As a potential human research participant, you are providing a vital service in helping to potentially develop new medical treatments. We have provided you with some information and resources to help you learn more about human research and understand your rights as a human research participant.
Research Participant Information
Your decision to participate in a research study is a very important one
What is research?
What is research?
Research is the study of disease and treatments that aide in the discovery of new and experimental treatment options for patients like you. Research can help us find answers and fill in gaps to possibly change the way care is provided for diseases.
What is a clinical trial?
What is a clinical trial?
A clinical trial is a type of research program in which participants receive a certain type of medical intervention that follows a research plan that has been created by a sponsor and/or investigator. The interventions may be experimental drugs or devices, procedures, or changes to the participants’ behavior, such as diet. Sometimes clinical trials may compare an experimental treatment to a standard treatment that is already available. It is important that you understand the details of the clinical trial design and ask questions if you do not completely understand the program.
What is an Institutional Review Board (IRB)?
What is an Institutional Review Board (IRB)?
The Institutional Review Board (IRB) is a group of professionals with different backgrounds, who review research, such as clinical trials that involve human participants. The primary purpose of an IRB is to safeguard the rights and welfare of human participants, like you.
The mission and purpose of the US Oncology IRB is to safeguard the rights and welfare of human research participants when they are participating in research programs. The IRB does this by reviewing research studies, such as clinical trials and making sure clinical trials are conducted in a manner that follows ethical principles and federal regulations. The IRB will review the clinical trial before it starts and will receive updates as it continues. If there is information that is important for a participant to know, the IRB will review any changes and require that participants receive that information.
If you are considering participating in a clinical trial, the US Oncology IRB encourages you to discuss any questions you may have with the research staff at your physician’s practice so you feel comfortable with your decision.
What are questions I should ask?
What are questions I should ask?
Before participating in a clinical trial, you will be presented with an informed consent form and complete a consent process which will help you understand the research being done and your rights. During this process, or at any time during your participation in the clinical trial, you have the right to ask questions so you understand:
- Why the research is being done and what will be involved
- The risks and potential benefits of the research – and that you will be told if any new risks and/or findings are discovered while you’re participating in the trial
- That participating in the research study is voluntary and there is no obligation for you to participate. There will be no penalty or loss of benefits if you decide not to participate
- The options available to you if you decide not to participate
- You can end your participation at any time during the clinical trial. In some cases, there may be additional step you may need take to ensure your safety before discontinuing your participation in the trial. Be sure to ask your healthcare professional if this would be the case for the study you are considering.
Resources for research participants
- To learn more about research participation visit The Office for Human Research Protections (OHRP).
- To learn more about clinical trials and common questions to ask prior to joining a clinical trial visit www.clinicaltrials.gov.
- Cancer treatment options and resources
If you are already participating in a clinical trial, please contact your research team for study specific questions. If you are experiencing any medical issues, please be sure to contact your physician immediately.
Contact Us
If you have questions regarding your rights as a research participant, general questions regarding clinical trials and/or to express concerns, please complete the form below.
US Oncology IRB staff can also be contacted at 1-800-381-2637 or 281-863-2406. Collect calls are accepted.