Att M_Human Subjects Fact Sheet

National Birth Defects Prevention Study

Rights of Research Subjects

Fact Sheet

As a potential participant in this research study, you have the right to:

• Be informed of the nature and purpose of the study.
  
  

• Be given an explanation of the procedures to be followed in the study.
  
  

• Be given a description of any discomforts and risks reasonably to be expected from the study procedures.
  
  

• Be given an explanation of any benefits you can reasonably expect from participation.
  
  

• Be informed of medical treatment, if any, available to you during and after the study if complications should arise.
  
  

• Be given an opportunity to ask any questions concerning the study or procedures involved.
  
  

• Be informed that you may withdraw from the study at anytime without penalty.
  
  

• Be given the opportunity to decide to participate or not without the use of any force or undue influence on your decision.

All information that we gather in this study will be kept private. This is because the study has been given a Certificate of Confidentiality by the Centers for Disease Control and Prevention. This means anything you tell us will not have to be given out to anyone, even if a court orders us to do so, unless you say it's okay. We may share information about you with other researchers but that information will not identify you or anyone else in the study. You should also understand that study investigators are not prevented from reporting information obtained from you to authorities in order to prevent serious harm to yourself or others. 

The National Birth Defects Prevention Study Question and Answer brochure will give you more information about how your privacy is protected in this study. If you have questions about your rights as a subject in this research study, please call the Office of the Deputy Associate Director for Science for CDC at 1-800-584-8814, leave a message including your name, phone number, and refer to protocol #2087, and someone will call you back as soon as possible.