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.

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

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 Tuskegee Syphilis Study of 1932–1973 and the Rise of Bioethics as Shown Through Government Documents and Actions

2019 ◽  
Vol 47 (4) ◽  
pp. 11
Author(s):  
Laura A. Barrett
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Information Science ◽  
Human Subjects ◽  
Medical Studies ◽  
Research Subjects ◽  
Tuskegee Syphilis Study ◽  
Institutional Review ◽  
Government Documents ◽  
Science Community

One government source regarding clinical trials is Clinicaltrials.gov (https://clinicaltrials.gov), which is available to health information seekers as a resource to find information about past, current, and recruiting clinical trials. Currently, if you participate in a clinical trial you are required to provide your “informed consent.” This means you have been informed of the risks, benefits, purpose of the study, and your rights. This information is provided to you so that you, as the potential participant, can make an informed decision before deciding whether or not to participate. If you work with or in research, you will become very familiar with the term IRB, which stands for “Institutional Review Board.” An IRB is a panel intended to oversee the entire scope of one or more medical research studies including protecting the rights and welfare of human research subjects. Although it may seem like common sense that these two things are necessary, there was a time when they did not exist. A new approach to bioethics and the regulation of clinical trials and medical studies using living human subjects came about from public and governmental outrage over one study, known as the Tuskegee Syphilis Study. By looking specifically at this case, which led to the rise of bioethics at the federal-government level in the 1970s, the origin of IRBs and informed consent as they relate to medical studies and human subjects will be illuminated. The issues of IRBs, informed consent, and bioethics are important in the library and information science community because we often interact with a public that is impacted by the policies and regulations related to these issues. In addition, we are the very researchers, or hold relationships with researchers, that are held to the strict standards set in place by IRBs and bioethics in general.

Qualitative research ethics on the spot

2015 ◽  
Vol 23 (4) ◽  
pp. 455-464 ◽  
Author(s):  
Christine Øye ◽  
Nelli Øvre Sørensen ◽  
Stinne Glasdam
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethical Dilemmas ◽  
Institutional Review Boards ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Institutional Review ◽  
Review Boards

Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. Objectives and ethical considerations: First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop.

scholarly journals The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

2022 ◽  
Vol 8 ◽  
Author(s):  
Hideki Maeda
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Personal Information ◽  
Human Subjects ◽  
Legal Framework ◽  
Current Status ◽  
Biological Research ◽  
Marketing Approval ◽  
Ethical Guidelines

In Japan, a law called the Clinical Trials Act went into being effective on April 1, 2018, and clinical research on human subjects conducted in Japan has been undergone major changes. Those other than clinical trials for marketing approval of drugs or medical devices are broadly classified into “specific clinical trials” and others, and regulations have been tightened for each. As a result, clinical interventional study was drastically reduced, and observational clinical study increased. For the observational clinical study, the two previous ethical guidelines were merged into the “Ethical Guidelines for Medical and Biological Research Involving Human Subjects,” which was enacted in March 2021. The observational clinical study is now subjected to these ethical guidelines. In addition, changes are planned for the Act on the Protection of Personal Information, which greatly affects data collection in clinical research. Clinical research in Japan must be conducted appropriately while adapting to these various changes in the external environment and legal framework. Adapting to these changes is not an easy task, as it requires increased financial and human resources for all stakeholders.

scholarly journals Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yanni Wu ◽  
Michelle Howarth ◽  
Chunlan Zhou ◽  
Mingyu Hu ◽  
Weilian Cong
Keyword(s):  
Informed Consent ◽  
Observational Study ◽  
Clinical Research ◽  
Clinical Studies ◽  
Human Subjects ◽  
Retrospective Observational Study ◽  
Ethical Review ◽  
Journal Citation Reports ◽  
International Nursing ◽  
Ethical Approval

Abstract Background Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P < 0.05). Conclusion The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation

2019 ◽  
Vol 31 (8) ◽  
pp. 710-718
Author(s):  
Rajesh Ranjan ◽  
Nidhi B. Agarwal ◽  
Prem Kapur ◽  
Amit Marwah ◽  
Rizwana Parveen
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Subjects ◽  
Cross Sectional Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Cross Sectional ◽  
Contract Research ◽  
Research Organizations ◽  
Informed Consent Document

Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.

scholarly journals Beyond the informed consent procedure: continuing consent in human research

2008 ◽  
Vol 13 (2) ◽  
pp. 381-389 ◽  
Author(s):  
Mary-Rose Mueller ◽  
Susan Instone
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Subjects ◽  
Informed Consent Process ◽  
Informed Consent Procedure ◽  
Patient Health Status ◽  
Consent Procedure ◽  
Patient Health ◽  
Federal Guidelines ◽  
Insight Into

