The Effect of Growth Mindset Psychoeducation on Modifiable Risk Factors for Common Mental Disorders
Phase: NA
Conditions: Depression, Anxiety
Sponsor: University of Nevada, Reno

 
Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD 
NCT03707522 
05/31/2018 

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1_Part II Application SOC-ED 112217 MRF.docx 
Part II Application – Social Behavioral/Education Research 
Note the following: 
1. A Part I Cover sheet is required for each project submitted in IRBNet; see Locating the Cover Sheet 
2. See IRB policy for submission requirements for new projects for Full Committee Review or Expedited 
Review. 
PI Responsibilities 
1. How will the PI ensure that all study personnel 
are informed about the research plan and their 
research-related duties? 
X 
Routine meetings 
X 
Regular communication (e.g., email, phone) 
__ Other research staff training, describe: 
Study Sites and Collaborating IRBS 
2. List/describe the study sites: 
University of Nevada, Reno 
3. Will this research be reviewed by other IRBs? 
X 
No 
__ Yesi (Consider contacting our office for 
assessment and coordination of single IRB 
review.) 
Selection of Research Participants 
4. How many participants (or records) will be 
enrolled? 
500 Number of participants/records 
5. What are the participant eligibility inclusion criteria? 
X 
Age, specify: 18-65 years old 
__ Gender, specify: 
__ Race/ethnicity, specify: 
X 
Language, specify: English 
__ Another country or specific cultureii, specify: 
__ Veteran status, specify: 
__ Adults with cognitive impairmentiii 
__ PI’s students, patients, or employeesiv 
__ Economically/educationally disadvantaged 
personsv 
__ Socioeconomic factors, specify: 
__ Additional, describe: 
6. What are the participant exclusion criteria? 
__ N/A, no exclusion criteria 
Description: Under the age of 18, not fluent in 
English. 
7. Justify exclusions based on age, gender, or race: 
__ N/A, no such exclusions 
Justification: Minors will not be included as freshmen 
at orientation will likely not have a guardian present 
to provide informed consent. Non-English speakers 
will not be included in the study as translations of the 
material and measures are not available. Individuals 
over the age of 65 will not be included because risk 
factors for older adults may differ in important ways 
that would affect the content of the intervention 
material (e.g., Beekman, 1995) 
8. Will the research involve researchers’ clients, 
students, or employees; or persons who are 
educationally or economically disadvantaged (see 
IRB policy for inherently influential situations)? 
X 
No 
__ Yes, specify and describe additional precautions 
to ensure participants are fully informed and 
agree voluntarily: 
Research Integrity 
218 Ross Hall / 331, Reno, Nevada 89557 
775.327.2368 / 775.327.2369 fax 
www.unr.edu/research-integrity 

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Recruitment Methods and Materials 
__ Check here if there are no processes/mechanisms to recruit participants; skip to next section. 
9. Who will recruit prospective participants? 
__ Recruitment exclusively through SONA 
__ PI 
X 
Co-investigators 
__ Study coordinator 
__ Research assistants 
__ Third party, specify and describe the party’s 
relationship to the study population: 
__ Other, specify: 
10. Describe where, when, and how recruitment will 
take place: 
__ N/A, recruitment exclusively through SONA 
Description of recruitment process: Participants will 
be recruited from freshmen orientation. Participants 
will be provided with a recruitment flyer in the binder 
provided by freshmen orientation programming staff. 
Research staff will also be present at orientation at a 
table with flyers to provide information about the 
study. 
11. What recruitment materials 
will be used?vi 
X 
Flyers/advertisements 
__ Emails/letters 
__ Scripts 
__ Slide or computer presentation 
__ SONA post 
__ Social media, specify: 
__ List serves 
X 
Other, specify: Table set up at 
orientation, flyer in student 
orientation binders 
Assessing Participants for Eligibility 
 
