Procedure for Submitting a Protocol to Western IRB

(Revised as of 03-03-15)

Introduction

To read more about the agreement between the BUMC IRB and the Western IRB, click here.

BUMC Principal Investigators have the option of submitting WIRB applications for multi-centered, industry-sponsored protocols involving an IND or IDE for pre-review by the BUMC IRB. The BUMC IRB will make the final determination as to whether a protocol is appropriate for WIRB review, or if it must be submitted for local review by the BUMC IRB. 

 

Process

  1.  The BUMC Principal Investigator must first determine whether the prospective industry-sponsored protocol will be managed by the Office of Sponsored Programs Office (OSP-MED) or the BMC Clinical Trial Office (BMC-CTO), and then begin the budget preparation (see WIRB Fee Schedule – effective January 1, 2015) and the CTA process with the appropriate office. WIRB will invoice the BUMC IRB for all review services. The BUMC IRB will approve the WIRB invoices and forward them to the appropriate office. The appropriate office will pay WIRB’s invoices, and later bill the sponsors. The attorney from the appropriate office will also work with the sponsor on an agreed-upon version of the BUMC compensation for injury language for the consent(s) which is consistent with the CTA.
     
  2. The BUMC Principal Investigator’s study coordinator should then complete the Preliminary WIRB Application Documents, and then email the documents to BUMC IRB Coordinator Roz Schomer at roz@bu.edu (Main IRB Phone 617-638-7207). (Note: If you are unable to email large documents because of limited Outlook email capacity, then try sending them in separate emails.) List of Preliminary WIRB Application documents for BUMC IRB-pre-review:
  • BUMC IRB Screening Form for WIRB Submissions with the BUMC Clinical Research Prior Authorizations checklist (Version 02-27-15) – Complete this form to determine whether the protocol is eligible for WIRB review, and to attach the approval emails from the department chair and appropriate special routing departments. For questionable protocols, the BUMC IRB Director will make the final determination as to whether the protocol must be reviewed by the BUMC IRB rather than by WIRB.
  • The correct WIRB Submission Form:
    • Initial Review Submission Form – (Version 07-2012r4). This form should be completed if WIRB has never reviewed and approved the sponsor’s protocol and BUMC will be the first site. The form is pre-filled with BUMC site-specific information
    • Investigator Submission Form – (Version 07-2012r3). This form should be completed if WIRB has previously reviewed and approved the sponsor’s protocol for other sites and BUMC will not be the first site. The form is pre-filled with BUMC site-specific information
    • A PDF file of the completed WIRB’s Online “Smart Form” by establishing an account to use WIRB’s Connexus system. Log on to WIRB Connexus at https://connexus.wirb.com to establish and account; or call (800) 562-4789 or send an email to clientservices@wirb.com for assistance. Refer to the above submission forms for inserting BUMC site-specific information into the “Smart Form”.
  • BUMC/WIRB Informed Consent – the sponsor’s consent form should be integrated into the BUMC/WIRB Informed Consent Template (Version 07-18-13) to create a consent form that is site-specific to BUMC.
  • FDA Documentation – the BUMC IRB needs to review the FDA letter awarding the IND or IDE to the industry sponsor to verify that the protocol is not investigator-initiated (or an email or document from the industry sponsor verifying this). This letter is required even if the IND or IDE number is listed on the industry sponsor’s protocol.
  1. Once the submission has been submitted to WIRB, please be sure your Sponsor Agreement is submitted to Attorney Anne Clark, Associate Director, Contracts and Agreements, BUMC Office of Sponsored Programs-MED (OSP-MED), Phone: (617) 638-5263; Fax: (617) 638-4686; E-mail: aclark4@bu.edu. Anne will be notified of the informed consent’s compensation for research injury language that was approved by the BUMC IRB for submission to WIRB.
     
  2. After WIRB approves the protocol, BUMC Principal Investigators must ensure that all institutional approvals and requirements are met before beginning research activities.
     
  3. Download forms from the WIRB website to submit future documents for approved WIRB protocols (change of research, renewals, adverse events, etc.) at www.wirb.com. These forms may also be submitted to WIRB electronically. Wherever indicated, list BUMC as the billing contact.

