Policies and Procedures: Research compliance and ethics
- Introduction: Accountability and integrity
- Financial conflict of interest
- Responsible conduct in research
- IRB manual: Standard Operating Procedures for Human Subjects Research
- Care and use of animals in research, testing, teaching, or demonstration
- IACUC application process
- IACUC training
- Occupational health and safety for animal handlers
- Renovations or construction of animal facilities
- Export control (to come)
Research is a complex business, whether you’re working in a lab, on a farm, or in a community setting. When sponsored funding is involved, an entirely new layer of complexity is added. No matter what your field or subject matter may be, all principal investigators and researchers are answerable to multiple levels of oversight. More information on Introduction of accountability and Integrity.
North Carolina A&T State University is committed to compliance with the Animal Welfare Regulations (AWRs), Public Health Service (PHS) Policy, and other regulations applicable to the care and use of animals in research, testing, teaching, and demonstration.
To ensure institutional compliance, the university established an Institutional Animal Care and Use Committee (IACUC). The IACUC is responsible for overseeing and evaluating all aspects of animal care and use. It is charged with:
- Reviewing proposals that involve animals to ensure that the criteria established in the PHS Policy and the AWRs are implemented. In its review of proposals, the committee’s primary goal is to facilitate compliance with applicable laws, regulations, and policies consistent with the performance of appropriate and productive scientific endeavors.
- Ensuring that all persons coming into contact with animals are trained to perform proposed procedures.
- Ensuring that all persons with significant exposure to animals are enrolled in the Occupational Health and Safety Program.
- Inspecting research facilities, including satellite facilities and study areas, semiannually.
- Reviewing the animal care and use program semiannually.
- Preparing reports of IACUC evaluations and submitting them to the Institutional Official.
- Establishing a mechanism for receipt and review of concerns involving the care and use of animals at N.C. A&T.
- Reporting significant problems or violations to federal law to the Institutional Official and, when necessary, the U.S. Office of Laboratory Animal Welfare (OLAW).
- Suspending any animal activity that does not comply with applicable regulations and policies.
All activity involving vertebrate animals in research, testing, teaching, and demonstration must be approved by the IACUC before initiating the activity. Proposed animal work is submitted electronically via the Animal Care Application (ACAP) System.
Training for researchers and research staff is provided through the N.C. A&T Research Training System. To gain access to training modules, send an email to the IACUC administrator requesting a username and passwor
All persons who are exposed to animals must enroll in the Occupational Health and Safety Program for Animal Handlers. Click here for the enrollment form.
All proposals for the renovation or construction of animal facilities must be approved in advance by the IACUC.
Additional information on animal care and use, or contact the IACUC administrator at 336 285-3184.
The N.C. A&T Institutional Biosafety Committee (IBC) acts as an agent for the university in the review, control, and mediation arising from the use or proposed use of biohazardous/biological materials, including recombinant DNA. The IBC derives its authority directly from the Chancellor in all matters involving biosafety and/or violations of accepted rules of practice and serves as an advisory committee to the Vice Chancellor for Research and Economic Development.
The IBC maintains institutional compliance with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines); the Center for Disease Control and Prevention (CDC); Biosafety in Microbiological and Biomedical Laboratories (BMBL) current edition; and local, state, federal, and international regulations pertaining to the handling of biological materials.
The IBC is required to review applications for research involving recombinant DNA (rDNA) and biological materials to determine whether the proposed facilities, procedures, and practices meet the standards required by the university and the NIH. It will, in addition, have the responsibility to certify annually to the NIH that such facilities, procedures, and practices, and the training and expertise of personnel meet NIH standards. Additional IBC responsibilities include:
- Reviewing applications and performing comprehensive risk assessments to determine the appropriateness and adequacy of containment levels and safety measures proposed and/or used in research and teaching. The IBC may down-grade or up-grade containment levels as appropriate to address the risks associated with the proposed activities.
- Assessing the adequacy of facilities, procedures, practices, training, and expertise of personnel involved in the research or instructional activities.
- Ensuring that approval to use select agents is granted only to individuals who meet the access requirements stated in Federal Regulations on the Possession, Use, and Transfer of Select Agents and Toxins as described in 42 CFR 73, 7 CFR 331, and 9 CFR 121, and other applicable federal regulations.
- Recommending to the Vice Chancellor for Research and Economic Development appropriate sanctions for noncompliance with biological safety standards, guidelines, or regulations.
- Ensuring that no activities involving rDNA in humans are approved until NIH OBA rDNA Assurance Committee approval has been obtained and compliance with Appendix M of NIH Guidelines can be ensured.
All principal investigators working with biological/biohazardous materials are required to complete and submit the IBC Application before initiating research (independent of its funding status) and/or bringing new biological/biohazardous materials to campus. Work at the BSL2 and BSL3 levels cannot begin until approval has been granted by the IBC. BSL4 level work is not permitted on N.C. A&T’s campus. The IBC Application must be kept current to accurately reflect the materials and their manipulations, personnel handling the material, and the location in which the material will be handled and/or stored.
Biohazardous materials include:
- Certain types of recombinant DNA: organisms and viruses infectious to humans, animals, or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia); and
- Biological agents (e.g. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community.
Biological materials are any materials containing genetic information and capable of reproducing itself or being reproduced in a biological system. Biological materials include but are not limited to:
- Recombinant DNA (rDNA),
- Cell lines,
- Animals (live or tissues and biological fluids),
- Human tissue or biological fluids, and
- Microbial toxins.
For additional information, see the IBC Biological/Biohazardous Safety Guide for Researchers or contact the IBC administrator at 285-3184.
The IBC application is submitted via a fillable PDF application. This application is online at: http://www.ncat.edu/research/dored/compliance-ethics/ibc/index.html.
Training for researchers and research staff is provided through the N.C. A&T Research Training System. To gain access to training modules an email must be sent to Donna Eaton requesting a username and password.
Click here for additional information or contact the IBC administrator at 336 285-3184.
The Radiation Safety Committee (RSC) is the governing body for all aspects of radiation protection within the university. Members are appointed by the Chancellor. Its mandate includes all affiliated research and instructional and service units using ionizing and non-ionizing radiation sources or devices in facilities owned or controlled by the university.
The RSC works collaboratively with the Office of Environmental Health and Safety to ensure that all possession, use, and disposition of radiation sources by university personnel complies with federal and state regulations and with specific conditions of licenses to the university, and that all concomitant radiation exposures are maintained As Low As Reasonably Achievable (ALARA).
All activity involving radiation sources must be approved by the RSC before purchasing or using the source. Applications can be requested from the RSC administrator, Cathy Collins, or the Radiation Safety Officer, Mr. Dan Hurley.
Basic radiation training for researchers and research staff is provided through the N.C. A&T Research Training System. To gain access to training modules, send an email to Cathy Collins, requesting a username and password.