A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research

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 dont 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

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Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership?

Tropical Medicine & International Health ◽

10.1111/j.1365-3156.2011.02732.x ◽

2011 ◽

Vol 16 (4) ◽

pp. 527-530 ◽

Cited By ~ 11

Author(s):

Raffaella Ravinetto ◽

Anne Buvé ◽

Tinto Halidou ◽

Pascal Lutumba ◽

Ambrose Talisuna ◽

...

Keyword(s):

Clinical Research ◽

Ethical Review

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Conference on ethical review of clinical research

BMJ ◽

10.1136/bmj.304.6839.1446-a ◽

1992 ◽

Vol 304 (6839) ◽

pp. 1446-1446

Author(s):

J. Williams

Keyword(s):

Clinical Research ◽

Ethical Review

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Experience at a clinical research ethical review committee

BMJ ◽

10.1136/bmj.284.6313.424-b ◽

1982 ◽

Vol 284 (6313) ◽

pp. 424-424

Author(s):

D R Laurence

Keyword(s):

Clinical Research ◽

Ethical Review ◽

Review Committee ◽

Ethical Review Committee

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

BMC Medical Ethics ◽

10.1186/s12910-019-0431-5 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 2

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.

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