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Responsible Conduct of Research Training

Protection of Research Subjects

IRBs and IACUCs

Research involving either human subjects or laboratory animals is 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, that 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 appropriate Presidential Committee is typically required BEFORE research can begin.

Human Subjects in Research (IRB)

The Institutional Review Board (IRB) is charged with the review of protocols involving the use of human subjects.

In determining whether or not your research involves human subjects, consider that the regulations define "HUMAN SUBJECT" as a living individual about whom an investigator (faculty, staff or student) obtains either
  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 who will work with human subjects complete an educational course on human subjects research (based upon the Federal Regulations 45 CFR Part 46). This is a federal requirement when NIH funds are involved.

Laboratory Animals (IACUC)

The Institutional Animal Care and Use Committee (IACUC) 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).