Human subject protection and special population issues

Abstract

Understanding the principles and processes for protecting human subject (HS) safety is paramount in successfully carrying out clinical research. This chapter outlines the obligations that you have to HS protections prior to engaging in HHS funded research which involves human subjects. You must have a basic understanding of the ''Common Rule (45 CFR 46 A). After participating in the human subjects training, you will have gained an appreciation for whether your proposed research involves human subjects, meets the criteria for exemption, requires the use of informed consent processes, etc. Another key component of the human subjects research plan is the inclusion of women and minorities section and the inclusion of children section. You will be asked to provide detailed information in the targeted/planned enrollment table to demonstrate how the required, diverse representation of the nation will be included. Prior to implementing your study, you must submit your protocol to your Institutional Review Board (IRB). You should consult with senior colleagues and review your institution's HS research policies and procedures. One of the most important challenges facing an IRB is evaluating the risks and benefits of a proposed study. In order to present your protocol clearly and convincingly to the IRB, you must have a solid understanding of the risks that your study may pose to subjects, and the (direct or indirect) benefits (if any) of subjects' participation in the study. In addition, appropriate informed consent documents must clearly define the risks and benefits. You must also have a working knowledge of data and safety monitoring when you are proposing a treatment (intervention) study. When developing your safety monitoring plan, you must consider the risks, size, and complexity of your study, and make a determination of whether or not your study requires an independent data and safety monitoring board (DSMB). You will also need to understand and identify adverse events and the requirements for reporting those events to the IRB, DSMB, NIH, OHRP, and/or the FDA. © 2011 Springer Science+Business Media, LLC.