|
R&D Forms Page
Alphabetical IRB Forms List
Proposed Project Questionnaire (PPQ)
Proposed
Project Questionnaire Revised
10/08 (899KB, MSWord)
The VA PPQ provides basic information necessary for
the VA Research Office to evaluate and route the project.
This form must be completed by a VA PI when submitting
a study/grant that uses VA resources (VA patients, VA
space, or VA equipment).
Conflict
of Interest in Research Form (118KB, MSWord)
If the screening questions on the Proposed Project Questionnaire
identify a conflict of interest for any member of the
research team, each team member with a potential
conflict must complete this form. The completed
form(s) must be submitted with the PPQ.
Top
Data Security Checklist
Data
Security Checklist (76KB,
MSWord)
The VA Data Security Checklist (formerly “Appendix
C”) must be submitted to the Research Office with
each new proposal.
Top
Financial Administrative Review
Financial
Administrative Review (183KB, MSWord)
The financial administrative review process identifies
those research-related study activities that impact
non-research resources of the VA Medical Center. This
paperwork is required for all human studies proposals
which will use medical center resources such as extra
clinic time, MRIs, labs, pharmacy, etc.
Be sure to include these research-related costs into
budgets for all new studies, regardless of study administrator
(OHSU, PVARF, or VA). The costs will be returned to
the VA Medical Center once study enrollment begins.
Top
Institutional Review Board (IRB)
Addition of Research Personnel Form (See: Research Personnel
Change Form)
Administrative
Review Forms (183KB, MSWord)
Adverse
Events Form (To be used ONLY until a Data Safety Monitoring
Plan has been approved by the IRB) (94KB, MSWord)
Advertisement
Content Requirements (24KB, MSWord)
Application
for Case Report Review (56KB, MSWord)
Certification
of Exemption (126KB, MSWord)
Conflict
of Interest in Research Form (118KB, MSWord)
Considerations
for Clinical Trials with a Placebo Controlled Design
(40KB, MSWord)
Data
Safety Monitoring Plan Form (IRQ Appendix K) (74KB,
MSWord)
Expedited Review Request Form (See: Request for Expedited
Review)
FDA
Form 1571 (FDA Forms Page)
FDA
Form 1572 (FDA Forms Page)
Human
Biological Specimens Memo of Understanding (MOU) Template
(41KB, MSWord)
Informed
Consent Form Checklist (104KB, MSWord)
Informed
Consent Instructions (24KB, MSWord)
Informed
Consent Form Template (246KB, MSWord)
IRQ
(Initial Review Questionnaire) Revised
10/08 (345KB, MSWord)
IRQ
Appendix A (Recruitment of Vulnerable Subjects) (38KB,
MSWord)
IRQ
Appendix B (Payment for Participation) (42KB, MSWord)
IRQ
Appendix C (Investigational Drugs) (81KB, MSWord)
IRQ
Appendix D (Dietary Supplements, Herbal Remedies, or other
Complementary / Alternative Remedies) (58KB, MSWord)
IRQ
Appendix E (Investigational Devices) (107KB, MSWord)
IRQ
Appendix F (Use of Radiation) (44KB, MSWord)
IRQ
Appendix G-1(Human Biological Specimens Questionnaire
- Non-Banked Specimens
New
10/08 (96KB, MSWord)
IRQ
Appendix G-2 (Human Biological Specimens Questionnaire
- Biorepositories and Banked Specimens New
10/08 (83KB, MSWord)
IRQ
Appendix H (Use of Audio/Videotapes) (35KB, MSWord)
IRQ
Appendix I (HIPAA: Safe Harbor De-Identification Certification)
(50KB, MSWord)
IRQ
Appendix J (HIPAA: Statistical Analysis De-Identification
Certification) (54KB, MSWord)
IRQ
Appendix K (Data Safety Monitoring Plan) New
7/08 (74KB, MSWord)
Investigational
Drugs - VA Form 10-9012 (VA Web Site, PDF)
Monitoring
Visit Report Revised
10/08 (35KB, MSWord)
Partial
Waiver of Authorization for Screening/Recruitment Purposes
(89KB, MSWord)
Personnel Change Form (See: Research Personnel Change
Form)
PPQ
(Proposed Project Questionnaire) (899KB, MSWord)
PRAF
(Project Revision/Amendment Form) Revised
7/08 (72KB, MSWord)
Prescription
Authorization Form (33KB, MSWord)
QA/QI
(Quality Assurance/Quality Improvement) vs. Research Checklist
(51KB, MSWord)
Radiological
Procedure Chart (27KB, MSWord)
Request
for Expedited Review (86KB,
MSWord)
Request
for Waiver of Informed Consent Documentation (82KB,
MSWord)
Request
for Waiver of Informed Consent Process (78KB,
MSWord)
Research
Personnel Change Form (103KB, MSWord)
Research
Project Termination Report (74KB, MSWord)
Scope
of Work (573KB, MSWord)
Unanticipated
Problems Report Form New
7/15/08 (125KB, MSWord)
Waiver of Informed Consent (See: Request for Waiver of
Informed Consent)
Top
Detailed Descriptions of IRB Forms:
Adverse
Events Form (94KB, MSWord)
In cases of an adverse event, use the OHSU/VA adverse
event form.
