Many areas and groups play a role in compliant research. The information below is a high-level overview of institutional oversight in certain areas of research.
There are also compliance training requirements that must be met. See the Trainings for Researchers page for a list of related compliance trainings.
Washington University in St. Louis is committed to the highest ethical and professional standards of conduct. Each community member is expected to report violations or concerns about violations of the Code of Conduct that come to their attention. For more information or to learn how to report a concern, see the page Procedures for Reporting Violations or Concerns.
Additionally, any member of the WashU research community has an obligation to report observed instances of research misconduct. For more information, see how to Report an Allegation of Research Misconduct.
Conflicts of Interest
Key Websites
- Conflicts of Interest website
- Research conflicts of interest topic page
- Individual (Research) Conflicts of Interest Policy
Offices & Committees
Conflicts of Interest (COI) Office
Assists with the administrative functions of disclosing, reviewing, and managing research conflicts of interest.
Danforth and School of Medicine Conflicts of Interest Review Committee (CIRC)
Helps to assure compliance with federal regulations and University and sponsoring agency policies and procedures governing financial conflicts of interest related to research
Training Requirements
Financial Conflicts of Interest (FCOI) training is required to be completed in Learn@Work every 4 years by faculty and any other individuals responsible for the design, conduct, or reporting of research.
Oversight
External Professional Activities (EPA) Disclosure – Disclose activities conducted with an external entity that are related to work at the University.
- Required for: Covered Individuals (All faculty; individuals responsible for the design, conduct, or reporting of research)
- Frequency: Annually or within 30 days of a new activity
- System: Research Management System (RMS)
Prior Approval
- Required for: Covered Individuals as part of the EPA Policy (All faculty; individuals responsible for the design, conduct, or reporting of research)
- Required prior to: Engaging in select external activities that are of higher risk for significant conflicts of commitment
- Timing: Submit request 60 days before signing a contract or beginning the activity
- System: Research Management System (RMS)
Travel Disclosure
- Required by some sponsors (including DHHS [NIH]) if threshold is met. See Travel Disclosure Procedures and Guidance for more information.
- System: Research Management System (RMS)
Research Disclosure – Gathers specifics about the research project
- Required in some cases of significant financial interest with an external entity. The research disclosure is only required if you are notified to complete it.
Animal Studies
Key Website
Animal Care and Use topic page
Offices
Institutional Animal Care and Use Committee (IACUC) & IACUC Office
- Approves animal use protocols
- Monitors research involving animals
- Investigates animal welfare concerns
Division of Comparative Medicine (DCM)
- Responsible for animals’ veterinary care and husbandry
- Manages animal procurement and billing
Training Requirements
Assigned by the Compliance Profile in Learn@Work. For more information, see the Animal Education page.
Oversight
Institutional Animal Care and Use (IACUC) Protocol
Requests to work with animal models are submitted and monitored through the Institutional Animal Care and Use (IACUC) Protocol.
- Required for: Research, testing, or teaching involving live, vertebrate animals. For full details, visit determine when a protocol is necessary.
- System: Lab Animal Management & Protocol System (LAMPS)
- Review and approval process
- Valid for: 3 years (can be renewed)
- Changes to protocol activities require an amendment that must be approved by the IACUC prior to implementation.
- If the research also requires an Institutional Biological & Chemical Safety Committee (IBC) protocol, the IBC protocol must be approved before the IACUC protocol can be approved. The two protocols can, however, be submitted and reviewed in parallel.
- If the research involves radioactive materials or radiological equipment, the Radiation Safety Office must approve the Authorized User prior to IACUC approval.
- Visit lamps.wustl.edu for more resources.
Pending Protocol with Award
If an award is received before the IACUC protocol is approved, the Principal Investigator must submit a letter to SPA verifying that until the protocol is approved, no research related to animal activities will be performed and no money will be spent on these activities. More information is available on the Pending Animal Subjects Approval Letter & Instructions page.
Monitoring
IACUC performs semi-annual facility inspections, lab inspections, spot checks, and other Post-Approval Monitoring (PAM) activities to ensure all personnel are following the requirements for maintaining and utilizing labs, drugs, housing, and animal care.
Investigators can request a Site Initiation Visit (SIV) by emailing iacuc@wustl.edu to learn more about specific focus areas related to their IACUC protocol.
Congruency
Principal Investigators are responsible to ensure the work performed follow the approved protocol and that the protocol aligns with the research activities and plans submitted to the sponsor.
