Definitions

Assent
Assent is the process by which a minor (aged 7 or above) gives agreement to participate in human subjects’ research to which their parents or guardians have already consented. The assent form must be written in age-appropriate language.

Consent
Consent means giving permission for something to happen or agreement to do something. When someone gives consent in HSR, it must be done freely without coercion, with full knowledge of what they are consenting too with the risks and benefits clearly explained in a language that the subject can understand and that the individual can exit the study at any time. Please note: Children cannot give consent, only their parents can. Children can assent if they are old enough to comprehend what they are assenting too.

Human Subjects
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.

Interaction:
Interaction includes communication or interpersonal contact between investigator and subject.

Intervention
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.

Minimal risk
Minimal Riskis defined as “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 (i))

Please note that the concept of minimal risk is a quantitative standard, not a qualitative one. The risks from the research can be unfamiliar, uncommon or even bizarre, as long as the probability and magnitude of harm are within the range of the risks of ordinary life as defined by an average individual. That means that a really serious risk may still be allowable under the minimal risk rubric if it’s an extraordinarily unlikely outcome. On the other hand, events of rather modest severity may, if they’re expected to be common, bring the research out of the minimal risk category. Additionally, when thinking about minimal risk, one must consider the age and mental capacity of the subject as well as social and other types of non-physical harm. For example, asking an elementary school student questions about puberty in front of their classmates could open the student up to social harm through teasing or even bullying.

Private information
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.

Protected Classes
Protected classesin HSR are protected because the law states that they have certain vulnerabilities. Protected classes include children, pregnant women, fetuses, prisoners and the intellectually impaired. Each of these classes has additional protection in HSR. (45 CFR 46 Part B, C, D)

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.