h er e]
D e p e n di n g o n  t h e n at ur e of t h e s u bj ect m att er i nv olv e d, c ert ai n s ec urit y r e q uir e m e nts m ust b e i n pl ac e f or t h e a u di o 
a n d/ or vi d e o r ec or di n g or p h ot o gr a p hi n g of s u bj ects. If t h e s u bj ect m att er pr es e nts m or e t h a n mi ni m al ris k t o t h e 
s u bj ects, t h e n, b ef or e c o m pl eti n g t h e s ecti o n b el o w, pl e as e c o nt act P e n n St at e I T - I nf or m ati o n S ec urit y at 
s ec urit y @ ps u. e d u t o c o nfir m w h et h er t h es e r e q uir e m e nts ar e r e q uir e d.
2 2. 9  
Will a n y t y p e of  r ec or di n gs ( e. g., a u di o or vi d e o) or p h ot o gr a p hs of t h e s u bj ects b e m a d e d uri n g t his 
st u d y ?
 N o - s ki p t o s ecti o n 2 2. 1 0
 Y es - a ns w er t h e f oll o wi n g q u esti o ns:
2 2. 9. 1 W h at will  b e us e d t o c a pt ur e t h e a u di o/ vi d e o/i m a g es ? Gi v e a bri ef d escri pti o n of c o nt e nt.
 A u di o – D escri b e t h e i nt e n d e d c o nt e nt of t h e a u di o r ec or di n g:
W e will c o n d uct q u alit ativ e i nt ervi e ws wit h t h e st aff a n d a d mi nistr at ors wit h o p e n-
e n d e d q u esti o ns a b o ut t h e f e asi bility of i m pl e m e nti n g a n d m ai nt ai ni n g t h e S A BL 
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li g hti n g i nt erv e nti o n. A h a n d h el d a u di o r ec or d er will b e us e d t o r ec or d t h e i nt ervi e w is 
i n- p ers o n. Z o o m a u di o r ec or di n g will b e utiliz e d if t h e i nt ervi e w is c o n d uct e d o nli n e.
 Vi d e o – D escri b e t h e i nt e n d e d c o nt e nt of t h e vi d e o r ec or di n g:
[ T y p e pr ot oc ol t ext h er e]
 P h ot o gr a p hs of t h e s u bj ects – D escri b e t h e i nt e n d e d c o nt e nt of t h e  p h ot o gr a p hs:
[ T y p e pr ot oc ol t ext h er e]
 3- D I m a g es – D escri b e t h e i nt e n d e d c o nt e nt of t h e of 3- D i m a g es:
[ T y p e pr ot oc ol t ext h er e] 
 Ot h er - S p ecif y: 
[ T y p e pr ot oc ol t ext h er e]
2 2. 9. 2 H o w  will t h e r ec or di n gs/ p h ot o gr a p hs/i m a g es b e st or e d ( el ectr o nic all y or p h ysic all y) ?
T h e a u di o  r ec or di n gs a n d tr a nscri pti o ns of t h e r ec or di n gs will b e st or e d 
el ectr o nic all y.
2 2. 9. 3 W h er e  will t h e r ec or di n gs/ p h ot o gr a p hs/i m a g es b e st or e d ?
T h e a u di o  r ec or di n gs a n d tr a nscri pti o ns of t h e r ec or di n gs will b e st or e d 
el ectr o nic all y i n P e n n St at e O n e Driv e.
2 2. 9. 4 W h o  will h a v e acc ess t o t h e r ec or di n gs/ p h ot o gr a p hs/i m a g es ?
O nl y I R B- a p pr o v e d  r es e arc h t e a m m e m b ers will h av e acc ess t o t h e a u di o r ec or di n gs 
a n d tr a nscri pti o ns.
2 2. 9. 5 Will a n y of  t h e r ec or di n gs b e tr a nscri b e d ?
 N ot a p plic a bl e
 N o
 Y es – i n dic at e w h o will b e d oi n g t h e tr a nscri bi n g ? 
I R B- a p pr o v e d r es e arc h t e a m m e m b ers will tr a nscri b e t h e a u di o r er ec or di n g
2 2. 9. 6 Will t h e  r ec or di n gs/ p h ot o gr a p hs b e us e d f or p ur p os es ot h er t h a n t his r es e arc h st u d y ?
