|Year : 2015 | Volume
| Issue : 3 | Page : 254-257
Reporting ethics committee approval and informed consent: Review of an Ayurvedic journal
Pravin M Bolshete
Professional Medical Writer, Airoli, Navi Mumbai, Maharashtra, India
|Date of Web Publication||20-May-2016|
Pravin M Bolshete
Amey CHS, Sector - 15, Airoli, Navi Mumbai - 400 708, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: Reporting of ethical approval and informed consent in clinical research articles involving human subjects is necessary as per the International Committee of Medical Journal Editors (ICMJE). Aim: To assess the reporting of ethics committee approval and informed consent in clinical research articles published in AYU journal. Materials and Methods: This was a retrospective analysis of published articles in AYU from 2012 to 2014. All original articles (clinical research) were included. Data was collected to note – Ethics Committee approval and written informed consent (assent from children when applicable). Descriptive statistics was used to report the findings. Results: A total of 104 articles were included in this analysis. Of these, 38 articles included children. Ethics committee approval was reported in 53 (51.0%) articles and consent was also reported in 51 (49.0%) articles. Thirty-eight (36.5%) articles reported both ethics committee approval and consent, whereas 38 (36.5%) articles did not report both. Only five articles reported consent from guardian or parent whereas none of the articles were reported assent. Conclusion: Findings from this study demonstrate that Ayurvedic clinical research articles lack in reporting ethics committee approval and written informed consent.
Keywords: Ethics committee approval, publication ethics, written informed consent
|How to cite this article:|
Bolshete PM. Reporting ethics committee approval and informed consent: Review of an Ayurvedic journal. AYU 2015;36:254-7
| Introduction|| |
Protecting research participants is reflected in the principles that are used to define ethical research. The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, which also guides on ethics committee approval and informed consent. It suggests that the research protocol must be approved by the ethics committee, and voluntary informed consent must be obtained from each participant before participation. In addition, when participant is minor and considered incapable to provide informed consent, an assent must be obtained in addition to the consent from guardians or parents (the legally acceptable representative [LAR]). The Declaration of Helsinki obligates researchers, authors, sponsors, editors, and publishers to publish reports of their research, including negative and inconclusive and expects publishers not to accept papers where the research is not in accordance with the Declaration of Helsinki.
The International Committee of Medical Journal Editors (ICMJE) offers recommendations and ethical standards in reporting of research, helping authors, editors, and others involved in peer review and biomedical publishing. The ICMJE recommendations have recently (December 2015) been updated and are now known as “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.” The ICMJE expects all reports/publications involving human data to “indicate whether the procedures followed have been assessed by the responsible Review Committee (institutional and national), or if no formal Ethics Committee is available, were in accordance with the Helsinki Declaration……… when informed consent has been obtained, it should be indicated in the published article.” The ICMJE expects journals to include these requirements in instructions to author section.
Journal editors play an important role in adherence to these ethical requirements in all submitted and published research papers in their journals  including AYU, an international quarterly journal of research in Ayurveda. AYU, in its instructions to the authors, included these requirements and expects authors to adhere to the same. The aim of this analysis was to assess the adherence to reporting of ethics committee approval and informed consent in research articles published in AYU.
| Materials and Methods|| |
This was a retrospective analysis of published articles in AYU from 2012 to 2014. All papers published under “Original Articles – Clinical Research” category were included. All other publications including review articles, case studies, pharmaceutical standardization, and pharmacological study were excluded from this analysis. This analysis did not need ethics committee approval as it did not constitute biomedical research. However, reporting is consistent with all ethical requirements.
An electronic version of each article was obtained, and data were collected to note-ethical clearance (by Institutional Ethics Committee or Independent Review Board), whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional or regional) and with the Declaration of Helsinki, written informed consent from study participants, and wherever applicable assent from children aged over 7 years in addition to consent from guardians or parents (LAR). Interventions were also noted which was defined as patients/participants who received any form of medication or underwent any procedure.
