WIRB Guidelines Policies & Procedures

WIRB Guidelines Policies & Procedures

WIRB Guidelines Policies & Procedures

All submissions to WIRB must go through the RowanSOM Institutional Review Board.

The Office the Institutional Review Board will review and submit applications to WIRB. Please contact the Office of the IRB at (856) 566-2712.

WIRB will not accept applications submitted directly from RowanSOM investigators.

All new, initial applications must be submitted electronically, click here to submit. 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

Billing Procedures:

RowanSOM 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 Rowan Univeristy-Accounts Payable in the “Billing Information” section of the WIRB submission form. This ensures that WIRB invoices will be paid as required by Rowan University accounting policy. The RowanSOM does not pay WIRB fees. In addition to the WIRB invoice, a one-time RowanSOM administrative submission service fee of $750 is charged for initial applications. Sponsors will be billed separately for this charge by the RowanSOM 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 RowanSOM Application for Review by WIRB. The RowanSOM 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 RowanSOM administrative submission service fee of $750 for initial applications. Sponsors will be billed separately by the RowanSOM staff. RowanSOM researchers submitting WIRB initial review application of human subjects research will indicate the contact information for billing the RowanSOM service fee in the “Billing Information” section of the RowanSOM Application for Review by WIRB.

RowanSOM/WIRB Service Fees:

Additional fees apply for the use of the WIRB review process

RowanSOM will charge $750 for each submission to WIRB (Generally paid for by the sponsor). This fee includes:

  • Initial eligibility review

RowanSOM 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 Rowan University School of Osteopathic Medicine (RowanSOM).

  • Initial submission to WIRB

RowanSOM 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 RowanSOM 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 RowanSOM IRB cannot approve any protocol which has been disapproved by WIRB.

  • Record maintenance
RowanSOM will maintain all records of local review in accordance with applicable federal, state, and local law.

Western Institutional Review Board Fees:

WIRB charges fees to cover the costs associated with the Board’s review and the related administrative responsibilities. Fees do not influence the decisions of the Board, and the same fee is charged regardless of the action taken by Board (fees are not billed until the Board review has occurred).

A copy of our current fee schedule is available upon request from WIRB Client Services at 1- 800-562-4789 or clientservices@wirb.com.

Research Review fees at WIRB fall into four general categories:

  1. Initial Review of the research. Initial review encompasses the review of the research protocol, qualifications of the investigator, associated consent forms, protocol-related advertisements, questionnaires, screening scripts, and other submitted materials. The initial review fee funds the costs of the initial research review, as well as the costs of the ongoing review of unanticipated problems, and the monitoring of research progress for the first approval period. In addition to the initial review fee, additional fees may be charged if teleconference or videoconference with the site is necessary to complete the initial review, if multiple consent forms are submitted, and if translation of consent forms and other subject materials is necessary. Initial review of generic non-protocol related materials and exemption determinations are billed at a lesser rate than initial review of a protocol, consent form and investigator combination.
  2. Research Renewal Review fee. In accordance with 45 CFR §46.109(e) and 21 CFR §56.109(f), IRBs must review ongoing research at least annually and that Guide for Researchers August 17, 2017 Page 63 of 83 review must be substantive and at least comparable to the initial review. The protocol is reviewed on an annual basis, or more frequently as directed by the Board. The Board also examines each investigator’s progress report and activities for the previous year, and if acceptable, grants approval for another period. The renewal review fee funds the costs of the Board’s renewal review, as well as the costs of the ongoing review of promptly reportable information, for the additional year.
  3. Changes to Research. Modifications to research which require board review, such as protocol amendments, revised protocols, updates to consent forms, and new recruitment or retention materials, incur a Change to Research fee, which covers the cost of reviewing the materials, and the related administrative responsibilities of preparing review documents and updating the investigator file at WIRB. The change in research fee applies each time board review and preparation of regulatory documentation is required for a research site.
  4. Miscellaneous. WIRB bills additional fees for services such as translations and acknowledgements.

Items disapproved by the Board can be reconsidered upon written request. The request must include a rationale for the reconsideration. There is no additional fee for the reconsideration. Reconsiderations of board-directed modifications do not incur additional fees if the requests concerns re-review of the same language or item originally reviewed by the Board. If new or alternate language is submitted, the Change to Research fee applies.

Continuing Reviews, Modification/Amendments, Adverse Events & Unanticipated Problems:

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

For Adverse Events or Unanticipated Problems: If the occurrence is serious (deaths or life-threatening events) and occurred at a RowanSOM performance site, a copy of the WIRB report form must be sent to the Office of the Institutional Review Board within twenty-four(24) hours of discovery.

Community Representation:

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


RowanSOM Western Institutional Review Board (WIRB) Procedures (Word)