VCU Research Compliance Matrix

• IACUC Written Policies and Procedures
• Federal Regulations

• AALAS Learning Library (ALL – required prior to IACUC submission)
• VCU Occupational Health and Safety Program for Animal Handlers

• Additional Resources
• Guidance
• IACUC Events and Deadlines
• AAALAC:  Information for Investigators
• NIH:  What Investigators Need to Know About the Use of Animals

Mark Bates, Ph.D., DVM, DACLAM, Interim Director, DAR

Bobby Collins, DVM, Assistant Director for Veterinary Services

Peter Tetlow, Manager, Finance and Administration

Robert Nelms, LATG, LVT, Operations Manager

DAR Telephone: (804) 828-9837

IACUC

Forms: (Electronic submission for pre-review required, refer to deadlines

• Website:  IACUC
• Email: iacuc@vcu.edu
• Reporting: Click here to report compliance problems or concerns

• Account Establishment
• Budget Establishment
• Pre-Award Costs
• Effort Reporting

Effort Reporting Training

• Mandatory Training for PIs and Research Administration Staff: A sponsored project compliance training program to increase awareness of grant accounting standards and improve accountability.
• Distinguishing a Sponsored Program  from a Gift

Mark E. Roberts, Director, Office of Grants and Contracts Accounting

• Effort Reporting System Access
• Others:  See Website

Website: Office of Grants and Contracts Accounting

• VCU Guidelines:
  • Extend, Closeout, or Release an Account
  • Transfers To/From Other Institutions
  • Record Retention
• Audits of Sponsored Programs

At discretion of the School

At discretion of the School

Mark E. Roberts, Director, Office of Grants and Contracts Accounting

Others: See Website

Website: Office of Grants and Contracts Accounting

• OMB Circulars:
  • A-21 Cost Accounting Standards (CAS)
  • A-110 Grant Administration
  • A-133 Audit
• VCU Guidelines:
  • Activation/Termination Notices
  • Billing and Collection
  • Cost Overruns
  • Cost Sharing
  • Cost Transfers
  • Direct and Indirect Costs
  • Effort Reporting
  • Intellectual Property
  • Post Award Changes and Approvals
  • Program Income
  • Purchasing Goods/ Services
  • Reporting
  • Unallowable Costs

Effort Reporting for Principal Investigators

Mandatory Training for PIs and Research Administration Staff: A sponsored project compliance training program to increase awareness of grant accounting standards and improve accountability.

Mark E. Roberts, Director, Office of Grants and Contracts Accounting

Others: See Website

Website: Office of Grants and Contracts Accounting

• Policies
• Select Agents Information Page

Chemical and Biological Safety – Laboratory Safety Training and Test

New Faculty Information

Institutional Biosafety Committee

Forms

Website:  Office of Environmental Health and Safety

Federal Regulations

• AALAS Learning Library (ALL – required prior to IACUC submission)
• VCU Occupational Health and Safety Program for Animal Handlers

• Division of Animal Resources (DAR) Guides
• DAR Rates
• Orders and Breeding Record Procedures
• Room Access
• Useful Resource Links

• Mark Bates, PhD, DVM, DACLAM, Attending Veterinarian and Director of Division of Animal Resources (DAR)
• Peter Tetlow, Associate Director of Operations, Animal Care Facility
• VCU Institutional Animal Care and Use Committee (IACUC)

Forms

Website: Division of Animal Resources

Clinical Trials Protocol Registration Policy

DHHS Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov Registration

• Fact Sheet (Registration at ClinicalTrials.gov as Required by Public Law 110-85 Title VIII)

At discretion of the School

Clinical Trial Registration:  A Statement from the International Committee of Medical Journal Editors

Francis Macrina, PhD, Vice President for Research

None

Website:  Clinical Trials Protocol Registration

• Conflicts of Interest in Research Policy
• 42 CFR Part 50, Subpart F: Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought
• 45 CFR Part 94.1:  Responsible Prospective Contractors
• NSF Conflict of Interest Policy
• Procedures for Compliance with Section 2.1-639.6.C.7 of the Virginia State and Local Government Conflict of Interest Act

Individuals designated as ‘COI Investigator’ by the PI must enter the Activity and Interest Reporting System (AIRS) to complete a Financial Interest Report (FIR).

See VCU Conflict of Interest Webpage for:

• Who is a ‘COI investigator’
• Entering the AIRS
• Training

• Intellectual Property Policy
• Misconduct in Research and Scholarly Activities
• Policy for Managing Undue Influence in Research Committees and Groups
• Responsible Conduct in Research & Scholarship
• School of Medicine Policy On Industry Relationships
• Outside Professional Activity Policy

• VCU Conflict of Interest Review Committee
• Office of Research Integrity and Ethics

Access AIRS

To access AIRS outside of VCU: Click here for VCU's VPN

• AIRS@vcu.edu
• ORIE@vcu.edu

• Policy on Research Data
• Data Ownership, Retention, and Access
• NIH Data Sharing Policy
• Shelby Amendment
• Code of Virginia (Chapter 7, Public Records Act)
• VCU Records Management Policy
• VCU Records Retention Policy
• VCU Computer Ethics Policy

At discretion of the School

At discretion of the School

Francis Macrina, PhD, Vice President for Research

None

• VCU Office of Technology Transfer
• Office of the Vice President for Research

• The Privacy Rule
• The Security Rule

• VCU HIPAA Internet Training Program
• VCU ACE Notice of Privacy Practices

• HIPAA Researcher’s Booklet
• Research Repositories, Databases, and the HIPAA Privacy Rule
• Security of Electronic Protected Health Information
• NIH: HIPAA for Researchers

• VCU Affiliated Covered Entity Privacy Board
• Cynthia Earnhardt, Chief Compliance and Privacy Officer, Health System Compliance Services

Forms (no current electronic submission)

Website:  HIPAA for Researchers

• Determining What Constitutes Human Subjects Research
• IRB Written Policies and Procedures
• VCU Human Research Protection Program Policy
• Federal and State Regulations

• Policies & Guidance
• Education
• IRB Events and Deadlines

• VCU Institutional Review Boards (IRB):  Panels A-D Panels A-D Meeting schedule
• Director, Office of Research Subjects Protection (ORSP)
• Monika Markowitz, PhD, Office for Education and Compliance Oversight (OECO)

Forms (no current electronic submission)

• Website: IRB
• Email:  orsp@vcu.edu
• Reporting: Click here to report compliance problems or concerns

VCU Health System Policy

At discretion of the School

At discretion of the School

Robin Sculhorpe, RPh, Clinical Pharmacist, VCU Health System Investigational Drug Services (IDS)

Contact: Robin Sculthorpe, RPh
VCU Health System
Investigational Drug Services

Website: Investigational Drug Services

VCU Intellectual Property Policy

At discretion of the School

At discretion of the School

• Intellectual Property Ownership Committee
• Ivelina Metcheva, PhD, MBA, Director, Office of Technology Transfer

Forms:  Invention Disclosure Form

• VCU Office of Technology Transfer
  
• VCU Intellectual Property Foundation

• Office of Sponsored Programs Procedures
• Industry Sponsored Research Agreements with VCU
• Polices & Regulations Links:
  • Pre-Award Costs
  • OMB Circulars:
    • A-21 Cost Principles
    • A-110 Grant Administration
    • A-133 Audit

Mandatory Training for PIs and Research Administration Staff: A sponsored project compliance training program to increase awareness of grant accounting standards and improve accountability.

Required VCUeRA System Training (for access to the VCUeRA Portal):

• Genius@VCU Profile
• VCUeRA System Account/Access Setup
• VCUeRA Proposal Development and Tracking
• NIH Submissions to Grants.gov using the VCUeRA

Check the calendar for upcoming system training and courses

• Funding Searches
• List of Training Opportunities

Susan Robb, CRA, Assistant Vice President for Research Administration

• Sponsored Programs Forms
• Electronic Submission Information

Website:  Office of Sponsored Programs

• Policies / Program Information
• Emergency Procedures – Radiation Safety
• Federal and State Regulations

Radiation Safety Training Schedule

• Radiation Safety Guide
• Radiation Safety Training Test for Research Laboratory Employees

Radiation Safety / Radioactive Drug Research Committee

Forms

Website:  Office of Environmental Health and Safety

• VCU Policy on Responsible Conduct in Research and Scholarship
• VCU Policy on Misconduct in Research
• PHS Policies on Research Misconduct
• HHS Debarment Regulations
• Federal Whistleblower Protection Act of 1989
• Policy for Managing Undue Influence

• Policy on NSF and NIH Responsible Conduct of Research Education Requirements (8-20-2010)
• VCU Responsible Conduct of Research courses

Postdoctoral Requirement – one of any of the above VCU-approved courses within 1 year of appointment

• Responsible Conduct of Research in Humans online textbook
• DHHS Office of Research Integrity
• VITA standards - at discretion of the School

• Francis Macrina, PhD, Vice President for Research
• Office of Research Integrity and Ethics

To report concerns or allegations of research misconduct:

• Research Integrity Officer
  Contact: msmarkow@vcu.edu
  or 827-2157
• VCU Ombudsperson