We’ve had several requests to put together a list of commonly used IRB acronyms. Below is what we could come up with right off the top of our heads. Please let Edith Paal in the IRB office know if there are others you’re curious about — we can track them down for you.
AARHPP – Association for the Accreditation of Human Research Protection Programs. This is our accrediting group, and our next application for reaccreditation is due in September 2015.
ACH – Arkansas Children’s Hospital
ACHRI – Arkansas Children’s Hospital Research Institute. A not-for-profit corporation owned by ACH.
CCTO – Cancer Clinical Trials Office. This office is part of the UAMS Winthrop P. Rockefeller Cancer Institute
CFR – Code of Federal Regulations. 45 CFR 46 is the Common Rule, which is one of the primary guides to IRB functioning.
CIRB – Central IRB. Can be used generally when describing a multisite study that is being reviewed by one IRB that covers all site, rather than a separate IRB at each site.
CITI – Collaborative Institutional Training Initiative, more commonly known as the group that puts together the online required human subject protection training at citiprogram.org.
CLARA – Clinical Research Administration System. CLARA replaced the now-defunct ARIA.
COI – Conflict of Interest
CR – Continuing review
CRF – Case report form (we shouldn’t see these too often at the IRB)
DSM – Data and Safety Monitoring (or Monitor)
DSMB – Data and Safety Monitoring Board
DSMP – Data and Safety Monitoring Plan – See UAMS IRB Policy 7.8 for information related to data and safety monitoring
FDA – Food and Drug Administration
FWA – Federalwide Assurance, through which an institution commits to the federal Department of Health and Human Services that it will comply with the requirements of 45 CFR 46.
ICF – Informed consent form
HDE – Humanitarian Device Exemption. The FDA grants HDEs to allow the use of HUDs.
HRPP – Human Research Protection Program
HUD – Humanitarian Use Device. Rhymes with “dud” (not “aitch-you-dee”, which differs from the usual way we pronounce IDE and IND). If you are ever assigned a HUD to review, remember the IRB office has a primer to guide you. Please ask us for it if we don’t remember to send it to you.
IDE – Investigational Device Exemption. An IDE pertains to some studies of FDA-regulated investigational devices
IND – Investigational New Drug. The FDA’s granting of an IND allows studies of investigational drugs to proceed
IRB – Institutional Review Board (but you knew that already, right?)
LAR – Legally authorized representative
NSR – Non-significant risk. This is a determination that pertains to some investigational devices.
OHRP – Office for Human Research Protections. The federal office that oversees human subject research.
PHI – Protected Health Information. A HIPAA term. See UAMS Admininstrative Guide policy 3.1.27 for everything you ever wanted to know, and more, about HIPAA and research.
PI – Principal Investigator
SAE – Serious Adverse Event. An FDA term, seen most often in connection with FDA-regulated trials. An SAE’s sibling is the AE, or adverse event. The FDA’s definitions of these can be found here.
SR — Significant risk. Another determination pertaining to investigational devices.
SOP – Standard Operating Procedure
UPIRTSO – Unanticipated problem involving risks to subjects or others. And no, we don’t know what the correct pronunciation of this acronym is either – we just pronounce it “you-PERT-so.”