Overview: Policies and Procedures

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USA Institutional Review Board:

WIRB Copernicus Group Initiative

Western IRB (WIRB)

EFFECTIVE DATE:  July 12, 2017

Introduction:

  1. The University of South Alabama (USA) has entered into an agreement with the WIRB Copernicus Group (WCG) to become the IRB of record for eligible (see Appendix 1) industry sponsors.
  2. WIRB is AAHRPP accredited and used by many institutions across the country. WIRB conducts rigorous reviews of the materials provided to them and ensures that the informed consent and HIPAA Authorization documents meet the stipulations set forth in the agreement.
  3. The conditions and procedures concerning the IRB review are contained in a memorandum of understanding between USA and WRB.
  4. Materials submitted for WIRB review will be pre-screened by the IRB staff to ensure USA IRB requirements are fulfilled.

Policy:  

  1. The USA IRB staff will prescreen to determine on a protocol-by-protocol basis if the research qualifies for submission to WIRB.
      1. The criteria for studies from USA investigators to be eligible for review by the
        WIRB include:
          1. Research meets the NIH definition of a clinical trial. “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)”.
          2. Research is a Phase II / III / IV clinical trial.
          3. Protocol must be written and designed by sponsor.
          4. The sponsor is a for-profit entity or company.
          5. The sponsor holds all INDs / IDEs.
          6. The research has not previously been submitted to the USA IRB for review.
      2. Studies which involve any of the following are not eligible for submission to WIRB:
          1. Phase I Studies (including I/II, studies)
          2. Planned emergency research.
          3. Single patient emergency use or compassionate use situations
          4. Embryonic stem cell or gene therapy research.
          5. Federally funded protocols.
          6. Investigator-initiated research.
          7. Industry sponsor that refuses to pay WIRB fees and/or the USA IRB fees.
          8. Research involving prisoners.
      3. USA may also require dual review by the USA IRB when the institution deems that the rights and welfare of subjects would be better served by local review.
  2.  Submission for WIRB review signifies that:
      1. WIRB becomes the IRB of Record for the research and is responsible for continuing review as well as review of subsequent amendments and serious adverse events (SAE) as notified by the Principal Investigator and/or the Sponsor.
      2. The USA IRB is responsible for local context and oversight, including the review of:
          1. Amendments affecting changes in local research personnel.
          2. Updating USA IRB local context language and HIPAA Authorization template (to be inserted in consent document, as applicable). WIRB will review USA IRB consent language requirements as part of the approval process. Discrepancies will be reported to the USA IRB.
  3. Fees
    Sponsors are responsible for paying WIRB fees.  Sponsors are also responsible for paying a one-time administrative fee to USA IRB for its institutional oversight functions.  

Procedures:

