Caring Cards to and From Veterans: Feasibility and Acceptability of a Peer Approach to Suicide Prevention and Recovery
Phase: NA
Conditions: Feasibility, Acceptability, Thwarted Belongingness, Perceived Burdensomeness, Suicide Risk, Social Connectedness
Sponsor: VA Office of Research and Development

Caring Cards to and from Veterans: Feasibility and 
Acceptability of a Peer Approach to Suicide Prevention 
and Recovery
 NCT04486677
November 22, 2022

Human Protocol (Version 1.12)
General Information
*Please enter the full title of your study::
Caring Cards to and from Veterans: Feasibility and Acceptability of a Peer Approach to Suicide 
Prevention and Recovery
 
 
*Please enter the Study Number you would like to use to reference the study:
Caring Cards RR&D SPiRE
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
Add departments
and Specify Research Location:
Is 
Primary? Department Name
VASDHS - VASDHS
 
Assign key study personnel(KSP) access to the study
*Please add a Principal Investigator for the study:
 
Treichler, Emily B., PhD
 
3.1 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Depp, Colin A., PhD 
 Co-Investigator
Doran, Neal M., PhD 
 Co-Investigator
Ehret, Blaire C., PhD 
 Co-Investigator
Granholm, Eric L., PhD 
 Co-Investigator
B) Research Support Staff
Chalker, Samantha A., PhD 
 Post-Doc
Chang, Cindy, PhD 
 Research Associate
G

Ehret, Phillip J., PhD 
 Research Scientist
Ferragut, Brandon 
 Research Associate
Martinez Ceren, Camila 
 Clinical Research Associate
Parrish, Emma M. 
 Research Associate
Pozun, Cara T., MA, LMFT 
 Study Coordinator
Shriver, Christen Lee 
 Study Coordinator
*Please add a Study Contact
 
Treichler, Emily B., PhD 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
 
VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
Emily B. Treichler, PhD
Protocol Title:
Caring Cards to and from Veterans: Feasibility and Acceptability of a Peer Approach to Suicide 
Prevention and Recovery
IRB Protocol Number:
H200125
Protocol Nickname:
Caring Cards RR&D SPiRE
Form Template Version:
v20150115
Date Prepared:
11/22/2022
Please be advised that this protocol application form has changed as a result of the 2018 Common 
Rule.  There are new questions and sections, and you may be required to provide additional information to 
previous sections.
1a) Is this study considered human research?
Yes 
No 
I don't know 
1b) Please select:

This is an application for a NEW human subject research protocol 
This is a revision of an existing protocol 
 Section 2 - Research Subjects
 
2a) What is the total planned number of VA-consented subjects?
Include the total number of subjects who will prospectively agree to participate in the study (e.g., documented 
consent, oral consent, or other).
80
 
2b) What is the total number of VA subjects who WILL NOT be consented?
Include the total number of subjects that will be included without consent (e.g., chart review).  Note: Data about 
people are still considered “human subjects” by the IRB, so even if you do not intend to contact the patients 
whose charts you will review, you still should enter the number of charts as your “planned subjects."
200
 Section 2.1 Consented Subject Groups
2.1) For each of the subject categories listed below, indicate whether or not these subject groups will 
participate in the study: 
2.1a) Children under the age of 18
Note:   If neonates or children will be involved in this study, certification by the Medical Center Director will be 
required. Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or 
prospective observational and retrospective record review studies that are minimal risk can be conducted in VA 
involving neonates.
  Yes  
  No
2.1b) Pregnant women
 Yes  
 No
2.1c) Individuals with cognitive/decisional impairment
  Yes  
  No
2.1d) Non-English-speaking individuals
  Yes  
  No
2.1e) Prisoners of War (explicitly targeting this group)
  Yes  
  No
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)
  Yes  
  No
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)
  Yes  
  No
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be 
required)
  Yes  
  No
2.1i) Students of the institution (e.g., resident trainees) or of the investigator

  Yes  
  No
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
  Yes  
  No
 Section 2.2 Subject Categories without consent
2.2) Indicate if data or specimens only will be used without enrollment consent for each category listed below:
2.2a) Non-Veterans
  Yes  
  No
2.2b) Prisoners
  Yes  
  No
2.2c) Neonates or Children
Note:  If neonates or children will be involved, certification by the Medical Center Director will be required. 
Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or prospective 
observational and retrospective record review studies that are minimal risk can be conducted in VA involving 
neonates.
 
  Yes  
  No
 Section 3 - Study Features   (these items default to "No" for convenience)
  
3) This section consists of several Yes/No questions addressing protocol characteristics.     Click on Save and 
.
Continue
 Section 3.1 Protocol Basics
Select all that apply
3.1a) The research 
 the participant.
intends to change
 Yes  
 No
3.1b) 
 with living participants to collect data or specimens with no intent to change them.
Interactions
  Yes  
  No
3.1c) This is a study that 
 has any 
 
never
subject contact and does not collect subject identifiers
  Yes  
  No
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
  Yes  
  No
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site 
  Yes  
  No
3.1f) There is an 
 component to this research. 
international
International research includes sending or receiving 
human derived data or specimens (identifiable, limited data set, coded, or deidentified) to or from an 
international source.  International research does not include studies in which VA is only one of multiple 
participating sites where the overall study-wide PI is not a VA investigator.
  Yes  
  No

3.1g) This study includes 
 (not including VA-leased space or CBOC clinics) conducted 
off-station activity
under VASDHS IRB approval.  Note: this does not include research conducted by a collaborator at their home 
institution under their institutional approval.
 Yes  
 No
3.1h) VA subjects will 
 in part or in full 
 (not including VA-leased space or 
participate
at other locations
clinics) under VASDHS IRB approval. Note: if this study involves remote participation of subjects, please 
indicate "no" and describe their remote participation in section 9 of the application.  This question is intended 
to understand whether participants must physically go to a non-VA location to participate in this VA research 
study. 
 Yes  
 No
 Section 3.2 Specimen Use and Data Repository
Indicate whether or not each of the following applies to this protocol
3.2a) Involves specimens that are left over from pathological or diagnostic testing (
)
non-research specimens
  Yes  
  No
3.2b) Involves 
 purposes 
specimens collected for research
only
  Yes  
  No
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this 
specimen banking
protocol)
  Yes  
  No
3.2d) The study involves 
genotyping or other 
DNA 
genetic analysis
  Yes  
  No
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
  Yes  
  No
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
data repository
 see  before checking "yes")
IMPORTANT:
?
  Yes  
  No
3.2g)  
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 
  Yes  
  No
 Section 3.3 Treatment and Clinical Trials
Indicate whether or not each of the following applies to this protocol
3.3a) Includes a 
 component (a research treatment)
treatment
 Yes  
 No
3.3b) Study is a 
  
clinical trial. Note:  A clinical trial is a research study in which one or more human subjects 
are 
 (which may include placebo or other control) to 
prospectively assigned to one or more interventions
evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
 Yes  
 No
3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB) 
  Yes  
  No

3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
 Yes  
 No
 Section 3.4 Drugs and Devices
Indicate whether or not each of the following applies to this protocol
3.4a) 
 that require 
 action such as an Investigational New Drug (IND) approval or exemption or 510
Drugs
FDA
(k) approval.
  Yes  
  No
3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
  Yes  
  No
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
  Yes  
  No
3.4d)
 medical 
 Other
devices
  Yes  
  No
 Section 3.5 Risk and Hazards
Indicate whether or not each of the following applies to this protocol
3.5a) Study places subjects at 
(do not include risks that are due to standard care)
greater than minimal risk 
  Yes  
  No
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
  Yes  
  No
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
  Yes  
  No
3.5d) Target population has psychiatric diagnosis, behavioral complaint, or chronic pain.
 Yes  
 No
 Section 3.6 Clinical Facilities and Standard Care
Indicate whether or not each of the following applies to this protocol
3.6a) Study 
 (e.g., adds required tests run in the VA lab for study purposes; research 
uses VA clinical services
procedures concurrent with clinical care)
 Yes  
 No
3.6b) Includes procedures or drugs that will be considered part of standard care.
  Yes  
  No
3.6c) Involves 
purposes.
lab tests done for research 
  Yes  
  No

 Section 3.7 Subject Expenses and Compensation
Indicate whether or not each of the following applies to this protocol
3.7a) There may be expense or added 
or the subject's insurance.
costs to the subject 
  Yes  
  No
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial
  Yes  
  No
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed
  Yes  
  No
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
 Yes  
 No
 Section 3.8 Subject Activities
Indicate whether or not each of the following applies to this protocol
3.8a) Involves 
 completed by subjects
surveys or questionnaires
 Yes  
 No
3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
 Yes  
 No
3.8c) Involves facial 
 or audio or video 
of 
photographs
recordings 
patients
 Yes  
 No
 Section 3.9 Sponsors and Collaboration
Indicate whether or not each of the following applies to this protocol
3.9a) This research is a funded research project (commercial (industry) sponsor, NIH, VA, other).
 Yes  
 No
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
  Yes  
  No
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
  Yes  
  No
3.9c) The PI or other study staff member has a financial interest or other
related to 
 real or potential conflict 
this study.
  Yes  
  No
3.9e) This study involves 
research activities (research conducted at other institutions under the 
c llaborative 
o
authorities or approvals of the other institution/s). Note: this may include other VA and/or non-VA institutions, 
but does not include off-site VA research.
  Yes  
  No

 Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
2 years; 12/01/2020-12/01/2022
 Section 5 - Lay Language Summary
5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 
paragraph)
Veteran suicide is a national problem; social disconnection is an important contributor to suicide 
risk. This study will recruit Veterans to take part in a peer-centered group called Caring Cards 
(CC). CC gives Veterans who have a history of increased suicide risk the opportunity to make 
cards that are then sent to Veterans who are currently at high-risk for suicide. CC is an 
innovative group that was developed at VA San Diego and piloted over the past two years. Since 
its inception, several CC groups have started in various clinics at the VASDHS, as part of 
standard clinical care. This project will directly benefit Veterans and contribute to the quality of 
services provided by VA San Diego by creating a safe, creative space for Veterans with lived 
experience related to suicide risk to join together to provide messages of hope, community, and 
resilience to their peers at risk for suicide. Helping Veterans support one another provides a 
bridge for social connection, which may help prevent Veteran suicide. This intervention may also 
improve Veterans’ satisfaction with VA healthcare and engagement with mental health treatment.
 Section 6 - Specific Aims
6) Provide a statement of specific aims and 
 that serve as the basis for this protocol.  Emphasize 
hypotheses
those aspects that justify the use of human subjects.
Aim 1: Establish the feasibility and acceptability of Caring Cards for Veteran card makers and 
recipients (i.e., 70% average group attendance, > 75% average satisfaction with group 
participation and card receipt, and 70% average follow-up response). Establish feasibility and 
acceptability for optional meetup groups (i.e., 70% average meetup group attendance 
[feasibility] and > 75% average satisfaction with meetup groups [acceptability]).
Aim 2: Evaluate pre/post changes in thwarted belongingness and perceived burdensomeness 
among card-makers and recipients.
Aim 3: Evaluate pre/post changes in social connectedness and suicide risk among card makers 
and recipients.
 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
Veteran suicide is an epidemic; from 2005-2016, suicide rates have risen 26% despite increased 
prevention efforts. Suicide prevention is VA’s highest priority. Efforts to expand and develop 
innovative services are required to address this ever-growing problem. Thwarted belongingness 
and perceived burdensomeness are potent transdiagnostic social risk factors for suicide. 
Unfortunately, few interventions have directly targeted these constructs to reduce suicide risk. 
The overarching goal of this project is to refine and evaluate Caring Cards, an innovative peer-
centered intervention that aims to reduces suicide risk by promoting social recovery 
among Veterans. Inspired by caring contacts for suicide prevention and the recovery model, 
Caring Cards employs a novel approach to social recovery by leveraging Veterans’ lived 
experience with mental health conditions. In Caring Cards, Veterans compose messages of hope 
and unity by handmaking one-of-a-kind cards in outpatient groups. These cards are then sent to 
their anonymous peers who identified to be at elevated risk for suicide.
In a recent pilot study conducted by Ehret and colleagues (IRB #H190032), preliminary data 
indicate Caring Cards is highly feasible and acceptable to both Veteran card makers and 
recipients. These data also suggest Caring Cards benefits both Veteran card makers and 

