|Association for the Accreditation of Human Research Protection Programs, Inc.
|An 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).
|Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
|Comprehensive Cancer Center
|Another 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 Monitor
|An 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.
|The 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.
|The Family Education Rights and Privacy Act
|Full Time Equivalent
|General Clinical Research Center
|The Department of Health and Human Services
|The Health Insurance Portability and Accountability Act
|Human Subjects Radiation Committee
|A living individual about whom an Investigator (whether professional or student) conducting research:a.obtains information or biospecimensthrough intervention or interaction with an individual and uses, studies, or analyzes the information or biospecimen; b.obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens; orc.identifies a subject as either a recipient of atest article or as a control. A subject might be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used. When medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.
|A 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]
|Institute of Medicine
|A 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.
|Joint Commission on the Accreditation of Healthcare Organizations
|Key Study Personnel
|A 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.
|National Cancer Institute
|National Committee for Quality Assurance
|National Institute of Health
|National Science Foundation
|Office of Civil Rights
|The 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.
|Protected Health Information
|The 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.
|Radioactive Drug Research Committee
|Research Health Information
|Any event that was serious, unanticipated, and related to the research.
|VA Tennessee Valley Healthcare System