Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
Phase: NA
Conditions: Healthy
Sponsor: Lehigh University

Task Switching Behavior Between Target
Templates During Visual Search in Healthy
Adults
Protocol Number*: 6 R15 EY030247-01A1
National Clinical Trial (NCT) Identified Number: NCT05786651
Principal Investigator*:Nancy Carlisle
Sponsor:Lehigh University
Grant Title: Examining Flexibility in Visual Attentional Control
Grant Number*: 1R15EY030247-01A1
Funded by: NEI
Version Number: v.1
10 May 2023

CONFIDENTIALITY STATEMENT
This document is confidential communication. Acceptance of this document constitutes agreement by
the recipient that no unpublished information contained herein will be published or disclosed without
prior approval of the Principal Investigator or other participating study leadership and as consistent with
the NIH terms of award.
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans

Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
Version1.0
Protocol 6 R15 EY030247-01A1
10 May 2023
Table of Contents
STATEMENT OF COMPLIANCE
1
INVESTIGATOR’S SIGNATURE
2
1
PROTOCOL SUMMARY
3
1.1
Synopsis
3
1.2
Schema
3
1.3
Schedule of Activities
6
2
INTRODUCTION
7
2.1
Study Rationale
7
2.2
Background
7
2.3
Risk/Benefit Assessment
7
2.3.1
Known Potential Risks
7
2.3.2
Known Potential Benefits
8
2.3.3
Assessment of Potential Risks and Benefits
8
3
OBJECTIVES AND ENDPOINTS
9
4
STUDY DESIGN
12
4.1
Overall Design
12
4.2
Scientific Rationale for Study Design
13
4.3
Justification for Intervention
13
4.4
End-of-Study Definition
13
5
STUDY POPULATION
13
5.1
Inclusion Criteria
14
5.2
Exclusion Criteria
15
5.3
Lifestyle Considerations
16
5.4
Screen Failures
16
5.5
Strategies for Recruitment and Retention
17
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
18
6.1
Study Intervention(s) or Experimental Manipulation(s) Administration
19
6.1.1
Study Intervention or Experimental Manipulation Description
19
6.1.2
Administration and/or Dosing
19
6.2
Fidelity
19
6.2.1
Interventionist Training and Tracking
19
6.3
Measures to Minimize Bias: Randomization and Blinding
20
6.4
Study Intervention/Experimental Manipulation Adherence
21
6.5
Concomitant Therapy
21
6.5.1
Rescue Therapy
22
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
22
7.1
Discontinuation of Study Intervention/Experimental Manipulation
23
7.2
Participant Discontinuation/Withdrawal from the Study
23
7.3
Lost to Follow-Up
24
8
STUDY ASSESSMENTS AND PROCEDURES
25
8.1
Endpoint and Other Non-Safety Assessments
25
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Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
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8.2
Safety Assessments
27
8.3
Adverse Events and Serious Adverse Events
28
8.3.1
Definition of Adverse Events
28
8.3.2
Definition of Serious Adverse Events
29
8.3.3
Classification of an Adverse Event
29
8.3.4
Time Period and Frequency for Event Assessment and Follow-Up
31
8.3.5
Adverse Event Reporting
33
8.3.6
Serious Adverse Event Reporting
33
8.3.7
Reporting Events to Participants
34
8.3.8
Events of Special Interest
34
8.3.9
Reporting of Pregnancy
34
8.4
Unanticipated Problems
35
8.4.1
Definition of Unanticipated Problems
35
8.4.2
Unanticipated Problems Reporting
36
8.4.3
Reporting Unanticipated Problems to Participants
37
9
STATISTICAL CONSIDERATIONS
37
9.1
Statistical Hypotheses
37
9.2
Sample Size Determination
38
9.3
Populations for Analyses
39
9.4
Statistical Analyses
39
9.4.1
General Approach
40
9.4.2
Analysis of the Primary Endpoint(s)
40
9.4.3
Analysis of the Secondary Endpoint(s)
41
9.4.4
Safety Analyses
42
9.4.5
Baseline Descriptive Statistics
42
9.4.6
Planned Interim Analyses
42
9.4.7
Sub-Group Analyses
43
9.4.8
Tabulation of Individual Participant Data
43
9.4.9
Exploratory Analyses
44
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
44
10.1
Regulatory, Ethical, and Study Oversight Considerations
44
10.1.1
Informed Consent Process
44
10.1.2
Study Discontinuation and Closure
45
10.1.3
Confidentiality and Privacy
46
10.1.4
Future Use of Stored Specimens and Data
48
10.1.5
Key Roles and Study Governance
49
10.1.6
Safety Oversight
50
10.1.7
Clinical Monitoring
50
10.1.8
Quality Assurance and Quality Control
52
10.1.9
Data Handling and Record Keeping
53
10.1.10
Protocol Deviations
56
10.1.11
Publication and Data Sharing Policy
57
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans

Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
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10.1.12
Conflict of Interest Policy
57
10.2
Additional Considerations
58
10.3
Abbreviations and Special Terms
58
10.4
Protocol Amendment History
