Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
Phase: PHASE2
Conditions: Early Stage Lung Cancer (I and II)
Sponsor: VA Office of Research and Development

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VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
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Protocol Title:
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IRB Protocol Number:
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Protocol Nickname:
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Form Template Version:
Q
Date Prepared:

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?
6@N
+J
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1b) Please select:
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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).

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."

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.
6@N
+J
2.1b) Pregnant women
6@N
+J
2.1c) Individuals with cognitive/decisional impairment
6@N
+J
2.1d) Non-English-speaking individuals
6@N
+J
2.1e) Prisoners of War (explicitly targeting this group)
6@N
+J
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)
6@N
+J
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)
6@N
+J
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be 
required)
6@N
+J
2.1i) Students of the institution (e.g., resident trainees) or of the investigator
6@N
+J
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
6@N
+J
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
6@N
+J
3.1b)
 with living participants to collect data or specimens with no intent to change them.
Interactions
6@N
+J
3.1c) This is a study that 
 has any 
never
subject contact and does not collect subject identifiers
6@N
+J
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
6@N
+J
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site
6@N
+J
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.
6@N
+J
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.
6@N
+J
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.
6@N
+J
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
6@N
+J
3.2b) Involves 
 purposes 
specimens collected for research
only
6@N
+J
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this 
specimen banking
protocol)
6@N
+J
3.2d) The study involves 
genotyping or other 
DNA
genetic analysis
6@N
+J
Does this include whole genome sequencing?
6@N
+J
Will participants be informed of the results of any DNA testing?

6@N
+J
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
6@N
+J
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
data repository
 see  before checking "yes")
IMPORTANT:
?
6@N
+J
3.2g)
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 
6@N
+J
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
6@N
+J
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.
6@N
+J
3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB)
6@N
+J
3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
6@N
+J
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.
6@N
+J
3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
6@N
+J
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
6@N
+J
3.4d)
 medical 
 Other
devices
6@N
+J
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 

6@N
+J
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
6@N
+J
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
6@N
+J
3.5d) Target population has psychiatric diagnosis, behavioral complaint, or chronic pain.
6@N
+J
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)
6@N
+J
3.6b) Includes procedures or drugs that will be considered part of standard care.
6@N
+J
3.6c) Involves 
purposes.
lab tests done for research 
6@N
+J
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 
6@N
+J
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial
6@N
+J
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed
6@N
+J
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
6@N
+J
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
6@N
+J
3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
6@N
+J

3.8c) Involves facial 
 or audio or video 
of
photographs
recordings
patients
6@N
+J
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).
6@N
+J
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
6@N
+J
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
6@N
+J
3.9c) The PI or other study staff member has a financial interest or other
related to 
 real or potential conflict 
this study.
6@N
+J
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.
6@N
+J
Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
T@<MN
Section 5 - Lay Language Summary
5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 
paragraph)
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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.
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 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
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 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.

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 Section 9.1 Clinical Procedures
9.1) Differentiate research procedures (or any procedures done for research purposes only) from clinical 
procedures (procedures that are done as part of standard care).
(Note: this differentiation should be clear in the consent form as well)
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 Section 9.2 IND Drugs
9.2) For each drug requiring an IND, provide the drug name, dose, and route of administration
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9.2b) Enter the IND Number:

