Research & Development - Forms and Policies - VA Portland Health Care System
Attention A T users. To access the menus on this page please perform the following steps. 1. Please switch auto forms mode to off. 2. Hit enter to expand a main menu option (Health, Benefits, etc). 3. To enter and activate the submenu links, hit the down arrow. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links.

VA Portland Health Care System

Menu
Menu
Veterans Crisis Line Badge
My HealtheVet badge
EBenefits Badge
 

Research & Development - Forms and Policies

PI User Guide for IRBManager (5,319KB)
Committee Member User Guide for IRBManager (4,014KB)
To access IRBManager click here:https://pvamc.my.irbmanager.com/

VAPORHCS Policies

GENERAL FORMS:
Financial Administrative Review
IRB (Institutional Review Board)
HIPAA (Health Insurance Portability and Accountability Act)
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:
Clarification of VA Research (32KB, MSWord)
Controlled Substances for Research
Data Use Agreement (DUA) to Share Data within the VAPORHCS (86KB, MSWord)
Data Use Agreement (DUA) to Share Data between VA Facilities (88KB, MSWord)
Data Use Agreement (DUA) to Share Data with a Non-VA Entity (88KB, MSWord)
Hiring and New Employee Information
Grant Submission Forms (Merit Review, Career Development, Career Scientist, etc.)
Office of Research Oversight (ORO)
Purchasing
Research Preparation Application
Abstract Template (29KB, MSWord)
Required Protocol Template (91KB, MSWord)
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.

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)
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 VAPORHCS IRB web page.

Determination of IRB Review Forms

IACUC FORMS

Animal Component of Research Protocol (ACORP)

Effective January 4, 2021, all initial submission and continuing review IACUC documents must be attached to the appropriate IACUC submission xForm in IRBManager (IRBM). Please see the PI User Guide (at the top of this page), for instructions on submitting in IRBM. Amendments for existing studies (as of January 4, 2021) must continue to be submitted using the current paper process until the time of transition to IRBM. All IACUC amendment documents should be attached to an email and sent to PVAMC-IACUC@va.gov.

The ACORP should be completed when a VA PI is submitting a study/grant which uses animals AND requests VA funds (i.e., Merit Review, Career Development) AND/OR the VA PI wishes to house the animals at the VA Portland Health Care System's Veterinary Medical Unit (VMU). Visit the VA Office of R&D Animal Documents and Resources web page for further information. Deadline for consideration at the next meeting is the 15th of the month (or the next business day).
NOTE: VA Central Office expects a detailed literature search of alternatives to animal testing with the ACORP submission. See the following document for details:

Database Searches for Alternatives to Animal Testing (34KB, MSWord)
ACORP (263KB, MSWord)
    (ACORP Instructions) (115KB, MSWord)
ACORP Appendix 1: Use of Non-VA Animal Facility (25KB, MSWord)
    (ACORP Appendix 1 Instructions) (25KB, MSWord)
ACORP Appendix 2: Antibody Production (56KB, MSWord)
    (ACORP Appendix 2 Instructions) (32KB, MSWord)
ACORP Appendix 3: Test Substances (98KB, MSWord)
    (ACORP Appendix 3 Instructions) (46KB, MSWord)
ACORP Appendix 4: Antemortem Specimen Collection (40KB, MSWord)
    (ACORP Appendix 4 Instructions) (32KB, MSWord)
ACORP Appendix 5: Surgery (108KB, MSWord)
    (ACORP Appendix 5 Instructions) (46KB, MSWord)
ACORP Appendix 6: Special Husbandry and Procedures (61KB, MSWord)
    (ACORP Appendix 6 Instructions) (35KB, MSWord)
ACORP Appendix 7: Request to Use Patient Care Procedural Areas for Animal Studies (30KB, MSWord)
    (ACORP Appendix 7 Instructions) (35KB, MSWord)
ACORP Appendix 8: Request to Use Explosive Agent (41KB, MSWord)
    (ACORP Appendix 8 Instructions) (34KB, MSWord)
ACORP Appendix 9: Additional Local Information (27KB, MSWord)
    (ACORP Appendix 9 Instructions) (265KB, MSWord)

Continuing Reviews
A continuing review is required annually prior to the expiration of the approved ACORP. Notices are generated to investigators at least one month prior to expiration. Continuing reviews will be submitted through IRBManager (IRBM) beginning January 4, 2021. Please refer to the PI User Guide for instructions on submitting.

