Definitions of Research Compliance Terms

IDE – Acronym for Investigational Device Exemption

Incapacity – When referring to a person’s mental status, incapacity means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence.

Inclusion Criteria – The criteria that establish whether a person is eligible to participate in a clinical trial.

Incompetence – Technically, a legal term meaning inability to manage one’s own affairs. Often used as a synonym for incapacity.

IND – Acronym for Investigational New Drug Application.

Informed Consent – A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic therapeutic or preventive procedure.

Institution – Refers to Clemson University.

Institutional Official – The individual at an institution who is responsible for ensuring the effective administration and implementation of the institution’s system for the protection of human subjects.

Institutional Review Board (IRB) – An independent committee comprised of scientific and non-scientific members established according to the requirements outlined in Title 38, part 16 (same as Title 45, part 46 and Title 21, part 56) of the U.S. Code of Federal Regulations. Other equivalent committees with the same or similar functions are also considered to be IRBs.

Institutionalized – Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).

Institutionalized Cognitively – Impaired persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).

Interaction – Includes communication or interpersonal contact between investigator and subject.

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.

Investigational Device Exemption (IDE) – An IDE is like an IND for a new drug. It allows an unapproved medical device to be used for investigational purposes. FDA has 30 days to review the IDE and notify the sponsor if approval is withheld. The requirements for an IDE are similar to an IND and are designed to ensure that the sponsor conducts adequate preclinical testing, selects appropriate subjects for clinical research, obtains IRB approval, obtains adequate informed consent, uses qualified investigators, monitors the investigation, and collects data promptly. In deciding whether to approve an IDE, the FDA focuses on how the investigation will be conducted rather than on a precise risk-benefit analysis. The IDE regulation is 21 CFR 812 (45 Fed Reg. 3751, January 19, 1980).

Medical devices are classified as non-significant risk (NSR) and significant risk (SR) by the sponsor and the IRB. If a sponsor designates a device as NSR and the IRB agrees, the investigation may begin without submission of an IDE (under the abbreviated IDE requirements). If, however, the IRB determines the device is SR, an IDE must be submitted before the study can be initiated. In this circumstance, it does not matter if the sponsor has classified the device as SR or not because the IRB has ultimate responsibility.

Investigational Drug – Includes those substances in any of the clinical stages of evaluation which have not been released by the FDA for general use or cleared for sale in interstate commerce. An investigational drug may also be defined by one of the following:

• A drug in any of the clinical stages of evaluation (Phase I, II, and III) which has not been released by the FDA for general use or cleared for sale in interstate commerce.
• Any commercially available drug proposed for a new use.
• A new dosage form or method of administration.
• A commercially available drug which contains a new component such as an excipient, coating or menstruum.
• A new combination of two or more commercially available drugs.
• A combination of commercially available drugs in new proportions.

Investigational Medical Device – A medical device is defined as any healthcare product that does not achieve any of its intended purposes by chemical action or by being metabolized. Before 1976, medical devices could be marketed without review by the FDA. However, in 1976 the medical device amendments of 1976 to the Federal Food, Drug and Cosmetic Act were passed in order to ensure that new devices were safe and effective before they were marketed. The FDA regulations which govern medical devices are 21 CFR 812, 814, 860, 861. An investigational medical device is a device not yet approved by marketing by the FDA.

Investigator – See Principal Investigator.

In Vitro – Literally, “in glass” or “test tube” – used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.

In Vivo – In the living body; processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory.

IRB – Institutional Review Board established in accord with and for the purposes of human subjects’ protection.

IRB Approval – 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.

IRB Documentation – Any method of documenting the IRB’s consideration, evaluation, and/or assessment of proposed or active research.