The ‘Consent to Research’ paradigm in critical care: challenges and potential solutions
Karen E. A. Burns Celia Zubrinich John Marshall Deborah Cook
-
Nowhere in medicine do health care providers, patients uncertainty regarding patient participation in research [7].
and families interact with such intensity and ambiguity, SDMs are clearly an imperfect surrogate for the
autonooften for protracted periods of time. For patients unable to mous decision of the patient.
give informed consent, debate exists over whether con- Substituted judgments may not only fail to accurately
sent should always be required and, if so, to whom the represent patients wishes, but may cause duress for
decision regarding participation in research should be SDMs that may be greater in magnitude than that
expeentrusted. Alternative models to SDM consent include rienced in making treatment decisions. In one study, being
deferred consent (deferred to patient, deferred to SDM), asked to provide consent to research was associated with
two physician consent, request for an objection to con- post-traumatic stress symptoms in 35% of family
memsent, and waived consent (or exemption from informed bers of critically ill patients with 9/18 (50%) and 33/69
consent). Although contemporary consent models for (48%) of individuals involved in discussions about
participation in acute care research are grounded in efforts appropriate level of care and consent to research
experito respect patient autonomy, protect potentially vulnera- encing these symptoms, respectively [8]. In contrast,
ble populations and ensure the ethical conduct of discussions and decisions about clinical care, such as
research, their application may have important conse- performing a tracheostomy and regarding appropriate
quences for SDMs, the care provided to critically ill level of care, induced substantially lower rates of
postpatients, and the results of studies in the ICU setting. traumatic symptoms, at 6 and 10%, respectively.
A combination of the complexity of the information and The challenges of the informed consent process
the stress inherent in making decisions for a gravely ill threaten the duration of studies and the generalizability of
loved one renders the integrity of the decision-making their results. An internet based survey of Canadian
Critprocess uncertain. A survey of SDMs providing consent for ical Care Trials Group (CCCTG) members involving 26
therapeutic measures revealed that more than half of SDMs ICUs (containing 609 beds and 2,698 admissions) during
failed to understand information presented to them April 2005, revealed that only 136 adult or pediatric
regarding diagnosis, treatment and prognosis [4]. No patients, representing 5% of all admissions, were
recruicomparable investigations have been conducted to evaluate ted into an observational or interventional study [9]. In a
SDMs comprehension regarding research participation. recent survey to examine implementation challenges,
Moreover, the perspectives of the SDM and the patient Rose et al. contacted CCCTG investigators who
commay be discordant. A systematic review, including 151 pleted eight large randomized controlled trials (RCTs)
scenarios involving 2,595 surrogatepatient pairs, asses- enrolling 6,658 patients. While the predicted mean trial
sed SDMs ability to predict patients treatment duration was 3.0 years, the actual trial enrolment period
preferences. SDMs predicted patients treatment prefer- was significantly longer and the anticipated mean monthly
ences with 68% accuracy. The accuracy of their recruitment rate tended to be higher than the actual
substituted judgments did not vary according to health monthly recruitment [10]. While the precise contribution
state or intervention, by prior discussion of the involved of lack of informed consent is not certain for the
foreparties or SDM type (patient-designated vs. legally des- going issues, these survey findings highlight the
ignated) [5]. In a study by Coppolino and colleagues, difficulties encountered in implementing critical care
patients agreed or declined to provide consent to two research under the SDM paradigm. As a result of these
hypothetical trials (minimal-risk and greater-than-mini- challenges, some investigators have opined that a more
mal-risk) and surrogates attempted to predict patients liberal approach is needed to allow for trial participation
responses. The authors found an overall surrogate positive in patients who cannot offer first person consent [11].
predictive value of 85% for the low-risk study and 80% Since federal rules in the United States were passed in
for the higher-risk study. The authors also found that 1996 requiring public disclosure to implement studies
SDM consent resulted in a false positive consent rate of without consent, there has been an estimated 35-fold
1620%, with SDMs frequently making decisions that decrease in the number of studies involving emergency
differ from those patients would have made [6]. Similarly, patients in the United States [12]. While the Food and
in a prospectiv (...truncated)