Your Rights as a Participant

Informed Consent

As part of the application to the IRB, researchers submit 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, please speak with the study team. If you still have questions and/or want to report a problem with the trial, please call the IRB. The first time that you go to a research site to learn about a trial, the research team will review 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.

You will be encouraged to take the informed consent form with you and talk it over with your healthcare provider, friends and family. If you decide to participate in the trial, and you are committed to following the trial procedures (which may include regular clinic visits and possibly laboratory tests), you will sign (or initial) and date each page of the form. You will be given a copy of the informed consent form for your records. If there are changes to the trial while it is in progress or if there are any additional risks or safety concerns, the consent form will be revised to reflect this information. The changes will be explained to you, and you will be asked to sign a new consent form if you wish to continue in the study.

Basic Parts of Informed Consent

The informed consent form must include the following:

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 the participant

And possible benefits

• A description of possible benefits to you or to others

• 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 and privacy will be protected

You may get paid

• A description of any compensation for time and travel
• A description of expenses that are covered and who, if anyone, covers those 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