Compliance Areas
There are many entities at Washington University that are responsible for issues related to research administration, management, and compliance. Below is a consolidated, descriptive listing of entities and/or resources by compliance area along with links to additional information for each area.
You may also search by entity name/title via the Offices & Committees section of this site.
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Institutional Animal Care and Use Committee (IACUC)
Federal regulations require the review of all projects (research, teaching, or other) involving the use of vertebrate animals by an Institutional Animal Care and Use Committee (IACUC). At Washington University, the Animal Studies Committee (ASC) fulfills this responsibility. The ASC oversees and evaluates animal care and use programs, procedures, and facilities at Washington University, including provisioning of animal care education, certification, and protocol approval.
Veterinary Care
The Division of Comparative Medicine (DCM) is responsible for providing routine animal husbandry, veterinary clinical care, and professional, technical, and facilities support for all animal research projects.
The Animal Studies Committee (ASC) and the Division of Comparative Medicine (DCM) coordinate to provide communication, education, and training for researchers, staff, and new ASC members and to assure that research involving animals is in compliance with Federal regulations and University and sponsoring agency policies and procedures.
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The FDA, the NIH, and the International Council of Medical Journal Editors all have policies regarding the registration of clinical trials at the ClinicalTrials.gov website. The guidelines and information on the Clinical Trial Registration at WUSTL page will assist faculty in the process of registering clinical trials being performed at the University.
The Disclosure Review Committees (DRC) for the Danforth Campus and the School of Medicine help to assure compliance with Federal regulations and University and sponsoring agency policies and procedures governing financial conflicts of interest. The DRC evaluates personal financial interests disclosed by university investigators and staff and provides communication and education regarding conflicts of interest to raise community awareness and assure that conflicts are identified, disclosed, and managed properly.
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Education and Training
Education for researchers and staff participating in research and related activities is divided among area specific compliance offices. For additional information, please visit the Education & Awareness webpage. For a schedule of upcoming educational events, please visit the Research Events Calendar.
Communication
Research Education and Information (REI) coordinates research-related communications initiatives, services, and tools for the Office of the Vice Chancellor for Research.
Research News is a voluntary, interanl listserv that disseminates information regarding funding opportunities, educational events, agency and regulatory updates, and other important research-related activities. Subscription to Research News is recommended for all members of the Washington University research community.
Research News Website* | Subscribe to Research News* | View the Research News Message Library*
* Access to this site requires a WUSTL IP address
The department of Environmental Health & Safety (EH&S) provides leadership for University health and safety programs; establishes, monitors, and enforces institutional policies and procedures; and helps ensure that investigators, staff, students, and contractors comply with all Federal, State, and local environmental, health, and safety regulatory standards and codes, including University policies and procedures. EH&S provides education and guidance on environmental health and safety issues, including work practices and activities involving hazardous and regulated materials, equipment, and environments. EH&S is comprised of four divisions: Biological & Chemical Safety, Environmental Compliance, Safety & Emergency Preparedness, and Radiation Safety.
The Institutional Biological & Chemical (IBC) Safety Committee is responsible for ensuring that research carried out at WUSTL is conducted in a safe and responsible manner. The IBC oversees research involving recombinant DNA, infectious or potentially infectious agents, and/or hazardous chemicals.
The Radiation Safety Committee (RSC) works with executive management and the Radiation Safety Officer (RSO) to implement the radiation safety program, and to evaluate new users and new uses of all radioactive materials at Washington University, Barnes-Jewish Hospital and St. Louis Children’s Hospital. The RSC is responsible for reviewing personnel dosimetry, users’ compliance records and the effectiveness of the radiation safety program.
The Radioactive Drug Research Committee (RDRC) works with the Human Research Protection Office (HRPO) and the RSC in reviewing human research involving radioactive drugs. The RDRC ensures this kind of human research meets Food and Drug Administration (FDA) requirements (21 CFR 351.1)
Federal regulations require that Washington University maintain a system that distributes salary charges among direct activities (e.g. sponsored research, instruction, clinical activity) and indirect activities (e.g. administration). Every Washington University employee who works on a sponsored project must periodically certify that the salaries charged are reasonable in relation to the actual work performed. Effort reports, or as they are known at Washington University, PARs (Personnel Activity Reports), are considered legal documents.
The Effort Reporting at WUSTL website contains information and a link to the WUSTL online training Effort Reporting Principles. The Sponsored Projects Accounting (SPA) website contains information about PARs distribution, timeliness, and processing. The Washington University Medical School Finance Office website has detailed definitions of cost accounting categories by function.
United States export control laws and regulations govern the export of information, software, commodities, and services. Restrictions are imposed on shipments abroad, on travel, and on the participation of foreign nationals in projects on our campus. For additional information, please visit Export Controls Information for Researchers.
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Federal HIPAA regulations address privacy, security, and electronic transaction issues related to the internal use and the external disclosure of protected health Information (PHI). For additional information, please visit Health Insurance Portability and Accountability Act (HIPAA)
Washington University provides Human Embryonic Stem Cell Research Guidelines to support investigators engaged in human embryonic stem cell research, assure the responsible conduct of human embryonic stem cell research and comply with federal, state, and local laws and regulations. In order to provide appropriate oversight of human embryonic stem cell research, Washington University has established the Embryonic Stem Cell Research Oversight Committee (ESCRO).