9.2c)  Identify who/what entity holds the IND and the status of the IND
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9.2d)  Identify the storage and security of the drug.  For example, at the VASDHS, state "The investigational 
drug will be stored in the Research Pharmacy in accordance with 119-SOPP-10/151-SOPP-38."  Also, identify 
whether the drug is a controlled substance.
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 Section 9.5 Data Banking
9.5) Provide details about the data repository for example,
Identify what information will be retained.
Whether participation in the repository will be optional or required.
Whether or not identifiers are included with the banked data, Note:  If banking is optional and 
identifiable information will be retained, then the combined consent/HIPAA form may not be used.  Please 
use the single consent and HIPAA form 10-0493.
 Provide future use examples. 
Indicate how the study will comply with VHA Handbook 1200.12.
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Section 9.6 Specimens
9.6) Identify the biological materials, procedures for obtaining material, and the sources of the specimens. 
Effective 12/01/2019:  Specify whether research or clinical staff (from which service) will be collecting the 
specimens and describe "hand-off" procedures to ensure that release of the specimens has been authorized by 
Pathology and Laboratory Medicine Service (PALMS).
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Section 9.7 Specimen Banking
9.7a) Select the specimen banking method(s):
9.7a1) Specimens will be banked at the local VA facility.
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9.7a2) Specimens will be banked at 
 facility.
another VA
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9.7a3) Specimens banked at a non-VA location.
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9.7b) Provide the details about the specimen repository/bank - 
What specimens are banked, where will they be stored?
How specimens will be labeled, etc.  Also include whether any data will be retained with or linked to the 
specimens (specify if identifiable information will be retained). .
Will banking be optional or mandatory? Note:  If banking is optional and identifiable information will be 
retained with the specimens, then the combined consent/HIPAA form may not be used.  Please use the 
single consent and HIPAA form 10-0493.
Who will have acess to and management of the specimens?
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 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.
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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.
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 Section 9.10 Laboratory Tests
9.10) For each 
 laboratory test (not lab tests used as part of standard care), identify the test and 
research
indicate if the test results will or will not be used clinically for diagnosis, treatment, or prevention of disease.
Please note, only results from properly accredited laboratories can be used for diagnosis, treatment, and 
.
prevention of disease
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 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
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 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.
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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.
0OP?TAGT@MRDGG=@PN@?
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?
6@N
+J
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.
6@N
+J
Identifiable information or biospecimens will be obtained by accessing records or stored identifiable 
biospecimens and this is not an FDA regulated study.
6@N
+J
Since both boxes were checked "no", a request for an informed consent waiver is needed.
12b)
 informed consent
Signed
6@N
+J
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral
6@N
+J
12d) Request for a 
 of consent for all or some study activities.
waiver
6@N
+J
12e) Alteration of 
 of consent.
other required elements
6@N
+J
12f)
assent to participate (Director approval will be required)
Child
6@N
+J
12g) Will any language 
 be used by those obtaining consent and understood by the 
other than English
prospective participant or the legally authorized representative?
6@N
+J
12h)
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
6@N
+J

12i)
 consent (legally authorized representative)
Surrogate
6@N
+J
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)?
6@N
+J
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.
6@N
+J
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
BM@@
!DN<BM@@
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.
-JO@IOD<GNP=E@>OND?@IODAD@?DI>GDID>RDGGADMNO=@<NF@?DAOC@TH<T=@DIO@M@NO@?DIK<MOD>DK<ODIB
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<IDIAJMH@?>JIN@IOAMJHRDGG=@@DOC@MKMJQD?@?OJ
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?PMDIBRCD>CODH@
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PI?@MBJN>M@@IDIBKMJ>@?PM@N1CDNORJOD@M@?KMJ>@NNRDGGKMJQD?@I@>@NN<MTODH@AJMKJO@IOD<G
K<MOD>DK<IONOJM@QD@ROC@>JIN@IOAJMH<I?<NFLP@NODJINKMDJMOJ?@>D?DIBOJPI?@MBJAJMH<G
N>M@@IDIB
OC@M@=THDIDHDUDIBOC@KJNND=DGDOTJA>J@M>DJIJMPI?P@DIAGP@I>@
Section 12.4 Waiver of Informed Consent
12.4a) Is it practicable to conduct the research without the waiver or alteration of consent?
6@N
+J
12.4b) Does the research examine public benefit or service programs and is subject to state or local 
government approval?
6@N
+J
12.4c) Will the research involve greater than minimal risk?
6@N
+J
12.4d) Will waiving or altering informed consent adversely affect the subjects’ rights and welfare?
6@N
+J

