Publication ethics of human studies in the light of the Declaration of Helsinki – a mini-review

Nadia Sawicka-Gutaj; Dawid Gruszczyński; Przemysław Guzik; Adrianna Mostowska; Jarosław Walkowiak

doi:10.20883/medical.e700

Authors

Nadia Sawicka-Gutaj Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences, Poland https://orcid.org/0000-0003-1510-4702
Dawid Gruszczyński Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences, Poland https://orcid.org/0000-0001-9519-4183
Przemysław Guzik Department of Cardiology-Intensive Therapy, Poznan University of Medical Sciences, Poland https://orcid.org/0000-0001-9052-5027
Adrianna Mostowska Department of Biochemistry and Molecular Biology, Poznan University of Medical Sciences, Poland https://orcid.org/0000-0003-4181-9402
Jarosław Walkowiak Department of Paediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poland https://orcid.org/0000-0001-5813-5707

DOI:

https://doi.org/10.20883/medical.e700

Keywords:

ethics, Declaration of Helsinki, publication, medical research

Abstract

The Declaration of Helsinki is a set of ethical principles to be followed by scientists involved in medical research with humans or human cells and tissues. This Declaration defines how scientific research should be planned, conducted, documented, analysed, and published.

We summarise and discuss some ethical issues related to publishing original articles, including clinical trials, review papers, and case reports based on the seventh revision of the Declaration of Helsinki.

The principles of the Declaration of Helsinki refer primarily to the publication of medical research results, in particular clinical trials, as original articles. Such papers are required to meet several ethical requirements, particularly the study protocol transparency and the presentation of the results. In terms of case reports, the bioethical aspects related to their publication are twofold - they need to include informed and voluntary consent and the confidentiality of study participants. The review papers are of the least bioethical concern. However, whether patients' agreements with specific studies are valid if the data are used in meta-analyses is uncertain.

Adherence to ethical policies and standards helps to ensure the highest possible quality of scientific publications. Responsibility for compliance with the Declaration of Helsinki lies not only with the authors preparing their manuscripts, but also with the editorial board and reviewers, who must evaluate the ethical soundness of the submitted papers. The additional guidelines for the different types of studies facilitate the implementation of the Declaration principles.

Downloads

Download data is not yet available.

References

Shrestha B, Dunn L. The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision. J. Nepal Health Res. Counc. 2020;17:548–52. doi: 10.33314/jnhrc.v17i4.1042. PMID: 32001865. DOI: https://doi.org/10.33314/jnhrc.v17i4.1042

WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 2022 May 5]; Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Krleza-Jerić K, Lemmens T. 7th revision of the Declaration of Helsinki: good news for the transparency of clinical trials. Croat. Med. J. 2009;50:105–10. doi: 10.3325/cmj.2009.50.105. PMID: 19399942. DOI: https://doi.org/10.3325/cmj.2009.50.105

Iyalomhe GBS, Imomoh PA. Ethics of clinical trials. Niger. J. Med. J. Natl. Assoc. Resid. Dr. Niger. 2007;16:301–6. doi: 10.4314/njm.v16i4.37326. PMID: 18080584. DOI: https://doi.org/10.4314/njm.v16i4.37326

Malik AY, Foster C. The revised Declaration of Helsinki: cosmetic or real change? J. R. Soc. Med. 2016;109:184–9. doi: 10.1177/0141076816643332. PMID: 27150712. DOI: https://doi.org/10.1177/0141076816643332

Sengupta S, Honavar SG. Publication ethics. Indian J. Ophthalmol. 2017;65:429–32. doi: 10.4103/ijo.IJO_483_17. PMID: 28643704. DOI: https://doi.org/10.4103/ijo.IJO_483_17

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int. J. Surg. Lond. Engl. 2012;10:28–55. doi: 10.1016/j.ijsu.2011.10.001. PMID: 22036893. DOI: https://doi.org/10.1016/j.ijsu.2011.10.001

Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Int. J. Surg. Lond. Engl. 2014;12:1500–24. doi: 10.1016/j.ijsu.2014.07.014. PMID: 25046751. DOI: https://doi.org/10.1016/j.ijsu.2014.07.014

Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ 2015;351:h5527. doi: 10.1136/bmj.h5527. PMID: 26511519. DOI: https://doi.org/10.1136/bmj.h5527

Montero-Aguilar M. Ethical Considerations in Case Report Writing. Odovtos Int. J. Dent. Sci. 2021;23:8–9. doi: 10.15517/ijds.2021.46724. DOI: https://doi.org/10.15517/ijds.2021.46724

Shevell MI. The ethics of case reports. Paediatr. Child Health 2004;9:83–4. doi: 10.1093/pch/9.2.83. PMID: 19654984. DOI: https://doi.org/10.1093/pch/9.2.83

CARE Checklist [Internet]. CARE Case Rep. Guidel. [cited 2022 Jun 25]; Available from: https://www.care-statement.org/checklist

Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D, et al. The CARE guidelines: consensus-based clinical case reporting guideline development. BMJ Case Rep. 2013;2013:bcr2013201554. doi: 10.1136/bcr-2013-201554. PMID: 24155002. DOI: https://doi.org/10.1136/bcr-2013-201554

Riley DS, Barber MS, Kienle GS, Aronson JK, von Schoen-Angerer T, Tugwell P, et al. CARE guidelines for case reports: explanation and elaboration document. J. Clin. Epidemiol. 2017;89:218–35. doi: 10.1016/j.jclinepi.2017.04.026. PMID: 28529185. DOI: https://doi.org/10.1016/j.jclinepi.2017.04.026

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71. PMID: 33782057. DOI: https://doi.org/10.1136/bmj.n71

Vergnes JN, Marchal-Sixou C, Nabet C, Maret D, Hamel O. Ethics in systematic reviews. J. Med. Ethics 2010;36:771–4. doi: 10.1136/jme.2010.039941. PMID: 20952493. DOI: https://doi.org/10.1136/jme.2010.039941