Research Compliance Matrix
A. Key Policies, Procedures & Regulations
- University Policy 4004 – Occupational Health & Safety Program for Animal Care and Use
- University Policy for the Care and Use of Animals
- Federal Regulations
- Animal Welfare Reporting Instructions
- NIH – Office of Laboratory Animal Welfare (OLAW)
- Animal Care and Use Training
- Occupational Health and Safety Program for Animal Handlers
- Supplemental
- IACUC: Events and Deadlines
- AAALAC: Site Visit – February 14-15, 2018
- NIH: What Investigators Need to Know About the Use of Animals
- Animal Care Resources (ACR) Policies & SOP’s
- ACR Rates
- Orders and Breeding Record Procedures
- Facility Access
- Animal & Vivarium Safety Training
D. Mason Regulatory & Administrative Oversight
E. Forms & Submissions
- Forms
- Email: iacuc@gmu.edu
- Reporting: Click here to report compliance problems and concerns
A. Key Policies, Procedures and Regulations
- Sponsored Programs Award Review, Negotiation, Acceptance and Notification
- Account Establishment
- Budget Establishment
- Pre-Award Costs
- Payroll Certification
- Fixed Price Awards
- Training for Research Administration Staff: Sponsored project certificate training programs and workshops are offered to increase awareness of grant accounting standards and improve accountability.
- Research Administrative Certificate Program
- Advanced Research Integrity Certificate Program
- Additional OSP Training
- Workshop Resources (Need Link)
C. Contact Information/More Information
- Office of Sponsored Programs (OSP)
- Email: osp@gmu.edu
- Phone: (703) 993-4806
A. Key Policies, Procedures and Regulations
- GMU Guidelines:
- Audits of Sponsored Programs (Need Link):
A. Key Policies, Procedures and Regulations
- Establishment of Sponsored Project Subcontracts and Sub-Awards
- Post Award Modifications
- Subrecipient Monitoring Policy
- Cost Sharing
- University Policy 4016
- Information (Need Link)
- Glossary and Acronyms
- Presentation
- Activation/Termination Notices
- Billing and Collection
- Financial Reporting, Billing and Closeout
- Cost Overruns
- Cost Transfers
- Direct and Indirect Costs
- OMB Uniform Guidance
- Payroll Certification
- Intellectual Property
- Program Income
- Purchasing Goods/Services
- Reconciliation
- Reporting
- Salary Cap Information
- Unallowable Costs
- See Section 2B
- Office of Sponsored Programs (OSP) Email: osp@gmu.edu
- Phone: (703) 993-4806
A. Key Policies, Procedures and Regulations
- Principal Investigators
- Postdoctoral Research Fellows
- Cost Sharing
- OMG Uniform Guidance – OMB 2 CFR §200
- NSF Proposal and Awards Policies and Procedures Guide (eff. JAN 29 2018)
- NSF Proposal and Awards Policies and Procedures Guide (eff. JAN 30 2017)
- NIH Grants Policy Statement (eff. OCT 2017)
- NIH Policy Changes (after OCT 2017)
- Sponsored Programs Proposal Submission Internal Deadlines Policy
- Office of Sponsored Programs Responsibilities
- Sponsored Agreements and Gifts
- Facilities and Administrative Cost Recovery
- Minimum Effort for Key Personnel on Sponsored Programs
- Limited Submission Review
- Corporate Research Agreements
- Supplemental
- Find Funding
- List of Training Opportunities
- From NIH: All About Grants Podcast Service - NIH and the Office of Extramural Research (OER) have made podcasts available which feature conversations with NIH staff members. The podcasts are designed for investigators, fellows, students, research administrators, and others. The podcasts vary in length (between 10-20 minutes), and relevant subject matter are updated every other week.
- PI Responsibilities
B. Forms and Submission
- Sponsored Programs Forms
- Online Request Form for Proposal Submission
- Data Management Plan (DMPTool) Researchers who are applying for grants that require data management plans can use this tool to help them with writing the plan. Based on the information entered, the tool will generate a customized DMP for them to submit with their grant application. When accessing “DMPTool”, researchers should click on “My Plans,” then select George Mason University from the list and use their Mason username and password to login.
- Office of Sponsored Programs (OSP) Email: osp@gmu.edu
- Phone: (703) 993-4806
A. Key Policies, Procedures and Regulations
- University Policy 1406 Environmental Health and Safety
- University Policy 1138 Minors on Campus
- George Mason University Environmental Health and Safety Office
- George Mason University Laboratory Safety Manual
- George Mason University Biological Safety Manual
- Centers for Disease Control and Prevention
- Environmental Protection Agency
- Guidelines for Research Involving Recombinant DNA and Synthetic Nucleic Acids
- Biosafety in Microbiological and Biomedical Laboratories
- National Institute for Occupational Safety and Health
- National Fire Protection Association (NFPA)
- Occupational Safety and Health Administration
- United States Department of Agriculture
- United States Department of Transportation
- Virginia Department of Health
- Virginia Department of Environmental Quality
B. Education and Training
C. Mason Regulatory and Administrative Oversight
D. Forms and Submission Procedures
E. Contact Information/More Information
- EHS Email: safety@gmu.edu
- EHS Phone: (703) 993-8448
- EHS Assistant
A. Key Policies, Procedures and Regulations
- Overview of Clinical Trial Registration and Results Reporting
- NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
- Summary of HHS/NIH Initiatives
- Summary Table of Final Rule and NIH Policy
- FDAAA Final Rule (42 CFR Part 11)
- Final Rule: How do I determine if my study is an applicable clinical trial?
