During WWII, Nazi physicians conducted experimental research on human subjects, exposing them to torturous injections of gasoline, viruses and poisons. Thousands of concentration camp prisoners were mutilated and killed by ‘medical professionals.’ This repeated and deliberate violation of human rights resulted in the constitution of the Nuremburg Code in 1947, which provided ten directives for human experimentation. The very first directive states, “The voluntary consent of the human subject is absolutely essential.” Now, in every study where human subjects are involved as participants, the study may not begin until the researchers have obtained informed consent from the participants, showing their complete understanding of the nature and potential risks of the study. Researchers believe that this understanding is primarily facilitated by the use of clear, plain language. Investigating the language used in general consent forms, specifically those used for parental or legal guardian permission on the behalf of child participants and others with decreased autonomy, shows that plain style language is necessary in the preservation of fundamental human rights.
The United States’ Department of Health and Human Services requires that researchers obtain informed consent in a way that allows participants to consider whether or not to participate in the study, to understand the potential risks involved in the study, and to acknowledge the right to withdraw at any time. The HHS actually requires that “The informed consent process […] be delivered in language that is understandable to the subject. This may mean adjusting the reading levels of documents provided or translating documents and presentations into the language with which participants are most comfortable.” Understanding the moral and ethical need to change the language to match the ability and reading level of the participants is one of the most successful ways the laws involving experimental research have used plain language to ensure the preservation of basic human rights.
The Office of Human Subjects Research at the Rochester Institute of Technology developed a set of tips for constructing consent forms. One of their tips is to “refer to the subjects as ‘you.’” This tip directly applies the plain language strategy of lower levels of formality by using the second person to directly address the reader. Another tip informs researchers, “It is recommended that forms for adult subjects be written at a 6th grade reading level or lower, which means […] sentences and paragraphs are short, terms and concepts are simple, and technical information is explained in non-technical ways.” This quote suggests the use of plain language through advocating for minimal jargon, low reading level and high reading ease, and shorter, less complex sentences.
These recommendations take into account the norms of average human abilities in order to establish norms for ethical treatment of human subjects. Establishing these norms is essential in providing a wide net under which most participants will fall. Unethical studies such as the research conducted at the concentration camps during WWII violate basic human rights by withholding information about the true intentions behind the research questions. Certain styles of prose language such as “the official style,” which is characterized by longer, more complex sentences and imperatives, limit the understanding of texts to the groups of individuals that are familiar with that language. However, this practice also withholds the same information from other groups that are not as familiar with the language being used. The necessity of using plain language emerges in the effort to broaden the population to which legitimate and fully informed consent is accessible, ensuring the ethical treatment of human subjects.
Using children in research studies requires extra protections as the Institutional Review Board (IRB) demands that children under the age of 18 must obtain permission from a parental guardian in addition to signing a general assent form. These assent forms use extremely simple and direct sentences such as “A research study is a way to learn more about people,” and “You do not have to be in this study if you do not want to be. If you decide to stop after we begin, that’s okay too. Your parents know about the study too.” Using the Flesch-Kincaid Reading Ease scoring technique, these passages received a 6th grade reading level, exactly. The assent form requires the use of language available to children. This is important because the IRB necessitates the ability of a child to deny assent to participate in the study even if their parents give the researchers signed permission, showing the IRB’s attention towards fundamental respect for the basic rights of every human, no matter the age or ability level. Similar protocol is used in consent for prisoners, pregnant woman and other participants with diminished autonomy.
Plain language is used in consent and assent forms for experimental research due to the laws that have been constructed on moral and ethical ground for research. Some may think that those with diminished autonomy may not be suitable to participate in such studies, however certain research questions are unanswerable with any other population of participants. In addition to these subjects, research with any population of human subjects has the potential to benefit every human being on a broader scale depending on the nature of the research implications and generalizability of the results. Because of these benefits, investigators still advocate the importance of using human subjects in research. In order to assure the ethical and moral treatment of these participants, the use of the understandable language of the plain style is implemented and sited as the most important directive for conducting research involving basic human rights. The use of language in the context of human research is an indispensable example of how influential our words can be on the lives of others and illustrates the level of attention we must pay to our language and its potential for broader societal consequences.