 N o
 Y es - s p ecif y p ur p os e(s) ( e. g., p u blic ati o n, pr es e nt ati o ns, e d uc ati o n al tr ai ni n g, f ut ur e
 u n d et er mi n e d r es e arc h):
T h e tr a nscri pti o ns will b e us e d f or p u blic ati o ns, pr es e nt ati o ns, e d uc ati o n al tr ai ni n gs, 
a n d f ut ur e u n d er mi n e d r es e arc h
2 2. 1 0
C ertific at e of C o nfi d e nti alit y ( C O C)  - Is t h e r es e arc h bi o m e dic al, b e h a vi or al, cli nic al or ot h er r es e arc h 
t h at is f u n d e d b y t h e N ati o n al I nstit ut es of H e alt h ( NI H) ?
 Y es - c h ec k o n e of t h e f oll o wi n g: 
  T h e r es e arc h i nv olv es h u m a n s u bj ects as d efi n e d b y t h e D H H S r e g ul ati o ns ( S e e W or ks h e et 
H R P- 3 1 0).
  T h e r es e arc h i nv olv es c oll ecti n g or usi n g bi os p eci m e ns t h at ar e i d e ntifi a bl e t o a n i n di vi d u al.
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DO NOT ALTER OR DELETE
  If collecting or using biospecimens as part of the research, there is a small risk that some 
combination of the biospecimen, a request for the biospecimen, and other available data 
sources could be used to deduce the identity of an individual.
  The research involves the generation of individual level, human genomic data.
Note: If any of the 4 items above are checked, a COC is automatically issued by NIH and 
applies to the research. Information about the COC must be included in the consent form.
 No - answer the following question.
If the research is not funded by NIH, will the investigator apply for a COC for this research study? 
 No
 Yes
Note: For research not funded by NIH, the IRB may require a COC if the research is collecting 
personally identifiable information and the information is sensitive and/or the research is 
collecting information that if disclosed could significantly harm or damage the subject. 
22.11
What steps will be taken to protect subjects’ privacy interests? (Check all that apply.)
  Identification and recruitment of potential subjects follows procedures consistent with privacy 
standards
  Consent discussion and research interventions will take place in a private setting
  Limiting the information being collected to only the minimum amount of data necessary to 
accomplish the research purposes 
  Limiting the people with access to the identifiable research data to the minimum necessary as 
specified in the application and consent process
  Other – Specify: 
[Type protocol text here]
22.12
What is the process for ensuring correctness of data entry?
  Double data entry to reduce risk of errors
  Electronic edit checks to ensure data being entered are not obviously incorrect
  Random internal quality and assurance checking of research data
  Direct entry by subjects
  Other - Specify: 
[Type protocol text here]
22.13
Does this research involve the generation of large-scale human genomic data as defined in NIH 
Genomic Data Sharing Policy (http://gds.nih.gov)?
  No
  Yes – describe the plan for de-identifying the dataset before sharing it with NIH-designated data 
repositories. 
[Type protocol text here]
Note: Data sharing with an NIH-designated data repository may require execution of an institutional 
certificate. Please review the ‘Institutional Certification for NIH Genomic Data Sharing’ section of the 
Investigator’s Manual for information about seeking institutional certification.
STUDY00020216
Approval: 4/24/2023

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DO NOT ALTER OR DELETE
22.14
Does this research involve data sharing to public/restricted data repositories or as part of a journal 
requirement?
Data sharing is an important part of rigorous scientific discovery and the validation of results.  Planning for data 
sharing is strongly recommended.  
Data sharing includes sharing of identifiable, coded, or de-identified data.  The data can be shared with public or 
restricted data repositories.  Increasingly, journals require the sharing of data as a stipulation for publication.  
NIH-funded studies require data sharing, unless explicitly granted an exception from the NIH.  
  Yes (may be required for publication and future grant submission)
  No 
22.15
Does this research involve transfer or disclosure of data and/or specimens to and/or from Penn State?
  No - skip the rest of section 22.14
  Yes - answer the following questions:
Check all that apply:
22.15.1  
 Data are being transferred or disclosed to Penn State 
What is the name of the third party(ies) (the institution, sponsor, etc.) sending or 
providing the data?
Christ the King Manor  and Centre Care.
We will obtain the permission from each clinical site to access the medical records.
Is the third party requiring us to sign a contract regarding the data? 
