Ethical Approval of Clinical Studies, Informed Consent, and the Declaration of Helsinki: What You Need to Know

2007 ◽  
Vol 119 (7) ◽  
pp. 2307-2309 ◽  
Author(s):  
Rod J. Rohrich
Keyword(s):  
Informed Consent ◽  
Clinical Studies ◽  
Declaration Of Helsinki ◽  
Ethical Approval

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.

Obtaining Informed Consent in an Egyptian Research Study

2004 ◽  
Vol 11 (4) ◽  
pp. 394-399 ◽  
Author(s):  
Amina M Rashad ◽  
Fiona MacVane Phipps ◽  
Melanie Haith-Cooper
Keyword(s):  
Informed Consent ◽  
Academic Research ◽  
Codes Of Ethics ◽  
Theoretical Work ◽  
Ethical Principles ◽  
Arab Muslim ◽  
Ethical Approval ◽  
The Uk ◽  
Collection Phase ◽  
British Research

This article explores the concept of internationally acceptable codes of ethics within the context of an Egyptian nurse’s PhD studies. Theoretical work, including gaining ethical approval for the project, took place in the UK, while the data collection phase of the study was done in Egypt. This highlighted areas where the Arab Muslim interpretation of some ethical principles, especially around the issue of gaining informed consent, differed from that currently accepted in British research ethics. The authors argue that it may not be possible, or even desirable, to standardize codes of ethics globally in areas such as academic research. Ethical principles develop from a unique mix of culture and religion. It may be more important to develop cultural competence that includes the ability to understand and respect the way in which ethical principles are interpreted by various societies.

scholarly journals Assessment of the Appropriateness of the i-CONSENT Guideline Recommendations for Improving Understanding of the Informed Consent Process in Clinical Studies

2021 ◽  
Author(s):  
Jaime Fons-Martínez ◽  
Cristina Ferrer-Albero ◽  
Javier Diez-Domingo
Keyword(s):  
Informed Consent ◽  
Clinical Studies ◽  
Informed Consent Process ◽  
Consent Process ◽  
Ethical Guidelines ◽  
Potential Participant ◽  
Virtual Meeting ◽  
Continuous Interaction ◽  
And Gender ◽  
First Contact

Abstract Background: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.Methods: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.Results: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertains changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate).The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.Conclusions: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.

scholarly journals Medical terminology circulation and interactional organisation in interpreter-mediated medical encounters

2021 ◽  
Vol 11 ◽  
Author(s):  
Sara Pittarello
Keyword(s):  
Informed Consent ◽  
Active Participation ◽  
Point Of View ◽  
Personal Interest ◽  
Medical Terminology ◽  
Institutional Talk ◽  
Italian Hospital ◽  
Ethical Approval ◽  
Medical Interpreters ◽  
Written Informed Consent

Two medical encounters taking place in a Northern Italian hospital are analysed in this paper from a qualitative point of view, based on the author’s previous research. The aim is to reveal the strategies adopted by medical interpreters, in these two specific cases, to translate medical terminology and promote/exclude interlocutors’ active participation. This latter aspect is influenced by the way the interaction is socially and linguistically organised and, in particular, by how interlocutors’ utterances are translated. The prevalence of dyadic or triadic sequences and especially the shifts between such communication exchanges are pivotal in fostering or hindering interlocutors’ participation. Furthermore, medical interactions, as a form of institutional talk, enshrine specific expectations, which are mainly of a cognitive nature but may also be affective, as in the two encounters observed. By conveying such expectations and expressions of personal interest, interpreters have proved to contribute to the fair distribution of active participation among primary interlocutors. Hospital ethical approval and subjects’ written informed consent have been obtained.

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

Ethical approval and informed consent reporting in ASEAN journals: a systematic review

2019 ◽  
Vol 35 (12) ◽  
pp. 2179-2186
Author(s):  
Junjira Laothavorn ◽  
Pantipa Wongwai ◽  
Shyam Prakash Dumre ◽  
Panida Kongjam ◽  
Kesara Na-Bangchang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Ethical Approval

Investigating the interpreter’s role(s)

Interpreting ◽  
2016 ◽  
Vol 18 (2) ◽  
pp. 172-197 ◽  
Author(s):  
Demi Krystallidou
Keyword(s):  
Informed Consent ◽  
Analytical Framework ◽  
Verbal Interaction ◽  
Medical Consultations ◽  
Significant Interest ◽  
Ethical Approval ◽  
Belgian Hospital

Although the interpreter’s function in interaction has attracted significant interest in the literature, the focus is often restricted to verbal interaction alone. This paper introduces an analytical framework, based on Goffman’s construct of role, to examine how participants’ actions: (i) carry communicative meaning that complements their use of language; ii) are interdependent with those of other participants. The analysis also takes into account the normative frameworks which, to a certain extent, shape the interpreter’s and the doctor’s actions. Transcribed excerpts of two authentic medical consultations are examined, along with video stills. The recordings, with interpreting between Dutch and Russian, were made at a Belgian hospital; informed consent and ethical approval were obtained. It is shown that interpreters’ use of non-verbal resources can favour the patient’s inclusion in interaction when s/he is bypassed by the doctor, possibly interested in involving only the interpreter and in leaving little, if any, opportunity for the patient’s voice to be heard.

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.

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