scholarly journals A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research

2020 ◽  
Vol 5 (2) ◽  
pp. 73-79
Author(s):  
Rajpal Nandra ◽  
Alan F. Brockie ◽  
Faisal Hussain
Keyword(s):  
Informed Consent ◽  
Emergency Care ◽  
Ethics Committees ◽  
Moral Obligations ◽  
Ethical Considerations ◽  
Vulnerable Patients ◽  
Ethical Approval ◽  
Life Threatening ◽  
Time Critical

A vulnerable participant in research lacks capacity to consent or may be exposed to coercion to participate. Capacity may be temporarily impaired due to loss of consciousness, hypoxia, pain and the consumption of alcohol or elicit substances. To advance emergency care, providing life-threatening measures in life-threatening circumstances, vulnerable patients are recruited into research studies. The urgent need for time-critical treatment conflicts with routine informed consent procedures. This article reviews ethical considerations and moral obligations to safeguard these participants and preserve their autonomy. A particular focus is given to research methodology to waive consent, and the role of ethics committees, research audits, research nurses and community engagement. Research on the acutely unwell patient who lacks capacity is possible with well-designed research trials that are led by investigators who are sufficiently trained, engage the community, gain ethical approval to waive consent and continuously audit practice. Cite this article: EFORT Open Rev 2020;5:73-79. DOI: 10.1302/2058-5241.5.180051

The Role of Psilocybin-Assisted Psychotherapy to Support Patients With Cancer: A Critical Scoping Review of the Research

2021 ◽  
pp. 089801012110390
Author(s):  
Rebecca H. Lehto ◽  
Megan Miller ◽  
Jessica Sender
Keyword(s):  
Mental Health ◽  
Health Issues ◽  
Mushroom Species ◽  
Patients With Cancer ◽  
Existential Suffering ◽  
Vulnerable Patients ◽  
Scoping Literature Review ◽  
Life Threatening ◽  
Self Transcendence

Treatments for addressing psychiatric mental health issues in vulnerable patients with cancer are established. Yet, many patients persist with unrelenting psychological difficulties despite intervention. There is growing interest in the role of psilocybin-assisted psychotherapy for managing treatment-resistant mental health challenges in patients with cancer. Psilocybin is a naturally occurring compound derived from certain mushroom species that can induce entheogenic experiences or an altered state of consciousness. Reed's Self-Transcendence Theory provides a holistic lens to examine existential concerns and mental health in individuals who perceive their illness as potentially life threatening, such as those with cancer. This scoping literature review used Arksey and O’Malley's template to evaluate research examining psilocybin-assisted psychotherapy for patients with cancer. Eight articles met inclusion/exclusion criteria (four quantitative, two mixed methods, and two qualitative). Review findings indicated that the majority of patient experiences were positive, centering on themes of death acceptance, reflection, and broadened spirituality. Although psilocybin-assisted psychotherapy is in early stages of clinical testing, it thus shows promise for carefully screened patients with cancer who have persistent existential suffering. It will be critical for investigators to tailor this emerging intervention to select patients and for clinicians to be engaged in assessment of outcomes and efficacy.

Ethics and the Ruling Relations of Research Production

2003 ◽  
Vol 8 (1) ◽  
pp. 70-80 ◽  
Author(s):  
Carole Truman
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Process ◽  
Research Governance ◽  
Community Mental Health Service ◽  
Moral Obligations ◽  
Research Participants ◽  
Research Production ◽  
Health And Social Care ◽  
Ethical Approval

The role of research ethics committees has expanded across the UK and North America and the process of ethical review has become re-institutionalised under proposals for research governance proposed by government. Ethics committees have gained a powerful role as gatekeepers within the research process. Underpinning the re-constitution of ethical guidelines and research governance, are a range of measures which protect institutional interests, without necessarily providing an effective means to address the moral obligations and responsibilities of researchers in relation to the production of social research. Discussion of research ethics from the standpoint of research participants who in this paper, are service users within health and social care, provides a useful dimension to current debate. In this paper I draw upon experiences of gaining ethical approval for a research study which focused on user participation within a community mental health service. I discuss the strategies used to gain ethical approval and the ‘formal concerns’ raised by the ethics committee. I then describe and discuss ethical issues which emerged from a participants’ perspective during the actual research as it was carried out. These experiences are analysed using aspects of institutional ethnography which provides a framework to explore how the experiences of research participants are mediated by texts which govern the processes of research production. The paper highlights incongruities between the formal ethical regulation of research, and the experiences of research participants in relation to ethical concerns within a research process.

