1/25/2016. Why so many rules? VA Research Website. The website includes information on:

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1 VA Portland Health Care System (VAPORHCS) How the VAPORHCS IRB differs from OHSU s Alex Mitchell VA IRB Analyst Ext January 28, 2016 Why so many rules? Highly Regulated by Congress Highly Visible news media Highly Reactive - it s the government We must follow Veterans Health Administration (VHA) Handbooks The Handbooks establish additional regulations specific to research within the VA VA Research Website The website includes information on: How to get started Policies/Procedures Staff appointments Training Submitting proposals Forms 1

2 VA IRB Structure For the VA IRB: Meets 1 st Wednesday of each month Materials expedited as much as possible PI invited to discuss initial review (for studies reviewed by convened board) Analysts will contact you to request changes VA/OHSU IRB & VA Central IRB VA/OHSU JOINT IRB For studies conducted at VAPORHCS and OHSU Submitted through eirb VA requirements are still applicable for the VA research VA Central IRB For studies conducted solely at VAs Allows for a central IRB review for multi-va projects Additional VA Committees IACUC Safety Space Committees Research and Development (R&D) Governing body of the Research Service at VAPORHCS All IRB-approved new studies must be reviewed at the next R&D meeting before we can provide approval to Research Team 2

3 Considerations when Preparing an IRB Submission Appointments Training Getting the materials together Privacy/Data Security Planning for the future Make clear distinction between VA Research and non-va Research VA Appointments Required if: You will work on site at VAPORHCS You need access to Computerized Patient Record System (CPRS) You will directly interact with VAPORHCS participants You will see identifiable data for VAPORHCS participants Note: All VA appointments require fingerprinting and background checks (so plan for this to take some time) VA Appointment Options Paid VA Employee Without Compensation (WOC) when any of the following apply: You are on a VA contract, or are not paid by VAPORHCS, e.g., paid by OHSU or the Portland VA Research Foundation (PVARF) Will see identifiable data or interact with human research subjects Will work on VA property Warning! This can take some (ok, a lot) of time. Also, if you have a healthcare license or the potential for licensure (MD, RN, MS Counseling, EMT, MSW, etc.), you also need to be credentialed in VetPro 3

4 Training VA specific trainings CITI Data Security/Privacy trainings And more! Submission Process Brand New Submissions: 1) Submit PPQ to 2) Submit IRQ & other IRB documents to Submissions for Ongoing Studies: to Some studies (~20) use eirb ( We are in the process of transitioning to the new eirb system. However, for now that transition is on hold. Tips for submissions for ongoing studies VA only accepts up to 5mb message; split into multiple messages if appropriate Each form/document should be a separate attachment Submit most things PDF format Please submit consent forms in Word format If sending fax, include cover memo with study title/id number 4

5 VA has its own forms IRB Paperwork VA Proposed Project Questionnaire (PPQ) Continuing Review Questionnaire (CRQ) IRQ Appendices as needed VA Consent Form VA HIPAA Authorization VA Advertisements Others prompted by forms Privacy and Data Security The VA Privacy Officer and Information Security Officer review all VA studies Privacy Officer Brooke Smith (503) x59602 Information Security Officer Scott Griffin (503) x51369 Distinguish Between VA Research and Non-VA Research For studies being conducted at multiple sites by the same individual(s) the VA IRB can only approve VA research VA Research = any research conducted by a PI (or other research team member) while on VA time, with VA patients, or utilizing VA resources. IRQ Appendix N is required for all new studies and continuing reviews 5

6 Banking for the Future If data/specimens will be taken from this study and banked for future research, VAPORHCS policy requires that they be stored in a separately-approved repository This requires a separate repository submission to the IRB Considerations During the Conduct of the Study Creating progress notes Delivering consents and authorizations to Research Office Keeping a master list VA-conducted audits What to do when a monitor pays a visit Reporting research problems CPRS (Medical Record) Progress Notes USE RESEARCH TEMPLATES 1. When consented Also Activate Flag if required by IRB 2. When enrolled and at each research visit 3. Termination/completion, research treatment ended, or withdrawal from study De-Activate Flag 6

7 Who may access CPRS Patient Records? Only those approved by the IRB to see identifiable information consistent with an approved Scope of Work form Outside monitors may NOT see a CPRS record except when an approved study staff member is present and driving the computer Outside monitors may not take identifiable information offsite Signed ICFs/Authorizations Make a copy Hand deliver the original to the VA Research Office (Bldg 101, Room 502) Do this within 3 business days, if possible This applies to the authorization, as well as video/voice consents You will get the original back for your records Yes, the VA Performs Audits All research studies must be audited at least once every 3 years or once during the life of the study if active less than 3 years All informed consent forms must be audited How can you be ready? Follow GCP Follow all the rules OHRP, VA, FDA, DOD When in doubt ASK! 7

8 Outside Monitor Visits Inform Shari Maier as soon as you schedule a monitor visit Bring monitor to the R&D Service to sign in and to sign out each day (if will be reviewing records at VAPORHCS) Prepare 1-page monitor report (on IRB Forms page of website) for monitor to complete and sign before leaving, fax to # on form Have monitor call RAO if any serious non-compliance or unreported problems found You must drive computer if monitor viewing CPRS records Reporting Research Problems See the top of the Reportable Events Form for what to report Unanticipated Serious Adverse Events Unanticipated Problems Involving Risk All Apparent Serious or Continuing Non-Compliance All Moderate or Major Protocol Deviations Report events within 5 business days of awareness Sponsor AE Reports lacking meaningful analysis do not get reported, but should be tracked by research team Breaches of Information Security must be reported within 1 hour of awareness Reporting Deviations The VA protocol deviation policy is in line with the policy in effect at OHSU VAPORHCS requires most reportable deviations be reported to the Research Office within 5 days of awareness Deviations are to be categorized by the PI as minor, moderate or major Minor protocol deviations should be tracked, and are then reported only at continuing review All moderate & major deviations must be reported 8

9 Questions? Resources! VA Clinical Research Alliance (VACRA) Mission is to provide education for clinical researchers from disparate backgrounds on campus about how to work within the Portland VA system efficiently, effectively and accurately. Meets 2 nd Tuesday of each month from Noon-1pm in Bldg 101, Rm 433 Webpage for PIs and coordinators Contact Paige Farris (Paige.Farris@va.gov), Kas Adams (Kathleen.Adams@va.gov), or Katherine Powers (Katherine.powers@va.gov) Research & Development Office Phone & Fax Main Office: (503) (When calling from VA just dial 55125) Secure FAX: (503) Location Building 101, Room 502 Website IRB Analysts pvamc-irb@va.gov 9