Research and Development Service - VA Portland HCS

VA Portland Health Care System's (VAPORHCS) Institutional Review Board (IRB)

Basic Information About the VAPORHCS IRB

Within the VA system, an Institutional Review Board is a subcommittee to the Research & Development (R&D) Committee, which is the primary governing body of a research program conducted at a VA medical center. The R&D Committee is responsible for the scientific quality and appropriateness of all research conducted at the VAPORHCS. The VAPORHCS has one in-house Institutional Review Board and also utilizess the VA Central IRB and one of the IRBs run by the university affiliate OHSU. The minutes of all three IRBs are provided to the R&D Committee.

IRB numbers are as follows:
VA IRB#1: IRB00001976
VA Central IRB: IRB00006332
OHSU IRB-3: IRB00000471

VAPORHCS FWA number is: FWA00000517

Basic Information About the VAPORHCS IRB

The VAPORHCS IRB forms are meant to work together and prompt you for all information and forms required for your submission. Please read through all instructions and take advantage of all the provided links to policies, definitions, and other forms when applicable. This will help ensure that you include all required elements for IRB review. It will also provide you with a better understanding of why/what is required for IRB review and approval.

The help guide can be found by clicking here(244KB, MSWord) Top

Guiding Philosophies of the IRB

The IRB is required by federal, state and VA regulations to review proposed human studies protocols in order to determine if they have been designed in a safe and ethical manner, and to assure that the risks to human participants will be reduced as much as possible. There is a long history to the review of human studies research.

In April, 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published The Belmont Report, (Federal Web Site) which serves as one of the primary guiding documents for the VAPORHCS IRB. The Belmont Report outlines the ethical principles and guidelines for research involving human subjects, primary among which are respect for persons, beneficence, and justice. Each of these are applied through the requirement for informed consent, assessment of risks and benefits, and selection of subjects, respectively. It is strongly recommended that all principal investigators, and others, conducting human studies research read the nine page Belmont Report.

The World Medical Association Declaration of Helsinki was initiated in 1964, and has been updated regularly since. Although the Declaration of Helsinki has not been fully accepted by the United States, it provides a strong outline for the ethical principals for medical research involving human subjects.

A more thorough history of human subjects research is provided on the NIH computerbased training module at http://cme.nci.nih.gov.

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Policies and Procedures

The IRB Policies and Procedures (formerly IRB SOP) (1,123KB, MSWord) at the VAPORHCS provides the background for the in-house IRB, including ethical principles and the regulatory mandate to protect human subjects, and information on how the IRB is administered. This includes types of IRB review, review and approval considerations, and required elements of informed consent.

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IRB Roster

The roster for the in-house VAPORHCS IRB is available by clicking here(56KB, MSWord). Study sponsors may require the study coordinator/principal investigator to keep an IRB roster on file with the study paperwork.

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IRB Deadlines and Meeting Schedules

Submission of Initial Reviews: 2^nd Monday of the month

Any requests that are received on time but are rejected for expedited review will be placed on the IRB docket for full review the following month. Because of the time required to prepare for full IRB review, any requests that are received after the 2nd Monday and are rejected for expedited review will likely have to be scheduled for the IRB meeting two months after submission.

Submission of Continuing Reviews: due dates will be provided in the email reminders

Submission of Reportable Events: within the required reporting time frame (see the IRB Policy and Procedures (formerly IRB SOP) for details)

Submission of other reviews - e.g., amendments, revisions, etc.: 3^rd Monday of the month
Note: All studies and revisions, etc. will initially be considered for expedited review. Those submissions which are not eligible for expedited review will be automatically scheduled for fullboard review at the next convened IRB meeting.

The in-house VAPORHCS IRB meets the first Wednesday of each month, unless it falls on a holiday.

The deadline for submission of revisions requested by the in-house VAPORHCS IRB to address a review that was “tabled” is generally the close of business on the Friday prior to the last Monday of each month. This applies to initial review submissions as well as tabled amendments, etc.

These deadlines have been created in order to allow sufficient time for IRB agendas to be created, packets to be copied, and to allow IRB reviewers time to complete a thorough review of all materials.