recipients by providing card makers with a safe, creative space to connect with others for a 
common purpose (targeting belongingness and perceived burdensomeness), and card recipients 
peer developed cards that facilitate connection to others with similar experiences (targeting 
thwarted belongingness). Caring Cards is a scalable and low intensity, intervention that bi-
directionally targets suicide prevention and promotes social recovery among two at-risk Veteran 
populations.
Our pilot study did not have any adverse events; all (100%) of the card recipients said receiving 
the card was a positive experience. A total of 14 (77.8%) said the card had an impact on their 
experience following discharge and recovery; all “yes” responses for this item were positive. A 
total of 16 (88.9%) Veterans denied any negative aspects to receiving the card; however, one 
Veteran mentioned uncertainty about privacy (i.e., asked if the card makers knew who they 
were; interviewer confirmed their anonymity) and another mentioned they felt some negative 
emotions, as receiving the card reminded them of their hospitalization.
In addition, when surveyed, all group members (100%) said they would recommend this group to 
other Veterans. When asked if the group has positively impacted their lives, the majority (90%) 
said “yes,” one Veteran did not answer this question; none said “no.” The majority (90%) said 
they believed this group should be a permanent clinic offering. When asked how long they would 
like to stay in this group, the majority (50%) said “other,” (four Veterans wrote in an 
undetermined amount of time [e.g., “forever,” “ongoing”] and one said, “not sure”). Other 
Veterans indicated they would like to participate in the group for “more than 6 months” (10%), 
“4-6 months” (10%), and “1-3 months” (30%). No Veterans said they would like to stay in the 
group for “less than 1 month.” 
Provided the positive feedback we received from our two cohorts of Veterans (card recipients and 
makers), Caring Cards is a minimal risk intervention that is highly acceptable to Veterans at 
elevated risk for suicide. 
This simple, yet potentially powerful intervention may help to meaningfully reduce suicidal 
ideation, attempts, and completions, as well as psychiatric hospital readmissions, contact with 
psychiatric emergency services among Veterans at increased risk for suicide. We successfully 
established feasibility and acceptability of Caring Cards with Veterans discharging from 
the VASDHS' inpatient psychiatry unit (pilot project described above). In an effort to understand 
if Caring Cards is feasible and acceptable with other groups of Veterans at risk for suicide, we aim 
to examine Caring Cards with a new group of at-risk Veterans, those with inactive high-risk flags 
(card makers) and those with current high-risk flags (card recipients). 
Prior to assessing the impact Caring Cards has on VASDHS' Veterans' suicide risk within these 
two new populations, noted above, two important initial steps should be taken: 1) determine if it 
is feasible for Veterans with inactive high-risk flags to make these cards, and to send these cards 
and collect Veterans with active high-risk flags feedback, and 2) determine if these groups 
of Veterans find making and receiving these cards acceptable (i.e., satisfaction). The current 
project aims to address these initial steps, as well as preliminary examine the impact Caring 
Cards has on suicide risk and social connectedness-related constructs (i.e., thwarted 
belongingness, perceived burdensomeness, perceived rejection, lonliness, and emotional 
support) within these two groups.
Last, based on Veterans' feedback from our pilot project, we will be inviting participants to 
attend optional meet-up groups, as an opportunity to socially connect with one another. Because 
this type of group has not been examined yet, feasibility and acceptability of these groups will 
also be investigated.
 Section 9 - Design and Methods
9) Describe the research design and the procedures to be used to accomplish the specific aims of the 
project.  Provide a precise description of the planned data collection (include what systems or databases will 
be used/accessed to gather data), analysis and interpretation.  For chart review studies, include the timeframe 
of collection.  Address sample size, inclusion of women and minorities.  Define in clear terms exactly what will 
 
be done to the human subjects.
We plan to recruit a total of 80 participants- 30 Veterans with inactive high-risk flags (HRFs) for 
suicide will be recruited to serve as the Caring Cards group members (i.e., card makers), and 50 
Veterans with active HRFs will be recruited to serve as as our card recipients. We have developed 
a targeted/planned enrollment specifically to ensure the inclusion of 
and racial/ethnic 
women 
min
. 
orities The VA San Diego serves a diverse population of Veterans, including by gender, ethnicity, 

age/era and mental health and physical diagnoses. Recent data indicate that 15% of the Veterans 
accessing the clinic were females and 14% were African-American and 11% were Hispanic/Latino. 
We will systematically monitor the gender and ethnic composition of the screened and recruited 
sample and contrast proportions with known gender and ethnic composition of Veterans on the 
inactive and active high-risk for suicide list. Should substantial discrepancies present (>10%) in 
regard to the rate of those screened or enrolled compared to the anticipated rate, our 
investigative team will review procedures and identify potential remedies. Children (persons 
under the age of 18) will not be recruited into the study. 
 The VASDHS keeps record of all Veterans with inactive and active HRFs. A waiver 
:
Recruitment
of HIPAA authorization will be obtained in order to extract CPRS contact information (i.e., mailing 
address and telephone number) of Veterans with inactive and active HRFs. The study coordinator 
will mail a letter to prospective participants introducing the study (see letter attached to protocol 
submission). Per standard protocol, two weeks after the letter is sent, the study coordinator will 
contact the prospective participants by phone and invite them to be screened for potential study 
enrollment. 
For inpatient prospects, the study coordinator will consult with the PI and/or the Veteran’s 
treating inpatient teams to determine the appropriate timing of approaching Veteran on the unit. 
If appropriate, the study coordinator will conduct screening on the unit, and if agreeable to 
participate, consent and baseline assessments may be completed prior to or following discharge.
In our original protocol, we were approved to recruit participants by mailing them an introductory 
letter followed by a telephone call two weeks after the letter.
We would like to amend our approach by including recruiting participants via their providers. 
Specifically, we would like to approach VA healthcare providers/clinics (e.g., Primary Care Mental 
Health Integration, Center of Recovery Education, Mood Clinic, PTSD Clinic), with information 
about the study, asking them to share this information with their Veterans. 
Providers will share study information verbally and/or via study flyer (see below) with Veterans 
during their standard clinical interactions. If a Veteran is interested in learning more about the 
study, providers will ask their permission to have our study personnel reach out to them to 
discuss screening/enrollment. Providers will alert study personnel to interested Veterans via 
encrypted VA email or adding them as additional signers to Veterans’ CPRS progress notes.
Last, providers will inform Veterans that they can directly reach out to our study personnel if they 
are interested in participating. Contact information for personnel will be provided on our study 
flyer described below.  
To facilitate recruitment via providers, we would like to share a study flyer with providers/clinics 
so they can distribute to their Veterans. Please see attached for a draft of our flyers – one for 
card makers and one for card recipients. Moreover, we have an information flyer for providers, 
which we have included as well. 
: 
Screening
As noted above, Veterans with inactive and active HRFs will be introduced to the 
study via a letter and subsequent phone call. The study coordinator will screen potential 
participants based on the following inclusion/exclusion criteria. 
Inclusion criteria for card-makers: (1) VASDHS Veteran with an inactive high-risk flag, (2) 18 
years of age or older, (3) access to transportation to attend the group, and (4) decisional capacity.
: (1) VASDHS Veteran with an active high-risk flag, (2) 18 years 
 Inclusion criteria card recipients
of age or older, and (3) decisional capacity. 
(1) 
Exclusion criteria for card makers and recipients: 
the absence of a mailing address, working phone number, and email address, (2) inability to read 
and write in English, (3) previous or current experience as either card maker or recipient, and (4) 
currently employed by the VA San Diego. If COVID-19 precautions are in effect, Veterans will also 
be screened for access to reliable computer, tablet, or smartphone with camera and internet 
access, as well as the willingness to participate in this study remotely. Participants' decisional 
capacity for informed consent in order to meet eligibility for this study will be assessed during 
consent (separate from screening call) via the University of California San Diego Brief Assessment 
of Capacity to Consent (UBACC) will be collected by the study coordinator. 
Given that we will likely be conducting at least some of our groups via telehealth, we would like to 
amend our inclusion criteria for card makers by distinguishing between in person groups vs. 
telehealth groups for criterion #3, which will be amended to (3) access to transportation to 
attend the group (if being held in person).
We would also like to amend our exclusion criteria for card makers by adding (5) if participating 
in group via telehealth, the absence of access to reliable computer, tablet, or smartphone with 
camera and internet access.

Enrollment- Consent and Baseline Assessment: Following the screening procedures outlined 
above, Veterans will be invited to participate as either a card maker or recipient (depending on 
their HRF status). Consent and baseline assessments will be completed either via phone, VA 
Video Connect (VVC), WebEx, or in-person. If consent is obtained via phone or VVC, or WebEx, 
we will adhere to current approved guidelines (i.e., use My Health-e-Vet, using MS Azure, have 
 fax, or have the study coordinator 
Veteran send signed consent form via email, have Veterans
take a screen shot of the signed consent during their VVC or WebEx session).
Following consent, Veterans will complete a baseline assessment battery that consists of the 
following questionnaires: Beck Scale for Suicidal Ideation (BSS), Columbia-Suicide Severity 
Rating Scale (C-SSRS), Interpersonal Needs Questionnaire (INQ-15), and NIH Toolbox Adult 
Social Relationship Scales.
If a Veteran is conserved, the study coordinator will obtain their conservator's consent for study 
enrollment, as well as the assent of the conserved Veteran.  
Caring Cards Groups (Veteran card makers with inactive HRFs): Our study will include 
three groups, each with 10 Veterans; they will meet separately for 120 minutes once per week at 
the VASDHS for six months. If groups are unable to take place in-person due to COVID-19 
precautions, groups will take place using the VA-approved virtual platform, WebEx. Groups will be 
facilitated by a post-doctoral or intern-level therapist supervised by the PI, who is a licensed 
clinical psychologist. If groups are unable to meet in-person, art supplies and cards will be mailed 
to the group members at their mailing address. If groups take place remotely, this may increase 
recruitment; however, due to the scope of this pilot project, enrollment will be capped at 10 
Veterans per group (a total of 30 card makers). Group members will be assessed for suicide risk 
at enrollment and follow-up. In addition, the groups' facilitator will remind Veterans at the start of 
each group to please let them know before the end of group if they are experieicing any thoughts 
of suicide or homicide. If group is conducted virtually, the Veteran may ask the facilitator to call 
them after the group has concluded. If suicide is reported, the group's facilitator will further 
assess their risk by completing a C-SSRS; if the Veteran's C-SSRS is positive, the facilitator will 
contact the PI for further risk assessment and Safety Planning. 
: A total of six cards, one 
Sending Caring Cards (Veteran card recipients with active HRFs)
per month, for six months will be mailed. Veterans recruited from psychiatric inpatient care will 
be mailed a card within the week following their discharge; cards will be sent on a monthly basis 
thereafter. This is consistent with post-discharge caring contacts recommendations. The study 
coordinator will contact Veterans via phone two weeks after the card was sent to confirm they 
received it. Because card-recipients are receiving regular contact by VA Suicide Prevention 
Coordinators and will receive formal suicide risk assessment at enrollment and follow-up, they will 
not be directly assessed for suicide risk following the mailing of each card. 
Optional Meet-Up Groups (card makers and recipients): All study participants will be invited 
to attend one or more monthly, 120-minute optional, unstructured meetup groups at the VASDHS 
facilitated by a therapist. A total of four meet-up groups will be offered throughout the study's 
duration. Again, if COVID-19 precautions are in effect and these groups cannot meet in person, 
they will be invited to meet via WebEx. Meet-up groups will begin with an introduction to the 
purpose of the group (i.e., the facilitator will explain that this is an opportunity for the card 
makers and recipients to meet one another) followed by a review of basic group rules (i.e., limits 
of confidentiality will be reviewed, group members will be informed that they are free to come 
and go as they please, meaning they can arrive later than the designated start time and leave 
earlier than the end time, and the facilitator will be available if anyone has any questions or 
concerns). The facilitator will remind meet-up group attendees that if they are having thoughts of 
suicide or homicide, they should speak directly to them. If group is conducted virtually, the 
Veteran may ask the facilitator to call them after the group has concluded. If suicide is reported, 
the group's facilitator will further assess their risk by completing a C-SSRS; if the Veteran's C-
SSRS is positive, the facilitator will contact the PI for further risk assessment and Safety Planning. 
: All follow-up assessments will be collected in-person or via remote 
Follow-up Assessments
methods described above by the study coordinator.
Follow-up assessment battery includes: Beck Scale for Suicidal Ideation (BSS), C-SSRS “Since 
Last Contact,” Interpersonal Needs Questionnaire (INQ-15), NIH Toolbox Adult Social Relationship 
Scales, and Intervention Satisfaction Questionnaire (developed by PI).
 Veterans are expected to participate in the Caring Cards groups for six months. 
Card makers:
Follow-up assessments will be collected within one month of the last group meeting. If a card 
maker drops out prior to the group's end date, follow-up will be collected within one month the 
last group meeting they attended. 
: Follow-up assessments will be collected 
Card recipients
within one month after the delivery of the final card. If a card recipient drops out prior to this, 
follow-up will be collected within one month after the last card they received. 