  1. Initial Review
    The instructions entitled “USA Procedures for Working with WIRB Copernicus” should be reviewed.  This guidance outlines the requirements for submission of protocols to WIRB.  Note:  The review of Clinical Trial Agreements (CTA) will be completed concurrent with the review by WIRB. 
  2.  Pre-Review Process
    The USA IRB provides written authorization to WIRB that the study may be reviewed upon completion of the screening process. The WIRB Pre-Submission and Authorization Form will be signed/dated by the USA IRB and returned to the study site for their submission to WIRB.  Do not submit an Initial Review submission to WIRB before the USA IRB pre-review is complete and acknowledgement letter published.
      1. Complete and submit the USA IRB Application Part A and WIRB Pre-Submission and Authorization Form.  (located in IRBNet) 
      2. The purpose of the USA IRB pre-review is to determine whether local concerns exist that need to be addressed and whether the research meets the criteria for WCG review. Such a review will ensure USA’s compliance with OHRP’s guidance that  "…an institution relying upon another institution's IRB has a responsibility to ensure that the particular characteristics of its local research context are considered through subsequent review by appropriate designated institutional officials, such as the Chairperson and/or other members of its local IRB." [Guidance document IRB Knowledge of Local Research Context”, dated August 27, 1998].  Additionally, review for eligibility for WIRB review confirmed.
      3. After the submission has been forwarded to WIRB for IRB review, WIRB will contact the investigator directly with questions about the submission and upon obtaining IRB approval. WIRB will send all approved documents directly to the investigator and a copy will be sent to USA IRB.
      4. Once WIRB has approved the research, WIRB becomes the IRB of record and is responsible for review of amendments to the research, documents or personnel; adverse event reports, protocol violations and /or unanticipated problems; continuing review; and study closure.
  3. Budget/Contract
      1. Budget:  The site and the sponsor are responsible for ensuring that the consent form (typically the costs and payment sections) is consistent with the negotiated budget.
      2. Contract: The sponsor is responsible for:
          1. Ensuring that the Compensation for Injury section of the informed consent is consistent with the negotiated contract.
  4. Continuing Review
      1. The investigator will receive email alerts from WIRB regarding the need for continuing review of WIRB approved protocols.
      2. Prior to the expiration of WIRB approval, the investigator must seek continuing review approval or close out the study by submitting a final report. For continuing review or to close the study, the investigator should submit all protocol documents directly to WIRB following the guidelines provided by WIRB.
      3. WIRB will contact the investigator with questions about the submission after receipt. WIRB will send all approved documents directly to the investigator. A copy will be sent to USA IRB by WIRB.
  5.  Amendments
      1. Amendments to the research should be submitted directly to WIRB, with the exception of research personnel changes and changing Principal Investigator. Typically, if an amendment requires any changes to the consent form, the sponsor is responsible for making these changes and submitting the revised consent form to WIRB for review.
      2. USA IRB requires all individuals who are engaged in the research, including but not limited to, being involved in the conduct, review, or oversight of human subject research, complete the required human subjects training and supplemental training, if applicable.  Individuals involved in research using PHI must also complete the HIPAA research training requirement.
      3. Amendments involving Research Personnel and/or a change in the Principal Investigator, the investigator must update the USA IRB Application Part A.  This amendment may be submitted to USA IRB concurrently with WIRB submission.
  6.  Unanticipated problems or other events requiring prompt reporting
      1. Unanticipated problems or other events requiring prompt reporting and/or serious or continuing non-compliance that involve the USA research site must be promptly reported to the WIRB following the guidelines provided by WIRB.  In addition, prompt reporting to the USA IRB is also required.
  7. Study Closure
      1. The investigator should submit the WIRB Study Closure Report Form and all required protocol documents directly to WIRB. WIRB will contact the investigator with questions about the submission after receipt. WIRB will send all approved documents directly to the investigator. A copy will be sent to USA IRB by WIRB.
  8.  Payment of Fees
      1. USA Fee:  USA charges a one-time fee of $2000 for processing/administrative fee for WCG review of eligible industry sponsored trials to cover the costs of screening, institutional oversight, and coordination with WIRB. Submission of eligible industry sponsored trials for review by the WIRB should include a line item in the clinical trial agreement/study budget for IRB review fees. Payment of these IRB review fees is considered a contractual obligation of the sponsor.
      2. WIRB Fees:  WIRB charges a fee for each review activity.  The fees are paid by the Sponsor directly to WIRB.  The WIRB fee schedule is posted in the IRBNet Library.  

        NOTE:  Fees paid by the Sponsor to WIRB are typically not included in the negotiated budget between the USA and the industry sponsor, because it is preferred that the sponsor pay WIRB directly.

        When the sponsor pays WCG directly, there are no additional fees charged by the USA in affiliation with the WCG fees.

REFERENCES:

WIRB Official Site

WIRB Investigator Handbook A Guide for Researchers

WIRB’s forms and templates


History
Published July 2017

Responsible Party
Office of Research Compliance and Assurance

Appendix 1

List of Eligible Industry Partners:


Abbott

Actelion

Alcon

Allergan

Amylin

AstraZenca

Bayer

Biogen Idec

Biotronik

Bristol-Myers Squibb

Boston Scientific

Celgene

Covance

Daiichi

Esai

Forest Laboratories

Genetech

Gilead

GlaxoSmithKline

Hoffman-La Roche

Incyte

Johnson & Johnson

Lilly

Merck

Medtronic

Medimmune

Millennium

Novartis

Novella

Novo Nordisk

Pfizer

Purdue

Quintiles

Regeneron

Sanofi

Shire

UCB

United Therapeutics

Vertex