AP Research Ethics

Nuremberg Code

A set of international ethical guidelines for conducting research with humans.

Belmont Report

The Belmont Report was written by an advisory committee created by Congress and published in 1979.

Respect for Persons

The principle of respect for persons acknowledges that individuals make decisions about how they want to live their lives, including if they want to volunteer for research studies.

Beneficence

The principle of beneficence acknowledges that research could bring about important contributions to the public good.

Justice

The principle of justice is concerned with the fair distribution of burdens and benefits.

Common Rule

Subpart A of the regulations is referred to as the Common Rule because many other Federal departments and agencies have also adopted it to protect participants in the research they conduct or fund.

Office for Human Research Protections (OHRP)

OHRP is part of the U.S. Department of Health and Human Services (HHS) that oversees and enforces the Common Rule and other HHS regulations for protecting people in research.

Institutional Review Board (IRB)

IRBs are committees that make sure researchers follow the HHS rules and ethical guidelines as they carry out their studies.

Federalwide Assurance (FWA)

FWA stands for Federalwide Assurance, which shows that institutions commit to comply with regulations and support IRB activities.

Informed Consent

The Common Rule generally requires researchers to obtain informed consent from volunteers, including information about the study, risks, and benefits.

Henry Beecher (1966)

An anesthesiologist and researcher known for publishing examples of unethical experiments involving human subjects.

U.S. Department of Health and Human Services (HHS)

The federal department overseeing the development of regulations protecting research subjects.

National Institutes of Health (NIH)

An HHS agency involved in human research oversight under OHRP regulations.

Centers for Disease Control and Prevention (CDC)

An HHS agency that funds human research overseen by OHRP.

U.S. Food and Drug Administration (FDA)

An HHS part ensuring the safety, efficacy, and security of drugs and medical devices.

Informed Consent

A process ensuring participation in research is voluntary, informed, and comprehended by the participant.

Documentation of Informed Consent

Consent must be recorded in writing and signed by the participant or an authorized representative.

Diminished Autonomy

Factors like age or illness may reduce a person's ability to independently consent to research.

Decisional Capacity and Legally Authorized Representatives

Researchers must provide for subjects who cannot make their own decisions by involving authorized representatives.

Assent and Permission for Children’s Participation

Children’s ability to agree to join research depends on their age and development, as judged by the IRB.

Risk-Benefit Analysis

Researchers must weigh and justify the risks to participants against the expected value of the new knowledge gained.

Compensation for Research Participation

Payment to reimburse participants for effort or inconvenience, not a benefit of the study itself.

Undue Inducement

Overly attractive offers may unfairly influence participants' decisions regarding research.

Privacy and Confidentiality

Privacy protects against unapproved intrusion; confidentiality keeps personal information secret.

Coded Private Information and Human Subjects Research

Research involves human subjects if researchers can link private information to identities.

Anonymized Data

Data is anonymized when no one can identify its source, protecting participant identities.

Autonomy

The right of individuals to make their own informed decisions freely and independently.

Maleficence

The ethical principle of avoiding harm or causing injury to others.

Confidentiality

The responsibility to keep personal and private information secure and undisclosed without consent.