 Feasibility for card makers will be assessed by the proportion of 
Feasibility & Acceptability:
enrolled Veterans who attend all scheduled Caring Cards groups. Feasibility for recipients will be 
assessed by the ratio of cards sent and received. For all participants, feasibility will be measured 
by the proportion of Veterans 1) referred for screening, 2) determined eligible, 3) enrolled
/completed baseline, and 4) complete follow-up assessments. Feasibility of the optional meet-up 
groups will also be evaluated based on average attendance. Acceptability for all participants will 
be assessed by the Intervention Satisfaction Questionnaire, a measure that will be developed by 
the research team to assesses Veterans’ satisfaction with their participation in the Caring 
Cards and meet-up groups (if attended), as well as asks for feedback about Caring Cards and 
assesses reasons for study dropout or non-attendance to meet-up groups.
: 
Participant Compensation
Participants will be paid a total of $120 to complete the baseline 
and follow-up assessment ($60 each). No recruitment will take place year two. We would like to 
pay participants $120 at baseline, or $60 at each assessment (baseline and follow-up). 
: For groups, Caring Cards is a manualized intervention and the facilitator (trained by the 
Fidelity
PI) will run the groups. The PI will review audiotapes of treatment delivery using a fidelity rating 
scale, and feedback will be shared in weekly supervision. To assess fidelity for sending cards, 
quantity, timing, and receipt of the cards will be recorded by the study’s research assistant. The 
study coordinator will monitor the accuracy of this record.
In our original protocol we were approved to use VA-approved audio recording devices to record 
the groups to ensure fidelity. Given that some groups are likely to take place via telehealth, we 
would like to amend our protocol to include recording groups via WebEx. VA WebEx has a 
recording features and for all telehealth groups, we propose to use this feature to record the 
sessions. The recordings of these WebEx groups will be stored via within the VA WebEx account 
used to facilitate the group. These recordings will be stored via password protection behind VA 
firewall and encrypted VA-specific WebEx account (i.e., veteransaffairs.webex.com). Only study 
personnel will have access to these recordings. 
12.15.21 Amenment Meet-up Groups for Former Participants: We plan to invite former 
study participants - i.e., those who have completed thier follow-up assessments, to participate in 
our optional meet-up groups. As noted above, we plan to hold 120-minute optional, unstructured 
meetup groups at the VASDHS (Rio or LJ clinics) facilitated by a therapist/research personnel. 
One to four meet-up groups may be offered throughout the study's duration. Meet-up groups will 
begin with an introduction to the purpose of the group (i.e., the facilitator will explain that this is 
an opportunity for the card makers and recipients to meet one another) followed by a review of 
basic group rules (i.e., limits of confidentiality will be reviewed, group members will be informed 
that they are free to come and go as they please, meaning they can arrive later than the 
designated start time and leave earlier than the end time, and the facilitator will be available if 
anyone has any questions or concerns). The facilitator will remind meet-up group attendees that 
if they are having thoughts of suicide or homicide, they should speak directly to them. If group is 
conducted virtually, the Veteran may ask the facilitator to call them after the group has 
concluded. If suicide is reported, the group's facilitator will further assess their risk by completing 
a C-SSRS; if the Veteran's C-SSRS is positive, the facilitator will contact the PI for further risk 
assessment and Safety Planning. 
Former participants who agreed at consent to be re-contacted will be called via telephone and 
invited to join these optional meet-up groups. See telephone script. In addition feasibility and 
acceptability data will be collected from those who join. Specifically, we will record attendance 
(feasibility) and one to two weeks following the final meet-up group offered, former participants 
will be called and invited to answer follow-up questions based on their participation the meet-up 
groups (acceptability). See script.  
 Section 9.8 Questionnaires & Surveys
9.8) Provide the name and a reference for questionnaires/surveys that are standard or identify them here and 
attach a copy of the questionnaire/survey.  Questionnaires or surveys that are not clinical standard references 
must be uploaded.  Reference the help link for additional information related to surveys administered to VA 
 
personnel and approved platforms for web-based surveys.
1) University of California San Diego Brief Assessment of Capacity to Consent
Jeste DV, Palmer BW, Appelbaum PS. A new brief instrument for assessing decisional capacity for
clinical research. Archives of general psychiatry. 2007;64(8):966-974.
2) Columbia-Suicide Severity Rating Scale (C-SSRS)

Posner K, Brent D, Lucas C. Columbia-suicide severity rating scale (C-SSRS). New York, NY: 
Columbia
University Medical Center;2008.
3) Beck Scale for Suicide Ideation (BSS)
Beck, A. T., Kovacs, M., & Weissman, A. (1979). Assessment of suicidal intention: the Scale for 
Suicide Ideation. Journal of consulting and clinical psychology, 47(2), 343.
4) Interpersonal Needs Questionnaire (INQ-15)
Van Orden KA, Cukrowicz KC, Witte TK, et al. Thwarted belongingness and perceived 
burdensomeness:
Construct validity and psychometric properties of the Interpersonal Needs
Questionnaire. Psychological assessment. 2012;24(1):197-215.
5) NIH Toolbox Adult Social Relationship Scales
Cyranowski JM, Bode R, Butt Z, et al. Assessing social support, companionship, and distress: 
National
institute of health (NIH) toolbox adult social relationship scales. Health psychology. 2013;32(3):
293-
301.
6) C-SSRS “Since Last Contact”
Posner K, Brent D, Lucas C. Columbia-suicide severity rating scale (C-SSRS). New York, NY: 
Columbia
University Medical Center;2008.
7) Intervention Satisfaction Questionnaire
- Will be developed and added as an amendment to protocol by the research team. 
8) Telephone screening Questions (developed by PI; attached to protocol submission)
 Section 9.9 Data Safety Monitoring Board or Plan
9.9) Provide a Data Safety Monitoring Plan (DSMP) or the details of a Data Safety Monitoring Board; if a 
written plan is available, attach a copy of the plan to the submission form.
Monitoring of Suicidal Ideation: This is a challenging aspect the study and so we have developed 
our procedures to be consistent with the recommendations of organizations such as NIH in 
clinical research in people with elevated suicide risk (e.g., Issues to Consider in Intervention 
Research with Persons at High Risk for Suicidality). We will further refine our procedures by use 
of deployment focused discussions with stakeholders in the study start up phase and in 
collaboration with the Data Safety Monitoring board. The referral sources for this study are 
VASDHS’ Veterans with inactive and active high-risk suicide flags. Veterans with active high-risk 
suicide flags are closely monitored and regularly assessed for suicide risk by the VASDHS’ 
Suicide Prevention Coordinator (SPCs). At baseline, participants are administered the C-SSRS55. 
Veterans are informed during consenting that all suicidal behavior is documented in Suicide 
Behavior Reports in CPRS if not already entered. If ideation exceeds a score of 2, the PI will be 
contacted and will perform a telephone evaluation and refer the screened potential participant to 
the SPCs or emergency services as necessary. Our safety monitoring guide details these 
procedures, how they are recorded, and what the staff, facility, and investigator responsibilities 
are. All Veterans are provided the contact information for the Veterans’ Crisis Line. Any new 
suicidal behavior will be documented in the Suicide Behavior and Overdose Report in CPRS by 
research staff. Participants who elect to withdraw from the study will continue to receive suicide 
prevention services per VA San Diego’s protocol. We will monitor these protocols during the 
course of the study and will make adjustments to inclusion/exclusion criteria or safety protocol in 
case of adverse events. 
All research personnel will complete VA TMS trainings pertinent to suicide prevention.
Confidentiality: In order to protect confidentiality, all participant data will be de-identified by 

assigning each participant a unique ID in computer files, and all physical files from the study will 
be kept in a locked cabinet in study offices at the Veterans Medical Research Foundation building 
in San Diego. All electronic data and files will be stored on a secure server. Only study 
investigators and personnel will have access to these data. All documentation will identify 
participants only by their Unique ID number and not other personally identifying information. 
 Section 9.11 Pictures and Audio/Video Recordings of Patients
9.11) Describe the purpose of photographs (facial), or audio, or video recordings of patients.  Describe 
whether the recordings will contain, or potentially contain, identifiers.  Note: use of photographs or recordings 
must be covered in the informed consent process and documented consent documents (e.g., consent form, 
information sheets, telephone screen scripts).
To ensure fidelity of the Caring Cards groups, the PI will review audiotapes of the group leader's 
treatment delivery using a fidelity rating scale; feedback will be shared with the group leader in 
weekly supervision. Audio recordings of the Caring Cards groups will contain Veterans speaking; 
Veterans in the group may say the names of one another; however, other identifying information 
(e.g., SSN) will likely not be shared out loud by group members. 
The delivery of the assessments (baseline and follow-up) will also be audio recorded for quality 
assurance and fidelity. 
In our original protocol we were approved to use VA-approved audio recording devices to record 
the groups to ensure fidelity. Given that some groups are likely to take place via telehealth, we 
would like to amend our protocol to include recording groups via WebEx. VA WebEx has a 
recording features and for all telehealth groups, we propose to use this feature to record the 
sessions. The recordings of these WebEx groups will be stored via within the VA WebEx account 
used to facilitate the group. These recordings will be stored via password protection behind VA 
firewall and encrypted VA-specific WebEx account (i.e., veteransaffairs.webex.com). Only study 
personnel will have access to these recordings.
 Section 9.12 Off Station Activities
9.12) Describe each off-station activity including where it occurs, subject involvement, and any additional 
required protections.  Note:  if the off-station activity is being conducted under the approval authority of another 
institution, this is not VA offsite research and should be described as collaborative research effort.  Please contact 
the HRPP office if you have any questions
Off-station activities will only apply if COVID-19 precautions are still in effective and participants 
cannot safely participate in the study in-person. 
In this case, off-station activity (e.g., Veterans' homes) will refer to: 1) Caring Cards group 
participation via WebEx, 2) optional meet-up groups via WebEx), and 3) collection of 
assessments via phone, VVC, or WebEx.
 Section 10 - Human Subjects
10) Describe the characteristics of the proposed subject population. Include age, gender, ethnicity, and health 
status as appropriate.  Note: Data about people are still considered “human subjects” by the IRB, so even if you 
do not intend to contact the patients whose charts you will review, you still describe the characteristics related to 
   
the subjects whose charts you will review.
Provide inclusion and exclusion criteria as appropriate.  Provide a statement how non pregnancy is 
confirmed if pregnancy is an exclusion criteria.
For multisite studies, provide the total number of subjects from all sites and include description of the 
local site's role as a coordinating center if applicable.
Indicate the number of VA participants to be studied.
Indicate the estimated number of 
 subjects that will fail the screening process, if any.
consented
The subject population in this study will be a total of 80 male and female Veterans (30 with 

inactive high-risk suicide flags and 50 current high-risk suicide flag). Potentially eligible 
participants will be screened by research staff. Our inclusion and exclusion criteria were selected 
in order to increase the generalizability of our sample and broad reach. Participants will be of 
either gender and any race/ethnicity, decisional capacity, and at least 18 years of age. Complete 
Inclusion/Exclusion Criteria are as follows:
Inclusion criteria for card makers: (1) VASDHS Veteran with an inactive HRF, (2) 18 years of age 
or older, (3) access to transportation to attend the group, and (4) decisional capacity.
Inclusion criteria for card recipients: (1) VASDHS Veteran with an active high-risk flag, (2) 18 
years of age or older, and (3) decisional capacity.
Exclusion criteria for all participants : (1) the absence of a mailing address or working phone 
number, (2) inability to read and write in English, (3) previous or current experience as either a 
card maker or recipient (in original pilot project), and (4) currently employed by the VA San 
Diego.
If COVID-19 precautions are in effect, Veterans will also be screened for access to reliable 
compter, tablet, or smartphone with camera and internet access, as well as the willingness to 
participate in this study remotely. Participants' decisional capacity for informed consent in order 
to meet eligibility for this study will be assessed during consent (separate from screening 
call) via the University of California San Diego Brief Assessment of Capacity to Consent 
(UBACC) will be collected by the study coordinator. 
 Section 10.2 Pregnant Women
10.2a) Are pregnant women the focus of the research?
  Yes  
  No
10.2b) Provide the justification for including pregnant women and address any special risks, protections, and 
safeguards.
Being pregnant is not an exclusion criterion for this study; they are not an explicit focus of this 
research. There are no risks associated with this study that would apply specifically to pregnant 
women.
 Section 11 - Recruitment
11) Describe, step-by-step, the plans for recruitment of subjects (or selection of subjects as in record review). 
This description must include how, when, and where potential subjects are approached as well as procedures 
for identifying potential participants (through medical records, physician referral, third-party 
sources, etc.).  Include how selection is equitable.  Indicate if vulnerability to coercion may be present and if so 
plans to ensure voluntary participation.
Recruitment: The VASDHS keeps record of all Veterans with inactive and active HRFs. A waiver 
of HIPAA authorization will be obtained in order to extract CPRS contact information (i.e., mailing 
address and telephone number) of Veterans with inactive and active HRFs. A letter to prospective 
participants introducing the study (see letter attached to protocol submission) will be sent. 
Letters to Veterans with inactive HRFs will be sent by the Chief of Psychology, Eric Granholm, 
who is a co-I of this project. Letters sent to Veterans with active HRFs will be sent by their 
Suicide Prevention Coordinators who are in regular contact with HRF Veterans (via phone and 
mail). Per standard protocol, two weeks after the letter is sent, the study coordinator will contact 
the prospective participants by phone. 
For inpatient prospects, the study coordinator will consult with the PI and/or the Veteran’s 
treating inpatient teams to determine the appropriate timing of approaching Veteran on the unit. 
If appropriate, the study coordinator will conduct screening on the unit, and if agreeable to 
participate, consent and baseline assessments may be completed prior to or following discharge.

