Definitions

Important words for Research Participants to understand:

Belmont Report

Beneficence

Benefit

Human Subject

Informed Consent

IRB (Institutional Review Board)

Justice

Research

Researcher

Respect for persons

Risk

Sponsor

Belmont Report

Ethical guidance for human subject research; written by members of a National Commission in 1978. The Belmont Report says that three key ideas must guide researchers. These are 1) Respect for persons (free choice); 2) Beneficence (do good, or at least do no harm); and 3) Justice (fairness).

Beneficence
Researchers should do the least harm to you and the most good for you as they can in conducting a study. This rule requires that researchers put your safety above all else. The benefits outweigh the risks of their research.

Benefit

Something good that happens to you or someone else. New knowledge is a benefit; better health is, too.

Human Subject

A living person about whom a researcher gets:

1. information through contact with her/him or
2. private information like school or medical records

Informed Consent

A process of communication between you and the researchers. Informed Consent should help you understand everything you need to know to make a decision. This takes place before you decide whether to take part in the study. If researchers learn about new risks, they should talk about consent with you again. If you have questions, you can ask the researchers and you can change your mind about giving consent and can withdraw if you choose.

IRB (Institutional Review Board)

A committee that reviews research plans before they are begun to help ensure safety and dignity for participants. Federal rules require IRB approval for research with humans if it is supported by the federal government. The Harvard School of Public Health applies the same high standards to all of its human research. Although “IRB” is the common name, some institutions may use different names.

Justice
Researchers should recruit subjects fairly. They should avoid recruiting people merely because they are convenient or easy to manage. Ideally, the people recruited will share in the benefits of the study.

Research

Learning about something in an organized way. Testing an idea or an invention is also research. Research is not the same as treatment.

Researcher

Someone who carries out a research study. Often researchers are called investigators.

Respect for persons
Researchers should show respect for you, because you can and should be allowed to make your own decisions about things that affect your life. This rule is the basis for Informed Consent.

Risk

The chance of a bad outcome. A minimal risk is one in which there is about the same chance of risk as what you experience in everyday life or during routine medical or psychological tests.

Sponsor

A person or group that gives resources (like money, tools, or medicines) for a study.