22.15.1.1  
 Yes - this contract must go through the Office of Sponsored Programs 
https://www.research.psu.edu/osp/overview-pages/data-use-agreements
22.15.1.2  
 No
22.15.2  
 Data are being transferred or disclosed from Penn State 
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) receiving or 
accessing the data?
[Type protocol text here]
Note: Data transfers or disclosures may require a Data Use Agreement (DUA).
22.15.3  
 Specimens are being transferred to Penn State 
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) sending the 
specimens?
[Type protocol text here]
22.15.4  
 Specimens are being transferred from Penn State 
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) receiving the 
specimens? 
[Type protocol text here]
STUDY00020216
Approval: 4/24/2023

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D O N O T  AL T E R O R D EL E T E
N ot e: All m at eri al tr a nsf ers,  eit h er s e n di n g or r ec ei vi n g, r e q uir e a M at eri al Tr a nsf er A gr e e m e nt 
( M T A).  Pl e as e c o nt act t h e Offic e of T ec h n ol o g y M a n a g e m e nt f or m or e i nf or m ati o n. 
2 2. 1 5. 5
 D escri b e h o w t h e d at a/s p eci m e ns will b e s ec ur el y tr a nsf err e d or discl os e d 
t o/fr o m t h e t hir d p art y(i es).
D at a extr acti o n fr o m m e dic al r ec or ds will b e c o n d uct e d i n t h e f oll o wi n g t w o w ays. T h e 
f acility m ay pr ovi d e us a l o gi n t o t h eir s ec ur e s erv er t o acc ess p ot e nti al r esi d e nt 
p artici p a nts’ m e dic al r ec or ds, a n d/ or pr ovi d e r esi d e nts’ h ar d c o pi es of t h e m e dic al 
r ec or ds f or t h e r es e arc h t e a m t o extr act t h e d at a. D at a extr act e d fr o m t h e m e dic al 
r ec or d will b e e nt er e d a n d st or e d i n R E D C a p a n d/ or O n e Driv e.
2 2. 1 5. 6
 H o w ar e t h e r es e arc h d at a/s p eci m e ns b ei n g tr a nsf err e d fr o m a n d/ or s e nt t o 
t h e t hir d p art y(i es) ? C o m pl et e t h e a p pr o pri at e s ecti o n(s) a n d c h ec k all t h at a p pl y wit hi n 
e ac h c o m pl et e d s ecti o n.
2 2. 1 5 . 6. 1 D at a  b ei n g tr a nsf err e d or discl os e d  t o P e n n St at e :
  D at a ar e b ei n g r ec eiv e d i n a g gr e g at e/ m etrics (j ust c o u nts, n o i n di vi d u al 
d at a)
  D e-i d e ntifi e d i n divi d u al d at a ar e b ei n g r ec eiv e d a n d t h er e is n o li n ki n g 
list at eit h er i nstit uti o n ( n o i d e ntifi ers, or li n ks t o i d e ntifi ers, s uc h as c o d e 
n u m b ers)
  C o d e d r es e arc h d at a wit h o ut a n y i d e ntifi ers ar e b ei n g r ec ei v e d a n d t h e 
li n ki n g list r e m ai ns wit h t h e e ntit y s e n di n g t h e d at a; t h e r eci pi e nt of t h e 
d at a will n ot h av e acc ess t o t h e li n ki n g list
  C o d e d r es e arc h d at a wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e 
i d e ntifi ers list e d i n s ecti o n 2 2. 1 4. 7 asi d e fr o m St u d y C o d e) ar e b ei n g 
r ec eiv e d a n d t h e li n ki n g list r e m ai ns wit h t h e e ntit y s e n di n g t h e d at a; t h e 
r eci pi e nt of t h e d at a will n ot h av e acc ess t o t h e li n ki n g list 
  D at a wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e i d e ntifi ers list e d i n 
s ecti o n 2 2. 1 4. 7) ar e b ei n g r ec eiv e d a n d t h e li n ki n g list r e m ai ns wit h t h e 
e ntit y s e n di n g t h e d at a; t h e r eci pi e nt of t h e d at a will h av e acc ess t o t h e 
