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Industry Sponsored Research

The UW IRB does not, in most cases, review research that is both industry-sponsored and industry-initiated. HSD currently requires that most industry-sponsored-and-initiated research be reviewed by one of two independent IRBs:

The UW PI, in consultation with the sponsor and/or CRO, is responsible for choosing which IRB to submit to for review and for preparing and submitting the application materials.
If the study is oncology related and the UW PI is a member of the Cancer Consortium, the study may instead be reviewed by the Cancer Consortium IRB at Fred Hutchinson Cancer Research Center.

IRB review fees

Advarra and WIRB charge fees for most of the IRB review services they provide. HSD will not pay these fees. In most cases, Advarra and WIRB will bill the sponsor directly. However in some cases, the UW study team will be billed and the sponsor expects to reimburse the costs of the fees. The UW PI is responsible for understanding how IRB review fees will be paid for.
If you have questions about WIRB or Advarra’s fees, contact the client services departments of the IRBs directly and mention that you are affiliated with the University of Washington. For WIRB, note that the “Institutional” Fee Schedule is the schedule that applies to industry-sponsored research for which the UW is one of multiple sites.

HSD administrative fee

HSD charges a one-time administrative fee of $1500 to help cover HSD’s costs for fulfilling mandatory regulatory and administrative responsibilities for some types of research with an indirect cost rate that does not cover those costs.

The fee applies only to human subjects research that is industry-sponsored-and-initiated that is reviewed by a non-UW IRB.

Process

For studies that go through Clinical Research Budget and Billing (CRBB), the one-time fee is automatically included in the study budget. For studies that are not using UW clinical services and don’t go through CRBB, the Office of Sponsored Programs (OSP) notes the fee in the Funding Action. Indirect costs are charged in connection with the fee. HSD does not send an invoice for the fee. The fee is automatically paid to HSD by Grant & Contract Accounting (GCA) when the UW receives initial payment from the sponsor. There is no requirement for study staff to do anything in connection with this fee.

Fee Waiver

In rare circumstances, HSD may waive the fee. Researchers may request a fee waiver by sending a written request to hsdrely@uw.edu. The request should include:

  • Name of the Principal Investigator (PI) and contact information;
  • Study title;
  • Sponsor name;
  • OSP e-GC1 number;
  • Protocol – including the monitoring plan and the Data and Safety Monitoring Board (DSMB) plan;
  • Contract or agreement (if available); and
  • Rationale for the waiver.

HSD considers the following factors when evaluating the waiver request:

  • Study purpose
  • Whether the UW is the only study site
  • The sponsor (type and size of company)
  • Relationship between the sponsor and the Principal Investigator

HSD will communicate its determination to the PI. It is the PI’s responsibility to provide this documentation to CRBB or OSP if the waiver is approved.

Requesting authorization

Before you submit for review to either Advarra or WIRB, follow the instructions under Ask for Non-UW IRB review to obtain authorization. Although HSD has established reliance agreements with Advarra and WIRB, it must authorize the use of any external IRB for each study. Advarra and WIRB will not review applications without documentation of this authorization.

UW researcher responsibilities

UW PIs are responsible for following the policies of the external IRB. This includes submitting to the reviewing IRB using their forms and processes (or assisting the sponsor or CRO with that process), following their reporting requirements for unanticipated problems and new information about the study, and complying with the stipulations of the IRB’s approval.

UW PIs are also responsible for:

  • Ensuring that any relevant financial conflicts of interest are disclosed to the reviewing IRB and that conflict of interest management plans issued by the Office of Research are given to the reviewing IRB.
  • Obtaining any required ancillary review and approvals and providing the results of these reviews to the reviewing IRB if requested.
  • Making copies of IRB approvals available for inspection by monitors and auditors.

See the CHECKLIST: External IRB for UW Researchers for a detailed list of responsibilities.

Post approval consent audit

As part of HSD’s Post Approval Verification and Education (PAVE) program, HSD will audit consent materials approved by the external IRB at initial review to ensure that:

  • UW required elements (as outlined in the GUIDANCE: Consent Elements for Externally Reviewed Studies) are present.
  • Any compensation for injury language is consistent with the applicable Master Clinical Trial Agreement (MCTA), study-specific Clinical Trial Agreement (CTA) or any other documents that address financial coverage for research-related injuries and that the language is not in violation of the Medicare Secondary Payer (MSP) rule.

If consent materials are not consistent with these requirements, HSD will contact the UW research team to describe the inconsistencies. Inconsistent consent materials may need to be re-reviewed by the external IRB at the sponsor and/or PI’s expense, and subjects who have already been enrolled in the study may need to sign the new consent materials.

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