Definitions & Review Criteria
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. (e-CFR §46.102)
Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (e-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.
Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (e-CFR §46.102)
Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format. (e-CFR §46.102)
Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. (e-CFR §46.102)
Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research. (e-CFR §46.102)
In reviewing proposals, the IRB considers the following general criteria:
- Are risks and discomforts to subjects minimized?
- Are risks and discomforts to subjects reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result? Although the IRB does not specifically evaluate the quality of the proposed research, it may become relevant in determining if potential benefits outweigh risks.
- Will voluntary and informed consent to participate in research be obtained from each subject or the subject's legally authorized representative and will it be appropriately documented? The consent process must permit the participant or legally authorized representative to exercise free power of choice without undue inducement or any element of deceit, fraud, force, duress, or other form of coercion or constraint.
- Will the privacy of subjects and confidentiality or anonymity of data be protected?