PVAMC's Institutional Review Boards
Basic Information About the PVAMC IRBs
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 Portland
VAMC. The Portland VA has two Institutional Review Boards,
which both report to the single R&D Committee.
IRB numbers are as follows:
VA IRB#1: IRB00001976
VA IRB#2: IRB00003313
VA Central IRB: IRB00006332
OHSU IRB-3: IRB00000471
PVAMC FWA number is: FWA00000517
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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 Portland
VAMC Institutional Review Board. The Belmont Report outlines
the ethical principals 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
Policy and Procedures (formerly IRB SOP) (812KB, PDF) at the
PVAMC provides the background for each IRB, including
ethical principles and the regulatory mandate to protect
human subjects, and information on how the IRBs are administered.
This includes types of IRB review, review and approval
considerations, and required elements of informed consent.
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IRB Roster
The rosters for the two Portland VAMC Institutional Review
Boards are available by selecting roster
#1 (56KB, MSWord) or roster
#2 (70KB, 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: 2nd 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.
The Grants Program Specialist, in conjunction with the IRB Analysts, will assign each new protocol to either PVAMC IRB #1 or #2. Once assigned to an IRB, a study will remain with that board for the life of the study.
Submission of Continuing Reviews: due dates will be provided in the email reminders
Submission of HRERs: 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.: 3rd 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.
Response to tabled review from IRB #1: 2013 due dates-
January 25, February 22, March 22, April 19, May 24, June 21, July 26, August 23, September 20, October 25, November 22 and January 4 (for 2014)
Response to tabled review from IRB #2: 2013 due dates-
February 1, March 1, March 29, April 26, May 31, June 28, August 2, August 30, September 27, November 2, November 29, December 27 (for 2014)
IRB #1 meets the first Wednesday of each month and IRB
#2 meets on the second Wednesday. However, the deadline
for submission of new IRB paperwork remains as noted above, regardless
of IRB assignment. (NOTE: In cases
where an IRB meeting falls on a federal holiday, the meeting
will be rescheduled.
The deadline for submission of revisions requested by
IRB #1 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.
The IRB #2 deadline to address a tabled review is generally
the close of business on the Friday prior to the first
Monday of the month. Please see the specific dates listed
above.
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.
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IRB Reviewer Checklists
Biorepository
Review Checklist (132KB, MSWord)
Consent
Form Checklist (105KB, MSWord)
Emergency
Use Reviewer Checklist (64KB, MSWord)
Expedited
Review Checklist (88KB, MSWord)
Humanitarian Use Device (HUD) Review Checklist (63KB, MSWord)
Initial/Continuing Review Checklist (196KB, MSWord)
Advertisement Checklist (51KB, MSWord)
Human Research Event Report Reviewer (HRER) Checklist (77KB, MSWord)
Termination Checklist (39KB, MSWord)
Modification Checklist (62kb, MSWord)
Visit the R&D
Forms page to access all other IRB forms.
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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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R&D Site Map
PVAMC and OHSU Joint IRB
PVAMC now utilizes an OHSU IRB for studies conducted on both sides of the bridge!
For more information and instructions on the process please choose one of the following options:
Initial Submission
Continuing Review Submission
Initial Submission
Investigators proposing human subjects studies that will be conducted at both OHSU and PVAMC, aka joint studies, should submit their study to OHSU IRB-3. This is accomplished by logging in to the OHSU eIRB system and creating a new study submission. In the eIRB system, please begin the Short Title with the phrase "PVAMC/OHSU".
When completing the eIRQ in the system, question 2.6.13 should be answered to indicate the VA components that will be included in the VA portion of the proposed research. This page contains guidance on how to submit a “joint study” to OHSU. The guidance is also captured in this standalone document: Preparing a Combined VA-OHSU IRB Submission (92KB, MSWord).
- GATHER TOGETHER ALL THE REQUIRED DOCUMENTS
In addition to the eIRB submission, all studies must have:
- OHSU PPQ (Proposed Project Questionnaire) – submitted as appropriate according to OHSU requirements
- VA PPQ – completed Word version uploaded into eIRB
- If #4 is answered "YES", complete the VA Financial Administrative Review
- Abstract (per item 1 on the VA PPQ) - sent to research.grants@va.gov
- Lay Language Protocol Summary (Note: In some cases, such a retrospective chart review only, the Lay Language Protocol Summary may serve as the protocol and may be longer than 1 page.)
- VA Supplemental Questionnaire (VASQ) (263KB, MSWord) - with signed assurances page uploaded into eIRB
- Scope of Work forms (VA IRQ Appendix L) – signed copy uploaded into eIRB for each individual listed on the VASQ
Note that each of these individuals must have some type of VA appointment and meet the PVAMC Research appointment requirements, including verification of education and credentialing. The requirements are outlined at: Appointment Requirements.
