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Regulatory Knowledge & Support

Participant Rights - Human Research Subject Advocate (RSA)

Research volunteers are important and essential partners in clinical research. Through their participation, volunteers help to advance our current understanding of science by contributing to new knowledge. This new information can give rise to deeper understandings and new treatment options, improving the health of millions of individuals. We value the role research volunteers play in research, and are committed to making sure research subjects have all the information necessary to make informed choices before deciding to participate in a research study. As a research participant, you have important rights, which you may exercise at any time during the study.

You have the right to:

  • Know why the research is being done.
  • Understand what will happen to you and what you will be asked to do if you are in the study.
  • Be told about all of the reasonably foreseeable risks or discomforts that you may experience from taking part in the study.
  • Understand the possible benefits you might expect from participating in the study.
  • Learn what other non-research treatment choices you have if you do not take part in the research.
  • Learn what medical treatment is available should you have a research-related injury and who will pay for the treatment if such an injury occurs.
  • Decide whether or not to be in the research study without feeling any pressure from the people who are conducting the research. Your decision will not affect your right to the usual care not related to the study.
  • Quit the study at any time after you begin the study.
  • Be told whether there are any costs associated with being in the study and whether you will be compensated for being in the study.
  • Be told who will have access to information collected about you, and how your private information will be kept safe.
  • Know whom to contact with questions about the research, either before you join the study or at any time during the research, whom to contact in the event of a research-related injury, and whom to contact with questions about your rights as a research participant.
  • Receive a copy of the signed and dated consent form.

All of this information should be provided to you in a document called an Informed Consent Form. You should take as much time as you need to decide whether or not to participate in a research study. You are encouraged to have your questions answered before you sign the consent form, and to ask questions throughout the study as they arise.

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