The key decisions involved with the institutional oversight of industry-sponsored clinical trials include the following:
The University of Washington Clinical Research Budget and Billing Office (CRBB) reviews the billing plan, and negotiates and finalizes the budget for your industry trial. Preparation of the budget and negotiation between you, your department, and the sponsor/Clinical Research Organization can take a few weeks to several months, and must be completed before you enroll subjects in the clinical trial. As Principal Investigator, you must complete Clinical Trial Policy Training prior to your first budget being finalized.
Using CRBB’s Detailed Budget Tool template to create the budget, you will combine the protocol requirements with information from your feasibility assessment and itemized research procedure fees to estimate costs for conducting protocol-required procedures and administering the research. Once the template is complete, submit to CRBB for review, negotiation with the sponsor/Clinical Research Organization, and finalization.
The ITHS Research Coordination Center offers assistance with the CRBB budget tool on a fee-for-service basis.
UW CLINICAL RESEARCH BUDGET AND BILLING
(206) 543-7774 | email@example.com
Budgeting and Billing Requirements for Clinical Research Using UW Medicine Faculty, Facilities or Services
The University of Washington Office of Sponsored Programs negotiates and executes Clinical Trial Agreements (CTA). The contract must be signed by the Office of Sponsored Programs and the Principal Investigator.
Once you’ve reviewed what the sponsor has sent you, forward the protocol, consent form, draft budget, and Clinical Trial Agreements to the Office of Sponsored Programs via an eGC1. The Office of Sponsored Programs and Clinical Research Budget & Billing will negotiate the Clinical Trial Agreements and budget concurrently. This process may take a couple weeks to a couple months.
All University of Washington investigators must disclose whether or not they have significant financial interest for every funding proposal via the Financial Interest Disclosure System. Conflicts of interest in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher when designing, conducting, or reporting research. The minimum monetary threshold for reporting a significant financial interest will be lowered from $10,000 to $5,000, with a $0 threshold for disclosure of equity in a non-publicly traded company.
The UW’s Financial Conflict of Interest Policy seeks to maintain the appropriate balance among all competing interests that have the potential to produce bias in the design, conduct, or reporting of the research or distort technology transfer transactions.
To report a potential financial conflict of interest, use the Financial Interest Disclosure System Link.
For general questions about financial conflicts of interest, contact:
UW OFFICE OF RESEARCH
(206) 616-0804 | firstname.lastname@example.org
UW Medicine provides additional guidance on financial conflicts of interest to faculty within the School of Medicine. Check with your department to determine if there are additional requirements for your trial.
The UW Office of Sponsored Programs will not sign a Clinical Trials Agreement until the significant financial disclosure has been reviewed and the study has been approved to proceed through a plan to manage or eliminate the financial interest.
UW OFFICE OF SPONSORED PROGRAMS
(206) 543-4043 | email@example.com
Once the research budget and contracting is finalized, the University of Washington Office of Sponsored Programs will release an eFA (Funding Action) to the Grants and Contracts Accounting Office, and they will issue your research budget number.
Western Institutional Review Board (WIRB) reviews industry-sponsored and industry-initiated research conducted by University of Washington faculty. Learn more about the WIRB.
If you will submit to WIRB, ask the sponsor/Clinical Research Organization if WIRB is designated as the central Institutional Review Board, reviewing the majority of research sites. If they are, you will submit documents as a trial site. If they are not, you will submit all trial documents (protocol, consent form and any additional documents) as a single site.
UW members of the Cancer Consortium conducting oncology trials may choose whether to send their studies to WIRB or to the Fred Hutchinson Cancer Research Center Institutional Review Board. For more information about submitting to the Fred Hutch Institutional Review Board, visit the Human Subjects Division website.
FRED HUTCH INSTITUTIONAL REVIEW OFFICE
(206) 667-5900 | firstname.lastname@example.org
If the trial involves issues of intellectual property such as provision/receipt of research materials to/from other institutions/corporate entities, licensing issues, confidentiality agreements, patents, copyrights, and so forth, contact University of Washington CoMotion to help you with intellectual property and commercial development issues with your trial.
If the trial involves testing an investigational device under the Food and Drug Administration’s Investigational Device Exemption (IDE), you will need to work with University of Washington’s Clinical Research Budget and Billing and UW Medicine Compliance to identify the expected reimbursement for the device and device-related treatment.
UW CLINICAL RESEARCH BUDGET AND BILLING
(206) 543-7774 | email@example.com
IDE Device Implementation Workflow and Contact List
If the IDE study includes services related to the device and or implant/removal at UW Medical Center, contact:
INVESTIGATIONAL IMPLANT AND DEVICE COMMITTEE
(206) 598-1771 | firstname.lastname@example.org
If the Investigational Device Exemption study includes services related to the device and or implant/removal at Harborview Medical Center, contact:
HMC SURGICAL COUNCIL COMMITTEE
Katie Glaser, Business Manager
(206) 744-8094 | email@example.com
UW Medicine requires advance local or national Medicare approval in order to submit claims for research participants enrolled in trials testing investigational devices under the Food and Drug Administration’s Investigational Device Exception (IDE). Medicare approval is not required if the trial will cover all costs to participants, or if a trial is exempt from the FDA IDE regulations.
For industry trials, study teams should expect sponsors to initiate national Medicare approval. As part of UW Medicine study start-up, CRBB will direct you to work with UW Medicine Compliance to notify the local Medicare Contractor about the IDE trial.
If advance approval to bill Medicare is not obtained, Medicare will not cover any research-related costs. If a patient is admitted to the hospital for an IDE-related procedure, then the entire stay and all related services will not be covered and will not be reimbursed.
The FDA places all investigational devices it approves for clinical trials into one of two categories to help Medicare make reimbursement decisions about the use of investigational devices. The category is provided in the IDE approval letter from the FDA. IDEs are classified as either Category A (experimental) or Category B (investigational; non-experimental) devices. With advance approval to bill Medicare, the related services (i.e., use of the device) for Category A and B device trials, as well as the cost of a Category B device, are covered. Medicare will not cover the cost of a Category A device. Medicare coverage is only available when approval to bill Medicare is obtained in advance.
UW MEDICINE COMPLIANCE
(206) 543-3098 | firstname.lastname@example.org
If the trial includes use of any type of radiation (e.g., x-rays, nuclear medicine, radiation therapy), you must apply for an Authorization to Use Radiation on Human Subjects from the University of Washington Radiation Safety Office.
Members of your research team may also need to complete radiation safety training or review “Radiation Safety Training for Ancillary Personnel” that is described below.
Trials involving human gene transfer or recombinant DNA-based vaccines must be reviewed and approved by the University of Washington’s Institutional Biosafety Committee (IBC) prior to enrolling patients. All human gene transfer trials must be reviewed by the National Institutes of Health Recombinant DNA Advisory Committee prior to approval by the UW IBC.
The University of Washington Embryonic Stem Cell Research Oversight Committee (ESCRO) reviews and approves research involving human embryonic stem cells (hESC). The ESCRO Committee review ensures that both institutional and public concerns regarding sensitive ethical, legal, scientific, and policy issues unique to hESC research are addressed. If your trial involves stem cells, contact ESCRO.
UW EMBRYONIC STEM CELL RESEARCH OVERSIGHT
Kim A. Blakemore, Office of Research Compliance Analyst
(206) 685-7010 | email@example.com
If the trial has an animal research component, you will need oversight by the University of Washington Institutional Animal Care and Use Committee.
OFFICE OF ANIMAL WELFARE
Institutional Animal Care and Use Committee
(206) 685-7363| firstname.lastname@example.org