Check here if participants will NOT be assessed for eligibility; skip to next section. 
12. How will researchers confirm participants’ 
eligibility for the research? 
Participants will complete a set of demographic 
questions to ensure that they are between the 
ages of 18-65, fluent in English, and UNR college 
freshmen. 
13. How will researchers inform participants about 
the process to assess eligibility? 
Eligibility information will be included in the informed 
consent and study flyer. 
14. What will happen to screening/eligibility data for 
individuals who are not eligible to participate?vii 
Screening/eligibility data for individuals who are not 
eligible to participate will be destroyed after study 
recruitment is complete. 
Recruitment Incentives/Payments 
X 
Check here if there are no recruitment incentives/payments; skip to next section. 
15. What types of recruitment incentives/payments 
will researchers give participants?viii 
X 
Credit through SONA: .5 SONA credit for follow 
up 
__ Course credit; equivalent, alternative 
opportunities must be available 
__ Money or gift cards; specify amount: 
__ Raffle or drawing; specify value, and odds of 
winning: 
__ Other; specify and value: 

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16. When and how will researchers distribute 
incentives/payments? 
X 
SONA credit awarded via standard procedures 
Description: 
17. For all incentives/payments, explain why the 
amount or value is reasonable for the research: 
X 
SONA credit, standard amounts 
Explanation: 
18. Will participants be required to provide Protected 
Personally Identifiable Information (PPII) 
including social security numbers, to receive 
incentives/payments?ix 
X 
No 
__ Yes, specify the PPII required for payment, to 
whom it will be provided, and how it will be 
protected during this process: 
Informed Consent Methods/Procedures 
__ Check here if you do not plan to obtain informed consent from participants); skip to the next section. x 
19. Describe the process for obtaining legally 
effective informed consent from each participant 
(i.e., describe when, where, and how each recruit 
will be told about the research and agree to 
her/his participation). 
__ N/A, research only involves childrenxi 
__ N/A, research only involves adults with impaired 
consent capacity and surrogate consentxii 
Description of informed consent process: All 
freshmen completing orientation receive a binder as 
part of orientation programming. This binder 
contains information and resources for freshmen 
students. This binder will contain a study flyer that 
contains a brief description of the study. Research 
staff will also be present at an information table at 
orientation. If participants are interested in learning 
more, they can choose to access the Qualtrics site 
through a survey link provided in the flyer. If they 
choose to access the Qualtrics survey link, they will 
be able to read the informed consent prior to 
agreeing to participate in the study. 
20. Specify which researchers will obtain informed 
consent from participants: 
X 
Via online or electronic information sheet 
__ PI 
__ Co-investigators 
__ Study coordinator 
__ Research assistants 
__ Other, specify: 
21. How will researchers ensure consent is obtained 
in a language understandable to participants? 
Check all that apply: 
X 
Consent materials reflect the expected literacy of 
the sample population 
X 
Participants speak English 
__ Researcher fluent in participants’ language will 
interpret 
__ Person in community will interpret 
__ Professional interpreter will be present 
__ Consent materials translated in participants’ 
language or short-form consent process used 
__ Other, specify: 
22. How will researchers ensure individuals have 
sufficient opportunity to consider participation? 
Participants will have as much time as they would like 
to review consent materials. 

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23. How will researchers protect participants from 
undue influence/coercion during the consent 
process? 
No incentives will be offered for the first portion of 
the study taking place during orientation. 
Participation in the follow-up assessment will be 
compensated using SONA credits. Participants 
may decline to participate in the study and 
participate in another research study in order to 
obtain credits. 
24. How will researchers assess each person’s 
comprehension of the research? 
X 
As recommended by the IRB 
__ Other, specify: 
Documentation of Consent 
25. Will participants sign an IRB-approved consent 
form, as required at 45CFR46.117? 
X 
N/A, minimal risk research that is NOT 
conducted/supported by a federal agency 
(including the VA); and does NOT involve 
incomplete disclosure or deception, or prisoners 
__ No, requesting IRB approval to waive 
requirement for documentation of consentxiii 
__ Yes, via short form consent documentation (for 
non-English-speaking participants) 
__ Yes 
Research Costs 
26. Will participation result in out of pocket expenses 
(including costs for cell phones used in research), 
co-pays, 3rd party payer costs, or research-related 
injury costs?xiv 
X 
No 
__ Yes, complete the following: 
What costs will participants or 3rd party cover? 
What costs will the researchers cover? 
What costs will the VA cover? 
What costs will the sponsor cover? 
Study Design/Research Methods 
Describe in non-technical terms. 
27. What is the background information that 
supports this research? (Summarize previous 
work and provide references.) 
The present study intends to determine the effect of 
psychoeducation on engagement with modifiable risk 
factors for depression and anxiety. While 
psychoeducation, and etiological beliefs about 
depression in particular, have been conceptualized as 
an important part of mental health literacy (MHL), 
little evidence exists to suggest what the content of 
psychoeducation should entail in order to improve 
the stated goals of MHL of recognition, management 
and prevention of common mental health problems 
such as anxiety and depression (Kelly, Jorm & Wright, 
2007). 
 