60
11
REFERENCES
61
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Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
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STATEMENT OF COMPLIANCE
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP) and the following:
•
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are
responsible for the conduct, management, or oversight of NIH-funded clinical trials have
completed Human Subjects Protection and ICH GCP Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will
be submitted to the IRB for review and approval. Approval of both the protocol and the consent
form(s) must be obtained before any participant is consented. Any amendment to the protocol
will require review and approval by the IRB before the changes are implemented to the study. All
changes to the consent form(s) will be IRB approved; a determination will be made regarding
whether a new consent needs to be obtained from participants who provided consent, using a
previously approved consent form.]
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Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
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Protocol 6 R15 EY030247-01A1
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INVESTIGATOR’S SIGNATURE
The signature below constitutes the approval of this protocol and provides the necessary assurances that
this study will be conducted according to all stipulations of the protocol, including all statements
regarding confidentiality, and according to local legal and regulatory requirements and applicable US
federal regulations and ICH guidelines, as described in the Statement of Compliance above.
Principal Investigator or Clinical Site Investigator:
Signed:
Date:
Name*: Nancy Carlisle
Title*: Associate Professor of Psychology and Cognitive Science
Investigator Contact Information
Affiliation*: Lehigh University
Address: Chandler-Ullmann Hall
Telephone: 610-758-5122
Email: nbc415@lehigh.edu
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1
PROTOCOL SUMMARY
No text is to be entered in this section; rather it should be included under the relevant subheadings
below. It may be useful to complete this section after the relevant sections in the protocol have been
completed.
1.1
SYNOPSIS
Title:
Examining Flexibility in Attentional Control
Grant Number:
1R15EY030247
Study Description:
Examine task switching when participants receive a target color cue or
distractor color cue, and meaning and/or color change across trials
Objectives*:
Examine task switching
Endpoints*:
Single day of testing
Study Population:
27, 15 F/ 11M, healthy adults, Lehigh University
Phase* or Stage:
NA
Description of
Sites/Facilities Enrolling
Participants:
Lehigh University
Description of Study
Intervention/Experimenta
l Manipulation:
participants receive a target color cue or distractor color cue, and
meaning and/or color change across trials
Study Duration*:
2 months
Participant Duration:
30 minutes
1.2
SCHEMA
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Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
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1.3
SCHEDULE OF ACTIVITIES
Pre-scr
eening
(Pre-co
nsent)
Visit 1
Day 1
Participants only see experiment if
meet criteria
X
Informed Consent
X
Demographics
X
Outcome Evaluation
Visual Search
Performance
X
Randomization (Trial order)
X
Adverse Events Reporting
X
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2
INTRODUCTION
2.1
STUDY RATIONALE
The PI provided the first evidence that attentional control can also be used to ignore known
distractor features (Arita, Carlisle, & Woodman, 2012). In this study, participants received a cue
before each trial of a visual search task where they searched for a shape-defined target (a
gap-up or gap-down Landolt-c) and reported the location of the gap. The cue could be a positive
cue (indicating the target would appear in that color in the upcoming array), a negative cue
(indicating the target would not appear in that color in the upcoming array), or a neutral cue (the
cued color did not appear in the upcoming array). These cue meanings were manipulated
across blocks. Importantly, because only two colors appeared in the search array, the positive
and negative cues had the same information value. If participants used the cue, they could
reduce the number of items they needed to search to find the target by half. We found
participants can use visual attentional control to actively ignore items based on a feature cue, as
indicated by reaction time (RT) benefits for the negative cued condition compared to the neutral
condition.
