Ethics and medical research
Pmc3574464ethics in medical research: general principles with special reference to psychiatry researchajit avasthi, abhishek ghosh, sidharth sarkar, and sandeep groverdepartment of psychiatry, postgraduate institute of medical education and research, chandigarh, indiaaddress for correspondence: dr. Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly article has been cited by other articles in ctethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them. The four fundamental principles of ethics which are being underscored are autonomy, non-maleficence, beneficence, and justice. Some special ethical issues have particular relevance to psychiatric research arising primarily from the specific vulnerabilities of those with mental illness and the risks posed by some research methodologies. It is suggested that though the value of published guidelines and the help that may be available from research ethics committees is quite great, the primary responsibility for maintaining high standards of practice in research rests with research workers ds: medical ethics psychiatry, research, confidentiality, consentintroductionthe word “ethics” is derived from the greek word, ethos, which means custom or character. Ethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them. Medical ethics also deals with the choices made by society, the distribution of resources, and access to health care, and the dilemmas arising from them. The challenge to international research ethics is to apply universal ethical principles to biomedical research in a multicultural world with a multiplicity of health-care systems and considerable variation in standards of health care. 3]historyhistory is unfortunately peppered with stories of abuse carried out in the name of medical research. It was the first international code for ethics in clinical research laying down the guidelines for research on human subjects. It laid down 10 clear principles to be followed by researchers and made voluntary consent essential, allowed subjects to withdraw from the experimentation at any time, banned experiments that could result in major injury or death of the subjects, and made mandatory to have preclinical data before experimenting on humans.
Eventually a set of guidelines was adopted by the 18th world medical association (wma)[5] general assembly, which was called the declaration of helsinki. It contained 32 principles, which stress on informed consent, confidentiality of data, vulnerable population, and requirement of a protocol, including the scientific reasons of the study, to be reviewed by the ethics committee. Though declaration of helsinki had created a stir in the medical community, medical atrocities continued. The malpractice in the tuskegee syphilis study in the us was possibly the next eye opener which ushered the belmont report[6] in 1979 and laid the foundation for regulations regarding ethics and human subjects’ research in the us. With the increasing interest of pharmaceutical industries in carrying out research experiments in the developing and the underdeveloped countries, the council for international organizations of medical sciences (cioms)[3] in association with world health organization (who) developed “international ethical guidelines for biomedical research involving human subjects” in al principles of ethics in researchthe four principles of beauchamp and childress – autonomy, non-maleficence, beneficence, and justice – have been extremely influential in the field of medical ethics, and are fundamental for understanding the current approach to ethical assessment in health care. 7,8]medical research – definition, types, and issuesthe term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Those who support the need for research argue that no new treatment should be offered outside the context of a controlled trial, so that treatments’ effectiveness and efficacy can be measured ab initio, not only for the sake of the patients currently receiving it but also for all future patients. Of a physiological, biochemical, or pathological process, or of the response to a specific intervention – whether physical, chemical, or psychological – in healthy subjects or patients;controlled trials of diagnostic, preventive, or therapeutic measures in larger groups of persons, designed to demonstrate a specific generalizable response to these measures against a background of individual biological variation;studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; andstudies concerning human health-related behavior in a variety of circumstances and cts of interest are inherent to the majority of relationships among individuals and of those with companies and institutions and, certainly, research involving human beings is no exception. In relation to clinical research, conflicts of interest occur at different levels and usually permeate through various lines (e. 10]therefore, medical research which is absolutely necessary and fundamental for acquiring and propagating worthwhile novel knowledge is equally controversial because of the conflicts of interest of the researchers or the sponsors.
Both universal and regional guidelines have been proposed to strike a balance between these two opposing interests and to ensure standardized ethical ples of ethics in medical researchprinciples of essentialityrefers to whether the research is considered to be absolutely essential after a due consideration of the existing scientific knowledge in the proposed area of research. This should be scrutinized by an independent and responsible body of persons who, after careful consideration, come to the conclusion that the research is likely to benefit the humanity or environment. 11]principles of voluntariness, informed consent, and community agreementresearch participants should be fully apprised of the research and the associated risks and benefits. The participants should be informed of the right to abstain from the research or withdraw consent at any time. Where research entails treating any community, the principles of voluntariness and informed consent apply to the community as a whole and to each individual member. In case a person is incapable of giving consent, a legally acceptable guardian should give the informed ples of non-exploitationthe participants should be fully apprised of all the possible dangers that may arise during the research so that they can appreciate all the physical and psychological risks. Each research should include an in-built mechanism for compensation for the human participants either through insurance cover or by any other appropriate means to cover foreseeable and unforeseeable risks, and provide remedial action and comprehensive ples of privacy and confidentialitythe identity and records of the participants are as far as possible kept confidential (except when required for legal reasons). This is to avoid any form of hardship, discrimination or stigmatization as a consequence of having participated in the ples of precaution and risk minimizationdue care and caution should be taken at all stages of the research and experiment to ensure that the research participant and those affected by it including the community are put to the minimum risk, suffer from no known irreversible adverse effects, and generally, benefit from the research or experiment. There should be a plan for interim reviews to detect whether any intervention arm (active or control) is associated with increased risks, so that undue harms are avoided by stopping the ples of professional competenceresearch should be conducted by competent and qualified persons who act with total integrity and impartiality and who have been made aware of the ethical considerations to be borne in mind in respect of such research or ples of accountability and transparencythe research or experiment should be conducted in a fair, honest, impartial, and transparent manner after full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist. Full and complete records of the research should be retained for such reasonable period as may be prescribed or considered necessary for the purposes of post-research monitoring, evaluation of the research, conducting further research, and scrutiny by the appropriate legal and administrative authority, if ples of the maximization of the public interest and of distributive justicethe research or experiment and its subsequent application should be conducted and used to benefit all human kind (and not just those who are socially better off), in particular, the research participants themselves and or the community from which they are ples of public domainthe research findings should be brought into the public domain so that its results are generally made known through scientific and other publications. This would help in consolidating the scientific knowledge base of the field being studied and would prevent the undue replication of studies which pose risks to some ples of totality of responsibilityprofessional and moral responsibility should be observed, for the due observance of all the principles, guidelines, or prescriptions of those directly or indirectly connected with the medical research.