As such, factors that increase both engagement with 
modifiable risk factors are key to the prevention of 
common mental disorders such as anxiety and 
depression. Risk factors are variables that if present 
increase likelihood of developing disorder. Modifiable 

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risk factors are those variables that could be 
reasonably altered by the individual without outside 
intervention). For depression and anxiety, these 
include health behaviors such as drug and alcohol 
use, weight management, coping strategies, sleep, 
positive activities, physical activities and social 
support (Cairns et al., 2014; Zimmermann, Chong, 
Vechiu & Papa, 2017). 
 
Prevention is especially warranted for college 
students, because they are at a developmentally 
unique time of life before which 80% of individuals 
have not yet developed anxiety or depression. With 
respect to onset of depression, 20% of those with 
depression experience their first symptoms at age 19, 
meet criteria by age 25, 50% meet criteria by age 25, 
meet criteria by 38. Thus, college freshmen are at a 
key stage before which most individuals will have 
developed a disorder (Munoz, Mrazek & Haggerty, 
1996). 
 
Growth mindset may be an important aspect of 
preventative psychoeducation. Dweck and 
colleagues’ (1995) cognitive model of motivation has 
generated a significant body of work demonstrating 
that individuals have “implicit theories,” related to 
the malleability of a trait, and that individuals set 
goals and behave with respect to that aspect. Thus, 
learned concepts about the mutability of a trait have 
consequences for future behavior, and persistence on 
challenging tasks in particular. Mueller and Dweck 
(1998) show that children who receive praise for 
intelligence are more likely to exhibit behaviors of 
entity theorists by choosing easier tasks and spending 
less time on challenging problems, whereas children 
praised for efforts are more likely to resemble 
incremental theorists by choosing mastery goals and 
working through difficult problems. Beliefs about the 
malleability of self-attributes are learned and apply to 
specific traits. For example, an individual may have 
learned that intelligence is fixed but that a 
personality trait such as hostility is flexible (Yeager & 
Dweck, 2012; Scott & Ghinea, 2014). With respect to 
mental health, research on malleability beliefs has 
been limited, but it does appear that engendering a 
“growth mindset,” is effective for the reduction of 
mental health problems (Schleider & Weisz, 2016).  
 

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Accordingly, beliefs about the malleability of 
emotions have been shown to predict depression 
outcomes in a sample of college students, with 
students endorsing beliefs in emotion malleability 
experiencing fewer symptoms of depression (Tamir 
et al., 2007). One possible mechanism through which 
this protective may occur is through the engagement 
with modifiable risk factors. Thus, research is needed 
to further demonstrate the effectiveness of growth 
mindset for the prevention of depression and 
anxiety, and to determine through what mechanism 
this intervention may be effective. 
28. State the study purpose, research hypothesis, or 
research questions: 
The present study aims to determine the effect of 
presenting psychoeducation emphasizing “growth-
mindset,” and information on modifiable risk factors 
on engagement with modifiable risk factors. We 
hypothesize that psychoeducation emphasizing that 
mental health is malleable will increase the 
participant’s engagement with risk factors outlined in 
the intervention. 
 