In this study, participants will receive a cue on each trial that indicates a feature (e.g. red) and
the cue meaning (positive + or negative -). Across trials, we will be able to independently alter
the feature template and the cue meaning (Figure 5A). This will allow us to ensure the results
are driven by shifts in the cue meaning, and not simply alterations to the color that is cued. This
will lead to trials where both the feature and the meaning repeat (RE-repeat trials), trials where
only the cue feature changes (CC-color change, meaning repeat), trials where only the cue
meaning changes but the color repeats (MC-meaning change, color repeat), and trials where
both feature and cue meaning change (BC-both change). To look for task switching costs, we
will subtract the reaction times for repeat trials from each type of switch trials. Importantly, the
visual search is defined by a shape-defined target across all trials, meaning that there should be
no cross talk or response interference that could interfere with our ability to measure
task-switching costs (Koch, Poljac, Müller, & Kiesel, 2018).
2.2
BACKGROUND
Previous research has shown that, when there are no competing task demands, attention is
likely to be directed to items in the visual field that match working memory (Downing, 2000).
This suggests that the prepotent response is to attend to memory-matching items, whereas to
utilize a negative cue one must actively avoid attending the memory-matching items. This is a
good example of how higher-order cognitive control can be used to inhibit prepotent responses.
A similar example from oculomotor control is the anti-saccade task. In this task, participants
must either make a pro-saccade toward a cue or and anti-saccade away from the cue,
depending on the identity of the cue. A unidirectional switch cost has been shown within the
anti-saccade task when participants must engage in task switching between pro- and
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anti-saccades (Weiler & Heath, 2012). When participants switch from an anti-saccade task to a
pro-saccade task, there is a typical switch cost as compared to pro-saccade repetition.
However, the opposite pattern is found for anti-saccades- participants are either faster to
perform an anti-saccade after a prosaccade (task switch) compared to an anti-saccade
repetition (Barton, et. al, 2002) or show no task switch effect (Weiler & Heath, 2012). This is
thought to reflect a residual inhibition of the pre-potent response following an anti-saccade. This
slows a subsequent pro-saccade, but can also slow an anti-saccade as well. Therefore, the
unidirectional switch cost is a hallmark of inhibition within the oculomotor system.
2.3
RISK/BENEFIT ASSESSMENT
The following subsections should include a discussion of known risks and benefits, if any, to human
participants. Text from the corresponding sections of the Human Subjects section of the grant
application, and/or IRB package may be used here.
2.3.1
KNOWN POTENTIAL RISKS
The risks associated with the behavioral tasks are similar to working on a computer or playing a video game. They include
possible eye strain, and boredom. We will try to reduce the possibility of these risks by providing frequent breaks during the
experiment (approximately every 5 minutes during data recording).
2.3.2
KNOWN POTENTIAL BENEFITS
There are no direct benefits expected for the participants, and no clinical benefits, however many participants enjoy being able to
learn more about how we use behavioral responses to understand more about cognition.
