Scientific and psychosocial ethical considerations for initial clinical trials of kidney xenotransplantation

BackgroundPrehospital ambulance based research has unique ethical considerations due to urgency, time-limitations and the locations (home, ambulance) involved. We sought to explore these issues through interviews with paramedics that have research experience.MethodsWe undertook semi-structured interviews with paramedics, seeking their views and experiences of undertaking research in ambulance based clinical trials. Participants were purposively chosen because they were actively involved research and had enrolled one or more patients into a clinical trial. Participants were questioned regarding their experiences of the enrolment and consent process, and their opinions regarding the facilitators and barriers to ambulance based research. Transcripts were digitally recorded, transcribed verbatim, and analysed thematically.ResultsWe interviewed 15 paramedics. They ranged from newly qualified to experienced advanced paramedics. Mental capacity and consent were discussed and the time and complexity for undertaking these processes were highlighted. Participants discussed problems with completing paperwork due to the complexity of recording systems. Most highlighted paramedic training and experience as a potential barrier to research, stating that those that had gone through a university education in general seemed more open to research than those that had ‘learnt on the job’. It was also felt that more information on the benefits of a trial to both patients and practice were needed from the outset to allow paramedics to make an informed decision about whether to take part in research or not. Several stated that they did additional reading around the subject before signing up. All stated that the training given prior to commencing the research was good and appropriate to each trial.ConclusionsWe identified patient capacity and consent, paramedic training and experience and complexity of processes as important potential barriers to prehospital research. There is scope to improve guidance for prehospital research studies in future.

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Ethical considerations in clinical trials

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt1979255part2728 ◽

1979 ◽

Vol 25 (5part2) ◽

pp. 728-741 ◽

Cited By ~ 49

Author(s):

Robert J. Levine ◽

Karen Lebacqz

Keyword(s):

Clinical Trials ◽

Ethical Considerations

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Ethical Considerations for Nurses in Clinical Trials

Nursing Ethics ◽

10.1191/0969733006ne836oa ◽

2006 ◽

Vol 13 (2) ◽

pp. 180-186 ◽

Cited By ~ 21

Author(s):

Kathleen Oberle ◽

Marion Allen

Keyword(s):

Clinical Trials ◽

Moral Obligation ◽

Potential Problem ◽

Ethical Issues ◽

Methodological Issues ◽

Ethical Considerations ◽

Ethical Concerns ◽

Principal Investigators ◽

Research Nurses ◽

Trial Failure

Ethical issues arise for nurses involved in all phases of clinical trials regardless of whether they are caregivers, research nurses, trial co-ordinators or principal investigators. Potential problem areas centre on nurses’ moral obligation related to methodological issues as well as the notions of beneficence/non-maleficence and autonomy. These ethical concerns can be highly upsetting to nurses if they are not addressed, so it is imperative that they are discussed fully prior to the initiation of a trial. Failure to resolve these issues can place both the conduct and the results of research in jeopardy.

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Reporting of ethical considerations in clinical trials in Chinese nursing journals

Nursing Ethics ◽

10.1177/0969733017722191 ◽

2017 ◽

Vol 26 (4) ◽

pp. 973-983 ◽

Cited By ~ 2

Author(s):

Yanni Wu ◽

Michelle Howarth ◽

Chunlan Zhou ◽

Xue Ji ◽

Jiexia Ou ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Human Subjects ◽

Journal Citation Report ◽

Mainland China ◽

Ethical Guidelines ◽

Ethical Considerations ◽

Research Papers ◽

Technology Journal ◽

Ethical Approval

Background: It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research. Objectives: To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China. Research design: A retrospective observational study. Participants: All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand to explicate rate of reporting ethical approval and informed consent. Ethical considerations: The study did not require approval from the research ethics committee as it did not involve human subjects or records. Results: In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively ( p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively ( p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval ( p < 0.05 or < 0.01). Conclusion: Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals.

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