Amendment to ACORP
The ACORP may be amended to reflect changes in the approved ACORP; for example, personnel changes, addition of animals, drugs or procedures. PLEASE NOTE: As of January 4, 2021, existing studies will submit amendments using the current paper process until the project transitions to the new system (IRBM) at the time of continuing review. After transition, all amendments must be submitted in IRBM.

Standard Operating Procedures (SOPs)
These Standard Operating Procedures have been approved by the IACUC and may be referenced in your ACORP. If you intend to reference any of these SOPs in your animal protocol, please add a statement in Item C.2. that you have read and understand the guidelines in the <specific title> SOP and that you will follow the procedure outlined. Additionally, if you would like to propose that a new SOP be reviewed and approved by the IACUC, please contact Margaret Doherty (margaret.doherty@va.gov) and Kim Neve (nevek@ohsu.edu) for additional information.

ThreeDay Locomotor Activity Test SOP (35KB, MSWord)
Conditioned Place Preference (or Aversion) Testing SOP (115KB, MSWord) 

Top


IRB FORMS:

Effective January 4, 2021, all initial submission and continuing review submissions must be submitted through IRBManager (IRBM). Please see the PI User Guide (at the top of this page), for instructions on submitting in IRBM. Amendments for existing studies (as of January 4, 2021) must continue to be submitted using the current paper process until the time of transition to IRBM. Please follow the submission instructions for amendments located within the form.

PLEASE NOTE: When selecting forms to use for your submission, you will need to know if your study is under the new Revised Common Rule, also referred to as 2018 requirements, or if your study is under the old Common Rule. Studies approved on, or after, January 21, 2019 are automatically covered by the 2018 requirements. If a document has two versions, those covered by the 2018 requirements MUST use the version of the document with 2018 in the title. If your study was approved prior to January 21, 2019 the study will be covered by the old common rule. If there are two versions of the document, these studies MUST use the version without 2018 in the title. Currently, we are not transitioning any studies that were approved prior to January 21, 2019, to the 2018 requirements.

(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)
2018 Application for a Waiver of Authorization for Screening/Recruitment Purposes (95KB, MSWord)
Application for a Waiver of Authorization for Screening/Recruitment Purposes (106KB, MSWord)
Biorepository CRQ (See: Repository CRQ)
Biospecimen Banking at a Non-VA Institution (41KB, MSWord)
Biospecimen Storage at a For-Profit Institution (243KB, MSWord)
Conflict of Interest in Research Form
Considerations for Clinical Trials with a Placebo Controlled Design (42KB, MSWord)
FDA Form 1571 (FDA Forms Page)
FDA Form 1572 (FDA Forms Page)
HIPAA Authorization: See Authorization for Use & Release of Individually Identifiable Health Information for Veterans Health Administration (VHA) Research (66KB, MSWord)
Human Research Event Report (HRER) is now the Reportable Events Form
Human Subjects Audit Tool (427KB, 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 Appendix A (Recruitment of Vulnerable Subjects) (48KB, MSWord)
IRQ Appendix B (Payment for Participation) (44KB, MSWord)
IRQ Appendix C (Investigational Drugs) (61KB, 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 I (HIPAA: Safe Harbor De-Identification Certification) (50KB, MSWord)
IRQ Appendix J (HIPAA: Statistical Analysis De-Identification Certification) (54KB, 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)
NCI CIRB ICF Addendum (20KB, MS Word)
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)
PRAF (Project Revision/Amendment Form) (88KB, 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 Frequently Asked Questions (FAQs) (38KB, MSWord)
Repository Sample SOP Template (47KB, MSWord)
Request for Expedited Review. This form is no longer necessary as of 5/10.
2018 Request for Waiver of Informed Consent Documentation (114KB, MSWord)
Request for Waiver of Informed Consent Documentation (105KB, MSWord)
2018 Request for Waiver of Informed Consent Process (124KB, 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)


Top


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)
Quality Assurance/Quality Improvement vs. Research Checklist (58KB, MSWord)
Research Preparation Application (76KB, 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)

Top


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 Use & Release of Individually Identifiable Health Information for Veterans Health Administration (VHA) Research (2,575KB, PDF)
Authorization for Use & Release of Individually Identifiable Health Information for Veterans Health Administration (VHA) Research Page 6 (38KB, PDF) This form is used when there will be a contribution to more than one repository.
2018 Request for Waiver of Informed Consent Documentation (114KB, MSWord)
Request for Waiver of Informed Consent Documentation (111KB, MSWord)
2018 Request for Waiver of Informed Consent Process (124KB, 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 for Use & Release of Individually Identifiable Health Information for Veterans Health Administration Research (1,897KB, PDF)
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)


EXEMPTION SUBCOMMITTEE

Effective January 4, 2021, all initial submission and continuing review submissions must be submitted through IRBManager (IRBM). Please see the PI User Guide (at the top of this page), for instructions on submitting in IRBM. Amendments for existing studies (as of January 4, 2021) must continue to be submitted using the current paper process until the time of transition to IRBM.