This extends to the institutes where this research is carried out, as well as the sponsors of the research. The research should be duly monitored and constantly subject to review and remedial action at all stages. 11]special reference to psychiatry researchneuropsychiatric disorders are highly prevalent conditions with significant morbidity, yet only modestly effective treatments are available. If a patient's impairment is severe enough, he or she will be incompetent to give informed consent for research. 16] therefore, research in psychiatry demands a special in relation to competence and consentparticipation in research usually involves some degree of risk, discomfort, or sacrifice of the personal care that patients enjoy when they receive ordinary treatment. 17] ordinarily, we allow research subjects to incur these discomforts or sacrifice personal care because we believe that people have the right to run certain risks for rewards that seem to them worthwhile. 18]to resolve these conflicts, proposals have been made that range from banning certain types of research with psychiatric patients to requiring independent evaluation of the capacities of potential subjects, to appointing representatives to remove subjects from studies when the risk–benefit ratio appears to be swinging against them. 19,20]as per wma guidelines for ethical research, “in research involving subjects who are mentally incapable of giving consent, the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for their inability to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative” (wma 2008; clause 29). An additional caveat in clause 28 reads, “when a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative.
Thus, although the presence of cognitive and related impairments in schizophrenia, for example, warrants concern about subjects’ abilities to decide whether to enter a research project, by no means does it call for the exclusion of all persons with schizophrenia from investigational studies. So, diagnosis of mental illness itself does not disqualify a person to enter into a research as competence of decision making is case specific and variable across the in relation to confidentialitypatients, health-care providers, and patient advocacy organizations have expressed increasing concern about the confidentiality of clinical information stored in large computerized databases. 28,30]firstly, continued research access to population-based records data is essential to protecting the rights and interests of people with psychiatric illness. Investigators conducting any such research should take all possible steps to limit access to confidential information, minimize risks of disclosure, and (when possible) obtain informed consent for research use of clinical data. The most effective strategy for preventing disclosure of confidential information is to remove all identifying information from medical records data before any research use. 31] secondly, when potential research uses are anticipated at the time of data collection, those collecting clinical information should be obligated to advise patients regarding possible research use. However, obtaining individual informed consent for each specific research use is impossible or extremely impractical. 32] lastly, research intended to increase public domain medical knowledge should be clearly differentiated from proprietary activities. If legitimate public domain research activities were clearly distinguished from other uses of large clinical databases, efforts to regulate storage and disclosure of clinical data could concentrate on the activities that are now largely unregulated. 33]however, advances in mental health science promise great benefits for those who suffer, or will come to suffer, from mental illness and, in some cases, for research subjects themselves. While persons with mental illness may be vulnerable in several ways, research regulations that focus primarily on their vulnerabilities and deficits could encourage and possibly exacerbate the stigmatization already felt by this population.
34,35] further, it may be unjust to exclude, by overly restrictive regulation, those people with mental illness who could benefit from research participation. An ethically appropriate framework for psychiatric research ethics balances rigorous protections for human subjects with recognition of the enormous social and individual benefits arising from well-designed and ethically conducted scientific research. 36–38] how this balance is struck has important implications for research ethics generally, particularly for research involving vulnerable uethough a number of ethical guidelines have been formulated for clinical research, malpractice is still widely acknowledged. 40] in this era of advanced globalization, the problems of medical ethics can no longer be viewed only from the perspective of wealthy countries. Global bioethics seeks to identify key ethical problems faced by the world's 6 billion inhabitants and envisages solutions that transcend national borders and cultures. The relevance of global bioethics is obvious with respect to international research ethics (as evidenced by the controversy over changes to the declaration of helsinki), global vaccine initiatives, or global health equity. 41] last but not the least; doctors are specially trained to be good clinicians but are seldom taught even the fundamentals of ethical clinical research. The post-graduate dissertation or the phd thesis is a precious opportunity to train tomorrow's investigators in the elements of ethical clinical research. 42] the attributes of a clinical researcher like truthfulness and accountability toward integrity are expected to propagate standardized ethical tessource of support: nil conflict of interest: none declaredreferences1. Naked before the world: will your medical secrets be safe in a new national databank? Protection of persons with mental disorders from research risk: a response to the report of the national bioethics advisory commission.
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