This form is to be used ONLY until a Data Safety Monitoring
Plan has been approved by the IRB.
Application
for Case Report Review (56KB, MSWord)
This form should be completed and submitted to the IRB
Coordinator if a clinician would like to conduct a case
report. For additional information, please review the
Policy for Determination of Institutional Review Board
Review for Case Report(s).
Certification
of Exemption (126KB, MSWord)
In accordance with federal regulations, if you feel your
research project qualifies for an exemption from IRB oversight,
this form must be completed and submitted to the IRB for
review.
Conflict
of Interest in Research Form (111KB, MSWord)
If the screening questions on the Proposed Project Questionnaire
or the Continuing Review Questionnaire identify a conflict
of interest for any member of the research team, each
team member with a potential conflict must complete
and submit this form.
Considerations
for Clinical Trials with a Placebo Controlled Design
(40KB, MSWord)
This form must be completed if a study design involves
a placebo control without standard therapy.
Data
Safety Monitoring Plan Form (IRQ Appendix K) (74KB,
MSWord)
This form is to be submitted with the Initial Review Questionnaire
for all studies. For currently approved studies as of
July 15, 2008, this form must be submitted and the plan
approved by the IRB before investigators may report only
unanticipated adverse events. Until the DSMP is approved
(at the time of continuing review or sooner), all
adverse events must continue to be submitted on the old
Adverse Events Report Form.
FDA
Form 1571 (FDA Forms Page)
This form is used to submit an Investigational New Drug
(IND) application to the Food and Drug Administration.
FDA
Form 1572 (FDA Forms Page)
This form is needed when an investigational new drug (IND),
followed by the Food and Drug Administration (FDA), is
being used in a Phase I, II or III clinical trial.
Human
Biological Specimens Memo of Understanding Template
(41KB, MSWord)
This template should be used if the research project
requires that human biological specimens be sent to a
non VA-approved institution for analyses or storage as
described in the protocol. The Human Biological Specimens
Questionnaires G-1 or G-2 will indicate whether or not
this template is necessary.
Informed
Consent Form Checklist (99KB, MSWord)
These checklists are offered to assist you in completing
the applicable consent form(s) for your study, but are
not required.
Informed
Consent Instructions (23KB, MSWord)
These instructions accompany the Informed Consent Form
template.
Informed
Consent Form Template (246KB, MSWord)
This template allows you to copy and paste text into the
template.
IRQ
(Initial Review Questionnaire) (353KB, MSWord)
The IRQ is required for all new proposals being submitted
to the IRB.
