Under the U.S. Food and Drug Administration (FDA) regulations, an Investigational Review Board (IRB) is a specially constituted review body established or designated to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. An IRB has the authority to approve, require revisions, or disapprove research studies. The protection of the rights and welfare of human research participants is the goal of the members of the Board that reviews a study for human research participants. The purpose of an IRB review is to assure that the Investigator, Sponsor, and all parties involved are taking the appropriate steps to protect the rights and welfare of humans participating as subjects in a research study. In order to accomplish this purpose, IRBs have developed a group of scientific and non-scientific experts to review research protocols and related materials (e.g. informed consent documents, study protocol, questionnaires, investigator brochures, and recruitment material) to ensure protection of the rights and welfare of human subjects of research.

Make sure:	all of your questions about the research have been completely and respectfully answered.
Make sure:	you do not feel that you are being pressured or threatened in any way to participate in the research study.
Make sure:	that you understand all of the risks in the study and what are your alternatives to participation.
Make sure:	you know what study procedures are required and if there are any restrictions required by the study.
Make sure:	if you are being paid to be in this study that it is clear when you will receive the payment and basis for partial payment if you do not complete the study.
Make sure:	you check with your insurance carrier or third party payer for limitations in coverage for treatment or injury.
Make sure:	that you have the opportunity to discuss your participation with your physician and family.