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

To develop and maintain anTo develop and maintain an

OUTSTANDING HRPP!!OUTSTANDING HRPP!!

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

How is it all connected?How is it all connected?

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)

Submit to VA Research Office

VA Annual RenewalsUpdated Training Certificates

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• matthew.morrow@va.gov

−Scott Donelenko, CRP Lake City• (386) 755-3016 x 3139• Scott.donelenko@va.gov

−Kelly Parks, RA• Extension 4369, • Kelly.parks@va.gov

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!