IRQ
Appendix A - Recruitment of Vulnerable Subjects
(38KB, MSWord)
IRQ
Appendix B - Payment for Participation (42KB, MSWord)
IRQ
Appendix C - Investigational Drugs (81KB, MSWord)
IRQ
Appendix D - Dietary Supplements, Herbal Remedies,
or other Complementary / Alternative Remedies (58KB,
MSWord)
IRQ
Appendix E - Investigational Devices (107KB, MSWord)
IRQ
Appendix F - Use of Radiation (44KB, MSWord)
IRQ
Appendix G-1 - Human Biological Specimens Questionnaire
- Non-Banked Specimens (96KB, MSWord)
IRQ
Appendix G-2 - Human Biological Specimens Questionnaire
- Biorepositories and Banked Specimens (83KB, MSWord)
IRQ
Appendix H - Use of Audio/Videotapes (35KB, MSWord)
IRQ
Appendix I - HIPAA: Safe Harbor De-Identification
Certification (50KB, MSWord)
IRQ
Appendix J - HIPAA: Statistical Analysis De-Identification
Certification (54KB, MSWord)
IRQ
Appendix K - Data Safety Monitoring Plan (74KB,
MSWord)
Investigational
Drugs - VA form 10-9012 (VA Web Site, PDF)
If you will be using an investigational drug (for which
an investigational new drug application has been filed
with, and approved by, the FDA) in a protocol, you must
complete VA form 10-9012. This form is also required if
you will be using an approved drug for an unapproved purpose.
Partial
Waiver of Authorization for Screening/Recruitment Purposes
(89KB, MSWord)
This form may be needed to waive the requirement to obtain
subject authorization during the screening and/or recruitment
process(es).
PRAF
(Project Revision/Amendment Form) (72KB, MSWord)
If you will be amending your project or changing any aspect
of an approved project, complete this form and submit
it to the IRB.
Prescription
Authorization Form (33KB, MSWord)
This form should be completed for, and signed by, individuals
in addition to the PI who should have the ability to write
prescriptions for study drugs. A separate prescription
authorization form should be completed for each authorized
prescriber and submitted to the IRB at the same time as
the initial submission, or, if being added at a later
date, with a revised investigational drug information
record (form 10-9012) which includes the prescriber.
QA/QI
vs. Research Checklist (51KB, MSWord)
This checklist should be completed and submitted to the
IRB if there is a question regarding whether a proposal
is considered human subjects research or a QA/QI (Quality
Assurance/Quality Improvement) project.
Radiological
Procedure Chart (28KB, MSWord)
Use this chart as a reference to complete sections of
the Informed Consent Form that deal with radiological
procedures.
Request
For Expedited Review (86KB, MSWord)
If you would like to request an expedited IRB review
of a new research project, amendment or consent form revision,
this form should be completed and submitted with the appropriate
forms.
Request
for Waiver of Informed Consent Documentation (82KB,
MSWord)
Request
for Waiver of Informed Consent Process (78KB, MSWord)
These form(s) must be completed and submitted if the research
project proposes to waive or alter any elements of informed
consent or the documentation of informed consent or waive
the HIPAA authorization requirements.
Research
Personnel Change Form (103KB, MSWord)
This form should be used when an individual is being added
to or removed from the research team. All applicable attachments
should be submitted with this form to the IRB to avoid
a delay in processing.
Research
Project Termination Report (74KB, MSWord)
This form should be submitted at the end of the research
project, i.e., when all data are gathered/analyzed, and
any final report(s) or publication(s) are complete.
Scope
of Work (573KB, MSWord)
The Scope of Work is specific to the duties and responsibilities
of the Principal Investigator or employee who performs
work involving human subjects under the supervision of
the Principal Investigator (PI). The PI and the employee
must complete, sign and date this Scope of Work.
Unanticipated
Problems Report Form (125KB, MSWord)
For examples of Unanticipated Problems and for descriptions
of when to use the Unanticipated Problems Report form
see the Human Research
Protection Program page.
Determination of IRB Review Forms
Are you unsure if your project requires IRB review
and approval?
If yes, please address your question in writing to the
IRB Coordinators (as a group to pvamc-irb@va.gov
or individually to Shari
Maier, Danielle
Beaudry, Nickie
Pierce, Anne
Dodge-Schwanz, Sola
Whitehead, Mica
Werner or Jessica
Ghidorzi). Requests should include a detailed explanation
of the project and how the project will be conducted.
The IRB Coordinators will forward written requests to
the IRB when necessary or request that you fill out one
of the forms below.