li n ki n g list 
  D at a wit h i d e ntifi ers al o n g wit h t h e li n ki n g list ar e b ei n g r ec ei v e d 
  Ot h er – S p ecif y: 
[ T y p e pr ot oc ol t ext h er e]
2 2. 1 5 . 6. 2 D at a  b ei n g tr a nsf err e d or discl os e d  fr o m P e n n St at e :
  D at a ar e b ei n g s e nt i n a g gr e g at e/ m etrics (j ust c o u nts, n o i n di vi d u al d at a)
  D e-i d e ntifi e d i n divi d u al d at a ar e b ei n g s e nt a n d t h er e is n o li n ki n g list at 
eit h er i nstit uti o n ( n o i d e ntifi ers, or li n ks t o i d e ntifi ers, s uc h as c o d e 
n u m b ers)
  C o d e d r es e arc h d at a wit h o ut a n y i d e ntifi ers ar e b ei n g s e nt a n d t h e li n ki n g 
list r e m ai ns wit h t h e e ntit y s e n di n g t h e d at a; t h e r eci pi e nt of t h e d at a will 
n ot h av e acc ess  t o t h e li n ki n g list
  C o d e d r es e arc h d at a wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e 
i d e ntifi ers list e d i n s ecti o n 2 2. 1 4. 7 asi d e fr o m St u d y C o d e) ar e b ei n g s e nt 
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D O N O T  AL T E R O R D EL E T E
a n d t h e  li n ki n g list r e m ai ns wit h t h e e ntit y s e n di n g t h e d at a; t h e r eci pi e nt 
of t h e d at a will n ot h av e acc ess t o t h e li n ki n g list 
  D at a wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e i d e ntifi ers list e d i n 
s ecti o n 2 2. 1 4. 7) ar e b ei n g s e nt a n d t h e li n ki n g list r e m ai ns wit h t h e e ntit y 
s e n di n g t h e d at a; t h e r eci pi e nt of t h e d at a will h av e acc ess t o t h e li n ki n g 
list 
  D at a wit h i d e ntifi ers al o n g wit h t h e li n ki n g list ar e b ei n g s e nt
  Ot h er – S p ecif y: 
[ T y p e pr ot oc ol t ext h er e]
2 2. 1 5 . 6. 3 S p eci m e ns  b ei n g tr a nsf err e d or discl os e d  t o P e n n St at e :
  D e-i d e ntifi e d s p eci m e ns ar e b ei n g r ec eiv e d a n d t h er e is n o li n ki n g list at 
eit h er i nstit uti o n ( n o i d e ntifi ers, or li n ks t o i d e ntifi ers, s uc h as c o d e 
n u m b ers)
  C o d e d s p eci m e ns wit h o ut a n y i d e ntifi ers ar e b ei n g r ec eiv e d a n d t h e 
li n ki n g list r e m ai ns wit h t h e e ntit y s e n di n g t h e s p eci m e ns; t h e r eci pi e nt 
of t h e s p eci m e ns will n ot h av e acc ess t o t h e li n ki n g list
  C o d e d s p eci m e ns wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e 
i d e ntifi ers list e d i n s ecti o n 2 2. 1 4. 7 asi d e fr o m St u d y C o d e) ar e b ei n g 
r ec eiv e d a n d t h e li n ki n g list r e m ai ns wit h t h e e ntit y s e n di n g t h e 
s p eci m e ns; t h e r eci pi e nt of t h e s p eci m e ns will n ot h av e acc ess t o t h e 
li n ki n g list 
  C o d e d s p eci m e ns wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e 
i d e ntifi ers list e d i n s ecti o n 2 2. 1 4. 7) ar e b ei n g r ec eiv e d a n d t h e li n ki n g list 
r e m ai ns wit h t h e e ntit y s e n di n g t h e s p eci m e ns; t h e r eci pi e nt of t h e 
s p eci m e ns will h av e acc ess t o t h e li n ki n g list 
  C o d e d s p eci m e ns wit h i d e ntifi ers al o n g wit h t h e li n ki n g list ar e b ei n g 
r ec eiv e d 
  Ot h er – S p ecif y: 
[ T y p e pr ot oc ol t ext h er e]
2 2. 1 5 . 6. 4 S p eci m e ns  b ei n g tr a nsf err e d or discl os e d  fr o m P e n n St at e :
  D e-i d e ntifi e d s p eci m e ns ar e b ei n g s e nt a n d t h er e is n o li n ki n g list at 
