Definitions
Assent: Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or person who is cognitively impaired) to participate in research.
Child /Minor: A person who has not attained the legal age for consent to treatments or procedures involved in the research.
Coercion: Use of a credible threat of harm or force to control another. Pertaining to unacceptable subject recruitment methods which involve undue influence or indirect pressure for participation from a subject. (For example, an employee may feel pressure from their supervisor if told to participate in a research project or a subject may feel coerced to participate if the payment were unusually large.)
Institution: Means any public or private entity or agency (including federal, state, and other agencies).
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.
Research: Means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human Subject: Means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
Intervention: Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
IRB: Means an institutional review board established in accord with and for the purposes expressed in this policy.
IRB Approval: Means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
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.