Otherwise, you may complete the appropriate form below
and submit it to the Research Service office. The Research
Service will make the determination as to whether or not
the project requires IRB review and approval. You may
not start the project until you have received written
confirmation from the Research Service that the project
may be initiated.
A detailed description of each of the
forms is available by clicking here.
Application
for Case Report Review (56KB, MSWord)
Certification
of Exemption (126KB, MSWord)
Quality
Assurance/Quality Improvement vs. Research Checklist
(51KB, MSWord)
Research
Preparation Application (78KB, MSWord)
Top
Initial IRB Review Forms
These forms may be needed, depending upon the study design.
All forms are NOT needed for every submission. A
detailed description of each form is available by
clicking here.
Request
For Expedited Review (86KB, MSWord)
IRQ
(Initial Review Questionnaire) (353KB, MSWord) -
required for every submission
If informed consent will be obtained from research participants,
one of the following templates needs to be completed,
depending upon whether or not protected health information
is involved:
Informed
Consent Form Template (246KB, MSWord)
Authorization
for the Release of Protected Health Information for
Research Purposes (66KB, MSWord)
If informed consent will not be obtained from research
participants, you will need to complete the following
form(s):
Request
for Waiver of Informed Consent Documentation (82KB,
MSWord)
Request
for Waiver of Informed Consent Process (78KB, MSWord)
If authorization will not be obtained from research participants
prior to using or accessing protected health information,
you will need to complete the following form:
Partial
Waiver of Authorization for Screening/Recruitment Purposes
(89KB, MSWord)
If your study will be using/evaluating/collecting human
biological specimens during the research project, you
may need to complete these forms:
IRQ
Appendix G-1 - Human Biological Specimens Questionnaire
- Non-Banked Specimens (96KB, MSWord) OR
IRQ
Appendix G-2 - Human Biological Specimens Questionnaire
- Biorepositories and Banked Specimens (83KB, MSWord)
Human
Biological Specimens Memo of Understanding Template
(28KB, MSWord)
If the research project involves a Food and Drug Administration-approved
drug or biologic that is being studied for an unapproved
or approved use or if a drug is being used as a comparator,
the following forms may need to be completed:
Investigational
Drugs - VA form 10-9012 (VA Web Site, PDF) – required
for each drug being evaluated
Please contact the Research Pharmacy at ext. 55543 for
assistance in completing this form.
(Required) Prescription
Authorization Form (IRQ Appendix C) (81KB, MSWord)
Considerations
for Clinical Trials with a Placebo Controlled Design
(40KB, MSWord) – required if the study is a placebo
control without standard therapy
FDA
Form 1571 (FDA Forms Page)
FDA
Form 1572 (FDA Forms Page)
If the research project is designed to evaluate the safety
and effectiveness of an investigational device or if a
Food and Drug Administration approved device is being
used for an unapproved purpose, the following form will
need to be completed:
Investigational
Device Information Record (IRQ Appendix E) (75KB,
MSWord)
If prompted from the Initial Review Questionnaire, these
additional forms may need to be completed:
Research
on Decedents' Information Application (94KB, MSWord)
Safe
Harbor De-Identification Certification Form (IRQ
Appendix I) (50KB, MSWord)
Statistical
Analysis De-Identification Certification Form (IRQ
Appendix J) (54KB, MSWord)
Post IRB Approval Forms
After initial IRB approval has been secured, these forms
may be needed to meet investigator reporting requirements.
A detailed description of each form
is available by clicking here.
PRAF
(Project Revision/Amendment Form) (59KB, MSWord)
Adverse
Events Form (94KB, MSWord)
Research
Personnel Change Form (103KB, MSWord)
Monitoring
Visit Report (35KB, MSWord)
Research
Project Termination Report (74KB, MSWord)
Top
Health Insurance Portability and Accountability
Act (HIPAA)
The forms are listed in alphabetical order below. If
you need a description of the form please scroll down
for more information.
