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Research & Development - Forms and Policies

Alphabetical IRB Forms List
Explanation of IRB Forms (56KB, MSWord)
PVAMC Policies

Forms Page Topics List:
PPQ (Proposed Project Questionnaire)
Financial Administrative Review
IRB (Institutional Review Board)
HIPAA (Health Insurance Portability and Accountability Act)
Subcommittee on Research Safety
Letter of Intent
VA Research Support Agreement
Career Development
MOU (Memorandum of Understanding) with OHSU
OHSU Grants
For New VA Investigators
Work Order Request
Other Useful Forms and Form Pages:
Hiring and New Employee Information
IACUC (Institutional Animal Care and Use Committee)
Merit Review (BLR&D/CSR&D) Forms
Purchasing
Controlled Substances for Research
Research Preparation Application
Data Use Agreement (DUA) to Share Data within the PVAMC (86KB, MSWord)
Data Use Agreement (DUA) to Share Data between VA Faciities (88KB, MSWord)
Data Use Agreement (DUA) to Share Data with a Non-VA Entity (88KB, MSWord)
Office of Research Oversight (ORO)
Clarification of VA Research (32KB, MSWord)

Proposed Project Questionnaire (PPQ)

Proposed Project Questionnaire (231KB, PDF)
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 (i.e., VA time, VA patients, VA space, and/or VA equipment).


Conflict of Interest

Conflict of Interest in Research Form (PDF)
As described in the Proposed Project Questionnaire under the Conflict of Interest section investigators, including all local Principal Investigators (PIs), study chairs, site PIs, co-PIs, co-investigators, and sub-investigators, must complete this form. The completed form(s) must be submitted with the PPQ.

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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.

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Institutional Review Board (IRB)

The Institutional Review Board (IRB) is the committee charged with protecting people participating in research studies. The forms necessary to submit a project to the IRB for review may be found below. Further IRB information, such as the IRB schedules, rosters, and education links, may be viewed at the PVAMC IRB web page.

Determination of IRB Review Forms
Initial IRB Review Forms
Post IRB Approval Forms


Alphabetical List of IRB Forms:
(Click here if you need descriptions of the IRB forms 56KB, MSWord)
(Click here if you need HIPAA forms)

