The IRB Process

Risk

Risk/Benefit Analysis

Introduction

Risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society. This requirement is clearly stated in all codes of research ethics, and is central to the federal regulations. One of the major responsibilities of the IRB, therefore, is to assess the risks and benefits of proposed research.

Definitions

Benefit: A valued or desired outcome; an advantage.

Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.

The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults.

Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk."

Overview

There are two sources of confusion in the assessment of risks and benefits. One arises from the language employed in the discussion: "Risk" is a word expressing probabilities; "benefits" is a word expressing a fact or state of affairs. It is more accurate to speak as if both were in the realm of probability: i.e., risks and expected or anticipated benefits. Another confusion may arise because "risks" can refer to two quite different things: (1) those chances that specific individuals are willing to undertake for some desired goal; or (2) the conditions that make a situation dangerous per se. The IRB is responsible for evaluating risk only in the second sense. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies inviting any person to undertake the risks. The IRB disapproves research in which the risks are judged unreasonable in relation to the anticipated benefits.

Responsibilities of the Researcher

It is the responsibility of the researcher to protect participants from physical and mental discomfort, harm, and danger that may arise from research procedures.

Risk is defined as when harm anticipated in the proposed research is greater than that encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Most Webster University research projects involve no physical risk to the participants, but some research projects have procedures which may be psychologically stressful for the participants. Research involving the use of personality inventories, interviews, questionnaires, observing, photographing, tape recording, may involve varying degrees of discomfort, harassment, invasion of privacy, or may constitute a threat to the subject's dignity and thereby expose subjects to risk other than physical.

It is necessary for the researcher to minimize the degree and duration of psychologically stressful conditions

If there is any possibility that the subject's responses might become known outside the research, care must be taken to ensure that the subject is protected against risks of criminal or civil liability and that his or her financial standing or employability is not damaged. Particular care must be taken when the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. Such considerations must be examined in the design of research procedures to eliminate or reduce risk to subjects.