Prestigious universities such as Stanford, Duke, and Yale failed to disclose the potential risk for blindness and death to the subjects’ parents, The New York Times reported on Wednesday. Of the 1,163 babies involved in a study on various oxygen levels’ effects on premature-birth babies, 18 percent of those who were placed into a high-oxygen environment developed an eye ailment “that in serious cases can lead to blindness,” and 20 percent of the premature babies placed into a low-oxygen environment died — distinctly predictable results that Federal Office for Human Research Protections argues “the researchers had sufficient available information to know, before conducting the study,” yet failed to highlight.
Federal officials claim that this particular study neglected to receive true informed consent, since researchers didn’t bother to tell the babies’ parents or caretakers about the risks. But even if the informed consent documents (ICDs) — which are subject to federal regulations and consumer protections — had been more thorough, it is still debatable whether or not the parents would have truly understood the study’s risks. That’s because increasingly-long ICDs are used to obfuscate pertinent risk data under an avalanche of information, and researchers’ oral explanations of a study’s risks — which patients tend to rely on a lot more than they do on wordy forms — are not subject to the same level of scrutiny as consent documentation is.
Multiple studies have highlighted the evolution of ICDs over the course of the last half century. During that time, the disclosure of risks explicitly addressed in ICDs has grown — but the documents have also gotten significantly wordier in the process:
The logical assumption would be that participants will have a more accurate understanding of a research study when there are more risk details in ICDs. But as a Hastings Center examination of ICDs and research ethics underscores, that’s not how things work out:
This study’s findings — particularly the increasing length of consent forms — are problematic given other data showing that the longer a form, the less likely subjects are to read and understand it. Thus, continuing to use current approaches — which have led to steadily larger amounts of information being included in consent forms — is unlikely to be effective in achieving informed decision-making by research subjects. Innovative approaches are likely needed as continue to strive for genuinely informed consent.
Whether researchers do it on purpose or not, the defensive practice of cramming ICDs with information could actually end up undermining efforts to protect participants. In fact, research organizations are aware that this is a significant problem and a detriment to public health, but have largely been unable to come up with effective ways to solve it.
One possible solution could involve instituting stricter rules on the information that researchers and doctors must provide orally to potential study participants — that way, doctors could cut through ICDs’ more technical details to the core information that is important to patients. Past research suggests that this could be an effective method, since “patients’ trust in their physician has in many studies been shown to be the single most important factor for their decision whether to participate in a study” and “patients may be more likely to make a decision on the basis of the inﬂuence from their treating physician, rather than their own knowledge about the study.”