Table 3

Ethical checklist for research with imminently dying patients in the intensive care unit

Ethical questionConsiderations
1. Does the study hypothesis require the inclusion of imminently dying patients?Could the research question be answered using another, less vulnerable population?
If the research question cannot be answered with another population, is the sample size sufficient to answer the research question?
Are vulnerable participants provided additional protections?
2. Are non-therapeutic risks and burdens minimised consistent with sound scientific design?Are clinically indicated interventions made use of where feasible?
Is standard of care followed so far as is possible?
How will interference with routine care be mitigated?
Will non-therapeutic interventions be as unobtrusive as possible?
Are plans in place to deal with participant distress or anxiety?
Does the protocol account for risks associated with any delay to WLSM?
3. Are the risks of these procedures no more than minimal risk?What are the risks of non-therapeutic study procedures?
Are these risks minimal?
Are adequate procedures in place for the protection and storage of data and biological samples?
4. Are these non-therapeutic risks justified insofar as they are reasonable in relation to the anticipated benefits of the study?What is the expected social value of the study?
Do the risks of non-therapeutic procedures stand in reasonable in relation to the anticipated benefits of the study?
5. Will valid informed consent be obtained from an authorised surrogate decision maker?Are plans for surrogate informed consent consistent with local regulations?
How will the risk of therapeutic misconception be addressed?
Who will approach surrogates for consent?
Where and when will consent discussions take place?
How will researchers assess the fitness of surrogates to offer informed consent, and how will they ensure approaches for consent do not cause further distress?
Is the consent document written in lay terms?
Will surrogates be given adequate time to ask questions and consider the patient’s study participation?
How will surrogates be assured that refusal will in no way impact patient care?
6. How will incidental findings be handled?Are there any foreseeable incidental findings which could indicate a change in the course of care?
Is a plan in place for dealing with incidental findings?
Will individual findings be shared with surrogates? Will summary findings?
7. What additional steps are in place to protect families and significant others of research participants?Have families and significant others of patients who have died in the ICU been involved in study design and development of consent materials?
How will families and significant others be prepared for the study process?
Are supports in place to help them cope during the process?
How will impacts on families and significant others be minimised consistent with sound study design?
Will opportunities for meaning-making for families and significant others be facilitated by research staff? How?
Will summary findings be shared with families and significant others of participants?
8. What additional steps are in place to protect clinical staff and researchers?Have clinical staff been informed of the study and have any concerns raised by them been addressed adequately?
Are researchers well trained and familiar with end-of-life situations? Are they familiar with the patient population?
Are they trained and experienced in approach for consent?
Do researchers have resources to support them during and after discussion with surrogates and families?
  • ICU, intensive care unit; WLSM, withdrawal of life-sustaining measures.