Research Compliance Matrix

Research Compliance Matrix

A. Key Policies, Procedures & Regulations
  1. University Policy 4004 – Occupational Health & Safety Program for Animal Care and Use
  2. University Policy for the Care and Use of Animals
  3. Federal Regulations
  4. Animal Welfare Reporting Instructions
  5. NIH – Office of Laboratory Animal Welfare (OLAW)
B. Care & Housing of Research Animals
  1. Guide for the Care and Use of Laboratory Animals, 8th Edition
C. Education & Training
  1. Animal Care and Use Training
  2. Occupational Health and Safety Program for Animal Handlers
  3. Supplemental
  4. IACUC:  Events and Deadlines
  5. AAALAC:  Site Visit – February 14-15, 2018
  6. NIH:  What Investigators Need to Know About the Use of Animals
  7. Animal Care Resources (ACR) Policies & SOP’s
  8. ACR Rates
  9. Orders and Breeding Record Procedures
  10. Facility Access
  11. Animal & Vivarium Safety Training
D. Mason Regulatory & Administrative Oversight
  1. Institutional Animal Care and Use Committee (IACUC)
  2. Safety Review Committees
E. Forms & Submissions
  1. Forms
F. Contact Information/More Information
  1. Email:  iacuc@gmu.edu
  2. Reporting:  Click here to report compliance problems and concerns
A. Key Policies, Procedures and Regulations
  1. Sponsored Programs Award Review, Negotiation, Acceptance and Notification
  2. Account Establishment
  3. Budget Establishment
  4. Pre-Award Costs
  5. Payroll Certification
  6. Fixed Price Awards
B. Education and Training
  1. Training for Research Administration Staff:  Sponsored project certificate training programs and workshops are offered to increase awareness of grant accounting standards and improve accountability.
C. Contact Information/More Information
  1. Office of Sponsored Programs (OSP)
  2. Email:  osp@gmu.edu
  3. Phone: (703) 993-4806
A. Key Policies, Procedures and Regulations
  1. GMU Guidelines:
  2. Audits of Sponsored Programs (Need Link):
A. Key Policies, Procedures and Regulations
  1. Establishment of Sponsored Project Subcontracts and Sub-Awards
  2. Post Award Modifications
  3. Subrecipient Monitoring Policy
  4. Cost Sharing
  5. Activation/Termination Notices
  6. Billing and Collection
  7. Financial Reporting, Billing and Closeout
  8. Cost Overruns
  9. Cost Transfers
  10. Direct and Indirect Costs
  11. OMB Uniform Guidance
  12. Payroll Certification
  13. Intellectual Property
  14. Program Income
  1. Purchasing Goods/Services
  2. Reconciliation
  3. Reporting
  4. Salary Cap Information
  5. Unallowable Costs
B. Education and Training
  • See Section 2B
C. Mason Regulatory and Administrative Oversight D. Contact Information/More Information
  1. Office of Sponsored Programs (OSP) Email:  osp@gmu.edu
  2. Phone: (703) 993-4806
A. Key Policies, Procedures and Regulations
  1. Principal Investigators
  2. Postdoctoral Research Fellows
  3. Cost Sharing
  4. OMG Uniform Guidance – OMB 2 CFR §200
  5. NSF Proposal and Awards Policies and Procedures Guide (eff. JAN 29 2018)
  6. NIH Grants Policy Statement (eff. OCT 2017)
  7. Sponsored Programs Proposal Submission Internal Deadlines Policy
  8. Office of Sponsored Programs Responsibilities
  9. Sponsored Agreements and Gifts
  10. Facilities and Administrative Cost Recovery
  11. Minimum Effort for Key Personnel on Sponsored Programs
  12. Limited Submission Review
  13. Corporate Research Agreements
  14. 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
  1. Sponsored Programs Forms
  2. Online Request Form for Proposal Submission
  3. 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.