The cognitive processes subserving attention and memory are critical for daily functioning. Individuals who have deficits in these
cognitive processes, such as individuals with Schizophrenia, often have difficulty in succeeding in their pursuits. Learning more
about how these processes occur in typical adults may lead to insights into how to help individuals with cognitive deficits, or
improve these functions in typical adults.
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS
The risks associated with the behavioral tasks are similar to working on a computer or playing a video game, and the benefits for
our understanding of basic human cognition are present. Therefore, we think the benefits outweigh the risks.
3
OBJECTIVES AND ENDPOINTS
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OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR
ENDPOINTS
PUTATIVE
MECHANISMS OF
ACTION
Primary
Compare Task-Switching
Costs for Positive Target Cues
and Negative Distractor Cues
Reaction Time
Accuracy
Cognitive Function
Conflict in
Cognitive Control
leads to
task-switching
costs
4
STUDY DESIGN
No text is to be entered in this section; rather it should be included under the relevant subheadings
below.
4.1
OVERALL DESIGN
Hypothesis: If the negative template requires the general inhibition of the oculomotor system to
reduce the likelihood of the prepotent response, we expect to find a unidirectional switch cost.
Within-Subjects, single arm design, single site.
Visual Search Information Type (target or distractor information) Participants will have
information about targets or distractors via cues before a visual search trials, in different trials of
the intervention.
4.2
SCIENTIFIC RATIONALE FOR STUDY DESIGN
Within-subjects design lead to strong conclusions about cognitive function.
4.3
JUSTIFICATION FOR INTERVENTION
Typical duration of trials, 481, for behavioral studies.
4.4
END-OF-STUDY DEFINITION
Complete 481 trials in single day.
5
STUDY POPULATION
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5.1
INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1.
Provision of signed and dated informed consent form
2.
Normal or corrected-to-normal visual acuity
3.
Normal color vision
4.
>=18 years of age
5.2
EXCLUSION CRITERIA
5.3
LIFESTYLE CONSIDERATIONS
N/A
5.4
SCREEN FAILURES
N/A
5.5
STRATEGIES FOR RECRUITMENT AND RETENTION
We plan to include women and minorities in this study. Participants will be recruited from the Lehigh
University community. As such, we expect the ethnicity distribution of our sample to roughly match the
ethnicity distribution of Lehigh (see Figure 1). Lehigh’s student body is 55% male and 45% female, so we
also expect this to be represented in our sample. We will gather information on participant age, sex, and
ethnicity for reporting purposes, and these factors will be entered into analysis as covariates in our
statistical analyses. We have no a priori expectations of differences based on these factors from prior
research, but will include these factors in our analysis to ensure that previous research has not neglected
between group differences.
Rationale for selection: Our research is designed to assess basic research related to human visual
attentional control. As such, we assume the basic processes will be shared among most adults humans.
We will take a convenience sample of adults to learn more about these basic procedures.
Outreach programs: Participants will be recruited from low-level Psychology participant pools, which are
often taken as a general education requirement at Lehigh. Paid participants will be recruited via fliers and
the Lehigh Paid Participant Pool. Fliers are posted around Lehigh’s campus as well as in public locations
within the community (grocery stores, other higher education institutions, coffee shops, etc.). Most paid
participants come from the Lehigh community, so we expect the sampling to draw heavily from Lehigh.
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
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6.1
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION
6.1.1
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION
Participants will receive one of three types of visual cues before performing a visual search task.
Positive cues for visual search (cues to enhance), or negative cues for visual search (cues to
suppress). After subjects receive the color cue for a trial, they will perform a visual search task
for a shape-defined target (landolt-C). We will examine task switching costs for changes in the
color of the cue, changes in the meaning of the cue, neither or both. We will measure
‘task-switching costs’ by contrasting reaction times when an aspect of the trial changes
compared to when neither aspect of the trial changes compared to the previous trials. We will
collect behavioral results using Matlab and a computer.
6.1.2
ADMINISTRATION AND/OR DOSING
Single day of testing, all conditions occur within single block of testing behavior.