Embryonic Stem Cell Protocol Application
Human Embryonic Stem Cell Guidelines Glossary
Human Embryonic Stem Cell Research Guidelines
ESCRO website coming soon!
Institutional Review Board (IRB)
Federal regulations require the review of all projects (research, teaching, or other) involving the use of human participants by an Institutional Review Board (IRB). At Washington University, the Human Research Protection Office (HRPO) administers ten independent Institutional Review Boards (IRBs), which review and approve protocols for all research involving human participants. HRPO also administers Washington University’s Human Subjects Education Program.
Institutional Statement of Commitment to the Protection of Human Participants in Research
Monitoring of Human Subjects Research
The Human Subject Research Quality Assurance / Quality Improvement Program (HSR QA/QI) performs on-site monitoring of open human subject research protocols to help assure compliance with Federal regulations and University and sponsoring agency policies and procedures governing the use of human research participants. The HSR QA/QI Committee oversees all HSR QA/QI monitoring activities and assesses findings.
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The University Compliance Office exercises independent oversight of the adequacy of compliance activities at Washington University and reports its findings to the Audit Committee of the University’s Board of Trustees. Areas reviewed by the Compliance Office include, but are not limited to, research, conflicts of interest, human resources, environmental health and safety, and the Health Insurance Portability and Accountability Act (HIPAA).
The Office of Technology Management (OTM) manages the intellectual property portfolio of the University and promotes the transfer of University technology for public use. Areas covered by OTM include industry-sponsored research, intellectual property licenses, patent management, confidential disclosure agreements, material transfer agreements, and other items that fit under the Intellectual Property Policy of the University.
The Internal Audit Department is responsible for planning and performing internal audits at the university. Internal Audit assists management by providing independent and objective analyses of activities and controls. Audit scopes can range from a single process to all business activities in a division, department, or school. Internal Audit makes recommendations as a result of those analyses. Internal Audit performs operational, financial, information technology and system development audits.
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The National Institutes of Health (NIH) Public Access Policy requires investigators to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. Compliance with this policy is a term and condition of all grants and cooperative agreements active in FY2008 (and beyond) and for all contracts awarded after April 7, 2008. Washington University provides its faculty with information about this policy and services to help them comply with these regulations.
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The Office of Physician Billing Compliance (OPBC) is responsible for physician and non-physician practitioner billing issues, including teaching physician services, documentation, CPT and ICD-9 coding guidelines, reimbursement requirements, and health care fraud and abuse. The OPBC conducts internal audits for 70 clinical departments/divisions in the Medical School and provides education to faculty and staff regarding billing compliance standards.
(see HIPAA above)
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Federal regulations require that institutions applying for or receiving federal research funding have an established administrative process for dealing with allegations of research misconduct. At Washington University, the Committee on Research Integrity (CRI) fulfills this responsibility. The CRI’s function is to respond to, review, and resolve allegations of research misconduct against researchers, staff, and students at Washington University as promptly and fairly as possible. Allegations of research misconduct should be made directly to the Research Integrity Officer, Aubrey Morrison, M.D. 454-8495, the Research Ethics and Compliance Office 747-4152 | RECO@msnotes.wustl.edu, or the Vice Chancellor for Research, Samuel L. Stanley, Jr., M.D. 362-7010.
Research Integrity Policy | Policy on Authorship of Scientific and Scholarly Publications
Many research sponsors require funding proposals to include a plan for education in the responsible conduct of research (RCR). There are currently many RCR resources at Washington University. Researchers should contact their department or division administrator for additional information about programs and/or resources in their area. Development of an institutional RCR education program named PERCSS is currently underway. For additional information on PERCSS and RCR at Washington University, please visit the Program for Ethical and Responsible Conduct of Science and Scholarship (PERCSS) website.
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Contracts and Sub-agreements
Contracts and Sub-agreements, in the Office of Sponsored Research Services (OSRS), provides University-wide contract and sub-agreement administration and negotiates acceptable terms and conditions with sponsors for all contracts and sub-agreements except pharmaceutical-industry sponsored clinical trials and non-federal flow through industry-sponsored agreements. The Research Office also provides communication, education, and training on contracts and sub-agreements to the Washington University research community.
The Center for Clinical Studies (CCS) negotiates pharmaceutical-industry sponsored clinical trial contracts for Washington University Medical School and its affiliated hospitals.
The Office of Technology Management (OTM) negotiates non-human participant related industry-sponsored contracts for Washington University.
Proposal Preparation and Award Management
The Office of Sponsored Research Services (OSRS), formerly known as the Research Office (RO) and Grants & Contracts (G&C), reviews and provides institutional signature for all WUSTL proposals, grants, and university-wide contract administration for non-clinical contracts. In addition, the Office of Sponsored Research Services is responsible for monitoring of compliance with Federal regulations and University and sponsoring agency policies and procedures regarding the management of non-financial aspects of sponsored programs. The Office of Sponsored Research Services provides communication, education, and training on proposal preparation, award management, and contracts and sub-agreements to the Washington University research community.
Financial Administration of Sponsored Projects
Sponsored Projects Accounting (SPA) serves as financial intermediaries between sponsoring agencies and Washington University Principal Investigators. SPA provides institutional signature for sponsored financial reports and is the primary source for interpretation of Federal regulations and University and sponsoring agency policies and procedures governing incurring, reimbursing, and reporting costs under sponsored-research agreements. SPA provides communication, education, and training on the financial administration of sponsored projects.
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