In our original protocol, we were approved to recruit participants by mailing them an 
introductory letter followed by a telephone call two weeks after the letter.
We would like to amend our approach by including recruiting participants via their providers. 
Specifically, we would like to approach VA healthcare providers/clinics (e.g., Primary Care Mental 
Health Integration, Center of Recovery Education, Mood Clinic, PTSD Clinic), with information 
about the study, asking them to share this information with their Veterans. 
Providers will share study information verbally and/or via study flyer (see below) with Veterans 
during their standard clinical interactions. If a Veteran is interested in learning more about the 
study, providers will ask their permission to have our study personnel reach out to them to 
discuss screening/enrollment. Providers will alert study personnel to interested Veterans via 
encrypted VA email or adding them as additional signers to Veterans’ CPRS progress notes.
Last, providers will inform Veterans that they can directly reach out to our study personnel if 
they are interested in participating. Contact information for personnel will be provided on our 
study flyer described below. 
To facilitate recruitment via providers, we would like to share a study flyer with providers/clinics 
so they can distribute to their Veterans. Please see attached for a draft of our flyers – one for 
card makers and one for card recipients. Moreover, we have an information flyer for providers, 
which we have included as well.
 Section 11.1 Recruitment Materials
11.1) Identify all recruitment materials (flyers, advertisements, letters, etc.) that will be used; include the web 
address for any web-based advertisements. The text of all communications with prospective participants must 
be reviewed and approved by the IRB before it can be used.  You will be reminded to attach copies of 
recruitment materials to the initial submission packet.  Note:  Posting of flyers with pull tabs is not permitted 
within VASDHS (including the VMRF building).  However, you may request to advertise on the e-boards (located 
 
at the elevators and throughout the facility) or on the VASDHS Research Opportunities web-page.
Below are the two introductory letters that will be mailed to each set of prospective participants 
(i.e., Veterans with inactive HRFs and active HRFs). 
Introductory Letter for Caring Cards Study 
Card Makers (Inactive HRF)
XX/XX/20XX
Dear [INSERT VETERAN’S NAME],
My name is Dr. Eric Granholm. I am the Chief of Psychology at the San Diego VA. The reason for 
my letter is to inform you about a new research study taking place at the San Diego VA. Based 
on our records, you were identified as someone who may be eligible to participate. 
The study is called “Caring Cards.” This project focuses on creating opportunities for Veterans to 
help other Veterans who share similar mental health experiences. 
What is Caring Cards?
Caring Cards is a project where Veterans with lived mental health experience create handmade, 
one-of-a-kind cards that are sent to Veterans who may be in need of extra support. 
We would like to invite you join a weekly group where you and other Veterans will make caring 
cards for your fellow Veterans. These cards will then be sent to anonymous Veterans at the San 
Diego VA; they will not know your identity.
Caring Cards Group
Caring Cards group will meet once per week for 2 hours for 6 months. Groups will be held at 
either the main San Diego VA hospital in La Jolla or at one of our Mission Valley clinics. You may 
choose which location is most convenient for you. If we are unable to safely meet in person due 
to COVID-19, the groups may meet remotely (i.e., WebEx or VA Video Connect). 
These groups are considered to be a standard clinical service, so you may be eligible to receive 
travel reimbursement for your attendance. 
What would I need to do if I participated?

If you are eligible and choose to be in the study, you will be asked to participate for 
approximately 7 months. During this time, you will be asked to attend weekly Caring Cards 
groups. Each group will last 2 hours. Groups will meet for a total of 6 months. 
In addition to participating in these groups, you will be asked to complete two sets of 
questionnaires to help us determine your satisfaction with making these cards and how your 
participation in this group made you feel. Each set of questionnaires take about 30-45 minutes to 
complete. The first set will be completed at the start of the study, soon after you enroll, and the 
other at the end of the study, approximately 7 months from when you enroll. You may complete 
these assessments either in person, which can be scheduled at your convenience, or by phone, 
WebEx, VA Video Connect, or online. 
You will also be invited to attend one or more monthly, 2-hour meet-up groups at the San Diego 
VA (La Jolla). These groups are completely optional, and you do not have to attend them as part 
of your participation in this study. These groups are meant to give Veterans who created the 
cards the opportunity to meet the Veterans who receive the cards. A total of four meet-up 
groups will be offered. Again, if COVID-19 precautions are in effect and these groups cannot 
meet in person, they will be held via WebEx or VA Video Connect. 
As a thank you for your participation and taking the time to answer the two sets of 
questionnaires, you can earn up to $120 ($60 for each set of questionnaires completed). 
Will my information be kept secure?
We will keep your answers confidential and will not share your personal information with anyone 
outside of our research team. Participation in this study may involve a loss of privacy, but 
information about you will be handled as confidentially as possible. Your survey responses will be 
identified by a randomly generated number that will not be associated with any of your 
identifying information. Any research records that identify you will be kept only as paper records 
in a secure San Diego VA location or as electronic files behind the secure San Diego VA computer 
firewall.
What happens after this letter?
In approximately two weeks, a member of our research team will reach out to you by phone to 
determine if you’re interested in participating in this study. Participating in this study is optional. 
If you do not want us to call you, please feel free to let me know by calling me at the telephone 
number below, or you may decline via phone when the research team member reaches out.
Questions? 
If you have questions, suggestions, or concerns regarding this study, or if you do not want us to 
contact you by phone to determine your interest and eligibility to participate in this study, please 
let me know. 
You may reach my research associate, Dr. Blaire Ehret, who is facilitating this study, at 619-228-
8080. 
If you have any questions or concerns about your rights as a research subject, the validity of a 
research study, or research personnel you can contact the Research Compliance Officer at 858-
642-3817, VA Research Service at 858-642-3657, VA Regional Counsel at 858-642-1540, or the 
VASDHS Institutional Review Board at 858-642-6362. This is the Board that is responsible for 
overseeing the safety of human participants in this study.
Best,
Eric
Eric Granholm, Ph.D.
Chief of Psychology, VA San Diego Healthcare System
Introductory Letter for Caring Cards Study
Card Recipients (Active HRF)
XX/XX/20XX
Dear [INSERT VETERAN’S NAME],
My name is [INSERT SPC'S NAME]. I am your suicide prevention coordinator at the San Diego 
VA. The reason for my letter is to inform you about a new research study taking place at the San 
Diego VA. Based on our records, you were identified as someone who may be eligible to 
participate. 

The study is called “Caring Cards.” This project focuses on creating opportunities for Veterans to 
help other Veterans who share similar mental health experiences. 
What is Caring Cards?
Caring Cards is a project where Veterans with lived mental health experience create handmade, 
one-of-a-kind cards that are sent to Veterans who may be in need of extra support. 
We would like to send you a series of these caring cards (one card every month for 6 months). 
These cards will be made by anonymous Veterans at the San Diego VA; they will not know your 
identity.
What would I need to do if I participated?
If you are eligible and choose to be in the study, you will be asked to participate for 
approximately 7 months. During this time, you will be asked to complete two sets of 
questionnaires to help us determine your satisfaction with receiving these cards and how the 
cards may make you feel. Each set of questionnaires take about 30-45 minutes to complete. The 
first set will be completed at the start of the study, soon after you enroll, and the other at the 
end of the study, approximately 7 months from when you enroll. 
You may complete these assessments either in person, which can be scheduled at your 
convenience, or by phone, WebEx, VA Video Connect, or online. 
You will also be invited to attend one or more monthly, 2-hour meet-up groups at the San Diego 
VA (La Jolla). These groups are completely optional, and you do not have to attend them as part 
of your participation in this study. These groups are meant to give Veterans who receive cards 
and opportunity to meet the Veterans who made the cards. A total of four meet-up groups will 
be offered. Again, if COVID-19 precautions are in effect and these groups cannot meet in person, 
they will be held via WebEx or VA Video Connect. 
As a thank you for your participation and taking the time to answer the two sets of 
questionnaires, you can earn up to $120 ($60 for each set of questionnaires completed). 
Will my information be kept secure?
We will keep your answers confidential and will not share your personal information with anyone 
outside of our research team. Participation in this study may involve a loss of privacy, but 
information about you will be handled as confidentially as possible. Your survey responses will be 
identified by a randomly generated number that will not be associated with any of your 
identifying information. Any research records that identify you will be kept only as paper records 
in a secure San Diego VA location or as electronic files behind the secure San Diego VA computer 
firewall.
What happens after this letter?
In approximately two weeks, a member of our research team will reach out to you by phone to 
determine if you’re interested in participating in this study.
Participating in this study is optional. If you do not want us to call you, please feel free to let me 
know by calling me at the telephone number below, or you may decline via phone when the 
research team member reaches out.
Questions? 
If you have questions, suggestions, or concerns regarding this study, or if you do not want us to 
contact you by phone to determine your interest and eligibility to participate in this study, please 
let me know. 
You may reach my research associate, Dr. Blaire Ehret, who is facilitating this study, at 619-228-
8080. 
If you have any questions or concerns about your rights as a research subject, the validity of a 
research study, or research personnel you can contact the Research Compliance Officer at 858-
642-3817, VA Research Service at 858-642-3657, VA Regional Counsel at 858-642-1540, or the 
VASDHS Institutional Review Board at 858-642-6362. This is the Board that is responsible for 
overseeing the safety of human participants in this study.
Best,
[INSERT SPC'S NAME]
[INSERT SPC'S NAME]
Suicide Prevention Coordinator, VA San Diego Healthcare System
Flyers:

