As part of the application to the IRB, the research doctor submits
an informed consent
form for review. This form includes complete information about the trial, written in easy to understand language. It also contains contact information for the IRB. If you have questions about your rights as a research participant or want to report a problem with the trial, you can call the IRB.
The first time that you go to a research site to learn about a trial, the research team will go over the informed consent form with you in detail. They will make sure that you understand everything about the trial, including any possible risks and the possible benefits. The form must include the following:
Basic Parts of Informed Consent
Look for Them!
- YES, this is research.
A statement that the study involves research.
An explanation of the purpose of the research.
The expected length of participation in the research.
A description of the research procedures [lab tests, physical exams, other procedures].
Identification of any procedures that are experimental.
- There are risks.
A description of risks/discomforts to you.
- And possibly benefits.
A description of possible benefits to you or to others.
- There may be alternatives to participating in this trial.
A description of other procedures/treatments that are options for you if you decide not to participate in the trial.
- Your research record is confidential.
A description of how your confidentiality will be protected.
- You may get paid.
A description of any compensation.
An explanation of who covers expenses if you are injured in the trial.
- If you have questions, ASK.
Contact information for questions about the trial and about your rights as a trial participant.
- The decision to participate is yours.
Your participation is voluntary.
If you do not wish to participate, there is no penalty, and you will not lose benefits at the site.
You may withdraw from the study at any time.
From the Code of Federal Regulations for Protection of Human Subjects.
You are encouraged to take the informed consent form with you and talk it over with your doctor, your friends, and your family. If you decide to participate in the trial, and you are committed to following the trial procedures (which will include regular clinic visits and laboratory tests), you will sign the form when you return to the clinic. You will be given a copy of the form for your records.
If there are major changes to the trial while it is in progress, the consent form will be updated. The changes will be explained to you, and you will be asked to sign a new consent form.