The History and Policy Evolution of Waivers of Informed Consent in Research.

We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person's abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would "destroy or invalidate" critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned.

Remote monitoring of medication adherence and patient and industry responsibilities in a learning health system.

A learning health system (LHS) seeks to establish a closer connection between clinical care and research and establishes new responsibilities for healthcare providers as well as patients. A new set of technological approaches in medication adherence monitoring can potentially yield valuable data within an LHS, and raises the question of the scope and limitations of patients' responsibilities to use them. We argue here that, in principle, it is plausible to suggest that patients have a prima facie obligation to use novel adherence monitors.

Macular corneal dystrophy with isolated peripheral Descemet membrane deposits.

Purpose: Macular Corneal Dystrophy (MCD, MIM #217800) is a category 1 corneal stromal dystrophy as per the current IC3D classification. While characterized by macular stromal deposits, we report a case of MCD type II with isolated bilateral peripheral Decemet membrane opacities, describing the clinical features and results of screening the gene and serum sulfated keratan sulfate levels.

Observations: A 68-year-old man with an unremarkable past medical and family history presented with bilateral progressive decrease in vision.