HRPP/IRB

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Glossary of Terms

Name

Definition

AAHRPPAssociation for the Accreditation of Human Research Protection Programs, Inc.
Adverse EventAn undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
AssentAgreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
CCCComprehensive Cancer Center
Common RuleAnother term for 45 CFR 46 Federal Policy for the Protection of Human Subjects (DHHS Policy for the Protection of Human Research Subjects).
Data and Safety MonitorAn individual assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. The individual should have expertise in the relevant medical, ethical, safety and scientific issues.
Data and Safety Monitoring Board (DSMB)A formally appointed independent group consisting of at least three (3) members assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics, and research study design.
Data and Safety Monitoring Committee (DSMC) Another name for a DSMB, or a less formal Board.
Data and Safety Monitoring Plan (DSMP)A DSMP describes how the Investigator plans to oversee the research participant’s safety and welfare and how adverse events will be characterized and reported. The intensity and frequency of monitoring should be tailored to fit the expected risk level, complexity, and size of the particular study.
FDAThe Food and Drug Administration
Federalwide Assurance (FWA)A formal written, binding commitment submitted to a federal agency where an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures to be used to achieve compliance. Vanderbilt University, FWA#00005756.
FERPAThe Family Education Rights and Privacy Act
FTEFull Time Equivalent
GCRCGeneral Clinical Research Center
HHSThe Department of Health and Human Services
HIPAAThe Health Insurance Portability and Accountability Act
HSRC Human Subjects Radiation Committee
Human SubjectIndividuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the Federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) indentifiable private information.
Informed ConsentA person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, a subject may not waive or appear to waive any of his/her legal rights, or release or appear to release the investigator, the sponsor, the institution or agents of the institution from liability for negligence. [Federal Policy 116; 21 CFR 50.20 and 50.25]
IOMInstitute of Medicine
IRBA specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or social/behavioral research.
JCAHOJoint Commission on the Accreditation of Healthcare Organizations
KSPKey Study Personnel
Minimal RiskA risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
NCINational Cancer Institute
NCQANational Committee for Quality Assurance
NIHNational Institute of Health
NSFNational Science Foundation
OCROffice of Civil Rights
OHRPThe Office for Human Research Protections (OHRP), formerly known as the Office for Protection from Research Risks (OPRR) is an administrative unit within the Department of Health and Human Services (DHHS). The OHRP’s functions include implementation of the DHHS Regulations for the Protection of Human Subjects (45 CFR 46), and the guidance on ethical issues in biomedical or social/behavioral research.
PHIProtected Health Information
ProtocolThe formal design or plan of an experiment or research activity, specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
QIQuality Improvement
RDRCRadioactive Drug Research Committee
RHIResearch Health Information
Unanticipated Event/ProblemAny event that was serious, unanticipated, and related to the research.
VATVHSVA Tennessee Valley Healthcare System