Human Subjects Research & IRB Study Guide

A set of flashcards covering key concepts, ethical principles, and regulations related to human subjects research and Institutional Review Boards (IRBs).

Nuremberg Code

Established the foundation of modern research ethics and informed consent following Nazi medical experiments.

Voluntary Participation

A key principle in ethical research indicating participants must choose to participate without coercion.

Informed Consent

A mandatory process ensuring participants understand the research risks and benefits before agreeing to participate.

Belmont Report

A report outlining ethical principles for human subjects research, including respect for persons, beneficence, and justice.

Respect for Persons

An ethical principle emphasizing the autonomy of individuals and the need to protect those with diminished autonomy.

Beneficence

The ethical principle of doing no harm and maximizing benefits while minimizing risks.

Justice in Research

Ensures fair distribution of research burdens and benefits, avoiding exploitation of marginalized populations.

Common Rule

U.S. federal policy established to protect human subjects in research, codified in 1991 and revised in 2018.

IRB (Institutional Review Board)

A committee that reviews research proposals to ensure ethical standards and participant protections are met.

Exempt Review

A type of IRB review for research involving minimal risk that fits specific regulatory categories.

Expedited Review

IRB review for research with minimal risk that includes sensitive data or vulnerable populations.

Informed Consent Process

An ongoing process that includes clear communication about purpose, risks, benefits, and voluntary participation.

Direct Identifiers

Information that can be used to directly identify an individual, such as name or social security number.

Anonymity

A state where no identifiers are collected, ensuring that participants cannot be identified.

Data Security

Management practices that ensure collected data are stored securely and only necessary data is collected.

Minimal Risk

Risk levels in research that are comparable to daily life experiences.