- Adverse events are events that are unfavorable, harmful, or detrimental to the welfare of the subjects. They are either unanticipated or anticipated but generally involve a higher level or greater frequency than expected.
- Assent is the affirmative agreement of the child to participate in research.
- Benefit is the positive value or advantage of being part of a research study.
This value may be concrete for an individual (e.g., a greater chance of having a good therapeutic outcome) or may be more intangible and general (e.g., the illumination of basic processes or causes that underlie a research topic). Compensation or inducement for study participation is not considered a benefit and should not be considered in balancing risk/benefit ratios.
- Children are persons who have not attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. In North Carolina, residents under 18 years of age are considered children unless they are “emancipated” by court order, marriage or military service.
- Emancipated Minor: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage or procreation.
- Mature Minor: Someone who has not yet reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consent to medical care). A mature minor is not necessarily an emancipated minor.
- Exempt research is research that is not subject to federal regulations and does not require informed consent.
- Expedited review is a process that the IRB may use when the research involves no more than minimal risk to subjects.
- Full board review is a process that the IRB will use when the research involves more than minimal risk.
- Human subject means a living individual about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.
- Informed consent is a continuing process that involves giving human subjects an explanation of the proposed research, its purpose, procedures, risks and benefits, and informing them that participation is voluntary and may be discontinued at any time without penalty.
- Intervention includes physical procedures by which data are gathered, and manipulation of the subject or the subject’s environment for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject. Administering a survey, even if you have no face-to-face contact with the subject, is considered to be interaction.
- Key personnel is defined as the principal investigator (PI) and other individuals who contribute to the research in a substantive, measurable way. Examples include but are not limited to the PI, co-investigators, the study coordinator, and other project personnel who:
- design studies,
- supervise studies,
- administer informed consent,
- administer questionnaires or surveys or collect data directly from
subjects using other methods,
- code data, or
- otherwise collect or analyze human subjects data.
Typically, these individuals have doctoral degrees or other professional degrees, although individuals at the masters or baccalaureate level may meet this definition. The PI typically identifies the key personnel on a research project.
- Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than that ordinarily encountered in everyday life or during the performance of routine physical or psychological examinations or tests.
- Private information must be individually identifiable (e.g., school transcripts, health records) if obtaining the information is to constitute research involving human subjects.
- Research means a systematic investigation (including research development, testing and evaluation) designed to contribute to generalizable knowledge.
- Special populations refers to subjects who may be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, handicapped or mentally disabled persons, or economically or educational disadvantaged persons, and for whom special safeguards must be built into the study to protect their rights and welfare.