Useful Websites

http://www.research.va.gov/programs/pride/default.cfm (VA Web Site)
The Program for Research Integrity Development & Education (PRIDE) is a VA office whose mission is to protect participants in VA human research. PRIDE is responsible for all policy development and guidance, and all training and education in human research protection throughout the VA.

http://grants1.nih.gov/grants/policy/coc/index.htm (Federal Web Site)
This website provides information regarding Certificates of Confidentiality. Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.

http://www.fda.gov/ (Federal Web Site)
US Food and Drug Administration web site

http://www.hhs.gov/ohrp/ (Federal Web Site)
Department of Health and Human Services Office for Human Research Protections. This web site includes information regarding regulations, policy guidance, education opportunities and compliance oversight.

http://www.clinicaltrials.gov/ (Federal Web Site)
This website provides regularly updated information about federally and privately supported clinical research in human volunteers. The site provides information about a trial's purpose, who may participate, locations, and phone numbers for more details.

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VAPORHCS-OHSU IRB

VA Portland Health Care System (VAPORHCS) now utilizes an OHSU IRB for studies conducted on both sides of the bridge!

Initial Submission

The VAPORHCS-OHSU IRB (also known as OHSU IRB-3) reviews the following types of studies that are being conducted at both institutions:

1. Brand new submissions that are not yet active at either institution
2. Studies which are active at OHSU, and are adding the VA as a new site
3. Studies which currently have IRB approval at BOTH VAPORHCS and OHSU, and want to transition to a single review at OHSU

Please follow the applicable instructions (specific to the type of study) located in the "Preparing a Combined VA-OHSU IRB Submission" (146KB, MSWord) document.

Questions regarding submissions to the joint VAPORHCS-OHSU IRB should be directed to:
Alissa Hooper: alissa.hooper@va.gov or x54989

Protocol Submission Forms

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.

Abstract Template (19KB MSWord)
Advertisement Content Requirements (26KB, MSWord)
Annual Check-In Form (50KB, 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)
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.
Biorepository CRQ (See: Repository CRQ)
Biospecimen Banking at a Non-VA Institution (42KB, MSWord)
Biospecimen Storage at a For-Profit Institution (75KB, MSWord)
Conflict of Interest in Research Form (2.24MB PDF)
Continuing Review Questionnaire (CRQ) for joint board studies (IRB3) (83KB, MSWord)
Humanitarian Use Device (HUD) Application (IRB3) (32KB, MSWord)
Humanitarian Use Device (HUD) Continuing Review Questionnaire (CRQ)(IRB3) (83KB, MSWord)
Initial Review Questionnaire (IRQ)
Informed Consent Form Template (137KB, MSWord)
IRQ Appendix C (Investigational Drugs) (28KB, MSWord)
IRQ Appendix D (Dietary Supplements, Herbal Remedies, or other Complementary / Alternative Remedies) (28KB, MSWord)
IRQ Appendix E (Investigational Devices) (35KB, MSWord)
IRQ Appendix F (Use of Radiation) (21KB, MSWord)
IRQ Appendix J (HIPAA: Statistical Analysis De-Identification Certification) (27KB, MSWord)
IRQ Appendix L (Scope of Work) (31KB MSWord)
IRQ Appendix M (Coordinating Center of Multi-site Research) (23KB, MSWord)
IRQ Appendix N (Distinguishing VA Research from Non-VA Research) (21KB, MSWord)
Investigational Drugs - VA Form 10-9012 (28KB, MSWord)
Protocol Template (91KB, MSWord)
Repository Annual Check-In Form (42KB, MSWord)
Repository Sample SOP Template (42KB, MSWord)
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 Information Sheet template (48KB, MS Word)
Research on Decedents' Information Application (38KB, MSWord)
Research Personnel Change Form (92KB, MSWord)
Research Recruiting - Template Phone Script (17KB, MSWord)
Research Recruiting - Template Recruitment Letter (28KB, MSWord)
Research Project Finalization Report (81KB, MSWord)

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IRB Reviewer Checklists

PLEASE NOTE: When selecting forms to use for your review, you will need to know if the study you're reviewing is under the new Revised Common Rule, also referred to as 2018 requirements, or if the study you're reviewing 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 studies covered by the 2018 requirements MUST use the version of the document with 2018 in the title. If the study you're reviewing 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.