**For all VA documents (such as the VA consent form, VA scope of work, etc.), please title the documents with the prefix "VA" when uploading them into eIRB.
Most studies must have:
- Protocol
- Describe the study purpose/aims, procedures, data collection, statistical analysis, sample size, measures to protect subjects’ safety, etc.
- Separate the VA activities/research from the OHSU activities/research - especially critical for studies that will combine VA and OHSU data
- "VA data" are data collected:
- By a VA investigator
- On VA time
- Under the portion of the protocol approved by PVAMC R&D Committee
- "OHSU data" are data collected:
- By an OHSU investigator
- On OHSU time
- Under the OHSU portion of the approved protocol
- If non-veterans will be recruited through PVAMC, the protocol also must include (either in the main body or as an appendix) a justification for doing so.
- If research subjects will be paid, include (either in the main body or as an appendix) substantiation that payments are:
- reasonable and commensurate with the expected contributions of the subject;
- fair and appropriate, and do not constitute (or appear to constitute) coercion or undue pressure or influence on the prospective research subjects to volunteer for the study.
- Consent and (HIPAA) Authorization Form(s) for VA and OHSU (or a Request for Waiver of Informed Consent and Authorization)
- When crafting these forms, consider whether the study includes:
- additional (“optional”) activities
- banking and/or genetics
- vulnerable populations (e.g., children, decisionally impaired, etc.)
- Templates for most situations are available:
- OHSU Consent Form Templates
- OHSU HIPAA Authorization Forms
- VA Consent Form Template
- VA HIPAA Authorization Form
- Additional documents that may be required:
- Full Grant – required if federally funded (e.g., NIH)
- Data Safety Monitoring Plan – can be described within the protocol or uploaded as a separate document
- Drug/Device Information – as applicable, include Investigator’s Brochures, Package Inserts, Manufacturer’s Product Information, FDA Communications (e.g., regarding IND/IDE, exemptions)
- Clinical Billing Schedule – if clinical procedures will be performed/li>
- Questionnaires, surveys, focus groups – include all study instruments used for interactions with subjects; for focus groups, provide an outline with as much detail as possible about anticipated topics/dialogue
- Recruitment materials - if ads or recruitment letters will be used for potential VA participants, check the VA’s Advertisement Requirement Contents and Recruiting Potential Research Subjects – Executive Summary
- Screening scripts – for example, if screening for eligibility by phone
- VA IRQ Appendices, as prompted by the VASQ:
- VA IRQ Appendix A - if vulnerable populations are recruited
- VA IRQ Appendix B - if participants are paid
- VA IRQ Appendix C or D and VA Form 10-9012 - if the study involves a drug, supplement, etc.
- VA IRQ Appendix F - if the study involves radiation
- VA IRQ Appendix G-1 or G-2 - if the study involves human biological specimens
- VA IRQ Appendix H - if the study involves audio or video recording
- VA IRQ Appendix N - to help clearly distinguish the VA activities versus OHSU activities/research on the study
- COMPLETE THE IRQ
As you go through the Initial Review Questionnaire (IRQ) in the eIRB, consider the following:
- The short title of your study should start with “VA” or “VA-OHSU”.
- The way you answer questions on one page will determine which pages populate as you move through the IRQ. Thus, it is important to consider each question carefully.
- There is Help Text that sits in the right hand margin. Links will lead you to templates for further documents that may be required [e.g., Data and Safety Monitoring Plan (DSMP), Clinical Billing Schedule, Ionizing Radiation in Humans].
- COMPLETE VA TRAINING REQUIREMENTS
The PVAMC requires that research team members conducting human subjects research at the VA (or with VA patients, patient records, VA resources or on VA time) complete required human subjects protection education. Please review the requirements and complete the required education.
- CONSIDER THE IRB’s FAQs
Consider the following frequently asked questions to increase your chances of a clear and consistent submission:
- Will you be screening for subjects prior to written consent/authorization?
- Describe if/how medical records, clinic schedules etc. might be used
- If using Protected Health Information before written authorization can be obtained, you will need to submit:
- for OHSU participants, either a HIPAA Activities Prep to Research Form or a Waiver of Authorization Form (WOA)
- Section 6: Privacy & Confidentiality
- IRB Forms - Human Subjects
and/or
- for VA participants, an Application for Waiver of Authorization and Informed Consent Process for Screening/Recruitment Purposes
- www.portland.va.gov/Research/piservices/rd_forms.asp
- Do you wish to collect data and/or samples without individuals’ written consent?
