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VA Research: IRB and R&D Approval Process From Initial Submission, Through the Informed Consent Process and Continuing Review, To Inactivation. Kimberly Summers, PharmD Deputy ACOS for Research South Texas Veterans Health Care System Research & Development Service. Overview.

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VA Research: IRB and R&D Approval ProcessFrom Initial Submission, Through the Informed Consent Process and Continuing Review, To Inactivation

Kimberly Summers, PharmD

Deputy ACOS for Research

South Texas Veterans Health Care System

Research & Development Service

overview
Overview
  • What needs IRB Approval?
  • Types of Review
  • How to Submit New Application
  • Principal Investigator Responsibilities
  • Summary
when is stvhcs r d approval needed
When is STVHCS R&D Approval Needed?
  • R&D Committee approval is required to conduct any and all VA research
  • What constitutes VA research?
definition of va research
Definition of VA Research
  • Research sponsored by the VA
  • Research conducted using any property or facility of STVHCS
  • Research conducted by or under the direction of any salaried or without compensation (WOC) employee of the STVHCS during and in connection with her/his STVHCS responsibilities
  • Funds for the research activities are managed by the STVHCS or Biomedical Research Foundation of South Texas
  • Research which recruits subjects at the STVHCS or uses the STVHCS's nonpublic information to identify or contact human research subjects for research purposes (i.e. CPRS)
types of irb review
Types of IRB Review
  • Not research or research not involving “human subjects”
  • Human research eligible for exemption
  • Human research (non-exempt) eligible for expedited IRB review
  • Human research (non-exempt) that is not eligible for expedited review and must be reviewed by a convened meeting of the IRB (full IRB board review)
types of irb reviews that require stvhcs r d approval
Types of IRB Reviews That Require STVHCS R&D Approval
  • Research NOT involving “human subjects”
  • Human research eligible for exemption
  • Human research (non-exempt) eligible for expedited IRB review
  • Human research (non-exempt) that is not eligible for expedited review and must be reviewed by a convened meeting of the IRB
non human research
Non-Human Research
  • Form available on IRB website
  • Obtaining aggregate data only with no identifiable information
  • Form I required
    • Person releasing the information has access to that information as part of their routine duties
    • Person releasing the information verifies all information provided is de-identified
  • Still requires R&D submission
types of irb reviews that do not require stvhcs r d approval
Types of IRB Reviews That Do NOT Require STVHCS R&D Approval
  • IRB determined to NOT be research
    • Quality Improvement Projects
    • Case reports
    • Meta-analysis of published studies
  • May still require Privacy Officer approval
    • Any VA sensitive information
    • Personal Health Information is NOT allowed
    • Mary Wohl (VA ext 15602; marywohl@va.gov )
irb required training
IRB Required Training
  • All investigators and research staff conducting human research at institutions using the HSC IRB must complete research ethics training provided by the University of Miami, Collaborative IRB Training Initiative (CITI).
  • Details on IRB website - http://research.uthscsa.edu/irb/training.shtml
  • The VA does not recognize the IRB CITI investigator training
r d required training
R&D Required Training
  • The VA requires completion of a different CITI investigator training course
    • Must complete the VA training if conducting VA Research
    • The HSC recognizes the VA CITI training
    • Must be taken annually
  • Information Security 201 for R&D Personnel
    • One time only
  • Training required to maintain VA appt
    • VA Cyber Security Awareness
    • VHA Privacy Policy Web Training
    • Must be taken annually
research privileges
Research Privileges
  • Research credentialing and privileges are required prior to work on any VA protocol
  • Requirements are different for the following groups
    • VA Employees
    • Fellows, Residents, and Students
    • Non-VA investigators or study personnel
    • Exempt study staff
exempt personnel
Exempt Personnel
  • Study personnel who are not physically conducting research on VA property, only have access to de-identified data and/or not directly working with research subjects
    • Examples: lab personnel, data or administrative personnel
  • Requirements
    • VA Data Security 201 Training
    • Memorandum from PI denoting what their role in the study will be 
    • Conflict of Interest Form        
irb submission form k
IRB Submission Form K
  • Pre-Notification of the Intent to Conduct Research that includes other Institutions
  • Required to submit with your IRB application
  • Notifies the R&D office of your intent to conduct VA research
  • R&D office signs Form K and returns with link to VA Research website
r d submission
R&D Submission
  • Submit a hard copy of all required forms with appropriate signatures
  • Original + 7 copies required
  • All study related documents and required forms must also be submitted electronically on a CD
r d submission date
R&D Submission Date

Submission prior to the first Monday of each month

Will be reviewed at the following month’s R&D meeting if all forms are completed and administrative stipulations addressed

Protocols requiring review by a convened IRB

One of the followingmust have occurred prior to application submission to the R&D office

IRB administrative review

IRB final resubmission

Final IRB approval

Protocols eligible for IRB expedited or exempt review

Application submission to the R&D office should be concurrent with IRB submission

r d administrative review
R&D Administrative Review

An appointment with the investigator and/or study coordinator is required to address any administrative stipulations

The intent of the meeting is to address, correct, and finalize any administrative stipulations in real time to shorten the overall approval time

Any changes required on IRB forms or informed consents can be incorporated into final IRB submissions, addressed at IRB admin review, or must be submitted as an IRB amendment

r d final approval
R&D Final Approval

All administrative stipulations must be addressed and resubmitted at least one week prior to the R&D Committee Meeting for the protocol to be placed on the agenda

