WSIRB Review Service Fee FAQs

WSIRB and IRB Administrative Human Research Review Section (HRRS)
Review Service Fees Frequently Asked Questions

  1. What are the review service fees?
  2. What does each review service fee cover?
  3. Which studies will be charged review service fees?
  4. Would review service fees be charged if a study was reviewed prior to December 1, 2015?
  5. What is the payment process?
  6. How long will the payment process take?
  7. How was the amount of each service fee determined?
  8. When would review service fees need to be paid?
  9. Will the review process be held up if the fee for human subjects review services is not paid?
  10. How often would the review service fees change?
  11. Would investigators be required to pay any other fees for conducting research subject to WSIRB or HRRS review?
  12. Can an investigator request a waiver of review service fees?
  13. Who decides whether to grant a waiver of some or all review service fees?

2. 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 and 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.

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3. 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 not subject to review service fees:

  • Department of Health
  • Department of Labor & Industries
  • Department of Social and Health Services
  • Health Care Authority

 

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4. Would review service fees be charged if a study was reviewed prior to December 1, 2015?

Studies that have been reviewed and approved by the WSIRB prior to the effective date and all studies that receive new sources of research funding may be charged review service fees for all reviews submitted for review on or after December 1, 2015. If a study is under a no cost extension and WSIRB receives proper documentation, some or all fees may be waived.

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The Payment Process

5. 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 Worksheet. 

As applicable, HRRS staff will send an acknowledgment email to the PI along with a worksheet of the review fee (based on the documents submitted for review). Payment is due upon investigator receipt of the Worksheet. 

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6. 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.

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7. 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.

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8. When would review service fees need to be paid?

Fees must be paid prior to review.

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9. 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.

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10. How often would the 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.

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11. Would investigators be 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.

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12. Can an investigator request a waiver of review service fees?

Exceptions to the requirement to pay review fees will be considered for 1) the investigator is working on behalf of a state agency which supports WSIRB, 2) previously approved research is in a no-cost extension as of December 1, 2015. Investigators requesting a waiver must complete a Request Waiver of WSIRB Review Service Fees, and submit it to wsirb@dshs.wa.gov.  Incomplete forms will be returned to the investigator via email, without consideration of a waiver.

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13. Who decides whether to grant a waiver of some or all review service fees?

The decision to extend a waiver will be made by HRRS staff, based on if: 1) the investigator is working on behalf of a state agency which supports WSIRB, 2) previously approved research is in a no-cost extension as of December 1, 2015.

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