UW Medicine Compliance
All members of the academic community – faculty, staff, and students – are expected to satisfy institutional stewardship obligations and conduct their research in compliance with federal, state, and local laws, and with the policies and procedures of the University.
Research compliance encompasses a wide variety of issues including human and animal subjects; pre- and post-award management; access to and retention of data; environmental and workplace safety; intellectual property; conflicts of interest; and scholarly integrity in research.
At the University of Washington, many different departments contribute to the advancement of research by engaging in activities that enhance and protect the University’s research efforts. To help navigate the numerous policies and regulations governing research, this site features a list of departments with responsibility for regulatory and policy compliance across the research environment and links to relevant information under their ownership.
Below is the link to the UW Medicine Research Billing Policies.
Office of Sponsored Programs
As part of the Office of Research [OR], the Office of Sponsored Programs [OSP] supports researchers in the acquisition, performance and administration of projects funded from sources outside of the University and helps researchers comply with institutional and federal policies and procedures.
- OR: Policies and Procedures
- OSP: Polices and Procedures
- OSP: Compliance Roles
- OSP: Export Controls Regulations
Human Subjects Division
Research that involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), requires human subjects review prior to beginning such a project. The Human Subjects Division [HSD] is responsible for the administration of Institutional Review Board [IRB] activities and oversight of human research protections activities such as educational programs and post-approval monitoring.
Institutional Animal Care and Use
The health and humane use of animals used in research is achieved through the policies and procedures established by the Institutional Animal Care and Use Committee [IACUC]. The office of Animal Welfare staff can answer questions regarding experimental protocols and provide guidance on US Department of Agriculture and Department of Health and Human Services regulations.
- Research Animal Policy
- OSP: Research Animals and Grants FAQs
- Department of Comparative Medicine: Animal Care and Use Hotline
Environmental Health and Safety
The office of Environmental Health and Safety [EHS] provides a variety of planning and assessment tools to help researchers maintain a safe research environment and comply with university, city, state, federal, and international regulations concerning environmental, facility, occupational, radiation and biological safety.
- EHS: Information for Principal Investigators
- EHS: Research Planning & Hazard Assessment Requirements
Research Accounting and Analysis
Research Accounting and Analysis is a division in the Office of Financial Management [FM] and includes Grant and Contract Accounting [GCA] and Management Accounting and Analysis [MAA]. GCA assists researchers with post award grand and contract management including establishing budgets, managing cash, compliance (including cost sharing) and reporting. MAA provides guidance to researchers on faculty effort certification, recharge center rates and costing.
- GCA: Award Management
- GCA: Post Award Process
- GCA: Post Award Compliance Checklist
- ORIS Researcher’s Guide: Award Management
- ORIS Researcher’s Guide: Award Closeout
- MAA: Guide to Completing Faculty Effort Certification Reports
- MAA: Recharge and Cost Center Overview
The protection and management of intellectual property arising from research is handled by UW TechTransfer [UWTT]. Innovations should be reported as soon as they have been made, and before they are publicly disclosed so that UW TechTransfer can evaluate the innovation for intellectual property protection and commercial potential. Disclosing the innovation or discovery to UW TechTransfer is required if the project has been supported by federal grants.
Material Transfer Agreements
The exchange of research materials is an important component of the research enterprise. The Agreements Group within UW TechTransfer [UWTT] manages most Material Transfer Agreements [MTAs] for the University of Washington. If the MTA is embedded in a Sponsored Research Agreement, or is linked to a clinical trial, then the Office of Sponsored Programs [OSP] may be responsible for the MTA. UW TechTransfer and OSP are the only units of the University authorized to review and sign MTAs.
Conflict of Interest in Research
Individuals who act on behalf of the University of Washington have an obligation to avoid situations or activities which may result in a conflict of interest or an appearance of conflict of interest. Prior to participating in a research or technology transfer activities, anyone having a significant financial interest related to the activity shall disclose the details of the interest to the University.
- OSP: Disclosure of Significant Financial Interest
- UW Medicine: Conflict of Interest
- University Handbook: Employee Conflict of Interest
The Office of Scholarly Integrity [OSI] coordinates inquiries and investigations into allegations of scholarly misconduct and is responsible for compliance with reporting requirements established by various federal and other funding agencies in matters of scientific and scholarly misconduct.
Resources for the Clinical Researcher
- OSP: Resources for the Clinical Researcher
- HSD: Categories of Research Requiring Review
- University of Washington: General Clinical Research Center
- UW Medicine: Clinical Research Budget and Billing Office
- UW Medicine: Office of Clinical Research
- UW Medicine: Quick Reference Guide – Access to Electronic Medical Records for non-UW Medicine Workforce for External Audits/Reviews
- UW School of Medicine: Compliance Training and Communication
- UW School of Medicine: Office of Research and Graduate Education
- UW School of Medicine: Office of Research and Graduate Education – Grant Process
Special Topic FAQs
What should I do if the FDA arrives to inspect my research? Answer
Use of Protected Health Information for Single Case Studies and Journal Publications
Do I need IRB approval? Do I need patient authorization? Answer
HIPAA – Information Security and Protected Health Information (Privacy) Training: Required of all UW Medicine workforce members, including faculty, employees, trainees (fellows, residents, and students, and volunteers, and for School of Medicine workforce members whose job function requires the use or disclosure of Protected Health Information.
Collaborative IRB Training Initiative [CITI]: Required for “key” personnel receiving NIH funding; encouraged for all individuals conducting research involving human subjects.
Faculty Grants Management Program: Required for all Principal Investigators with active, externally funded grants and contracts; new faculty are encouraged to complete the training prior to submitting a grant or contract proposal; includes training on Faculty Effort Certification reporting.
UW General Clinical Research Center: Offers a variety of training and educational offerings for clinical researchers and staff.