Participants will randomly be assigned to complete 
one of four conditions: 
 
(1) Growth mindset + Modifiable risk factor 
information 
(2) Control + Modifiable risk factor information 
(3) Control + Growth mindset 
(4) Control + Control 
 
This design will allow assessment of the incremental 
effects of growth mindset and modifiable risk factor 
information as well as interactions between these 
conditions. We hypothesize that condition 1 will be 
associated with the greatest increase in engagement 
with modifiable risk factors for depression and 
anxiety followed by conditions 2-3 which will be 
associated with greater increases in engagement with 
modifiable risk factors than the control group 
(condition 4). 
 
 
29. When appropriate (e.g., community-based 
participatory research, international research), 
how will you involve community members as 
advisors in the design/implementation of the 
research, and dissemination of results? 
X 
N/A, not necessary/appropriate to involve 
community members 
Describe: 

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30. Check all research methods/procedures that apply to this research: 
X 
Psychological or behavioral 
interventions/treatments 
__ Educational activities/interventions 
__ Experimental-control group assignment 
__ Cross-over design 
__ Computerized simulations 
__ Equipment/devicesxv, specify: 
__ Ethnographic research 
__ Needs assessment research 
__ Program evaluation research 
__ Observational research 
X 
Surveys, interviews, focus groups 
__ Collection of data from records 
__ Retrospective 
__ Prospective 
__ Other, specify: 
31. Which of these methods/procedures are 
experimental (i.e., conducted to evaluate 
safety/efficacy or other outcomes)xvi? 
The article containing psychoeducation related to the 
mental health will be experimentally 
manipulated. Participants will be randomly 
assigned to one of four conditions. 
 
(1) Growth mindset + Modifiable risk factor 
information 
(2) Control + Modifiable risk factor information 
(3) Control + Growth mindset 
(4) Control 
 
32. Which of these methods/procedures are 
considered standard-of-care? 
Neither procedure is considered usual care. 
33. Who will provide the standard treatment or care 
referenced above? 
X 
N/A, research does not include usual 
care/standard treatment 
__ Study team 
__ Participant’s own health care provider 
__ Other, specify 
34. Why is group assignment necessary, and how will 
participants be assigned to 
treatment/experimental or control groups? 
__ N/A, research does not involve group assignment 
Justification/description: Group assignment is 
necessary to determine the differential effect of 
each article on task engagement and persistence. 
Participants will be randomly assigned to a 
condition using Qualtrics survey software. 
35. What will participants experience or be asked to 
do when assigned to the treatment / 
experimental group or to the control group? 
In all conditions, participants will be asked to read an 
article about mental health and complete a battery of 
questionnaires at Time 1. In both conditions, 
participants will complete a battery of questionnaires 
at Time 2 and Time 3. 
36. Note the expected number/length of 
contacts/meetings, and time commitment for 
participation (include similar information in 
consent materials): 
3 
Expected number of contacts/meetings 
________ Minutes/hours for each contact/meeting 
30 minutes at Time 1 
15 minutes at Time 2 
15 minutes at Time 3 
________ Duration of participation (in 
weeks/months) for intervention 
30 minutes for intervention 

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________ Duration of participation (in 
weeks/months) for long-term follow-up 
Follow up at Time 2 (one week following Time 1) 
Follow up at Time 3 (during Fall semester, 3-4 months 
following Time 1) 
Data Collection and Analysis 
37. List the information/specimens that researchers 
will obtain for this research xvii: 
Information collected will be data from the battery of 
questionnaires at Time 1, Time 2 and Time 3. At Time 
1, participants will be provided with a participant ID 
number. Participants will provide their e-mail address 
at this time. Participant ID will be stored in a file with 
the participant’s e-mail address for follow-up contact 
purposes. 
38. How will research data be obtained?xviii 
Research data will be obtained through Qualtrics 
survey software. 
39. Identify each research instrument (e.g., diary, 
questionnaire, data collection log) and describe 
how its use relates to the study purposexix: 
Demographic questions. Participants will be asked 
their gender, age, marital status, race/ethnicity, level 
of education and treatment seeking history and 
intent. 
 
Patient Health Questionnaire. Severity of depression 
will be measured via the Patient Health 
Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 
2001), a 9-item questionnaire associated containing 
one item for each symptom of MDD as specified by 
the DSM. The PHQ-9 score ≥10 has a sensitivity of 
88% and a specificity of 88% for MDD. This measure 
has demonstrated good internal reliability (a=.86). 
 