Exemption Research Information Sheet template (30KB, MSWord)
Exemption PRAF (23KB, MSWord)
Project Finalization Form (99KB, MSWord)



SRS FORMS

PLEASE NOTE: Effective January 4, 2021, new submissions and continuing reviews (for February and after) of existing studies will be submitted in IRBManager (IRBM). Please refer to the PI User Guide on how to submit within IRBM. Amendments for existing studies will continue to be done through the current paper process until the study has transitioned to IRBM.

Safety Approval of Research Proposals

Approval from the Subcommittee on Research Safety (SRS) is required for any project that includes work taking place in a VA research lab. This includes work with chemicals, biospecimens (including establishing a biorepository), cells/tissue culture, microbiological agents, recombinant DNA, controlled substances, or radioisotopes.

FOR INITIAL REVIEW: Please see the PI User Guide, on the Forms & Policies page for how to submit in IRBM.

FOR CONTINUING REVIEW: Please see the PI User Guide, on the Forms & Policies page for how to submit in IRBM.

FOR AMENDMENTS TO ALREADY APPROVED PROJECTS (prior to transition to IRBM): SRS Project Amendment Form (1,028KB, MSWord)
This form is to be completed by the Principal Investigator to request approval for changes to any VA wet lab work on a project. This includes changes to chemicals, recombinant DNA, types of biospecimens collected or biohazardous or radioactive agents used, and addition of new wet lab personnel.

VA Form 10-0398 (VA Web Site, PDF)
This form must be completed by a PI following notification of award of VA funding for a grant proposal. Also note that a Project Safety and Hazard Assessment form (above) must also be included with the submission of the VA Form 10-0398.

Laboratory Chemical Inventories and Safety Data Sheets
Each investigator with a VA wet lab is required to maintain an online Safety Data Sheet (SDS) database for hazardous chemicals using the VA SDS/Chemical Inventory Service. This database is reviewed by multiple regulatory entities throughout the year. The VAPORHCS Industrial Hygienist will require an assurance from the PI twice yearly that the inventory is up-to-date. To begin the process to request database access, contact the SRS Coordinator at research.grants@va.gov. Additionally, all individuals working in a VA wet lab must be trained by the PI to locate an SDS for a chemical, either by using the VA chemical inventory database or by locating the chemical’s SDS on the manufacturer’s website.

Top


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)

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.

Top


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)

Top


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.

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 VAPORHCS. 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

Top

VAPORHCS Policies

All Research Types:
Code of Conduct in Research (14KB, MSWord)
Conflict of Interest in Research (47KB, PDF)
Credentialing of Personnel Involved in Research (33KB, PDF)
Education Requirements for the Conduct of Research (169KB, PDF)
Physical Security of Research Space; And the Control of Hazardous Agents (218KB, PDF)
Presentation and Publication Policy (83KB, PDF)
Research and Development Committee Standard Operating Procedures (103KB, PDF)
Research Records Management Policy (108KB, PDF).
Research Information Protection Program (RIPP) (200KB, PDF)
Research Misconduct (65KB, PDF)
Responsibilities of the Principal Investigator (All Research Types) (50KB, MSWord)
Responsible Conduct of Research at the VAPORHCS (52KB, PDF)
Research & Development Service Emergency Preparedness Plan (54KB, PDF)

Human Subjects Research:
Institutional Review Board Policies and Procedures (1,123KB, MSWord)
Exemption Subcommittee Policies and Procedures (70KB, MSWord)
VA NCI Central Institutional Review Board Policies and Procedures (95KB, MSWord)
VA WIRB Standard Operating Procedures (54KB, MSWord)
VA Advarra Standard Operating Procedures (46KB, MSWord)
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:
Biosafety Manual (1,022KB, MSWord)
Chemical Hygiene Plan (645KB, MSWord)
Link to Subcommittee on Research Safety Standard Operating Procedures (SOP)

| R&D Site Map |