12.4e) Is it appropriate to provide pertinent information to subjects later BUT this information will NOT be 
provided?
6@N
+J
12.4f) Identify to what aspects of the study you are requesting a waiver of consent (i.e., full study or specific 
aspects). Describe the waiver or alteration needed and why it can be granted (include why the research is not 
practical without the waiver or alteration and how the waiver enables conducting the study).
Waiver of informed consent or alteration of consent elements may be allowed if the IRB documents these 
findings and approves waiver or alteration.
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-PGHJI<MTJMOCJM<>D>NPMB@MTKMJQD?@MN
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-<OD@IO[NKPGHJI<MTJMOCJM<>D>NPMB@MTKMJQD?@MNRDGGDIAJMHK<OD@IONH@@ODIB<Q<DG<=G@@IOMT
>MDO@MD<<=JPOOC@NOP?T<I?OC<OOC@TRDGG=@>JIO<>O@?=TOC@NOP?T>JJM?DI<OJM1C@NOP?T
>JJM?DI<OJMRDGGOC@IKMJQD?@OCJMJPBC@SKG<I<ODJIJAOC@NOP?T
H<DGJM?@GDQ@MOC@DIAJMH@?
>JIN@IOAJMHOJOC@K<OD@IO
OC@IN>C@?PG@OC@N>M@@IDIBQDNDO
12.4g) Explain why the research could not practicably conducted without using identifiable information.
1CDNNOP?TAJ>PN@NJIK<OD@IONRDOCNPNKD>DJPNG@NDJINAJMGPIB><I>@M<I?@IMJGG@S>GPNDQ@GT@<MGT
NO<B@GPIB><I>@MAJMI@J<?EPQ<IOOM@<OH@IO
&?@IODAD><ODJIJAKJO@IOD<G><I?D?<O@N><IIJO=@K@MAJMH@?RDOCJPOM@QD@RDIBK<OD@IO[NH@?D><G
M@>JM?N&I<??DODJI
M@QD@RJA@IOMT>MDO@MD<RDGGC@GK@S>GP?@OCJN@RCJH<T=@<OPI?P@MDNFAJM
DIQ<NDQ@KMJ>@?PM@NRCJ<M@IJONPMBD><G><I?D?<O@N@BM@NODIBCTKJS@HD<
JOC@M>JI>PMM@IO
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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.
 MDO@MD<AJM!@>DNDJI*<FDIB <K<>DOT
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<&OC<N=@@I?J>PH@IO@?=T<LP<GDAD@?KM<>ODODJI@M
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K<MOD>DK<O@DIOC@KMJKJN@?NOP?T+,1"1C@LP<GDAD@?KM<>ODODJI@MH<T=@<H@H=@MJAOC@
M@N@<M>CO@<H
=1C@DI?DQD?P<GC<N=@@IMPG@?DI>JHK@O@IO=T<>JPMOJAG<R
&AOC@M@DN<ITLP@NODJI<NOJRC@OC@MJMIJO<KJO@IOD<G<?PGONP=E@>OC<N?@>DNDJIH<FDIB
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?@>DNDJIH<FDIB><K<>DOT=@AJM@KMJ>@@?DIBRDOCOC@DIAJMH@?>JIN@IOKMJ>@NN
12.6b) If subjects with limited decisional capacity will be enrolled, describe methods for obtaining subject 
assent or why they are not indicated:
+

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:
+
12.6d) If subjects with limited decisional capacity will be enrolled, describe the risk and, if greater than 
minimal, the relation to potential benefits:
+
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:
+
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**
6@N
+J
12.9b) HIPAA waiver to cover the entire study
6@N
+J
12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
6@N
+J
12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
6@N
+J
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.
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KMJQD?@MN
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-<OD@IO[NKPGHJI<MTJMOCJM<>D>NPMB@MTKMJQD?@MNRDGGDIAJMHK<OD@IONH@@ODIB<Q<DG<=G@@IOMT
>MDO@MD<<=JPOOC@NOP?T<I?OC<OOC@TRDGG=@>JIO<>O@?=TOC@NOP?T>JJM?DI<OJM+JAJMHNJA
>J@M>DJI
KM@NNPM@JMJOC@MO<>OD>NRDGG=@@HKGJT@?JI<ITKJO@IOD<G><I?D?<O@AJMOCDNNOP?T
1C@NOP?T>JJM?DI<OJMRDGGKMJQD?@OCJMJPBC@SKG<I<ODJIJAOC@NOP?T
H<DGJM?@GDQ@MOC@
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M@QD@RKJO@IOD<G><I?D?<O@[NH@?D><GM@>JM?OJ<NN@NNAJMDI>GPNDJI@S>GPNDJI>MDO@MD<
12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the 