Card Makers
Caring Cards to and from Veterans
A Peer Approach to Suicide Prevention
Researchers at the VA San Diego are studying a group therapy that focuses on Veterans helping 
other Veterans by making cards with messages of hope and support. 
Research is always voluntary! 
Would this study be a good fit for me? 
The study may be a good fit if you: 
• Have an interest in helping other Veterans.
• Like connecting with other Veterans for a common purpose. 
• Enjoy drawing, writing, and being creative.
What would happen if I participated? 
You would: 
• Attend weekly sessions of a card making group, delivered via WebEx or in person for six 
months.
• Complete a set of assessments at the beginning and end of your participation.
• Allow study staff to audio record your group sessions. 
• Be compensated $60 for each set of assessments you attend (up to $120 total). 
For more information or to sign up for this study,
contact Dr. Blaire Ehret at (619) 800-6707 or (619) 228-8080.
You can also talk to the provider who gave you this flyer.
Card Recipients
Caring Cards to and from Veterans
A Peer Approach to Suicide Prevention
Researchers at the VA San Diego are studying if anonymous cards made by Veterans help other 
Veterans.
Research is always voluntary! 
Would this study be a good fit for me? 
The study may be a good fit if you: 
• Would enjoy receiving anonymous cards from other Veterans.
• Would like to connect with other Veterans.
What would happen if I participated? 
You would: 
• Receive six cards via mail for six months (one card per month).
• Complete a set of assessments at the beginning and end of your participation.
• Be compensated $60 for each set of assessments you attend (up to $120 total). 
For more information or to sign up for this study,
contact Dr. Blaire Ehret at (619) 800-6707 or (619) 228-8080.
You can also talk to the provider who gave you this flyer.
Providers
Caring Cards to and from Veterans:
A Peer Approach to Suicide Prevention and Recovery
Researchers at the VA San Diego are studying if anonymous cards made by Veterans with a 
history of elevated suicide risk help Veterans with current elevated suicide risk. We are seeking 
referrals for card makers and recipients!
Card Makers 
Inclusion criteria:
• VA San Diego Veteran with an inactive high-risk flag for suicide
• 18 years of age or older
• Access to transportation to attend groups (if held in person; groups may be held via telehealth 

due to COVID-19)
• Decisional capacity
Exclusion criteria:
• Absence of a mailing address or working phone number
• Inability to read and write in English
• Previous experience as either a card maker or recipient 
• Currently employed by the VA San Diego
• If groups are held via telehealth, the absence of access to reliable computer, tablet, or 
smartphone with camera and internet access
What would being a card maker entail?
Veterans would meet weekly for 120-minutes for six months. In the group meetings they would 
connect with other Veterans and anonymously create caring cards for the card recipients 
described below. 
Card Recipients
Inclusion criteria:
• VA San Diego Veteran with an active high-risk flag for suicide
• 18 years of age or older
• Decisional capacity
Exclusion criteria:
• Absence of a mailing address or working phone number
• Inability to read and write in English
• Previous experience as a card recipient 
• Currently employed by the VA San Diego
What would being a card recipient entail?
Veterans would receive six cards via mail for six months (one card per month).
All participants will:
• Complete a set of brief baseline and follow-up assessments.
• Be compensated $60 for each assessment (up to $120 total). 
For more information, please contact Blaire Ehret, Ph.D.
Phone: (619) 800-6707 or (619) 228-8080
Email: Blaire.Ehret@va.gov
 Section 12 - Informed Consent
12) Indicate whether or not each category of consent is involved in this study:
12a) Will the study team obtain information or biospecimens for the purpose of screening, recruiting, or 
determining the eligibility of prospective subjects without (or prior to) obtaining informed consent of the 
prospective subject or the prospective subject’s LAR?
 Yes  
 No
Check one or both of the below boxes if they apply to this study:
Information will be obtained through oral or written communication with the prospective subject or the subject’s 
Legally Authorized Representative (LAR) and this is not a FDA regulated study.
 Yes  
 No
Identifiable information or biospecimens will be obtained by accessing records or stored identifiable 
biospecimens and this is not an FDA regulated study.
 Yes  
 No
If either or both of the above boxes is checked "yes", an informed consent waiver does not have to be requested 
 if the protocol is initially approved after 01/01/2019 or if it has been converted to the 
for this activity
2018 Common Rule requirements. However, a request for a HIPAA waiver will still need to be requested and 
informed consent obtained for any research interventions after eligibility is established.  Otherwise, waivers of 
consent and authorization must be requested for this activity.  Waivers of consent and authorization are 
required for screening purposes for FDA regulated research. 

12b) 
 informed consent
Signed
 Yes  
 No
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral 
  Yes  
  No
12d) Request for a 
 of consent for all or some study activities.
waiver
  Yes  
  No
12e) Alteration of 
 of consent.
other required elements
  Yes  
  No
12f) 
assent to participate (Director approval will be required)
Child 
  Yes  
  No
12g) Will any language 
 be used by those obtaining consent and understood by the 
other than English
prospective participant or the legally authorized representative?
  Yes  
  No
12h) 
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
 Yes  
 No
12i) 
 consent (legally authorized representative)
Surrogate
 Yes  
 No
 Section 12.1 Informed Consent Process
12.1a) Will consent be obtained before any study procedures are performed (including screening procedures 
 
except screening procedures with Consent and/or HIPAA waiver when required)?
 Yes  
 No
12.1b) Will the information being communicated to the participant or legally authorized representative 
during the consent process include exculpatory language through which the participant or legally authorized 
representative is made to waive or appear to waive any of the participant’s legal rights or release or appear to 
release the Researcher, Sponsor, the VA or its agents from liability for negligence.
  Yes  
  No
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
 Agree
 Disagree
12.1d) Identify the circumstances under which consent will be obtained including where the process will take 
place; any waiting period between describing the research and obtaining consent including sufficient time for 
the prospective participant to consider participation, and any steps taken to minimize the possibility of 
coercion or undue influence.
An introductory letter will be sent to all prospective participants, describing the research (see 
11.1 Ads & Flyers for details). Letters to Veterans with inactive HRFs will be sent by the Chief of 
Psychology, Eric Granholm, who is a co-I of this project. Letters sent to Veterans with active 
HRFs will be sent by their Suicide Prevention Coordinators who are in regular contact with HRF 
Veterans (via phone and mail).

Prospective participants will have approximately two weeks to consider participation. Following 
two weeks from the date the letter was sent, a member of the research team will reach out to 
the Veteran via phone to determine if they are interested in being screened for the study. To 
minimize the possibility of coercion or undue influence, the letters do not guarantee Veterans 
any direct benefits and clearly state participation in the study is options. There is also 
information in the letter for Veterans to opt out of being called by a member of the research 
team, as well as contact information the local Research Compliance Officer, VA Research Service, 
VA Regional Counsel and the VASDHS Institutional Review Board should they have any questions 
or concerns about this study or their prospective participation. 
For all study prospective participants, after they have been screened, determined to be eligible 
to participate, and agree to participate, a member of the research team (e.g., study coordinator) 
will obtain Veterans' consent to participate in the study and assess decisional capacity for 
informed consent at this time. Consent may be obtained in person (at VA San Diego La Jolla or 
Rio clinic locations), via phone, WebEx, or VA Video Connect. As previously mentioned, if consent 
if obtained remotely, we will adhere to current approved guidelines (i.e., use My Health-e-Vet, 
using MS Azure, have Veteran send signed consent form via email, have Veterans fax, or have 
the study coordinator take a screen shot of the signed consent during their VVC or WebEx 
session).
For inpatient prospects, the study coordinator will consult with the PI and/or the Veteran’s 
treating inpatient teams to determine the appropriate timing of approaching Veteran on the unit. 
If appropriate, the study coordinator will conduct screening on the unit, and if agreeable to 
participate, consent and baseline assessments may be completed prior to or following discharge.
If a Veteran is conserved, the study coordinator will obtain their conservator's consent for study 
enrollment, as well as the assent of the conserved Veteran. 
Due to the persistence of the COVID-19 pandemic, we plan to enroll participants via telehealth. 
In our original protocol, we received approval to obtain consents via telehealth. Per our original 
protocol, “If consent is obtained via phone or VVC, or WebEx, we will adhere to current approved 
guidelines (i.e., use My Health-e-Vet, using MS Azure, have Veteran send signed consent form 
via email, have Veterans fax, or have the study coordinator take a screen shot of the signed 
consent during their VVC or WebEx session).” We would like to amend this approach to include 
obtaining consent via the WebEx File Transfer feature. Below are the procedures that will be 
taken to obtain consent via this method. 
Webex Consent Appointment (for participant on laptop/computer)
1. Go to your Personal Room by visiting its URL on your computer’s browser outside of your 
remote connection/CAG and click Join Meeting. 
a. https://veteransaffairs.webex.com/meet/first.lastname
2. Go to your Personal Room by visiting its URL on the browser inside your remote connection 
(CAG).
3. Allow your outside connection entrance into the meeting
4. In the WebEx app inside your CAG connection, 
a. click the red X, select Leave Meeting, 
b. Select a New Host —> select your outside account 
This will transfer hosting privileges to your non-CAG connection and allow you to run the meeting 
outside of a VA connection.
5. Invite your participant
a. Hit button with 3 dots “More options”
b. Click “Invite and remind”
c. Type in participants email address and hit send 
6. Call participant phone-to-phone and help them with downloading process, can let them know 
they do not need to enable audio or video
7. Obtain location, phone information and emergency contact at start of call
8. Documents to have open inside your citrix desktop
(Fill out participant’s name and the date prior to appt.)
a. HIPPA
i. Need signatures on PAGES 4 & 5
b. Informed Consent
i. Need signatures on PAGES 5 & 6
c. Bill of Rights
d. Vendor Form (if participant is not vendorized)
e. UBACC
Instructions for sharing inside Citrix
9. After participant joins webex—> RA shares screen from outside of Citrix by clicking “Share 
Window” and chooses “Citrix Workspace” desktop
a. Informed consent & HIPPA inside your Citrix desktop should appear on screen

10. Read through informed consent with participant
11. Conduct UBACC to confirm decisional capacity
12. Once decisional capacity is determined and Veteran agrees to be enrolled, set up the 
document to allow participant to sign the consent
a. Participant will sign and date the consent form by clicking “Sign” on adobe
i. This is done by clicking “Add Signature +” 
ii. Clicking the “Draw” tab
iii. Inform them of the slight delay
13. Have participant gain control of the RA’s screen
Option 1:
a. Once sharing your citrix screen, go to orange box on top of the screen and click assign
b. Choose “Pass keyboard and mouse control”
c. Choose participant’s name
Option 2:
a. Have participant gain control by clicking “Ask to Control” button in the left-hand side of their 
screen (2nd button from the top)
14. RA grants control either way
a. Participant uses their mouse to draw their signature
b. Participant places their drawn signature on the line on page “Subject’s Signature”
15. RA takes back control by going back to the assign button in the orange box and unclicking 
the participants name/ or having the participant push ESC / or by stopping the screen share 
16. RA saves the document into participant folder
17. Read through HIPAA with participant
a. Either repeat steps 11-14, or ask permission from participant to use their signature that was 
saved from their last signature
b. Save the form into the participant folder
18. Read through Participant’s bill of rights
19. Fill out vendor form with participant *if not vendorized
20. Fill out Screen packet with participant 
Inform them of their options to 1) have control shifted to them again so they can fill out the 
packet on their own, or 2) indicate to the RA which answers to put
21. End screen share
22. Conduct 
a. Instructions and fillable form open 
23. Re-join Webex from inside your citrix connection 
a. Hit file —> transfer
i. Select Informed Consent, HIPAA, and Bill of Rights over to participant
ii. Have them click on each file and hit “Download”
24. End Appointment
If participant is using phone or tablet:
Follow steps 1-12 above, then
13. Have participant click the “annotate” option. (it is a squiggly line button for them)
14. Have participant adjust width and color of the pen tool and then draw their signature and 
place it onto appropriate areas
15. Ensure a blank word document is open and that the page you are screenshotting is zoomed 
to view entire page
PC: Take a screenshot by hitting “Print Screen” and have screenshot appear in the word 
document, can save as pdf, crop the sides, and combine into original consent or HIPAA materials
MAC:
a. From inside citrix, ensure that your WebEx screen shows the adobe document
i. Go into that word document
ii. Hit insert —> Screenshot —> screen clipping
iii. Take screen clipping of desired page
iv. Ensure screen clipping inserts into the open word document
v. Can save as pdf, crop the sides, and combine into original consent or HIPAA materials
16. Complete these steps for necessary pages in both HIPAA and Consent Packet, ensuring to 
review with participant. Resume @ step 17
17. Print out and mail informed consent documents
—
The study investigators are requesting to use DocuSign (eSig) to consent participants. We 
received approval to use DocuSign (eSig) by ORD on 2/3/2021. 
ORD is providing us with 150 envelopes for this study. We've been instructed to work with our 
local IRB/research office to integrate the SOPs, which have been sent to the IRB team, into the 
local processes. I have corresponded with Debra Van Etten about next steps for setting up this 
process. 
Below are the steps the research team will take to use DocuSign (eSig) to consent participants:

1) Potential subjects will be mailed our IRB approved introductory letter explaining the study and 
providing a study staff contact phone number. (These letters have already been IRB approved for 
both card makers and recipients).
2) During the screening phone call with the potential subject (scripts have already been IRB 
approved), if the potential subject screens eligible and is interested in learning more about the 
study, the study team member will schedule a time to go over study documents (Informed 
Consent Form and HIPAA Authorization [or combined ICF/HIPAA]) using DocuSign. 
3) At the time of remote consenting, the study team member/consenter will send a DocuSign 
envelope (email containing links to the study documents) to the potential subject. The email will 
contain a reminder for the recipient to not sign the documents prior to the scheduled contact 
time. (See “Email Script” and “Stand Alone eSig service SOP,” section 3 [attached and 
highlighted for reference]).
4) At the scheduled time, the study team member (referred to as “consenter”) will contact the 
potential subject via phone, VA Video Connect (VVC), or other approved secure communication 
method (i.e., WebEx). The consenter will guide the potential subject to open the DocuSign 
envelope (email) and the linked study documents therein. The consenter will open a copy of the 
study documents on their own computer as a reference. The consenter will review the study 
documents with the potential subject, ask questions to gauge comprehension, and answer any 
questions and concerns. If the potential subject agrees to participate in the study, the consenter 
will guide them to fill in the fields in the study documents (e.g., “Last, First, Middle Initial” name 
field, Last 4 SSN field, etc.) and to sign the documents. When the subject has signed the 
documents, they will click “FINISH” to finalize the documents.
5) While still on the phone/VVC (or other approved secure communication method, i.e., WebEx) 
with the subject, the consenter will receive an email notification to log into DocuSign. The 
consenter will verify that all fields are completed accurately and, if necessary, subsequently sign 
the document(s) (e.g., ICF). The consenter will guide the subject on how to download a copy
(ies) of the signed document(s) to the subject’s personal computer for their record. The 
consenter will thank the subject and end the call. 
6) The consenter will download a copy(ies) of the signed document(s) (see “Stand Alone eSig 
service SOP,” section 3) to a study folder in VA network drive (i.e., R:\Ehret) as study record. If 
necessary, the consenter can sign the ICF and save it back to this folder. The consenter will also 
place another copy(ies) of the signed document(s) in another study-specific folder (e.g. W:\) for 
HIMS to upload the documents into Electronic Health Record (EHR; i.e., VistA/CPRS or Cerner) 
(or other ways as agreed upon by local HIMS). The consenter should notify HIMS that the 
documents need to be placed in the EHR (per local agreement). The consenter will then check 
the EHR one week later to ensure the documents have been uploaded. If the documents have 
been uploaded, the consenter will remove the documents from the W:\ drive. If the documents 
have not been uploaded within one week, the consenter will re-notify HIMS to upload the 
documents into the EHR.
7) The consenter will document the consenting process as a “Research/Informed Consent” note 
in the subject’s medical record (in CPRS). The note will specify that consent was obtained over 
phone/VVC/WebEx and DocuSign on the specific date. HIMS will attach the signed documents to 
this note.
 Section 12.6 Decisional Capacity Assessment
12.6a) Describe the method(s) for determination of decisional capacity: (see  for guidance)  
?
Please note that 
 
documentation of the assessement is required.
Participants must have decisional capacity for informed consent in order to meet eligibility for 
this study. To ensure this, the University of California San Diego Brief Assessment of Capacity to 
Consent (UBACC) will be used. The UBACC is a 10-item questionnaire tailored to specific study 
procedures. It queries participants about the basic procedures, risks, benefits, and purpose of 
the study, along with participant rights. Each item on the UBACC is scored on a 0 (incapable) to 
2 (capable) scale. This will be administered at the time of obtaining informed consent. 
The following are the questions and answers to this study's UBACC for card makers and 
recipients:
Card Makers:

1. What is the purpose of the study that was just described to you?
a. Response (2 = Study about Veterans making and receiving cards for suicide prevention and/or 
social connection)
2. What makes you want to consider participating in this study?
a. Response (2 = Increased social connection, help others, decreased suicide risk/behaviors)
3. Do you believe this is primarily research or primarily treatment?
a. Response (2 = Research)
4. Do you have to be in this study if you do not want to participate?
a. Response (2 = No)
5. If you withdraw from this study, will you still be able to receive regular treatment?
a. Response (2 = Yes)
6. If you participate in this study, what are some of the things that you will be asked to do?
a. Response (2 = Answer questions and attend a weekly card making group) 
7. Please describe some of the risks or discomforts that people may experience if they participate 
in this study. 
a. Response (2 = Feeling bored or fatigued, feeling anxious or discomfort while talking about 
myself and/or symptoms, feeling uncomfortable drawing upon my lived mental health experience 
to create caring cards for other Veterans in need.)
8. Please describe some of the possible benefits of this study.
a. Response (2 = Increased social connectedness and sense of purpose, help others, decreased 
suicide risk and related behaviors).
9. Is it possible that being in this study will not have any benefit to you?
a. Response (2 = Yes)
10. Who will pay for your medical care if you are injured as a direct result of participating in this 
study?
a. Response (2 = VA San Diego)
Card Recipients:
1. What is the purpose of the study that was just described to you?
a. Response (2 = Study about Veterans making and receiving cards for suicide prevention and/or 
social connection)
2. What makes you want to consider participating in this study?
a. Response (2 = Increased social connection, decreased suicide risk/behaviors)
3. Do you believe this is primarily research or primarily treatment?
a. Response (2 = Research)
4. Do you have to be in this study if you do not want to participate?
a. Response (2 = No)
5. If you withdraw from this study, will you still be able to receive regular treatment?
a. Response (2 = Yes)
6. If you participate in this study, what are some of the things that you will be asked to do?
a. Response (2 = Answer questions and receive cards)
7. Please describe some of the risks or discomforts that people may experience if they participate 
in this study. 
a. Response (2 = Feeling bored or fatigued, feeling anxious or discomfort while talking about 
myself and/or symptoms, feeling uncomfortable receiving cards that might remind me of my 
symptoms)
8. Please describe some of the possible benefits of this study.
a. Response (2 = Increased social connectedness, decreased suicide risk and related behaviors).
9. Is it possible that being in this study will not have any benefit to you?
a. Response (2 = Yes)
10. Who will pay for your medical care if you are injured as a direct result of participating in this 
study?
a. Response (2 = VA San Diego)
12.6b) If subjects with limited decisional capacity will be enrolled, describe methods for obtaining subject 
assent or why they are not indicated:
Participants with limited decisional capacity will not be enrolled.
12.6c) If subjects with limited decisional capacity will be enrolled, describe procedures for respecting subject 
dissent and any additional safeguards or why these features are not needed:

Participants with limited decisional capacity will not be enrolled.
12.6d) If subjects with limited decisional capacity will be enrolled, describe the risk and, if greater than 
minimal, the relation to potential benefits:
Participants with limited decisional capacity will not be enrolled.
12.6e) If subjects with limited decisional capacity will be enrolled, describe the justification for the inclusion of 
any incompetent persons or persons with impaired decision-making capacity:
Participants with limited decisional capacity will not be enrolled.
 Section 12.7 Consent by Legally Authorized Representative (Surrogate Consent)
12.7a) Where endorsed by the IRB, the following persons may be authorized to consent on behalf of persons 
 
who lack decision-making capacity in the indicated order of priority: (a) Health care agent (i.e., an individual 
 
named by the individual in a Durable Power of Attorney for Health Care (38 CFR.17.32(a)(iii)); (b) Legal 
 
guardian or special guardian; (c) Next of kin in this order: a close relative of the patient 18 years of age or 
 
older, in the following priority: spouse, child, parent, sibling, grandparent, or grandchild; (d) A close friend 
 
[however, California Health and Safety Code §24178 does NOT include the close friend category]  
 Agree
 Disagree
12.7b) Legally Authorized Representatives (LARs) will be told that their obligation is to try to determine what 
 
the subjects would do if able to make an informed decision. If the potential subject's wishes cannot be 
 
determined, the LARs must be told they are responsible for determining what is in the subjects' best interests.
LARs generally assume the same rights and responsibilities as the individuals who lack decision-making 
capacity in the informed consent process.
 Agree
 Disagree
12.7c) If feasible, the investigator will explain the proposed research to the prospective research subject even 
when the surrogate gives consent.  Although unable to provide informed consent, some persons may resist 
participating in a research (i.e., if they dissent) protocol approved by their representatives. Under no 
circumstances may a subject be forced or coerced to participate in a research study even if the LAR has 
provided consent.
 Agree
 Disagree
12.7d) For subjects with fluctuating decision-making capacity or those with decreasing capacity to give 
consent, a re-consenting process with surrogate consent will be employed when needed
 Agree
 Disagree
 Section 12.9 HIPAA Authorization
For each category below, indicate whether or not this study involves the indicated process:
12.9a) 
 HIPAA Authorization.  
Signed
**New Template is available in the ?  Help section**
 Yes  
 No
12.9b) HIPAA waiver to cover the entire study
  Yes  
  No

12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
 Yes  
 No
12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
  Yes  
  No
 Section 12.10 HIPAA Waivers and Alterations
12.10a) Describe the purpose/nature of the HIPAA waiver or alteration and list specifically, what identifiers 
and health information are being requested under the waiver/alteration and identify whether the waiver is 
for access, use, and/or collection of this information.
The purpose/nature of the HIPAA waiver is for screening activities; the study coordinator will 
need access to CPRS to collect and use potential subjects' names, telephone numbers, mailing 
address, SSNs, as well as CPRS medical records (notes) as they apply to the inclusion/exclusion 
criteria and the use of VASI. The following will be collected from the Veteran during the initial 
telephone screen. 
Inclusion criteria for card-makers: (1) VASDHS Veteran with an inactive high-risk flag, (2) 18 
years of age or older, (3) access to transportation to attend the group, and (4) decisional 
capacity. Inclusion criteria card recipients: (1) VASDHS Veteran with an active high-risk flag, (2) 
18 years of age or older, and (3) decisional capacity. Exclusion criteria for card makers and 
recipients: (1) the absence of a mailing address, working phone number, and email address, (2) 
inability to read and write in English, (3) previous or current experience as either card maker or 
recipient, and (4) currently employed by the VA San Diego. If COVID-19 precautions are in 
effect, Veterans will also be screened for access to reliable computer, tablet, or smartphone with 
camera and internet access, as well as the willingness to participate in this study remotely. 
Participants' decisional capacity for informed consent in order to meet eligibility for this study will 
be assessed during consent (separate from screening call) via the University of California San 
Diego Brief Assessment of Capacity to Consent (UBACC) will be collected by the study 
coordinator. 
12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the 
privacy of individuals.
 Agree
 Disagree
12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
 Agree
 Disagree
Describe the plan
To prevent improper use and disclosure of identifies, only the PI and study coordinator will have 
access to the database of these identifiers, as stored it on a secure VA computer within a 
password protected file.
12.10d) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the 
research, unless there is a health or research justification for retaining the identifiers or such retention is 
otherwise required by law.
 Agree
 Disagree
12.10d2) Describe the plan:
The secure database with identifiers will be destroyed at the earlier opportunity, consistent with 
RCS-10 guidelines.
12.10e) By signing this protocol for submission, the PI is providing written assurance that the PHI will not be 
reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the 

research project, or for other research for which the use or disclosure of protected health information would 
 
be permitted by the Privacy Rule.
:  If the waiver of HIPAA authorization is for 
38 U.S.C. 7332 Information
the use of 38 USC 7332 information (applicable to drug abuse, alcohol abuse, HIV infection, and sickle cell 
anemia records), by signing this protocol for submission the PI is providing written assurance that the 
purpose of the data is to conduct scientific research and that no personnel involved may identify, directly or 
indirectly, any individual patient or subject in any report of such research or otherwise disclose patient or 
subject identities in any manner. (Ref:  38 U.S.C. 7332(b)(2)(B))
 Agree
 Disagree
12.10f) The research could not practicably be conducted without the waiver or alteration.
 Agree
 Disagree
12.10f2) Describe how the waiver/alteration enables the research to be conducted
The waiver is essential is for screening subjects and having access to CPRS to collect and use the 
names, telephone numbers, mailing address, as well as CPRS medical records (notes) as they 
apply to the inclusion/exclusion criteria (see 12.10a for details on what information will be 
collected during the telephone screens).
12.10g) The research could not practicably be conducted without access to and use of the PHI.
 Agree
 Disagree
12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3
/8/18)
Access to and use of the PHI is critical to identifying eligible participants, sending them an 
introductory letter to the study, and conducting a telephone screen thereafter. The present study 
depends entirely on access to this PHI and could not be completed without it.
 Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see  for guidance)
?
The alternative to participation is to not participate. Veterans with inactive HRFs may participate 
in other VASDHS mental health groups; Veterans with active HRFs may continue receiving 
regular outreach by VASDHS' Suicide Prevention Coordinators (e.g., phone calls).
 Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see  for 
?
guidance)
There are minimal risks to participating in the Caring Cards group, meet-up groups (optional), or 
receiving cards. 
Disclosure or Identification of Suicidal Ideation or Intent to Harm Self: Participants to be enrolled 
are at elevated risk of suicide and reporting active suicidal ideation. During structured interviews 
concerning suicide (via the C-SSRS and BSS) or extemporaneous discussion with rater or other 
staff, participants may disclose a level of risk of harming themselves that would require a higher 
level of care. Further, during the intervention, participants may experience an increase in suicidal 
ideation beyond that which they reported at baseline. 
Assessments: The questionnaires are non-invasive clinical assessments associated with minimal 
risk. All measures are physically non-invasive, have been used in prior studies with seriously 
mentally ill participants, and have been found to elicit minimal distress and discomfort. 
Nevertheless, participation in the psychosocial evaluation and responding to questions will 
require time and attention. Some participants may become bored or fatigued completing the 
evaluation. Some participants may also become distressed during the psychiatric evaluation, 
which requires them to discuss their current symptoms.