(Examples include retrospective chart review or blood/tissue samples analysis only studies.)
- For VA sources, a Request for Waiver of Informed Consent Process (or Documentation) will be needed.
- For OHSU sources, a Waiver of HIPAA Authorization will be needed.
- Make very clear how “identifiable” the source of the information you receive or collect is. Ways to do this include:
- Submit your data collection form
- Ensure that all study documents and the IRQ are consistent
- Does the study involve banking of data and/or samples?
- If so, do all the study documents (particularly the consent and authorization forms) consistently and accurately reflect this?
- If the banking will take place at the VA, review the HRPP policies.
- Does the study involve genetic analysis?
- If so, do all the study documents consistently and accurately reflect this?
- Consider in particular the consent and authorization forms, and be sure to include required genetic template language.
- How/where are data and samples stored and coded/identified, and when are the OHSU data and samples destroyed?
NOTE: Due to current VHA requirements, VA data must be stored indefinitely.
- What is required for study participation and what is “optional” (e.g., additional sub-studies)? Has this been explained clearly throughout?
- Are there any inconsistencies within any given document and/or amongst documents, including the IRQ?
- USE TOOLS & RESOURCES AVAILABLE TO YOU
In addition to links cited above and the Help Text in the eIRQ, please feel free to contact the following as appropriate:
- for questions related to the OHSU components of the study, contact the OHSU Research Integrity Office at (503) 494-7887 (option 1) or irbinbox@ohsu.edu; or
- for questions regarding the VA components of the study, contact the PVAMC Research Office at (503) 273-5125 or pvamc-irb@va.gov.
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R&D Site Map
PVAMC and OHSU Joint 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.
R&D Site Map
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 Portland VA Medical Center (PVAMC), 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 PVAMC'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 Portland VA Medical Center 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 three 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 Portland VA Medical Center 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 PVAMC IRBs are:
VA IRB#1: IRB00001976
VA IRB#2: IRB00003313
VA Central IRB: IRB00006332
OHSU IRB-3: IRB00000471
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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:
Human Research Report Form
Required Reports in Human Research (123KB, MSWord)
Required Reports for Research Information Protection (40KB, MSWord)
Protocol Deviation Policy (excerpt from IRB P&P) (116KB, PDF)
Decision Chart for Reporting of Noncompliance in VA Human Research (VA Web Site, PDF)
Decision Chart for Reporting Serious Adverse Events and Problems Involving Risk in Research (VA Web Site, PDF)
Addendum for FDA-regulated Research (67KB, MSWord)
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HRPP Policies and Procedures
Complaints and Allegations of Non-Compliance (59KB, PDF)
Conducting a "Warm Transfer" (28KB, MSWord)
VACO has established a relationship with the National Suicide Prevention Hotline so that when a research subject indicates during a phone call with a researcher that they are suicidal, they can be transferred to the Hotline without being dropped from the call. A “warm transfer” allows you to keep someone on the phone and, if needed, conduct a 3-way conversation. In that way someone who may be suicidal can be transferred to the Hotline without a disruption in the phone call.
Conflict of Interest in Research Policy (50KB, PDF)
Continuous Quality Improvement in the Human Research Protection Program (23KB, PDF)
Credentialing of Personnel Involved in Research (60KB, PDF)
Education for Conducting Research(34KB, 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 Review of Repositories Located at the PVAMC (71KB, PDF)
Repository Frequently Asked Questions (FAQs) (38KB, MSWord)
Guidelines for Biorepository or Data Repository Standard Operating Procedures (SOPs) (34KB, MSWord)
Sample Repository SOP (47KB, MSWord)
Repository Checklist for IRB Reviewers (132KB, MSWord)
IRB Review of Case Reports and Retrospective Chart Reviews (34KB, PDF)
IRB Policy and Procedures (formerly IRB SOP) (1,161KB, PDF)
Monitoring Policy (See: Requirements for Outside Monitoring of Portland VA Medical Center Human Research)
Protocol Deviation Policy (excerpt from IRB P&P) (116KB, PDF)
Recruiting Potential Research Subjects - Executive Summary (25KB, MSWord)
Required Reports in Human Research (123KB, MSWord)
Requirements for Outside Monitoring of Portland VA Medical Center Human Research (30KB, MSWord)
For information on Research Files Storage Policy and Procedures, please email Kenneth Fouse at Kenneth.Fouse@va.gov.
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 Misconduct (65KB, PDF)
Research Preparation Application (80KB, MSWord)
Responsible Conduct of Research at the PVAMC (MCM 151-01) (105KB, PDF)
Responsibilities of the Principal Investigator (50KB, MSWord)
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R&D Site Map
