Reporting ethical processes: Survey of 'instructions to authors' provided by Indian journals

Indian Journal of Medical Sciences, Jun 2009 by Bavdekar, S, Gogtay, Nithya, Chavan, Ranjeet

Dear Sir,

Ethical approval by an independent review board and written informed consent given by research participants are the two cornerstones of ethical research. A previous study has noted that only 30% of manuscripts published in 2 Indian pediatric journals have mentioned ethics committee approval (ECA), and only 47% of prospective study reports have indicated that informed consent (IC) was obtained. [1] Because authors prepare manuscripts on the basis of guidelines provided by journals, we examined if Indian medical journals provide explicit guidelines to their contributors in this regard.

We obtained a list of Indian journals from Google ( www.google.co.in/ ), PubMed ( http://www.ncbi.nlm.nih.gov/pubmed/ ), MedIndia ( www.medindia.net/doctors/journals/indian/indian_journals.asp?alpha=j ) and the National Informatics Center ( http://indmed.nic.in/ ). The journals belonging to streams of medicine other than allopathy (modern medicine), like those on Ayurveda, Siddha or Unani medicine, and those whose 'Instructions to authors/ contributors' could not be located were excluded from analysis. Also, newsletters, periodicals and journals that published only reviews were excluded. The 'Instructions to authors' were read by all the three authors of this article to determine whether ethical aspects were mentioned and whether the guidelines explicitly required a mention of ECA and approval from the animal ethics committee, obtaining IC and assent, and that research had to be carried out in accordance with the national guidelines provided by the Indian Council of Medical Research, 2006, [2] or Declaration of Helsinki. [3] From a list of 340 Indian medical periodicals (including journals, bulletins and other scientific publications), 240 were excluded from the analysis as their print or electronic versions could not be located (166) or they belonged to other streams of medicine (74). The 'Instructions to authors' found in the remaining 100 Indian journals on modern medicine constituted the study population. As shown in [Table 1], 38 of the Indian journals surveyed did not provide explicit instructions to their contributors regarding reporting of ECA, and 56 of them did not provide instructions regarding reporting of IC. Only 3 journals provided instructions about reporting of assent. It is possible that many of the journals surveyed do not expect to receive manuscripts based on studies carried out in children; however, it is still imperative that explanatory statement regarding assent is carried as a part of the 'Instructions to authors', as it serves to educate researchers.

It must, however, be conceded that the situation is not unique to India. Investigators have found that many foreign journals demonstrate similar lacunae. [4],[5],[6] It is the editors' duty to ensure that reports of clinical trials state that research has been conducted in accordance with Declaration of Helsinki, Good Clinical Practice (GCP) Guidelines or such other guidelines and that research has been carried out after ECA and enrollment has been done after obtaining IC. [7] Reporting on these crucial issues should be considered as a minimum requirement, as it serves to assure readers and the general public that research is being carried out in conformity with basic principles, viz., respect for individuals, beneficence and justice. As the instructions provided by several journals are deficient, editors could first concentrate on updating them by asking authors to include an 'ethics section' under 'Material and Methods'. This section can be used to describe ECA, provision for IC and conformity to Declaration of Helsinki and National Ethical Guidelines for Conducting Biomedical Research on Human Participants. This might help improve compliance with reporting of research ethics, as has been shown by Karlawish et al.[8] Other measures such as providing checklists for authors and reviewers to ensure compliance with reporting of ethical processes could also help. The journals could consider providing links to Declaration of Helsinki, [3] National Ethical Guidelines for Conducting Biomedical Research on Human Participants, [2] etc., from the journal website.

1. Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci 2008;62:134-40.

2. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Participants. http://icmr.nic.in//ethicalguidelines.pdf. [accessed on 2009 Jun 10].

3. World Medical Association. Declaration of Helsinki. http://www.wma.net/e/policy/b3.htm [accessed on 2009 Jun 10].

4. Rowan-Legg A, Weijer C, Gao J, Fernandez C. A comparison of journal instructions regarding institutional review board approval and conflict-of-interest disclosure between 1995 and 2005. J Med Ethics 2009;35:74-8.

5. Freeman SR, Lundahl K, Schilling LM, Jensen JD, Dellavalle RP. Human research review committee requirements in medical journals. Clin Invest Med 2008;31:E49-54.

6. Atlas MC. Emerging ethical issues in instructions to authors of high-impact biomedical journals. J Med Lib Assoc 2003;91:442-9.