Intervention Period: Risks involved in participating in this intervention are minimal. During the 
Baseline assessment and follow-up assessments, participants may experience feelings of anxiety 
or discomfort while talking about themselves and/or symptoms. Participants may also become 
fatigued by filling out questionnaires or answering questions in person. 
In addition, card makers may experience some discomfort drawing upon their lived mental 
health experience to create caring cards for other Veterans in need. Card recipients may 
experience discomfort receiving cards, as it may remind them of their mental health concerns. 
Participants do not have to answer any assessment question they do not want to, and can decide 
at any time to withdrawal from the study.
Confidentiality: As with any research study, a risk of disclosure of personal material exists.
COVID-19 Exposure: During the COVID-19 pandemic, all face-to-face visits (i.e., group 
participation and assessments) present risk for virus exposure. 
 Section 15 - Risk Management
15) Describe the procedures for protecting against or minimizing any potential risks/discomforts, and the 
adequacy of resources for conducting the study and resources participants may need as a consequence of the 
research.  When applicable, include detail of the following safety measures:   
(a) The type of safety 
information to be collected, including AEs; 
(b) Frequency of safety data collection; 
(c) 
Frequency or periodicity of review of cumulative safety data; 
(d) Statistical tests for analyzing the 
safety data to determine if harm is occurring; and 
(e) Conditions that trigger an immediate suspension 
of the research.  See  for further requirements.
?
During the telephone screening portion of our study, risk will be mitigated by using a set of 
screening questions that will elicit the least amount of sensitive or personal information 
necessary to assess eligibility. Only qualified interviewers with significant prior experience in 
treatment or assessment of relevant populations/conditions will conduct these assessments. All 
study personnel will be trained, observed, and certified by the study's PI, who is a licensed 
clinical psychologist. The first three months of this study will be included focused training on 
assessment administration. For example, the C-SSRS has a standard series of training videos 
that study personnel will undergo to ensure proper administration of this instrument. Standardize 
trainings will take place for any instruments where this type of formal training is available. 
In addition, to further mitigate risk participants will be informed that they do not have to answer 
any question they do not want to, and can decide, at any time, if they want to withdrawal from 
the study. The study PI will be available to discuss any concerns participants may have with the 
study. 
If during the course of the study participants experience an adverse reaction during screening, 
assessment administration, or group participation (i.e., for card makers), imminent risk for 
suicide is determined, or a suicide attempt (that has not been previously recorded) is disclosed, 
the research team will adhere to the following to ensure Veterans' safety. 
Monitoring of Suicidal Ideation: This is a challenging aspect the study and so we have developed 
our procedures to be consistent with the recommendations of organizations such as NIH in 
clinical research in people with elevated suicide risk (e.g., Issues to Consider in Intervention 
Research with Persons at High Risk for Suicidality). We will further refine our procedures by use 
of deployment focused discussions with stakeholders in the study start up phase and in 
collaboration with the Data Safety Monitoring board. The referral sources for this study are 
VASDHS’ Veterans with inactive and active high-risk suicide flags. Veterans with active high-risk 
suicide flags are closely monitored and regularly assessed for suicide risk by the VASDHS’ 
Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered 
the C-SSRS and BSS. Veterans are informed during consenting that all suicidal behavior is 
documented in Suicide Behavior Reports in CPRS if not already entered. 
As such, if any of the following items are endorsed (respective item scores are noted below) on 
the Beck Scale for Suicidal Ideation (BSS) a LIP will be notified immediately:
• Item 4 (2)
• Item 9 (1 or higher)
• Item 13 (2)
• Item 14 (2)

• Item 15 (2)
• Item 16 (1 or higher)
• Item 17 (1 or higher)
• Item 18 (2)
• Item 20 (1 or higher)
If any of the following items are endorsed on the C-SSRS (initial screener):
• Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) 
• If a Veteran answers "Yes" to the question about preparatory acts or behaviors within the past 
month - i.e., "Have you taken any steps towards making a suicide attempt or preparing to kill 
yourself (such as collecting pills, getting a gun, giving valuables away or writing a suicide note)?"
If any of the following items are endorsed on the C-SSRS (since last contact):
• Item 4, "Have you had any intention of acting on these thoughts of killing yourself? (As 
opposed to you have the thoughts, but you definitely would not act on them?)"
• Item 5, "Have you started to work out, or actually worked out, the specific details of how to kill 
yourself and did you intend to carry out your plan?"
• Item 6 "Have you done anything, started to do anything, or prepared to do anything to end 
your life?"
Our safety monitoring guide details these procedures, how they are recorded, and what the staff, 
facility, and investigator responsibilities are. All Veterans are provided the contact information for 
the Veterans’ Crisis Line. Any new suicidal behavior will be documented in the Suicide Behavior 
and Overdose Report in CPRS by research staff. Participants who elect to withdraw from the 
study will continue to receive suicide prevention services per VA San Diego’s protocol. We will 
monitor these protocols during the course of the study and will make adjustments to inclusion
/exclusion criteria or safety protocol in case of adverse events. 
Adverse events in this research project are expected to be extremely rare. However, we have 
established plans for resolving any adverse event should one occur. First, during screening for 
the project, trained research personnel will assess (using standardized screening tools) for any 
serious medical or psychological conditions that may require immediate medical attention or 
psychiatric treatment. The rationale for this is because the presence of serious medical or 
psychiatric conditions would make these individuals inappropriate for the proposed research 
study. Should attention be required, staff will provide these individuals with information about 
suitable referrals, including local hospitals, clinics, and/or relevant healthcare and mental health 
professionals, and they will strongly encourage the individuals to follow up with these referrals. 
All research personnel will complete VA TMS trainings pertinent to suicide prevention.
Confidentiality: In order to protect confidentiality, all participant data will be de-identified by 
assigning each participant a unique ID in computer files, and all physical files from the study will 
be kept in a locked cabinet in study offices at the Veterans Medical Research Foundation building 
in San Diego. All electronic data and files will be stored on a secure server. Only study 
investigators and personnel will have access to these data. All documentation will identify 
participants only by their Unique ID number and not other personally identifying information. 
COVID-19 exposure: To mitigate participants' exposure to COVID-19, web (i.e., VVC, WebEx) or 
telephone-based visits may be used instead of face-to-face visits.
WebEx and DocuSign Consenting:
Veterans may feel uncomfortable using WebEx and DocuSign to sign consent forms. To mitigate 
this, we will offer alternative routes to obtaining signed informed consent, including the 
approaches in our original approved protocol (i.e., use My Health-e-Vet, using MS Azure, have 
Veteran send signed consent form via email, have Veterans fax, or have the study coordinator 
take a screen shot of the signed consent during their VVC or WebEx session).
Inclusion/exclusion criteria card makers:
With our additional exclusion criteria for card makers, we may exclude Veterans without access 
to reliable forms of technology. To mitigate this, we will either (1) invite Veterans to consider 
participating in an in-person group (if offered during study’s duration), or (2) remind Veterans of 
alternatives to participation (i.e., other VASDHS mental health groups).
 Section 17 - Potential Benefits

17) Discuss benefits that may be gained by the subject as well as potential benefits to society in general  (see  ?
for guidance)
There is no guaranteed direct benefit to Veterans who participate in this study. This study has 
the potential to enhance our understanding the feasibility and acceptability of Caring Cards as a 
potential suicide prevention intervention, and may improve Veterans' satisfaction with VASDHS 
services. 
Participation in CC may not directly benefit to participants. However, benefits to the individual 
participants may include increased social connectedness and sense of purpose. Participants’ 
suicide risk and related behaviors may decrease. They may be more engaged in subsequent 
mental health appointments as well.
 Section 18 - Risk/Benefit Analysis
18) Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in 
relation to the importance of the knowledge that may reasonably be expected to result.
There are minimal risks to participants (e.g., Veterans may feel discomfort answering questions 
and/or making/receiving cards), and although there are no guaranteed direct benefits, there are 
potential benefits that could improve Caring Cards, as a suicide prevention intervention, as well 
as Veterans' satisfaction with VASDHS' services. In addition, participation may enjoy connecting 
with one another, receiving support from another Veteran, and doing something kind for another 
Veteran in need. COVID-19 exposure during face-to-face visits is another potential risk for 
participants. As such, web (i.e., VVC, WebEx) or telephone-based visits may be used instead of 
face-to-face visits.
 Section 20 - Compensation for Participation
20) Provide all details and justifications of the compensation plan.  See  for detailed requirements.
?
Participants will be paid a total of $120 to complete baseline and follow-up assessments ($60 
each). We elected to provide compensation for participation due to the time commitment these 
assessments will require. 
We would like to include two options to pay participants: 
Option #1 - pay $120 at baseline
Option #2 - pay participants at two assessment timepoints ($60 baseline and $60 follow-up)
 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
Emily B. Treichler, PhD
Blaire C. Ehret, PhD, Colin A. Depp, PhD, Eric L. Granholm, PhD, Neal M. Doran, PhD, Camila 
Martinez Ceren, Cara T. Pozun, MA, LMFT, Christen Lee Shriver, Phillip J. Ehret, PhD, Brandon 
Ferragut, Cindy Chang, PhD, Emma M. Parrish, Samantha A. Chalker, PhD
21) For each staff member listed above, describe their role and qualifications.  Also indicate which of the 
study staff are authorized to obtain consent, when applicable to the study. 
Emily B. Treichler, Ph.D.- P.I and clinical psychologist; will oversee management of staff, 
administrative tasks, database collection, publication(s), and budgetary requirements. 
Blaire C. Ehret, Ph.D.- Non-VASDHS Collaborator and former PI; will serve as consultant to study 
personnel, assist with database preparation, and assist with publications.
Colin A. Depp, Ph.D.- co-I and clinical psychologist; serves as project co-investigator.

Eric Granholm, Ph.D. - co-I and clinical psychologist; serves as co-investigator.
Neal Doran, Ph.D. - co-I and clinical psychologist; serves as co-investigator.
Christen Lee Shriver- Will assist until permanent study coordinator is hired and added to IRB via 
amendment; will oversee administrative duties of the project (e.g., coordinating to secure 
provision of funds)
Phillip Ehret, Ph.D.- Health Science Research Specialist; will assist with database cleaning and 
preparation. 
Samantha Chalker, Ph.D.- facilitate Caring Cards groups; provide administrative and data 
collection support.
Camila Martinez Ceren - research assistant; provide administrative support and may administer 
assessments under PI's supervision; will co-facilitate Caring Cards group
Cara Pozun, LMFT - Will serve as study coordinator; will oversee administrative duties of the 
project (e.g., coordinating to secure provision of funds) and facilitate Caring Cards groups
Cindy Chang, Ph.D. - provide administrative and data collection support; will assist with database 
cleaning and preparation; will collaborate with team for authoring publications
Emma Parrish, M.S. - Provide administrative and data collection support.
 Section 22 - Bibliography
22) List relevant articles that the IRB can use to provide necessary background for the protocol. Do not 
include an extensive NIH-grant-style bibliography.  (Up to 5 recommended, but use more if needed to support 
the protocol or citations above.)
Motto, J. A., & Bostrom, A. G. (2001). A randomized controlled trial of postcrisis suicide 
prevention. Psychiatric services, 52(6), 828-833.
Denchev, P., Pearson, J. L., Allen, M. H., Claassen, C. A., Currier, G. W., Zatzick, D. F., & 
Schoenbaum, M. (2017). Modeling the cost-effectiveness of interventions to reduce suicide risk 
among hospital emergency department patients. Psychiatric services, 69(1), 23-31.
Luxton, D. D., Thomas, E. K., Chipps, J., Relova, R. M., Brown, D., McLay, R., ... & Smolenski, D. 
J. (2014). Caring letters for suicide prevention: Implementation of a multi-site randomized 
clinical trial in the US military and veteran affairs healthcare systems. Contemporary Clinical 
Trials, 37(2), 252-260.
Carter, G. L., Clover, K., Whyte, I. M., Dawson, A. H., & D'este, C. (2013). Postcards from the 
EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning. The 
British Journal of Psychiatry, 202(5), 372-380.
Reger, M. A., Gebhardt, H. M., Lee, J. M., Ammerman, B. A., Tucker, R. P., Matarazzo, B. B., ... 
& Ruskin, D. A. (2018). Veteran preferences for the caring contacts suicide prevention 
intervention. Suicide and Life#Threatening Behavior.
 Section 23 - Sponsors and Collaborators
23) Clarify any industry financial or other support (e.g., NIH funds the study or Company X provides the 
    
assay kits).
Identify non-VA Research collaborators and their role in this protocol, including whether or not 
 
they have access to subjects or identified data.
VA RR&D SPiRE
In the submission form, upload a copy of the grant, subaward, CRADA, etc. as appliable to the study.

