Our results demonstrate that most participants in our study (93.6%) provided consent without spending sufficient time to thoroughly read and comprehend the informed consent document. The 81 (6.7%) participants with consent times greater than the minimum predicted reading time (566 seconds) may overestimate the number of participants who actually read the consent document because participants were not directly observed during the informed consent process and the consent interval could include time spent on other distracting activities. The latter might include multitasking on cell phones, audio players, and other electronic devices, activities which seem to be ubiquitous in our study demographic (27
). This hypothesis is supported by about one third of this group, which had consent times greater than 1000 seconds (range, 1007 to 69 407 seconds)—far longer than the time necessary to read the consent document. Overall, these data suggest that the 2.5% of total participants who identified the hyperlink may provide a more accurate estimate of careful readers than the 6.7% of participants with consent times greater than the minimum predicted reading time.
Although these data suggest that only a very small proportion of participants carefully reviewed the consent document, limitations of our study should be noted. Participants had the opportunity to read about the study on the home page and through Web links that described eligibility requirements and payment for participation. Because participants were not observed, discussion of the issues raised in the consent document with a sibling, friend, or parent or guardian who had more thoroughly read the document cannot be excluded. However, only 81 (6.7%) of persons had consent times greater than 566 seconds, 6 in sibships in which both participants had consent times greater than 566 seconds and 57 in sibships in which all of the other members had consent times less than 566 seconds. Of the latter group, only 34 (60%) were the first to consent in their family, suggesting that the potential bias from family members who read the consent on the other family members’ reading time was minimal. The 57 participants who downloaded the consent document PDF are another subgroup that may have more thoroughly read or shared the consent document with their siblings who had short online consent times. Forty-seven participants who downloaded the consent PDF also had siblings in the study. However, participants who had a member of the sibship download the PDF had a median time to consent of 49 seconds, compared with 38 seconds for sibships in which no one downloaded the PDF. Thus, sharing of printed consent documents does not seem to contribute to a shorter consent time. Finally, there was a discrepancy between the number of informed consent Web pages viewed (n = 1303) and the number returned to the server as “Agree” (n = 1219). A subset of these participants could have clicked “Disagree” or exited the Web site without agreeing. Although we cannot exclude more than 1 login session for as many as 84 participants, which could have led to an underestimate of total consent time, the high mean consent time for persons who identified the hyperlink (621 seconds) suggests that careful reading of the consent document over several sessions was uncommon.
This analysis used a Web-based consent form, in contrast to the more common face-to-face consent process, which could result in differences in the decision to carefully read the consent document. One previous report suggested better reading of the informed consent document in a clinical setting, where face-to-face consenting was done (28
). In contrast, 69% (172 of 250) of patients consenting to intrathoracic, intraperitoneal, or vascular surgery in another study admitted to not reading the consent document before signing (29
), and another analysis concluded that online informed consent is as effective as traditional printed documents in terms of reading and recall of information (30
). By avoiding observation bias from study investigators, our online approach may have allowed participants more freedom to choose how much time to spend reading the informed consent document.
Taken together, these results suggest that the consent by participants to participate in this and many other studies that rely on informed consent documents for communication is unlikely to have been as truly informed as originally intended by the investigators and the IRB. This deficiency in the informed consent process may be particularly relevant to low-risk research studies, which represent a large proportion of the new protocols under review by most academic IRBs, including our own (7
). In addition, this lack of truly informed consent is likely to extend beyond research studies, to include informed consent documents used for treatment in the clinical care setting (29
For the persons who chose to participate in this and many other studies, the length of the standard informed consent document and the marked imbalance with perceived risk may seem equivalent to the frequently encountered end-user license agreement (EULA) that is routinely invoked to protect a software company against unlawful use of its product. The intentions behind an informed consent document and a EULA differ, however: The former is designed to educate and inform study participants and record their consent, and the latter is a legal document that protects a vendor. However, the increasing similarity in the appearance of these documents may contribute to a perception among study participants that the informed consent document exists to protect the investigators and institution, not the research participant (14
). Although careful review of EULAs by consumers may be rare, with few exceptions the EULA remains an enforceable legal contract (32
). A recent news story reported that 7500 online shoppers inadvertently “sold their souls” to a video game company by failing to select the “opt out” check box when granting consent to the online EULA (33
). Remarkably, the 12% of customers who opted out of this provision exceeds the 2.5% of participants in our study who successfully identified the masked hyperlink.
Local IRB involvement in multi-institutional studies can reduce participation and delay data collection (34
). Waiver of the need for consent documents seems to improve participation in minimal-risk research and medical testing rates (35
). Although our study was designated as minimal-risk research by the University of Michigan IRB, the final approved consent documents, based on standard templates provided by the IRB, were considerably longer (>2800 words) than many published articles and more than twice the length of a typical chemotherapy protocol consent document (average, 1087 words in 2005 to 2007 [range, 399 to 2345 words]) (37
). The length and complexity of informed consent documents for many types of human research has steadily increased over the past 2 decades (37
). In fact, the consent document for the current study has increased from 2736 words in 2006 to 3179 words (14%) in 2011. The length of informed consent documents seems to be directly associated with decreased rates of participation in research, the introduction of recruitment bias, and increased costs of research (40
Minimal-risk research is currently estimated to constitute greater than 50% of the direct costs to IRBs, representing a significant administrative burden that potentially compromises the capacity for thorough evaluation of higher-risk studies (7
). These concerns have led to calls for major reform to the regulatory process, including exemptions from IRB review or dramatically simplified consent documents for some forms of minimal-risk research (7
). Our data highlight the need for such reform and suggest that Web-based approaches may provide a useful tool for monitoring the informed consent process.