IN THE PAST

In 1947, the Nuremberg Court found sixteen doctors guilty of crimes against humanity for experimenting on concentration camp prisoners. The court released the Nuremberg Code that outlined 10 points to help make sure that research on human subjects was ethical. Since the Nuremberg Code, there have been many changes in how research is carried out and what we do to protect research participants.

In the USA, scientists and the research community did not always protect the people who were involved in research studies, and there was no one to look out for research participants’ rights. As a result, in 1974, the government passed a law to create the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This group created the Belmont Report, which defines three (3) principles that should guide research involving human subjects: 1) respect for persons, 2) beneficence, and 3) justice. In 1981, the government used these principles to create regulations to protect human subjects and make sure that research studies were reviewed.

TODAY: The research team or researchers must follow these rules and principles

If a researcher has an idea for a research study, s/he will create a very detailed plan that explains the project. The researcher then gives this research plan to a group of people called an Institutional Review Board (IRB). The IRB reads over the research plan to make sure that it asks a good question and that the volunteers will be as safe as possible. If the IRB thinks that the research is good, it will approve it. 

The IRB will also review the research study at least once a year to make sure that everything is going well. If a research participant has a complaint or a question, the participant should contact the IRB. 

Quick Review 

I stands for INSTITUTIONAL, meaning that the study must follow the hospital, university or institution rules that apply to wherever the research will be done.

R is for REVIEW, meaning the study is checked closely to see that rules are followed. 

B stands for BOARD. This means a group of professionals and community members look at the research study.  

What the IRB can do?

When the IRB reviews a study plan that people are a part of, they:

• Agree with the study plan
• Do not agree with the study plan
• Rule that the study plan be changed and state how
• Monitor the research
• Put a hold on the study if needed
• Stop the study

The IRB keeps research ethical

In reviewing research plans, the IRB makes sure that researchers follow these basic ethical principles:

• Justice
• Respect
• Beneficence

Justice

Equal benefits and equal burdens — the idea behind the principle of justice is to make sure that no one is being taken advantage of or doing more than their fair share. We have to be careful not to burden specific groups just because they may not or cannot say “no.” Certain groups may be more likely to be taken advantage of in a research setting. These people may be less able to defend themselves than other persons. These groups include:

• Children
• Prisoners
• Pregnant women
• Fetuses
• Persons with physical or mental disabilities
• Persons with low economic or low education who are economically or educationally disadvantaged

The IRB has extra ways to protect and keep these groups safe. The IRB does this when they review research that has these special groups taking part.

Respect for Persons

Researchers must show that their study plan follows the correct informed consent process. Informed consent tells you your rights as a person taking part and what you are being asked to do. This must be clear and easy to understand. It includes

• Why the study is being done
• What you must do if you agree to take part
• What your risks and discomforts might be
• How you (or others) will benefit from the study
• How long the study will last
• How your confidentiality will be kept safe
• Who to contact if you have questions
• What happens if you change your mind about being in the study after starting
• That your taking part is all voluntary

Voluntarily taking part in a study is a vital part of informed consent. It is okay for people taking part to be allowed to stop taking part at any time, and there will be nothing negative happen to you if decide to stop. Researchers must also show how they will protect your privacy and confidentiality. They must tell the IRB what they will do with the information they collect and how others will not be able to see what you have shared without your saying it is okay.

Beneficence

Beneficence means trying to make good things happen and making sure means that the risk of harm or injury for people who take part is kept as low as possible. A risk is minimal when the chance of harm is no more than what might happen in daily life or during a routine exam.

The IRB also ensures that the potential for benefit has been maximized. Some benefits directly help the people who take part, such as taking a medicine as a research that helps the person’s medical condition. Benefits include adding to new knowledge that will help others.

For more information:

Go to the Research Center health topic.