aahrpp association for the accreditation of human research protection programs thanks to: lisa...
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AAHRPPAssociation for the Accreditation
of Human Research Protection
ProgramsThanks to:Lisa Demanuel, Program SpecialistBrain Rehabilitation Research CenterVA RR&D Center of Excellence
Human Research Protection Program (HRPP)
An institution’s
unique system
to safeguard
human subjects.
HRPP Responsibilities
Protection of Human SubjectsProtection of Human Subjects
Protection of Human SubjectsProtection of Human Subjects
Protection of Human Protection of Human SubjectsSubjects
Who is responsible for the HRPP?
• Director –Thomas A. Cappello MPH , FACHE− Responsible for the R&D program of the institution, advised and assisted
by an R&D Committee − Responsible for HRPP of institution
• Chief of Staff-Bradley Bender, MD- Ensure R&D and subcommittees have sufficient resources and support- Consulted by the R&D Committee and IRB Chair regarding suspension of
research studies, after consideration of the best interest of individual subjects
• Associate Chief of Staff for Research – Paul Hoffman, MD− Responsible for the daily management of the R&D program, monitors and
disseminates information regarding the HRPP
• Research & Development Committee− Responsible for reviewing and approving all proposed research in which
NF/SGVHS is engaged.
• Affiliate IRB - UF IRB-01 − Responsible for protecting the rights and welfare of human subjects in
research at, or conducted by faculty, staff, or students at the NF/SGVHS.
Accreditation is: A mechanism to support
quality improvement An external validation
of performance A seal of approval from a trusted source
Accreditation is NOT: A guarantee An audit
AAHRPP Accreditation…
achieves its mission by using an
accreditation process based
on self-assessment, peer
review, and …
education.
AAHRPP Standards
• Domain I: Organization
• Domain II: Institutional Review Board or Ethics Committee
• Domain III: Researcher or Research Staff
AAHRPP – Training Objectives
−Protocol submission to UF IRB-01 and the VA R&D Committee
−Reporting processes for VA and UF IRB-01.
−Resources at the VA and UF IRB-01 and how to access information.
−Specific VA Requirements (e.g. consent documentation, required training)
Today’s Topics
1. Review who can conduct research and the approvals needed to initiate research activities
2. Review NF/SGVHS Research Processes
3. Review Investigator Obligations
Acronyms• AAHRPP = Association for the
Accreditation of Human Research Protection Programs
• HRPP = Human Research Protection Program
• IDE = Investigational Device Exemption
• IDS = Investigational Drug Study
• IND = Investigational New Drug
• PI = Principal Investigator
• SAE = Serious Adverse Event
• UAP = UnAnticipated Problem
• UF IRB-01 = University of Florida Health Science Center Institutional Review Board
• VA R&D = VA Research & Development Committee
• WOC = WithOut Compensation Employee
Acronyms
VA Research
• ANY person who does NOT have a
VA appointment and wishing to
conduct research at NF/SGVHS
must apply to Research Service
for a WOC appointment.
Policy for Status of Individuals to Conduct VA Research.
VA Policy to Conduct Research• Residents, fellows, students cannot
be PI’s on VA projects. However a
written statement can be submitted
by a VA appointed investigator who
will serve as PI, requesting that the
individual serve as an investigator
on the project.
TheThe VA-AppointedVA-Appointed PI PI
is Responsible for is Responsible for
the Conduct of the the Conduct of the
Research Project Research Project
at the VAat the VA
Who can help?• UF IRB 01 staff
− 273-9600− http://irb.ufl.edu/irb01/officeinfo.htm
• NF/SGVHS Research
Service Staff− 376-1611 x6069− http://www.northflorida.va.gov/
Research/indexResearchers.asp
• NF/SGVHS Research
Compliance Officer−376-1611 x5542
VA Research: Investigator Training Compliance
• Investigators and WOCs−ALL individuals who are involved in VA
research must complete ANNUAL training as follows:• CITI Training (Human Subjects Protection and
GCP)• *Information Security 201 is a one-time
requirement for researchers• VA Cyber Security Awareness• VA Data Security & Privacy• VHA Privacy Policy Training
Training Certificates
• Researchers are required to
maintain proof of training
• Privacy Officer and Information
Security Officer require proof of
institutional trainings before
approval of projects
Investigator Training Compliance
• UF IRB-01 Required Training−In addition to the VA training ALL
research staff are required to complete the following UF training every 12 months:
HIPAA for Researchers at the University of Florida
Training Compliance
IMPORTANT!!ALL required training MUST be current BEFORE IRB or VA approval will be granted!
