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Ethical Issues in Biomedical Research and Publication

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Ethical Issues in Biomedical Research and Publication Editorial Ethical Issues in Biomedical Research and Publication (BIRDEM Med J 2018; 8(1): 1-8) “Ethics” in simple terms is defined as “norms for obligation to ethics and ethical issues are prerequisite conduct” that distinguishes between acceptable and to be generated among scientific community,teachers, unacceptable behavior. Though ethical norms are learnt postgraduate and graduate students and professionals since childhood at home, school, religious places, etc., engaged in sponsored or selfsponsored research about it is influenced throughout the life, impacted by various what constitutes “research misconduct” and life experiences which explain the large variations in “deviations,” so that one can guard against these and interpretation of ethical norms among individuals. follow the ethical norms while perusing research/ Ethical norms related to biomedical research and publication as well as while reviewing articles submitted publication are laid down by various national and for editorial review. international agencies. The Nuremberg Code and In relation to biomedical research and publication, it Declaration of Helsinki by World Medial Association has several perspectives for which a researcher needs is the landmark in ethical standards followed all over to be knowledgeable and sensitive. These are:(i) the world for biomedical research and uniform Research design: Careful approach to research design, requirements for manuscripts submitted to biomedical data collection and interpretation.(ii) Confidentiality: journals (formulated by International Committee of Maintaining confidentiality of research subjects and Medical Journal Editors) for publication. personnel records.(iii) Acknowledgement: Always acknowledging the source; using scientific materials The best evidence shows that misconduct is a very rare without acknowledging the source amounts to occurrence in research and there is no evidence that plagiarism.(iv) Knowledge advancement: Aim to science has become ethically corrupt. The rate of advance knowledge and research and not one’s career. misconduct has been estimated to be as low as 0.01% Avoid temptation for duplicate publication of the same to as high as 1% of researchers per year. According to research in different journals or in different languages, the “bad apple” theory, most scientists are highly ethical. without proper declaration to the effect.(v) Risk/benefit: Only those who are morally corrupt, economically Protect the subjects/patients included in the research desperate (in cases of grant application), or study, minimizing risks and maximizing benefits, psychologically disturbed will commit misconduct. specially the vulnerable population. Informed consent of the patient/guardian (in the case of minors) in the Research and publication play a very vital role in presence of witness is absolutely essential to protect progress of sciences in any field. As publication of the interests of the human subjects enrolled in the scientific papers is now linked to professional career study.(vi) Animal design: Design animal experiments up gradation, the pressure for publication of papers is only if absolutely necessary and meaningful. Show tremendous. Postgraduate teachers lack adequate proper care and compassion and minimize pain and experience themselves and time to guide the students suffering during the experiments. into research design, its execution, analysis, and more importantly, into research norms and ethics. In current PRINCIPLES OF WRITING A SCIENTIFIC scenario, there is a real danger of compromising the PAPER scientific quality of research papers. We need to focuse Scientific research demands precision. Scientific writing on four general ethical issues: authorship, peer review, should respect this precision in the form of clarity. The duplicate or repetitive publication, and conflict of scientific way of thinking and application of scientific interest. There is increased temptation to deviate from methods require honesty, criticality, trust, creativity and the ethical norms for research and publication. Hence, openness. Acceptance of these principles are desirable Birdem Medical Journal Vol. 8, No. 1, January 2018 prerequisites for successful engagement in science by characteristics of the sample (experimental group, students and young researchers.These help qualifying controls, and their properties). It is necessary to explain research institution that produces competent promoters what is researched, asked, tested as follows: Sampling (initiators) for the future technological cultural and (random, consecutive, and representative), the sample political development of society. Defining principles of size (patient gender, age), the control group, and the good scientific and good laboratory practice should criteria for exclusion from the study, the control group encourage the development of standardized principles if any.It should be described how the research was done: and guidelines for accurate and quality data in scientific Type of study (prospective, retrospective or combined), research. data collection (surveys, inventory or checkup), the The text of observational and experimental articles: technique of measuring results (operative treatment, is usually divided into sections in accordance with so laboratory tests). It is necessary to specify where the called “IMRAD” structure: Introduction, Methods, research was conducted. Results, and Discussion. Papers related to public health Result: Results are an important part of writing an programs and practice might have different than IMRAD article. The research results are usually most carefully structure (drug). There is a key question for each section read and should be a detailed plan, welldocumented of the IMRAD structure of the paper, which an author Discussion: Discussion is a critical review of the data needs to keep in mind, while writing the manuscript. described in the results. The results should be compared Title of the scientific paper: contains a brief description with other findings and discuss the theoretical and of the content. The title should accurately describe the practical research outcome. It should point out gaps with content of the article. There are two types of titles: explanation. Indicative title talks about the work that covers and Conclusion: Conclusion should be short, clear and informative titleconvey the message of the article and precise. It is necessary to make the final statement of recommended for beginners. A good title should be: (a) what logically follows from the results of the work, list Short, (b) correct, (c) clear, (d) complete, (e) informing, only the most important and give the message. Good (d) attractive. It should also include: Characteristics of conclusions should not surprise attentive reader. The the article, showing what is most important in the work. reader should get the impression that he himself had It is necessary to specify the names of the authors and written it. their affiliations. References: References should be in accordance with Abstract/summary and title can be written in two the instructions provided by the journal, and otherwise forms: Reference and Information. It can be written in used Vancouver or Harvard citation style. author’s native language and English. ETHICAL PRINCIPLES FOR MEDICAL The structure of the summary should look like this: RESEARCH INVOLVING HUMAN SUBJECTS Introduction, goal, materials and methods, the location The World Medical Association (WMA) has developed of the study, measuring the outcomes of the study, the the Declaration of Helsinki {http://www. results and conclusions. hopitalmontfort.com/en/neweditiondeclaration Summary: Summary is the distillate of which will be helsinki1] as a statement of ethical principles for medical presented and should show: What has been done, what research involving human subjects, including research are the results, what the results means. on identifiable human material and data. Consistent with Introduction: Writing an introduction has its own rules: the mandate of the WMA, the declaration is addressed A clear definition of a the problem, why exactly this primarily to physicians. issue was explored, there is no need to explain what General principles can be found in the textbooks, do not need to explain The Declaration of Geneva of the WMA binds the the terms of the title. physician with the words, “The health of my patient will Materials and Methods: Materials and Methods be my first consideration”, and the International Code describe how the study was conducted and the of Medical Ethics declares that, “A physician shall act 2 Editorial in the patient’s best interest when providing medical Transparency care”. Sources of funding for research or publication should Medical progress is based on research that ultimately always be disclosed. Editors should state this directly must include studies involving human subjects. Medical in their editorial policy. Authors should routinely include research is subject to ethical standards that promote and information about research funding in all papers they ensure respect for all human subjects and protect their prepare for publication. Where a clinical trial health and rights. It is the duty of physicians who are registration number is available, this should be included. involved in medical research to protect the life, health, dignity, integrity, right to selfdetermination, privacy, Authorship acknowledgment and confidentiality of personal information of research The International Committee
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