 

Required WIRB Forms and Documentation for a New Submission

If the preliminary WIRB application documents are acceptable, then the BUMC IRB will provide a PDF file attachment titled, “BUMC IRB WIRB Authorization Letter”.

Forward the complete list of documents below directly to WIRB by one of the following methods:  (1) Emailing all documents as attachments to clientservices@wirb.com; (2) Using WIRB’s on-line submission tool at www.wirb.com; or (3) Sending paper copies or CDs via Fedex or UPS.

  • The “BUMC IRB WIRB Authorization Letter” PDF file.
  • The final approved versions of the BUMC IRB Screening Form for WIRB Submissions, the Submission Form, and the Consent(s).
  • Documentation verifying that the FDA granted the IND, IDE, or FDA Exempt Letter to the Industry Sponsor, and not to an individual Investigator — this documentation is required as part of the WIRB Screening Form. Investigator-initiated protocols cannot be submitted to WIRB (NOTE: This documentation is required even if the IND number is listed on the sponsor’s protocol.)
  • Sponsor’s protocol (for Initial Review submissions only)
  • Curriculum vitae for the Principal Investigator and each Sub-Investigator (separate electronic file for each)
  • Current medical license for the Principal Investigator showing expiration date.  (Study Coordinators must ensure that licenses kept on file for physician Sub-investigators, nurses, etc. are current.)
  • Current Nursing license for any nursing staff on the research team (separate electronic file for each)
  • HIPAA Partial Waiver – this form is needed if identifiable health information will be used or disclosed for research screening or recruitment purposes
  • Advertising and recruitment materials
  • Documents that will be given to the subjects
  • Pre-screening forms or screening scripts as instructed in WIRB’s Screening Information Procedures form

 
Additional Documents for Studies Involving Investigational Drugs (IND), Food Supplements, or Biologic Agents:

  • Current Department of Massachusetts Research License for the Principal Investigator or the Department Chair (separate electronic file)
  • Investigator’s drug brochure (for Initial Review submissions only)
  • FDA letter granting the IND to the Industry sponsor (or an email or document from the sponsor verifying this)
  • For research involving Food Supplements, attach Background Information.

 
Additional Documents for Studies Involving Investigational Devices (IDE):

  • Signed Investigator Agreement
  • One of the following:
    • FDA letter granting the IDE (or an email or document from the sponsor verifying this); OR
    • Letter from sponsor stating that this is a non-significant risk study; OR
    • Letter explaining why the investigation is exempt from IDE requirements under 21CFR 812.2c or otherwise exempt.

 

Key Contacts:

WIRB Budget Preparation
Elizabeth Alcock
Senior Research Administrator, Contracts & Agreements
BUMC Office of Sponsored Programs-MED (OSP-MED)
85 E. Newton Street, Rm 816C
Boston, MA 02118
Phone: 617-638-5347
Fax: 617-638-4686
Email:   liz@bu.edu

Industry Sponsor Contracts:
Anne Clark, J.D.
Associate Director, Contracts and Agreements
BUMC Office of Sponsored Programs-MED (OSP-MED)
85 E. Newton Street, M
Phone: 617-638-5263
Fax: 617-638-4686
Email:  aclark4@bu.edu

New WIRB Submission Documentation:
Rosana B. Schomer (“Roz”)
IRB Coordinator
BUMC Institutional Review Board
560 Harrison Avenue, 3rd Floor, Suite 300
Phone:  617-638-7207     Fax:  617-638-7234
Email:  roz@bu.edu

BUMC IRB Director:
John F. Ennever, MD, PhD, CIP
BUMC Institutional Review Board
560 Harrison Avenue, 3rd Floor, Suite 300
Phone:  617-638-7210
Email:  ennever@bu.edu

WIRB Financial Administration:
Kristin M. Sacca
Research Administrator
Boston University
Research Accounting
25 Buick Street
Phone: 617-358-5117 Fax: 517-353-6740
Email:  ksacca@bu.edu

Primary teaching affiliate
of BU School of Medicine