Genetics research can tell us more about how our genes work.
Research in people
To learn more about how genetics plays a role in disease, scientists need help from people. Genetics research in people can lead to a better understanding of a disease, better testing for a condition, or better treatments for the disease or condition. It also can help researchers to:
- Study how well a treatment works and how safe it is
- Understand why some treatments work for some people and not others
- Look at how your environment and lifestyle affect your genetics and health
How Are People in Research Studies Protected?
The government has policies to protect people that participate in genetics research. These policies are called human subjects protections, and they came about because of unethical research being performed on humans. The most infamous examples are experiments conducted by the Nazis during World War II and the Tuskegee syphilis study in the United States.
Human subjects protections say that a group of experts must approve all research studies involving people. The group of experts is called an Institutional Review Board, or IRB. IRBs, were created by the National Research Act in 1974. IRBs approve, monitor, and review research. The IRB’s primary goal is to protect the rights of people in research. The IRB is made up of experts in areas like medicine and ethics. IRBs must also include one person who is not a scientist and one person who is a member of the community.
What Does an Institutional Review Board (IRB) Do?
The IRB makes sure that risks to people are as low as possible. The potential benefits of the study must outweigh the potential risks. Researchers present their plans to the IRB before they begin work. If an IRB thinks that a research study is too risky for participants, they will ask for changes to the research plan or not allow it to go on. The IRB also reviews the research regularly (at least once a year). Researchers are required to report to the IRB any changes to the research methods, all adverse reactions (bad effects of a medicine), and any new information that may affect the safety of the participants.
What Is the Informed Consent Process?
Before you agree to participate in a research study, you will be a part of the informed consent process. In the informed consent process, someone involved with the research study will explain what you will need to do if you participate in the study. This person will explain the risks and benefits of the study. You will have an opportunity to ask questions. Your participation is voluntary; it is your choice, and you can choose to say no. You will receive a form that explains everything about the study and who to contact with questions. This form is called an informed consent form. It is very important that you understand this form and ask questions about anything that you don’t understand.
The informed consent form will give you information about the research project, including the risks and benefits, study requirements, sample donations, and if you will be paid in any way to participate. It also tells you the rules that researchers must follow when using your samples and information. It tells you about how your privacy and confidentiality will be protected, who will have access to your information, and where your information will be stored. You should be comfortable with what is expected from you and researchers before you take part. When you sign the informed consent form you are agreeing to take part in the research study. However, you can leave any study at any time. The informed consent form explains how and tells you who to contact. There are special forms and requirements for working with children or others who are at risk or cannot give consent on their own.