Western Institutional Review Board (WIRB)

All submissions to WIRB must go through the RBHS Office of Human Subjects Protection Program.

The Office of Human Subjects Protection Program will review and submit applications to WIRB.

WIRB will not accept applications submitted directly from RBHS investigators.

All new, initial applications must be submitted electronically via eIRB. Make sure that you select WIRB as your IRB of record.

Upon receipt by WIRB, WIRB will issue a tracking number via email directly to the investigator by which the investigator can track the application.  WIRB will also notify the investigator directly via email of the approval or disapproval of the study after the WIRB meeting. WIRB will contact the investigator directly about any issues that may arise during the review process, and about those matters relevant to the conduct of the study once approved.  WIRB will arrange for monitoring ongoing research, as its policies and procedures require.

Notice of Recent Documentation Changes – March 2013 Updates

Guidelines, Procedures and Policies

Click on a topic below for details:

Billing Procedures: Print view (PDF format)

RBHS researchers submitting to WIRB, whether initial applications, continuing review applications and/or modifications of human subjects research must indicate the name and address of the sponsor or the investigator in the “Billing Information” section of the WIRB submission form, in accordance with the Clinical Trial Agreement or study contract. This information will make clear to WIRB who will be responsible for paying the WIRB fees and whom WIRB should bill. If the CTA or study contract indicates that the sponsor will only reimburse the investigator for WIRB reviews, instead of the sponsor paying WIRB directly, the researcher must establish a purchase order payable to WIRB. The investigator must provide the number and mailing address to RBHS-Accounts Payable in the “Billing Information” section of the WIRB submission form. This ensures that WIRB invoices will be paid as required by RBHS accounting policy. The RBHS Human Subjects Protection Program (HSPP) does not pay WIRB fees. In addition to the WIRB invoice, a one-time HSPP administrative submission service fee of $750 is charged for initial applications. Sponsors will be billed separately for this charge by the HSPP staff. If the sponsor will only reimburse the investigator for WIRB-related expenses, the researcher must identify who will receive the invoice in the “Billing Information” section of the RBHS Application for Review by WIRB. The HSPP invoice will be forwarded to the individual responsible for processing payment through a Banner Index number.

In addition to the WIRB invoice will be a one-time HSPP administrative submission service fee of $750 for initial applications.. Sponsors will be billed separately by the HSPP staff. RBHS researchers submitting WIRB initial review application of human subjects research will indicate the contact information for billing the HSPP service fee in the “Billing Information” section of the RBHS Application for Review by WIRB.

HSPP/WIRB Service Fees: Print view (PDF Format)

Additional fees apply for the use of the WIRB review process

The Human Subjects Protection Program (HSPP) will charge $750 for each submission to WIRB. This fee includes:

  • Initial eligibility review

HSPP staff will review each submission for assurance of proper training of all investigators, completeness of initial review documents, and eligibility for submission to WIRB in accordance with criteria agreed upon by WIRB and the University of Medicine and Dentistry of New Jersey (RBHS).

  • Initial submission to WIRB

HSPP staff will submit all initial documents to WIRB for review. All further correspondence will take place between WIRB and the investigator.

  • Continuing local review of all protocols and study changes

When a centralized IRB is listed as the IRB of record for a study, federal regulations require that the local IRB retain authority regarding local considerations, especially adverse events and unanticipated problems. Throughout the continuation of the study, the HSPP will review all decisions made by WIRB for such local considerations and may take additional action when necessary, including but not limited to expedited or full board review of unanticipated problems and adverse events, additions or changes to informed consent and assent documents, suspension pending inquiry, and even disapproval. A Rutgers Health Sciences IRB cannot approve any protocol which has been disapproved by WIRB.

  • Record maintenance

The HSPP will maintain all records of local review in accordance with applicable federal, state, and local law.

