Surrogate Consent for Genomics Research in Intensive Care

Abstract

Surrogate decision makers may be poorly prepared to give informed consent for genomics research for their loved ones in intensive care. A review of the challenges and strategies associated with obtaining surrogates' consent for genomics research in intensive care patients revealed that few wellcontrolled studies have been done on this topic. Yet, a major theme in the literature is the role of health care professionals in guiding surrogates through the informed consent process rather than simply witnessing a signature. Informed consent requires explicit strategies to approach potential surrogates effectively, educate them, and ensure that informed consent has been attained. (American Journal of Critical Care. 2009;18:418-427) Notice to CE enrollees:A closed-book, multiple-choice examination following this article tests your under standing of the following objectives:1. Understand the challenges associated with obtaining surrogates' consent for genomics research. 2. Describe strategies for obtaining surrogates' consent for genomics research. 3. Recognize the importance of evaluating surrogates' understanding of essential information before concluding the consent process.

Biobanking in the Pediatric Critical Care Setting: Adolescent/Young Adult Perspectives

“…Additional layers of ethical complexity exist for conducting biorepository-based research in the critical care setting. (Menon & Ward, 2014; Shelton et al, 2009; Truog, 2008) Critically ill children are often too sick to provide assent, and their parents may be unusually stressed, making truly informed consent difficult. Determining the appropriate timing of consent during critical illness is also challenging, and perspectives regarding delayed consent are not well elucidated.…”

Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali

“…Empirical research demonstrates, however, that a number of issues and difficulties can arise when seeking to ensure participants are appropriately informed about research [3-5]. In some cases, features of the context in which research is conducted may make consent processes particularly challenging, such as when research is conducted in emergency situations [6] or in populations with low levels of literacy and limited familiarity with relevant concepts [7-9]. Aspects of specific research protocols may also prove difficult to explain: in genomic research such issues include the unfamiliar and technical research methods, the implications for participants of the complicated infrastructure and data sharing requirements, and potential consequences of future research with samples and data (the nature of which may be unknown at the time consent is sought) [10-13].…”

Seeking consent to genetic and genomic research in a rural Ghanaian setting: A qualitative study of the MalariaGEN experience

“…Particular challenges can arise when seeking consent from impoverished populations with high levels of illiteracy [5-7], when seeking consent to paediatric research [8], when seeking consent to research in emergency situations [9-11] and when seeking consent to genomic research [12]. Specific challenges arising when seeking consent for genetic and genomic research include explaining the research methods, the implications of the complex informatics infrastructure required to support such studies and the potential consequences of future research with samples and data (the nature of which may be unknown at the time consent is sought)[13].…”