Informed consent is based on the idea that research study subjects should be given sufficient information needed to make an informed and rational decision regarding their participation in the study. The principles that form the basis of informed consent are respect for persons, beneficence, and justice. These principles were established with the publication of the Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [Lazar et al. 2010].
Participants should fully understand the reason for the study, the procedures involved in the study, the risks of participation, and how they can obtain more information about the study. Additionally, participation in the study should be voluntarily and participants should not be coerced in any way [Lazar et al. 2010]. There are three fundamental components of informed consent: voluntariness, comprehension, and disclosure. Voluntariness implies that the participant has not been unduly influenced by researchers. Comprehension assumes that participants have the capacity to make an informed choice about their participation. Disclosure requires researchers to inform participants about the purpose of the study, any inherent risks, potential benefits, research alternatives, confidentiality, compensation in the event of injury, how participants can get more information about the research, and the conditions of participation [NIH 2008].
Lazar et al. suggest a general template for informed consent documents, to include the following sections: title and purpose, description of procedures, duration of the study, risks, benefits, alternatives to participation, confidentiality, costs and expenses, participants’ rights, and contact information if participants have any additional questions or concerns [2010]. Many institutions follow this general format for their own informed consent documents, although they may address additional concerns. For example, some additional elements that Iowa State’s Institutional Review Board suggests addressing when appropriate include: currently unforeseeable risks; circumstances whereby the subject’s participation could be terminated without the subject’s consent; the consequences of the subject’s decision to withdraw from the research, and the procedures for subject withdrawal; and procedures for providing significant new findings to the subject [2010].
Also, it is important that informed consent information is communicated using simple language that is easily understood by the subject, and using whatever means required to convey the information clearly.
REFERENCES
Iowa State University Office for Responsible Research. 2010. Elements of Informed Consent. Iowa State University, Ames, IA.
Jonathan Lazar, Jinjuan Heidi Feng, and Harry Hocheiser. 2010. Research Methods in Human-Computer Interaction. Wiley, Chichester, West Sussex, UK.
NIH Office of Extramural Research. 2008. Protecting Human Research Participants. National Institutes of Health, Bethesda, MD.