Publication Date

2-1-2009

Abstract

This role-play addresses issues involved with human subject research and working with an Institutional Review Board (IRB).

The Belmont Report (1979) identifies three basic ethical principles that underlie all human subject research. These principles are Respect for persons, Beneficence, and Justice. Respect for persons requires us to treat individuals as autonomous human beings and not to use people as a means to an end. We must allow people to choose for themselves and provide extra protection to those with limited ability to choose, such as children. Rules derived from the principle of respect for persons include the requirements to obtain informed consent and to respect the privacy of research subjects. Beneficence reminds us to minimize harms and maximize benefits. Rules derived from the principle of beneficence include the requirement to use the best possible research design to maximize benefits and minimize harms, the requirement that researchers perform procedures competently and mitigate risks, and the prohibition of research whose risk-benefit ratio is unfavorable. Justice requires us to treat people fairly and to design research so that its burdens and benefits are shared equitably. Rules derived from the principle of justice include the requirement to select subjects equitably and the requirement to avoid exploitation of vulnerable populations or populations of convenience.

IRBs ensure that research with human subjects follows these principles. Research may be reviewed by a convened Institutional Review Board (full review), by one or more IRB members (expedited review), or by an individual designated by the institution who may not be an IRB member (exemption approvals). Criteria for determining who will conduct the review include the level of risk, the type of research activity, vulnerability of subjects, and institution-specific criteria. It is a critical task to make the distinction between activities that meet the definition of research with human subjects and those that do not. If a project doesn’t meet the definition, it will not need review by an IRB.

Consent forms are normally required except when the research involves no more than minimal risk or when subjects are anonymous. Informed consent begins with recruiting and screening of subjects and continues throughout the subjects’ involvement in the research procedures. Researchers must provide specific information about the study to subjects in a manner comprehensible to them, answer questions to better ensure subjects understand the research and their role in it, give subjects adequate time to consider their decisions, and obtain the voluntary agreement of subjects to participate in the study. The agreement is only to enter the study, because subjects may withdraw at any time, and they may decline to answer specific questions or complete specific tasks.

This role-play also covered issues involving communication and collegiality. In this case, unfortunately, the data collected before IRB approval probably cannot be included in the analysis and publication.

Topic

Human Subjects

Material Type

Teaching Module

Research Area

Engineering | Life Sciences | Medicine and Health Sciences | Physical Sciences and Mathematics | Social and Behavioral Sciences

Acknowledgement and Disclaimer

Supported by the National Science Foundation under grant EEC-0628814. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the University of Illinois or the National Science Foundation.

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