RESEARCH: means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of these standards, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
HUMAN SUBJECT: a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual (including interviews, surveys, and participation in experiments);
- Identifiable private information.
PRIVATE INFORMATION: includes both:
a) Information about behavior that occurs in circumstances where the individual can reasonably expect that no observation or recording is taking place; and
b) Information which the individual has provided for a specific purpose and which he or she can reasonably expect will not be made public (such as a medical record).
IDENTIFIABLE: means the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
IRB: (Institutional Review Board) Generic term used to designate the local institutional review committee which is required under the regulations to review research involving human subjects. At local institutions, these committees are given various names, such as committee on human subjects, or the human investigations committee.
CERTIFICATION: Term used to denote the documentation that must be sent to potential funding agencies to certify that the proposed research project has been reviewed and approved by an Institutional Review Board (i.e., a human subjects review committee).
CODE OF FEDERAL REGULATIONS (CFR): A compendium of rules issued by Federal agencies.
COMPETENCE: A legal term, used to denote capacity to act on one's own behalf, the ability to understand information presented to appreciate the consequences of acting (or not acting) on that information, and to make a choice.
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 in ways that are inconsistent with the understanding of the original disclosure without permission.
INFORMED CONSENT: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic or preventive procedure.
MINIMAL RISK: Risks of harm anticipated in proposed research that are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or in the performance of routine medical or psychological examinations.
PRINCIPAL INVESTIGATOR: The scientist or scholar with primary responsibility for the design and conduct of a research project.
PRIVACY: Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally or intellectually) with others.