Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...) of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal. (shrink)

Electronic informed consent represents an opportunity to redesign the way that participants understand and elect to enroll in clinical research studies. However, electronic consent faces certain barriers common to all informed consent processes and other barriers specific to the technical environment. At Sage Bionetworks, we designed an electronic consent process as a software product and released it as an open source tool. We believe that using contemporary design processes to intentionally create cognitive friction, where potential study participants are confronted with (...) interfaces that require them to slow down and contemplate study concepts, offers a significant opportunity for ethical design as research increasingly uses smartphones and digital methodologies. (shrink)

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.