Organizing Intensive Care for Patients Undergoing Cardiac Surgery.

1572 www.ccmjournal. org September 2017 • Volume 45 • Number 9 slope toward invasion of privacy, in particular around studies that gather genetic data. Additional considerations are likely needed in cases of particularly vulnerable populations such as children, as well as for certain cultural or religious groups who may be less likely to engage in research and for whom a deferred consent approach may be less accepted. According to the Federal Policy for the Protection of Human Subjects (the “Common Rule”), a study presents minimal risk if “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (7). Thus, minimal risk research encompasses a broad category of research and extending the findings of this study to all minimal risk research protocols in the ICU is in question, particularly studies that involve more invasive sampling. For example, the authors report that patient/surrogate support for a hypothetical research study involving taking extra blood was less favorable with 53% reporting preference for a consent first process and only 31% favoring a deferred consent approach. It is important to note, as the authors do, that although survey-based research is a powerful method of revealing attitudes around controversial topics, interviewer-administered surveys, as used in this study, have inherent limitations and are prone to bias. For example, were the respondents truly comfortable expressing their candid attitudes about deferred consent? Were the nonresponders intimidated from participating because the process was not truly anonymous? Future studies will benefit from rigorous survey methodology that maximizes participant engagement while minimizing unintended selection or response biases. In sum, this study by Terry et al (6) opens the door for important discussions regarding the utility and safety of delaying consent for minimal risk research in the ICU. Current regulations around the protection of human research subjects stand firmly on familiar historical guidelines including the Nuremberg Code, the Belmont Report, and the Common Rule (7–9). As modern medicine and biomedical research continue to become more complex and time-sensitive, the framework of informed consent will likely need to evolve. Current regulation does not directly address the concept of deferred consent; however, recent reforms to the Common Rule, due to be implemented in early 2018, aim to simplify (and in some cases even eliminate) the informed consent process for minimal risk research (10). Deferred, rather than waived, consent may strike a balance between adequately protecting vulnerable patients while facilitating important research that may ultimately lead to improved therapies for the critically ill. Leaders in critical care medicine should spearhead efforts to support further investigation in this field, and intensive care professional societies should formulate best practice recommendations for deferred consent for minimal risk research going forward.