Glossary | Human Research Protections

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule:

The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).

Healthcare Provider:

A person considered to be engaged in the patient's medical care.

Healthy Volunteer:

A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.

HIPAA Authorization:

Authorization is defined under HIPAA as the granting of rights to access protected health information (defined below) (PHI). Authorization is required by HIPAA for disclosures or uses of PHI other than for treatment and related procedures and operations. Importantly, treatment cannot be conditioned on granting of an authorization. An authorization is a specific, detailed document requesting patient-subject permission for the use of covered PHI.

Human In-Vitro Fertilization:

Fertilization involving human sperm and ova that occurs outside the human body (e.g. a test tube).

Human Research Protection Program (HRPP):

The Human Research Protection Program (HRPP) is the total of all departments and individuals responsible for the protection of human research subjects. At WCM, the HRPP consists not only of the Office of Research Integrity and the IRB, but also the entire research community. The HRPP is headed by the Institutional Official (IO).

Human Subject:

A patient or healthy individual who is or becomes a participant in research, either as a recipient of the intervention or as a control.

Human Subjects Research:

According to IRB policy, research involving human subjects (participants) is defined as any one of the following:

Human subjects research subject to FDA regulation: Activities are human research subject to FDA regulations when they meet the FDA definition of "clinical investigations" and involve a "subject" as defined in FDA regulation.

Under FDA regulation activities are "clinical investigations" when they involve:

Use of a drug other than the use of an approved drug in the course of medical practice
Use of a medical device other than the use of an approved medical device in the course of medical practice
Gather data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product.

In the above criteria "approved" means "approved by the FDA for marketing."
Under FDA regulations, individuals are considered "subjects" when they become a participant in research, either as a recipient of the test article or as a control. If the research involves a medical device, individuals are considered "subjects" when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.

Human subjects research subject to DHHS regulation: Activities are human subject research subject to DHHS regulations when they meet the DHHS definition of "research and involve a "subject" as defined in DHHS regulations.

Under DHHS regulations activities are "research" when they are a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Under DHHS regulations "subjects" 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 included 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.

Research that does not meet the definition of research involving human subjects must be determined by the IRB staff, not an individual investigator. Investigators must complete and submit an IRB new study application with any applicable documents.

Humanitarian Device Exemption (HDE):

FDA approval of a Humanitarian Device Exemption (HDE) application is necessary in order to allow the marketed use of a Humanitarian Use Device (HUD). The HDE is similar to a Pre-Market Approval (PMA), but because a HUD is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The HDE must contain sufficient information for FDA to determine that the probable benefit to health outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.

Humanitarian Use Device (HUD):

A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 4,000 individuals in the United States per year. To be considered for HUD status, a device sponsor must complete a humanitarian device exemption (HDE) application with the FDA. An approved HDE application authorizes the applicant to market the HUD. The labeling for the HUD must state that the device is an HUD and that the effectiveness of the device has not been demonstrated.