Examples 3-7m

Key
Points Pitfalls ExamplesSimple Words View Document


Example 1 of 4

This consent form tells you about the study. Your study nurse or doctor will go over it with you and answer any questions you may have. Once you understand the study and if you agree to volunteer, you will be asked to sign this consent form. You will be given a copy to keep. The most important thing for you to understand is that no one can force you to take part in this study. This decision is up to you alone. You are free to decide at any time (even after you begin the study), without penalty, that you do not want to take part. Also, if the study is changed in any way that could affect you after you begin, you may be asked to sign a new consent document.

Example 2 of 4

You will be taken off this study, without your consent, for any of the following reasons:
  • if the investigator decides that continuing in the study would be harmful to you;
  • if you need a treatment not allowed on this study;
  • if you do not keep appointments or take the study medication as instructed;
  • if you have a serious adverse reaction to the study medications that prevents continued therapy with these drugs;
  • if you become pregnant and choose to remain so;
  • if the study is canceled by the Food and Drug Administration (FDA), the National Institute of Allergy and Infectious Disease (NIAID), or the pharmaceutical companies supplying the study drugs.

Example 3 of 4

Your participation in this study is voluntary, and you may refuse to participate or stop participating at any time once the study has started. In either case, you will not lose any benefits to which you are entitled. If you decide to withdraw from the study, we will talk to you about the best way to end your participation to reduce any risk to you. You may be asked to stop the study if we decide it is not in your best interest, or you fail to follow the study procedures. Your care will not be affected by your decision either to participate or not to participate.

The alternative plan to this study is not to participate and to continue with your standard medical care, which may include an MRI study using an approved contrast agent. If new information about the uses, safety, or efficacy of MS-325 develops during the course of your participation in this research, the findings, including unforeseen risks, will be discussed with you.

Example 4 of 4

Your decision whether or not to participate will not affect your current or future relations with California State University, Los Angeles. If you decide to participate, you are free to withdraw at any time without affecting your relationship with California State University, Los Angeles. Furthermore, should you choose to discontinue your participation, you will not forfeit your small financial compensation/credit.


Top