Module 1 of a 3 part series. This module focuses on the ethics for research involving human subjects. After viewing this module you will be able to discuss why ethics are necessary when conducting research involving human subjects. You will become familiar with the federal regulations that provide basic protections to human subjects: informed consent, institutional assurance, and review by Institutional Review Board (IRB). Following this introduction to ethics, we describe the major historical events that have influenced how research involving human subjects is conducted, and identify problems with past studies that have violated ethical standards. The three Belmont Principles are introduced next, being; respect for persons, beneficence, and justice, which must each possess equal moral force. Finally, we will discuss the ethical standards for research that guide us today. Keywords: Belmont Principles, Institutional Review Board (IRB), ethics, human subjects, informed consent, research
Module 2 of a 3 part series. The importance of protecting the privacy of research subjects and ensuring confidentiality of research data is widely acknowledged. Confidentiality procedures allow subjects to decide what measure of control over their personal information they are willing to relinquish to researchers. This module details the distinction between public and private information and introduces the investigators and IRB’s (Institutional Review Boards) that make judgements about what is private, based on their knowledge of the population, and the context in which the research will take place. Several concerns about privacy in the context of research are defined, including covert observation, privacy and study questions, and communication with subjects. Once these concerns have been addressed, it is vital to lay out a research plan that contains the following components: an objective hypothesis and end-point; a locale-sensitive method of conducting research; a scientifically meritorious protocol; and IRB approval. Keywords: Institutional Review Board (IRB), confidentiality, privacy, research, research subjects
Module 3 of a 3 part series. There is a consensus regarding the importance of informed consent. As mandated by the Code of Federal Regulations (CFR), informed consent should protect human subjects and volunteers, ensure that study subjects clearly understand the benefits and risks associated with their participation in a study, and provide possible study subjects with all information needed to reach a decision on their potential participation in a research study. This module outlines the informed consent requirements as stipulated by the CFR, how to obtain informed consent, exceptions from informed consent, the various assessments of risk surrounding participation in research, and how to minimize and manage risk. Keywords: Code of Federal Regulations (CFR), informed consent, risk
