VCU Research Compliance Matrix

Animal Subjects

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
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

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

VCU Institutional Animal Care and Use Committee (IACUC)
Rosemary Kelso, MSW, Director, Office of Research Subjects Protection (ORSP)
Monika Markowitz, PhD, Office for Education and Compliance Oversight (OECO)

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

Award Acceptance and Establishment

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
Account Establishment Budget Establishment Pre-Award Costs Effort Reporting	Effort Reporting Training	A-21 Faculty Training (Coming Soon) Distinguishing a Sponsored Program from a Gift

VCU Regulatory & Administrative Oversight	Forms and Submission Procedures	Where to go for More Information:
Margie R. Booker, Director, Office of Grants and Contracts Accounting	Effort Reporting System Access Others: See Website	Website: Office of Grants and Contracts Accounting

Award Extension and Closeout

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
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

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

Margie R. Booker, Director, Office of Grants and Contracts Accounting

Others: See Website

Website: Office of Grants and Contracts Accounting

Award Management

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
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	A-21 Faculty Training (Coming Soon)

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

Margie R. Booker, Director, Office of Grants and Contracts Accounting

Others: See Website

Website: Office of Grants and Contracts Accounting

Biohazardous & Infectious Agents, Carcinogens and rDNA

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
Policies Select Agents Information Page	Chemical and Biological Safety – Laboratory Safety Training and Test	New Faculty Information

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

Institutional Biosafety Committee

Forms

Website: Office of Environmental Health and Safety

Care and Housing of Research Animals

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
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

VCU Regulatory & Administrative Oversight	Forms and Submission Procedures	Where to go for More Information:
Bobby Collins, DVM, 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 Trial Protocol Registration

Key Policies, Procedures,
& Regulations

Education and Training

Required for Investigators

Supplemental

Clinical Trials Protocol Registration Policy

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

QUICK FACTS regarding NEW registration requirements (new deadlines as early as December 26, 2007)

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

VCU Regulatory & Administrative Oversight	Forms and Submission Procedures	Where to go for More Information:
Francis Macrina, PhD, Vice President for Research	None	Website: Clinical Trials Protocol Registration

Conflict of Interest

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
Conflict of Interest 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 Outside Professional Activity Policy	At discretion of the School	Responsible Conduct of Research in Humans online textbook Policy for Managing Undue Influence VCU Ombudsperson

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

VCU Conflict of Interest Review Committee

COI Disclosure Statement
COI Disclosure Supplement Form
VCU CP-1 Form : Request for Approval of Outside Professional Activity
VCU CP-2 Form : Report on Outside Professional Activity

Contact the Office of the Vice President for Research: ovpr@vcu.edu

Data Management and Ownership

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
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

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

Francis Macrina, PhD, Vice President for Research

None

Websites:

HIPPA/Protected Health Information

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
Federal Regulations: 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 Regulatory & Administrative Oversight	Forms and Submission Procedures	Where to go for More Information:
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

Human Subjects

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
Determining What Constitutes Human Subjects Research IRB Written Policies and Procedures VCU Human Research Protection Program Policy Federal and State Regulations	CITI Training (required prior to IRB submission)	Policies & Guidance Education IRB Events and Deadlines

VCU Regulatory & Administrative Oversight	Forms and Submission Procedures	Where to go for More Information:
VCU Institutional Review Boards (IRB): Panels A-D Panels A-D Meeting schedule Rosemary Kelso, MSW, 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

In-patient Use of FDA-Regulated Drugs and Biologics

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
VCU Health System Policy	At discretion of the School	At discretion of the School

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

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

Intellectual Property

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
VCU Intellectual Property Policy	At discretion of the School	At discretion of the School

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

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

Forms: Invention Disclosure Form

Websites:

Proposal Submission

Key Policies, Procedures,
& Regulations

Education and Training

Required for Investigators

Supplemental

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

VCUeRA System for Electronic Research Administration

Training Required for Access to the VCUeRA Portal:

Check the calendar for upcoming system training and courses

Funding Searches
Link to Additional Training for Faculty and Administrators
A-21 Faculty Training (Coming Soon)

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

Susan Robb, CRA, Assistant Vice President for Research Administration

Website: Office of Sponsored Programs

Radionuclides and Radiation-Producing Devices

Key Policies, Procedures, & Regulations	Education and Training
Key Policies, Procedures, & Regulations	Required for Investigators	Supplemental
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

VCU Regulatory &
Administrative Oversight

Forms and Submission Procedures

Where to go for More Information:

Radiation Safety / Radioactive Drug Research Committee

Forms

Website: Office of Environmental Health and Safety

Responsible Conduct of Research (RCR)

Key Policies, Procedures,
& Regulations

Education and Training

Required for Investigators

Supplemental

MICR 510 Scientific Integrity (1cr. Fall Course)
RCR Workshop (Program Sponsored by OVPR)
Any one of the following: Responsible Conduct of Research Online Courses

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

Responsible Conduct of Research in Humans online textbook
Policy for Managing Undue Influence
VCU Ombudsperson
Research Integrity Officers
VITA standards - at discretion of the School

VCU Regulatory & Administrative Oversight	Forms and Submission Procedures	Where to go for More Information:
Francis Macrina, PhD, Vice President for Research VCU Office of Postdoctoral Services (OPS) in the Office of the Vice President for Research	None	Website: VCU Responsible Conduct in Research