Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient.
We interviewed 33 family members involved in surrogate research consent decisions for dying patients in intensive care. Non-therapeutic research involved continuous physiological monitoring of dying patients prior to and for 30 min following cessation of circulation. At some study centres participation involved installation of bedside computers. At one centre electroencephalogram monitoring was used with a subset of participants. Aside from additional monitoring, the research protocol did not involve deviations from usual end-of-life care.
Thematic analysis of interviews suggests most family members did not perceive this minimal-risk, non-therapeutic study to affect their time with patients during the dying process, nor did they perceive research consent as an additional burden. In our analysis, consenting for participation in perimortem research offered families of the dying an opportunity to affirm the intrinsic value of patients’ lives and contributions. This opportunity may be particularly important for families of patients who consented to organ donation but did not proceed to organ retrieval.
Our work supports concerns that traditional models of informed consent fail to account for possible benefits and harms of perimortem research to surviving families. Further research into consent models which integrate patient and family perspectives is needed.
- informed consent
- research ethics
- research on special populations
- vital organ donation
Data availability statement
All data relevant to the study are included in the article.
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Contributors AvB, VG, AS, LH, SD and JC contributed to the conception and design of the project. AvB, VG, AS and JC participated in the acquisition and analysis of data for the work; NM, CW, LH and SD additionally contributed to interpretation of data for the work. AvB, NM, CW, VG, AS, LH, SD and JC drafted the work and revised it critically for important intellectual content and gave final approval of the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This project was partially funded by the Bertram Loeb Research Chair and by the Canadian Donation and Transplantation Research Program.
Competing interests CW receives consulting income from Cardialen, Eli Lilly and Company and Research Triangle Institute (RTI) International. LH is a paid consultant for Canadian Blood Services.
Provenance and peer review Not commissioned; externally peer reviewed.
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