Culture of Compliance

Access resources below for best practices and guides for upholding the highest standards in the responsible and ethical conduct of research.

University Research Compliance Guide

Locate resources and expertise supporting the university’s culture of compliance.

University Code of Conduct

Ethical and legal standards we use as the basis for our decisions and actions as a university community.

Research Roles & Responsibilities

Duties of key individuals and organizational units involved in WU research activities.

University Research Policies

Policies, procedures and other guidance applicable to the performance of research.

A robust culture of responsible conduct of research is one of Washington University’s greatest assets, which is only made possible by every community member’s commitment to upholding the highest ethical, legal and regulatory standards. It is with this in mind that we will continue to work with integrity as we further our mission of discovering and sharing new knowledge in service to, and for the benefit of, our community, country and world.

Mark Lowe, MD, PhD, Interim Vice Chancellor for Research, WUSTL, Research Compliance Guide, 2022

Resource List

General
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Human Stem Cell Research

Guidelines and committees overseeing use of human stem cells in research

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Research Compliance Guide

Locate resources and expertise in support of Washington University’s culture of compliance

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Stem Cell Research

Oversight of human embryonic stem cell research and certain uses of human pluripotent stem cells

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University Research Policies

List of key procedures and policies governing research at WU

Animal Studies
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Animal Care & Use

Click on the Education and Training accordion for a list of trainings related to animal research.

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Animal Education in Learn@Work

Required training for individual involved in animal studies

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Division of Comparative Medicine (DCM)

Animal procurement, husbandry, facility operations, technical and veterinary support

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IACUC Protocol/Amendment Review Process

Guide to animal studies protocol review

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Institutional Animal Care and Use Committee (IACUC)

Guidelines and Tools for the appropriate, ethical and safe conduct of research involving vertebrate animals. Log in with WUSTL Key.

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LAMPS Training Resources

Login with WUSTL Key to BOX folder

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LAMPS: Lab Animal Management & Protocol System

System for processing WU animal protocols and hazardous materials

Conflicts of Interest
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COI.WUSTL.EDU

Resource page for disclosure of Financial and Research Conflicts of Interest

Applicability: All faculty members with an academic appointment of instructor or higher, or any individual having independent responsibility for the design, conduct, or reporting of research.

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Conflict of Interest – OVCR Resources

Admin resource page for Conflicts of Interest.

Addresses various COI types, forms, committees

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Financial Conflicts of Interest (FCOI) Education

Training required for all individuals who must complete a Financial Disclosure Statement.

Data Security and Intellectual Property
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HIPAA Policies & Procedures

WU policies and procedures for compliance with the Health Information Portability and Accountability Act

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HIPAA Privacy Office

Resources for compliance with the Health Information Portability and Accountability Act

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Information Security & NIST Guidance

University resources and guidance on federal requirements

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Information Security Policies

WU Infosec policies and guidelines for use of WU systems and data security

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Joint Research Office for Contracts

JROC

The mission of JROC is to provide high quality customer service to principal investigators, administrators, and sponsors by drafting, reviewing, negotiating and signing research-related agreements on a university-wide basis. JROC facilitates the timely execution of federal and foundation subawards and contracts, industry-supported research agreements, industry supported clinical trials, data transfers, service agreements, and other research-related agreements.

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Office of Information Security

Office charged with securing WU systems and data

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Securing Controlled Unclassified Information (CUI)

Considerations for proposals and awards with terms related to CUI. Guide by JROC.

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The EU’s General Data Protection Regulation (GDPR)

Privacy for individuals protected under the EU’s GDPR

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Intellectual Property Policy

Governing WU research, inventions and other discoveries

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Material Transfer Agreements (MTAs)

Guide and procedures to sharing materials with partner institutions and researchers

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Office of Technology Management

Mission: Pair cutting-edge WU research with expertise and exceptional service in order to create a pipeline of opportunities that can benefit society.

OTM acts as a resource for faculty in the areas of copyrights; patent prosecution; material transfer agreements; consulting agreements; marketing; licensing

Effort Reporting
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Effort Reporting – Sponsored Projects

Policies and procedures for reporting effort on sponsored projects

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Review Effort for One Award Split Across Multiple Lines

Workday guide for effort split on multiple grant lines

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Reviewing and Certifying Your Effort

Workday guide to reviewing and certifying your university effort

Environmental Health & Safety and Controlled Substances
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Controlled Substances

Approval, acquisition, storage, and disposal of DEA-controlled substances used in laboratory and animal research

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Controlled Substances Overview

Flow chart indicating the acquisition process and resposibilities by types of research and location

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Division of Comparative Medicine (DCM)

Animal procurement, husbandry, facility operations, technical and veterinary support

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Emergency Information

Sign up for WUSTL emergency alerts and learn more about emergency preparedness and programs on campus.

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Environmental Health and Safety (EHS)

Explore training for lab safety protocols involving hazardous and regulated materials, equipment, and environment. Megan Flake is the McKelvey liaison with the staff from the EH&S department of the University.

