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WCG IRB | Research Protections Office (RPO) | ¶¶Òõ̽̽(title)

Introduction

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As of January 25, 2018, requires that all NIH multi-site protocols use a single IRB of record. Institutional Officials have decided that ¶¶Òõ̽̽ will subcontract with  for single IRB services where ¶¶Òõ̽̽ researchers wish to be the lead single IRB for their NIH proposals. Proposals should include the use of WCG IRB as the IRB of record for the multi-site research activities and budgets must be developed to include the expense for the use of this commercial IRB.

¶¶Òõ̽̽ Principal Investigator (PI) is Lead on a Grant

Prior to Grant Application

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  1. ¶¶Òõ̽̽ PI needs to identify the project as a domestic multicenter trial with two or more sites.
  2. ¶¶Òõ̽̽ PI determines, with other sites, who they wish to be the IRB of record. 
  3. If ¶¶Òõ̽̽ takes on that responsibility, ¶¶Òõ̽̽ PI contacts Carolann Schimanski (email link), phone 484-351-9962, to assist with budget development. A complimentary, detailed, quote will be provided for the submission.
  4. ¶¶Òõ̽̽ PI should contact their assigned SPA Research Administrator to assist with the proposal development and submission process.

Just-in-Time Received, Site Start Up Materials

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  1. ¶¶Òõ̽̽ PI works with account manager, Jon Gellert (email link), phone 360-570-1309, to provide necessary start up materials.  The following are a few examples of what may be requested/required:
  • ¶¶Òõ̽̽ PI may request for WCG IRB to provide administrative support if needed.  This service is free of charge at this time.
  • Point of contact information for the ¶¶Òõ̽̽ protocol.
  • ¶¶Òõ̽̽ PI or designee needs to set up MyConnexus access for applicable ¶¶Òõ̽̽ study personnel (this is the electronic portal that WCG IRB uses for all submissions).
  • If requested, a  can be provided.
  • If requested, a (e.g. state law, etc) can be provided.

If Awarded See Additional Information

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Additional information can be found in the IRB Policies and Procedures Manual - Section 13.3. Procedures for Relying on External IRB for NIH Research.