Western IRB WIRB

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Western IRB (WIRB)
All you need to know as a GWU investigator

• Irb forum - January, 11 2007
• GWU Office of Human Research
• Ross Hall, Suite 613

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Why is GWU outsourcing to wirb?

• To ensure that all industry sponsored trials are
  reviewed carefully and in full compliance with
  all state and federal laws.
• To ensure studies receive an IRB review are
  reviewed in a timely manner.

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Will this affect GWUs Federal Wide Assurance
(FWA)?

• Using WIRB will not change GWUs obligations
  under its existing FWA.
• GWU remains responsible for ensuring compliance
  with the IRBs determinations and with the Terms
  of its FWA. GWU OHR will continue to ensure this
  through the Post Approval Monitoring Program.
• WIRB will report its findings and actions to
  appropriate officials at GWU.

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What research activities will be eligible for
review by wirb?

• Only new industry-sponsored clinical trials are
  eligible to be reviewed by WIRB.

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What is an industry-sponsored clinical trial?

• Protocol for the project is designed and written
  by a pharmaceutical or device sponsor or another
  for profit entity/company that holds
  the INDs/IDEs for the protocol.
• A controlled study involving human subjects,
  designed either to
• test drugs, devices, diagnostics, treatments,
  interventions or preventative measures including
  testing for an unapproved indication,
• evaluate the safety and effectiveness of new
  drugs, devices, diagnostics, treatments,
  interventions or preventative measures or
• collect data to increase knowledge that would
  lead to enhanced safety and efficacy of a drug,
  device, diagnostic, treatment, intervention or
  preventative measure, AND

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Types of research not eligible for review by Wirb

• planned emergency research
• Xenotransplantation
• gene transfer
• embryonic stem cell research
• investigator-initiated research (regardless of
  funding source)
• research that must be conducted under the purview
  of the Insitutional Biosafety Committee (IBC) or
  Radiation Safety Committee.

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What to submit to Ohr prior to sending the
studies to WIRB?

• You must register studies in the OHR prior to
  submitting to WIRB.
• Submit a copy of
• Completed WIRB Initial Submission Form
• GWU OHR WIRB Sign-Off Sheet with the PIs
  original signature (this may be scanned or hard
  copy original)
• Submit via e-mail to ohrirb_at_gwumc.edu or via hard
  copy to Ross Hall, Suite 613.
• A GWU IRB will be assigned to the study and the
  signed GWU OHR WIRB Sign-Off Sheet will be
  returned to you via e-mail as a PDF. This form is
  part of the required documents submitted to WIRB.
  WIRB will not review the study unless they
  receive the GWU OHR WIRB Sign-Off Sheet.

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GWU Sign Off Sheet To be signed by both the PI
and OHR designee. This form will soon be
available on the OHR website. This may be
submitted as a PDF via e-mail or as a hard
copy. This document MUST have the original PIs
signature
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WIRB Websitewww.WIRB.com

• All forms for WIRB are located on their web page.
• If you have any questions about the forms you may
  contact either WIRB or OHR and we will be glad to
  assist you.
• WIRB Contact
• Phone [phone] or 1-800-562-4789
• E-mail clientservices_at_wirb.com
• OHR Contact
• Phone [phone]
• E-mail OHRIRB_at_gwumc.edu

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WIRB INITIAL SUBMISSION FORM Located on the web
at www.WIRB.com All forms are downloadable in
both PDF and Word format.
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What about other research studies?

• All other university research will be reviewed by
  GWU IRB.
• All investigator initiated clinical trials
  research, regardless of funding will be reviewed
  by GWU IRB.

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Is WIRB going to review emergency use?

• No. However, if an emergency request turns into
  an industry-sponsored clinical trial, then that
  trial can go to WIRB.

Is wirb going to review patient Registries?

• Yes. However, the primary goal of the registry
  must be to to collect data on long-term safety
  and efficacy, and it must be managed by the
  industry sponsor rather than the GWU.

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What about the Radiation Safety and/or Biosafety
review for a clinical trial?

• The GWU OHR will continue to review these aspects
  of all clinical trials.

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What are the advantages of an outside IRB?

• The turn-around time for review and approval
  may be much faster.
• Conflict of interest is eliminated.
• With decreased administrative burden, GWU OHR
  staff can dedicate additional resources to
  quality improvement activities associated with
  the human subjects protections program

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What are the fees charged by WIRB?

• WIRB charges a separate fee for each review
  activity
• initial review
• continuing review
• review of modifications
• See the WIRB Fee Schedule available on line
• http//www.wirb.com/shell.php?contentcontent/wirb
  _services_irbservices_fees

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Who pays the WIRB fees? are those fees
negotiated as part of the contract with the
sponsor?

• GWU and the GWU-IRB are not responsible for
  paying fees associated with WIRB review
  activities.
• Researchers should arrange payment directly with
  the industry sponsor. WIRB can bill the sponsor
  directly. WIRB fees are NOT negotiated or
  referenced in any agreements between the GW
  Office of Research Services and sponsors.

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What if the sponsor refuses to pay the WIRB fees?

• If the sponsor refuses to pay the billed amounts
  after the study has been reviewed by WIRB, the
  investigator or his/her department will be
  responsible for the fees.
• Please note
• The financial specifics of the contract are
  still being negotiated.

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What if my sponsor requires review by a local IRB?

• The agreement between
• GWU and WIRB anticipates
• that WIRB will undertake activities to allow it
  to assure knowledge of the GWU local research
  context.

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Can I use the wirb consent form templates?

• Yes, you may use either the GWU or WIRB
  templates. However, there is required
  information from the GWU template that must be
  added to the WIRB document. This is underlined
  in the GWU template.

What about HIPAA?

• Use the GWUMC HIPAA forms, and include them in
  your application packet to WIRB. They will be
  reviewed and approved by WIRB.

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If I need a Certificate of Confidentiality, who
signs it?

• The GWU Institutional Official. Send these
  requests to the Office of Health Research in Ross
  Hall, Suite 712

How can I document training completion for WIRB?

• You must obtain training through the GWU
  web-based CITI program. WIRB will verify your
  completion by communication with the GWU OHR.

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After receiving WIRB approval, what about
modifications?

• You may apply directly to WIRB, without going
  through the GWU OHR. Use the appropriate forms
  and instructions that are posted on the WIRB web
  site

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Where do I send adverse event reports or reports
of unanticipated problems?

• Send them to WIRB
• Use forms provided on the WIRB web site.
• If you are reporting an on-site adverse event
  that is unexpected and serious, report them to
  WIRB and send a copy to the GWU OHR, within 24
  hours.

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If my trial is placed on hold, suspended, or
terminated, should I notify the GWU OHR?

• Yes. The GWU OHR must be notified immediately.
• It does not matter whether the hold, suspension,
  or termination was initiated by the researcher,
  WIRB, the sponsor, the FDA, or any other agency.

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Who should subjects contact if they have
concerns, questions, or complaints?

• They may contact the GWU Human Protections
  Administrator. This is stated in the research
  consent form contact information.

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• Questions?
• Thank you!
• Please join us next month on 2/8/2007
• Our topic will be
• EXEMPT Research