| Term |
Definition |
| Belmont Report |
Under the auspices of the former United States Department of Health, Education, and Welfare (later renamed the Department of Health and Human Services), the Belmont Report was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and was entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report was created on April 18, 1979 and gets its name from the Belmont Conference Center where the document was drafted. The conference center, once a part of the Smithsonian Institution, is in Elkridge, Maryland, 10 miles south of Baltimore, and is now operated by Howard Community College. The Commission was initiated in response to public outrage over revelations about the Tuskegee Syphilis Study (1932–1972). |
| Children |
Persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. In Texas, a child is anyone under 18 years of age. See also Vulnerable Subjects. |
| Common Rule |
In 1991, 14 other Federal departments and agencies joined the U.S. Department of Health and Human Services in adopting a uniform set of rules for the protection of human subjects of research, identical to subpart A of 45 CFR 46. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.” |
| Declaration of Helsinki |
The Declaration of Helsinki, developed by the World Medical Association, is a set of ethical principles for the medical community regarding human experimentation. It was originally adopted in June 1964 and has since been amended multiple times. |
| Exempt |
Whether or not a research activity is exempt is determined by the IRB, NOT the researcher. In general, the types of research activities that will be considered exempt are:
Research conducted in established or commonly accepted educational settings, involving normal educational practices;
Research involving the use of educational tests, survey procedures, etc., unless the information is identifiable and disclosure would place the subject at risk (Important Note: Survey and interview research with children are NOT EXEMPT!);
Research involving educational tests, surveys, interviews or observation of public behavior if the subjects are elected or appointed public officials or federal statutes require confidentiality without exception
Research involving the collection or study of existing data if the sources are publicly available or the information is recorded in a manner in which the subjects cannot be identified
Research and demonstration programs designed to study, evaluate, or examine federal public benefit or service programs. |
| Expedited Review |
Certain kinds of research can be reviewed more quickly by one or more experienced IRB members either because the research is found by the reviewer(s) to involve no more than minimal risk, or it involves minor changes in previously approved research during the period (one year or less) for which approval was authorized. Whether or not review of a research activity is expedited is determined by the IRB, NOT the researcher. |
| 45 CFR 46 |
Refers to the Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects. 45 CFR 46 is the the U.S. Government policy for ensuring that the human subjects of behavioral and biomedical research receive the protections to which they are entitled and to minimize risks to them.
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| Full Review |
Research that potentially poses more than minimal risk to human research subjects must be reviewed by the entire IRB. |
| Human Subject |
A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information; i.e., information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place or information provided for specific purposes that the individual can reasonably expect will not be made public. |
| Informed Consent |
Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of any actions. The individual needs to be in possession of all of her/his faculties, such as not being mentally retarded or mentally ill and without an impairment of judgment at the time of consenting. Impairments include illness, intoxication, drunkenness, using drugs, insufficient sleep, and other health problems.
Some acts cannot legally take place without informed consent. In other cases, consent of someone on behalf of a person not considered able to give informed consent is valid. Examples of this include the parents or legal guardians of a child or caregivers for the mentally ill.
Informed consent is important in social/behavioral and biomedical research. For example in survey research, people need to give informed consent before they participate in the survey. In medical research the Nuremberg Code has set a base standard since 1947, and most research proposals are reviewed by ethics committees (IRBs). |
| Institutional Assurances |
Formal documentary assurance submitted by an institution to the U.S. Office for Human Research Protections attesting to the institution’s compliance with the requirements set forth in 45 CFR 46. Institutions engaged in research which is covered by 45 CFR 46 and which is conducted or supported by a federal department or agency must provide written assurance satisfactory to the department or agency head that it will comply the policy. |
| Institutional Review Board |
An independent administrative body established to protect the rights and welfare of human research subjects. It consists of at least five members from varied disciplinary backgrounds who are qualified to review research. Membership should be diverse, with at least one member having a scientific background and at least one having a nonscientific background. Members should not participate in decisions in which they have conflicts of interest. People with specialized expertise may be invited to advise on specific reviews where the body lacks expertise. |
| IRB |
Abbreviation for Institutional Review Board. |
| IRB Approval |
The determination of the IRB that a research activity has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. |
| Minimal Risk |
The probability and magnitude of harm or discomfort anticipated in research activity that are no greater than those encountered in daily life or the performance of routine physical or psychological examinations or tests. |
| Nuremberg Code |
A set of principles for human experimentation set as a result of the Nuremberg trials at the end of the Second World War. Specifically, they were in response to the inhumane Nazi human experimentation carried out during the war. |
| Research |
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. |
| Vulnerable Subjects |
Human subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Vulnerable subjects must be afforded special safeguards in a study to protect their rights and welfare. |
| Sources: 45 CFR 46; Wikipedia; Sapp & Martin, 2005. |