6.2
FIDELITY
6.2.1
INTERVENTIONIST TRAINING AND TRACKING
Participants are all read the same instructions before trials begin to ensure understanding.
6.3
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
Within-subjects manipulation, no blinding.
6.4
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE
Practice trials were administered to ensure participants understood the task instructions.
6.5
CONCOMITANT THERAPY
N/A
6.5.1
RESCUE THERAPY
N/A
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7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Participants are informed their participation in voluntary, and they may stop participating at any time
during the 30-minute testing session.
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
N/A
7.3
LOST TO FOLLOW-UP
N/A
8
STUDY ASSESSMENTS AND PROCEDURES
No text is to be entered in this section; rather it should be included under the relevant subheadings
below.
8.1
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS
Participants receive task instructions, practice the task, and are allowed to ask questions prior to
beginning the experimental block.
8.2
SAFETY ASSESSMENTS
Researchers monitor for any safety concerns (e.g. headaches), and participants are informed they may
withdraw from the study at any time as part of our consent process.
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
8.3.1
DEFINITION OF ADVERSE EVENTS
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical
occurrence associated with the use of an intervention in humans, whether or not considered
intervention-related.
8.3.2
DEFINITION OF SERIOUS ADVERSE EVENTS
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Adverse events which go beyond typical daily occurrences.
8.3.3
CLASSIFICATION OF AN ADVERSE EVENT
1.1.1.1
SEVERITY OF EVENT
All AEs will be assessed by the principal investigator. Any adverse events that go beyond typical events in
daily life from computer use (e.g. headache) will be reported to Lehigh IRB.
1.1.1.2
RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Consultation with the Lehigh IRB will determine if the AEs are related or unrelated to the basic science
intervention.
1.1.1.3
EXPECTEDNESS
We expected events such as mild headache or boredom within our design, as these are typical for
computer-based tasks. We did not expect any more serious adverse events. All researchers are told to
report any potential adverse events to the PI.
1.1.2
TIME PERIOD
AND FREQUENCY
FOR EVENT ASSESSMENT
AND
FOLLOW-UP
Day of testing. If the PI has any concerns about an adverse event, she may directly reach out to the
participant to obtain additional details or check on the participant.
1.1.3
ADVERSE EVENT REPORTING
Adverse events are reported to Lehigh’s IRB.
1.1.4
SERIOUS ADVERSE EVENT REPORTING
The PI will be responsible for conducting an evaluation of a serious adverse event and shall report the
results of such evaluation to the NIH and the reviewing Institutional Review Board (IRB) as soon as
possible, but in no event later than 10 working days after the investigator first learns of the event.
1.1.5
REPORTING EVENTS TO PARTICIPANTS
N/A
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1.1.6
EVENTS OF SPECIAL INTEREST
N/A
1.1.7
REPORTING OF PREGNANCY
N/A
1.2
UNANTICIPATED PROBLEMS
1.2.1
DEFINITION OF UNANTICIPATED PROBLEMS
•
We experience unanticipated computer issues (e.g. code not working, file not saving)
occasionally.
1.2.2
UNANTICIPATED PROBLEMS REPORTING
The PI will report unanticipated problems (UPs) that are deemed significant (e.g. not the expected
unanticipated issues listed above) to the reviewing Institutional Review Board (IRB). The UP report will
include the following information:
•
Protocol identifying information: protocol title and number, PI’s name, and the IRB project
number
•
A detailed description of the event, incident, experience, or outcome
•
An explanation of the basis for determining that the event, incident, experience, or outcome
represents an UP
•
A description of any changes to the protocol or other corrective actions that have been taken or
are proposed in response to the UP
See CD Section 8.4.1 for additional example text applicable for devices.
1.2.3
REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS
N/A
2
STATISTICAL CONSIDERATIONS
2.1
STATISTICAL HYPOTHESES
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If the negative template requires the general inhibition of the oculomotor system to reduce the
likelihood of the prepotent response, we expect to find a unidirectional switch cost (e.g. a switch
cost for positive cues which is not present for negative cues).
