Understanding Informed Consent
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate.
Key Facts to Think About:
- Why the research is being done
- What the researchers want to accomplish
- What will be done during the trial and for how long
- What risks are involved in the trial
- What benefits can be expected from a trial
- What other treatments are available
- The fact that you have the right to leave the trial at any time
Joining a Clinical Trial:
If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision.
It also is a good idea to take the consent documents home and discuss them with family members or friends. Remember informed consent is more than signing a form. It is a process that continues through your study. You should feel free to ask the research team questions before, during and after the study. Informed consent continues as long as you are in the study.
Bill of Rights:
Most importantly you have a bill of rights when participating. The rights below are the rights of every person who is asked to be in a research study. As an experimental subject, I have the following rights:
- To be told what the study is trying to find out.
- To be told what will happen to me and whether any of the procedures, drugs, or devices are different from what would be used in standard practice.
- To be told about the frequent and/or important risks, side effects, or discomforts of the things that will happen to me for research purposes.
- To be told if I can expect any benefit from participating, and, if so, what the benefit might be.
- To be told of the other choices I have and how they may be better or worse than being in the study.
- To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study.
- To be told what sort of medical treatment is available if any complications arise.
- To refuse to participate at all or to change my mind about participation after the study has started. This decision will not affect my right to receive the care I would receive if I were not in the study.
- To receive a copy of the signed and dated consent form.
- To be free of pressure when considering whether I wish to agree to be in the study.
If you have any other questions or concerns, please contact us as we will help guide you in the right direction.
For information about clinical trials available through Scottsdale Healthcare Research Institute, contact the Cancer Clinical Trials Coordinator at 480-323-1339 (toll free: 1-877-273-3713), or e-mail firstname.lastname@example.org.