Descriptive statistics was used to report the result. The number of research articles reporting ethics committee approval, consent, and assent were expressed as percentages.
| Observations and Results|| |
A total of 104 clinical research articles published in AYU from 2012 (volume 33) to 2014 (volume 35) were included in this analysis. All included studies were deemed to have ethics committee approval or ethical clearance. Studies reporting that the consent was obtained before operation (presurgical consent; n = 2) were not considered as consented as it was not clear whether consent was obtained for participation in the study.
Among these, in 38 (36.5%) articles study participants were children (2014, n = 9; 2013, n = 14; 2012; n = 15); 32 studies included both adults and children and six studies included only children.
Of 104 studies, 61 (58.7%) included vulnerable population (children [aged <18 years], n = 38; elderly [aged >60 years], n = 33; pregnant women, n = 2; students, n = 2; Note: Vulnerable population may not be exclusive in particular study). A total of 96 studies had some intervention whereas other eight studies were non-interventional (surveys/questionnaires) [Table 1].
Reporting of ethics committee approval and consent
Ethics committee approval was reported in 53 (51.0%) articles, and consent was reported in 51 (49.0%) articles. Both ethics committee approval and consent were reported in 38 (36.5%) articles; however, 38 (36.5%) articles did not report both ethics committee approval and consent. Only two articles reported that the study was in accordance with Declaration of Helsinki. The percentage of reporting of ethics committee approval was improved from 33.3% (2012) to 78.6% (2014) and reporting of consent from 35.7% (2012) to 57.1% (2014). Higher numbers of articles were observed reporting both ethical approval and consent from 2012 to 2014 [Figure 1].
Reporting of consent from guardians/parents and assent
Only five (2014, n = 2; 2013, n = 3) articles reported consent from guardians or parents (LAR); however, none of the articles reported assent from participating children. In studies, where both adults and children participated (n = 32), consent was obtained in 15 articles (including LAR, n = 1).
Phrases used to report consent
Various phrases were used to report consent. The most commonly (n = 20, 39.2%) used phrase was “informed consent,” followed by “written consent” (n = 14, 27.5%), “consent” (n = 9, 17.6%), “written informed consent” (n = 5, 9.8%), “signed informed consent” (n = 2, 3.9%), and “ethical consent” (n = 1, 2.0%). One article reported consent in the abstract and not in the body of the article. Few notable statements concerning consent were (1) “patients…. were selected, who have been informed about the details of the trial in brief,” (2) “Every selected patient was explained about the procedure of hemodynamic observations upon him, its benefits and thereby was obtained with consent.”
| Discussion|| |
This retrospective analysis assessed reporting of ethics committee approval and consent in AYU. Overall, observation is poor adherence in reporting of ethics committee approval and consent in published clinical research papers in AYU; however, the reporting practices were improved over the period of time from 33.3% to 78.6% in ethics committee approval and from 35.7% to 57.1% in consent. Reporting of studies that they were conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and local requirements was lacking. In addition, it was observed that the absence of reporting of assent in addition to consent from parents or guardians in studies where participants were more than 7 years of age despite this was clearly stated in journal instructions to authors of AYU.
There are previous similar analyses in other streams of medicine where ethics committee approval was not reported in 24–84% of articles whereas consent was not reported in 20–75% of articles.,,,,,,, However, in previous reports, the assent was not reported in 81–85% of articles.,
It was also observed that various phrases were used to report ethics committee approval and consent, and the most common were “informed consent” and “written consent.” More clear and standardized statements could help reader whether fully written informed consents were obtained. One of the articles reported that patients were informed “about the details of the trial in brief,” whereas the Declaration of Helsinki expects all participants must be adequately informed. Another article reported that “its benefits” were explained; however, Declaration of Helsinki suggests that “the anticipated benefits and potential risks of the study and the discomfort it may entail” should be adequately explained.
