ETHICS IN DENTAL RESEARCH BY - SHRUTI RAJENDRA AHIR
• Research and its Importance • Research Ethics • Need of ethics in research • Objectives In Research Ethics • Ethics In Dental Research Contents
WHY RESEARCH IS DONE? Researches are done • For advancement- which is already known should be evaluated continuously • To further knowledge in a particular area • To increase understanding • To invent or develop new strategies, equipments etc.
• Ethics are the moral principles that govern a person's behavior. Research ethics may be referred to as doing what is morally and legally right in research. • Research ethics is concerned with the responsibility of the researchers to be honest and respectful to all individuals who are involved in research study and research should not inflict harm on researcher as well as research subjects . Research Ethics
• Research ethics provides guidelines for the responsible conduct of biomedical research. • Research ethics also educates and monitors scientists/researchers conducting research to ensure a high ethical standard. • Research ethics involves the application of fundamental ethical principles to a variety of topics involving scientific research. Need Of Ethical Research
The first and broadest objective is to protect human participants. The second objective is to ensure that research is conducted in a way that serves interests of individuals, groups and/or society as a whole. Finally, the third objective is to examine specific research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent . Objectives In Research Ethics
ETHICS IN DENTAL RESEARCH Ethics review committee approval Scientific merit Social value Risk and benefits Inform consent Confidentiality Conflict of roles Honest reporting of result Whistle blowing
Ethics review committee approval The researchers nor research subjects are always knowledgeable and objective enough to determine whether a project is scientifically and ethically appropriate, therefore every proposal for research on human subjects must be reviewed and approved by an independent ethics committee before it can proceed. In order to obtain approval, researchers must explain the purpose and methodology of the project; demonstrate how research subjects will be recruited, and how their privacy will be protected specify how the project is being funded Researchers need to demonstrate to an impartial expert committee that the project is worthwhile, and that potential research subjects will be protected against harm to the greatest extent possible.
Scientific merit Research involving human subjects must be justifiable on scientific grounds, to eliminate projects that are unlikely to succeed, for example, because they are methodologically inadequate, or that, even if successful will likely produce trivial results. If patients are being asked to participate in a research project, even where risk of harm is minimal, there should be an expectation that important scientific knowledge will be the result. A further requirement is that only scientifically qualified persons should conduct research on human subjects.
Social value One of the more controversial requirements of a research project is that it contribute to the well-being of society in general. The importance of the project's objective, understood as both scientific and social importance, should outweigh the risks and burdens to research subjects.
Once the scientific merit and social worth of the project have been established, it is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or disproportionate to the expected benefits of the research. A risk is the potential for an adverse outcome to occur. It has two components: the likelihood of the occurrence of harm the severity of the harm. Risks And Benefits
Informed consent The voluntary consent of the human subject is absolutely essential. The research subject should have sufficient knowledge and comprehension of the elements of Informed consent, both a legal and an ethical concept, is an essential component of a patient's right to autonomy. Informed consent is the first stated and the largest principle of the Nuremberg code. The Nuremberg Code identifies four attributes of consent without which consent cannot be considered Consent must be • voluntary • legally competent • informed • comprehending
The informed consent is a two-step process. First, information is presented to the patient by the doctor. Secondly, the patient satisfies himself or herself that he or she understands, and based upon this understanding either agrees or refuses to undergo the treatment. Components of informed consent 1 ) A description of the procedures to be carried out. 2) A description of any reasonably foreseeable risks or discomforts to the subject. 3) A description of any benefits to the subject or to others which may reasonably be expected from the treatment A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 5) A statement that the patient has understood the procedure and is willing to undergo the treatment. 6) The signature of the patient and of a witness.
As with patients in clinical care, research subjects have a right to privacy with regard to their personal health information. Unlike clinical care, however, research requires the disclosure of personal health information to others, including the wider scientific community and sometimes the general public. In order to protect privacy, researchers must ensure that the subjects are told in advance about the uses to which their information is going to be put but transmitted securely . Confidentiality
Although it is understood that research results should be reported accurately, but unfortunately there have been numerous recent accounts of dishonest practices in the publication of research results, such as data fabrication, duplicate publication. Such practices can cause great harm to patients, who may be given incorrect treatments based on inaccurate or false research reports, and to other researchers, who may waste much time and resources trying to follow up the studies. Honest reporting of results
In order to prevent unethical research, or to expose it after the fact, anyone who has knowledge of such behavior not only should refuse to participate in practices that they consider clearly unethical, but also have the obligation of disclosing this information to the appropriate authorities. Whistle-blowing
Guided by Dr Shweta Habbu Ma’am Dr Kunal Deshmukh Sir