Table 3.

Author’s disposition on the use of advance consent for research

Author	Author’s disposition	Description of supporting evidence
Backlar24	In favour of use of advance consent for research	The author reasons that ‘substantive and procedural research advance directives allow potential subjects to make a choices of their own as to whether they wish to be enrolled and participate in a research protocol, to appoint a surrogate decision maker of their own choosing, and to additionally spell out specific safeguards’ and that ‘research advance directives provide potential subjects with the opportunity not only to make choices of their own but provide a mechanism that guarantees them a cluster of important protections’.
Biros et al26	Against use of advance consent for research	The authors contend that ‘patients may not consider consent carefully when the changes of entry into a specific study are remote. Thus, they may not be adequately protected from research risks’. Regarding advance consent at hospital admission for a potential future research protocol, the authors argue that preconsent ‘cannot be used for emergency research in the prehospital setting or for studying the treatment of acute illnesses that occur in the out-of-hospital setting’. Regarding obtaining advance consent from unaffected subjects who may require emergency care in the future, the authors argue that ‘identifying those patients who have previously consented may not be feasible when the critical situation occurs’.
Cole et al29	Against use of advance consent for research	The authors screened 1461 patients for their RCT on loxapine versus IM haloperidol+lorazepam for treatment of acute agitation in the ED secondary to bipolar disorder type 1 or schizophrenia. ‘Despite screening >1400 patients and obtaining preconsent in 43 patients’, not a single patient was enrolled using preconsent methods. Only two patients were enrolled in the study, and the study was terminated 1 month after enrolment of the first patient due to loss of funding. The article concludes that the use of preconsent in their study was ‘found to be infeasible’.
Corneli et al27	In favour of use of advance consent for research	Structured interviews detail that ‘patients and caregivers expressed no concerns about being approached in the ICU about a clinical trial on treatment for pneumonia before the patient was diagnosed with the condition’ and that ‘the IRB representatives expressed no ethical or regulatory concerns with the early enrollment strategy using advance consent’. The article concludes that ‘early enrollment strategy with advance consent appears to be an acceptable approach among key stakeholders’.
Karlawish et al28	No opinion for or against the use of advance consent for research	The authors outline that ‘advance informed consent means, that at a time before enrollment, an investigator seeks the consent of a competent person who is a potential subject of a research trial.(…)Like advance directives for clinical care such as living wills, regulations could endorse advance directives for research’. They then explain that ‘a moral conflict can occur when an advance directive conflicts with substituted judgement or best interests principles’ and that ‘there are the practical limits, including that an advance directive cannot address every circumstance a potential subject faces and that many people do not execute them’.
McGehrin et al25	In favour of use of advance consent for research	The article states that ‘one solution to preserving patient autonomy in acute stroke care is the advent of a stroke advance directive. An advance directive for acute stroke therapy was created at the University of California, San Diego (UCSD) in 2015 titled COAST (Coordinating Options for Acute Stroke Therapy). This 4-page form allows patients to document their preferences regarding acute stroke treatment interventions, as well as participation in clinical stroke trials, in a nonurgent setting and in advance of a potential stroke’.

ED, emergency department; IM, intramuscular; RCT, randomised controlled trial.