IRB approval may still be pending at the time of resubmission

Final R&D approval can be granted following R&D Committee review when:

IRB approval is in place

All R&D Committee stipulations have been addressed

stvhcs r d approval
STVHCS R&D Approval
  • Must have R&D approval letter prior to any of the following being conducted at the VA
    • Recruitment
    • Obtaining informed consent
    • Enrollment
    • Providing patient follow up
  • An IRB approval letter does NOT constitute R&D approval
informed consent process
Informed Consent Process
    • An IRB approved and stamped VA Informed Consent document does NOT constitute R&D approval
  • IRB approved and stamped informed consent required
    • ONLY the most recent IRB approved and stamped consent form can be used to consent subjects
  • Documentation in the medical record required
  • Scanning of IC document required
amendments modifications
Amendments & Modifications
  • Changes in previously approved studies cannot be made without prior IRB review
    • Except when necessary to eliminate immediate hazards to a subject
  • Examples of changes requiring IRB approval
    • Number subjects consented and enrolled
    • Design, methods or procedures
    • Study staff, study sites/locations
    • Consent procedures, consent document
    • Recruitment advertisements, payments
amendments and modifications
Amendments and Modifications
  • PI is responsible for submission to the IRB
  • STVHCS R&D office is notified by the IRB
    • All studies identified as VA Research
  • IRB and R&D reviews are combined
  • Any required changes by the IRB or R&D are forwarded by the IRB to the PI
  • Corrective actions are required prior to IRB approval and initiation at the STVHCS
changes in personnel
Changes in Personnel
  • Personnel list submitted to IRB
    • IRB Form B-2
    • VA Form Personnel List for Human Studies
  • For personnel engaged in research conducted at the VA
    • IRB will verify with the R&D office that all study personnel have submitted the required documentation and been assigned research privileges at the VA prior to approval of the amendment
continuing review
Continuing Review
  • IRB may approve a study for a period of no longer than 1 year
  • For re-approval, the IRB must review the protocol, any amendments, and a status report including:
    • Number of subjects accrued
    • Description of adverse events, unanticipated problems, withdrawal of subjects, complaints
    • Summary of relevant information
    • Copy of current consent document(s)
continuing review process
Continuing Review Process
  • Continuing Review of Research Protocols form must be submitted to the VA R&D office
    • Contains VA specific information in addition to IRB continuing review form
    • Submission of the IRB continuing review form and/or approval letter to the R&D office is NOT required
    • R&D office staff coordinate with IRB continuing review team for VA required changes
  • Exempt research
    • IRB requires updates every 3 years
    • VA continuing review form required at least annually
continuing review process37
Continuing Review Process

Protocol approval at the STVHCS will expire if

Continuing review is not completed

Training requirements for the PI are not up-to-date at the time of continuing review

Co-investigators and other study personnel will be removed from active protocols if training requirements are not up-to-date

Expiration of approval will be corrected upon receipt and satisfactory review and approval of the required documentation

unanticipated problems involving risks to subjects or others
Unanticipated Problems Involving Risks to Subjects or Others
  • Any incident, experience or outcome that meets all of the following criteria
    • Unexpected (in terms of nature, severity, or frequency)
    • Related or possibly related to participation in the research
    • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized
  • May be an adverse event or non-adverse event
  • Events reported to the IRB related to VA research are communicated to the R&D and vice versa
reporting noncompliance
Reporting Noncompliance
  • Conducting research in a manner that disregards or violates federal regulations, failure to follow the IRB requirements & determinations, or institutional policies and procedures
    • In the case of VA research includes the requirements of the VA Handbook 1200.5
  • Handled by governing IRB
  • Findings of serious or continuing noncompliance reported to:
    • OHRP
    • FDA if IND/IDE
    • ORO (VA Office of Research Oversight)
inactivation of irb approval
Inactivation of IRB Approval
  • When is it appropriate to inactivate IRB approval?
    • Enrollment of new subjects is permanently closed
    • Data, private information, and/or clinical specimens are no longer being collected for research purposes (including long term follow up)
    • Subjects are no longer being treated under the research protocol (includes no plan for future research treatment)
    • Research assessments or procedures are no longer being performed (includes no plan for future research procedures)
    • Federal research funding for this study is closed
    • If a multi-center study where UTHSCSA is the study operations center or the UTHSCSA investigator is the Lead Investigator, if the study closed at all participating sites
    • Data/specimen analysis has been completed locally, or if analysis continues locally and the data has been permanently de-identified
specific irb questions
Specific IRB Questions
  • Expedited review new studies:
    • Rhonda Barnard, MS, CIP 210-567-2372
  • Full Board review new studies:
    • Debbie Etter, Team Leader 210-567-2356
  • Modifications/Amendments
    • Helen Cavazos, Team Leader 210-567-2353
  • Progress or Final reports:
    • Clara Perkins, Team Leader 210-567- 3086
specific r d questions
Specific R&D Questions
  • New study submissions and modifications/amendments for VA pending studies :
    • Angela Casas, (210)617-5300 VA ext 15523
  • Progress or final reports and modifications/amendments for VA approved studies:
    • Tracy Jackson, (210)617-5300 VA ext 15520
questions

Questions?

Kimberly Summers, PharmD

Office: (210) 617-5300 ext 15969

Email: kimberlyk.Summers@va.gov