RCR Part 1

RESPONSIBLE CONDUCT OF RESEARCH

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Overview

The investigator is in a critical position to understand the operation and equipment involved, the material and methods used, and therefore, the potential risks associated with the work being done on a project.  The investigator’s attitude toward health and safety contributes significantly to both the institution’s commitment to safety and to the education of students regarding the conduct of research. 

The proper management of chemicals, biological materials, animals, and radioactive materials that can pose hazards to health and the environment is not only good lab management; it is also a regulatory and institutional requirement.  Such management creates particular requirements for investigators in laboratories and is overseen by a variety of intern and external offices and agencies.

Offices and Committees

The Office of Environmental Health and Safety provides a chemical waste management system, a safety policies and procedures manual, extensive training programs, fact sheets, laboratory safety manual templates, safety standard operating procedures, a biosafety manual template and blood born pathogen exposure control plan templates, as well as other resources and tools.

Biological agents used in research will be overseen by the Institutional Biosafety Committee (IBC) as soon as it is established. The IBC will be a Presidential Committee reporting through the Vice President for Academic Affairs. Work with recombinant DNA and infectious or biohazardous agents will require special review and approval by the IBC prior to the initiation of research.

Use of animals in research is overseen by the Agricultural and Laboratory Animals Care and Use Committee. Work with animals requires special review and approval by this committee. Assistance with these requirements is usually available through the Veterinary Technology and Animal Science programs.

Radiation Safety

A special category of research is that involving the use of sources of ionizing radiation. Currently, Fort Valley State University does not engage in such research. A Radiation Safety Office, at institutions that do engage in research involving radiation, would have sole responsibility for the radiation safety program. Institutions must apply and maintain all aspects of the licenses issued by federal and/or state authorities.  Radioactive materials and radiation producing equipment or machines used in research are overseen and approved by the Radiation Safety Committee (RSC) and Radiation Safety Office (RSO) or EH&S.

Shipping and Receiving (Department of Transportation Regulations for Hazardous Materials)

Many products in daily use are dangerous, and some can have catastrophic effects on people, property and the environment. In 1974 Congress passed The Hazardous Materials Transportation Act. Over time the regulations have become more stringent and inclusive to the point that it has become impossible for the untrained person to handle or ship HAZMAT safely and within the law.

Protection of Research Subjects (IRBs and IACUCs)

Research involving either human subjects or laboratory animals is also regulated by Government agencies and by institution policy. Many institutions extend regulatory requirements in this regard to ANY research activity, regardless of the source of funding for the activity, which involves the use of human subjects or laboratory animals. As is also the case when research will involve either biohazards or radiation, protocol approval by the Human Subjects Committee or the Agricultural and Laboratory Animals Care and Use Committee is required before research can begin.

Human Subjects in Research (IRB)

The Institutional Review Board (IRB) at FVSU is called the Human Subjects Committee. It is charged with the review of protocols involving research involving human subjects, including:

  1. data through intervention or interaction with the individual; or
  2. identifiable private information, e.g., school transcripts or medical records.

Before any project involving human subjects can begin, many institutions require that all researchers involved complete a course on such research (based upon the Federal Regulations 45 CFR Part 46). This is a federal requirement when NIH funds are involved. Researchers must follow the requirement that records related to human subjects must be kept confidential.

Laboratory Animals (IACUC)

The Institutional Animal Care and Use Committee (IACUC) at FVSU is called the Agricultural and Laboratory Animals Care and Use Committee. It is charged with reviewing all research protocols involving research animals. Typically, no research involving the use of vertebrate animals can proceed without the approval of this Presidential Committee.

In addition to concern for the humane care and use of the animals, research with laboratory animals can also raise environmental health and safety issues. Many Animal Care and Use Programs are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

 

 
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RCR Part 2: Conflict of Interest

 

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