VCU's regulatory committees are charged with ensuring all research conforms to the highest standards of integrity, ethics and professional responsibility. Researchers must comply with government regulations and the latest university policies and guidelines for the protection of human and animal research subjects, scientific conduct and laboratory safety. Education about these requirements is provided for researchers and students on a regular basis.
The Conflict of Interest in Research Committee (COIC) is a standing committee of the university, composed of faculty, administrative personnel, and ex-officio members, convened under the authority of the vice president for research and innovation. The COIC is charged to evaluate investigator reports of research-related financial and non-financial interests and to determine an appropriate resolution, including the development of a management strategy, as appropriate. Committee members are required to adhere to applicable rules of privacy and confidentiality pertaining to conflict of interest review.
Monika Markowitz, Ph.D.
Executive director, COIC chair
The IACUC comprises members representing university faculty (scientists experienced in research with animals), veterinarians with training or experience in laboratory animal science and medicine, nonscientists whose primary concerns are in nonscientific areas, and community/non-affiliated members. The IACUC is typically scheduled to meet twice a month. The second Wednesday of each month is normally scheduled for protocol reviews. The third Wednesday of each month usually conducts the program review or facility inspection.
The VCU IACUC is responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide). Its oversight functions include an ongoing assessment of animal care and use.
IACUC responsibilities include:
- Review, at least semiannually, VCU's animal care and use program for the humane care and use of animals
- Inspect, at least semiannually, VCU's animal facilities (including satellite facilities)
- Prepare reports to the Institutional Official (IO, currently VCU’s IO is Dr. P. Srirama Rao, Vice President for Research and Innovation) of the IACUC evaluations, including program reviews and facility inspections
- Review animal welfare concerns
- Make recommendations to the IO on any aspect of the animal program, facilities, or personnel training
- Review and approve, those components of PHS conducted or supported activities related to the care and use of animals
- Review and approve, proposed significant changes to the use of animals in ongoing activities
- Be authorized to suspend an activity involving animals
Complete information on IACUC policies and procedures can be found on the Animal research webpage.
Institutional Biosafety Committees (IBCs) are the cornerstone of institutional oversight of recombinant DNA research. – NIH Office of Science Policy
VCU’s IBC regularly meets to review proposed research or work to be conducted at or on behalf of the university that involves recombinant/synthetic DNA (rDNA). In addition to rDNA research, the IBC reviews and approves MUAs for research that is in compliance with NIH Guidelines, and that can safely be performed at VCU involving select agents; certain human, plant, and animal pathogens and biological toxins; clinical trials involving any administration of rDNA and/or pathogens to human subjects; or other research projects conducted at or on behalf of the university which are deemed, by the Biosafety Office, to require IBC oversight. IBC's charter information.
- CITI training modules
CITI login instructions
- From the main menu select “Add a course or Update Learner Groups”
- Click the appropriate radio button for Question 12
- When you exit the screen your new course(s) will be available
- NIH Recombinant Advisory Committee (RAC) revisions factsheet
- NIH Guidelines
- Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- Centrifuging of biohazardous materials
- Cleanup of large biohazardous spills
- Cleanup of biohazardous spill in biological safety cabinet (BSC)
- Exposure/Incident reporting and reporting procedures
- Handling infectious/human samples-FACS aria
- Live imaging of potentially biohazardous live samples
- Percutaneous hazards
- Vacuum system operation involving biohazardous materials
- VCU Biosafety manual
- VCU Select Agent information
- VCU lab safety training modules
- Log in
- Select the “Organizations” tab at the top
- Type “Chemical Safety” into the “Organization Search” box
Assistant biosafety officer
The Institutional Review Entity (IRE) reviews any research or work conducted at, or on behalf of the University that involves one of the 15 agents/toxins designated as Dual Use Research of Concern (DURC) agents/toxins by United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The IRE operates as a subcommittee of the IBC.
Dual Use Research of Concern is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products or technologies that could be directly misapplied to pose a significant threat, with broad potential consequences, to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
The U.S. government has published several policies relevant to Dual Use Research of Concern, with the intention of raising awareness and limiting the potential for misuse of scientific information derived from life sciences research.
