Frequently Asked Questions About Clinical Trials

Duke clinical trials and research studies take place at various Duke Health locations.

It's important to realize that there are risks to participating in a clinical research study or trial, including:

• Unpleasant or serious side effects
• Ineffective experimental treatment
• Inconvenience resulting from trips to the study site, hospital stays, invasive procedures, complex dosage requirements, etc.

Researchers must follow the same ethical and legal codes they follow during routine care. Certain federal regulations also apply specifically to clinical research. The process starts with a study protocol, which is a plan that must meet certain safety standards to be approved by Duke’s Institutional Review Board (IRB). Potential risks must be balanced against potential benefits, and the safety of participants must be safeguarded. Risks must be minimized and benefits must be maximized to the extent possible. Our IRB requires researchers to report back at least annually throughout the course of the research to ensure patient safety. The IRB also carefully reviews the consent form for the study to ensure that it meets all the criteria of the federal regulations that govern health research.

The U.S. government regulates clinical research that involves human beings, and all studies are required to protect your privacy and safety. Just like when you visit your provider, health information collected about you in a clinical research study is kept private. The research study follows a carefully controlled study plan that details what researchers can and will do in the study, including what they must do to protect your safety and privacy. As a clinical research study progresses, researchers report the results of the study to various oversight groups, and decisions may be made about whether to continue with the study. You will be kept informed of any changes that may affect your willingness to continue participating.

Study records that identify you will be kept confidential as required by law. Federal privacy regulations provide safeguards for your privacy and security. Except when required by law or for your care, you will not be identified by name, Social Security number, address, telephone number, or any other direct personal identifier in study records disclosed outside of Duke University Health System. For records disclosed outside of DUHS, you will be assigned a unique code number that will be used on your study results or health data when they are sent outside of Duke. The key to that code will be kept secure at Duke. When researchers publish the results of the trial, your name will never be disclosed.

Informed consent is the process of learning key information about a health research study before deciding whether to participate. The informed consent process involves talking to a doctor, nurse, or research staff about the study and reviewing the consent form document.

During the consent process, you will learn about the study’s purpose, the things you will be asked to do, how long you will be in the study, any potential benefits or risks (side effects) you may experience as a result of the study, and other aspects of the study.

You will be encouraged to ask any questions you may have about the study. If you decide to participate, you will be asked to sign the consent form. However, the informed consent process does not stop once you sign the form. The researchers must alert you when changes occur, when new risks are identified, or when new knowledge is gained that may change the risk-benefit ratio and allow you to decide whether to continue your participation.

Research participants have the right to withdraw from a study at any time. You can withdraw, or decide not to participate at all, without affecting your access to health care at Duke.

After a research study or clinical trial has finished or ended, researchers will analyze the results to determine what they mean.

After a phase I or II trial, the researchers will need to decide whether to advance to the next phase or stop testing.

When a study has completed phase III, researchers will assess the medical importance of the results. If the results show that the new treatment or drug is safe and effective, it may become standard practice. By law, the results of most -- but not all -- clinical trials must be posted at ClinicalTrials.Gov. Many researchers and study teams who are not required by law to post their study results may elect to do so anyway.

We are committed to notifying participants and volunteers of the results (or outcomes) of the studies in which they participate. Ask your study team what their plans are for notifying study participants of the results.

• U.S. Department of Health and Human Services Office of Human Research Protections (OHRP) research participation resources (available in English and Spanish)
  • Informational Videos
  • Questions to Ask
  • Protecting Research Volunteers
• National Institutes of Health (NIH) Clinical Research Trials and You
• U.S. National Library of Medicine (NLM) ClinicalTrials.Gov: Learn About Clinical Studies
• Food and Drug Administration (FDA) Clinical Trials: What Patients Need to Know
• National Cancer Institute (NCI) Clinical Trials Information for Patients and Caregivers
• Center for Information and the Study of Clinical Research Participation (CISCRP)
  • Important Information
  • Informational Videos (in English and Spanish)
  • Questions to Ask
  • African Americans and Clinical Research
  • Los Hispanos y la Investigación Clinica
  • Participant Bill of Rights
  • Should My Child Participate?

Call the Duke Institutional Review Board Office at 919-668-5111 to discuss problems, concerns, or questions or to obtain information or offer input. You can also send a message to the IRB using this online contact form.