Ethics in 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. Statement of the ethical considerations involved and should indicate how the principles in this declaration have been addressedinformation 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 clinical trials, the protocol must also describe appropriate arrangements for posttrial ch ethics committeesthe research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. 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 set forth in this committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study's findings and y and confidentialityevery precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal ed consentparticipation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely medical research involving human subjects capable of giving informed consent, 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 and the discomfort it may entail, poststudy provisions and any other relevant aspects of the study. All medical research subjects should be given the option of being informed about the general outcome and results of the seeking informed consent for participation in a research study the physician must 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 must be sought by an appropriately qualified individual who is completely independent of this a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorized representative. 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 group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

When a potential research subject who is deemed incapable of giving informed consent 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. The potential subject's dissent should be ch 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 group. 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 involving subjects with a condition that renders them unable 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 must be obtained as soon as possible from the subject or a legally authorized physician must fully inform the patient, which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never adversely affect the patient-physician medical research using identifiable human material or data, such as research on material or data contained in bio banks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations, the research may be done only after consideration and approval of a research ethics of placebothe benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this ial provisionsin advance of a clinical trial, sponsors, researchers and host country governments should make provisions for posttrial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent ch registration and publication and dissemination of resultsevery research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. 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. Reports of research not in accordance with the principles of this declaration should not be accepted for en interventions in clinical practicein the treatment of an individual patient, where proven interventions do not exist or other known interventions 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 judgment it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. Good decisions and strong editorial processes designed to manage these interests will foster a sustainable and efficient publishing system, which will benefit academic societies, journal editors, authors, research funders, readers, and publication practices do not develop by chance, and will become established only if they are actively promoted. 10]the general principles of publication ethics are:transparencysources of funding for research or publication should always be disclosed.

Authors should routinely include information about research funding in all papers they prepare for publication. Where a clinical trial registration number is available, this should be ship acknowledgmentthe international committee of medical journal editors (icmje) provides a definition of authorship that is applicable beyond the medical sector. The icmje authorship criteria state ‘authorship credit should be based on:Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data;drafting the article or revising it critically for important intellectual content; andfinal approval of the version to be s of research papers should state whether they had complete access to the study data that support the publication. 1]this guidance is applicable outside the medical ational committee of medical journal editors guidance states: “when a large, multi-center group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. The individual authors who accept direct responsibility for the manuscript should list the members of the larger authorship group in an appendix to their ting research subjectsjournals should ask authors to state that the study they are submitting was approved by the relevant research ethics committee or institutional review board. If a paper has been submitted from a country where there is no ethics committee, institutional review board, or similar review and approval, editors should use their own experience to judge whether the paper should be published. 11]research organizations and the literature have defined these behavioral patterns within the umbrella title of “research misconduct”. 12]there are three major and most severe forms of scientific fraud, scientific and publishing dishonesty or misconduct, in proposing, conducting or evaluation of research and presentation of the research results:Inventing data and results (fabrication);alteration or changing the results (falsification); andplagiarism (plagiarism), including self-plagiarism (self-plagiarism), fragmented, repetitive and double publication (duplicate publication). These, there are a number of other kinds of misconduct that scientists should know how to recognize and avoid that is, “pathology” of authorship, conflict of interest, conflicts of loyalty, “pathological” science, the process of publishing scientific papers, it is important to know how a completed research should be described in a scientific paper. 6]falsification/fabrication of datathe integrity of research depends on the integrity of the data and the data record. As falsification and fabrication call into question the integrity of data and the data record, they represent serious issues in scientific ethics. Falsification is the practice of omitting or altering research materials, equipment, data, or processes in such a way that the results of the research are no longer accurately reflected in the research record. Fabrication is the practice of inventing data or results and recording and/or reporting them in the research record. Both of these schemes are probably among the most serious offenses in scientific research as they challenge the credibility of everyone and everything involved in a research effort. 13]however, it is questionable whether a clinical researcher who fabricates data to enroll a terminally ill patient into a trial that ultimately may lead to that individual receiving treatment that may prolong their life should receive the same penalty as someone fabricating data for their own professional gain.

13]referring to the united states’ office of research integrity (ori) definition of plagiarism, which is “unattributed textual copying”, many have questioned its applicability in real life situations. Furthermore, “salami-slicing”-the selective use of research-project results to maximize the number of presentations possible-has also been classed as a type of plagiarism by some, but not by others. 15]researchers rely on the published data, and have to be skilled to selectively process these data, to incorporate previous knowledge into a new paper, and to distinguish original ideas and research results from already publicized ones. 16]national bodiesone of the oldest organizations dealing with research misconduct is the ori in the united states. With a huge budget of $30 billion, it provides significant funds in the areas of health, research, and development, and oversees bodies such as the national institute of health and the office of public health and science. 14]the committee on publication ethics (cope) was established in 1997 by a small group of medical journal editors in the uk, but now has over 7000 members worldwide from all academic fields. Cope provides advice to editors and publishers on all aspects of publication ethics and in particular, how to handle cases of research and publication misconduct. Cope does not investigate individual cases, but encourages editors to ensure that cases are investigated by the appropriate authorities (usually a research institution or employer). 17]the uk research integrity office is another body representing the interests of over 50 universities and organizations dedicated to scientific research. Set up in 2006, its aims are to:Promote the good governance, management, and conduct of academic, scientific, and medical research;share good practice on how to address poor practice, misconduct, and unethical behavior; andgive confidential, independent, and expert advice and guidance about the conduct of academic, scientific, and medical research. One wants to create a scientific work, must have on his mind that creating a scientific work requires creativity and openness, honesty, trust, and obeying the ethical principles for writing a scientific well an author in medical sciences should always follow the words; “the health of my patient will be my first consideration”, (declaration of geneva, adopted by the 2nd general assembly of the wma, geneva, switzerland, september 1948). 19]while working on a an biomedical research involving human subjects medical workers should have on mind that it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried subjects should be volunteers-either healthy persons or patients for whom the experimental design is not related to the patient's investigator or the investigating team should discontinue the research if in his/her or their judgment it may, if continued, be harmful to the research on man, the interest of science and society should never take precedence over considerations related to the well-being of the ing in education of researches and potential researches already in the level of medical schools, educating them on research ethics, what constitutes research misconduct and the seriousness of it repercussion is essential for finding a solution to this problem and ensuring careers are constructed on honesty and tessource of support: nil conflict of interest: none nces1. Ethical aspects and dilemmas of preparing, writing and publishing of the scientific papers in the biomedical journals. Available from:Formats:article | pubreader | epub (beta) | printer friendly | ch ethics review orating l standards and procedures for research with human ch ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld.

Defines research with human subjects as 'any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings:Are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment; individually identifiable through investigator's collection, preparation, or use of biological material or medical or other rds and operational guidance for ethics review of health-related research with human participants pdf, ational ethical guidelines for biomedical research involving human subjectscouncil for international organizations of medical sciences. Pdf, medical association: declaration of an group on ive 2001/20/ec of the european parliament and of the council pdf, l of europe (oviedo convention - protocol on biomedical research). Council: the ethics of research related to healthcare in developing research ethics review committee (erc). The erc reviews all research projects, involving human participants supported either financially or technically by a proposal to the research ethics review committee (erc). The erc reviews all research projects, involving human participants supported either financially or technically by a proposal to the health ethics ment of information, evidence and health l standards and procedures for research with human mmes and region of the south-east asia eastern mediterranean western pacific up for who updates.