The following post should be read in conjunction with: "Why We Believe in Research Studies".
You may come to find out about a clinical trial when:
- Your physician refers you for a specific clinical trail
- Your nurse may ask a research coordinator to locate a trial for you
- You (the patient) may ask if there are any research studies available
Once a trial has been identified the study coordinator (research nurse) reviews your chart and the available protocols to determine if you qualify.
If you qualify the study coordinator will provide you with an “Informed Consent Form” to review. We encourage our patients to take a few days to review and share the information with your spouse, significant others and family.
After review you’ll be asked to meet with the physician and research coordinator. You’ll spend this time discussing the consent form, treatment plan, expectations, risks and benefits. Don’t worry, you’ll have plenty of time to ask questions. If, at the end of this conversation you’re still interested you will begin the consenting process.
The consent process is legally required by the FDA and other governing authorities like the Institutional Review Board (IRB). You (the patient), the physician and the research nurse must all sign and date the same consent form.
- You are given a copy of the signed consent form
- A copy is stored in your patient chart (along with the protocol details)
- The original is stored in research
The consent process should never feel rushed—you as the patient should receive the information you need about the study. The process must:
- Give you enough time to consider all your options
- Respond to all of your questions
- Ensure you understand all the information
- Continue to provide all the information you require