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.

Nanomedicine First-in-Human Research: Challenges for Informed Consent

2012 ◽  
Vol 40 (4) ◽  
pp. 823-830 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Consent Form ◽  
Human Research ◽  
Research Challenges ◽  
Starting Point ◽  
Human Subjects Protections

First-in-human (FIH) research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form and process are by no means the primary protectors of human subjects (although they are sometimes so regarded). Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications.

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 Ethics in clinical research

2012 ◽  
Vol 3 (3) ◽  
pp. 16-20 ◽  
Author(s):  
Md Fakruddin ◽  
Abhijit Chowdhury ◽  
Md Nur Hossain ◽  
Khanjada Shahnewaj Bin Mannan
Keyword(s):  
Clinical Research ◽  
Human Subjects ◽  
Second World War ◽  
Ethical Review ◽  
Ethical Guidelines ◽  
Nuremberg Code ◽  
The World ◽  
Long Time ◽  
History Of ◽  
Second World

History of unethical clinical research practice date back to a very long time, though the most remarkable unethical clinical research was those by the Nazis during second world war, which eventually shaken the scientific community and gives birth to the first guideline of ethics in clinical research, the Nuremberg Code. Following Nuremberg code, a number of ethical guidelines has been formulated most important of which are the declaration of Helsinski. To make any research involving human subjects or samples ethically acceptable, a number of key features have to be considered by the scientists. These guidelines are internationally accepted and without following these guidelines, no clinical research is acceptable in the world. Though, there are many countries in the world like Bangladesh, which don’t have any ethical guidelines of their own and thus scientists in those countries do not adhere the any ethical guideline while conducting their research. Each country should have their own ethical guidelines and each clinical research institutes should have own ethical review committee to ensure ethical clinical research. DOI: http://dx.doi.org/10.3329/bioethics.v3i3.12560 Bangladesh Journal of Bioethics 2012; 3(3):16-20

scholarly journals Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease

2021 ◽  
Vol 12 ◽  
Author(s):  
Swati Sathe ◽  
Jen Ware ◽  
Jamie Levey ◽  
Eileen Neacy ◽  
Robi Blumenstein ◽  
...  
Keyword(s):  
Informed Consent ◽  
Observational Study ◽  
Clinical Research ◽  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Clinical Database ◽  
Consent Forms ◽  
Online Portal ◽  
Research Platform ◽  
Contractual Agreements

Established in July 2012, Enroll-HD is both an integrated clinical research platform and a worldwide observational study designed to meet the clinical research requirements necessary to develop therapeutics for Huntington's disease (HD). The platform offers participants a low-burden entry into HD research, providing a large, well-characterized, research-engaged cohort with associated clinical data and biosamples that facilitates recruitment into interventional trials and other research studies. Additional studies that use Enroll-HD data and/or biosamples are built into the platform to further research on biomarkers and outcome measures. Enroll-HD is now operating worldwide in 21 countries at 159 clinical sites across four continents—Europe, North America, Latin America, and Australasia—and has recruited almost 25,000 participants, generating a large, rich clinical database with associated biosamples to expedite HD research; any researcher at a verifiable research organization can access the clinical datasets and biosamples from Enroll-HD and nested studies. Important operational features of Enroll-HD include a strong emphasis on standardization, data quality, and protecting participant identity, a single worldwide study protocol, a flexible EDC system capable of integrating multiple studies, a comprehensive monitoring infrastructure, an online portal to train and certify site personnel, and standardized study documents including informed consent forms and contractual agreements.

Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?

2009 ◽  
Vol 16 (4) ◽  
pp. 271-276
Author(s):  
CSK Tay
Keyword(s):  
Patient Safety ◽  
Informed Consent ◽  
Medical Ethics ◽  
Clinical Research ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Well Being ◽  
Research Subjects ◽  
Medical Research Ethics

Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.

scholarly journals The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection

2002 ◽  
Vol 30 (3) ◽  
pp. 411-419 ◽  
Author(s):  
Arlene M. Davis ◽  
Sara Chandros Hull ◽  
Christine Grady ◽  
Benjamin S. Wilfond ◽  
Gail E. Henderson
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Critical Role ◽  
Invisible Hand ◽  
Community Settings ◽  
Institutional Review ◽  
Research Organizations ◽  
Study Staff ◽  
Protection Of Human Subjects

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research.

scholarly journals Normative framework of informed consent in clinical research in Germany, Poland, and Russia

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcin Orzechowski ◽  
Katarzyna Woniak ◽  
Cristian Timmermann ◽  
Florian Steger
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Biomedical Research ◽  
Human Subjects ◽  
Ethical Conduct ◽  
Vulnerable Groups ◽  
Research Subjects ◽  
Normative Framework ◽  
Declaration Of Helsinki ◽  
Normative Requirements

Abstract Background Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. Trial registration: Not applicable.

Sign in / Sign up

Export Citation Format

Share Document