The federal regulations have defined the following core terms related to human subject research:
Children: According to federal regulations, children can be defined as persons who have not attained the legal age for consent treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. Investigators must consult the state law in which they will be recruiting prior to IRB submission.
- Data through intervention or interaction with the individual, or
- Identifiable private information.
Individually identifiable health information is the information that is a subset of health information including demographic information collected from an individual.
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.
IRB means an institutional review board established in accord with and for the purposes expressed in the code of federal regulations (45 CFR 46 and 21 CFR 50 & 56).
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.
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.
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.
Pregnancy: As defined by federal regulations, this encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
Prisoners: According to federal regulations, prisoner means any individual involuntarily confined or detained in penal institution. The term is intended to encompass individuals detained in other facilities by virtue of statues or commitment procedures which provide alternatives to criminal prosecution or incarceration in penal institution, and individuals detained pending arraignment, trial or sentencing.
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 Health Information: Federal regulations define protected health information as basically individually identifiable (links to subject) health information. This includes but not limited to social security number, date of birth, address, name, any admission dates (i.e. visit date), phone number, email address, health plan/medical record/health account numbers, license plate number, certificate or license number, IP addresses, URLs, biometric information (i.e. finger prints) and full face photos.
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.
Use is defined under HIPAA regulations in respect to individually identifiable health information as the sharing, employment, application, utilization, examination, or analysis of such information within an entity that maintains such information.