PVMAC and OHSU Joint IRB
PVAMC now utilizes an OHSU IRB for studies conducted on both sides of the bridge!
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).
I. GATHER TOGETHER ALL THE REQUIRED DOCUMENTS
In addition to the eIRB submission, all studies must have:
A. OHSU PPQ (Proposed Project Questionnaire) – submitted as appropriate according to OHSU requirements
B. VA PPQ – completed Word version uploaded into eIRB
D. Lay Language Protocol Summary (Note: In some cases, such as retrospective chart review only, the Lay Language Protocol Summary may serve as the protocol and may be longer than 1 page.)
E. VA Supplemental Questionnaire (VASQ) (263KB, MSWord) - with signed assurances page uploaded into eIRB
F. 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.
B. VA PPQ – completed Word version uploaded into eIRB
If #4 is answered "YES", complete the VA Financial Administrative Review
C. Abstract (per item 1 on the VA PPQ) - sent to research.grants@va.govD. Lay Language Protocol Summary (Note: In some cases, such as retrospective chart review only, the Lay Language Protocol Summary may serve as the protocol and may be longer than 1 page.)
E. VA Supplemental Questionnaire (VASQ) (263KB, MSWord) - with signed assurances page uploaded into eIRB
F. 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:A. Protocol
Consent and (HIPAA) Authorization Form(s) for VA and OHSU (or a Request for Waiver of Informed Consent and Authorization)
C. Additional documents that may be required:
II. COMPLETE THE IRQ1. Describe the study purpose/aims, procedures, data collection, statistical analysis, sample size, measures to protect subjects’ safety, etc.
2. Separate the VA activities/research from the OHSU activities/research - especially critical for studies that will combine VA and OHSU data
4. If research subjects will be paid, include (either in the main body or as an appendix) substantiation that payments are:
2. Separate the VA activities/research from the OHSU activities/research - especially critical for studies that will combine VA and OHSU data
a. "VA data" are data collected:
3. 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.i. By a VA investigator
ii. On VA time
iii. Under the portion of the protocol approved by PVAMC R&D Committee
b. "OHSU data" are data collected:ii. On VA time
iii. Under the portion of the protocol approved by PVAMC R&D Committee
i. By an OHSU investigator
ii. On OHSU time
iii. Under the OHSU portion of the approved protocol
ii. On OHSU time
iii. Under the OHSU portion of the approved protocol
4. If research subjects will be paid, include (either in the main body or as an appendix) substantiation that payments are:
a. reasonable and commensurate with the expected contributions of the subject;
b. 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.
b. 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)
1. When crafting these forms, consider whether the study includes:
a. additional (“optional”) activities
b. banking and/or genetics
c. vulnerable populations (e.g., children, decisionally impaired, etc.)
2.Templates for most situations are available:b. banking and/or genetics
c. vulnerable populations (e.g., children, decisionally impaired, etc.)
C. Additional documents that may be required:
1. Full Grant – required if federally funded (e.g., NIH)
2. Data Safety Monitoring Plan – can be described within the protocol or uploaded as a separate document
3. Drug/Device Information – as applicable, include Investigator’s Brochures, Package Inserts, Manufacturer’s Product Information, FDA Communications (e.g., regarding IND/IDE, exemptions)
4. Clinical Billing Schedule – if clinical procedures will be performed/li>
5. 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
6. 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
7. Screening scripts – for example, if screening for eligibility by phone
8. VA IRQ Appendices, as prompted by the VASQ:
2. Data Safety Monitoring Plan – can be described within the protocol or uploaded as a separate document
3. Drug/Device Information – as applicable, include Investigator’s Brochures, Package Inserts, Manufacturer’s Product Information, FDA Communications (e.g., regarding IND/IDE, exemptions)
4. Clinical Billing Schedule – if clinical procedures will be performed/li>
5. 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
6. 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
7. Screening scripts – for example, if screening for eligibility by phone
8. VA IRQ Appendices, as prompted by the VASQ:
a. VA IRQ Appendix A - if vulnerable populations are recruited
b. VA IRQ Appendix B - if participants are paid
c. VA IRQ Appendix C or D and VA Form 10-9012 - if the study involves a drug, supplement, etc.
