Role of the IRB

 

The “institutional review board (IRB)” also known as an “IRB Committee” is a group of people who are responsible for protecting the rights and welfare of research subjects taking part in a clinical research study.

The IRB is an independent committee and includes:

    • Members of the scientific community such as doctors, nurses, and pharmacists

    • Members of the non-scientific community such as clergy, priest, or social worker

    • Community members such as volunteers, retirees, or former research subjects

    • Diverse members in terms of race, gender, cultural, and ethnic backgrounds

 

The IRB is composed of at least five members that include scientists, doctors and community members. The purpose of the IRB is to review research studies or clinical trials and to ensure that appropriate steps are in place to protect the rights and welfare of research subjects participating in research.

The IRB protects the rights and welfare of research subjects by:

    • Reviewing the research study, the design of the study, the drugs or the device being studied, the study criteria, the data that will be collected, and how research subjects will be recruited.

    • Reviewing the research study to ensure the risks are minimized

    • Evaluating the risks and benefits of the research to assure an acceptable balance

    • Reviewing the informed consent document and ensuring that the study description, procedures, and risk and benefits are described clearly, accurately and completely

    • Ensuring that the informed consent document includes all of the elements required by law, and that it is written at the appropriate reading level, so that research subjects are able to understand the document.

    • Requiring that the informed consent document provides the research subject with the phone number for the study doctor and the phone number of the IRB

    • Ensuring that all research subjects who volunteer to participate in the research study have provided informed consent

    • Ensuring that the research is conducted in an ethical manner

After the IRB has completed its review of the research study documents and the conditions for approval have been met, the IRB Committee may approve the research study and allow it to begin.

When the research study begins, the IRB is responsible for periodically reviewing the approved research study, the progress of the research study, and to assure that the rights and welfare of research subjects taking in part in the research study continue to be protected and that the risks and benefits of the research are acceptable.

eMedicus, Inc.  •  169 Concord Road  •  PO Box 329  •  Bedford MA 01730  •  Phone 781-275-3403  •  Fax 781-402-0201
Copyright © 2012 eMedicus, Inc. All Rights Reserved