HOW AM I PROTECTED?

There are ethical guidelines in place that protect research volunteers and the integrity of science. These guidelines are upheld by the investigator and a reviewing body called the Institutional Review Board, or IRB for short. Each entity is responsible for the ethical treatment of all research volunteers.

• Investigator: Investigators are responsible for conducting research that positively impacts society as well as treating volunteers with respect and dignity. They are the people responsible for the oversight of a study. They and their research team are responsible for providing you with a clear presentation of procedures, possible risks and benefits of the research, and any incentives or costs to you. They are also responsible for clearly answering questions you may have about the study at any time.
• Institutional Review Board (IRB): Institutions delegate a board of professional scientists and others from different backgrounds to review research studies in order to ensure the rights, welfare, and safety of volunteers is protected. This board is called an Institutional Review Board, or IRB. Before investigators begin any research, their studies must go through IRB review. This process is in place to ensure all research is ethical and meets regulatory guidelines for the protection of human research participants.

WHAT ARE MY RIGHTS?

As a research participant, you have the right:

• To know the purpose of the research study
• To know the research study procedures
• Understand potential risks and benefits of participating in the study
• Withdraw from the study at any time without it affecting your employment, social standing, or relationship with the institution or investigator

Learning as much as possible about a research study will help you to make a clear decision of whether or not you want to engage in the study.

Your research team is your biggest resource when learning about studies. This team is a well-trained and knowledgeable source for information regarding all aspects of your participation. They should be able to openly describe why they are conducting the research, what type of data will be collected from you, how it will be stored, and what you will be doing during the course of the study.

Before you begin a study, your research team will provide you with an informed consent document that discloses in detail what to expect. You have the right to take this document home with you to discuss these details if you feel it is necessary. You may seek advice from family members, your community, clergymen, or other providers to see if the study is a good fit.

A few helpful questions to consider before you participate in research include:

• What is the purpose of this research?
• Will I know which treatment I will receive?
• How will my information be used?
• How long the study will last?
• Will my insurance cover the costs associated with research?
• How will this study help my family or community?
• What will I be doing?
• Why are you doing this study?
• Who can I call if something goes wrong?
• Is there a sponsor for this study?
• Who will see my data?

For additional information, please read the NIH's article 'What You Should Know About Research.

What to do if you have concerns about research

If you feel that your rights have been violated or have questions regarding your rights as a research participant, you may contact the Institutional Review Board Office to report your concerns.