Research with one or more of the fifteen DURC agents and/or toxins currently listed in the U.S. government DURC Policy and which produces, aims to produce or can be reasonably anticipated to produce one or more of the 7 experimental effects of concern listed in the policy must be evaluated by the VCU Institutional Review Entity (IRE) for its DURC potential.
PIs must notify John Ryan, the Institutional Contact for Dual Use Research, that they are using DURC agents. See PI Responsibilities below. Review and oversight of DURC are outlined in the VCU policy on DURC.
Procedure for DURC research
The Institutional Review Entity (IRE) will conduct a review of the research and make a determination. If the IRE determines the research meets the definition of DURC, it will promptly notify the PI, and, within 30 calendar days, will also notify the applicable U.S. funding agency. The IRE, PI and U.S. funding agency will work together to develop a risk mitigation plan. This process is outlined in detail in the VCU policy on DURC. Upon approval of the draft plan by the U.S. funding agency, the IRE will present the final risk mitigation plan to the PI, and the Institutional Contact for Dual Use Research (ICDUR) will collaborate with the PI to ensure its implementation.
For research determined to be DURC, the IRE shall review, at least annually, all active Risk Mitigation Plans at the university. The IRE, working with the PI, shall modify the applicable risk mitigation plan as needed to ensure that the plan still adequately mitigates the risks associated with the DURC.
DURC: PI responsibilities
Principal Investigators (PIs) are responsible for assessing whether their research is DURC, reporting this assessment to the VCU DURC Institutional Review Entity (IRE), and, if applicable, implementing a risk mitigation plan.
Before commencing research with DURC Agents, the PI must first determine whether any of the following apply:
- The research directly involves non-attenuated forms of one or more of the potential DURC agents
- The research with non-attenuated forms of one or more of the potential DURC agents also produces, aims to produce or can reasonably be anticipated to produce one or more experimental effects of concern
- The PI concludes that his/her research may meet the definition of DURC. If research is determined not to meet the DURC criteria, it is the responsibility of the PI to monitor his other research on an ongoing basis and notify the Institutional Review Entity (IRE) if anything changes that may alter the initial IRE determination.
The PI’s assessment regarding the above should be summarized in writing. This summary shall be registered and retained with the VCU DURC Institutional Review Entity (IRE).
The PI will provide the Institutional Contact for Dual Use Research (ICDUR) with documentation in accordance with local campus policies and procedures, indicating the reasons for concluding that his/her research involves, or does not involve potential DURC, along with sufficient data to permit the IRE to complete the review required.
Implement risk mitigation
If the IRE determines that the proposed research is DURC, the PI will be expected to:
- Collaborate with the IRE to develop the risk mitigation plan
- Conduct DURC in accordance with the final risk mitigation plan
- Notify the ICDUR of any substantive change in the on-going conduct of the DURC
- Notify the ICDUR if for whatever reason (e.g., changes in the research, new discoveries), he/she feels that the research should no longer be considered DURC
- Ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff and visiting scientists) conducting research with one of more of DURC agents have received appropriate education and training on DURC
- Be knowledgeable about and comply with all UC and federal policies and requirements for oversight of DURC
- Communicate about the DURC in a responsible manner and in compliance with the approved risk mitigation plan
DURC and sub-awards
Federal DURC policy requires that where elements of a potential DURC project are carried out at multiple institutions through a sub-award with a primary institution that directly receives the grant or contract from the U.S. funding agency, (the “prime institution”), the prime institution will be responsible for notifying the applicable U.S. funding agency of research that may constitute DURC and if such research is determined to be DURC, providing copies of each institution’s risk mitigation plan. The Prime Institution should also ensure that DURC oversight is consistently applied by all entities participating in the collaboration. If the prime institution’s procedures or standards are less rigorous than the sub-awardee’s, the more rigorous standard will be applied.
DURC: additional resources and sub-awards
Additional resources related to Dual Use Research of Concern (DURC):
- Federal government DURC policy and guidance
- United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012)
- United States Government Policy for Institutional Oversight of Dual Use Research of Concern (September 2014)
- FAQs on USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
- National Institutes of Health – Office of Science Policy: Dual Use Research of Concern
- Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern: A Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern
- Training Slide Set: Training on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
For guidance about DURC, email Peter Landsman, Assistant Director, Export Compliance Program.
