Virginia Western supports the ethical principles for protection of human subjects as stated in the Code of Federal Regulations, 45CFR46 and the Belmont Report. The Belmont Report, created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, sets forth the following basic ethical principles for the conduct of research involving human subjects:
- Respect for Persons. Acknowledgement of the autonomy of the individual and the responsibility to provide special protection for individuals with reduced autonomy.
- Beneficence. A responsibility to do no harm, to maximize possible benefits, and to minimize possible harm.
- Justice. An expectation of fairness in distribution of benefits realized from research as well as its burdens.
As stated in the Code of Federal Regulations, 45CFR46, it is the charge of the IRB to ensure that in the conduct of research:
- Risks are minimized and reasonable in relation to anticipated benefits
- Subjects give informed consent
- Rights and welfare of the subjects are maintained
To ensure that adequate safeguards are provided, Virginia Western follows the principles listed below which apply to all research and student projects involving human subjects:
- Subjects’ legal rights will be respected; their rights to privacy, dignity, and comfort will also be considered in approving proposed research.
- Risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
- Adequate provision(s) must be made for all facilities, procedures, and professional attention necessary for the protection of the individual as a research subject.
- Adequate provisions should be made for recruiting a subject population that is representative of the population base in terms of gender and minority representation unless scientifically justified.
- Research involving Human Subjects must be supervised by qualified persons, including qualified clinicians for all study-related healthcare decisions and faculty members for undergraduate research projects.
- Participation of a human subject in research must be voluntary and the right to withdraw at any time must be provided. Information provided to gain subject consent must be adequate, appropriate, and presented in lay language appropriate to the subject population.
- All research programs that involve Human Subjects must be reviewed by and must receive approval of a formally constituted review prior to their initiation or prior to initiating any changes to the project. Continuing research programs are subject to periodic review, to be carried out no less often than once a year.