Review Service Fees
Information for Investigators: Fees for WSIRB and IRB Administrative Review Services
Fees are charged for WSIRB and Human Research Review Section (HRRS) administrative review of research and non-research projects, effective December 1, 2015. These service fees will cover the costs associated with WSIRB review and related HRRS administrative review requirements to offset costs to state agencies that support the WSIRB. Fees offset the public funds used to support the WSIRB.
The Department of Social and Health Services is “authorized to charge fees for services provided unless otherwise prohibited by law” (RCW 43.20b.020). Because the WSIRB is a board within the agency, and its members are appointed by the Secretary and maintained and supported by HRRS staff at DSHS, the WSIRB and HRRS are part of DSHS and have statutory authority to charge fees.
Fees are non-refundable regardless of the outcome of the human subjects review. Fees are due in full from the investigator or their home institution, even if the WSIRB does not approve or the HRRS does not provide clearance for the project, subjects are never enrolled, or the project is canceled or terminated before project objectives have been achieved. Because considerable time, effort, and resources are committed to all reviews, fees must be received before a study is assigned to a staff reviewer. This means the study will not be placed on the agenda for full Board review, scheduled for expedited review or a regulatory determination or other administrative action or decision is made. Review will not be conducted unless review service fees are paid in full in advance.
Payment of review fees will not result in preferential review or faster response time, nor will it influence WSIRB decisions in any way.
Please note that WSIRB review service fees have changed to reflect the Revised Common Rule.
|
Review Service Requested |
Fee |
|---|---|
| New Application, Full Board | $3,000 |
| New Application, Expedited (minimal risk) | 2,000 |
| Continuation Review, Full Board or Expedited | 500 |
| Continuation Review, Exempt Project with a Confidentiality Agreement | 250 |
| Study Closure, Full Board or Expedited | 250 |
| Study Amendment Request, Full Board | 500 |
| Study Amendment Request, Expedited | 250 |
| Unanticipated Problem Involving Risks to Subjects or Others | No charge |
| Protocol Deviation | No charge |
| Non-Compliance | No charge |
| Confidentiality Agreement | 1,000 |
| Exempt Determination Request | 750 |
| Exempt Amendment Request | 250 |
WSIRB and IRB Administrative Human Research Review Section (HRRS)
Review Service Fees Frequently Asked Questions
- What does each review service fee cover?
- Which studies will be charged review service fees?
- What is the payment process?
- How long will the payment process take?
- How was the amount of each service fee determined?
- When do review service fees need to be paid?
- Will the review process be held up if the fee for human subjects review services is not paid?
- Do review service fees change?
- Are investigators required to pay any other fees for conducting research subject to WSIRB or HRRS review?
1. What does each review service fee cover?
New application: Review of the application; qualifications of the investigator; recruitment and consent procedures and documents, as applicable; risk-benefit assessment; required special protections for vulnerable subjects, as applicable; waivers of documentation of consent, elements of informed consent, parent permission for participation of a child, and/or waivers of authorization (including HIPAA), as applicable; data collection instruments; requests for state agency records; grant applications; verification of training in human subjects protection; conflict of interest reporting; and preparation and administrative processing of all such review actions.
Continuation Approval Request: Review of compliance with WSIRB approved procedures; recruitment and consent documents, as applicable; assessment of risks of the research and anticipated benefits, and any additional human subjects protections that may be required ; subject accrual, as applicable, and study progress; assessment of reported unanticipated problems involving risks to subjects or others and/or adverse events; verification of training in human subjects protection; conflict of interest reporting; compliance review of any required Confidentiality Agreement and addenda; and preparation an administrative processing of all such review actions.
Study Amendment Request: Review of all proposed revisions to approved research in relation to the initial risks/benefit assessment and study objectives; review of requests for state agency records; review of new investigator/new research staff qualifications and required training; conflict of interest reporting; review of recruitment and consent/assent documents in relation to proposed revisions to the study; preparation of addenda to Confidentiality Agreements, and administrative procedures to obtain state agency approval(s) for disclosure of identifiable records, if applicable; review of adverse events and/or unanticipated problems involving risks to subjects or others and review of protocol deviations and development of appropriate corrective action plans; and preparation and administrative processing of all such review actions.
Study Closure Request: Review of project file to ensure that all WSIRB requirements have been met; review of final study report; destruction of identifiers of study subjects, if so stated in consent documents; destruction of identifiable records disclosed under RCW 42.48; review of and administrative and WSIRB actions related to terminations due to noncompliance; and preparation and administrative processing of all such review actions.
Confidentiality Agreement: Preparation and administrative processing of Confidentiality Agreements for disclosure of state agency records, in accordance with 45 CFR 164.512(i) and RCW 42.48.020. A Confidentiality Agreement may be required for exempt research, activities that are determined “non-research” and for disclosure and use of non-identified or de-identified state agency records.
Exempt Determination Request: Assessment of whether an activity comprises research that requires WSIRB review, is research that does not involve human subjects, or is a non-research activity; review of requests for disclosure of state agency records, if applicable, and related requests for waiver(s) of authorization (including HIPAA); review of consent, assent, parent/guardian permission and authorizations; review of required conflicts of interest reporting for PHS-sponsored research; and preparation and administrative processing of all such review actions.
2. Which studies will be charged review service fees?
Research and non-research projects will be charged for WSIRB and HRRS review services and oversight.
Studies for which the following Washington State agencies are the sole sponsors or the Principal Investigator’s (PI's) employer are generally not subject to review service fees:
- Department of Health
- Department of Labor & Industries
- Department of Social and Health Services
- Health Care Authority
- Office of Financial Management
- Department of Corrections
- Department of Children, Youth, and Families
The Payment Process
3. What is the payment process?
After submission of an Application, Study Amendment Request, Continuation Approval Request, Study Closure Request, or Exempt Determination Request, HRRS staff will send a Review Fee Invoice.
As applicable, HRRS staff will send an acknowledgment email to the PI along with an invoice of the review fee (based on the documents submitted for review). Payment is due upon investigator receipt of the Invoice.
4. How long will the payment process take?
It may take 2-3 weeks for administrative processing of fees, once payment is received. Investigators should plan accordingly.
5. How was the amount of each service fee determined?
Each fee was determined by assessing the administrative costs of managing review processes. The fee level represents the mid-range of fees charged by peer institutions, such as agencies in other states, universities, hospitals, large research organizations, and corporate IRBs.
7. Will the review process be held up if the fee for review services is not paid?
Yes. The review process will not occur until the review service fee is paid in full for each submission. It is the investigator’s responsibility to ensure that all required fees are paid such that the review process may occur in a timely manner.
Study Amendment Requests that involve a Report of Unanticipated Problems/Adverse Events and/or a Protocol Deviation will only be reviewed after payment is received, unless the WSIRB or HRRS determines that review is required in order to protect the rights and welfare of study subjects. In such cases, the ability of the investigator to submit any additional items for WSIRB or HRRS administrative review will be suspended until all fees have been paid.
8. Do review service fees change?
Fees are subject to change at the beginning of each Washington State fiscal year (July 1st). Additional review services for which fees may be charged may be added to the fee schedule at any time, as needed. The current fee schedule is posted in this section of the WSIRB website.
9. Are investigators required to pay any other fees for conducting research subject to WSIRB or HRRS review?
Fees for review services are separate from any fees charged by a state agency for use/disclosure of identifiable records or for charge-back of other state agency resources needed in order to conduct the research (e.g., use of state facilities, assistance contacting agency clients, etc.). Neither the DSHS Human Research Review Section nor the WSIRB can waive state agency fees required by the program area(s) assisting with the research.