2.2
SAMPLE SIZE DETERMINATION
GPower analysis: Repeated measures ANOVA with 8 factors (4 different trial types x 2
cue types, positive vs. negative cues)
F tests - ANOVA: Repeated measures, within factors
Analysis:
A priori: Compute required sample size
Input:
Effect size f
=
0.2
α err prob
=
0.05
Power (1-β err prob)
=
0.8
Number of groups
=
1
Number of measurements
=
8
Corr among rep measures
=
0.5
Nonsphericity correction ε
=
1
Output:
Noncentrality parameter λ
=
15.3600000
Critical F
=
2.0668747
Numerator df
=
7.0000000
Denominator df
=
161
Total sample size
=
24
Actual power
=
0.8115711
We will recruit 24 participants to meet the required sample size.
2.3
POPULATIONS FOR ANALYSES
Participants will be included if they complete the experimental session, have saved data, and do not fall
below 2.5 s.d. below the mean of accuracy performance for the group.
2.4
STATISTICAL ANALYSES
2.4.1
GENERAL APPROACH
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As a guide, the following should be addressed, as appropriate:
●
Descriptive statistics:means with standard deviations.
●
Inferential tests: p-value=.05
2.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S)
For both Reaction time and Accuracy, we will perform an ANOVA with these factors: Cue Meaning (Target
Color Positive Cue or Distractor Color Negative Cue) x Cue Meaning Repetition (Repeat, Non-Repeat) X
Cue Color Repetition (Repeat, Non-Repeat) Repetition.
2.4.3
SAFETY ANALYSES
N/A
2.4.4
BASELINE DESCRIPTIVE STATISTICS
N/A
2.4.5
PLANNED INTERIM ANALYSES
N/A
2.4.6
SUB-GROUP ANALYSES
We will include sex as a between-subjects variable in our analysis.
2.4.7
TABULATION OF INDIVIDUAL PARTICIPANT DATA
N/A
2.4.8
EXPLORATORY ANALYSES
N/A
3
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
3.1
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
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3.1.1
INFORMED CONSENT PROCESS
Informed consent will occur before the study session begins.
3.1.1.1
CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the
participant and written documentation of informed consent will be completed prior to starting the study
intervention.
Behavioral Research on Human Cognition: Lehigh IRB 864576-10
3.1.1.2
CONSENT PROCEDURES AND DOCUMENTATION
Participants are told: Ok, the next thing I will have you do is fill out the informed consent
document. The important things to note about the consent document are that:
>Your participation is voluntary
>If you choose to withdraw your participation, you will still be given your experimental credit
>Your name will not be associated with your data
>Your name will be kept confidential
3.1.2
STUDY DISCONTINUATION AND CLOSURE
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable
cause. Written notification, documenting the reason for study suspension or termination, will be
provided by the suspending or terminating party to NEI. If the study is prematurely terminated or
suspended, the Principal Investigator (PI) will promptly inform the Institutional Review Board (IRB), and
sponsor/funding agency and will provide the reason(s) for the termination or suspension.
3.1.3
CONFIDENTIALITY AND PRIVACY
We will collect behavioral results using Matlab and a computer. All data will be recorded using a
non-identifiable participant code (e.g. TS_B01) to ensure participant confidentiality. All informed
consent documents will be kept in a lockable cabinet in a locked room.
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff,
and the sponsor(s) and funding agency. This confidentiality is extended to the data being collected as
part of this study. Data that could be used to identify a specific study participant will be held in strict
confidence within the research team. No personally-identifiable information from the study will be
released to any unauthorized third party without prior written approval of the sponsor/funding agency.
All research activities will be conducted in as private a setting as possible.
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The study monitor, other authorized representatives of the sponsor or funding agency, representatives of
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or
organizations supplying the product, may inspect all documents and records required to be maintained
by the investigator.
