Understanding Informed Consent

clinicaltrials7The most important aspect of any clinical trial is that it’s participants are willing and consenting to be a part of the study. Prior to participating in any clinical study, you will be asked to give your consent, usually in writing, to the governing body of the clinical trial. In giving your consent though, it is of vital importance to be completely informed of the study before doing so. Your informed consent, is acknowledging that you understand everything you need to before partaking, so it becomes your responsibility to take advantage of any and all information regarding the study before consenting to do so.

By consenting to the clinical study, you are agreeing that you are making an informed decision, and agreeing to the terms set out by the study. With your given consent though, you are entitled to certain rights:

1) You have the right to be told the trial’s purpose.

2) You have the right to be informed of any risks or benefits where the products use is concerned.

3) You have the right to be told how the study will be conducted, where it will be conducted, and what options are available to you in case of medical emergency.

4) You have the right to time to make up your mind on whether or not you want to partake in the study.

5) You have the right to refuse participation, or if consenting to be a part of the study, to receive a signed copy of your informed consent form.

By giving your informed consent prior to a study, you must understand that your consent is not something that can be taken away from you. In the process of the trial, you can, of course, at any time revoke your consent. You can never be forced to do something you are not comfortable with. In certain studies of course, it may not be as simple as just stopping the trial, but measures will be taken to wean you out of the study if that is your wish.

Before giving consent to any clinical study, the first process to go through is discussion the study itself with the researchers in charge of it’s running. This includes sitting down and discussing every aspect of the trial itself. This gives you the opportunity to raise any questions you may have, and for the governing body to make you aware of every piece of pertinent information regarding the trial. A few questions that you may want to bring up at your discussion are as follows:

What is the studies purpose? Why am I a good candidate for this study? Will I be part of a “blind-control” group? How long will the study take?

Also:

Will I have access to medical personnel if needed? What if there are major side effects? What if I regularly take other medicines? Can I keep my family doctor during this period?

And:

Do I keep a record of my daily activities? Who do I report to? Will this be at home or in a medical facility?

Before partaking in any clinical study, it is important to discuss every matter you can think of, and to be informed as to whether or not the particular study is a proper fit to your health, or lifestyle. The only risk you should take, is a risk you are prepared for. And without your express and informed consent, there is no risk necessary in asking questions.