Ethical checklist for research with imminently dying patients in the intensive care unit
| Ethical question | Considerations |
| 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.