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What do I need to know about participating in a research study?

Research studies try to answer important questions.
A research study is an organized program that is designed to answer a question. Any research study that collects information about people or uses existing information is considered human subjects research. This research study hopes to answer questions about whether or not a new program can help African American breast cancer survivors prevent weight gain.

Research studies have certain criteria for participation.
All research studies have specific requirements about who can participate. These requirements are called inclusion and exclusion criteria. Inclusion criteria define specific conditions or characteristics that make it appropriate to enroll a person into a study. Exclusion criteria define conditions or characteristics that would make it inappropriate for a person to be enrolled. These criteria are often based on such factors as age, gender, medical history, and health status. A person must qualify for the study before being asked to join. It is important to understand that these criteria are not used to reject people personally. Instead, the criteria identify appropriate participants for whom the research is relevant and help minimize the risks those participants face. The criteria also help researchers answer the research questions.

Research studies have different groups they are testing.
Research studies compare different treatments. The best research studies randomly assign participants into treatment groups, meaning you can’t choose which group you want to be in. It is like flipping a coin to determine which group you are in. If you do not agree to be randomly assigned to a group, you should not sign up for a research study. In this study, all groups receive a weight gain prevention program. The main difference between the groups is when they receive the weight gain prevention program.

Research studies require data collection and follow up with participants.
One important difference between a weight gain prevention program that is not part of a research study and one that is a research study is that researchers will be collecting data before the program starts and at the end of the program in order to evaluate the program. It is CRITICAL that all participants complete data collection visits at all times. You should not participate in this program if you are not willing to complete the data collection. Data collection will include measurements of your height and weight, blood pressure, lab tests for cholesterol and HbA1c, and questionnaires about your health history, habits, and ideas.

Research studies offer cutting edge free treatment.
Research studies are great opportunities to get treatment for free and to contribute to the greater good by helping researchers improve treatment programs.

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