WIRB Fee Schedule: Print View (PDF Format)

RBHS Human Subjects Protection Program Service Fee:

  • One time charge : $750

2015 Western IRB Institutional Fee Schedule


*For locations outside the U.S., Canada, and Puerto Rico, please see International Fee Schedule
Effective: January 1, 2015
Western IRB | 1019 39th Ave SE, Suite 120 | Puyallup, WA 98374 | T: 800.562.4789 | www.wirb.com

 

Services Rendered

Cost

Initial Review

Initial Review of Protocol

(Protocol/grant, First Consent Form, Recruitment Materials)

Initial Review of Investigator

Per Investigator. Includes previously approved consent form(s),

site-specific recruitment materials.

Additional Consent Form (Each, Per Investigator)

Co-Principal Investigator or Change of Investigator

 

$1,275

 

$1,400

 

 

$450

$1,400

Continuing Review

Study Renewal Review (Each Site, At Least Annually)

Annual Review of Generic or Non-Protocol Related Material

Per item

Study Close Out (Each Site)

Protocol Close Out (When WIRB is the Central IRB)

 

$1,400

$725

 

$165

$200

Change to Research*

Change to Research – Protocol Amendment with Consent Form

Change to Research – Protocol Amendment without Consent

Form

Change to Research – Revised Consent Form

Change to Research – Recruitment/Retention Materials and

Other Subject Related Material, Additional Location, etc.

Change to Research – Review of Revised Product Information

(Investigator Brochure, Package Insert, Dear Inv. Letters, etc.)

*Charges will be per submission, per PI unless the items require multiple and substantively independent review (e.g. consistent changes across several documents will receive a single charge; substantively different changes to different documents submitted at the same time but requiring independent review by the Board may receive more than one charge

 

$620

$380

 

$505

$380

 

$320

Other Services

Emergency Use Post-Use Report Reviews; Compassionate Use

of a Device

New or Modified Generic or Non-Protocol Related Material

Per Item

e.g. Regulatory exempt determination, site pre-screening

consent forms, generic advertising, centralized call screening or

recruitment scripts

WIRB Translation Services

Cost based on number of words, minimum translation fee of

$165 plus $380 administrative fee

IRB File Duplication Requests

Request for Board Acknowledgement of Protocol/Study Specific

Materials

Pre-review of Research (Protocol Development, etc.)

 

$100

 

$725

 

 

 

       

Variable

 

 

$75

$100

 

$1,100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As an alternative to this fee-for-service schedule and item-by-item invoicing, WIRB offers a simplified, single-price option with four quarterly payments. Please call us if you wish to consider a single-price option.
Please contact WIRB for a detailed fee breakdown for your research, or for questions and additional fee schedules, including schedules for international trials.
All fees payable in U.S. Dollars. GST/HST tax will be added to all fees billed to Canada. Amounts past due 90 days subject to 1% monthly finance charge

Continuing Review:

WIRB will provide the investigator with a continuation notice before the expiration of the study.  All continuation requests must be sent directly to WIRB by the investigator.

To access the WIRB Continuing Review Report Form (CRRF), please click the link below:

http://www.wirb.com

http://www.wirb.com/Pages/DownloadForms.aspx

Modification/Amendments:

All changes to the study must be submitted directly to WIRB by the investigator.
To access the WIRB Change in Research/Subject Recruitment Submission Form, please click the link below:

http://www.wirb.com

http://www.wirb.com/Pages/DownloadForms.aspx

Adverse Events & Unanticipated Problems:

In the event of an adverse event or unanticipated problem involving risk to subjects or others, follow the instructions on the following WIRB website:  

http://www.wirb.com

http://www.wirb.com/Pages/DownloadForms.aspx

If the occurrence is serious (deaths or life-threatening events) and occurred at a RBHS performance site, a copy of the WIRB report form must be sent to the Office of Human Subjects Protection (OHSP) within twenty-four(24) hours of discovery.

Community Representation:

The WIRB contract provides that, where additional knowledge of the community is required, representatives of Rutgers community may participate in WIRB reviews by teleconferencing.