UW Research

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:

If the study is cancer-related and the UW PI is a member of the Cancer Consortium, the study may instead be reviewed by the Fred Hutch IRB.

The UW PI, in consultation with the sponsor and/or any Contract Research Organization (CRO) managing the study, is responsible for choosing which IRB to submit to for review and for preparing and submitting the application materials.

Contents

IRB review fees

Advarra and WCG IRB charge fees for most of the IRB review services they provide. HSD will not pay these fees. In most cases, Advarra and WCG IRB 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 WCG IRB 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 WCG IRB, note that the “Institutional” Fee Schedule is the schedule that applies to industry-sponsored research for which the UW is one of multiple sites.

The Fred Hutch IRB also charges fees for review of industry-sponsored research. HSD will not pay these fees. The sponsor and/or study team is responsible for paying any review fees charged by the Fred Hutch IRB.

HSD administrative fee

HSD charges a one-time administrative fee to help cover HSD’s costs for fulfilling mandatory regulatory and administrative responsibilities where the indirect cost rate does not cover these activities.

This includes industry-sponsored-and-initiated clinical trials that are reviewed by a non-UW IRB and for which the contract for the study was executed by the UW Office of Sponsored Programs (OSP).

As of July 1, 2024, the fee is $2060.06. The fee is evaluated annually with any increases applied at the start of each fiscal year (i.e., July 1st).

Process

When requesting authorization from HSD for each study, researchers must provide the worktag they wish the fee to be charged to. This may be any worktag the unit chooses. HSD may begin work on the application without a worktag, however it will not authorize the research for review by the external IRB until a worktag has been provided.

After the study has been authorized, HSD will work with the Office of Research to charge the fee to the worktag in Workday. The Office of Research does not send paper or electronic invoices.

Fee Waiver

In rare circumstances, HSD may waive the fee. Note that not successfully getting funded is not a valid reason for a fee waiver. Researchers must request a fee waiver by sending a written request to hsdrely@uw.edu. The request must be made prior to applying for authorization in Zipline. Waivers are not granted after HSD’s review has begun. The request should include:

  • Name of the Principal Investigator (PI) and contact information;
  • Study title;
  • Sponsor name;
  • OSP e-GC1 number;
  • Protocol;
  • 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.

Requesting authorization

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

WCG IRB specific instructions

On the WCG IRB application form, under this question:

Will this research be conducted through an organization that has a contract or Master Services Agreement (MSA) to use WCG IRB for IRB services?

  1. Answer: Yes
  2. Name of the organization: University of Washington
  3. WCG IRB Institution #: 55014

Applications may be submitted to the IRB by the UW study team or by the sponsor/CRO. When applications relevant to the UW are submitted by the sponsor or CRO, WCG IRB will hold the submission for 5 days and notify the UW study team so that they may confirm that the submission is correct and reflects the UW sites activities.

New to submitting applications to WCG IRB? Work with WCG IRB’s representative to the UW to understand the application and approval process.

Andy Parkhurst (Institutions Partnership Manager)
aparkhurst@wcgclinical.com

Advarra specific instructions

When registering for an account in CIRBI, Advarra’s online system, make sure to list your institutional affiliation as “University of Washington.”

New to submitting applications to Advarra? Work with Advarra’s representatives to the UW to understand the application and approval process.

Celeste Duran or Andrew Saunders
institutions@advarra.com

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.

Consult 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 for industry-sponsored clinical trials approved by the external IRB after initial IRB approval 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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