Ethics in animal experiments
Ethics is very important to any research. Authors are expected to report if the research was done in an ethical manner. Various studies have highlighted the fact that reports of research involving human participants do not always give adequate information on ethical aspects of the study, such as how informed consent was obtained, and details of the ethics review (1, 3). This has been reiterated in studies on articles published in Indian medical journals (4, 6).
While reporting of ethical parameters in clinical studies is discussed widely, the issue of ethical reporting in animal studies seems to have been ignored.
The present study was designed with the primary aim of analysing the reporting of ethical parameters in animal studies published in Indian journals. The secondary aim was to compare the reporting of ethical parameters between Indian and international journals. Most animal studies are published in pharmacology journals. Studies published in two leading indexed pharmacology journals, Indian Journal of Pharmacology (IJP) and Indian Journal of Physiology and Pharmacology (IJPP), were selected for the study. The British Journal of Pharmacology (BJP) was selected as a comparator international journal.
All the articles published in IJP and IJPP between 2002 and Jan – March issue of 2010 were downloaded from the journals’ websites http://www.ijp-online.com, http://www.ijpp.com. Animal studies published in BJP from 2002 to September 2009 were downloaded from the journal’s website http://onlinelibrary.wiley.com/journal/10.1111/%28ISSN%291476-5381s. In the case of BJP, articles published after September 2009 were not available for open access. As for IJPP, articles published since 2002 were available on the website. So, to maintain uniformity, all articles published in or after 2002 were downloaded. Only original animal studies were considered for the study. Short communications, research letters and letters to the editor were not taken into account. Of the studies downloaded, 50 animal studies each from IJP and IJPP were selected randomly (by computer-generated random numbers) and 100 animal studies were selected randomly from BJP by the first author. For equal comparison, animal studies only related to pharmacology were downloaded from IJPP. Each author evaluated these animal studies on the basis of reporting of animal ethics committee approval and reporting of ethical guidelines. Discrepancies in evaluation were resolved by consensus.
Values were shown in the form of frequencies, and comparison between various ethical parameters between the Indian journals (IJP, IJPP) and the international journal (BJP) was done with the help of chi – square test through excel sheet.
Our study revealed that 79% of animal studies published in the two Indian journals reported permission from an ethics committee, which is more than the comparator international journal (62% in BJP). Information related to various guidelines was reported more often in BJP (58%) as compared to the Indian journals (38%). Regarding ethics committee approval and information related to ethical guidelines, there was no significant difference between the two journals.
Our findings show that reporting of ethical parameters such as institutional ethics committee approval is better in animal studies published in Indian journals as compared to clinical studies published in Indian journals. In a study by Chaturvedi et al of articles published in the Indian Journal of Psychiatry, it was observed that permission from an ethics committee was reported in 25% of the articles (5). In a similar study undertaken for articles published in two Indian paediatrics journals, permission from an ethics committee was reported in 29.5% of the articles (4).
In a new guideline ARRIVE (Animal Research: Reporting In Vivo Experiments) for reporting animal studies, authors of articles reporting research are instructed to report on: the nature of ethics review permission; the relevant licence, and the national and institutional guidelines related to the care and use of animals (7). This study shows that though reporting of ethical parameters is better in animal studies as compared to clinical studies, there is room for improvement and authors should be encouraged to report these ethical parameters in the articles.
Though efforts have been made by journal editors towards improving the reporting of ethical parameters (8), there is a need for more in animal as well as clinical studies. Young researchers and students working in the field of biomedical research involving animal studies should be trained in ethical aspects of research while conducting experiments and reporting the same in publications. Journal editors and peer reviewers should make sure that information regarding ethical parameters is incorporated in the manuscript.
Jaykaran, Assistant Professor, Department of Pharmacology,Government. Medical College, Surat 395 001 INDIA e-mail: firstname.lastname@example.org Preeti Yadav, Associate Professor, Department of Pharmacology, Government Medical College, Surat395 001 INDIA. N D Kantharia, Professor and Head, Department ofPharmacology, Government Medical College, Surat 395 001 INDIA
- Ruiz-Canela M, Gomez-Gracia E. Informed consent and approval by institutional review boards in published reports on clinical trials. N Engl J Med. 1999 Apr 8;340:1114-5.
- Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. JAMA. 2002 Jun 5;287:2835-8.
- 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 Dec;32 (12):718-23.
- Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci. 2008 Apr;62 (4):134-40.
- Chaturvedi SK and Somashekar BS. Reporting ethical aspects in published research articles in the Indian Journal of Psychiatry. Indian J Psychiatry. 2009 Jan – Mar;51(1):34.
- Jaykaran, Gohiya S, Gohiya V, Sharma G, Saurabh MK, Yadav P. Reporting of the methodological quality and ethical aspects in clinical trials published in Indian journals: a survey. J Pharm Research. 2010 Mar;3(2):307-9.
- Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: The ARRIVE guidelines for reporting animal research. PLoS Biol. 2010 Jun;8(6):e1000412. doi:10.1371/journal.pbio.1000412.
- Bavdekar SB, Gogtay NJ, Chavan R. Reporting ethical processes: survey of instructions to authors provided by Indian journals. Indian J Med Sciences. 2009 Jun;63(6): 260-2.