A Narrative Review of the Rationale for Conducting Neonatal Emergency Studies with a Waived or Deferred Consent Approach
Anup Katheria, Georg M. Schmölzer, Annie Janvier, Vishal Kapadia, Ola Didrik Saugstad, Máximo Vento, Alla Kushnir, Mark Tracy, Wade Rich, Ju Lee Oei
Abstract
Emergency research studies are high-stakes studies that are usually performed on the sickest patients, where many patients or guardians have no opportunity to provide full informed consent prior to participation. Many emergency studies self-select healthier patients who can be informed ahead of time about the study process. Unfortunately, results from such participants may not be informative for the future care of sicker patients. This inevitably creates waste and perpetuates uninformed care and continued harm to future patients. The waiver or deferred consent process is an alternative model that may be used to enroll sick patients who are unable to give prospective consent to participate in a study. However, this process generates vastly different stakeholder views which have the potential to create irreversible impediments to research and knowledge. In studies involving newborn infants, consent must be sought from a parent or guardian, and this adds another layer of complexity to already fraught situations if the infant is very sick. In this manuscript, we discuss reasons why consent waiver or deferred consent processes are vital for some types of neonatal research, especially those occurring at and around the time of birth. We provide a framework for conducting neonatal emergency research under consent waiver that will ensure the patient's best interests without compromising ethical, beneficial, and informative knowledge acquisition to improve the future care of sick newborn infants.