interdisciplinary seminarpart 2 (1).pptx

Interdisciplinary

1. Ethics in dental research The Nuremberg code Declaration of Helsinki Ethical guidelines for Biomedical Research on Human participants - by the Indian Council of Medical Research (ICMR) Conclusion CONTENT

2. The ethical values of the dentist apply to the dental researcher as well. As long as dentists understand and follow the basic rules of research ethics, they can successfully integrate research into their clinical practice . ETHICS IN DENTAL RESEARCH

3. Ethics review committee approval . Scientific merit: Social value: Risks and benefits: Informed consent: Confidentiality: Conflict of roles: Honest reporting of results: Whistle-blowing:

4. 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, how their consent will be obtained and how their privacy will be protected; specify how the project is being funded, and disclose any potential conflicts of interest on the part of the researchers. The ethics committee may approve the project as presented, require changes before it can start, or refuse approval altogether. The reason why ethics committee approval of a project is required is that neither researchers nor research subjects are always knowledgeable and objective enough to determine whether a project is scientifically and ethically appropriate. Researchers need to demonstrate to an impartial expert committee that the project is worthwhile, that they are competent to conduct it, and that potential research subjects will be protected against harm to the greatest extent possible. Ethics review committee approval

5. Research involving human subjects must be justifiable on scientific grounds. This requirement is meant 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. A further requirement is that only scientifically qualified persons should conduct research on human subjects . Scientific merit:

6. 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. Furthermore, the populations in which the research is carried out should benefit from the results of the research. This is especially important in countries where there is potential for unfair treatment of research subjects who undergo the risks and discomfort of research while the drugs developed as a result of the research only benefit patients elsewhere. Social value:

7. 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 (from highly unlikely to very likely), and the severity of the harm (from trivial to permanent severe disability or death). Risks and benefits:

8. The voluntary consent of the human subject is absolutely essential. The research subject should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. Informed consent:

9. As with patients in clinical care, research subjects have a right to privacy with regard to their personal health information . . 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:

10. If the dentist and the researcher are the same person, the dentist role must take precedence. This means that the dentist must be prepared to recommend that the patient not take part in a research project if the patient seems to be doing well with the current treatment and the project requires that patients be randomized to different treatments and/or to a placebo. Only if the dentist is truly uncertain whether the patient's current treatment is as suitable as a proposed new treatment, should the dentist ask the patient to take part in the research project. Conflict of roles:

11. 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 plagiarism, data fabrication, duplicate publication and 'gift' authorship. 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:

12. 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:

13. The Nuremberg Code is a set of research ethical principles for human experimentation set as a result of the Nuremberg Trials at the end of the Second World War. It was the first international instrument on the ethics of medical research, promulgated in 1947 The Nuremberg Code (1947)

14. Specifically, they were in response to the inhumane Nazi human experimentation on unconsenting prisoners and detainees during the second world war. The trials were held in the city of Nuremberg, Germany, from 1945 to 1949. The Code, designed to protect the integrity of the research subject, set out conditions for the ethical conduct of research involving human subjects, emphasizing their voluntary consent to research.

15. The voluntary informed consent of the human subject is absolutely essential. The experiment should be such as to yield fruitful results for the good of society. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease. Justify the performance of the experiment.

16. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur . The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

17. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

18. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

19. These recommendations guiding physicians in biomedical research involving human subjects was issued by the World Medical Association (WMA) in 1964, adopted by the 18 th World Medical Assembly, Helsinki, Finland, June 1964, amended 6 times, latest at the 59 th WMA general assembly at Seoul in October 2008 Declaration of Helsinki

20. What is declaration of Helsinki ? Set of ethical principles. Developed by WMA for medical community Human experimentation. Followed Nuremberg-1947. Regarded as cornerstone document of human research ethics. included with clinical trial protocals .

21. The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs. Although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles. It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician’s knowledge and conscience a re dedicated to the fulfilment of this duty. A. Introduction

22. The Declaration of Geneva of the WMA binds the physician with the words, "The health of my patient will be my first consideration/' and the International Code of Medical Ethics declares that, "A physician shall act in the patient's best interest when providing medical care. Medical progress is based on research that ultimately must include studies involving human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research. In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.

23. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). In medical practice and in medical research, most interventions involve risks and burdens.

24. Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

25. It is the duty of physicians who participate in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy of subjects . Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected. B. Principales For All Medical Research

26. Appropriate caution must be exercised in the conduct of medical research that may harm the environment. The design and performance of each research study involving human subjects must be clearly described in a research protocol. The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. It must take into consideration the laws and regulations of the country or countries.

27. Medical research involving human subjects must, be conducted only by individuals with the appropriate scientific training and qualifications. Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research. .

28. Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation . Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject. Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed.

29. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects. Participation by competent individuals as subjects in medical research must be voluntary . no competent individual may be enrolled in a research study unless he or she freely agrees.

30. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity. In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study.

31. For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse. When seeking informed consent for participation in a research study the physician should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship.

32. For a potential research subject who is incompetent. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, and the research entails only minimal risk and minimal burden.

33. When a potential research subject who is deemed incompetent is able to give decisions about participation in research . Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative.

34. Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors 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. They should adhere to accpted guideline for Ethica Reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

35. The physician may combine medical research with medical care only to the extent that the research is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects. C. Additional Principales For Medical Research Combined with Medical Care

36. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

37. At the conclusion of the study, patients entered into the study to be informed about the outcome of the study and to share any benefit that result from it. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never interfere with the patient-physician relationship. In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy.

38. Indian counseling of medical Research brought out the policy of ethical consideration involved in Research on human subject 1980.and revised the guidelines in 2000. And again revised in 2006. Purpose of these guidelines is to safeguard the dignity, rights, safety and well-being of the human participants involved in biomedical and health research. These guidelines must be followed by all stakeholders including institutions, ethics committees (Ecs), researchers and sponsors/ funding agencies. This handbook provides a quick reference to all 12 sections of the ICMR National Ethical Guidelines. Ethical guidelines for biomechanical Research on human participants

39. Section 1 Statement of general principal Secton 2 General ethical issues Section 3 Responsible conduct of Research (RCR) Section 4 Ethical review procedure

40. Section 5 Informed consent procedure Section 6 Vulnerability Section 7 Clinical trial of drug and other intervention Section8&9 Public and behavioural science Research for health

41. Section 10 Human genetics testing and Research Section 11 Biobanking and datasets Section 12 Humanitarian emergency and disaster

42. A profession consists of a limited group of persons who have acquired some special skill and are therefore able to perform that function in society better than the average person. A professional person is expected to have respect for human beings, competence in his chosen field, integrity and a primary concern with service rather than with prestige or profit. Ethical codes are the result of an attempt to direct the moral consciousness of the members of the profession to its peculiar problems. Ethical codes are important in developing higher’standards of conduct, for they are based upon what is considered to be the correct attitude and the correct procedure. CONCLUSION

43. Guided by- Dr Shriram Sir Dr Abhijeet Sir