privacy of individuals.
BM@@
!DN<BM@@
12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
BM@@
!DN<BM@@
Describe the plan
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DHH@?D<O@GTAJGGJRDIB>JHKG@ODJIJAOC@DIO@MQD@RJMO@NON1C@>JIAD?@IOD<GDOTH@<NPM@NRDGG=@
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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.
BM@@
!DN<BM@@
12.10d2) Describe the plan:
&?@IODAD@MN<I?NJPM>@?J>PH@IONRDGG=@?@NOMJT@?<OOC@@<MGD@NOJKKJMOPIDOT<>>JM?DIBOJ3%
/!KJGD>T
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))
BM@@
!DN<BM@@
12.10f) The research could not practicably be conducted without the waiver or alteration.
BM@@
!DN<BM@@
12.10f2) Describe how the waiver/alteration enables the research to be conducted
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&?@IODAD><ODJIJAKJO@IOD<G><I?D?<O@N><IIJO=@K@MAJMH@?RDOCJPOM@QD@RDIBK<OD@IO[NH@?D><G
M@>JM?N&I<??DODJI
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12.10g) The research could not practicably be conducted without access to and use of the PHI.
BM@@
!DN<BM@@
12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3
/8/18)
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Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see  for guidance)
?
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1C@<GO@MI<ODQ@NDNOJIJOK<MOD>DK<O@DIOCDNM@N@<M>C
Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see  for 
?
guidance)
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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.
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 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)
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 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.
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 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
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study staff are authorized to obtain consent, when applicable to the study. 
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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.)
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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.
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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
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25b)  Describe the specific impact or service that will be provided for this protocol.
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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.
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KMJO@>O@?
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?

 -/0IJO@N<M@I@@?@?AJM))NP=E@>ON
 -/0IJO@N<M@I@@?@?AJM0,*"NP=E@>ON
 -/0IJO@N<M@+,1I@@?@?AJM<ITNP=E@>ON
Identify for which group or groups CPRS records will be entered and to which groups this requirement does not 
apply.
-<OD@IORCJH@@O@IOMT>MDO@MD<<I?<M@@IMJGG@?OJM@>@DQ@?NOP?TH@?D><ODJIRDGGM@LPDM@@IOMT
JA< -/0M@N@<M>CDIAJMH@?>JIN@IOIJO@
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IJ?D<BIJNDNJA@<MGTNO<B@GPIB><I>@MRDGGIJO=@@IMJGG@?<I?@IOMTJA -/0/@N@<M>C
&IAJMH@? JIN@IOIJO@RDGGIJO=@M@LPDM@?
27c) Select the VA Sensitive Information (VASI) use category
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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:
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#<SIPH=@MN
 @MODAD><O@JMGD>@IN@IPH=@MN
#PGGA<>@KCJOJBM<KCD>DH<B@N<I?>JHK<M<=G@DH<B@N
GGB@JBM<KCD>NP=?DQDNDJINNH<GG@MOC<I<NO<O@
3@CD>G@&!<I?N@MD<GIPH=@MNDI>GP?DIBGD>@IN@KG<O@IPH=@MN
0J>D<GN@>PMDOTIPH=@MNJMN>M<H=G@?00+N?@N>MD=@=@GJR
,OC@MPIDLP@D?@IODATDIBIPH=@M
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JM>J?@?@N>MD=@=@GJR
27.1a1)  Describe why SSN are needed for this study
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,>><NDJI<GGTAPGG00+H<T=@M@LPDM@?RC@IOC@M@<M@K<OD@IONRDOCN<H@ADMNOG@OO@MDIOC@DMG<NO
I<H@<I?N<H@G<NOJA00+
27.1b) Consent Forms and/or HIPAA Authorization