The study participant’s contact information will be securely stored at each clinical site for internal use
during the study. At the end of the study, all records will continue to be kept in a secure location for as
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency
requirements.
At the end of the study, all study databases will be archived at Open Science Framework.
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies
It is NIH policy that the results and accomplishments of the activities that it funds should be made
available to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms
used to share data will include proper plans and safeguards for the protection of privacy, confidentiality,
and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not
be traceable to a specific study participant). Plans for archiving and long-term preservation of the data
will be implemented, as appropriate.
Certificate of Confidentiality
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical
or other human subjects research funded wholly or in part by the federal government.  Recipients of NIH
funding for human subjects research are required to protect identifiable research information from
forced disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set
forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research
covered by this Policy are required to establish and maintain effective internal controls (e.g., policies and
procedures) that provide reasonable assurance that the award is managed in compliance with Federal
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and
others who have access to research records will not disclose identifying information except when the
participant consents or in certain instances when federal, state, or local law or regulation requires
disclosure. NIH expects investigators to inform research participants of the protections and the limits to
protections provided by a Certificate issued by this Policy.
3.1.4
FUTURE USE OF STORED SPECIMENS AND DATA
Data collected for this study will be analyzed and stored at Lehigh University. After the study is
completed, the de-identified, archived data will be transmitted to and stored on the Open Science
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Framework, for use by other researchers including those outside of the study. Reuse of anonymized data
will be outlined in the informed consent.
3.1.5
KEY ROLES AND STUDY GOVERNANCE
Principal Investigator
Nancy
Carlisle,
PhD, Associate
Professor
of
Psychology
and
Cognitive Science
Lehigh University
17 Memorial Drive, Bethlehem,
PA, 18017
610-758-5122
nbc415@lehigh.edu
3.1.6
SAFETY OVERSIGHT
Safety oversight will be maintained by the PI, in consultation with the researchers, and, if necessary,
Lehigh’s IRB.
3.1.7
CLINICAL MONITORING
The PI and senior personnel (e.g. Post-doc, graduate students) will be responsible for training researchers
and ensuring adherence to research protocols.
3.1.8
QUALITY ASSURANCE AND QUALITY CONTROL
Quality control (QC) procedures will be implemented as follows:
Informed consent --- Study staff will review the consenting process and consent documents. Feedback
will be provided to the study team to ensure proper consenting procedures are followed.
Source documents and the electronic data --- Data will be initially captured on research computers (see
Section 10.1.9, Data Handling and Record Keeping) and the anonymized data will ultimately be
maintained on a secure Lehigh data storage system.
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the
intervention phase of the study by providing scripts for our research personnel. see Section 6.2.1,
Interventionist Training and Tracking.
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Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of
concern.
Should independent monitoring become necessary, the PI will provide direct access to all trial related
sites, source data/documents, and reports for the purpose of monitoring and auditing by the
sponsor/funding agency, and inspection by local and regulatory authorities.
3.1.9
DATA HANDLING AND RECORD KEEPING
No text is to be entered in this section; rather it should be included under the relevant subheadings
below.
Each participating site will maintain appropriate medical and research records for this trial, in compliance
with ICH GCP and regulatory and institutional requirements for the protection of confidentiality of
participants. As part of participating in a NIH-sponsored or NIH-affiliated study, each site will permit
authorized representatives of the NIH, sponsor, and regulatory agencies to examine (and when permitted
by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits, and
evaluation of the study safety, progress, and data validity. Indicate who will have access to records.
The following subsections should include a description of the data handling and record keeping for the
conduct of the trial.
3.1.9.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES
We will collect behavioral results using Matlab and a computer. All data will be recorded using a
non-identifiable participant code (e.g. TS_B01) to ensure participant confidentiality. All informed
consent documents will be kept in a lockable cabinet in a locked room.
