Ethical Challenges

5. Current and Unresolved Issues


Example 2

A group of academic institutions are collaborating on a survey study of alcohol consumption by students. They develop a common protocol. During the consent process, participants are informed of the purpose of the study and the methods. They are asked to voluntarily respond to a questionnaire about social activities and drinking behavior. Because some of the students are below legal drinking age and because some of the institutions prohibit alcohol on campus, the investigators plan to obtain a certificate of confidentiality prior to starting data collection. The purpose of the certificate is explained during the consent process along with its limitations. Each institution’s IRB is to review the study and each institution is to apply for a Certificate of Confidentiality. The study begins. Of the participating institutions, one fails to apply for and obtain the Certificate of Confidentiality. What is the issue? Is the consent valid?

Empirical research on the consent process indicates that research participants often may not understand enough about research to make a fully informed decision. Concepts such as randomization, controls and double blinding are particularly difficult. Many subjects believe that there will be therapeutic benefit from participating in research (Applebaum, Roth, & Lidz, 1982; Applebaum, Lidz, & Grisso, 2004; Pace et al., 2005).

More information than can be retained often is included in consent forms. Research also shows that subjects prefer short consent forms to very detailed ones, though there is some indication that both satisfaction and comprehension are similar (Stunkel et al., 2010).

Is Consent Informed?

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  • In a clinical trial of a drug for cancer, 30% of participants reported that they were receiving an unproven drug.  70% believed that the drug was the best therapy for their cancer (Joffe et al., 2001).
  • In a questionnaire study, caretakers/parents who brought a child to an emergency room for treatment were queried about their willingness to enroll a child in research. More were willing to have their child participate in a research study than in a research project, research experiment, medical experiment or medical study. Only 18% responded that the choices were equivalent.  A research study or project  was perceived as safer while  the words medical and experiment were associated with higher risk and unproven treatment (Cico, Vogeley, & Doyle, 2011).
  • When comparing  a video presentation with a written explanation, more people who saw the video correctly reported the purpose of Phase I. trials. In both groups, a majority thought that Phase I. related to efficacy rather than safety and that their doctor thought they might benefit from the drug (Kass et al., 2009).
  • A study of Phase I drug testing consent forms reported that virtually all stated clearly that the study was research, that its goal was to test the drug for safety, and addressed benefits and risks. However, 96% of the forms also referred to the drug as treatment or therapy without reference to research or the agent’s experimental nature. (Horng et al., 2002).
  • Readability of consent forms analyzed with the Flesch-Kincaid Scale was 10.6, 2.8 grade levels above the recommended reading level (Paasche-Orlow, Taylor, & Brancati, 2003). A recent study of consent forms for HIV trials  reported median readability  was 9.2 – 12.2 grade level, depending on section. Median length of all forms was 22.4 pages. This clearly is more information than most people can process and remember (Kass et al., 2011).