C. Contact Information/More Information
  1. Office of Sponsored Programs (OSP) Email:  osp@gmu.edu
  2. Phone: (703) 993-4806
A. Key Policies, Procedures and Regulations
  1. University Policy 1406 Environmental Health and Safety
  2. University Policy 1138 Minors on Campus
  3. George Mason University Environmental Health and Safety Office
  4. George Mason University Laboratory Safety Manual
  5. George Mason University Biological Safety Manual
B. Education and Training
  1. Resources and Tools
  2. Training
C. Mason Regulatory and Administrative Oversight
  1. Institutional Biosafety Committee (IBC)
  2. Radiation Safety Committee (RSC)
D. Forms and Submission Procedures
  1. Forms
E. Contact Information/More Information
  1. EHS Email:  safety@gmu.edu
  2. EHS Phone: (703) 993-8448
  3. EHS Assistant
A. Key Policies, Procedures and Regulations
  1. Overview of Clinical Trial Registration and Results Reporting
  2. NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
  3. Summary of HHS/NIH Initiatives
  4. Summary Table of Final Rule and NIH Policy
  5. FDAAA Final Rule (42 CFR Part 11)
  6. Final Rule:  How do I determine if my study is an applicable clinical trial?
  7. Applicable Clinical Trial Checklist
B. Education and Training
  1. ClinicalTrials.gov:  FAQ’s and Resources
  2. ClinicalTrials.gov
  3. ClinicalTrials.gov – Help for Researchers
C. Forms and Submission Procedures
  1. Clinical Trials Registration Form
D. More Information
  1. ClinicalTrials.gov Protocol Registration and Results System (PRS)
A. Key Policies, Procedures and Regulations
  1. University Policy 4001:  Conflicts of Interest
  2. Code of Virginia:  State and Local Government Conflict of Interest Act
  3. HHS - 42 CFR Part 50, Subpart F:  Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought
  4. HHS – 45 CFR Part 94:  Responsible Prospective Contractors
  5. NSF – Conflict of Interest Policy
B. Education and Training
  1. See Mason Conflict of Interest Webpage for:
    • Who is a “COI Investigator”
    • Entering in the COI System
    • Training
  2. Understanding Disclosure Requirements
    • Supplemental
C. Mason Regulatory and Administrative Oversight
  1. Mason Conflict of Interest Review Committee
  2. Research Development, Integrity and Assurance (ORIA)
D. Forms and Submission Procedures
  1. Access COI System
E. Contact Information/More Information
  1. Aurali Dade,  Research Development, Integrity & Assurance
  2. Elizabeth Woodley, Compliance, Diversity and Ethics
  3. Michael Laskofski, Office of Sponsored Programs
A. Key Policies, Procedures and Regulations
  1. University Policy 1406 Environmental Health and Safety
  2. George Mason University Laboratory Safety Manual - DEA Office of Diversion Control
  3. Code of Federal Regulations, 21 CRF 1300-1399
  4. New DEA Registration Applications
  5. Renewal DEA Registration Applications
  6. Virginia Board of Pharmacy Regulations
  7. Virginia Board of Registration Application
B. Education and Training
  1. Controlled substances are considered hazardous chemicals, and require, at a minimum, successful completion of Laboratory Safety Orientation.
  2. Additional safety training may be required; please contact EHS for further information.
C. Mason Regulatory and Administrative Oversight
  1. George Mason University Environmental Health & Safety Office
D. Forms and Submission Procedures
  1. Controlled Substances Guide
E. Contact Information/More Information
  1. EHS Email:  safety@gmu.edu
  2. EHS Phone: (703) 993-8448
A. Key Policies, Procedures and Regulations
  1. NIH – Data Sharing Policy
  2. FAS – Shelby Amendment
  3. Code of Virginia – Chapter 7, Public Records Act
  4. The Library of Virginia:  Virginia Public Records Management Manual
  5. University Policy 1102:  Records Management
  6. Mason Records Retention Policy
  7. 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
  1. Office of Technology Transfer (OTT)
  2. Office of the Vice President for Research
A. Key Policies, Procedures and Regulations
  1. University Policy 1141
  2. University Policy 1134
  3. Office of Foreign Assets Control (OFAC)
  4. International Traffic in Arms Regulations (ITAR)
  5. Export Administration Regulations (EAR)
  6. Mason Compliance with United States Export Control Laws (Mason Export Controls Guidance)
  7. Sponsored Program Export Compliance Procedures
  8. New Faculty Checklist & Procedure – Federal Export & Sanctions Compliance
  9. Visiting and Permanent International Faculty Engagement Procedures
  10. International Travel Guidance
  11. Export Control FAQs
  12. Export Control Red Flags
B. Education and Training
  1. Training Available through MyMason.gmu.edu
C. Mason Regulatory and Administrative Oversight
  1. Rebecca Hartley, Director of Export Compliance and Secure Research
  2. Melissa Perez, JD, Export Compliance and Secure Research Program Manager
D. Forms and Submission Procedures
  1. Export Control Forms – Clean Laptops and Laptop Certification
E. Contact Information/More Information
  1. General Export Inquires:  export@gmu.edu
A. Key Policies, Procedures and Regulations
  1. The HIPAA Privacy Rule
  2. The HIPAA Security Rule
B. Education and Training
  1. Required for Investigators
    • HIPAA Training Program
    • ACE Notice of Privacy Practices
  2. Supplemental
C. Mason Regulatory and Administrative Oversight D. Forms and Submission Procedures E. Contact Information/More Information
  1. HHS:  HIPAA for Researchers
A. Key Policies, Procedures and Regulations
  1. Commonwealth of Virginia:  Laws Relevant to Human Subjects Research & Informed Consent
  2. 45 CRF 46:  DHHS Human Subjects Regulations (The Common Rule)
  3. 21 CRF 50:  FDA Protection of Human Subjects Regulations
  4. 21 CFR 56:  Institutional Review Boards
  5. 21 CFR 312:  Investigational New Drug Application
  6. 21 CFR 812:  Investigational Device Exemptions
  7. Office of Human Research Protections (OHRP) Guidance
  8. FDA Clinical Trials Guidance Documents
  9. Human Subjects Policies, Procedures and Guidelines
B. Education and Training
  1. Human Subjects in Research
  2. Human Subjects Training
  3. CITI
  4. IRBNet Training
  5. FAQS on Human Subjects in Research
C. Mason Regulatory and Administrative Oversight
  1. Institutional Review Board (IRB)
D. Forms and Submission Procedures
  1. Submit a Human Subjects Application
  2. Release of Funds Request Form – Human Subjects
  3. Forms and Templates
  4. IRBNet
E. Contact Information/More Information
  1. Email:  irb@gmu.edu
  2. 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
  1. Inventor Disclosure Form
  2. PTO Guidance on Patentability
  3. Researchers’ Guide to Technology Commercialization
B. Policy, Education and Training
  1. NIH:  Intellectual Property Policy
  2. Bayh-Dole Act (37 CFR 401)
C. Contact Information/More Information
  1. Office of Technology Transfer (OTT)
  2. Email:  ott@gmu.edu
  3. Phone: (703) 993-8933
A. Key Policies, Procedures and Regulations
  1. University Policy 4007:  Misconduct in Research and Scholarship
  2. PHS Policies on Research Misconduct
  3. HHS Debarment Regulations
  4. Federal Whistleblower Protection Pilot Project (41 USC §4712 & DFAR 3.908)
  5. Policy for Managing Undue Influence in Research Committees and Groups
B. Education and Training
  1. Responsible Conduct of Research Training Plan
  2. Additional Training in the Responsible Conduct of Research
C. Mason Regulatory and Administrative Oversight D. Forms and Submission Procedures E. Contact Information/More Information
  1. Aurali Dade, Associate Vice President of Research Development, Integrity and Assurance
  2. Additional Sources of RCR Information