gms | German Medical Science

Background and status of (inter)national research: In a project aiming to pilot a digital monitoring of symptom burden and concerns in specialist palliative home care (SPHC), patients were involved to ensure later usability of the tool. Due to this vulnerable setting, careful ethical considerations and planning were necessary to receive ethics approval of the local institutional review board (IRB).

Research question and objective: Which ethical considerations arose in conducting research with terminally ill interview partners? Was ethical planning of the procedures for conducting the research project appropriate for the research practice?

Methods: Thematic content analysis of research documents (field notes from interviews with patients and visits in SPHC) and secondary thematic content analysis of transcripts and postscripts of interviews with patients and focus groups with health care professionals (HCP) from SPHC regarding a priori addressed ethical considerations and procedures.

Results: We obtained results regarding the implementation of ethical principles of voluntary participation, informed consent and avoiding harm of the participant. Voluntary participation: HCPs supporting the recruitment played an important role. Two extremes arose: i) gatekeeping from HCPs prevents some patients from voluntarily deciding whether to participate in the project; ii) committed HCPs supporting the study make it challenging for patients to refuse participation as they are dependent from HCPs.

Informed consent: Due to poor health status, patients often declined to read or listen to the complete study information sheet, as required. Researcher sometimes struggled to assess patients’ current capacity of providing informed consent on site because of patients’ fluctuating symptom burden and drug use. Avoiding harm: The complex symptom burden of patients made it difficult for the researcher to decide when patients come to their limit whilst participating in the project. Patients also benefit from study participation as they feel to make a difference and to give something back to the SPHC team and other patients. Patients also welcome being addressed in the different role of a participant. Furthermore, challenging ethical considerations in research practice in a vulnerable setting can also potentially burden the researcher due to moral or emotional distress.

Discussion: To make procedural research ethics applicable means to “translate” it into the research practice. Therefore, researchers have to continuously make ethical decisions during the research process.

Practical implications: Researchers should be trained in ethical decision-making conducting research in vulnerable settings.

Appeal for practice (science and/or care) in one sentence: IRBs should consider the applicability of procedural ethics and researchers should be aware of how to translate them into practice.

Funding: Innovationsfonds/Versorgungsforschung; 01VSF17014