“The most important human endeavour is stiving for morality in our actions. Our inner balance and even our very existence depend on it. Only morality in our actions give beauty and dignity of life” - Albert Einstein
Ethics is the study of principles relating to right and wrong conduct. Ethics are the moral principles that an individual must follow irrespective of time or place. Bioethics is the branch of ethics that studies the implications of biological and biomedical advances. Primary purpose of dental research is to generate new knowledge. However, this goal can never take precedence over the rights and interests of individual research subjects.
Research ethics is a codification of scientific morality in practice. Guidelines for research ethics specify the basic norms and values of the research community. Ethical standards in research promote aims of research, values that are essential to collaborative work, ensure accountability, build public support and promote moral and social values. Research ethics focuses on ethical principles to be followed in all research studies- honesty, objectivity, carefulness, openness, integrity, accountability, transparency, intellectual property, confidentiality, responsible mentoring, responsible publication, respect for colleagues, social responsibility, non-discrimination, competence, legality, animal care and human rights protection.1
Research Integrity is defined as an active adherence to the ethical principles and professional standards essential for the responsible conduct of research. Responsible Conduct of Research (RCR) involves components such as planning and conducting research; reviewing and reporting research; responsible authorship and publication of the research work.1 Main purpose is to ensure the highest professional and ethical standards for biomedical and health research at all stages right from its inception, honesty in conduct of research, obtaining relevant approvals, efficiency, judicious use of resources, ensuring accountability, transparency, declaration and management of conflict of interest, justice, reliable data collection, handling, interpretation, integrity in analysis, reporting, publication and translation for the benefit of population.
Research must conform to generally accepted scientific principles and based on a thorough knowledge of the scientific literature, their relevant sources of information, and adequate laboratory and as appropriate, animal experimentation. Design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. Information regarding funding, sponsors institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. In clinical trials, the protocol must also describe appropriate arrangements for post trial provisions. 1
Research Ethics Committee /Institutional Ethics Committee /Institutional Review Board must be duly qualified, function in a transparent manner, must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards, but these must not be allowed to reduce or eliminate any of the protections for research subjects. All dental research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimize the risks must be implemented. All vulnerable groups and individuals who may have an increased likelihood of being wronged or of incurring additional harm should receive specifically considered protection.
Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information. Informed consent (IC) is the process of informing the potential participants about the proposed research in a systematic manner and empower them to take an informed decision to participate in the research study. IC is voluntary and preferably written. If the consent cannot be expressed in writing, the non written consent must be formally documented and witnessed. 2
Both academic and financial conflict of interest may have serious implications and threaten quality of research and its outcomes. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. In our country, registration with Clinical Trial Registry-India is mandatory for clinical trials but desirable for other types of research to maintain transparency and accountability.
Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. 3
We must ensure the highest professional and ethical standards for research at all stages right from inception, conduct, review, reporting and publication. Greater focus should be on quality of research than quantity. The quality and credibility of research is dependent on the integrity of the researchers who have a significant social responsibility to abide by the standards prescribed for their professions and by their institutions and also to be guided by the applicable regulations and guidelines.
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