Authorization
for the Release of Protected Health Information for
Research Purposes (66KB, MSWord)
Request
for Waiver of Informed Consent Documentation (82KB,
MSWord)
Request
for Waiver of Informed Consent Process (78KB, MSWord)
Research
on Decedents' Information Application (94KB, MSWord)
Research
Preparation Application (78KB, MSWord)
Revocation
of Authorization (22KB, MSWord)
Safe
Harbor De-Identification Certification (IRQ Appendix
I) (50KB, MSWord)
Statistical
Analysis De-Identification Certification (IRQ Appendix
J) (54KB, MSWord)
VHA
Notice of Privacy Practice (VA Web Site, PDF)
Authorization
for the Release of Protected Health Information (PHI)
for Research Purposes (66KB, MSWord)
If your research project requires informed consent
from research subjects, the boilerplate language in this
form should be adapted to be consistent with the research
study. At the time of informed consent, the research subject
must also sign this authorization.
Request
for Waiver of Informed Consent Documentation (82KB,
MSWord)
Request
for Waiver of Informed Consent Process (78KB, MSWord)
These form(s) must be completed and submitted if the research
project proposes to waive or alter any elements of informed
consent or the documentation of informed consent or waive
the HIPAA authorization requirements.
Research
Preparation Application (78KB, MSWord)
If you are a VHA Investigator conducting research preparation
with Protected Health Information from the Portland VA
Medical Center, you must fill out this form and submit
it to the Portland VA Medical Center Institutional Review
Board prior to beginning your research preparation.
Research
on Decedents' Information Application (94KB, MSWord)
If you are a VHA Investigator conducting research on PVAMC
decedents’ protected health information, you must fill
out this form and submit it to the PVAMC IRB prior to
beginning the research.
Revocation
of Authorization (22KB, MSWord)
If a research subject would like to revoke his/her authorization
for use of his/her PHI, he/she must fill out this form
and submit it to the principal investigator.
VHA
Notice of Privacy Practice (VA Web Site, PDF)
This VHA document provides information to Veterans on
how the VHA protects their protected health information.
This form should be given to Veterans at the time of enrollment
in a research study conducted at the Portland VA Medical
Center if they have not previously been given a copy of
it.
Top
Subcommittee on Research Safety (SRS)
Principal
Investigator Annual Biosafety Review Form (291KB,
MSWord)
This form should be completed every three years by the
Principal Investigator with laboratory space or when
a new Principal Investigator is setting up laboratory
space at the VA. The subcommittee on research safety
will review and approve all forms.
SRS
Grant Approval Request (51KB, MSWord)
This form should be completed when a PI submits a study/grant
that utilizes VA laboratory space.
VA
Form 10-0398 (VA Web Site, PDF)
This form must be completed by a PI for “Just-in-Time”
review by VA Central Office following notification of
award of VA funding for a previously submitted grant proposal.
Submit VA Form 10-0398, along with a list of hazardous
chemicals being used in the proposal, to the SRS for review.
Top
Top
VA Research Support Agreement
VA
Research Support Agreement (VA Web Site, PDF)
This is a post-award form. This signed agreement is
required prior to award of Merit Review Funding from
Medical Research Service and Rehabilitation Research
& Development Service. Once you have printed and
signed this form, it must be submitted to the Research
Service Office for additional signatures and routing.
Career Development
In order to submit a Career Development Application,
the investigator must submit a Letter of Intent (LOI).
The LOI must be approved by Central Office before
the applicant can submit an entire proposal. The Letter
of Intent form is below.
Listed below are the forms needed to submit a complete
Career Development Application.
Top
Memorandum of Understanding (MOU) with
OHSU
Top
OHSU Grants
To submit grants to Oregon Health &
Science University, go to the OHSU
grants web site. Grants for which the funds are administered
through OHSU, such as NIH grants, must also be submitted
through the OHSU Research Office.
Top
For New Investigators
The Investigator Data Sheet (also called a “page 18")
is needed for investigators new to the Portland VAMC.
It is completed once and updated on an annual basis. The
data codes are needed to complete the form. Please print
the data codes sheet and complete, print, and sign the
investigator data sheet.
Investigator
Data Sheet Form (36KB, MSWord)
Data
Codes Sheet (30KB, MSWord)
Hiring New
Employees
Work Order Request
Please fill out the work
order request (31KB, MSWord) with all the appropriate
information and then email the completed form to Heather
Parman at: heather.parman@va.gov
Top
|
