Research Terms/Definitions – I
IACUC: Institutional Animal Care and Use Committee – The local committee, at every VA medical center with a research program involving the use of live vertebrate animals, responsible for assuring compliance with animal research regulations and guidelines. In the VA system, the IACUC reports to the R&D Committee as a subcommittee. www.iacuc.org
IDE: Investigational Device Exemption - An FDA requirement for use of any medical device to be used in a clinical investigation, unless exempt. New medical products not yet been approved for marketing by the FDA require a special status so they can be legally shipped for the purpose of conducting clinical investigations to establish safety and efficacy. An approved investigational device exemption (IDE) permits a device to be shipped to conduct clinical investigations of that device. [21 CFR 812]
Identifiable: The identity of the individual is or may readily be ascertained by the investigator or associated with the information.
IND: Investigational New Drug Application – An FDA requirement for any drug or biological product used in a clinical investigation, unless exempt. IND is an investigational new drug application and is synonymous with “Notice of Claimed Investigational Exemption for a New Drug,” given so the drug can be legally shipped. An investigational drug must have an IND before it can be shipped.
*May also be required of an existing drug being evaluated for a new indication, dose or route of administration.[21 CFR 312]
Informed Consent: Prospective subjects must be given sufficient information about the research and its risks and benefits to reach an informed decision as to whether they will voluntarily participate. Investigators must obtain the informed consent of prospective subjects before they can be included in research, unless waived by the IRB.
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 institutional and federal requirements. An IRB shall have the authority to suspend research that is not being conducted in accordance with the IRB’s requirements.
IRB: Institutional Review Board - A committee established by law that oversees all research involving human subjects at an institution. The IRB is legally viewed as the protector of integrity and ethical standards of all research and has the authority to enforce these standards. The main functions of IRB review are to assure that the regulations are met and the rights and welfare of participants is protected.
The IRB has the authority to
- approve, disprove or modify
- conduct continuing review
- observe/verify changes
- suspend or terminate approval
The institution or institutional officials cannot approve research that has not been approved by the IRB. In the VA system, the IRB is the Human Subjects Subcommittee of the Research & Development Committee. (Note: The R&D cannot approve research that has not been approved by the IRB. A protocol must have approval from both the IRB and the R&D to be performed at a VA facility.)
[38 CFR 16, 21 CFR 56; 45 CFR 46; VA Manual 3, Part 1, Chapter 9]
[Note: Often referred to as the Human Subjects Subcommittee to R&D Committee]