During the past year, we completed 4 papers. One paper has been published, and 3 are in press. All were normative analyses papers, and are described below. Reframing of the practice of informed consent for research by breaking it down into functional components, better accounting for the various elements that might be met in different ways, especially for pragmatic trials and other studies that pose obstacles to traditional consent. Dickert NW, Eyal N, Goldkind S, Grady C, Joffe S, Lo B, Miller FG, Silbergleit R, Weinfurt KP, Wendler D, Kim SYH. Re-Framing Consent for Clinical Research: A Function-Based Approach. American Journal of Bioethics. Accepted. An analysis of one type of post-randomization consent. Vickers AJ, Young-Afat DA, Ehdaie B, Kim SYH. Just-in-time consent: the ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care. Clinical Trials. Accepted. An analysis of another type of post-randomization consent, which involves use of longitudinal cohorts. Kim SYH, Flory J, Relton C. Ethics and Practice of Trials within Cohorts (TwiCs): An Emerging Pragmatic Trial Design. Clinical Trials. Accepted. An analysis of whether waivers or alterations of consent might be ethically feasible for studies that are conducted around the time or just after approval of a drug. Kalkman S, Kim SYH, van Thiel GJMW, Diederick E, Grobbee DE, van Delden JJM. Ethics of informed consent for pragmatic trials with new interventions. Value in Health. 2017. http://dx.doi.org/10.1016/j.jval.2017.04.005