 Section 25 - Impact on Clinical Services
25a) Which VA Clinical Services participate in the performance of the project? (NOTE: All clinical trials and 
any use of clinical services will require project review and approval by the Office of Research Agreements 
Management (ORAM) to assure availability of those clinical resources. Prior discussion with the appropriate 
clinical service chief is strongly encouraged)
Check all that apply
Pharmacy
Laboratory
Cardiology
Radiology
Nursing
Pathology
Nuclear Medicine
MAS (Charts)
Other (list below)
List others here
Mental Health
25b)  Describe the specific impact or service that will be provided for this protocol.
Caring Cards group will be offered as part of the VASDHS' Mental Health Care Line as therapy 
groups.
 Section 27 - Privacy, Confidentiality, and Information Security
27a) Provide a brief description of how participant privacy and confidentiality will be protected in this study. 
Describe the circumstance under which it may be possible for a research team member to identify subjects 
and any related protections or assurances to prohibit or avoid identification. Describe how the number of 
people with access to identifiers for research purposes is limited in order to protect a participant’s privacy.
Veterans' information is stored in a password protected Excel file stored on a secure VA 
computer. Only the PI and study coordinator will have access to this database. Once data 
collection has ended, the Research Scientist will be granted access so he can clean and prepare 
the database. The number of people who have access to this document are limited in order to 
protect Veterans' privacy.
27.b) Entry of a CPRS 
is required when subjects will be 
 
Research Informed Consent Note
admitted as 
for research 
the study 
inpatients or treated as an outpatients 
 
and
involves research medical care or may affect 
medical care.
If a Research consent Note is required, then a 
 should also be entered for each 
Research Progress Note
procedure or intervention.
Scanning the Consent and HIPAA Authorization into CPRS is 
.  Linking the Consent to the 
not required
Research Informed Consent Note may be permitted and can be useful for trials involving the Research 
Pharmacy or when research will be performed in conjunction with clinical procedures.
For Non-Veterans, if Research Informed Consent Notes are entered, then the 
 
NOPP Acknowledgment
must be scanned into the record.  Otherwise a copy of the signed NOPP must be retained with the 
Investigator's research records and a copy sent to the Privacy Officer; see the   Help for more information.
 ?
27.b1) Is entry of CPRS notes required based on the above criteria?

CPRS notes are needed for ALL subjects 
CPRS notes are needed for SOME subjects 
CPRS notes are NOT needed for any subjects 
27c) Select the VA Sensitive Information (VASI) use category
This study does not collect or use any VASI 
This study uses but does not save, collect, copy, or record VASI 
This study does collect or record VASI 
 Section 27.1  VA Sensitive Information (VASI)
27.1a) For each type of VASI, indicate all that apply:
Indicate which of the following will be collected/recorded:
Protected Health Information (PHI)
Names
Device identifiers and serial numbers
E-mail addresses
Medical record numbers
URLs (Universal Resource Locator)
All elements of dates (except year) or any age over 89
Health plan beneficiary numbers
IP Addresses (Internet Protocol)
Telephone numbers
Account numbers
Biometric Identifiers including finger and voice print
Fax numbers
Certificate or license numbers
Full face photographic images and comparable images
All geographic subdivisions smaller than a state
Vehicle ID and serial numbers including license plate numbers
Social security numbers or scrambled SSNs (describe below)
Other unique identifying number, characteristic, or code (describe below)
27.1a1)  Describe why SSN are needed for this study
So Veterans' charts can be reviewed for project-relevant information (e.g., confirm address, 
telephone number) in order to send them an introductory study letter and follow-up with them 
concerning study participation.
27.1a2)  Identify the specific other identifier/s that will be used or recorded
Mailing address, high-risk flag status
27.1b) Consent Forms and/or HIPAA Authorization
 Yes  
 No
27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record 
numbers, dates, etc.)?

  Yes  
  No
27.1d) Photos with faces or audio video recordings are used for this study.
 Yes  
 No
27.1d1) Identify the device or devices that will be used to take/make the photographs or recordings. 
Philips Pocket Memo Voice Recorder DPM8000. Secure VA WebEx account for WebEx groups.
27.1d2) Identify where images will be stored (e.g., in the medical record, with study hardcopy records, with 
study electronic VASI records
Audiotapes will be stored in a locked box within a locked filing cabinet. Only the PI and study 
coordinator will have access to these. These will be located in VMRF (building 13) C2-228 
(cubicle). Secure VA WebEx account for WebEx groups.
27.1e) Biological specimens with identifiers are used for this study.
  Yes  
  No
 Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
  Yes  
  No
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?
  Yes  
  No
27.2c) Does the study require use of an electronic data capture system? 
  Yes  
  No
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, 
or processing data)?
 Yes  
 No

27.2d1) Provide the web address, details regarding their security features, the nature of the data involved, and 
the research purpose.  Also include a description of how VA retains a copy of the data generated using these 
tools.
If COVID-19 precautions are in effect, and assessments cannot be collected safely in person, 
baseline assessments will be collected via phone, WebEx or VA Video Connect. Due to the 
specific C-SSRS version collected at baseline, this questionnaire cannot be completed online (i.e., 
without assessor). However, the C-SSRS "Since Last Visit" is able to be completed online 
(without assessor administration). As such, follow-up assessments may be completed via phone, 
WebEx, or VA Video Connect.
27.2e)  Will coded data that excludes personal identifiers be used?   Coded data excludes 
HIPAA identifiers 
all 
(per VHA Handbook 1605.1 Appendix B), including dates
 Yes  
 No
27.2e1) Identify where the code key is stored and in what format (electronic, paper).
On the research drive behind the VA firewall and is in password protected electronic format. 
\\R01SDCHSM02.R01.MED.VA.GOV\Research
 Section 27.3  Data Sharing and Transportation
27.3a) Does this study involve collecting, sharing or transporting any type of data outside of the local VA?
 Yes  
 No
27.3b) This study collects VASI outside of VA (i.e., at a non-VA location).
  Yes  
  No
27.3c) VASI is transported outside of VA for any purpose other than sharing.
  Yes  
  No
27.3d) PHI may be disclosed to monitoring/auditing agencies by HIPAA Authorization.  Note:  The Research 
Office must be notified when monitors come to audit
 Yes  
 No
27.3e) Data may be shared with collaborators or others in the conduct of this protocol.

 Yes  
 No
27.3e1)  Describe the data to be shared or disclosed, the entities to which the data are to be disclosed, how the 
data are to be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further 
disclosed and to whom. This includes data from individual subjects as well as other data developed during the 
research such as the analytic data and the aggregate data.  For PHI and VASI, indicate the authority/ies 
permitting the sharing or disclosure of data (HIPAA Authorization, Limited Data Set, Data Use Agreement, VA 
Form 10-5345-Request for and Authorization to Release Health Information., etc.).
Final data sets underlying publications resulting from this research will be shared upon written 
request. Requests for access must be made in writing signed by a requestor from the United 
States and include an email address for delivery and an assurance that the recipient will not 
attempt to identify or re-identify any individual. The request should reference the publication 
underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact 
for the publication. If the investigator leaves the VASDHS the requests may be sent to the 
Associate Chief of Staff for Research.
 
Section 27.4  Research Record Storage and Retention
For each type of record, indicate whether it is collected for this study
27.4a) Hardcopy records/data (includes paper, pictures, film, etc.)
 Yes  
 No
27.4a1) Identify precisely where hardcopy data will be stored to include physical site, building, and room 
number, etc.  For each location identify whether VASI or non-sensitive information is stored at that 
location.  For VASI, identify how the data is secured. 
In a locked filing cabinet inside of VMRF. Specific space to be assigned.
27.4a2) Are all of the above locations at VA?
 Yes  
 No
27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
 Yes  
 No
27.4b1) Identify precisely where 
electronic records/data will be stored to include the full map 
 
non-sensitive
drive, network location/server name, etc., and a brief description of what data/information is stored at each 
location.
Non-sensitive information, which is the standard letter that was includes with each card was 
stored on the PI's personal H Drive on her secure, VA desktop. See below for full map drive.
\\R01SDCHSM02.R01.MED.VA.GOV\Homedir$\VHASDCEHRETB\My Documents\Research\Caring 
Cards
27.4b2) Identify precisely where 
electronic records/data will be stored to include the full map drive, 
 
VASI
network location/server name, etc., and a brief description of what data/information is stored at each location.

If no VASI is collected or recorded for this study, simply indicate that the “Study does not collect or record 
VASI”.
A database of VASI is stored on the S drive, CORE folder, behind the VA firewall. See below for 
full map drive. The database is an Excel document that is password protected and only the PI 
has the password. The document includes the following information: Veteran name, last 4 of 
SSN, mailing address, telephone number, presence of high-risk flag, if eligible to receive card, 
date cards are mailed, date of assessments, all survey questions and the participants' answers, 
information about attendance to Caring Cards groups, and optional meet-up groups. 
R:\Psychology\CORE\Research\Caring Cards
27.4b3) Are any of the locations described in 27.4b outside of the VA Secure Network? Note: this includes 
storage on a computer local hard drive.
  Yes  
  No
27.4c)  Record Retention - VHA requires compliance with Records Control Schedule (RCS-10) for retention 
of electronic and hard copy records.  Following study closure, these temporary records must be retained 
for six years and then destroyed.  Longer retention may be permitted if requred by other Federal regulations 
or requirements.  Will RCS-10 requirements be followed (i.e., 6-year retention)?
I will adhere to VHA Records Control Schedule-10 requirements 
I request an exception to RCS-10 requirements 
 Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
 Section 27.6  Attestations
In the event of real or suspected breach of security, the Information Security Officer, Privacy Officer, VA 
Police (if appropriate), and the individual’s supervisor will be notified within one hour of learning of the event.
 Agree
 Disagree
Study staff will be up to date on any required VHA Privacy Policy and Information Security training or they 
will not be allowed access to VA Sensitive Information.
 Agree
 Disagree
Access to research sensitive information, if any, will be removed when study personnel are no longer part of 
the research team.
 Agree
 Disagree
At least one copy of all study records (whether sensitive or non-sensitive) will be retained under VA control 
and only destroyed in compliance with the approved Records Control Schedule
 Agree
 Disagree
The VA retains ownership of the research data.  Should the investigator leave the VA, custody of the research 
records will be assigned to another investigator and the Research Service notified in writing, or custody of the 

research records will be transferred to the Research Service.
 Agree
 Disagree
 Section 28 - Protocol Association to New or Existing Project
  
28) Is this a new R&D Project?  Before you go on to complete the 
 (which is 
Initial Review Submission Form
used for attachments), please address the association of this Protocol to an R&D Committee Project.  This 
Protocol may represent a new R&D Project, or it may be an additional Protocol under an existing R&D 
  
Project (such as when a single grant supports multiple Protocols).  Will this Protocol be submitted to the 
R&D Committee as a new Project?
  Yes  
  No
 Section 29 - Existing Project Association
  
29) The associated R&D Project should already exist in the database.  Identify the R&D Project(s) that 
correspond to this protocol.
Project Status
Proposal Number
Project Title
Principal 
Investigator
No Projects are Linked to this Study
 The Protocol Application is now complete for a Protocol attached to an existing Project.
 
Next you will go on to the Initial Review Submission Form.  This form is used to collect the Application 
and any other needed attachments for submission to the IRB for review.
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