An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol requirements and patient health status triggered the actions and decisions of researchers and human subjects during the conduct of these trials. U.S. federal guidelines recommend that informed consent should be conceptualized as more than a one-time event. Rather, a process of continuing consent should be the standard but little is understood about how exactly this process should unfold. We used a proposed typology of continuing consent to frame our analysis and were able to document that only some of the proposed types took place at the site of our study. The most frequent practice involved the researchers' re-consent of their subjects for major protocol revisions. Only one subject dissented and chose to withdraw even though he was technically eligible to continue in the study. Two other types of continuing consent were not observed. We discovered an additional type of continuing consent not described in the typology whereby subjects gave implied consent through their cooperation and adherence to the on-going requirements of the protocols. Implications for the informed consent process and the need for further research are presented.

scholarly journals Influence of Academic Qualifications, Place of Employment and Prior Research Experience on Physiotherapy Research Practice

2005 ◽  
Author(s):  
Peter Thomas ◽  
Marie Williams ◽  
Jeffrey Lipman
Keyword(s):  
Research Experience ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Research Papers ◽  
Research Practices ◽  
Human Research Ethics ◽  
Research Activities ◽  
High Level ◽  
Academic Qualifications ◽  
Good Research

An increasing number of physiotherapists are undertaking research activities, but the level of overall awareness and understanding of ethical research practices is unknown. The aim of this study was to describe physiotherapist's knowledge of good research practices. Physiotherapists who presented abstracts at an Australian Physiotherapy Association conference in 2003/2004 were surveyed (n = 184, response rate = 55%). Excluding literature reviews, the majority of abstracts involved humans (95%), with 89% of these having human research ethics committee (HREC) approval. Only eight (6%) experimental research papers involving humans did not seek or gain HREC approval. Despite the high level of HREC approval, only 47% (n = 83) of respondents had read or referred to ethical documents governing research in Australia. For guidance on ethical considerations in research, 30% (n = 53) of respondents indicated a primary reliance on colleagues, 36% (n = 65) would use local HREC guidelines alone and 32% (n = 58) would use HREC guidelines in conjunction with other ethical guidelines. Responses indicated that place of employment, academic qualifications and prior research involvement impact on a physiotherapist’s ability to apply for research funding and progress research to completion through publication. This survey has implications for tertiary training programs, research supervisors, clinicians and physiotherapy managers.

scholarly journals Seven Snags of Research Ethics on the Qualitative Research Voyage

2019 ◽  
Vol 12 (6) ◽  
pp. 1
Author(s):  
MacDonald Kanyangale
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Research Ethics ◽  
Research Process ◽  
Qualitative Inquiry ◽  
Ethical Guidelines ◽  
Ethical Approval ◽  
Conceptual Paper ◽  
Research Students ◽  
The University

Responsible researchers with ethically sound research skills are fundamental to success in an ever-changing business and social world. Embedding ethics into research by students seems to be intuitively easy given tight, standardized ethical guidelines and rigorous ethical approval process in the university. In reality, there are Masters and PhD research students who feel ill-prepared when they encounter ethical ambiguities and complexities in the field which are unique, beyond what they had foreseen at the outset of a qualitative inquiry or were prescribed, advised and forewarned by a research ethics committee (REC). The aim of this conceptual paper is to discuss seven pitfalls of research ethics in a qualitative research voyage in order to educate and sensitize current and prospective research students. The seven pitfalls are: (1) complexity and ambiguity of informed consent; (2) embedding informed consent as a process rather than an event; (3) navigating the moral conundrum of unintentional disclosure; (4) dealing with deductive disclosure; (5) dialectic between participant`s desire for recognition and greater confidentiality; (6) researcher role conflict and (7) difficulty of embedding researcher reflexivity. The paper concludes that only research students who are ethically literate and actively reflexive in the entire research process are more likely to know whenever they encounter ethical pitfalls, deal with them properly; and ultimately entrench relevant skills to conduct ethically sound research. Highlighted are implications for research educators to develop research competence of current and future researchers. Responsible researchers with ethically sound research skills are fundamental to success in an ever-changing business and social world. Embedding ethics into research by students seems to be intuitively easy given tight, standardized ethical guidelines and rigorous ethical approval process in the university. In reality, there are Masters and PhD research students who feel ill-prepared when they encounter ethical ambiguities and complexities in the field which are unique, beyond what they had foreseen at the outset of a qualitative inquiry or were prescribed, advised and forewarned by a research ethics committee (REC). The aim of this conceptual paper is to discuss seven pitfalls of research ethics in a qualitative research voyage in order to educate and sensitize current and prospective research students. The seven pitfalls are: (1) complexity and ambiguity of informed consent; (2) embedding informed consent as a process rather than an event; (3) navigating the moral conundrum of unintentional disclosure; (4) dealing with deductive disclosure; (5) dialectic between participant`s desire for recognition and greater confidentiality; (6) researcher role conflict and (7) difficulty of embedding researcher reflexivity. The paper concludes that only research students who are ethically literate and actively reflexive in the entire research process are more likely to know whenever they encounter ethical pitfalls, deal with them properly; and ultimately entrench relevant skills to conduct ethically sound research. Highlighted are implications for research educators to develop research competence of current and future researchers.

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