RESEARCH NOTES
COMMON ETHICAL ISSUES IN RESEARCH AND PUBLICATION
Ng Chirk Jenn MBBS (Singapore), MMed (FamMed Singapore)
Address for correspondence: Dr Ng Chirk Jenn, Senior lecturer, Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Tel: 03-79492306, Email: ngcj@um.edu.my
Ng CJ. Common ethical issues in research and publication. Malaysian Family Physician. 2006;1(2&3):74-76
INTRODUCTION
Research is the pillar of knowledge, and it constitutes an integral part of progress. In the fast-expanding field of biomedical research, this has improved the quality and quantity of life. Historically, medical doctors have been in the privileged position to carry out research, especially in clinical research which involves people. They are able to control “life and death” of patients and have free access to their confidential information. Moreover, medical researchers have also enjoyed immunity from accountability due to high public regard for science and medicine. This has resulted in some researchers conducting unethical researches. For instance, in World War II, medical doctors had conducted unethical experiments on human in the name of science, resulting in harm and even death in some cases.1 More recently, the involvement of pharmaceutical industry in clinical trials have raised issues about how to safeguard patient’s care and to ensure the published research findings are objective.2
In the light of these ethical controversies, the Declaration of Helsinki was established to inform biomedical researchers the principles of clinical research.3 This declaration highlighted a tripartite guidelines for good clinical practice which include respect for the dignity of the person; research should not override the health, well-being and care of subjects; principles of justice. Committee on Publication Ethics (COPE) was also founded in 1997 to address the breaches of research and publication ethics.4
How do we apply all these principles in our daily conduct of research? This paper will discuss different ethical issues in research, including study design and ethical approval, data analysis, authorship, conflict of interest and redundant publication and plagiarism. I have also included two case scenarios in this paper to illustrate common ethical issues in research and publication.ETHICAL ISSUES IN RESEARCH
1. Study design and ethics approval
According to COPE, “good research should be well adjusted, well-planned, appropriately designed, and ethically approved. To conduct research to a lower standard may constitute misconduct.”3 This may appear to be a stringent criterion, but it highlights the basic requirement of a researcher is to conduct a research responsibly. To achieve this, a research protocol should be developed and adhered to. It must be carefully agreed to by all contributors and collaborators, and the precise roles of each team member should be spelled out early, including matters of authorship and publications. Research should seek to answer specific questions, rather than just collect data.
It is essential to obtain approval from the Institutional Review Board, or Ethics Committee, of the respective organisations for studies involving people, medical records, and anonymised human tissues. The research proposal should discuss potential ethical issues pertaining to the research. The researchers should pay special attention to vulnerable subjects to avoid breech of ethical codes (e.g. children, prisoners, pregnant women, mentally challenged, educationally and economically disadvantaged). Patient information sheet should be given to the subjects during recruitment, detailing the objectives, procedures, potential benefits and harms, as well as rights to refuse participation in the research. Consent should be explained and obtained from the subjects or guardians, and steps should be taken to ensure confidentiality of information provided by the subjects.
2. Data analysis
It is the responsibility of the researcher to analyse the data appropriately. Although inappropriate analysis does not necessarily amount to misconduct, intentional omission of result may cause misinterpretation and mislead the readers. Fabrication and falsification of data do constitute misconduct. For example, in a clinical trial, if a drug is found to be ineffective, this study should be reported. There is a tendency for the researchers to under-report negative research findings,5 and this is partly contributed by pressure from the pharmaceutical industry which funds the clinical trial.
To ensure appropriate data analysis, all sources and methods used to obtain and analyse data should be fully disclosed. Failure to do so may lead the readers to misinterpret the results without considering possibility of the study being underpowered. The discussion section of a paper should mention any issues of bias, and explain how they have been dealt with in the design and interpretation of the study.