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.

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.

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.

Clinical Research Center

CRCs are a national network of clinical research units typically located within hospitals at academic medical centers. UVM has a CRC at UVM Medical Center. 

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).

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.

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.

Flether Allen Health Care

The hospital associated with the University of Vermont.

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.

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).

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.

(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).

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.

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.

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.

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.

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.

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.

Office of Human Research Protection

UVM is the "institution" referred to throughout the tutorial. It is associated with UVM Medical Center Health Care to create our local academic medical center.

University of Vermont Cancer Center

The UVMCC is a department of the College of Medicine at UVM charged with the research, diagnosis and treatment of cancer at our academic medical center.