R

1
RD Committee Role and Responsibilities

• By Salar Khan, MD, MBA
• Acting Research Compliance Officer
• Jesse Brown VA Medical Center

2
RD Committee Introduction

• The Collaborative IRB functions as the Human
  Studies Subcommittee for the JBVAMC RD
  Committee, the findings of which are recorded and
  reported to the JBVAMC RD Committee.

3
RD Committee Introduction

• The JBVAMC RD Committee reviews and provides to
  the JBVAMC Director an evaluation of all JBVAMC
  RD Subcommittees, including committees at
  external entities.
• Communication exists between the JBVAMC RD
  Committee and the Collaborative IRB, including
  the timely exchange of meeting minutes and board
  actions.

4
Organizational Flow Chart

• Director
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• Chief of Staff
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• ACOS for RD
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• RD
  Committee..
• RD Committee meets 2nd Monday and
  4th Wednesday of each month
• 
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• 
  
• .
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• Research Safety Common Animal Care
  Laboratory Office
• Resources Subcommittee Use Subcommittee
  Allocation Space Subcommittee

5
RD Committee Meetings

• RD Committee at Jesse Brown VA meets on the 2nd
  Monday and 4th Wednesday of each month.

6
Institutional Authority

• Through existing MOUs with the JBVAMC, two UIC
  IRBs (UIC IRB 1 and 3) and three NU IRBs (NU
  IRB 3, 5 and 6) currently serve as IRBs of
  record for the JBVAMC until the Collaborative IRB
  (IRB 4) becomes fully operational.
• Protocols active at the JBVAMC at the time of the
  establishment of the Collaborative IRB will be
  transferred from their original NU or UIC IRB to
  the Collaborative IRB at their next continuing
  review cycle.
• During the transition period, the term
  Collaborative IRB means the appropriate IRB of
  record, which may include UIC IRB 1, NU IRB 3,
  NU IRB 5, NU IRB 6, UIC IRB4 or UIC IRB 3.

7
History and Background of the Collaborative IRB
(IRB 4)

• Formation requested by AAHRPP
• IRB 4 has been operating since July 7, 2008.
• FWA 00000290
• MOU agreement between UIC and JBVAMC
• An Authorization Agreement exists between UIC and
  NU

8
Scope of Collaborative IRB Review

• The Collaborative IRB reviews human subjects VA
  Research. VA Research is defined as research that
  is conducted by VA investigators (serving on
  compensated, WOC, or IPA appointments) while on
  VA time, utilizing VA resources, and/or on VA
  property including space leased to, and used by,
  VA. The research may be funded by VA, by other
  sponsors, or be unfunded. (VHA Handbook 12001).

9
RD Committee Relationship to the Collaborative
IRB

• The JBVAMC RD Committee can accept or reject an
  IRB decision, but cannot reverse an IRB
  disapproval of the research.
• If the R D Committee disapproves the research,
  the R D Committee must notify the Collaborative
  IRB in writing of the reason(s) for disapproval
  in accordance with VHA Handbook 1200.1.

10
Role of RD Office in Protocol Submission

• Neither UIC nor NU OPRS will not accept any
  protocol directly.
• For all New Initial Review, Continuing Review,
  Amendment, including requests to add the JBVA as
  a performance site, protocol applications must be
  accompanied by the JBVAMC RD IRB Protocol
  Submission Checklist will be first reviewed and
  signed by the RD office. The documents,
  including the JBVAMC RD IRB Protocol Submission
  Checklist, will be then given back to the PI to
  submit to the IRB, for review and approval. After
  IRB approval it will be reviewed by the RD
  Committee.
• It is required to simultaneously drop off copies
  of final report and adverse events reports, if
  any, to the RD Office and the IRB.
• PI needs to visit affiliates UIC or NU web-site
  to find IRB applications and JBVAMC RD IRB
  Protocol Submission Checklist.

11
RD Office Responsibilities Training

• RD office will check valid annual mandatory
  training for all key research personnel involved
  in human subject research.
• The components of the mandatory training are the
  following
• CITI Training
• VHA Privacy Training
• VA Cyber Security Awareness Training
• Information Security 201 for RD personnel

12
RD Office Responsibilities Training

• The JBVAMC RD staff indicates to the
  Collaborative IRB at the time of submission of an
  initial or continuing review application whether
  the education and training requirements for PIs
  and other research personnel are up to date via
  the JBVAMC RD IRB Protocol Submission Checklist
  
• The Collaborative IRB will not review and approve
  research for performance at JBVAMC at initial or
  continuing review unless the PI is current with
  required VA training. If training is deficient
  at the time of continuing review and not
  corrected prior to the expiration date, IRB
  approval is considered to have lapsed

