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.
Research Review fees at WIRB fall into three general categories:
- Initial Review of the research fee: 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 adverse events, protocol variances, site visits, and the monitoring of research progress via WIRB Continuing Review Report Forms.
In addition to the initial review fee, fees may be charged if a teleconference or videoconference with the site is necessary to complete the initial review and if translation of consent forms and other subject materials is necessary.
Initial review of generic materials is billed at a lesser rate than initial review of a protocol, consent form and investigator combination.
- Study 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 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 examines each investigator's progress reports and activities for the previous year, and if acceptable, grants approval for another period. The study renewal review fee funds the costs of the Board's renewal review, as well as the costs of the ongoing review of adverse events, protocol variances, site visits, and the monitoring of research progress via WIRB Continuing Review Report Forms for the additional year.
- Changes to Research fee: 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.
- Miscellaneous fees: WIRB bills additional fees if videoconferencing or teleconferencing with the site is necessary in the course of the review process and if translations are requested.
Items disapproved by the Board can be reconsidered upon written request. The request should include a justification for the reconsideration. There is no additional fee for the reconsideration. Reconsiderations of board-directed modifications do not incur additional fees if the requests concern 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.
A copy of our current fee schedule is available upon request from Client
Services at 1-800-562-4789 or e-mail to clientservices@wirb.com.
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