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).
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 unanticipated problems,
site visits, and the monitoring of research progress via WIRB Continuing Review
Report Forms for the first approval period.
In addition to the initial review fee, additional 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 non-protocol related materials and exemption determinations
are 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 unanticipated problems, site visits, and the monitoring of research progress
via WIRB Continuing Review Report Forms for the additional year.
- 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.
- 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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