Funding
Funding sources must be added to the IACUC protocol before funds can be used to order animals. Changes to funding are submitted via an amendment. If funding updates are the only changes for the amendment, it can be reviewed administratively (typically 1-2 business days). A single grant may support multiple IACUC protocols or a single protocol may be supported by multiple grants.
Human Subjects
Key Websites
Offices and Committees
Human Research Protection Office (HRPO)
- Supports administrative functions of the Institutional Review Board (IRB).
- The IRB:
- Reviews proposals to conduct research with human participants
- Oversees research to protect participants’ rights and welfare
Institutional Review Board (IRB)
- Reviews proposals to conduct research with human participants
- Oversees research to protect participants’ rights and welfare
Human Research Quality Assurance (HRQA)
- Monitors research to protect the rights and safety of human participants
Training Requirements
Human Subjects Education is required one time for all members of the research community engaged in the design, conduct and reporting of research with human participants.
Good Clinical Practice is required every 3 years for all research team members listed on an IRB application for research meeting the definition of a clinical trial.
Oversight
Institutional Review Board (IRB) Protocol
- Required for: Research projects involving human participants. Detailed information on what activities are subject to IRB review are available within the IRB policy document. Additional guidance is available within the “Do I need to Submit to the IRB?” section of the HRPO Research Guide.
- System: myIRB
- Reviewed by: Institutional Review Board (IRB)
- Valid for: Until study expiration date unless the PI is notified continuing review is not required.
- Periodic check-ins are required for studies that do not require continuing review.
- Changes to study parameters require approval prior to implementation.
Monitoring
HRQA monitors and reviews active research protocols to ensure that the participants’ rights, safety, and welfare are protected and that the research is conducted in accordance with the approved research plan and complies with all applicable Federal regulations and University policies.
Pending Protocol with Award
If an award is received before the IRB approval is received, the Principal Investigator must submit a letter to SPA verifying that no research related to human subjects activities will be performed until the protocol is approved. More information is available on the Pending Animal Subjects Approval Letter & Instructions page.
Hazardous Materials (Biological, Chemical, and Radiation Safety)
Key Website
Environmental Health & Safety website
Offices and Committees
- Provides compliance oversight and consulting help for the University for biological, chemical, radiological and other hazardous materials.
- Consults with researchers to develop safe practices
- EH&S administers or participates in various committees (including the Institutional Biological & Chemical (IBC) and Radiation Safety Committee) that are responsible for specific areas of conducting safe research.
Training Requirements
Assigned by the Compliance Profile in Learn@Work. For more information, see the EH&S training page.
Oversight
Institutional Biological & Chemical Safety Committee (IBC) Protocol
- Required for research involving recombinant or synthetic nucleic acids, infectious or potentially infectious materials, and/or hazardous chemicals administered to research animals.
- System: myIBC
- Reviewed by: Institutional Biological & Chemical Safety Committee
- Valid for: 5 years
Radiation Safety Authorization
- Required for research use of ionizing radiation
- System: EHS Assist
- Reviewed by: Radiation Safety Committee
- Valid for: 5 years
- Also responsible for permitting the use of lasers, radiation-producing machines and strong magnets
Chemical Hygiene Plan
- Required by OSHA for any lab scale use of chemicals. Administered through the Laboratory EH&S Handbook.
- Addresses requirements of the OSHA Lab Standard.
- Mandates use of the online chemical inventory system.
Export Control
Key Websites
Office
Office of Research Integrity & Ethics
- Manages the transfer of controlled technology and information to foreign countries and to foreign nationals within the U.S.
Oversight
Export Licenses
- Required for some physical exports, deemed exports, or transactions with restricted entities or embargoed countries.
- Submit requests to: Export Control Manager
- Required when the export-controlled technology or technical information must be protected from unauthorized foreign national access
- Developed by: Principal Investigator and Export Control Manager
Stem Cells
Key Websites
Offices and Committees
Office of Research Integrity & Ethics
- Supports the administrative functions of the ESCRO
Embryonic Stem Cell Research Oversight Committee (ESCRO)
- Provides oversight of all human embryonic stem cells and certain research uses of human pluripotent stem cells at WashU
Oversight
Stem Cell Project Approval
- Approval is required when any of the following biological materials are used
- Human embryonic stem cells (hESC)
- Materials derived from a human embryo
- Other human pluripotent stem cells
- Approval is also required for all research proposing to generate new hESC lines.
- Valid for: 1 year (can be renewed)
- Submission: ESCRO New Project Application
- Reviewed by: Embryonic Stem Cell Research Oversight (ESCRO) Committee