13
RD Office Responsibilities Training

• Failure by the PI to have met the annual training
  requirements results in a lapse of approval of
  any ongoing research at the JBVAMC.
• The RD office immediately notifies the
  Collaborative IRB and the PI in writing of the
  lapse of RD approval.
• The PI is instructed to stop all research
  activities and to submit to the IRB Chair a list
  of subjects who are still active in the research
  and for whom research interventions or
  interactions must be continued to prevent harm.
• The IRB Chair in consultation with the VA COS
  determines if it is in the best interest of the
  subject(s) to continue in the research. The
  failure to complete the required educational
  programs is considered by the Collaborative IRB
  as non-compliance

14
Additional JBVAMC RD Committee Responsibilities

• As noted in the UIC-JBVAMC MOU, the JBVAMC RD
  Committee is responsible for the following
• Flagging of medical records for subjects involved
  in research and
• Privacy Board Authority Although the
  Collaborative IRB reviews all documents related
  to the research protocol, including the review of
  HIPAA Authorization and documents to grant
  waivers, the JBVAMC RD Committee serves as the
  Privacy Board for the JBVAMC. Therefore, the
  JBVAMC RD Committee, in coordination with the
  JBVAMC Privacy Officer, has the final
  responsibility for review of HIPAA Authorizations
  and approval of waivers or alterations of
  authorization related to JBVAMC subjects.

15
Flagging CPRS for Research Subject

• Enter CPRS
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• Enter Patient Record
• ?
• Click New Note
• 
  ?
• Progress
  Note Opens Title Research 6 options
• 
  ?
• Initial Close Clinical Warning/Research
  Protocol
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• ?
  
  ?
• Enter Follow-up notes
  Can also scan informed consent
  under research as appropriate
  into VISTA Imaging Display

16
Checklist Components Verified by the RD Office

• P.I. Statement of Disclosure
• Research Financial COI
• P.I. certification of storage security of VA
  information data security Checklist
• P.I. Assurance checklist

17
Checklist Components Verified by the RD Office

• Investigational New Drug (IND) and
  Investigational Device (ID) Use require to
  Complete additional Forms
• FDA Form 1571 and 1572
• VA Form 10-9012
• Need a memo from sponsor that FDA has issued an
  IND or ID

18
Checklist Components Verified by the RD Office

• VA Consent Form 10-1086
• Note Always use current version
• Use VA Form 10-3203 for use of picture and or
  voice

19
Checklist Components Verified by the RD Office

• Human research protocol radiation dose supplement
  form (see RD Packet).
• Any study that requires multiple X-Rays or CT
  Scan has to have a completed radiation dose
  supplement form for the Radiation Safety Officer
  (RSO) at the JBVA. After RSO approval the RD
  Office will sign IRB checklist. RSO has 3
  business days.

20
Checklist Components Verified by the RD Office

• Tissue Banking declaration
• VA Research Pharmacy charge form
• Advertisement for Recruitment of VA Subjects

21
General Principles Exempt Research

• Exempt Research. Exempt research is research
  determined by the Institutional Review Board
  (IRB) to involve human subjects only in one or
  more of certain minimal risk categories (38 CFR
  16.101(b)).
• The full RD Committee must review and approve
  all IRB approved exempt research and than the RD
  Committee has to review annually the progress
  report on all these studies.

22
General Principles Expedited Review

• Research eligible for expedited review is
  research determined by the IRB to present no more
  than minimal risk to human subjects. IRB
  chairperson or designee expedited review pertain
  to both initial and continuing IRB review.
• Under VA regulation Expedited Review is not
  allowed. The full RD Committee must review all
  initial and continuing protocols.

23
General Principles Payment

• The IRB and RD Committee must review all
  proposals for payment of subjects to ensure
  conformity with VA policies.
• The facility research office is responsible for
  ensuring that IRB-approved payment to subjects is
  made from a VA approved funding source for
  research activities.

24
General Principles Electronic Medical Record
CPRS GUI

• CPRS GUI (Computerized Patient Record system
  Graphical Use Interface)
• UIC-IRB 4 will make determination on which
  protocol will be required in CPRS.
• Research related issues require documentation in
  CPRS as
• a) Clinical Warning/ Research Protocol
• b) Informed Consent/ Research
• c) Research Progress Note
• d) Research Protocol Completed

25
General Principles CPRS

• CPRS Clinical Coordinator Contact Information is
  available at JBVAMC to arrange training
• Betsy Levin, MA, 312-569-6764
• or pager 312-389-6173

26
General Principles Record Retention

• Records are retained for a minimum of six
  years, but the sponsor agreement, other
  applicable state requirements and regulations,
  federal regulations, VA regulations and/or
  directives may require a longer period of time.

27
General Principles P.I. Reporting Requirement

• Reporting Timelines to the IRB.
• Reporting is required within 5 working days of
  becoming aware of the event for
• Internal adverse events considered serious (e.g.,
  death, life threatening injury),
• Changes to the protocol made without IRB approval
  to eliminate apparent immediate harm to subjects.
  
• Any unanticipated death of a VA subject must be
  reported within 24 hours of discovery.

