WU IRB is the Single IRB (sIRB) for a Multi-site Study

If your study is not funded by a for-profit entity, you should request the budget of approximate costs associated with the WU IRB acting as the single IRB at the time of grant/funding application submission. These costs must be included as a direct cost in your budget. If the costs are not included in the grant/funding application and a single IRB is required, the fees cannot be waived and funds will have to be reallocated or additional funds will have to be requested from the funding entity to cover single IRB fees.

HRPO uses a costing model to determine rates for acting as a single IRB.  The costing model was built based on historical and expected workloads for the HRPO and IRB functions. At-cost rates are calculated specific to form types:  new submissions, modifications and continuing reviews. The at-cost rates are reviewed and revised on a regular basis. It is important to keep in mind that the sIRB fees only apply to form submissions from non-WU sites.

sIRB studies that receive for-profit funding only are charged a higher rate.

The at-cost rates for sIRB review fees are evaluated on an annual basis and updated as needed to accurately reflect HRPO’s costs for conducting reviews.  These rates can be provided upon request, however, these rates should not be used to create a budget. Also, it is important to note the rate at the time a form is processed will be used.

See FAQ titled “What are the fees if I want WU to serve as a single IRB and my study is funded by a for-profit entity?” for rates on studies funded by a for-profit entity.

You should request a budget from HRPO to determine the approximate costs associated with the WU IRB being the single IRB. Complete the sIRB Grant Intake Form.

No.  The budgets provided are based on available data about the types and number of forms that are typically submitted to the IRB for review on multi-site research studies. The budget provided will lay out the approximated costs per year and will account for inflation.  The actual amount charged will vary depending on the number of forms (new submission, modifications and continuing reviews) actually submitted for review, the number of sites, length of time the study remains open with the IRB and the at-cost rate at the time the form is submitted.

If Washington University IRB is serving as the single IRB for a study that is funded by a for-profit entity the charge per form for each site (except the WU site) is based on the following fee schedule.

For-profit funded studies only

*If adding industry support to an approved study contact the Business Office, hrpobusinessoffice@wustl.edu, regarding appropriate fees.

It is recommended that language be included in the agreement indicating the funder will pay applicable IRB fees rather than designating a specific amount as fees may change over the course of the study.

The following entities will be considered sites and will incur fees for reviews:

• Entities that are engaged in the research and have a human research protection program (HRPP) or research infrastructure that is tasked with providing oversight in the conduct of human subject research and/or protection of human subjects. This HRPP/infrastructure can be broad and include an IRB or limited in scope such as an individual who is charged with ensuring proper research conduct and managing administration of research related tasks.
• Institutions or entities that are the Prime Awardee of a grant (this includes small business partners that have received SBIR or STTR awards)
• For profit entities that are engaged in research.

An entity is considered engaged if their employees or agents intervene or interact with living individuals for the purpose of research, obtain individually identifiable private information about living individuals for the purposes of research, or receive an award to conduct human subject research even when all activities involving human participants are carried out by a subcontractor or collaborator.

Examples of sites that would not be considered engaged are entities that:

• only release identifiable private information about individuals,
• serve as a recruitment site and the employees or agents are not involved in the recruitment or consent process other than to provide general information about the study or
• only provide a commercial service (example a commercial lab for blood draws).

If you are unsure if your research partner is engaged in the research and/or will be considered a site for sIRB charging purposes, please consult with HRPO at the time of your budget request.

Charges apply to the types of forms listed below for sites other than Washington University.

• New Project Fee
  This fee is charged when a non-WU site submits a new study (New Project form) for review by the WU IRB.  This is the scenario when the non-WU site is responsible for the overall protocol and WU is only a participating site.
• New Site Fee
  This fee is charged when a New Site form is submitted to add a new site to conduct the research.

If a non-WU site submits both the New Project form and a New Site form they will only be charged for the site approval.

• sIRB Modification (Mod)
  A PER SITE modification fee will be assessed for:
  • Changes to the protocol
  • Changes to the consent form template that was approved for all sites
  • Changes to questionnaires or other study-wide materials
  • Changes to the overall project that require myIRB form changes for sites

Fees are not charged for single site modifications. For example: changes to contact information in a single site’s consent form or approval of a recruitment document to be used at only one site.

If the non-WU site submits both the overall project modification and a site modification they will only be charged for the site modification.

• sIRB Continuing Review (CR)
  This fee is charged PER SITE when a continuing review form is submitted.

If the non-WU site submits both the overall project continuing review and a site continuing review they will only be charged for the site continuing review.

There is not a charge for Reportable Event Form submissions. Exception forms are not a functionality available in myIRB for sIRB studies.

When the WU IRB acts as the single IRB for sites other than WU there are costs associated with using HRPO and IRB resources.  SIRB fees are not subject to the University indirect cost rate.

Fees are charged to cover a number of tasks including but not limited to:

• the costs associated with the HRPO staff time spent screening and reviewing the IRB submission and the associated study materials
• supporting the committee in their reviews
• educating outside researchers on sIRB process and procedures
• coordination, management, and liaison activities with outside institutions for reliance documentation and negotiation of reliance agreements
• education and support of researchers to enable compliance

The sIRB fees will apply but only for the sites that are using the sIRB model.

The single IRB requirements do not apply to international sites and generally the WU IRB will not agree to serve as the IRB for international sites.

No. The single IRB mandate applies only to federally funded research. It is not always recommended that a single IRB be used if it is not required for certain types of research.

As a recharge center, HRPO must charge consistently for sIRB fees. If your study is not funded and you do not have departmental funds to cover the sIRB fees, WU cannot act as the single IRB.

No. As a recharge center, HRPO must charge consistently for sIRB fees. Discounts and waivers are not possible in any circumstance based on the rules of a recharge center.

IRB review can occur prior to payment of the fee. Single IRB fees are invoiced on a monthly basis.