GAD-7. Anxiety severity will be measured using the 
Generalized Anxiety Disorder 7-item scale (GAD-7; 
Spitzer, Kroenke, Williams & Lowe, 2006) is a 
common, brief measure of anxiety symptom severity 
(a=.92;).  
 
ARM-CMD. Mental health literacy will be assessed 
using the Awareness of Risks and Management of 
Common Mental disorders (ARM-CMD) measure 
developed to assess knowledge and attitudes related 
to the effective recognition, management and 
prevention of mental disorders (Zimmermann et al., 
in preparation). 
 
SF-36- Physical and Mental Health Short Forms. This 
measure includes sleep, social activity and health 
subscales. Sub-scales vary in response formats with 

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items rated from either 1-6 or 1-5 (Tarlov et al., 
1989). 
 
Healthy diet questionnaire. Healthy diet will be 
assessed using a 10-item yes/no scale total of 10 
points for health eating behaviors. Higher scores 
indicates that the participant tries to eat more fiber, 
more fruit, more vegetables, more fish, less meat, 
less sweets and pastries, tries to avoid the intake of 
fat, the consumption of butter, removes fat from 
meat does not add sugar to drinks (Zazpe et al., 
2011). 
 
Substance Use Measure. Alcohol and substance use 
will be assessed using a 3-item substance use 
measure including frequency of alcohol use, cigarette 
use and drug use (Lee et al., 2015) The internal 
reliability estimate is (α) .74. 
 
Brief COPE. Coping strategies will be assessed using 
the Brief COPE, a 28-item scale assessing various 
dimensions of healthy and unhealthy coping (B-COPE; 
Carver, 1997). 
 
Ryff Purpose in life scale. Purpose in life will be 
assessed using a 9-item scale (Ryff & Keyes, 1989). 
 
Mental health immutability beliefs measure. 
Immutability beliefs will be assessed after the 
manipulation is complete using a 4-item Likert scale 
from “strongly disagree,” to “strongly agree.” Items 
will be modified from the depression immutability 
beliefs questionnaire (Schroder et al., 2016) to refer 
to general mental health (e.g., “Your mental health is 
something about you that you cannot change very 
much.”) 
 
40. How will researchers analyze the data?xx 
SPSS will be utilized to conduct a 4 factor between 
subjects ANOVA,  to determine differences 
between groups in engagement with modifiable 
risk factors as well as to probe interactions 
between the effect of receiving the growth 
mindset education and information about 
modifiable risk factors. 
41. Will this research include records of participants’ 
voices or images?xxi  
X 
No 
__ Yes, audio; describe and justify: 
__ Yes, video; describe and justify: 
__ Yes, photographs; describe and justify: 

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Research Risks 
42. Describe how risks will be minimized through use 
of sound research design: 
X 
N/A, minimal risk research 
Description: 
43. What precautions will researchers use to avoid 
unnecessarily exposing participants to risk? 
Check all that apply: 
X 
N/A, minimal risk research 
__ Using recognized standard practices 
__ Ensuring researcher expertise/credentialing 
__ Researcher training 
__ Minimizing time required for procedures 
__ Using procedures that are already being 
performed (e.g., for education or treatment) 
__ Monitoring participants for adverse reactions 
__ Monitoring data for safety 
__ Other, specify: 
44. List the discomforts and physical harms that 
might result from participation in this research; 
assess the probability, severity, and duration of 
each discomfort/harm: 
No physical discomfort or harm is expected to 
result from participation in this study. 
45. List the social, legal, financial, emotional, or 
familial harms might result from participation in 
this research; assess the probability, severity, and 
duration of each of these harms: 
It is possible that emotional discomfort may 
result from reading about mental health. It is 
unlikely that this emotional discomfort will 
persist after the completion of the study. 
46. Identify secondary and incidental findings (see 
Policy Manual Definitions) that are reasonably 
expected to result from this research. 
Explain the plans for whether the findings to 
participants or others will be disclosed: 
X 
N/A, secondary/incidental findings not expected 
 
