Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study

Consent for research participation in the intensive care unit (ICU) is often obtained from a substitute decision maker (SDM). In this study we explored SDMs' reasons for declining or providing consent for research studies for critically ill adult family members. Two questionnaires were developed, one directed at SDMs who agreed to have their relative participate in a research study (AGREE group), and another for SDMs who declined participation (DECLINE group). The questionnaires explored SDMs' opinions about research in general, timing of research approach, the informed consent process, and reasons for agreeing or declining participation. Ninety-six SDMs completed the questionnaire (68 AGREE, 27 DECLINE). There were no differences between AGREE and DECLINE groups with respect to SDM demographics, perceived severity of illness of the patient, or the research study approach. The most common reasons for providing consent were potential for research to help others (91%), research is important for medical progress (88%), and trust in the medical team (87%). The most common reasons for declining consent were SDM was too anxious to consider research (67%), fear that patient would receive experimental treatment (37%), and concern about risks of the study (33%). SDMs who agree to have a relative participate in an ICU research study are motivated by the potential benefit to the patient and altruism. SDMs who decline research participation, while not generally opposed to research, are fearful of study-related harm or discomfort for the patient, and are too anxious to consider a research study at that time.