Informed Consents and Clinical Trials



Informed Consents and Clinical Trials

Introduction

The informed consent process is designed to inform the subject of the risks, rights, and benefits of participation in a clinical research trial. Informed consent, while not always necessary, is a critical component of ethical research involving human subjects. This article includes an overview of two sets of regulations regarding informed consent found in the Code Of Federal Regulations (cfr) Titles 21 and 45: 21 cfr 50 and 56, the Food And Drug Administration Regulations, and 45 cfr 46, where applicable, The Department Of Health And Human Services Regulations. Also included in this discussion are the general requirements of informed consent; challenging issues regarding informed consent; determining and obtaining informed consent in research involving vulnerable subjects (e.g., children, critically ill patients); the use of genetic information; confidentiality and privacy of subject information; and compensation for injury during a research study. Examples of acceptable and unacceptable (exculpatory) informed consent language are also provided as they may pertain to commercial gain, confidentiality, and compensation for injury (jimison hb, sher pp, appleyard r, levernois y. 1998). The goal of this article is to provide the clinical researcher with an explanation of the legal requirements for informed consent in clinical research. The researcher faces many challenges in implementing effective informed consent beyond the federal regulations.

Informed Consent

In 1979, the Belmont Report was issued in the United States. This report summarized the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was established as a result of the National Research Act in 1974. Three major principles emerged from the Belmont Report: beneficence, justice, and respect for persons. This article will focus on the principle of respect for persons. From the principle of respect for persons, the individual is viewed as an autonomous agent (capable of self-determination); therefore, humans as research subjects should be given the opportunity to choose whether they will participate in clinical research. This is accomplished through the process of informed consent (which encompasses not only the informed consent document but also, importantly, verbal discussions with the potential subject) (Heinze-Lacey B, Saunders C, Sugar A. 1993). This concept of autonomy also implies that people with diminished capacity (or diminished autonomy) are entitled to additional protection. The Belmont Report also discusses the voluntary nature of informed consent and explains that the information must be complete, understandable, and presented in an unhurried fashion. Importantly, the investigator is responsible for determining whether the subject really understands this information. How is the potential subject's understanding measured? Some investigators give short tests on the information; some investigators ask for verbal feedback; and some simply ask the subjects if they understood the information presented.

In the United States, there are 2 sets of regulations regarding informed consent: regulations found in the Code of Federal Regulations Titles 21 and 45: 21 CFR 50 and 56, the Food and Drug Administration (FDA) regulations, and 45 CFR Part 46, where applicable, the Department of ...