d. VA IRQ Appendix F - if the study involves radiation
e. VA IRQ Appendix G-1 or G-2 - if the study involves human biological specimens
f. VA IRQ Appendix H - if the study involves audio or video recording
g. VA IRQ Appendix N - to help clearly distinguish the VA activities versus OHSU activities/research on the study
b. VA IRQ Appendix B - if participants are paid
c. VA IRQ Appendix C or D and VA Form 10-9012 - if the study involves a drug, supplement, etc.
d. VA IRQ Appendix F - if the study involves radiation
e. VA IRQ Appendix G-1 or G-2 - if the study involves human biological specimens
f. VA IRQ Appendix H - if the study involves audio or video recording
g. VA IRQ Appendix N - to help clearly distinguish the VA activities versus OHSU activities/research on the study
As you go through the Initial Review Questionnaire (IRQ) in the eIRB, consider the following:
A. The short title of your study should start with “VA” or “VA-OHSU”.
B. 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.
C. 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].
B. 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.
C. 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].
III. COMPLETE VA TRAINING REQUIREMENTSThe 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.
IV. CONSIDER THE IRB’s FAQs
Consider the following frequently asked questions to increase your chances of a clear and consistent submission:
A. Will you be screening for subjects prior to written consent/authorization?
(Examples include retrospective chart review or blood/tissue samples analysis only studies.)
V. USE TOOLS & RESOURCES AVAILABLE TO YOU
1.0Describe if/how medical records, clinic schedules etc. might be used
2. If using Protected Health Information before written authorization can be obtained, you will need to submit:
B, Do you wish to collect data and/or samples without individuals’ written consent?2. If using Protected Health Information before written authorization can be obtained, you will need to submit:
a. for OHSU participants, either a HIPAA Activities Prep to Research Form or a Waiver of Authorization Form (WOA)
and/or
b. for VA participants, an Application for Waiver of Authorization and Informed Consent Process for Screening/Recruitment Purposes
and/or
b. for VA participants, an Application for Waiver of Authorization and Informed Consent Process for Screening/Recruitment Purposes
(Examples include retrospective chart review or blood/tissue samples analysis only studies.)
1. For VA sources, a Request for Waiver of Informed Consent Process (or Documentation) will be needed.
2. For OHSU sources, a Waiver of HIPAA Authorization will be needed.
3. Make very clear how “identifiable” the source of the information you receive or collect is. Ways to do this include:
NOTE: Due to current VHA requirements, VA data must be stored indefinitely.
7. What is required for study participation and what is “optional” (e.g., additional sub-studies)? Has this been explained clearly throughout?
8. Are there any inconsistencies within any given document and/or amongst documents, including the IRQ?
2. For OHSU sources, a Waiver of HIPAA Authorization will be needed.
3. Make very clear how “identifiable” the source of the information you receive or collect is. Ways to do this include:
a. Submit your data collection form
b. Ensure that all study documents and the IRQ are consistent
4. Does the study involve banking of data and/or samples?b. Ensure that all study documents and the IRQ are consistent
a. If so, do all the study documents (particularly the consent and authorization forms) consistently and accurately reflect this?
b. If the banking will take place at the VA, review the HRPP policies.
5. Does the study involve genetic analysis?b. If the banking will take place at the VA, review the HRPP policies.
a. If so, do all the study documents consistently and accurately reflect this?
b. Consider in particular the consent and authorization forms, and be sure to include required genetic template language.
6. How/where are data and samples stored and coded/identified, and when are the OHSU data and samples destroyed?b. Consider in particular the consent and authorization forms, and be sure to include required genetic template language.
NOTE: Due to current VHA requirements, VA data must be stored indefinitely.
7. What is required for study participation and what is “optional” (e.g., additional sub-studies)? Has this been explained clearly throughout?
8. Are there any inconsistencies within any given document and/or amongst documents, including the IRQ?
- In addition to links cited above and the Help Text in the eIRQ, please feel free to contact the following as appropriate:
- A. for questions related to the OHSU components of the study, contact the OHSU Research Integrity Office at (503) 494-7887 (option 1) or irb@ohsu.edu; or
- B. for questions regarding the VA components of the study, contact the PVAMC Research Office at (503) 273-5125 or pvamc-irb@va.gov.
