Is a Research Study for You?
A Guide to Understanding Your Rights and Responsibilities as a Participant in a Research Study

Meeting the Research Team

In this section, you will read about the information shared during your meeting with the research team including:

• the details of the research study
• safety
• conflicts of interest

Details of the Research Study
The first step in the informed consent process is a meeting between you and a member of the research team. The best place for this meeting is where you are comfortable sharing your confidential medial information and discussing your participation in the research study.

During this meeting, you will receive detailed information about the research study. These details will include:

Purpose of the Research Study – what the study is investigating and the reasons why the research study is being done

Benefits and Risks of Participation – what possible good and bad results (benefits and risks) might happen to you from participation in the research study. The research study is an experiment and some of the risks and benefits may not yet be fully known. While you may not receive direct benefits from the research, your participation could help people in the future.

Description of the Procedures – what will happen during the research study. Procedures might include the tests that will be done at each visit, drugs to take or activities to do between study visits, and how long the research study will last.

Alternative Treatment Options – what options are available other than volunteering in a research study You may decide to choose standard medical treatment, or to do nothing. The research study team will tell you about the treatment alternatives during the informed consent process.

Future use of specimens or information collected during your participation – a research study may or may not include the collection of specimens or information from you as part of the procedures of the study. It is possible that these specimens or information could be stored for another purpose(s) and used in the future.

Financial incentives – a research study may or may not include a financial incentive for volunteering. Examples of financial incentives include money, coupons, vouchers, or reimbursement of your expenses.

Financial risks - the research team will explain any financial risks or costs that you or your insurance company might be responsible for during the  study. For example not all of your medical care may be covered if you are injured because of a research study.  

Safety
The research study has been designed to make your participation as safe as possible. But you can also help make it safe:

• Be sure that you understand what you are expected to do as a research volunteer.
• Ask questions if you don't understand what you are to do, and describe your understanding in words to make sure you have it right.
• If you have questions during the study, ask a member of the research team.
• If something unusual happens, tell a member of the research team.

Remember, the research team would rather stop the study than have anyone be unsafe. As a research volunteer, your safety is of great importance to the research.

Conflicts of Interest
In your meeting with the research team, you will also hear about any conflicts of interest that either the Principal Investigator or the institution may have in carrying out the research. A conflict of interest is when a Principal Investigator, a member of the research team, or the institution has the possibility of personal or significant professional gain from a research study. Examples of conflicts of interest can be:

• Money: if the study sponsor pays the researcher to conduct the study
• Opportunity for Career Advancement
• Reputation in the Research Community
• If your doctor is also the Principal Investigator of the research study. The difference is that your doctor's main goal is to treat your illness or condition (provide healthcare) and the Principle Investigator's main goal is to learn if a drug, device, procedure, or behavioral change is safe and effective. When the same person is filling both roles, this is a conflict of interest.

If the research team tells you about a conflict of interest and you do not understand, keep asking questions. To many people, conflicts of interest can be confusing but it is important that you understand what they are before making your decision to join the research study.