Informed Consent

PEDIATRICS ◽  
1967 ◽  
Vol 39 (2) ◽  
pp. 309-309
Author(s):  
H. DAVID MOSIER
Keyword(s):  
Informed Consent ◽  
Clinical Investigation ◽  
Ethical Considerations

It is difficult to imagine a physician investigator who does not also at the same time play the role of "physician-friend" in the sense of Dr. Silverman's proposal (Pediatrics, 38:373, 1966). Any physician responsible for the subjects of clinical investigation must perform his role guided by the same ethical considerations that guide other physicians in the care of their patients. Were it otherwise, the subjects would be placed at some jeopardy as to their welfare and the preservation of their dignity.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2017 ◽  
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Conflicts Of Interest ◽  
Institutional Review Boards ◽  
Ethical Considerations ◽  
Governmental Organizations ◽  
Institutional Review ◽  
The Us ◽  
Guidelines And Recommendations ◽  
Study Designs

Ethics and conflicts of interest are important considerations when planning and carrying out research. It is the role of the institutional review board to weigh these against protection of the research subject when evaluating research proposals. The ethical considerations when performing research include basic ethical principles (e.g., autonomy, confidentiality, non-maleficence, informed consent, beneficence, justice, and utility), as well as nuances such as appropriate study designs, investigator conflict of interests, and bias in all its forms. To help guide clinicians, a number of professional and governmental organizations have published guidelines and recommendations on various aspects of clinical research (e.g., the American Medical Association, the National Institutes of Health, and the US Food and Drug Administration).

scholarly journals Decision-making in an emergency department: A nursing accountability model

2019 ◽  
Vol 27 (2) ◽  
pp. 567-586 ◽  
Author(s):  
Alfonso Rubio-Navarro ◽  
Diego José García-Capilla ◽  
Maria José Torralba-Madrid ◽  
Jane Rutty
Keyword(s):  
Decision Making ◽  
Emergency Department ◽  
Participant Observation ◽  
Ethics Committees ◽  
Healthcare Institution ◽  
Structured Interviews ◽  
Ethical Considerations ◽  
Clinical Nursing ◽  
Ethical Approval ◽  
Acute Patients

Introduction: Nurses who work in an emergency department regularly care for acute patients in a fast-paced environment, being at risk of suffering high levels of burnout. This situation makes them especially vulnerable to be accountable for decisions they did not have time to consider or have been pressured into. Research objective: The objective of this study was to find which factors influence ethical, legal and professional accountability in nursing practice in an emergency department. Research design: Data were analysed, codified and triangulated using qualitative ethnographic content analysis. Participants and research context: This research is set in a large emergency department in the Midlands area of England. Data were collected from 186 nurses using participant observation, 34 semi-structured interviews with nurses and ethical analysis of 54 applicable clinical policies. Ethical considerations: Ethical approval was granted by two research ethics committees and the National Health Service Health Research Authority. Results: The main result was the clinical nursing accountability cycle model, which showed accountability as a subjective concept that flows between the nurse and the healthcare institution. Moreover, the relations among the clinical nursing accountability factors are also analysed to understand which factors affect decision-making. Discussion: The retrospective understanding of the factors that regulate nursing accountability is essential to promote that both the nurse and the healthcare institution take responsibility not only for the direct consequences of their actions but also for the indirect consequences derived from previous decisions. Conclusion: The decision-making process and the accountability linked to it are affected by several factors that represent the holistic nature of both entities, which are organised and interconnected in a complex grid. This pragmatic interpretation of nursing accountability allows the nurse to comprehend how their decisions are affected, while the healthcare institution could act proactively to avoid any problems before they happen.

scholarly journals Reporting of ethical considerations in clinical trials in Chinese nursing journals

2017 ◽  
Vol 26 (4) ◽  
pp. 973-983 ◽  
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.