28
General Principles Informed Consent Form

• VA regulations require that each page of the
  consent form be initialed by the subject.
• Add a running footer of Short Study title or
  Number, Version , date, and Page of
• Subject participation in this research is
  voluntary.
• Injured as a result of participation in research.

29
General Principles Informed Consent Process

• According to the VHA Handbook 1200.05, Appendix
  C, Item 3, "Documentation of Informed Consent,"
  the consent form must be signed by
• The subject or the subject's legally-authorized
  representative
• A witness whose role it is to witness the
  subject's or the subject's legally-authorized
  representative's signature, and
• The person obtaining the informed consent.
• Principal Investigator Signature is not required.

30
RD Committee Role in Compliance

• Audits, On-site Evaluations, FDA Inspections,
  Reports to Sponsors These events should be
  reported to the IRB and JBVAMC RD Committee
• RD office will issue notification to all P.I. to
  submit a list of manuscripts submitted for
  publication/ published for the RD Committee
  Review each year.

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NON-COMPLIANCE TO HUMAN RESEARCH PROTECTION
PROGRAM LEAD TO

• Suspension Suspension of approved research by
  the IRB may arise from an evaluation of
  unanticipated problems involving risks to
  subjects or others, substantive allegations of
  serious or continuing non-compliance, or findings
  arising from continuing review or monitoring of
  research activities.
• Termination A termination represents a
  directive from the IRB to permanently stop all
  previously approved research activities.

32
Additional Compliance Matters

• An administrative hold is a voluntary action by
  an investigator or sponsor to temporarily or
  permanently stop some or all research activities
  as a modification to approved research.
• Administrative holds are not considered
  suspensions or terminations, and do not meet
  reporting requirements to OHRP, FDA and other
  federal agencies.
• Although the investigator may discuss this action
  beforehand with the IRB, IRB chair, OPRS
  Director, OPRS Associate Director or Assistant
  Director, the hold must be initiated voluntarily
  by the investigator and must not be used to avoid
  IRB mandated suspension or termination or
  reporting requirements. During administrative
  hold, the research remains subject to continuing
  review and requirements for reporting
  non-compliance and unanticipated problems
  involving risks to subjects or others.

33
Reporting Structure in Suspensions or Terminations

• The ACOS reports suspensions or terminations of
  IRB approval to the IRB Chair.
• The ACOS sends the report to the following
• COS
• Medical Center Director
• Chair, RD Committee
• VA Legal Counsel
• JBVAMC Privacy Office (if the report involves the
  unauthorized use of, loss or disclosure of
  individually identifiable patient information)
• JBVAMC Information Security Officer (if the
  report involves violations of the information
  security requirements)

34
Reporting Structure in Suspensions or Terminations

• The following agencies are also sent the report
  by the ACOS
• The Regional VA Office of Research Oversight (ORO
  RO)
• The Office of Research and Development
• The DHHS, OHRP - The communication is sent even
  if the UIC IO or Director of OPRS has already
  notified OHRP. This duplication ensures that
  OHRP is notified as research at JBVAMC typically
  meets the criteria of being federally funded or
  conducted and, as such, falls under the purview
  of OHRP
• The IRB, as an information item in the agenda
  and
• Any Common Rule agency that is supporting or
  conducting the research when they require
  reporting separately from OHRP.

35
Quality Assurance/Quality Improvement (QA/QI)

• It is the responsibility of P.I. to update the
  RD office twice a year, June and December,
  regarding full names of patients enrolled, last
  four digits SS , last page of sign consent for
  CPRS and telephone audit.

36
Web-Sites

• JBVAMC http//www.chicago.med.va.gov
• UIC website for Research Information
•   http//tigger.uic.edu/depts/ovcr/research/protoc
  olreview/irb/jbvamc/index.shtml
• NU website for Research Information
•   http//www.research.northwestern.edu/OPRS/irb/
• VACO
• www.research.va.gov

37
Contact Information

• Research Staff Telephone and E-Mail
• At JBVAMC
• 1. Salar Khan, MD, MBA [phone]
  salar.khan_at_med.va.gov
• Karen Lenehan, Acting AO [phone]
  karen.lenehan_at_med.va.gov
• 3. Doreene Wierzgacz [phone]
  doreene.wierzgacz_at_va.gov
• Fax [phone]
• AT UIC
• Barbie Maleckar [phone] maleckar_at_uic.edu
• Fax
  312-413-2929
• AT NU
• Piper Hawkins-Green (312)-503-7929
  piper_at_northwestern.edu
• Fax
  312-503-0555

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Collaborative JBVAMC / NU / UIC -IRB (IRB 4)

• Contact Information
• Chair Kathryn Rugen, DnSc, RN-CS
• 312-569-6933
• e-mail kathryn.rugen_at_va.gov
• Vice -Chair Jonathan Goldman, MD, MS
• 312-569-6872
• e-mail j-goldman3_at_northwestern.edu

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JBVAMC RD

• Thank You for participating in the orientation
  class for HRPP
• Questions?