3.2.11 Human and Animal Subjects in Research

To protect research subjects, any study involving human subjects must be performed under conditions that insure subjects' rights and welfare through adequate safeguards and the informed consent of those involved. Such consent is valid, however, only if the subjects are first given a complete explanation of the procedures to be followed, their possible benefits and attendant risks and discomforts, and the purpose and objectives of the research. This is particularly important when the research does not directly benefit the subjects involved. Safeguards should be especially stringent when subjects are legally, physically, or otherwise unable to give consent.

The University requires review of research projects involving human subjects by the Human Subjects Review Board (Policy 6-04) to insure that (1) subjects' rights and welfare are adequately protected, (2) the methods used to obtain informed consent are adequate and appropriate, and (3) any risks and inconveniences to the subjects are outweighed by the potential benefits to them or by the importance of the knowledge to be gained.

Faculty, staff, and students who use or care for laboratory animals assume responsibility for the humane care and general welfare of the animals. Such responsibilities are outlined in University Policy 6-13, the Guide for the Care and Use of Laboratory Animals (National Institutes of Health), and the "U. S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training." Researchers using animals are also expected to comply with the Public Health Services Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions and the "University of Delaware Assurance of Compliance with PHS Policy on Care and Use of Laboratory Animals by Awardee Institutions." The appropriate University Animal Care and Use Committees review projects that use animal subjects.

The Vice Provost for Research is the general administrator of all policies concerning the use of human subjects or animals in research. Additional information concerning these policies can be obtained from the Office of the Vice Provost for Research.