Concerns raised during REB review at five study sites
| Study site | Modification request | Examples |
|---|---|---|
| Site 1 | Study procedures (consent process) | ‘The investigator was also asked to ensure…that the recruitment strategy be revised to allow the most responsible physician to directly obtain a family's consent, rather than having the research assistant do so. To avoid the appearance of a conflict of interest, [the site investigator] could request that another clinical staff member approach [their] patients and their families about the study. [The site investigator] would also be free to answer questions about the study if asked’. |
| General language | ‘The Board also requested that the investigators consider rewording the title of the study, which appeared on the consent form… The Board members were concerned that the title might mislead parents into believing that the point of death was being defined differently within the study, or that competing conceptualizations of death were being evaluated. A more descriptive title might avoid this possibility…’. | |
| Study procedures | ‘the consent form should state explicitly, “the research assistant would not need to be in [the patient's] room in order to collect this information”’. ‘the consent form should state that the continued monitoring should not prevent [families] from holding [the patient], if they wished. [Families] should also be re-assured that if they wanted to discontinue the monitoring, they could do so by simply advising the bedside nurse’. | |
| Site 2 | Study procedures | ‘Will physical contact with the deceased, by family members, be permitted during the monitoring phase? If not, please advise in the [consent form]’. |
| General language in consent form | ‘…consider re-working the parenthetical phrase “(i.e. social services, pastoral services, etc.)” to something a bit more conciliatory/less technical or dismissive (for example, by removing “i.e.” and “etc.”)’. | |
| Study purpose | ‘I understand the purpose of the study; but technically, “time of death” has already been determined, at least as far as the surrogate decision maker providing informed consent is concerned. To avoid confusion, you might consider substituting “…about any physiological changes that may continue to occur…”’. | |
| Site 3 | Study procedures (consent process) | ‘Clarify who is performing the consent process. If it the same person that had (or will be) discussed(ing) organ donation, address how this apparent conflict of commitment will be managed’. ‘It is not clear where in the process the family will be approached. After the decision has been made to remove life support, but before it is done? Is that an appropriate window of time? Is the risk of drawing out the process for families longer than it would otherwise be?’ |
| Study procedures | ‘Make it clear that consent will not affect standard treatment they would otherwise receive & that the intervention is done to the machine not the actual person’. ‘Include details about pastoral or social services that will be made available’. | |
| Study purpose | ‘Make it clear that organ donation is not part of this study’. | |
| Site 4 | Patient population | ‘Please comment on why competent patients such as ventilator-dependent patients quadriplegics are not included in the study’. |
| study purpose | ‘It is suggested that the purpose of the research be initially focused on “determining the physiologic changes that occur just before and following determination of death after cardiac arrest in ICU patients” even though the ultimate goal of the study is to clarify criteria for organ transplantation later on’. ‘The study title has the term “pilot study”. This should be explained in relation to the purpose of the study’. | |
| Study procedures | ‘Patient family members will be allowed to stay at the bedside for the duration of monitoring following [withdrawal of life sustaining therapy] and declaration of death. In the event that monitors are left open and autoresuscitation is documented, this may be witnessed by the family members/SDM. How will this be dealt with?’ ‘It should be mentioned that all patients will receive standard care for patients at the end of life and no changes will be made other than the 30 minutes of monitoring following declaration of death’. | |
| Site 5 | General language in consent form | ‘The [site REB] felt that the wording in the letter of information was a bit too frank. Would it be possible to take the edge off the wording slightly. For example instead of stating “no chance the patient will live” would it be appropriate to say “no chance the person would recover”’. ‘Please remove signature line for the participant as you have indicated they will be unable to provide consent’. |
| Study purpose | ‘The [site REB] was also concerned about informing the family members that their loved ones heart might restart and the implications of this statement. The [site REB] appreciates that you are trying to be informative to the family however, is it possible to reword these statements to better inform the family of the possibility of the heart restarting but that it would be temporary and the patient would still not recover’. |
ICU, intensive care unit; REB, research ethics board; SDM, substitute decision maker.