Research to inform the consent-to-research process

Excerpt

Critically ill patients are often incapable of providing first-person research consent at the time that they meet eligibility criteria for study interventions, either due to the nature of their underlying critical illness or to the treatments that they require. To ensure that science and knowledge can continue to advance while respecting the ethical principle of autonomy, we commonly asked substitute decision-makers (SDMs) to provide consent on patients’ behalf [1, 2]. In situations where a study is deemed to pose only minimal risk, for example, observational studies, some research ethics boards may waive the need for informed consent, although the criteria used to establish minimal risk have varied [3, 4]. Studying interventions that must be administered on an emergency basis can further complicate the informed consent process due to the inability to identify SDMs within a suitable time frame [5]. Delayed consent is an approach that has been increasingly used to allow incapable patients to participate in emergency research. It involves enrolling patients into a study before consent is obtained, but then later approaching either the patient or the SDM to obtain consent for ongoing participation and use of data. While the acceptability of this approach to patients has been a topic of research and debate, one thing is certain: delayed consent can facilitate dramatic increases in study enrolment when SDMs are not immediately available [6]. …