When it comes to ethics, what would occur to us is the slow process of bureaucracy we wish to just pass. We may think that we are ethical enough to just conduct a research without having the need to understand the ethics itself – but honestly, are we?
The word “ethics” is rooted from the ancient Greek word “Ethos”, that means ‘character’ or ‘custom’. It deals with the consideration of decision making in regard to moral values and our actions towards our decision.1,2 Looking back, ethical aspect of research had drawn public attention when the case of human exploitation through experimentation without consent was conducted by Nazi doctors in 1946.1-3 As a result, this led to the establishment of Nuremberg Code in 1948, the first international ethic code in clinical research that focused on the urgency of subjects’ consent in research. However, this code had failed to stop the act of unethical research. It was only later in 1964 that an updated guideline on biomedical research was established by the World Medical Association (called as the Declaration of Helsinki); emphasizing the need of protection for human involved in research and that social and scientific interests were not as important as the well being of individuals.1-3
As well as practical medicine, ethics in research is originated from the cardinal principles which are autonomy, beneficence, non-maleficence, and justice; however, there are some ethical issues that needs to be considered, such as the advancement of new technologies, globalization, and the wide range of research activities.4 According to the NIH Clinical Centers,5 the main principle to ethical research consists of informed consent, social and clinical value, respect for potential and enrolled subject, fair subject selection, favorable risk-benefit ratio, scientific validity, and independent review, which are involved throughout the planning, execution, and follow up studies.
We might think that we have learned ethical norms from our own setting – family, school, and environment – and it seems to us that everyone has had the sense of understanding about what is right and what is wrong. However, as the same ethical norms can be interpreted and applied in different ways depending on one’s values and experiences, it is not impossible to find a situation where different ethical principles may clash, or conflict of interest arises.1,6 That is why it is important to learn ethics. Ethical guideline enables research to seek the truth and avoid errors by prohibiting the act of falsifying, fabricating, plagiarism, and misrepresentation. It also promotes collaborative work by regulating the authorship, data-sharing, copyright, and confidentially rules in peer review. Through the establishment of ethical guideline, researchers can be held accountable, researched can be protected, and the research integrity and quality can be trusted.6
Nowadays, each discipline, institution, national government, and even international agency has adopted specific codes that emphasize ethics in conducting research. In addition, most academic institutions have now developed a curriculum in research ethics that their students are required to take.6 In Indonesia, the standard of ethic in biomedical research is regulated by Law No. 32 Year 1992 and Government Regulation No. 39 Year 1995, encompassing the research on pharmaceutics, medical devices, radiation and imaging, surgical operation, medical records, biologic sample, and also epidemiologic, social, and psychosocial research.7
As medical students, it is our responsibility to have decent knowledge regarding issues on medical ethics and research ethics, or else we may get entangled with problems. When it comes to saving lives, there would be so many options (or in the contrary, no longer option) that they become a dilemma – say, a chronic patient wishing to end his life due to the never-ending treatment and no hope; a patient rejecting a treatment that determines their life and death; vaccination; informed consent. In research, too, dilemmas may arise. For instance, to what extent can an intervention be? Is there a limit between free consent and informed consent?
Given all these considerations, how do we, as medical students, face these issues? Are we sure we are ready yet?
- Avasthi A, Ghosh A, Sarkar S, Grover S. Ethics in medical research: General principles with special reference to psychiatry research [Internet]. Indian J Psychiatry. 2013 [cited 2018 Aug 23];55(1):86-91. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3574464/#ref1
- Fuoka G, Mantzorou M. What are the major ethical issues in conducting research? is there a conflict between the research ethics and the nature of nursing? [Internet]. Health Science Journal. 2011[cited 2018 Aug 23]:5(1):3-14. Available from: http://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.pdf
- Mandal J, Acharya S, Parija SC. Ethics in human research [Internet]. Trop Parsitol. 2011[cited 2018 Aug 23];1(1):2-3. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3593469/
- Muthuswamy V. Ethical issues in clinical research. Perspect Clin Res [Internet]. 2013[cited 2018 Aug 23];4(1):9-13. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601715/
- National Institutes of Health. Guiding principles for ethical research [Internet]. Bethesda: National Institutes of Health; 2016 [cited 2018 Aug 23]. Available from: https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
- Resnik DB. What is ethics in research & why is it important? [Internet]. Bethesda: National Institute of Environmental Health Sciences; 2015 Dec 1 [last reviewed 2016 July 07, cited 2018 Aug 24]. Available from: https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm
- FKUI. Komite etik penelitian kesehatan [Internet]. Jakarta: Fakultas Kedokteran Universitas Indonesia; [date not published] [cited 2018 Aug 23]. Available from: http://fk.ui.ac.id/riset-publikasi/komite-etik-penelitian-kesehatan.html