Ethical considerations in the biomedical research: analysis of national biomedical research ethics guidelines in Iran
AbstractThe national guidelines for biomedical research ethics are approved by the “National Committee for Ethics in Biomedical Research” at the Iranian Ministry of Health and Medical Education as the regulatory body for biomedical research in the country. The focus of these guidelines should be on the ethical issues related to different stages of the research process, which would lead to increased research integrity and better supervision of research activities. The present study analyzed the contents of these national guidelines to clarify the ethical considerations connected to the five stages of a research process including 1) proposing, 2) approval, 3) operation, 4) documentation and 5) publishing. The findings showed that the assessed guidelines laid more emphasis on the ethical considerations related to the research operation stage rather than the proposal stage. In other words, activities such as identification of the research problem, formulation of hypotheses and questions, financial evaluation, data analysis and data interpretation did not receive adequate attention in these guidelines. Most of the guidelines presented subject categories such as the rights of participants and supervisory considerations in the “research operation stage”, ethical considerations in the “evaluation and approval procedure stage”, and editorial responsibilities in the “research review and publication stage”. In general, despite noticeable content for guiding researchers for ethical conduction of research the national guidelines are not adequately developed to cover comprehensive and sufficient ethical considerations regarding all the activities of research.
Afshari B, Eshaghian Z, Bakhtiyar Nasrabadi HA. An analysis of ethical principles in the process of conducting researches in the field of educational sciences. [Faslanemeh Akhlagh].1394; 11(40): 67-94. [in Persian]
Ana J, Koehlmoos T, Smith R, Yan LL. Research misconduct in low-and middle-income countries. PLoS Medicine. 2013; 10(3): e1001315.
Fierz K, Gennaro S, Dierickx K, Achterberg T, Morin KH, De Geest S. Scientific misconduct: also an issue in nursing science?. J Nurs Scholarsh. 2014; 46(4): 271-80.
Anonymous. Ethical considerations. [Cited on December 2018]; available from: https://cirt.gcu.edu/research/developmentresources/tutorials/ethics
Lashkarbolouki M. A framework for codification of values and ethical codes of scientific and technological researches. International Journal of Ethics and Society. 2009; 1: 105-114. [in Persian]
Resnik DB, Rasmussen LM, Kissling GE. An international study of research misconduct policies. Account Res. 2015; 22(5): 249-266.
Anonymous. Guidelines for responsible conduct of research. [Cited on December 2018]; available from: http://www.provost.pitt.edu/documents/GUIDELINES%20FOR%20ETHICAL%20PRACTICES%20IN%20RESEARCH-FINALrevised2-March%202011.pdf
Mardani AH. Designing A Model to Identify Factors Associated with Research Misconduct in Medical Research in Iran [Dissertation]. Tehran (Iran): University of Tehran; 2018. [in Persian]
Hickey G, kippin C. A multi- stage approach to the coding of data form opened questions. Nurse Res. 1996; 4(1): 81-91.
Anonymous. Code of ethical conduct and statement of commitment. [Cited on December 2018]; available from: https://www.naeyc.org/sites/default/files/globally-shared/downloads/PDFs/resources/position-statements/Ethics%20Position%20Statement2011_09202013update.pdf
BahmanAbadi S, Kalateh Jafarabadi T, Shabani Varaki B. The degree of observation of ethical standards in research: A case study of PhD theses of faculty of humanities of Ferdowsi University, Mashad, 2007-2012. Strategy for Culture. 2014; 7(25): 129-52. [in Persian]
Bornmann L. Research misconduct: definitions, manifestations and extent. Publications. 2013; 1: 87-98.
Fanelli D. Redefine misconduct as distorted reporting. Nature. 2013; 494(7436): 149. doi: 10.1038/494149a.
Post SG. Encyclopedia of Bioethics, 3rd ed. USA: Macmillan Reference USA; 2003, Vol. 4.
Alahmad G, Al-Jumah M, Dierickx K. Review of national research ethics regulations and guidelines in Middle Eastern Arab countries. BMC Med Ethics. 2012; 13: 34.
Yazdizadeh B, Majdzadeh R, Janani L, et al. An assessment of health research impact in Iran. Health Res Policy Syst. 2016; 14(1): 56.
Martinson BC, Crain A, Anderson MS, De Vries R. Institutions' expectations for researchers' self-funding, federal grant holding, and private industry involvement: Manifold drives of self-interest and researcher behavior. Acad Med. 2009; 84(11): 1491-1498.
Mardani AH, Nakhoda M, Shamsi Goshki E, Noruzi A. Reported causal factors for research misconducts in Iranian research. Medical Ethics and History of Medicine. 2017; 10(1): 243-57. [in Persian]
Tijidnk JK. Publish and perish: research on research and researchers. Tijdschr Psychiatr. 2017; 59(7): 406-13.
Fanelli D. Do pressures to publish increase scientists’ bias? an empirical support from US states data. PLoS One. 2010; 5(4): e10271.
Anonymous. International ethical guidelines for biomedical research involving human subjects. [Cited on December 2018]; available from: http://www1.paho.org/hq/dmdocuments/2011/CIOMS%20Guidelines.pdf
Munafò MR, Nosek BA, Bishop DVM, et al. A manifesto for reproducible science. Nature Human Behavior. 2017; 1(0021): DOI: 10.1038/s41562-016-0021.