47. How will participants be referred to 
psychological, or other services that may be 
required as a consequence of participation in the 
research? 
__ N/A, need for referrals not anticipated 
Explanation: All participants will be provided with a 
list of contact information for on-campus 
psychological services including the Counseling 
Services Center, Psychological Services Center and 
Downing Clinic (see attached). 
Safety Monitoring for Greater than Minimal Risk Research 
X 
Check here if this is minimal risk research and safety monitoring is not required; skip to next section. 
48. Describe the plan to monitor data for safety. 
Include: 
• 
Who will monitor the data for safety 
concerns? 
• 
What data will be reviewed? 
• 
How often will the monitoring occur? 
• 
How often will cumulative data be reviewed? 
 
49. Are there specific findings that would trigger an 
immediate suspension of the research? 
__ No 
__ Yes, specify: 

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Research Benefits 
50. Are individual participants expected to benefit 
from being in this research? 
X 
No: It is possible that the individual may benefit 
from learning more about mental health, but 
these benefits are not certain. 
__ Yes, specify: 
51. What is the potential value of the knowledge to 
be gained from this research? 
The knowledge gained from this research would be 
valuable in determining what should constitute core 
psychoeducation components of mental health 
literacy interventions in ways that serve to promote 
mental health through the increased engagement 
with modifiable risk factors to prevent anxiety and 
depression. 
Protecting Participant Privacy 
52. Will Protected Personally Identifiable Information 
(PPII) be collected for this research (see Policy 
Manual Definitions)? 
X 
No 
__ Yes, specify what PPII will be collected and why it 
is necessary to collect it: 
53. How will researchers protect the privacy of 
prospective participants during initial contact, 
and interventions or interactions? 
Data will be de-identified stored on a secure 
password protected computers that will only be 
available to the PI and study personnel. 
54. What protections will be in place for investigators 
to access records generally considered private 
(e.g., education or personnel records)? 
X 
N/A, records generally considered private will not 
be accessed for the research 
__ Compliance with FERPA (for education records) 
__ Other, describe: 
55. Do any state laws for mandatory reporting apply 
to this research? (See IRB policy for applicable 
Nevada State Laws.) 
X 
No 
__ Yes, specify and include in consent document: 
56. For researching involving the collection of 
identifiable information that may have legal 
ramifications (e.g. illegal drug use, criminal 
activity), will a Certificate of Confidentiality be 
obtained (see IRB CoC policy)? 
__ N/A, no such information will be collected 
X 
N/A, identifiers not collected or not maintained 
__ No, explain why not: 
__ Yes, upon receipt of the COC, create a new 
package, and Add the certificate. 
Maintaining Data Confidentiality 
57. Identify the formats in which research records 
will be maintained by the PI: 
__ Paper 
X 
Electronic 
__ Recorded media (e.g., audio/video, digital 
photos) 
__ Other, specify: 
58. Where will research records be maintained by the PI?xxii (Check all that apply.) 
X 
Password-protected file on University/Affiliate 
server (e.g., UNRNAS) or secure VA network 
server 
__ In the UNR Med-hosted environment 
__ On an external cloud-based solution; Add 
Business Associate Agreement or ORD approval 
for VA research 
__ In a locked file cabinet in the PI’s office or lab 
__ In a locked or password-protected office or lab at 
the University, Affiliate site, or VASNHCS 
__ Off-site in a secure facility with password-
protected access, Add Business Associate 
Agreement 
__ VA research only, off-site in another VA facility, 
specify: 