Protocol Submissions
Prior to beginning ANY research activities at the VAMC the following approvals MUST be in place:
• SubCommittee for Research Safety (as appropriate)
• VA Radiation Safety Committee (as appropriate)
• Privacy Officer
• Information Security Officer
• UF Health Science Center IRB-01 (IRB)
• VA Research & Development Committee (R&D)
Protocol Submissions
• IRB approval should be obtained BEFORE R&D submission, however protocols may be submitted simultaneously.
• Privacy Officer final review requires stamped IRB documents
Protocol Submissions
Following initial VA approval,
ALL IRB actions must also
be submitted to the VA
Research Service for approval.
These include the following:
Submit the following documents to VA Research Service after IRB approval
Revisions to Protocol
Revisions to Informed Consent
IRB Annual RenewalsSponsor Changes (Letters
from the Sponsor, DSMB reports)
Project Closure (send copy of IRB closure submission and IRB closure letter)
IDS Requirements before a Drug Study Commences
• Investigational Drug Information Form [(IDIR) VAF 10-9012]-signed version
• R&D Approval [VAF 10-1223]
• Informed Consent [VAF 10-1086]
• Prescription [VAF 10-2577F]
• Initial meeting with Investigator and/or Study Coordinator
• Receipt of Study Supplies
Study Supplies
• Remember that ALL investigational agents are required by 1200.5 and 1108.04 to be routed through VA IDS.
• Under special circumstances, storage at another site is allowed, but this typically requires a Letter of Understanding (L.O.U.) signed by both institutions.
VA IDS Contacts• Contact the VA Investigational Drug
Service for more information−Matthew Morrow, CRP, RPM NF/SG
• (352) 374-6178, Pager 1755• [email protected]
−Scott Donelenko, CRP Lake City• (386) 755-3016 x 3139• [email protected]
−Kelly Parks, RA• Extension 4369, • [email protected]
Submission Forms
All project submission forms can be found on the UF IRB-01 and VA Research websites, including instructions and frequently asked questions. Always use the most recent form from the website!!
•UF IRB-01−http://irb.ufl.edu/irb01
•VA Research−http://
www.northflorida.va.gov/Research/indexResearchers.asp
Valuable Researcher Tools
The following items are helpful tools to assist researchers in the conduct of research at our institution:
−IRB Position Papers−IRB-01 Help−IRB Bi-monthly Brown Bags
SAE’s and UAP’s must be reported to IRB and ACOS/R within 5 days• More info on Unanticipated Problem
available at:−http://irb.ufl.edu/irb01/help/upr.html
• More info on Serious Adverse Event
available at:−http://irb.ufl.edu/irb01/help/aer.html
Conflict of Interest
• There are two classifications of Conflict of Interest− Institutional Conflict of Interest
− Individual Conflict of Interest
• How is a potential COI disclosed−You must complete a conflict of interest form for
each research project and update it if any changes
−You must complete UF IRB-01 Addendum A and Addendum L as needed
−All R&DC and sub-committee members must sign COI forms annually
Conflict of Interest
• COI evaluation is done by NF/SGVHS
Conflict of Interest Administrator in
conjunction with Regional Counsel
and UF IRB01
Research Records
• All research records must be maintained
according to VA Record Retention
Schedule (indefinitely at this time)
• PI’s are responsible to maintain all study
records
• PI’s are responsible to contact Research
Service when relocating from NF/SGVHS
Informed Consent• VA form 10-1086 must be used for VA
research− IRB approved and stamped
• Witness signature is required on all VA
Research Consent forms
• Consent progress note is required for each
subject − CPRS documentation is required when subject has record− Other progress notes in Investigator Files
• Copies of all consent forms must be sent to
Research Service for entry into CPRS
Subject Questions and Complaints
• Subjects may discuss questions and
complaints with any member of
NF/SGVHS
• Detailed information should be obtained
and forwarded to ACOS/R, Research
Service and/or the RCO in addition to the
IRB
Things NOT to Say. . . in an AAHRPP Interview I don’t know…
Let me tell you…
Or, for example..
IRB, what’s that?
I pay physicians $50 for every referral.
HIPAA, isn’t that an animal?
When the research is done I just let the study expire.
Isn’t pregnancy an adverse event?
Complaints? I advise my staff to ignore them.
Interview Tips
Key points to REMEMBER…
• Keep answers short and to the
point.
• If you don’t know the answer, be
sure to know where to find it!