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

Rights as a Volunteer

In this section you will read about:

• Your rights as a volunteer in research
• Importance of knowing your rights

Your rights as a volunteer in research
As a volunteer in research you have certain rights and responsibilities. Your rights and responsibilities are the same no matter what kind of research you volunteer for.

Your rights include:

• Right to volunteer: After listening to all of the Informed Consent information, you may decide to volunteer for the research study.
• Right to keep personal information confidential: The information and specimens collected during the study will not be shared with any one other than those listed in the Informed Consent Document. However, there may be an exception if follow-up is needed for safety reasons.
• Right to receive information about the research study in a way that makes sense to you: The information described to you by the research team may include medical words or spoken in a language that you are not familiar with. If there is anything you do not understand, ask the research team to explain.
• Right not to volunteer or to withdraw if you are already in a research study : At any time, if you decide not to be a part of the research study please share your decision with the research team. Remember, deciding not to volunteer or withdrawing from a research study will not affect the quality of your future health care.
• Right to ask questions : At any time you may ask questions about the research study. Here are several contacts that can answer your questions:
  • Principle Investigator (PI):
    This person has designed the research study, is in charge of the informed consent process, and sets the standards for
    quality during the research study.
  • Research Staff:
    The research staff is composed of people trained and supervised by the Principal Investigator to help conduct the research
    study. As an example, research staff might help with informed consent, drawing blood or keeping study records.
  • Patient Advocate or Research Subject Advocate :
    This is a person employed by the institution but is not directly involved in the research study. A research subject advocate
    may be able to help you understand more about the research study and the choices available to you.
  • Institutional Review Board (IRB):
    The members on this board review and evaluate research studies before they begin. These members also make sure the rights and welfare of human participants are protected. The IRB has the authority to approve, require changes, or disapprove research studies involving human participants
  • Human Research Protection Program (HRPP):
    This program works with Principal Investigators, the research team and IRBs to make sure that the rights and welfare of
    human volunteers are protected in research. The head of the program is someone you can share your questions and
    concerns with.
• Right to know that vulnerable persons or groups exist and have special protections in place. Vulnerable persons or groups
  are those who are usually less able to protect themselves in certain situations. Examples:
  • Children
  • The Mentally Ill
  • Fetuses
  • Pregnant Women
  • Prisoners
  • Students
  • Employees
  • Patients who have been recently diagnosed with an illness or medical condition
  • Socially or economically underprivileged

Importance of knowing your rights
Your rights are a critical piece of information you must understand before agreeing to volunteer for a research study. Along with the many rights you have, you also have a responsibility to yourself and to the research study. Your responsibility is to understand all of the informed consent information before making your decision to volunteer .