Repository Review Checklist (140KB, MSWord)
Consent Form Checklist (105KB, MSWord)
Emergency Use Reviewer Checklist (64KB, MSWord)
Humanitarian Use Device (HUD) Review Checklist (63KB, MSWord)
Initial Review Checklist (259KB, MSWord)
Continuing Review Checklist (196KB, MSWord)
Advertisement Checklist (51KB, MSWord)
Research Project Finalization Report Checklist, formerly Termination Checklist (56KB, MSWord)
Modification Checklist (62kb, MSWord)
Radiation Checklist (27KB, MSWord)
Phase 0-1 Checklist (96KB, MSWord)

Visit the R&D Forms page to access all other IRB forms.

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VA Central IRB

The VA Central IRB currently only reviews VA Office of Research and Development (ORD) funded multisite research projects. After September 30, 2010, all new ORD-funded multisite research projects must be submitted to the VA Central IRB for review. This does not apply to studies that have already undergone review by other IRBs prior to this date and it only applies to studies with more than one site "engaged" in research.

Central IRB SOP for Portland (44KB, PDF)

For more information, forms or additional resources, please go to the VA Central IRB web page.

Human Research Protection Program

Frequently Asked Questions

What is a Human Research Protection Program (HRPP)?
A HRPP is the systematic and comprehensive approach of an organization, such as the VA Portland Health Care System (VAPORHCS), to ensure human subject protection in all human research conducted under the auspices of the institution. The implementation of any part of the program may be delegated to specific committees, individuals, or entities by the organization. The VAPORHCS's HRPP is established in the Medical Center Memorandum No. 151-01, "Responsible Conduct of Research at the VA Medical Center."

What is a Federal Wide Assurance (FWA)?
The Office of Human Research Protections (OHRP) mandates that each institution's Institutional Review Board be registered with the OHRP. Our VAPORHCS IRB operates under an OHRP approved Federal Wide Assurance (FWA). We, as an institution, must be compliant with the terms set forth in the FWA for protecting human subjects and renew this FWA every five years. The FWA states that our IRB and the VA Central IRB (applicable for studies determined by ORD to be candidates for review by the VA Central IRB) are responsible for abiding by the federal regulations set forth in Title 45 Part 46, regarding the protection of human subjects, and that the Medical Center Director is the Signatory Official legally authorized to represent the institution.

The VAPORHCS FWA number is FWA00000517. Information regarding that FWA can be found by accessing the U.S. Department of Human Services Office for Human Research Protections web site and entering the FWA number.

The OHRP registration numbers for the VAPORHCS IRBs are:
VA IRB#1: IRB00001976
VA Central IRB: IRB00006332
OHSU IRB-3: IRB00000471

Required Research Reporting

VA regulations require reporting within five (5) business days of awareness to the IRB of unanticipated problems involving risk, reportable protocol deviations, local serious adverse events that are unanticipated, and all possible serious or continuing non-compliance. For more precise guidance, please see the following:

Reportable Event Form

HRPP Policies and Procedures

Continuous Quality Improvement in the Human Research Protection Program (23KB, PDF)

Glossary of Lay Terms for Use in Preparing Consent Forms (58KB, PDF)

HIPAA Human Subjects Research Policies and Procedures (76KB, PDF)

Investigational Device and/or Drug Usage (189KB, PDF)

Investigational Drugs for Human Use (91KB, PDF)

IRB Policy and Procedures (formerly IRB SOP) (1,161KB, MSWord)

Monitoring Policy (See: Requirements for Outside Monitoring of VA Portland Health Care System Human Research)

Requirements for Outside Monitoring of VA Portland Health Care System Human Research (30KB, MSWord)

Research Flags (29KB, MSWord)
This document includes instructions for activating and deactivating research flags in CPRS for participants on studies that require a flag, as indicated by the IRB.

Research Preparation Application (80KB, MSWord)

Responsibilities of the Principal Investigator (50KB, MSWord)

External IRBs of Record

NCI IRB Project Application and policies and procedures can be found on the Forms and Policies page.
WIRB SOP can be found on the Forms and Policies page.
Advarra SOP can be found on the Forms and Policies page.