6@N
+J
27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record 
numbers, dates, etc.)?
6@N
+J
27.1c1) Identify where images will be stored (e.g., in the medical record, with study hardcopy records, with 
study electronic VASI records).
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=MJI>CJN>JKT
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27.1d) Photos with faces or audio video recordings are used for this study.
6@N
+J
27.1e) Biological specimens with identifiers are used for this study.
6@N
+J
Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
6@N
+J
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?
6@N
+J
27.2b1) Provide details of the device/s.  Indicate whether the device is FIPS 140-2 encryption validated and 
confirm that the device is listed in the VA EIL.  Provide details regarding the nature of the data that will be 
stored or transmitted on the device and confirm whether a copy of all data will be stored on the VA network. 
1C@M@RDGG=@20?MDQ@NPN@?OJNOJM@>J?@?NOP?T?<O<
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20NRDGG=@GDNO@?PI?@MOC@-&N"&)JI>@KPM>C<N@?>JKTJAOC@?<O<NOJM@?JIOC@N@?@QD>@N
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27.2c) Does the study require use of an electronic data capture system? 

6@N
+J
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, 
or processing data)?
6@N
+J
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
6@N
+J
27.2e1) Identify where the code key is stored and in what format (electronic, paper).
1C@>J?@F@TRDGG=@NOJM@?DIKMJO@>O@?
NOP?TNK@>DAD>AJG?@MJIJIOC@N@>PM@?3+@ORJMF/
!MDQ@/9*<J;',IGT<KKMJQ@?NO<AAC<Q@<>>@NNOJOC@-&N/?MDQ@
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?
6@N
+J
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.)
6@N
+J
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. 
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DI>GP?DIBNJPM>@?J>PH@ION
><N@M@KJMOAJMH /#N
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>JJM?DI<OJMNRDGGC<Q@<>>@NNOJOC@ADGDIB><=DI@O
27.4a2) Are all of the above locations at VA?
6@N
+J

27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
6@N
+J
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.
NOP?TNK@>DAD>
K<NNRJM?KMJO@>O@?@G@>OMJID>AJG?@MRDGG=@CJPN@?DIOC@/@N@<M>CAJG?@MRDOCDI
OC@/?MDQ@/9*<J;'
0P=AJG?@MNRDGG=@>M@<O@?AJMM@BPG<OJMTDO@HN
=DJM@KJNDOJMT
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/JJHN

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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”.
NOP?TNK@>DAD><>>@NNKMJBM<HC<N=@@I?@Q@GJK@?<I?RDGG=@CJPN@?DIOC@NOP?TNK@>DAD>

K<NNRJM?KMJO@>O@?@G@>OMJID>AJG?@MRDOCDIOC@/@N@<M>CAJG?@MDIOC@/?MDQ@/9*<J;'
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.
6@N
+J
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 required by other Federal regulations 
or requirements.  Will RCS-10 requirements be followed (i.e., 6-year retention)?
&RDGG<?C@M@OJ3%/@>JM?N JIOMJG0>C@?PG@M@LPDM@H@ION
&M@LP@NO<I@S>@KODJIOJ/ 0M@LPDM@H@ION
Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
I<
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.
BM@@
!DN<BM@@
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.

BM@@
!DN<BM@@
Access to research sensitive information, if any, will be removed when study personnel are no longer part of 
the research team.
BM@@
!DN<BM@@
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
BM@@
!DN<BM@@
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.
BM@@
!DN<BM@@
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?
6@N
+J
The Protocol Application is now complete for a Protocol that will also be a new R&D Committee 
Project.
Next you will go on to the Initial Review Submission Form which is used to package up the Protocol 
Application and any needed attachments and submit them to the IRB.
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