Acknowledgement of the Notice of Privacy Practices (See: Acknowledgement of the Notice of Privacy Practices)
Addition of Research Personnel Form (See: Research Personnel Change Form)
Accounting of Disclosures (43KB, MSExcel)
Administrative Review Form (183KB, MSWord)
Advertisement Content Requirements (24KB, MSWord)
Application for Case Report Review (56KB, MSWord)
Application for a Waiver of Authorization and Informed Consent for Screening/Recruitment Purposes (106KB, MSWord)
Biorepository CRQ (See: Repository CRQ)
Certification of Exemption (124KB, MSWord)
Conflict of Interest in Research Form
Considerations for Clinical Trials with a Placebo Controlled Design (42KB, MSWord)
Continuing Review Questionnaire (CRQ) (298KB, MSWord)
FDA Form 1571 (FDA Forms Page)
FDA Form 1572 (FDA Forms Page)
HIPAA Authorization: See Authorization for the Use and Disclosure of Protected Health Information for Research Purposes (66KB, MSWord)
Human Research Event Report (HRER) is now the Reportable Events Form
Human Subjects Audit Tool (427KB, MSWord)
Humanitarian Use Device (HUD) Application (295KB, MSWord)
Humanitarian Use Device (HUD) Continuing Review Questionnaire (293KB, MSWord)
Informed Consent Form Checklist (105KB, MSWord)
Informed Consent: Sample ICF Contact Information Sheet (24KB, MSWord)
Informed Consent: Glossary of Lay Terms for Use in Preparing Consent Forms (58KB, PDF)
Informed Consent: VA Informed Consent Reference with Color Coded Changes (211KB, MSWord)
Informed Consent Form Template (206KB, MSWord)
IRQ (Initial Review Questionnaire) (419KB, MSWord)
IRQ Appendix A (Recruitment of Vulnerable Subjects) (49KB, MSWord)
IRQ Appendix B (Payment for Participation) (44KB, MSWord)
IRQ Appendix C (Investigational Drugs) (58KB, MSWord)
IRQ Appendix D (Dietary Supplements, Herbal Remedies, or other Complementary / Alternative Remedies) (58KB, MSWord)
IRQ Appendix E (Investigational Devices) (97KB, MSWord)
IRQ Appendix F (Use of Radiation) (44KB, MSWord)
IRQ Appendix G-1(Human Biological Specimens Questionnaire - Non-Banked Specimens (83KB, MSWord)
IRQ Appendix G-2 (Human Biological Specimens Questionnaire - Biorepositories and Banked Specimens (76KB, MSWord)
IRQ Appendix H (Use of Audio/Videotapes) (36KB, 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 and Safety Monitoring Plan) (55KB, MSWord)
IRQ Appendix L (Scope of Work) (74KB, MSWord)
IRQ Appendix M (Coordinating Center of Multi-site Research) (41KB, MSWord)
IRQ Appendix N (Distinguishing VA Research from Non-VA Research) (24KB, MSWord)
Investigational Drugs - VA Form 10-9012 (84KB, MSWord)
Monitoring Visit Report (35KB, MSWord)
Partial Waiver of Authorization for Screening/Recruitment Purposes (See: Application for Waiver of Authorization...)
Personnel Change Form (See: Research Personnel Change Form)
Placebo Controlled Design (See: Considerations for Clinical Trials with a Placebo Controlled Design)
PPQ (Proposed Project Questionnaire) (231KB, PDF)
PRAF (Project Revision/Amendment Form) (88KB, MSWord)
Prescription Authorization Form (33KB, MSWord)
QA/QI (Quality Assurance/Quality Improvement) vs. Research Checklist (58KB, MSWord)
Radiological Procedure Chart (27KB, MSWord)
Recruiting Subjects (See: Research Recruiting)
Reportable Events Form (52KB, MSWord)
Repository Continuing Review Questionnaire (CRQ) (75KB, MSWord)
Request for Expedited Review. This form is no longer necessary as of 5/10.
Request for Waiver of Informed Consent Documentation (105KB, MSWord)
Request for Waiver of Informed Consent Process (110KB, MSWord)
Research Personnel Change Form (92KB, MSWord)
Research Recruiting - Template Phone Script (24KB, MSWord)
Research Recruiting - Template Recruitment Letter (32KB, MSWord)
Research Project Finalization Report (81KB, MSWord)
Scope of Work Form (See: IRQ Appendix L)
Site Visit Monitoring Report (See: Monitoring Visit Report)
Termination Report (See: Research Project Finalization Report)
Waiver of Informed Consent (See: Request for Waiver of Informed Consent)

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Detailed Descriptions of IRB Forms:

Explanation of IRB Forms (56KB, MSWord)


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 at pvamc-irb@va.gov. 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 (124KB, MSWord)
Quality Assurance/Quality Improvement vs. Research Checklist (58KB, MSWord)
Research Preparation Application (78KB, MSWord)

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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.

IRQ (Initial Review Questionnaire) (358KB, 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 (206KB, MSWord)
Authorization for the Use and Disclosure of Protected Health Information for Research Purposes (57KB, 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 (111KB, MSWord)
Request for Waiver of Informed Consent Process (107KB, 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:

Application for a Waiver of Authorization and Informed Consent for Screening/Recruitment Purposes (120KB, 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) (79KB, MSWord)
Research Personnel Change Form (94KB, MSWord)
Monitoring Visit Report (35KB, MSWord)
Research Project Finalization Report (75KB, MSWord)

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Health Insurance Portability and Accountability Act (HIPAA)

The forms are listed in alphabetical order below. If you need a description of the forms please click here.

Acknowledgement of the Notice of Privacy Practices (309KB, PDF)
Authorization for the Use and Disclosure of Protected Health Information for Research Purposes (57KB, MSWord)
Request for Waiver of Informed Consent Documentation (111KB, MSWord)
Request for Waiver of Informed Consent Process (107KB, 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)
List of 18 HIPAA Identifiers (28.5KB, MSWord)


Subcommittee on Research Safety (SRS)

Biosafety Approval of Research Proposals
Submission of all forms is electronic; hard copies are not required. Submit all required documents to research.grants@va.gov. These must be sent from the Principal Investigator’s email address as this will serve in lieu of a signed hard copy. All submissions received by the 15th of each month will be reviewed at the upcoming SRS meeting.