The Institutional Review Board is a key component of VCU’s Human Research Protection Program.
VCU’s IRB consists of faculty, students, and staff representing faculty from both campuses. Membership expertise includes scientists (biomedical and social behavioral), nonscientists, and unaffiliated members.
Federal human research regulations (45 CFR 46.107, 21 CFR 56.107) require IRBs to include at least one member whose primary concerns are in scientific areas. Scientific expertise is vital to ensure that studies minimize risks to research participants through sound research design and, whenever appropriate, procedures already performed for diagnostic or treatment purposes (45 CFR 46.111, 21 CFR 56.111).
Nonscientist and unaffiliated members
Federal human research regulations (45 CFR 46.107, 21 CFR 56.107) require IRBs to include at least one member whose primary concerns are in nonscientific areas. Community participation on the IRB is vital as these members review research from a nonscientific lens, sharing community and cultural perspectives in reviewing research. Unaffiliated members serving on the University’s IRB are not affiliated with the Virginia Commonwealth University or VCU Health System.
Service on the IRB is vital to supporting the research mission of the University and the protection of participants in that research. The IRB draws members both from the University and its affiliates, as well as the external community.
If you are interested in serving on the IRB, we have a continuous application process that is reviewed as members are needed. Click here to submit an application.
Protocol submission and instructions
Complete information on protocol preparation and submission and meeting information can be found on the Human Subjects website.
The LSC meets periodically to provide oversight, review metrics and make recommendations to improve laboratory safety and maintain a positive safety culture at VCU. The committee focuses on overall accident and injury reduction, chemical safety and physical hazards. It fills the space between VCU’s Radiation Safety Committee and Biosafety Committee. The LSC also evaluates safety in other areas that are grant funded and academic in nature, including art safety, field research safety, teaching labs, and machine/shop safety. Additional concerns identified by Environmental Health and Safety may be brought to the committee for review. The LSC has representation from all Schools and Colleges on campus and is chaired by a senior faculty member at VCU.
Important documents and forms
- ACS Green Chemistry Institute
- American Chemical Society (ACS): Chemical and Laboratory Safety
- ACS Hazard Assessment in Research Laboratories (online tool on how to conduct a risk assessment in a laboratory)
- OSHA Safety and Health Topics: Laboratories
- OSHA Occupational Exposure to Hazardous Chemicals in Laboratories
- Campus Safety Health and Environmental Management Association (CSHEMA)
- Safety Training Consortium
- University of California (UC) Center for Laboratory Safety
- UCLA PPE Selection Guide Assessment Tool
- Lab Safety Workspace: Lab Safety for Scientists (free online training)
As required by Commonwealth of Virginia regulations, the RSC meets quarterly. One of its primary responsibilities is to evaluate new users and new uses of radioactive material. This includes evaluating the training and experience of applicants who request authorization to use radioactive material at the facility, using criteria developed by the RSC. The committee is also responsible for reviewing personnel dosimetry data, discussing the results of required radiation surveys, and any significant incidents, including spills, contamination, medical events, etc. The RSC is required to review the radiation safety program every 12 months for maintaining doses As Low As Reasonably Achievable (ALARA) and providing any necessary recommendations to ensure doses are ALARA. The overall compliance status for authorized users and all uses of radioactive material is also thoroughly reviewed. The RSC, working with the executive management, shares responsibility with the Radiation Safety Officer (RSO) for conducting periodic audits of the radiation safety program and providing oversight and regulatory compliance of all uses of radioactive material at VCU and VCU Health. Additionally, the Committee reviews any consultant's audit findings and acts upon those findings. The RSC has representation from both the research and clinical areas of radioactive materials use and is chaired by a senior faculty member at VCU or VCU Health.
Important documents and forms
- Radiation Safety – Safety and Risk Management
- Guidelines for IRB protocols involving the use of ionizing radiation
Radiation safety officer
Assistant radiation safety officer