Critical care research is essential to improve the outcomes of the five million patients admitted annually to intensive care units (ICUs) in the United States. The need for critical care research is even more evident in the face of the COVID 19 worldwide epidemic as these patients often required ICU care. However, conducting critical care research can be challenging. Critically ill patients are often cognitively impaired due to their acute illness and the use of sedative medications. As a result, most critically ill patients are not competent to consent for research participation. Therefore, a surrogate is utilized during the informed consent process to protect the best interests of the patient. Our qualitative interviews with surrogates of critically ill patients revealed that the informed consent process does not always provide the information that is needed to make an informed decision. Consequently, surrogates have poor comprehension of study related information and fail to understand vital information regarding study-related procedures and treatments. Currently, there are no consensus guidelines for the surrogate informed consent process for critical care research. We have assembled an optimal team of world-renowned investigators and ethicists to enhance the surrogate informed consent process. We will initially utilize the NHLBI Prevention and Early Treatment of Acute lung Injury (PETAL) network to identify surrogates, critical care survivors, investigators and coordinators to identify and synthesize individual site best practices for the surrogate informed consent process for research participation. Then we will collaborate with various stakeholders from multiple international critical care research networks to create universally accepted guidelines. We hypothesize that consensus guidelines will improve the surrogate informed consent process and allow surrogates to make more informed decisions with less conflict and stress. Initially, we will conduct iterative qualitative needs assessments with the following stakeholder groups: surrogates, patients, and research personnel. Subsequently, we will convene a Delphi process of multiple stakeholders including investigators, coordinators, surrogates, and patients to create consensus guidelines for the surrogate informed consent process for research participation. Finally, we will utilize a multi-faceted approach to disseminate our findings and facilitate the implementation of these guidelines in future critical care trials. In summary, this proposal has the potential to dramatically transform the surrogate consent process for research participations and ultimately improve the ethical conduct of critical care clinical research.
Due to excessive morbidity and mortality, effective clinical research is needed to improve the outcomes of the more than five millions patients annually admitted to intensive care units (ICUs) in the United States. Most critically ill patients are not competent to consent for their own research participation, and a surrogate is utilized on their behalf. These surrogates do not usually receive the proper information needed to make an informed decision and have poor comprehension of study related information. Using qualitative interviews with multiple stakeholders and a Delphi consensus building process, we will develop universally accepted guidelines for the surrogate informed consent process for research participation.