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__ On a password-protected stand-alone 
desktop/laptop computer (must be encrypted) 
__ On a password-protected Electronic Portable 
Device (must be encrypted) 
__ VA research only, off-site in a secure non-VA 
facility with password-protected access, Add 
documentation of ORD approval 
__ Other location, specify: 
59. Who will have access to research records? 
NOTE: It is understood the US DHHS, and UNR RI 
and IRB will have access. 
Check all that apply: 
X 
Principal Investigator 
X 
Co-Investigators 
__ Research assistants 
__ Collaborating researchers, institutions or 
organizations, specify: 
__ Study sponsor 
__ VASNHCS or Affiliate Site Research Office 
__ Other federal agencies, specify: 
__ Other, specify:  
60. How will researchers protect against 
unauthorized disclosure of identifiable 
information about participants? 
__ N/A, data will be collected without identifiers 
__ Data will immediately be stripped of personal 
identifiers; no master code list 
X 
Data will be coded; master code list will be stored 
securely and separately 
__ Other, specify: 
61. Will web-based applications be used to obtain, 
record, or store data (e.g., online survey 
administrator or sponsor-portal)? 
__ No 
X 
Yes, identify the server/applicationxxiii Qualtrics 
62. Will software provided by a 3rd party (e.g., 
sponsor) be used to record or transmit data? 
X 
No 
__ Yes, identify the software and the source; 
summarize or Add data security policy: 
63. Will mobile devices be used to collect or record 
data for this project? 
X 
No 
__ Yes, with FIPS 140-2 encryption standard 
__ Yes, with other security measures, specify: 
64. Will identifiable research records be transmitted 
or shipped to another location/institution? 
X 
No 
__ Yes, describe how confidentiality will be 
maintained during transmission/shipping: 
65. How long will the PI store identifiable records? 
__ N/A, identifiers not collected or not kept 
__ N/A, data coded; master list will be destroyed 
before permanent storage 
X 
Until the study closes 
__ Years after study closure (note number): 
__ Indefinitely 
__ Other, specify: 
66. What will happen to identifiable records after the storage period ends? (Check all that apply.) 
__ N/A, identifiable data not collected or not stored 
__ N/A, research data and records will be stored 
indefinitely (per VHA Records Control Schedule 
10-1 when applicable) 
__ Paper/electronic records will be destroyed. 
__ Audiotapes/videotapes will be erased or 
destroyed 
__ Coded data will be placed in an existing 
repository; master code list will be destroyed 
__ Coded data will be placed in an existing 
repository; master code list will be maintained by 
the repository 
__ Data along with PPII will be maintained by the PI 
for future research purposes 

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1_Part II Application SOC-ED 112217 MRF.docx 
X 
The master code list will be destroyed; de-
identified data will be maintained by the 
Investigator indefinitely 
__ Other, describe: 
Transferring Research Data to a Bank or Repository for Future Uses 
X 
Check here if this is data will not be transferred to a bank or repository; skip to next section. 
67. Will identifiable research data be transferred to a 
data bank or repository for future use? 
NOTE: Information about future uses must be in 
consent documents. 
__ No 
__ Yes, name the bank/repository, justify the 
retention of identifiers, and describe future uses: 
68. Specify the oversight mechanisms for future uses 
of identifiable data transferred to a 
bank/repository: 
__ N/A, identifiable data will not be transferred to a 
bank/repository 
__ Existing repository has appropriate oversight 
mechanisms in accordance with VHA Handbook 
1200.12. 
__ IRB of Record for the bank/repository is 
responsible for approval and oversight of 
research involving the records 
__ Other, specify: 
Additional Requirements for VA Research 
X 
Check here if this is not VA research; skip to next section. 
69. Check the employment category that applies to 
the Principal Investigator: 
__ VA employee, specify VA percentage of time in 
8ths: _____ 
__ VA WOC (Without Compensation) 
__ VA-contracted personnel 
__ Other, specify:  
70. How is this research relevant to Veterans? 
 
71. If the research involves non-Veteran participants, 
describe VA’s coverage of costs resulting from 
research-related injury: 
__ N/A, all participants will be Veterans 
Description: 
72. Will a non-VA entity (other than as disclosed 
above) have access to VA-Sensitive 
Information/Data (as defined in VA Handbook 
6500, Appendix A)? 
__ No 
__ Yes, name the entities and check the type of 
agreement that will be in place, and Add a copy 
of the agreement: 
__ Data Use Agreement 
__ Cooperative Research and Development 
Agreement (CRADA) 
__ Other, specify: 
Informed Consent Documents/Materials 
__ Check here if you request IRB approval to waive the requirement for informed consent and skip section. 
73. What materials will be used to inform 
participants about the research?xxiv 
__ N/A, not obtaining consent 
__ Sponsor consent template, revised using Consent 
Checklist 
X 
Consent form or information sheet based on a 
Consent Form Template from IRBNet 

