home

Human Subjects Research - Institutional Review Boards - IRBs

Tutorial Acronyms (UVM)

Acronyms Used in the Tutorial

Acronymn Term Description
CFR Code of Federal Regulations The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.
CHRBSS Committee on Human Research in the Behavioral and Social Sciences One of the two institutional review boards at the University. This committee reviews all behavioral research on humans.
CHRMS Committee on Human Research in the Medical Sciences One of the two institutional review boards at the University. This committee reviews all medical and/or clinical research on humans.
DHHS (also "HHS") Department of Health and Human Services The Department of Heath and Human Services is the US government's principle agency for human health and welfare issues. Departments include the Food and Drug Administration (FDA), the Centers for Disease Control(CDC), the National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS).
DSMB Data and Safety Monitoring Board A Data and Safety Monitoring Board is an independent committee, formally established to monitor data throughout the duration of a study and determine if continuation of the study is appropriate scientifically and ethically.
DSMP Data and Safety Monitoring Plan A Data and Safety Monitoring Plan is required for all intervention protocols. The plan should include adverse event grading, and the monitoring plan and address any conflicts of interest, interim study analyses, and plans for informing the IRB. The "plan" should state whether or not a DSMB is required.
FAHC Flether Allen Health Care The hospital associated with the University of Vermont.
FDA Food and Drug Administration The FDA is the federal agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FWA Federal Wide Assurance Every institution engaged in human subjects research supported or conducted by DHHS must create a written assurance of compliance. This assurance is called a Federal Wide Assurance (FWA) and must be approved by the Office for Human Research Protections (OHRP).
GCP Good Clinical Practices Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of FDA clinical trials.
GCRC General Clinical Research Center GCRCs are a national network of clinical research units typically located within hospitals at academic medical centers. UVM has a GCRC at Fletcher Allen Health Care.
HHS (also "DHHS") (Department of) Health and Human Services The Department of Heath and Human services is the US government's principle agency for human health and welfare issues. Departments include the Food and Drug Administration (FDA), the Centers for Disease Control(CDC), the National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS).
HIPAA Health Insurance Portability and Accountability Act HIPAA: [pr: hip'-ah] The Health Insurance Portability and Accountability Act of 1996. HIPAA is a federal law that was designed to allow portability of health insurance between jobs. In addition, it required the creation of a federal law to protect personally identifiable health information; if that did not occur by a specific date (which it did not), HIPAA directed the Department of Health and Human Services (DHHS) to issue federal regulations with the same purpose. DHHS has issued HIPAA privacy regulations as well as other regulations under HIPAA.
HIV Human Immunodeficiency Virus HIV is the virus that causes AIDS. Confidentiality and privacy measures are especially important when subjects have, or may have, either HIV or AIDS.
IDE Investigational Device Exemption An IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support Premarket Approval. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
IND Investigational New Drug An IND Application is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of a full FDA application.
IRB Institutional Review Board The IRB is operated by the institution to review and provide oversight of human subject research, regardless of where the research takes place, regardless of funding or by whom it is conducted.
NIH National Institutes of Health NIH is one of the agencies of the Public Health Services which, in turn, is part of the U.S. Department of Health and Human Services. 84% of the NIH budget (24 billion) is for grants and contracts supporting research and training in more than 2,000 research institutions throughout the U.S. and abroad.
OHRP Office of Human Research Protection The OHRP is an executive department in the US government, charged with the compliance and education of institutions performing human subject research. The OHRP distributes advisory documents about human protections, and approves an institution's FWA.
PHI Protected Health Information PHI is a HIPAA term that is only applicable when HIPPA applies. It is any information created or received by a covered entity that relates to the past, present, or future physical or mental health or condition of an individual.
PI Principal Investigator The PI is the person responsible for the conduct of the research. If a project is conducted by a team of individuals, such as multiple sub-investigators and research staff, the principal investigator is the responsible leader of the team.
PRC Protocol Review Committee The Protocol Review Committee (PRC) is a Vermont Cancer Center entity that reviews all clinical cancer protocols at the University of Vermont and Fletcher Allen Health Care prior to initiation. This is in addition to IRB approvals.
UVM University of Vermont UVM is the "institution" referred to throughout the tutorial. It is associated with Fletcher Allen Health Care to create our local academic medical center.
VCC Vermont Cancer Center The VCC is a department of the College of Medicine at UVM charged with the research, diagnosis and treatment of cancer at our academic medical center. The VCC is an NCI-designated Clinical Cancer Center.


Last modified February 06 2014 10:50 AM

Ethics and Compliance Reporting and Help Line
Contact UVM © 2014 The University of Vermont - Burlington, VT 05405 - (802) 656-3131