- Applicable Clinical Trial Checklist
B. Education and Training
- ClinicalTrials.gov: FAQ’s and Resources
- ClinicalTrials.gov
- ClinicalTrials.gov – Help for Researchers
- ClinicalTrials.gov Protocol Registration and Results System (PRS)
A. Key Policies, Procedures and Regulations
- University Policy 4001: Conflicts of Interest
- Code of Virginia: State and Local Government Conflict of Interest Act
- HHS - 42 CFR Part 50, Subpart F: Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought
- HHS – 45 CFR Part 94: Responsible Prospective Contractors
- NSF – Conflict of Interest Policy
- See Mason Conflict of Interest Webpage for:
- Who is a “COI Investigator”
- Entering in the COI System
- Training
- Understanding Disclosure Requirements
- Supplemental
C. Mason Regulatory and Administrative Oversight
- Mason Conflict of Interest Review Committee
- Research Development, Integrity and Assurance (ORIA)
- Aurali Dade, Research Development, Integrity & Assurance
- Elizabeth Woodley, Compliance, Diversity and Ethics
- Michael Laskofski, Office of Sponsored Programs
A. Key Policies, Procedures and Regulations
- University Policy 1406 Environmental Health and Safety
- George Mason University Laboratory Safety Manual - DEA Office of Diversion Control
- Code of Federal Regulations, 21 CRF 1300-1399
- New DEA Registration Applications
- Renewal DEA Registration Applications
- Virginia Board of Pharmacy Regulations
- Virginia Board of Registration Application
- Controlled substances are considered hazardous chemicals, and require, at a minimum, successful completion of Laboratory Safety Orientation.
- Additional safety training may be required; please contact EHS for further information.
C. Mason Regulatory and Administrative Oversight
D. Forms and Submission Procedures
- Controlled Substances Guide
- EHS Email: safety@gmu.edu
- EHS Phone: (703) 993-8448
A. Key Policies, Procedures and Regulations
- NIH – Data Sharing Policy
- FAS – Shelby Amendment
- Code of Virginia – Chapter 7, Public Records Act
- The Library of Virginia: Virginia Public Records Management Manual
- University Policy 1102: Records Management
- Mason Records Retention Policy
- University Policy 1301: Responsible Use of Computing
B. Education and Training
C. Mason Regulatory and Administrative Oversight
D. Forms and Submission Procedures
E. Contact Information/More Information
- Office of Technology Transfer (OTT)
- Office of the Vice President for Research
A. Key Policies, Procedures and Regulations
- University Policy 1141
- University Policy 1134
- Office of Foreign Assets Control (OFAC)
- International Traffic in Arms Regulations (ITAR)
- Export Administration Regulations (EAR)
- Mason Compliance with United States Export Control Laws (Mason Export Controls Guidance)
- Sponsored Program Export Compliance Procedures
- New Faculty Checklist & Procedure – Federal Export & Sanctions Compliance
- Visiting and Permanent International Faculty Engagement Procedures
- International Travel Guidance
- Export Control FAQs
- Export Control Red Flags
- Training Available through MasonLEAPS (https://masonleaps.gmu.edu)
C. Mason Regulatory and Administrative Oversight
- Melissa Perez, JD, Export Compliance and Secure Research Program Manager
- Email: mperez21@gmu.ed
- Phone: (703) 993-5222
- Export Control Forms – Clean Laptops and Laptop Certification
- General Export Inquires: export@gmu.edu
A. Key Policies, Procedures and Regulations
B. Education and Training
- Required for Investigators
- HIPAA Training Program
- ACE Notice of Privacy Practices
- Supplemental
- HIPAA Researcher’s Booklet
- Research Repositories, Databases, and the HIPAA Privacy Rule
- Security of Electronic Protected Health Information
- NIH: HIPAA for Researchers
C. Mason Regulatory and Administrative Oversight
D. Forms and Submission Procedures
E. Contact Information/More Information
A. Key Policies, Procedures and Regulations
- Commonwealth of Virginia: Laws Relevant to Human Subjects Research & Informed Consent
- 45 CRF 46: DHHS Human Subjects Regulations (The Common Rule)
- 21 CRF 50: FDA Protection of Human Subjects Regulations
- 21 CFR 56: Institutional Review Boards
- 21 CFR 312: Investigational New Drug Application
- 21 CFR 812: Investigational Device Exemptions
- Office of Human Research Protections (OHRP) Guidance
- FDA Clinical Trials Guidance Documents
- Human Subjects Policies, Procedures and Guidelines
C. Mason Regulatory and Administrative Oversight
D. Forms and Submission Procedures
- Submit a Human Subjects Application
- Release of Funds Request Form – Human Subjects
- Forms and Templates
- IRBNet
- Email: irb@gmu.edu
- The IRB office staff offers walk-in assistance to faculty/students/staff conducting human subjects research each Tuesday from 2 – 4pm in Research Hall, Room 142. You can also email irb@gmu.edu to schedule an appointment outside of office hours.
A. Inventor Disclosure Forms and Research Information
- Inventor Disclosure Form
- PTO Guidance on Patentability
- Researchers’ Guide to Technology Commercialization
- NIH: Intellectual Property Policy
- Bayh-Dole Act (37 CFR 401)
- Office of Technology Transfer (OTT)
- Email: ott@gmu.edu
- Phone: (703) 993-8933
A. Key Policies, Procedures and Regulations
- University Policy 4007: Misconduct in Research and Scholarship
- PHS Policies on Research Misconduct
- HHS Debarment Regulations
- Federal Whistleblower Protection Pilot Project (41 USC §4712 & DFAR 3.908)
- Policy for Managing Undue Influence in Research Committees and Groups
- Responsible Conduct of Research Training Plan
- Additional Training in the Responsible Conduct of Research
- Aurali Dade, Associate Vice President of Research Development, Integrity and Assurance
- Email: adade3@gmu.edu
- Phone: (703) 993-5381
- Additional Sources of RCR Information