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 amp Development Service ID: 667910
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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, PharmDDeputy ACOS for ResearchSouth Texas Veterans Health Care SystemResearch & Development ServiceSlide2
OverviewWhat needs IRB Approval?Types of Review
How to Submit New ApplicationPrincipal Investigator ResponsibilitiesSummarySlide3
When is STVHCS R&D Approval Needed?
R&D Committee approval is required to conduct any and all VA research What constitutes VA research?Slide4
Definition of VA ResearchResearch sponsored by the VA
Research conducted using any property or facility of STVHCSResearch 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 responsibilitiesFunds for the research activities are managed by the STVHCS or Biomedical Research Foundation of South TexasResearch 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)Slide5
Types of IRB ReviewNot
research or research not involving “human subjects”Human research eligible for exemptionHuman 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)Slide6
Types of IRB Reviews That Require STVHCS R&D Approval
Research NOT involving “human subjects”Human research eligible for exemptionHuman research (non-exempt) eligible for expedited IRB reviewHuman research (non-exempt) that is not eligible for expedited review and must be reviewed by a convened meeting of the IRBSlide7
Non-Human ResearchForm available on IRB website
Obtaining aggregate data only with no identifiable informationForm I requiredPerson releasing the information has access to that information as part of their routine dutiesPerson releasing the information verifies all information provided is de-identifiedStill requires R&D submissionSlide8
Types of IRB Reviews That Do NOT Require STVHCS R&D Approval
IRB determined to NOT be researchQuality Improvement ProjectsCase reportsMeta-analysis of published studiesMay still require Privacy Officer approvalAny VA sensitive informationPersonal Health Information is NOT allowedMary Wohl (VA ext 15602;
marywohl@va.gov
)Slide9
Training Requirements Slide10
IRB Required TrainingAll 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.shtmlThe VA does not recognize the IRB CITI investigator trainingSlide11
R&D Required Training
The VA requires completion of a different CITI investigator training courseMust complete the VA training if conducting VA ResearchThe HSC recognizes the VA CITI trainingMust 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 annuallySlide12
VA Research Privileges are Required in Addition to Training Requirements Slide13
Research PrivilegesResearch credentialing and privileges are required prior to work on any VA protocol
Requirements are different for the following groupsVA Employees Fellows, Residents, and StudentsNon-VA investigators or study personnelExempt study staffSlide14
http://www.southtexas.va.gov/research/ Slide15
Exempt PersonnelStudy 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 personnelRequirementsVA Data Security 201 TrainingMemorandum from PI denoting what their role in the study will be
Conflict of Interest Form Slide16
Submission Process Slide17
IRB Protocol SubmissionSlide18
IRB Submission Form KPre-Notification of the Intent to Conduct Research that includes other Institutions
Required to submit with your IRB applicationNotifies the R&D office of your intent to conduct VA researchR&D office signs Form K and returns with link to VA Research websiteSlide19
http://www.southtexas.va.gov/research/ Slide20Slide21
R&D SubmissionSubmit a hard copy of all required forms with appropriate signatures
Original + 7 copies requiredAll study related documents and required forms must also be submitted electronically on a CDSlide22
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 addressedProtocols requiring review by a convened IRBOne of the following
must 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 submissionSlide23
R&D Administrative ReviewAn 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 amendmentSlide24
R&D Final ApprovalAll 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 resubmissionFinal R&D approval can be granted following R&D Committee review when:IRB approval is in placeAll R&D Committee stipulations have been addressed Slide25
IRB and R&D Initial Submission Summary Slide26
Full IRB Board Review ProtocolsSlide27
Exempt and Expedited ProtocolsSlide28
R&D Approval Timelines
BASELINE
R&D REVIEWS SINCE JAN 2009
Time from IRB approval until R&D approval
Median
72 days
34 days
Time from R&D meeting until R&D approval
Median
89 days
26 daysSlide29
STVHCS R&D ApprovalMust have R&D approval letter prior to any of the following being conducted at the VA
Recruitment Obtaining informed consentEnrollmentProviding patient follow upAn IRB approval letter does NOT constitute R&D approvalSlide30
Informed Consent Process
An IRB approved and stamped VA Informed Consent document does NOT constitute R&D approvalIRB approved and stamped informed consent requiredONLY the most recent IRB approved and stamped consent form can be used to consent subjectsDocumentation in the medical record requiredScanning of IC document requiredSlide31
Continuing Review and Protocol Modifications Slide32
Amendments & Modifications
Changes in previously approved studies cannot be made without prior IRB reviewExcept when necessary to eliminate immediate hazards to a subjectExamples of changes requiring IRB approvalNumber subjects consented and enrolledDesign, methods or procedures
Study staff, study sites/locations
Consent procedures, consent document
Recruitment advertisements, paymentsSlide33
Amendments and ModificationsPI is responsible for submission to the IRB
STVHCS R&D office is notified by the IRB All studies identified as VA ResearchIRB and R&D reviews are combinedAny required changes by the IRB or R&D are forwarded by the IRB to the PICorrective actions are required prior to IRB approval and initiation at the STVHCSSlide34
Changes in Personnel Personnel list submitted to IRB
IRB Form B-2VA Form Personnel List for Human StudiesFor personnel engaged in research conducted at the VAIRB 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 amendmentSlide35
Continuing Review
IRB may approve a study for a period of no longer than 1 yearFor re-approval, the IRB must review the protocol, any amendments, and a status report including: Number of subjects accruedDescription of adverse events, unanticipated problems, withdrawal of subjects, complaints
Summary of relevant information
Copy of current consent document(s)Slide36
Continuing Review Process
Continuing Review of Research Protocols form must be submitted to the VA R&D officeContains VA specific information in addition to IRB continuing review formSubmission of the IRB continuing review form and/or approval letter to the R&D office is NOT requiredR&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
annuallySlide37
Continuing Review ProcessProtocol 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 reviewCo-investigators and other study personnel will be removed from active protocols if training requirements are not up-to-dateExpiration of approval will be corrected upon receipt and satisfactory review and approval of the required documentationSlide38
Reporting Requirements Slide39
Unanticipated Problems Involving Risks to Subjects or Others
Any incident, experience or outcome that meets all of the following criteriaUnexpected (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 versaSlide40
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 1200.5Handled by governing IRBFindings of serious or continuing noncompliance reported to:
OHRP
FDA if IND/IDE
ORO (VA Office of Research Oversight)Slide41
Protocol Inactivation Slide42
Inactivation of IRB Approval
When is it appropriate to inactivate IRB approval?Enrollment of new subjects is permanently closedData, 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-identifiedSlide43
Inactivation of R&D ApprovalSlide44
Specific IRB QuestionsExpedited review new studies
:Rhonda Barnard, MS, CIP 210-567-2372Full Board review new studies:Debbie Etter, Team Leader 210-567-2356Modifications/AmendmentsHelen Cavazos, Team Leader 210-567-2353Progress or Final reports:
Clara Perkins, Team Leader 210-567- 3086Slide45
Specific R&D Questions
New study submissions and modifications/amendments for VA pending studies :Angela Casas, (210)617-5300 VA ext 15523Progress or final reports and modifications/amendments for VA approved studies:Tracy Jackson, (210)617-5300 VA ext 15520Slide46
Questions?
Kimberly Summers, PharmDOffice: (210) 617-5300 ext 15969Email: kimberlyk.Summers@va.gov