What it means

Being a Volunteer

Choosing to volunteer for a research study is an important decision. Being in a research study is not the same as receiving care from your regular doctor or nurse. Your decision to participate will not affect your right to your usual medical care. Participation in research is completely voluntary and you can change your mind at any time. Ask the study researcher to explain anything you do not understand. Take time to talk about the study with those you trust. You should feel comfortable about your decision. Be informed before you decide.

Volunteer's Bill of Rights

As a research volunteer, you have the following rights:

  1. To be told the purpose of the study.
  2. To be told what will happen to you if you take part in the study and whether any procedures, drugs, or devices are different than those that are used in standard medical treatment.
  3. To be told about all the risks, side effects, or discomforts of the things that will happen to you for research purposes.
  4. To be told if you can expect any benefit from participating, and if so, what the benefit might be.
  5. To be told about all options available to you and how they are better or worse than being in a research study.
  6. To be allowed to ask any questions about the study before signing the consent and/or at any time during the course of the study.
  7. To be allowed ample time, without pressure, to decide whether or not to consent to participate.
  8. To be assured that study records will remain confidential to the extent allowed by law.
  9. To be told what compensation you will receive and what charges you will pay.
  10. To be told what sort of medical treatment is available if any complications arise.
  11. To be told about any new findings that may affect your willingness to continue participating in the study.
  12. To refuse to participate or to change your mind about participating at any time during the study, even after the study has started, without penalty.
  13. To receive a signed and dated copy of the Informed Consent Form.
  14. Studies have a set expiration date. No research can be conducted after this date without further review and approval by the IRB.

Volunteer Protections

UNC-Chapel Hill is dedicated to protecting the rights and safety of all volunteers who participate in research.

The University of North Carolina at Chapel Hill, along with UNC Health Care and associates, is dedicated to protecting the rights and safety of all research participants. The Institutional Review Board, or IRB, is a group of concerned people for the medical, scientific and local community that review all research conducted at UNC before it begins and on a regular basis.

A research study cannot be conducted at UNC if the IRB does not review and approve it. The United States government has rules and regulations that the IRB must follow. The IRB makes sure that the rules set up by the Department of Health and Human Services and the Food and Drug Administration are followed.

Guidelines the IRB Follows:

  1. Risks to volunteers are as small as possible.
  2. Unavoidable risks to volunteers are reasonable.
  3. The selection of volunteers is fair.
  4. Additional protections are in place for special groups such as children.
  5. Volunteers are fully informed about the study.
  6. Volunteers have an opportunity to ask questions and get answers before they agree to be in the study.
  7. Information is provided about how volunteers will receive care in case they get sick during a study.
  8. A written explanation of the study is provided that the volunteer can read and sign. The volunteer is given a copy.
  9. Procedures are in place to protect the privacy of volunteers.
  10. Studies are reviewed regularly.
  11. Studies have a set expiration date. No research can be conducted after this date without further review and approval by the IRB.

More information about the IRB and volunteer rights and protections can be found at: