lightbulb [View Image]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 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:
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.
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 Susan Robb, 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.
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.
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 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.
If the IRE determines that the proposed research is DURC, the PI will be expected to:
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.
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).
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.
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.
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.
When you fly a drone in the United States, it is your responsibility to understand and abide by the rules.
Unmanned aircraft systems (UAS), commonly referred to as “drones,” may be used for a variety of purposes, including Public Uses, Civil Uses (such as research and instruction), and recreation. Using a UAS requires familiarity with various regulations, an understanding of the public’s privacy and safety concerns, and knowledge of how to operate a UAS.
This page contains basic resources for drone pilots and enthusiasts at VCU. Drones must be operated safely; in compliance with the applicable federal, state, and local regulations; and in compliance with VCU’s University Related Use of Unmanned Aircraft Systems (UAS) Policy.