Nurses’ attitudes towards euthanasia in conflict with professional ethical guidelines

2016 ◽  
Vol 24 (1) ◽  
pp. 70-86 ◽  
Author(s):  
Anja Terkamo-Moisio ◽  
Tarja Kvist ◽  
Mari Kangasniemi ◽  
Teuvo Laitila ◽  
Olli-Pekka Ryynänen ◽  
...  
Keyword(s):  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Cross Sectional ◽  
Web Based ◽  
Ethical Approval ◽  
Research Questions ◽  
The Moment ◽  
The Right ◽  
The University

Background: Despite the significant role of nurses in end-of-life care, their attitudes towards euthanasia are under-represented both in the current literature and the controversial debate that is ongoing in several countries. Research questions: What are the attitudes towards euthanasia among Finnish nurses? Which characteristics are associated with those attitudes? Research design: Cross-sectional web-based survey. Participants and research context: A total of 1003 nurses recruited via the members’ bulletin of the Finnish Nurses Association and social media. Ethical considerations: Ethical approval was obtained from the Committee on Research Ethics of the university to which the authors were affiliated. Findings: The majority (74.3%) of the participants would accept euthanasia as part of Finnish healthcare, and 61.8% considered that Finland would benefit from a law permitting euthanasia. Most of the nurses (89.9%) thought that a person must have the right to decide on his or her own death; 77.4% of them considered it likely that they would themselves make a request for euthanasia in certain situations. Discussion: The value of self-determination and the ability to choose the moment and manner of one’s death are emphasized in the nurses’ attitudes towards euthanasia. Conclusion: A continuous dialogue about euthanasia and nurses’ shared values is crucial due to the conflict between nurses’ attitudes and current ethical guidelines on nursing.

scholarly journals Informed consent: A study of patients with life-threatening illnesses

2015 ◽  
Vol 24 (4) ◽  
pp. 430-440 ◽  
Author(s):  
Montserrat Busquets ◽  
Jordi Caïs
Keyword(s):  
Informed Consent ◽  
Health Sector ◽  
Ethical Considerations ◽  
Consent Document ◽  
Key Factor ◽  
Life Threatening ◽  
Informed Consent Document ◽  
The Moment ◽  
Spanish Health ◽  
The Relationship

Background: The relationship between healthcare professionals and patients in the Spanish health sector has undergone dramatic change. One aspect of this is that the use of informed consent has become a key factor in the delivery of adequate healthcare. But although a certain period of time has already passed since informed consent started to be used, in Spain there is still doubt about how adequately informed consent is being used. Objectives: (a) To look at how patients understand the notion and purpose of informed consent, and (b) how the informed consent is applied – the way patients receive such information affects their level of participation and decision making during the time they receive medical care. Methodology: We use interpretative description of interviews with patients. We developed guiding questions for the interviews with patients in two preliminary and exploratory focus groups. Then, we carried out 20 personal open-ended interviews with 20 purposive selected patients with illnesses that had a serious impact on their lives. Ethical considerations: Permission from ethical committees and institutions involved in the study, and consent and confidentiality were ensured before conducting the research. Results: The findings show that while patients agreed that their consent should be necessary for health professionals to be able to intervene, they had serious difficulty obtaining and then understanding information offered to them at the moment when they were being asked to sign informed consent documents. The participants were critical of the consent documents, which they considered were treated as merely a formality and even some of them had felt coerced to sign. Discussion: Participants confirmed that the informed consent documents that they signed did not meet their ethical objectives. Their perception of the purpose of consent indicates that informed consent document may still be largely understood as a formality rather an ethical obligation.

Sedation for refractory symptoms

2015 ◽  
pp. 440-448
Author(s):  
Patti Knight ◽  
Laura A. Espinosa ◽  
Bonnie Freeman
Keyword(s):  
Informed Consent ◽  
Case Studies ◽  
Nursing Care ◽  
Hospital Setting ◽  
Palliative Sedation ◽  
Ethical Considerations ◽  
Time To Death ◽  
Refractory Symptoms

This chapter explores the use of palliative sedation in the hospital setting. It presents case studies involving palliative sedation, discusses several definitions of palliative sedation, frequency of palliative sedation, reasons for palliative sedation, medications used, guidelines for nursing care, time-to-death issues, ethical considerations, informed consent, and the role of the nurse-caregiver.

Sign in / Sign up

Export Citation Format

Share Document