Procedure for Submitting a Protocol to Western IRB

(Revised as of 7-22-2013)

Introduction

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

Multi-centered, industry-sponsored protocols must meet the BUMC IRB eligibility criteria for WIRB review.  The BUMC IRB will make the final determination as to whether a protocol is appropriate for WIRB review, or must be submitted to the BUMC IRB via INSPIR.

A WIRB submission should be submitted as described under the PROCESS and REQUIRED WIRB FORMS AND DOCUMENTATION FOR A NEW SUBMISSION sections below. If the BUMC IRB determines that the submission can be submitted to WIRB, then the Principal Investigator will receive a “BUMC IRB WIRB Authorization Letter” to include with the WIRB submission.

Once WIRB approves the protocol and consents, the approved consents are sent to Anne Clark, J.D., Contracts and Agreements, BUMC Office of Sponsored Programs-MED (OSP-MED).   She will then process the final Sponsor’s agreement assuring that the consent language is consistent with the sponsor’s agreement.

Effective July 1, 2013

BUMC has template language which has been accepted by BUMC IRB and WIRB for the Compensation For Injury Language in the informed consents.   This language contains some “optional statements” which can be inserted if that is preferred by the sponsor.     This template language is the language that should be used on all  BUMC WIRB submissions.    Changes to this language could result in a delay in processing or in a determination that the study cannot be sent to WIRB for IRB review.

Questions about alternate compensation for injury language should be directed to Attorney Anne Clark in the BU Office of Sponsored Programs (OSP) at 617-638-5263.

BUMC Preferred Language for Industry Sponsored Studies” (Revised 7/1/13):

If you think you have been injured by being in this study, contact [insert PI name and contact information] right away.  You can get treatment for the injury at Boston Medical Center.   The study sponsor, [insert sponsor’s name], has agreed to cover the reasonable costs of treatment for a research injury that are not covered by your insurance or a government program.   [Optional language:  However, a number of factors will influence whether the sponsor will or will not pay for the injury, such as:  if the injury is a result of normal progression of your disease rather than the research; if you do something that contributes to the injury; if you do not follow the instructions of the investigator or the protocol; or if the investigators do not follow the research protocol.]    A research injury is any injury or illness directly caused by your participation in the study.  If you are injured by a medical treatment or procedure that you would have received even if you were not in the study, that is not a research injury.  Payment for such things as lost wages, expenses other than medical care, or pain and suffering is not routinely available.  To help avoid injury, it is very important to follow all study directions.  You are not giving up any of your legal rights by signing this form.  [Additional optional text:  If you have additional questions about the sponsor’s agreement regarding research injuries, please contact Attorney Anne Clark in the BU Office of Sponsored Programs at (617) 638-5263), and she will be happy to assist you or put you in contact with a sponsor’s representative to answer your questions.]

 

 “BUMC Preferred Language for Industry Sponsored Studies Involving Children” (Revised 7/1/13):

If you think your child has been injured by being in this study, contact [insert PI name and contact information] right away. Your child can get treatment for the injury at Boston Medical Center. The study sponsor, [insert sponsor’s name], has agreed to cover the reasonable costs of treatment for a research injury that are not covered by your insurance or a government program.   [Optional language:  However, a number of factors will influence whether the sponsor will or will not pay for the injury, such as:  if the injury is a result of normal progression of your child’s disease rather than the research; if you or your child do something that contributes to the injury; if you or your child do not follow the instructions of the investigator or the protocol; or if the investigators do not follow the research protocol.]   A research injury is any physical injury or illness directly caused by your child’s participation in the study. If your child is injured by a medical treatment or procedure that your child would have received even if he/she were not in the study, that is not a research injury. Payment for such things as lost wages, expenses other than medical care, or pain and suffering is not routinely available. To help avoid injury, it is very important to follow all study directions. You and your child are not giving up any of your legal rights by signing this form. [Additional optional text:  If you have additional questions about the sponsor’s agreement regarding research injuries, please contact Attorney Anne Clark in the BU Office of Sponsored Programs at (617-638-5263), and she will be happy to assist you or put you in contact with a sponsor’s representative to answer your questions.]

 

Process

  1. Contact the BUMC Office of Sponsored Programs-MED (OSP-MED) (617-638-5347) to be sure you include appropriate IRB charges in your contract with the sponsor (see WIRB Fee Schedule – effective January 7, 2013.) WIRB will invoice the BUMC IRB for all review services. BU Research Accounting will pay WIRB’s invoices, and later bill the sponsors.
     
  2. Complete the Preliminary WIRB Application Documents (see next section of this web page); then email the documents to BUMC IRB Coordinator Roz Schomer at roz@bu.edu (Phone 617-414-1320). (Note: If you are unable to email large documents because of limited Outlook email capacity, then try sending them in separate emails. You can also fax them to Roz at Fax 617-638-7234; and email Roz to let her know of your incoming fax.)
     
  3. 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.
     
  4. After WIRB approves the protocol, BUMC Principal Investigators must ensure that all institutional approvals and requirements are met before beginning research activities.
     
  5. 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

Preliminary WIRB Application Documents to submit to the BUMC IRB for all WIRB protocols:

  • BUMC IRB Screening Form for WIRB Submissions with the BUMC Clinical Research Prior Authorizations checklist (Version 07-18-13) – Complete this form to determine whether the protocol is eligible for WIRB review. For questionable protocols, IRB Director Mary Banks 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 – Refer to the new Instructions for Completing Key Questions on WIRB Submission Forms (Version 07-18-13):
    • Initial Review Submission Form - (Version 07-2012r1) 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 07-2012r1) 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
    • WIRB’s Online “Smart Form” – As an alternative to the above “paper” submission forms, an electronic “Smart Form” can be completed at WIRB’s website at www.wirb.com. Go to the “WIRBNet CLIENT LOGIN” section in the upper right corner to sign up and register (click on the link “Sign up now”). When you have registered and have obtained a Username and Password: Under “Select Service”, select “IRB Portal” from the drop down menu, and then click LOGIN. When completing the Smart Form, refer to the above Instructions for Completing Key Questions on WIRB Submission Forms. Print out your completed draft, scan the pages, and send the PDF file to Roz Schomer at roz@bu.
    • ** Effective July 2013:  WIRB’s launched their new Connexus on-line submission management tool which will replace their current WIRBNet system (a conversion deadline has not yet been set.)   Users will be enabled to view, track, and manage elements of WIRB submissions more easily and more effectively, and are encouraged to use Connexus as the primary submission method.  When completing the application form in Connexus, refer to the above Instructions for Completing Key Questions on WIRB Submission Forms. Print out your completed draft, scan the pages, and send the PDF file to Roz Schomer at roz@bu.edu.  Registration is required to access Connexus, even for current WIRBNet users.  During this transition period, WIRBNet users will have their existing protocols and drafts converted to Connexus and will be able to use and view existing protocols and drafts in both WIRBNet and Connexus.   For questions on Connexus or on on-line training session dates, contact the WIRB Client Services team at (800) 562-4789, clientservices@wirb.com.  Follow these steps to register for access to WIRB Connexus:
        1. Log on to https://connexus.wirb.com .
        2. Click on “Register Me” and follow the instructions provided.
        3. You will soon receive an email containing your activation link.
        4. Click on the link in the email and follow the instructions to log-in.
        5. Welcome to WIRB Connexus!  

         

  • 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.

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