Glossary—Terms Used in Research With Humans (Home, A-C)

IRB Glossary
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IRB Acronyms
Spelled-out versions of acronyms

Merriam-Webster Online

Other Online Glossaries Related to Clinical Research
Not maintained by UAB but possibly useful for researchers and participants

A

Abuse-Liable
Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroine) and licit drugs (e.g., methamphetamines).

Adjuvant Therapy
Therapy provided to enhance the effect of an primary therapy; auxiliary therapy.

Adverse Effect (from OHRP IRB Guidebook)
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).

Adverse Drug Experience (Life-threatening, Serious, Unexpected)
21 CFR 312.12

Adverse Experience (Life-threatening, Serious, Unexpected)
21 CFR 600.80

Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
Alcohol, Drug Abuse, and Mental Health Administration; reorganized in October 1992 as the Substance Abuse and Mental Health Services Administration (SAMHSA). ADAMHA included the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), the Office for Substance Abuse Prevention (OSAP), and the Office for Treatment Intervention (OTI). NIMH, NIAAA, and NIDA are now part of the National Institutes of Health (NIH). (See also: SAMHSA.)

Approved with Limited Modifications (ALM)
Refers to status of reviewed protocols. See the IRB Guidebook Section 6 for more.

Assent
Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

Assurance
A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [Federal Policy §___.103].

Authorized Institutional Official
An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human participants in biomedical and behavioral research.

Autonomy
Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

Autopsy
Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts.

B

Belmont Report
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm)

Beneficence
An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

Benefit
A valued or desired outcome; an advantage.

Biologic
Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

Blind Study Designs
See: Masked Study Designs; Double-Masked Design; and Single-Masked Design.

C

Cadaver
The body of a deceased person.

Case-Control Study
A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors. (See also: Retrospective Studies.)

Centers for Disease Control and Prevention (CDC)
An agency within the Public Health Service, Department of Health and Human Services.(www.cdc.gov)

Children
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)].

Children's Risk Level (CRL)
CRL 1 (45 CFR 46.404)—Research not involving greater than minimal risk.

CRL 2 (45 CFR 46.405)—Research involving greater than minimal risk but of possible direct benefit to the child, in which the risk is at least as favorable to the subject as that presented by available alternative approaches.

CRL 3 (45 CFR 46.406)—Research involving greater than minimal risk and no prospect of direct benefit to the individual child, but likely to yield generalizable knowledge about the disorder or condition, in which the risk is minor relative to the potential improvement in knowledge to be applied to general understanding.

CRL 4 (45 CFR 46.407)—Research not meeting the specifications above, but which presents an opportunity to understand, prevent or alleviate a serious problem affecting the health and welfare of children.

For further information, see the form for Special Population Review – Children/Minors in Section 10, "Forms," of the UAB IRB Guidebook.

Class I, II, III Devices
Classification by the Food and Drug Administration of medical devices according to potential risks or hazards.

Clinical Trial
A controlled study involving human participants, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.

Code of Federal Regulations (CFR)
"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" (http://www.gpoaccess.gov/cfr/about.html ¶1).

Regulations related to human research are 45 CFR 46 (Tiitle 45 , Part 46) and for the FDA only 21 CFR 50 and 56 (Title 21, Parts 50 and 56).

Cognitively Impaired
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

Cohort
A group of participants initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.

Collaborative IRB Training Initiative (CITI)
An online training program for researchers and staff, hosted at University of Miami.
Register for initial or continuing IRB training.

Common Rule
Regulations that govern human subjects of research and have been adopted by seventeen federal agencies, as delineated in Title 45 of the Code of Federal Regulations Part 46 Subpart A

Compensation
Payment or medical care provided to participants injured in research; does not refer to payment (remuneration) for participation in research. (Compare: Remuneration.)

Competence
Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.

Computerized Axial Tomography (CAT Scan)
An X-ray technique for producing images of internal bodily structures through the assistance of a computer.

Confidentiality
Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.

Consent
See: Informed Consent.

Contract
An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. Research performed under contract is more closely controlled by the agency than research performed under a grant. (Compare: Grant.)

Contraindicated
Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).

Control (Participants) or Controls
Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of participants is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.

Correlation Coefficient
A statistical index of the degree of relationship between two variables. Values of correlation coefficients range from -1.00 through zero to +1.00. A correlation coefficient of 0.00 indicates no relationship between the variables. Correlations approaching -1.00 or +1.00 indicate strong relationships between the variables. However, causal inferences about the relationship between two variables can never be made on the basis of correlation coefficients, no matter how strong a relationship is indicated.

Crossover Design
A type of clinical trial in which each participant experiences, at different times, both the experimental and control therapy. For example, half of the participants might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.

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