The key decisions involved with the institutional oversight of investigator-initiated clinical research includes the following:
If your study includes UW Medicine clinical procedures or facilities, you will need to work with the UW Clinical Research Budget and Billing (CRBB) office to finalize costs, such as itemized research procedure fees, and administrate billing processes for the study. As PI, you must complete Clinical Trial Policy Training, described in the Clinical Trial Policy Training in Training/Credentialing below, prior to your first budget being finalized.
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
All University of Washington investigators must disclose whether or not they have significant financial interest (SFI) 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 an SFI 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.
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 study.
Once the UW Office of Sponsored Programs has finalized your funding, they will release an eFA (Funding Action) to the Grants and Contracts Accounting Office, who will issue your research budget number.
To prepare your IRB submission:
If your funding is processed through the University of Washington Office of Sponsored Programs, you will most likely submit your Institutional Review Board application materials to the UW IRB.
UW HUMAN SUBJECTS DIVISION
(206) 543-0098 | email@example.com
UW members of the Cancer Consortium conducting investigator-initiated oncology studies should send their studies to the Fred Hutchinson Cancer Research Center IRB. Visit the Cancer Consortium IRB at the Fred Hutchinson Cancer Research Center web page for information on whether to submit to the Fred Hutch IRB.
FRED HUTCH INSTITUTIONAL REVIEW OFFICE
(206) 667-5900 | firstname.lastname@example.org
If you will conduct your study onsite at Seattle Children’s, you may need to submit your research study to Seattle Children’s IRB even if the funding is through the UW.
SEATTLE CHILDREN’S INSTITUTIONAL REVIEW BOARD
206-987-7804 | email@example.com
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 | firstname.lastname@example.org
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
Ellie Sun, Interim Program Manager of Surgical Services
(206) 598-1771 | email@example.com
If the IDE study includes services related to the device and or implant/removal at Harborview Medical Center, contact:
HMC SURGICAL COUNCIL COMMITTEE
Ketra Hayes, Assistant Administrator of Surgical Services
(206) 744-8094 | firstname.lastname@example.org
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 FDA’s Investigational Device Exception (IDE). Medicare approval is not required if the trial will cover all costs to participants.
You should contact UW Medicine Compliance early in the start-up process of your IDE study to prepare the application for permission to bill Medicare. 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 classifies IDEs as either Category A (significant risk) or Category B (non-significant risk) devices. With advance approval to bill Medicare, the related services 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 | email@example.com
If the study 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.
The FDA permits basic research using radioactive drugs or biologics in humans without an IND when the drug is not intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the radioactive drug or biologic, as outlined under the Radioactive Drug Research Committee (RDRC) regulations.
Radioactive Drug Research Committee (RDRC) Program
Guidance for Industry and Researchers
Supplemental information on working with radioactive materials is available from UW Environmental Health and Safety.
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.
Research studies involving human gene transfer or recombinant DNA based vaccines must be reviewed and approved by the University of Washington’s Institutional Biosafety Committee prior to enrolling patients. All human gene transfer studies must be reviewed by the NIH Recombinant DNA Advisory Committee prior to approval by the UW Institutional Biosafety Committee.
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 study involves stem cells, contact ESCRO.
To help navigate the numerous policies and regulations governing clinical research, UW Medicine Compliance provides a list of departments with responsibility for regulatory and policy compliance across the research environment and links to relevant information under their ownership.
If your study has an animal research component, you will need oversight by the University of Washington Institutional Animal Care and Use Committee.
You may want to contact UW Comparative Medicine for additional resources:
UW DEPARTMENT OF COMPARATIVE MEDICINE
(206) 543-8047 | Website