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Institutional Biological and Chemical Safety

Oversight of research involving recombinant or synthetic nucleic acids, infectious or potentially infectious agents, and/or hazardous chemicals

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LAMPS: Lab Animal Management & Protocol System

System for processing WU animal protocols and hazardous materials

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Radiation Safety

Safe and compliant use of radiation and radioactive materials for research, teaching and medical applications

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Stem Cell Research

Oversight of human embryonic stem cell research and certain uses of human pluripotent stem cells

Ethics in Research
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Author’s Checklist for Preparation of Publications

Supporting co-author agreement and shared planning of publications

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Avoid Authorship Disputes

Guidelines helping to prevent situations that may lead to new authorship disputes

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COI.WUSTL.EDU

Resource page for disclosure of Financial and Research Conflicts of Interest

Applicability: All faculty members with an academic appointment of instructor or higher, or any individual having independent responsibility for the design, conduct, or reporting of research.

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Conflict of Interest – OVCR Resources

Admin resource page for Conflicts of Interest.

Addresses various COI types, forms, committees

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Financial Conflicts of Interest (FCOI) Education

Training required for all individuals who must complete a Financial Disclosure Statement.

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Human Stem Cell Research

Guidelines and committees overseeing use of human stem cells in research

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Office of Research Integrity & Ethics (ORIE)

Provides programmatic resources for: Individual and Institutional Conflicts of Interest, Human Stem Cell Research, Research Integrity and Authorship Standards , Human Research Quality Assurance and Improvement, Institutional Animal Care and Use.

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PERCSS – Training in the Responsible and Ethical Conduct of Research

WU Curriculum: Program for the Ethical and Responsible Conduct of Science and Scholarship

The PERCSS Core Curriculum features eight web-based learning modules in areas related to ethical and responsible conduct of research. The PERCSS Core Curriculum is available through Learn@Work.

Financial Compliance
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Effort Reporting – Sponsored Projects

Policies and procedures for reporting effort on sponsored projects

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Prior Approval Letter Matrix – SPA

Guide to when prior approval letters are required – guide by SPA and OSRS

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Prior Approval Matrix – FDP

Matrix depicting when sponsor pre-approval is required on federal funds.

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Small Business Subcontracting Plan Guide (OVCR)

Requirement for federal contracts and subawards with over $700,000 total costs.

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Sponsored Expenditures Guidelines

Guidance on appropriate budgeting and expenditures of federal and non-federal sponsored funds directed toward research, training, or other purposes

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Uniform Guidance (UG)

Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards

Human Subjects
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Center for Clinical Studies

Provides WU researchers with administrative and clinical research services from the initial proposal phase through study close-out.

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Clinical Research Coordinator Orientation Manual

Training manual for staff supporting human subjects research. Produced by the WU OVCR.

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Clinical Research Training Center

Provides a cohesive and supportive infrastructure to foster clinical and translational research training and career development for predoctoral students, house-staff, postdoctoral fellows, staff, and faculty.

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Clinical Trials Registration and Informed Consent Posting Guideline

WU Guidelines from the Office of the Vice Chancellor for Research

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Decision Tool: Am I Doing Human Subjects Research? (NIH)

Complete this questionnaire to determine whether your reserach classifies as human subjects research

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Education in Good Clinical Practices Policy

Applicable for faculty and staff involved in the conduct, oversight or management of clinical trials

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HIPAA Policies & Procedures

WU policies and procedures for compliance with the Health Information Portability and Accountability Act

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HIPAA Privacy Office

Resources for compliance with the Health Information Portability and Accountability Act

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HRPO Education Programs

These programs provide a variety of ways to help investigators and research teams navigate the approval and conduct of human subjects research.

International: Foreign Partners and Export Control
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Disclosure & Reporting Requirements for International Research

University resources around the government’s concerns and best practices

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Export Control

Information and Technology Sharing Regulations

Applies to transfer of technical information or controlled items to foreign nationals or across U.S. boundaries

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Export Control Exclusions

Fundamental research, public domain, educational information exclusions

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Foreign Corrupt Practices Act (FCPA) Policy

Regarding improper payment to foreign officials and other improper business payments

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International Travel Resources

Important information to know before you travel internationally

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MyTrips International Travel Registry

Inform WU that you are overseas: register your trip

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Office for International Students and Scholars

WUSTL’s Office for International Students and Scholars enables international students and scholars to thrive academically and socially by meeting their unique needs and engaging them in American life and culture. Please contact your Department Administrator before contacting OISS.

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The EU’s General Data Protection Regulation (GDPR)

Privacy for individuals protected under the EU’s GDPR

Training (A – Z List) – See Right Menu for Specific Topics
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Animal Education in Learn@Work

Required training for individual involved in animal studies

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Avoid Authorship Disputes

Guidelines helping to prevent situations that may lead to new authorship disputes

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Clinical Research Coordinator Orientation Manual

Training manual for staff supporting human subjects research. Produced by the WU OVCR.

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Education in Good Clinical Practices Policy

Applicable for faculty and staff involved in the conduct, oversight or management of clinical trials

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EH&S Training

Education and training resources for environmental health and safety

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Financial Conflicts of Interest (FCOI) Education

Training required for all individuals who must complete a Financial Disclosure Statement.

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HRPO Education Programs

These programs provide a variety of ways to help investigators and research teams navigate the approval and conduct of human subjects research.

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Human Subjects Education Policy

Applicable to individuals responsible for the design, conduct and reporting of research involving human participants

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LAMPS Training Resources

Login with WUSTL Key to BOX folder

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PERCSS – Training in the Responsible and Ethical Conduct of Research

WU Curriculum: Program for the Ethical and Responsible Conduct of Science and Scholarship

The PERCSS Core Curriculum features eight web-based learning modules in areas related to ethical and responsible conduct of research. The PERCSS Core Curriculum is available through Learn@Work.