Better Late Than Never? Deferred Consent for Minimal Risk Research in the ICU*

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Attaining permission to conduct research in the critically ill patient presents a peculiar dilemma—those eligible to participate in research are often incapacitated and unable to consent and their healthcare proxies either unavailable or overwhelmed. Thus, a quandary arises: must research on critically ill patients conform to the existing requirements for up-front informed consent or might delaying consent be an acceptable alternative? Federal legislation supports the right of institutional review boards to waive the requirement for informed consent when the research involves no more than minimal risk and obtaining consent is not practical (1). In the 1980s, the concept of deferred consent for research was introduced (2) where incapacitated patients were entered into research protocols without consent, and permission for continued inclusion in research was sought from a surrogate at a later time. The role for deferred consent has been explored in situations of greater than minimal risk research in emergency circumstances (3), and patients and their surrogates have expressed favorable opinions regarding delayed or exempted research consent in emergencies (4, 5).
Would a delayed consent approach mitigate barriers to enrolling critically ill ICU patients in research? In this issue of Critical Care Medicine, Terry et al (6) used a deferred consent approach for a minimal risk research protocol and used a survey to assess patient/surrogate attitudes about delaying informed consent for research. Patients were enrolled from five ICUs in a tertiary care hospital, and oral and perianal swabs were obtained as part of the parent study. Patients who had capacity or surrogates for patients lacking capacity were enrolled and samples collected on day 1. Patients who lacked capacity and for whom a surrogate was not available were enrolled and samples collected on day 1 and delayed consent was obtained on day 3. Of the 135 patients/surrogates who agreed to the survey study, samples were obtained from 69 patients without up-front informed consent. Seventy-three percent of patients who were consented later responded positively when asked if it was the right decision to wait until day 3 for consent, commonly citing stress of the early ICU experience as a reason they supported delayed consent.
This study has several strengths that support a potentially important role for deferred research consent in the ICU. First, a delayed consent approach significantly increased the number of subjects enrolled in the study (91% vs 47% enrollment rate). Significant barriers exist to enrolling critically ill ICU patients in research protocols. Incapacitated patients cannot consent for themselves, and the acuity of the clinical situation can preclude meaningful informed consent discussions with families who are often too stressed or distracted to fully consider participation in research. Delaying consent until the acute clinical situation wanes may overcome barriers to research enrollment.
Importantly, this study had a well-defined procedure for the destruction of data and samples if a subject or surrogate declined to consent at the delayed time point. This is critical as a rigorous method to protect and safeguard data and samples collected before consent is obtained is paramount to prevent a potential violation of patient autonomy or protected health information if a patient ultimately decides to not participate in research. If a delayed consent approach is used, meticulous data management must be ensured to avoid a potential slippery 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.
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