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__ Simplified info script, sheet, email, letter based 
on a Consent Information Script/Sheet Template 
from IRBNet 
__ Other, specify: 
74. Will participants in greater than minimal risk 
research be provided with the DHHS required 
basic and additional elements of informed 
consent (as specified at 45CFR46.116)?  
X 
N/A, minimal risk research 
__ N/A, under IRB-Flex for greater than minimal risk 
research, elements that do not apply to the 
research are excluded 
__ Yesxxv 
__ Other: 
75. Will participants in minimal risk research that is 
conducted/supported by a federal agency, or that 
involves incomplete disclosure/deception or 
prisoners be provided with the DHHS required 
basic and additional elements of informed 
consent (as specified at 45CFR46.116)? 
__ N/A, greater than minimal risk research 
(addressed above) 
X 
N/A, minimal risk research that does NOT involve 
federal funding, incomplete disclosure or 
deception, or prisoners 
__ N/A, PI requesting IRB approval for alteration of 
DHHS requirements for informed consentxxvi 
__ Yes, using a Consent Form Template from IRBNet 
to create the consent document 
Obtain the electronic signature of Principal Investigator to confirm the following PI assurances: 
University/Affiliate Principal Investigator Assurance 
My electronic signature certifies that I have read/prepared the project documents and agree to comply with 
the PI responsibilities in the IRB Policy Manual and applicable Affiliate policies. 
Obtain the electronic signature of a Responsible Official (RO) or Affiliate Representative. 
University/Affiliate Responsible Official Assurance 
My electronic signature certifies that I have read the project documents, and agree to comply with the RO 
responsibilities in the IRB Policy Manual and applicable Affiliate policies. 
 
i 
Add copies of collaborating IRB decisions, as Other 
ii 
Add form Research: International 
iii Add form Population: Persons with Cognitive Impairment 
iv See IRB policy for inherently influential recruitment situations 
v 
See IRB policy for inherently influential recruitment situations 
vi Add copies of all recruitment materials, as Advertisements. 
vii NOTE: Data must be retained for VA research. 
viii Disclose in consent materials, gift value and odds of winning. 
ix Disclose in consent materials, requirement for participant to provide PPII to receive payment. 
x 
Add form Consent Waivers. 
xi Add form Population: Children to describe child assent and parental permission 
xii Add form Population: Persons with Cognitive Impairment 
xiii Add form Consent Waivers. 
xiv Disclose costs to participants or 3rd-party payer in consent materials. 
xv For example: Retinal scans, skin galvanometers,  
xvi NOTE: All research components that are experimental must be identified as such in consent materials. 
xvii  Include information that will be obtained from existing records, from activities/procedures performed solely 
for the research, or from activities/procedures performed as part of standard treatment/educational practice. 
                                                             

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xviii Include descriptions for obtaining data from existing records, prospectively from study procedures, or 
prospectively from procedures performed for standard treatment/educational practices. 
xix Add non-standard instruments as Questionnaire/Survey or Data Collection, as applicable. 
xx For multi-site research specify if site-specific data will be analyzed separately. If data will be pooled, indicate if 
participant identifiers will be maintained and describe how findings will be shared among cooperating PIs. 
xxi ONLY for video or photographs, Add video/photo release form. (Release form not required for VA research.) 
xxii See University IT Data Management on the web for information about electronic data management/storage 
solutions. Additional requirements apply to storage of identifiable information outside of the University. 
Investigators planning to store Identifiable data on a cloud-based solution or off-campus, must contact the 
University Chief Information Security Officer in the University IT office for requirements. 
xxiii Add copies of the site’s privacy/data security policies. 
xxiv Add all consent materials. 
xxv Use either the Consent Checklist to revise sponsor consent templates or a Consent Form Template from IRBNet 
to create a consent document. 
xxvi Add form Consent Waivers.