Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102)
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data or private information. (45 CFR 46.102)
Risk means the extent to which a human, subject to research procedures, may be exposed to physical, psychological, or other types of harm.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102)
Informed consent means subjects’ willingness to participate after the researcher communicates to subjects, in language they can understand, information that the subjects may reasonably be expected to desire in considering whether or not to participate, and that minimizes the possibility of coercion or undue influence.
Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Protocol is the formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
Institutional Review Board is the specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
Full Review means a review of proposals by the entire IRB. This will be conducted for research that involves greater than minimal risk,, or the research is of a psychologically sensitive nature.
Expedited Review means a review by the chair of the IRB and/or one other member of the IRB for research that involves no more than minimal risk, or to review minor revisions in previously approved research, or review revisions for proposals that were approved with contingencies.
Exempt Status means a research proposal where the subjects are at no more than minimal risk, the subjects' confidentiality is maintained, and the proposal meets one of the six criteria for exemption.
Sample of Informed Consent Form
Sample of Informed Consent Letter
Sample of Implied Consent Letter for Surveys
Louis J. De Maio, Ph.D. |
Graduate Studies Office |