(Un)Informed Consent in Exercise and Sport Science Research? A Comparison of Forms Written for Two Reading Levels
Cardinal, Bradley J., Research Quarterly for Exercise and Sport
Key words: ethics, human subjects, Institutional Review Board, readability
The Research Quarterly for Exercise and Sport (American Alliance for Health, Physical Education, Recreation and Dance, 1999) "Guide-lines for Contributors" state, "The RQES editorial board requires all authors submitting manuscripts for review and possible publication to take all appropriate steps to obtain the informed consent of all humans participating in the research...." (inside back cover). Informed consent generally refers to the researcher's responsibility to share information with potential research participants about her or his study, and, once this information is shared, the potential research participant's permission is sought with regard to either becoming involved with or declining to become involved with the researcher's study (Kroll, 1993). In obtaining informed consent, the rights of all parties involved in the research project (i.e., researcher, research participant, institution where research occurs), as well as the research enterprise in general, are being protected (Drowatzky, 1995). In t he United States, the Office for Protection from Research Risks, National Institutes of Health (1991) regulates informed consent policies. Several professional societies also have established guidelines in the area of informed consent (American College of Sports Medicine, 1999; American Educational Research Association, 1992; American Psychological Association, 1992; Henschen, Ripoll, Hackfort, & Mohan, 1995; Last, 1991; Reid, Dunn, & McClements, 1993; Whelan, 1996).
While all researchers should be familiar with the basic idea of informed consent, both anecdotal and descriptive evidence suggests researchers in exercise and sport science may be performing suboptimally in this important area of ethical and professional responsibility. For example, Albrecht, Anderson, McCrew, McKeag, and Hough (1992) commented, "...the consent forms used by institutions may be written at a much higher grade level than the typical undergraduate student-athlete is capable of understanding or reading" (p. 246). In a descriptive study, Cardinal, Martin, and Sachs (1996) examined the informed consent forms used by researchers in sport and exercise psychology and found the forms were too difficult for the "average adult" to read and comprehend.  In their study, the average informed consent form was written at the 13th-grade reading level, whereas the most liberal recommendation for constructing these forms suggests they be written at or below the 8th-grade reading level (Young, Hooker, & Freeb erg, 1990). If a potential research participant cannot read an informed consent form, the validity of the document, as well as the entire informed consent process, can be questioned (LoVerde, Prochazka, & Byyny, 1989; Ogloff & Otto, 1991; Olivier, 1995).  The main message of Cardinal and colleagues' study was that researchers should strive to write research informed consent forms that are matched to the reading level of the target audience, or, if the researcher is uncertain about the reading level of the target audience, the forms should be written at or below the eighth-grade reading level.
But does writing a research informed consent form at a lower reading level result in better understanding by potential research participants? There is no empirical evidence within exercise or sport to suggest this is true, and results from other content domains have yielded mixed results on this issue. For example, after making an informed consent form more readable, Taub, Baker, and Sturr (1986) reported no significant improvements in comprehension scores, whereas Handelsman and Martin (1992) reported significant improvements but in only one of three comparisons. On the other hand, Young et al. (1990) found writing an informed consent form at a lower reading grade level resulted in improved comprehension by research participants. Interestingly, Davis, Holcombe, Berkel, Pramanik, and Divers (1998) found research participants preferred an "easy" to read informed consent form over a "difficult" to read informed consent form; however, the easy to read form did not significantly improve research participants' understanding of the form's content in comparison to the difficult to read form. …