To the best of author's knowledge, this was the first time when adherence to reporting of ethics committee approval and consent was assessed in any Ayurvedic journal. The results of the present study provide current status of ethical publication practices concerning protection of research participants in Ayurvedic clinical research and may provide direction or early guidance on the need to report ethical approval and consent. The high proportion of articles lacking reporting of ethics committee approval and informed consent in this report demonstrates that there is a need to raise awareness on this topic for better and complete adherence.
It is important that editor enforces these ethical standards in all submitted manuscripts. If a manuscript does not meet these requirements, editor may inform authors that it could be rejected, due to unsatisfactory ethical non-adherence. It could also be helpful if mandatory steps are added to online submission portal so that during submission authors can confirm to each of these components. Following such high standards will also help building journals credibility and confidence of readers.
Author also acknowledges limitations of this analysis. The present analysis only assessed articles published in clinical research category, and articles published in issues before 2012 were not included. Generalizability could be limited as the author has only assessed articles from one journal; however, these results could provide insights on ethical reporting practices among Ayurvedic researchers.
| Conclusion|| |
Overall, the present analysis demonstrates that a significant proportion of articles involved in Ayurvedic clinical research lack in reporting ethics committee approval and written informed consent; however, improvements have been observed over time. Articles were completely lacking in reporting whether assents were obtained from children whenever applicable, along with consent from guardians or parents. Additional training may be necessary to raise awareness regarding the importance of reporting ethics committee approval and written informed consent.
Financial support and sponsorship
Conflicts of interest
Author is an employee of Tata Consultancy Services, Mumbai, however the views presented in this paper are of the author and not necessarily of his employer.
| References|| |
The World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Available from: http://www.wma.net/en/30publications/10policies/b3/. [Last accessed on 2016 Jan 30; Last revised in 2013].
International Committee of Medical Journal Editors. Recommendations for the Conduct R, Editing, and Publication of Scholarly Work in Medical Journals. Available from: http://www.icmje.org. [Last accessed on 2016 Jan 30; Last updated in 2015].
Schroter S, Plowman R, Hutchings A, Gonzalez A. Reporting ethics committee approval and patient consent by study design in five general medical journals. J Med Ethics 2006;32:718-23.
Yadav SS, Galib R, Patgiri B, Prajapati PK. Clinical efficacy of two different samples of Shirishavaleha in Tamaka Shwasa (Bronchial Asthma). Ayu 2012;33:255-60.
Rastogi S, Chiappelli F. Hemodynamic effects of Sarvanga Swedana (Ayurvedic passive heat therapy): A pilot observational study. Ayu 2013;34:154-9.
Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci 2008;62:134-40.
Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. JAMA 2002;287:2835-8.
Olson CM, Jobe KA. Reporting approval by research ethics committees and subjects' consent in human resuscitation research. Resuscitation 1996;31:255-63.
Belhekar MN, Bhalerao SS, Munshi RP. Ethics reporting practices in clinical research publications: A review of four Indian journals. Perspect Clin Res 2014;5:129-33.
Ruiz-Canela M, Martínez-González MA, Gómez-Gracia E, Fernández-Crehuet J. Informed consent and approval by institutional review boards in published reports on clinical trials. N Engl J Med 1999;340:1114-5.
Harrison JE. Orthodontic clinical trials III: Reporting of ethical issues associated with clinical trials published in three orthodontic journals between 1989 and 1998. J Orthod 2005;32:115-21.
Murphy S, Nolan C, O'Rourke C, Fenton JE. The reporting of research ethics committee approval and informed consent in otolaryngology journals. Clin Otolaryngol 2015;40:36-40.
Sifers SK, Puddy RW, Warren JS, Roberts MC. Reporting of demographics, methodology, and ethical procedures in journals in pediatric and child psychology. J Pediatr Psychol 2002;27:19-25.