WHAT ARE MY RIGHTS?

-You must be FULLY informed of the risks of the trial

-You must give FULLY informed consent

-You can stop participating at any time for any reason

-You can refuse any research procedure done to you

WHO IS LOOKING OUT FOR MY SAFETY AND RIGHTS?

Your study doctor and study staff are obligated to place your well being above any other study goals.  This means that if the study is causing you any harm that the doctor believes is unnecessary, they will withdraw you from the clinical trial and place you on the current standard of appropriate treatment.   

IS MY PERSONAL HEALTH INFORMATION KEPT CONFIDENTIAL?

Yes.  We do not share your information with anyone outside of our study staff.  Even the study sponsor will never see any information about yourself such as social security numbers, medication or medical history, nor will your information be provided to any insurance company.  Furthermore your insurance will NOT be billed and you may even receive compensation for your time and efforts.  

ARE CLINICAL TRIALS SAFE?

If you are a participant in a Phase 2, 3, or 4 (the types of studies we conduct) study, you may be getting cutting edge treatments and most certainly will receive highly supervised safety monitoring of your medical condition throughout your participation in the study.  On the flip side, you may experience a worsening of your medical condition due to receiving the placebo control group, or if the study drug simply does not show efficacy.  If this occurs, it is the duty of the study doctor to determine whether you should be withdrawn from the trial, be put on a different treatment regimen, or continue with the study.  It is also the right of the study participant to make these decisions as well.  In either case, the medical attention that all study participants receive is far more thorough than is usually available in a non-research setting.  The physicians run more tests, spend more time with you, and discuss your condition much more extensively than you would likely otherwise experience. 

WHAT IS AN INFORMED CONSENT?

It is important to understand that you will sign an Informed Consent Form prior to your participation in any clinical trial.  The informed consent will highlight all the known risks, benefits, responsible parties, regulatory agencies, ethical review boards, and study staff involved in the study.  This Informed Consent Form might look like a contract, butin no way does it serve as a binding agreement between you and any entity associated with the study.  As a matter of fact, you could quit the study immediately after you sign the form.  It simply serves as documentation that all appropriate and relevant information was given to you and highlights some study contacts for you to reach out to should the need ever arise.