The basic principles that govern the IRB in assuring that the rights and welfare of subjects are protected are contained in Ethical Principles and Guidelines for the ProtectionofHumanSubjectsofResearch (“The Belmont Report”), and The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979.
Therefore, the following principles apply to all research, including student projects, involving human subjects at Chaminade University to ensure that adequate safeguards are provided:
- Therefore, the following principles apply to all research, including student projects, involving human subjects at Chaminade University to ensure that adequate safeguards are provided:
- Subjects’ legal rights will be respected; their rights to privacy, dignity, and comfort will also be considered in approving proposed
- Risks to subjects must be minimized and reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to
- 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
- Research involving human subjects must be supervised by qualified persons, including qualified clinicians for all study-related healthcare
- Participation of a human subject in research must be voluntary and the right to withdraw at any time must be 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 Continuing research programs are subject to periodic review, to be carried out no less often than once a year.