eit h er i nstit uti o n ( n o i d e ntifi ers, or li n ks t o i d e ntifi ers, s uc h as c o d e 
n u m b ers)
  C o d e d s p eci m e ns wit h o ut a n y i d e ntifi ers ar e b ei n g s e nt a n d t h e li n ki n g 
list r e m ai ns wit h t h e e ntit y s e n di n g t h e s p eci m e ns; t h e r eci pi e nt of t h e 
s p eci m e ns will n ot h av e acc ess t o t h e li n ki n g list
  C o d e d s p eci m e ns wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e 
i d e ntifi ers list e d i n s ecti o n 2 2. 1 4. 7 asi d e fr o m St u d y C o d e) ar e b ei n g 
s e nt a n d t h e li n ki n g list r e m ai ns wit h t h e e ntit y s e n di n g t h e s p eci m e ns; 
t h e r eci pi e nt of t h e s p eci m e ns will n ot h av e acc ess t o t h e li n ki n g list 
  C o d e d s p eci m e ns wit h i d e ntifi ers (s uc h as d at es a n d/ or a n y of t h e 
i d e ntifi ers list e d i n s ecti o n 2 2. 1 4. 7) ar e b ei n g s e nt a n d t h e li n ki n g list 
r e m ai ns wit h t h e e ntit y s e n di n g t h e s p eci m e ns; t h e r eci pi e nt of t h e 
s p eci m e ns will h av e acc ess t o t h e li n ki n g list 
  C o d e d s p eci m e ns wit h i d e ntifi ers al o n g wit h t h e li n ki n g list ar e b ei n g 
s e nt 
  Ot h er – S p ecif y: 
[ T y p e pr ot oc ol t ext h er e]
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D O N O T  AL T E R O R D EL E T E
2 2. 1 5. 7 If tr a nsf erri n g d at a/s p eci m e ns wit h i d e ntifi ers t o or fr o m P e n n St at e, w hic h of t h e f oll o wi n g i d e ntifi ers will 
b e i ncl u d e d wit h t h e d at a/s p eci m e ns ? C h ec k all t h at a p pl y:
 N a m es
 M e dic al r ec or d n u m b ers 
 I niti als
 H e alt h pl a n b e n efici ar y n u m b ers 
 Str e et a d dr ess 
 Acc o u nt n u m b ers 
 Cit y
 C ertific at e/lic e ns e n u m b ers
 Dri v er’s Lic e ns e n u m b ers
 P ass p ort n u m b ers
 St at e
 St at e I D n u m b ers
 Zi p C o d es  
 V e hicl e i d e ntifi ers a n d s eri al n u m b ers, i ncl u di n g lic e ns e pl at e 
n u m b ers 
 C o u nt y
 D evic e i d e ntifi ers a n d s eri al n u m b ers 
 G e oc o d es
 W e b U niv ers al R es o urc e L oc at ors ( U RLs)
 Pr eci ncts
 I nt er n et Pr ot oc ol (I P) a d dr ess n u m b ers
 All el e m e nts of d at es ( exc e pt y e ar) f or 
d at es dir ectl y r el at e d t o a n i n divi d u al, 
i ncl u di n g birt h d at e, a d missi o n d at e, disc h ar g e 
d at e, d at e of d e at h 
 Bi o m etric i d e ntifi ers, i ncl u di n g fi n g er a n d v oic e pri nts
 A g es > 8 9 a n d all el e m e nts of d at es 
(i ncl u di n g y e ar) i n dic ativ e of s uc h a g e, exc e pt 
t h at s uc h a g es a n d el e m e nts m a y b e 
a g gr e g at e d i nt o a si n gl e c at e g or y of a g e 9 0 or 
ol d er 
 F ull f ac e p h ot o gr a p hic i m a g es a n d a n y c o m p ar a bl e i m a g es 
 T el e p h o n e n u m b ers
 A n y ot h er u ni q u e i d e ntif yi n g n u m b er, c h ar act eristic, or c o d e 
(s uc h as t h e p at h ol o g y n u m b er)
S p ecif y: [ T y p e  pr ot oc ol t ext h er e]
 F ax n u m b ers
 St u d y c o d e n u m b ers 
 El ectr o nic m ail a d dr ess es
 M ast er list li n ki n g st u d y c o d e n u m b ers t o s u bj ect(s)
 S oci al s ec urit y n u m b ers
 G e n o mic s e q u e nc e d at a
 Ot h er – s p ecif y: [ T y p e pr ot oc ol t ext h er e if b ox is c h ec k e d]
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