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. |
UVM Medical Center |
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 UVM Medical Center. |
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. |
PRMC |
Protocol Review and Monitoring Committee |
The Protocol Review and Monitoring Committee (PRMC) is a Vermont Cancer Center entity that reviews all clinical
cancer protocols at the University of Vermont and UVM Medical Center 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 UVM Medical Center
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. |