FOR INITIAL REVIEW: Project Safety and Hazard Assessment (1,052KB, MSWord)
This form is to be completed by the Principle Investigator and approved by the SRS prior to any work being conducted in VA space.

FOR CONTINUING REVIEW: SRS Annual Continuing Review Form (974KB, MSWord)
This form is to be completed by the Principle Investigator and approved by the SRS annually for all projects that have already received initial approval by the SRS.

FOR AMENDMENTS TO ALREADY APPROVED PROJECTS: SRS Project Amendment Form (1,028KB, MSWord)
This form is to be completed by the Principle Investigator and approved by the SRS for changes made to the chemicals used or the experimental protocols conducted, including possible use of BSL2 agents, radioactive materials, or rDNA.

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. Also note that a Project Safety and Hazard Assessment form (above) must also be included with all submitted VA 10-0398 Forms.

Laboratory Chemical Inventories
Each investigator is required to maintain and post a hard copy of the laboratory chemical inventory. This document will be reviewed by multiple regulatory entities during the course of a year. These inventories must provide some required information, including CAS numbers for the chemicals, and all hazardous chemicals must be indicated. Hazardous Chemicals are those that are: corrosive, reactive, flammable, or toxic. This can be determined from a material safety data sheet (MSDS) or by contacting the PVAMC Industrial Hygienist. A Sample Chemical Inventory (23KB, Excel) is available for informational review. In addition, investigators are required to maintain their online MSDS database for hazardous chemicals within the VISN 20 online system. The PVAMC Industrial Hygienist in Facilities Management Service will review these documents twice yearly to ensure compliance.

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Letter of Intent (LOI)

Letter of Intent (VA Web Site, PDF)
This form must be completed when submitting a Career Development or Merit Review Application to the following VA Services:
Career Development (VA Web Site)
Rehabilitation Research & Development (RR&D) (VA Web Site)

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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.

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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.

10-1313-13 (VA Web Site, PDF)

Listed below are the forms needed to submit a complete Career Development Application.
10-0102 (Cover Page) (VA Web Site, PDF)
10-1313-3 (VA Web Site, PDF)
10-1313-4 (VA Web Site, PDF)
10-1313-5 (VA Web Site, PDF)
10-1313-6 (VA Web Site, PDF)
10-1313-7 (VA Web Site, PDF)
10-1313-8 (VA Web Site, PDF)

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Memorandum of Understanding (MOU) with OHSU

Memorandum of Understanding (MOU) for OHSU (OHSU Web Site)
MOUs are an NIH requirement in the cases of joint university/VA appointments. Any PI who is compensated (paid) by both VA and OHSU must initiate an MOU when submitting a grant to NIH to be administered at OHSU, regardless of within which facility he/she will conduct the research. VA Without Compensation (WOC) appointees do not need MOUs because they do not receive VA salary compensation.

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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.

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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.
Investigator Data Sheet Form (26KB, PDF)

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

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PVAMC Policies

All Research Types:
Conflict of Interest in Research (47KB, PDF)
Credentialing of Personnel Involved in Research (33KB, PDF)
Education Requirements for the Conduct of Research (169KB, PDF)
Presentation and Publication Policy (83KB, PDF)
Research and Development Committee Standard Operating Procedures (103KB, PDF)
For information on Research Files Storage Policy and Procedures, please email Kenneth Fouse at Kenneth.Fouse@va.gov.
Research Information Protection Program (RIPP) (200KB, PDF)
Research Misconduct (65KB, PDF)
Responsible Conduct of Research at the PVAMC (52KB, PDF)
Research & Development Service Emergency Preparedness Plan (398KB, PDF)

Human Subjects Research:
Institutional Review Board Policies and Procedures (578KB, PDF)
Link to Human Research Protection Program (HRPP) Policies

Animal Research:
Link to Veterinary Medical Unit Policies
Link to Institutional Animal Care and Use Committee (IACUC) Guidelines

Wet Lab Research:
Link to Subcommittee on Research Safety Standard Operating Procedures (SOP)