Ranking Research Methodology by Risk - a cross-sectional study to determine the opinion of research ethics committee members.

BACKGROUND: When reviewing a protocol, research ethics committees (RECs, equivalent to institutional review boards - IRBs) have the responsibility to consider whether the proposed research is justified. If research is not justified, it can waste participants' time, researchers' time and resources. As RECs are not constituted to cover all areas of scientific or academic expertise, it can be difficult for RECs to decide whether research is scientifically or methodologically justified especially in the absence of authoritative (often in the form of systematic) reviews. Where such reviews are absent, some have argued that RECs should insist on a new review of existing evidence as a condition of the REC favourable opinion. However, as RECs review a wide range of research, such requests must be proportionate to the type, and extent, of proposed projects. Risk is one factor that may influence the extent of evidence need for a REC to determine that the new project is justified, but not the only factor. The aim of the work described here was to determine whether REC members and researchers specifically link risk to the type of research methodology, and if so, whether this link could be used to help guide the need for systematic, or other, types of reviews. METHOD: We conducted a cross-sectional study, gathering data between November 2020 and January 2021, to examine whether proposed research methodologies impact how RECs perceive risk to participants. We presented 31 research methodologies to REC members and researchers in the form of an international survey. RESULTS: We collected 283 responses that included both qualitative and quantitative data as to how research methodology impacts perceptions of risk to participants. We used the data to conclude that RECs did see a link between risk and type of research. We therefore constructed a hierarchy of risk with Phase 1 and 2 clinical trials, and clinical psychology/psychiatry intervention studies, at the top (i.e. viewed as most risky). CONCLUSIONS: We discuss whether this hierarchy is useful for guiding RECs as to the level of scientific justification that they should seek when reviewing proposed research protocols, and present a one-page guidance sheet to help RECs during their reviews.

Bulgaria at the onset of clinical ethics consultation.

BACKGROUND: Over the years, Bulgarian bioethics has been mainly an academic enterprise and fallen short of providing health professionals with skills for ethical decision-making. Clinical ethics support (CES) was piloted by the author through two bottom-up models - METAP (Modular, Ethical, Treatment, Allocation of resources, Process) and MCD (Moral Case Deliberation). AIMS: This paper aims to present and analyse developments in the area of clinical ethics and the first experiences in CES in Bulgaria. METHODOLOGY: The project reported here included a review of relevant literature on CES methods and evaluation and a documentary review of data from two CES pilot projects: METAP and MCD. RESULTS: Most of the 69 METAP ethics meetings reviewed were first time meetings (88,4%); the average duration was 36 min and the average number of participants was four (44,9%). The meetings were organized in response to cases of severely or critically ill patients. The ethical dilemmas included choice of treatment (31,9%) and conflicts with the patient or their relatives (23,2%). Consensus was achieved in 34,8% of the cases. The situation was clarified with the patient (27,5%) and within the team (15,9%). The rights and obligations of both sides were discussed in 7,2% of the cases. The experience of the members of the Bulgarian Association of Bioethics and Clinical Ethics (BABCE) with MCD was also presented to justify the inference about the applicability of the two CES models in a Bulgarian context. CONCLUSION: Among Eastern European countries Bulgaria has made progress in CES. Both METAP and MCD have been found to be useful methods.

Development of Bioethics and Clinical Ethics in Bulgaria.

BACKGROUND: Bioethics and clinical ethics emerged from the classical medical ethics in the 1970s of the 20th century. Both fields are new for the Bulgarian academic tradition. AIM: The aims of this paper were to demarcate the subject fields of medical ethics, bioethics, and clinical ethics, to present the developments in the field of medical ethics in Bulgaria, to delineate the obstacles to effective ethics education of medical professionals, and to present the results of the application of an adapted bottom-up methodology for clinical ethics consultation in several clinical units in Bulgaria. MATERIALS AND METHODS: Extended literature review and application of an adapted METAP methodology for clinical ethics consultation in six clinical units in the Northern Bulgaria between May 2013 and December 2014. RESULTS: Teaching of medical ethics in Bulgaria was introduced in the 1990s and still stands mainly as theoretical expertise without sufficient dilemma training in clinical settings. Earlier studies revealed need of clinical ethics consultation services in our country. METAP methodology was applied in 69 ethics meetings. In 31.9% of them non-medical considerations affected the choice of treatment and 34.8% resulted in reaching consensus between the team and the patient. Participants' opinion about the meetings was highly positive with 87.7% overall satisfaction. CONCLUSION: Development of bioethics in Bulgaria follows recent worldwide trends. Several ideas could be applied towards increasing the effectiveness of ethics education. Results of the ethics meetings lead to the conclusion that it is a successful and well accepted approach for clinical ethics consultation with a potential for wider introduction in our medical practice.

An innovative approach to teaching bioethics in management of healthcare.

BACKGROUND: Bioethical courses were introduced in the curricula in medical universities in Bulgaria in 1990s. In the beginning, the courses were mainly theoretical, and systematic case analyses and discussions of movies were introduced later on. The benefits of using films to teach ethics have been previously analyzed in the literature; however, to our knowledge such studies in Bulgaria are yet lacking. OBJECTIVE: The aim of this study was to survey the opinions of students and analyze the results from the application of movies in bioethics teaching in a medical university in the north of Bulgaria. METHODOLOGY: A survey was carried out among 92 students in the management of healthcare. Two movies were used, and separate protocols for film discussion were developed. ETHICAL CONSIDERATIONS: The study was conducted anonymously and with students' free informed consent. RESULTS AND DISCUSSION: The students distinguished in total 21 different dilemmas and concepts in the first movie. The ethical dilemmas were classified into five groups: general ethical issues, deontological issues, special ethical issues, principles of bioethics, and theories of ethics. The second movie focused students' attention on the issues of death and dying. In total, 18 elements of palliative care were described by the students. The range of different categories was a positive indicator of an increased ethical sensitivity. The students evaluated the movies' discussions as a generally positive educational approach. They perceived the experience as contributing to their better understanding of bioethical issues. CONCLUSION: The innovative approach was well accepted by the students. The introduction of movies in the courses of bioethics had the potential to provide vivid illustrations of bioethical issues and to contribute to the exploration of specific theses and arguments. The presentation and discussion should be preceded by accumulation of theoretical knowledge. The future of effective bioethics education lays in the interactive involvement of students.

Survey of staff and family members of patients in Bulgarian hospices on the concept of "good death".

The concept of a "good death" has been intensely discussed over the past decades. The objective of this study is to investigate this concept among staff and patients' relatives in 29 Bulgarian hospices and 5 palliative care units. Self-administered questionnaires were completed by 190 members of staff and 216 patients' relatives. Death without pain and suffering and death in one's sleep were leading concepts in both the groups. Staff preferred death in the presence of relatives, while relatives preferred fast and sudden death. Although we were able to define the common concept of a good death as painless and sudden death in one's sleep, death is unique phenomenon and good palliative care should be based on communication with patients about their idea of a good death.