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility,
and timeliness of the data reported.
3.1.9.2
STUDY RECORDS RETENTION
Study documents will be retained for a minimum of 5 years have elapsed since the end of the study.
3.1.10 PROTOCOL DEVIATIONS
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This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol,
International Council on Harmonisation Good Clinical Practice (ICH GCP). The noncompliance may be
either on the part of the investigator, or the study site staff. As a result of deviations, corrective actions
will be developed by the site and implemented promptly.
These practices are consistent with ICH GCP:
•
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3
•
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1
•
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.
It will be the responsibility of the site investigator to use continuous vigilance to identify and report
deviations from protocol. Protocol deviations will be sent to the reviewing Institutional Review Board
(IRB) per their policies. The site investigator will be responsible for knowing and adhering to the
reviewing IRB requirements.
3.1.11 PUBLICATION AND DATA SHARING POLICY
This study will be conducted in accordance with the following publication and data sharing policies and
regulations:
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for
publication.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in
peer-reviewed journals.
Data from this study may be requested from other researchers after the
completion of the primary endpoint and publishing of the study by contacting the PI or checking on OSF.
Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3.
3.1.12 CONFLICT OF INTEREST POLICY
The independence of this study from any actual or perceived influence, such as by the pharmaceutical
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design,
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore,
persons who have a perceived conflict of interest will be required to have such conflicts managed in a
way that is appropriate to their participation in the design and conduct of this trial. The study leadership
in conjunction with the NEI has established policies and procedures for all study group members to
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disclose all conflicts of interest and will establish a mechanism for the management of all reported
dualities of interest.
3.2
ADDITIONAL CONSIDERATIONS
3.3
ABBREVIATIONS AND SPECIAL TERMS
The list below includes abbreviations utilized in this template. However, this list should be customized for
each protocol (i.e., abbreviations not used should be removed and new abbreviations used should be
added to this list). Special terms are those terms used in a specific way in the protocol. For instance, if the
protocol has therapist-participants and patient-participants, those terms could be included here for
purposes of consistency and specificity.
AE
Adverse Event
ANOVA
Analysis of Variance
CFR
Code of Federal Regulations
EC
Ethics Committee
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act of
2007
FFR
Federal Financial Report
GCP
Good Clinical Practice
GLP
Good Laboratory Practices
HIPAA
Health Insurance Portability and Accountability Act
ICH
International Council on Harmonisation
ICMJE
International Committee of Medical Journal Editors
IDE
Investigational Device Exemption
IND
Investigational New Drug Application
IRB
Institutional Review Board
NCT
National Clinical Trial
NEI
National Eye Institute of NIH
NIH
National Institutes of Health
NIH IC
NIH Institute or Center
OHRP
Office for Human Research Protections
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
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3.4
PROTOCOL AMENDMENT HISTORY
The table below is intended to capture changes of IRB-approved versions of the protocol, including a
description of the change and rationale. A Summary of Changes table for the current amendment is
located in the Protocol Title Page.
Version
Date
Description of Change
Brief Rationale
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REFERENCES
Arita, J. T., Carlisle, N. B., & Woodman, G. F. (2012). Templates for
rejection: configuring attention to ignore task-irrelevant features. Journal
of experimental psychology: human perception and performance, 38(3),
580.
Barton, J. J., Cherkasova, M. V., Lindgren, K., Goff, D. C., Intriligator, J.
M., & Manoach, D. S. (2002). Antisaccades and task switching: studies of
control processes in saccadic function in normal subjects and
schizophrenic patients. Annals of the New York Academy of Sciences,
956(1), 250-263.
Downing, P. E. (2000). Interactions between visual working memory and
selective attention. Psychological science, 11(6), 467-473.
Weiler, J., & Heath, M. (2012). The prior-antisaccade effect: Decoupling
stimulus and response inhibits the planning and control of subsequent
prosaccades. Journal of Vision, 12(9), 1253-1253.
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