G.5 General terms pertaining to research and research participants
Assent: In the context of clinical research, assent means the participant agrees to take part. To give assent means that the participant is engaged in research decision-making in accordance with his or her capacities. Children and adolescents who are legal minors cannot give legally valid informed consent, but they may be able to give assent. Assent demands that the legal minor provide affirmative agreement to participate in research.
Clinical research: Any systematic research conducted with human subjects or groups of human subjects or on materials from humans, such as tissue samples.
Clinical trials: Any research study that prospectively assigns human subjects or groups of human subjects to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, diagnostics, devices, behavioral treatments, process-of-care changes, preventive care.
Compensation: Payment for research subjects’ non-financial burdens incurred during the course of their research participation, most commonly their time, effort, and inconvenience.
Correlative studies: Studies, typically occurring within clinical trials, that explore the cause and effects of an intervention on biological targets involved in a disease process or linkages among groups or different elements of a group.
Incidental finding: A discovery concerning an individual research participant or tissue donor that does not relate directly to the aims of a study but that has potential health or reproductive importance for the individual.
Minimal risk: Risk from procedures to human subjects or tissue donors that is comparable to the probability and the magnitude of harms that are ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Minor increase over minimal risk: An increment in risk that is only a fraction above the minimal risk threshold and considered acceptable by a reasonable person.
Observational studies: A type of clinical research where investigators observe human subjects or groups of human subjects to measure variables of interest; the assignment of subjects into a treated group versus a control group is not controlled by the investigator.
Reimbursement: Repayment for research subjects’ out-of-pocket expenses incurred during their participation in research.
Sham procedures: Procedures used as controls in clinical trials that mimic experimental procedures for research subjects in the “treatment” arm. These are performed to prevent research subjects and physicians assessing their outcomes and from knowing which arm of the trial the subject has been enrolled in. They are also sometimes performed to control for the effects that treatment delivery (rather than the treatment per se) has on a disease process. Sham procedures vary in their invasiveness. Examples include saline injections (where research subjects are injected with saline instead of cells), sham cardiac catheterization (where research subjects receive cardiac catheterization but are not injected with cells), and partial burr holes to the cranium (where researchers imitate the experience of receiving brain surgery by drilling a depression in the skull).
Undue inducement: An offer or reward so attractive that it threatens to impair the ability of prospective research subjects or donors to exercise proper judgment, or it encourages them to agree to procedures for which they are strongly averse.