Use and Protection of Human and Animal Subjects – Key Vocabulary

Thirty vocabulary flashcards summarizing essential ethical terms, historical studies, regulations, and principles related to the protection of human and animal research subjects.

Nuremberg Code (1947)

Ten principles that established voluntary, informed consent and risk-benefit limits for human experimentation after WWII war-crime trials.

Declaration of Helsinki (1964)

World Medical Association ethical code for human research; adds requirements for independent review boards, vulnerable populations, and six later revisions.

Belmont Report (1978)

U.S. document outlining the three core principles—Respect for Persons, Beneficence, and Justice—that guide ethical human-subjects research.

Common Rule (1991)

Federal policy (45 CFR 46) that codifies protections for human subjects, IRB requirements, and informed-consent standards across U.S. agencies.

Institutional Review Board (IRB)

Committee that reviews proposed human-subjects research to ensure risks are minimized, benefits justified, and ethical standards met.

Full Board Review

IRB review category for studies involving more than minimal risk or vulnerable populations; requires discussion and vote by the convened board.

Expedited Review

IRB process for minimal-risk studies fitting specific categories; reviewed by the chair or designated reviewers instead of the full board.

Exempt Review

Research categories considered very low risk and exempt from ongoing IRB oversight, although an initial determination is still required.

Informed Consent

Process ensuring participants receive understandable information, voluntarily agree, and may withdraw without penalty before or during a study.

Consent Form

Written document (≈6th-grade reading level, second-person) signed by subject, witness, and investigator, summarizing study purpose, procedures, risks, and rights.

Beneficence

Ethical principle requiring researchers to maximize possible benefits and minimize potential harms to participants and society.

Justice

Ethical principle demanding equitable selection of subjects and fair distribution of research burdens and benefits.

Respect for Persons

Principle emphasizing individual autonomy, voluntary participation, and additional protection for those with diminished decision-making capacity.

Research (45 CFR 46.102[d])

Systematic investigation designed to develop or contribute to generalizable knowledge, including development, testing, and evaluation.

Human Subject (45 CFR 46.102[f])

Living individual about whom data or identifiable private information are obtained via intervention or interaction for research purposes.

Institutional Animal Care and Use Committee (IACUC)

Body overseeing animal research to ensure humane care, compliance with regulations, and ethical scientific justification.

Animal Welfare Act (1966)

U.S. federal law setting minimum standards for housing, handling, and care of research animals; amended multiple times for stricter protections.

Unit 731

Japanese WWII program that infected prisoners with pathogens and concealed results as work on “monkeys,” exemplifying unethical human experimentation.

Tuskegee Syphilis Experiment

1932–1972 U.S. study where Black sharecroppers with syphilis were misled and left untreated to observe disease progression.

Operation Whitecoat

1950s-1970s study where conscientious objectors (mostly Seventh-day Adventists) voluntarily exposed themselves to pathogens to test vaccines.

Jewish Chronic Disease Hospital Study (1963)

Researchers injected elderly patients with live cancer cells without proper informed consent to study immune rejection.

Willowbrook Hepatitis Study

1956–1971 New York state-school study infecting mentally disabled children with hepatitis; parents consented partly to secure admission.

Monster Study (1939)

University of Iowa experiment giving orphaned children positive or negative speech feedback to observe development of stuttering.

Milgram Obedience Study (1963)

Yale experiment showing that ordinary individuals would administer what they believed were painful electric shocks under authority pressure.

Tearoom Trade Study (1970)

Sociological research by Laud Humphreys observing anonymous public sexual encounters without initial consent, raising privacy concerns.

Risk (Research Context)

Potential physical, psychological, social, legal, or economic harm that may arise from participation, both immediate and latent.

Benefit (Research Context)

Value or advantage to the subject or society; financial payment is not considered a research benefit in ethical analysis.

Vulnerable Subjects

Populations such as children, prisoners, pregnant women, cognitively impaired, or students who may require extra protections during research.

Consent Process

Dialogue before participation in which investigators disclose information, assess comprehension, and obtain voluntary agreement.

Risk/Benefit Analysis

IRB evaluation comparing anticipated harms with potential gains to ensure the benefit-to-risk ratio is ethically favorable.