Human research ethics
Pmc3593469ethics in human researchjharna mandal, srinivas acharya, and subhash chandra parijadepartment of microbiology, jawaharlal institute of postgraduate medical education and research (jipmer), puducherry - 605 006, india. It involves acting in the right spirit, out of an abiding respect and concern for one's fellow research is research conducted with or about people, or their data or tissues, with the sole intention to do research involves significant risks and it is possible for things to go wrong. Now and then mishaps may arise because of technical errors or an ethical insensitivity, neglect or rare occasions, the practice of research has even involved deliberate and appalling violation of human beings. Earlier, in the 1900s, there were no regulations regarding the ethical use of human subjects in research. Here is a brief account of why rules and regulations were established and the need for all established research institutes to have an irb became a necessity. 1]the nuremberg codea well-known chapter in the history of research with human subjects opened on december 9, 1946, when an american military tribunal opened criminal proceedings against 23 leading german physicians and administrators for their willing participation in war crimes and crimes against humanity. Most of the subjects of these experiments died or were permanently crippled as a a direct result of the trial, the nuremberg code was established in 1948, stating that ‘the voluntary consent of the human subject is absolutely essential,’ making it clear that subjects should give consent and that the benefits of the research must outweigh the gh it did not carry the force of law, the nuremberg code was the first international document, which advocated voluntary participation and informed consent. 2]the declaration of helsinkiin 1964, the world medical association established recommendations guiding medical doctors in biomedical research involving human subjects. The declaration governs international research ethics and defines rules for ‘research combined with clinical care’ and ‘non-therapeutic research. The declaration of helsinki was revised in 1975, 1983, 1989, and 1996, and is the basis for good clinical practices used addressed in the declaration of helsinki include:Research with humans should be based on the results from laboratory and animal experimentationresearch protocols should be reviewed by an independent committee prior to initiationinformed consent from research participants is necessaryresearch should be conducted by medically / scientifically qualified individualsrisks should not exceed tuskegee syphilis study (1932 – 1972)one of the turning points in the development of a consensus for guidelines for ethical conduct in research was a project conducted by the us public health service. In some cases, when the subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. The study sparked off a wide-scale public outrage when it became publicly known, and the us government had to close it in to the publicity from the tuskegee syphilis study, a national commission for the protection of human subjects of biomedical and behavioral research was formed in the us, which was in charge of identifying the basic ethical principles that should underline the conduct of biomedical and behavioral research involving human subjects and to develop guidelines that should be followed, to assure that such research is conducted in accordance with those principles. The commission drafted the belmont report, a foundational document for the ethics of human subjects’ research in the united states. The report is a statement of the basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. The three basic ethical principles and their corresponding applications according to the report are:the belmont report established three basic ethical principles – respect for persons, beneficence, and justice – which are the cornerstones for the regulations involving human subjects. 3]common rulethis is a set of regulations that have been adopted by many research agencies in the united states and main elements of the common rule include:[3]. For assuring compliance by research institutionsrequirements for researchers obtaining and documenting informed consentrequirements for institutional review board (irb) membership, function, operations, review of research, and record keepingadditional protection for certain vulnerable research subjects – pregnant women, prisoners, and ion in indiaas in the case of many other nations, india too has developed national guidelines for research involving human beings. In our country the guidelines, which are often cited and followed, are those issued by the indian council of medical research, new delhi. The indian council of medical research brought out the ‘policy statement on ethical considerations involved in research on human subjects,’ in 1980, and revised these guidelines in 2000, as the ‘ethical guidelines for biomedical research on human subjects’. Since then it has been revised and the latest version has been published in its general statement the document stresses on the fact that only such research should be undertaken whose purpose would be to advance the ‘betterment of all, especially the least advantaged’. The manner in which the research is conducted should not compromise the dignity and well-being of the subjects, and it should avoid the historical pitfalls of unethical research, to ensure sound scientific output ‘the research must be subjected to a strict regime of evaluation at all stages of the proposal’. 4]all human beings are born free and equal in dignity and rights; it is the duty of each and every man related or unrelated to science to treat their fellow beings with love and nces1. Human research ethics handbook - commentary on national statement on ethical conduct in research involving humans. Department of health & human al institutes of main menu display toggle search form display email the human subjects mailbox search tions policies & l guidelines l guidelines & ation of l for international organizations of medical sciences (cioms) - international ethical guidelines for biomedical research involving human subjects. Cfr part 50, subpart f hhs regulations for responsibility of applicants for promoting objectivity in research for which phs funding is sought. Those who have been are human ation ptable human utional officials and administrators, irb adnministrators and utional reviewers and information about the peer review review evaluation the peer review subjects information for specific nih award i doing human subjects research?
Policies & l guidelines & human subjects policies and information sheet ntial effort has been made to provide accurate and complete information on this web site. Government, the national institutes of health (nih) nor the office of extramural research (oer) assumes any legal liability for the accuracy, completeness, or usefulness of any information, products, or processes disclosed herein, or represents that use of such information, products, or processes would not infringe on privately owned rights. Government, and they may not be used for advertising or product endorsement graphic notice ( ) means that you are leaving the office of extramural research (oer) website. You will be subject to the destination site's privacy policy when you follow such for human research protections. Department of health & human ance & er irbs & obtain home > ohrp > regulations & policy > the belmont tionshas sub items, regulations45 cfr cehas sub items, guidancefrequently asked questions45 cfr 46 nce process en: research with children research determination ed consent igator responsibilities registration process er research y improvement activities able ical materials & ts for tions & policy archived belmont reportoffice of the l principles and guidelines for the protection of human subjects of national commission for the protection of human subjects of biomedical and behavioral : department of health, education, and : notice of report for public y: on july 12, 1974, the national research act (pub. 93-348) was signed into law, there-by creating the national commission for the protection of human subjects of biomedical and behavioral research. One of the charges to the commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research belmont report attempts to summarize the basic ethical principles identified by the commission in the course of its deliberations. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. The department requests public comment on this al commission for the protection of human subjects of biomedical and behavioral s of the h john ryan, m. Attorney, vombaur, coburn, simmons & turtle, washington, l principles and guidelines for research involving human subjects. Basic ethical ment of risk and ion of l principles & guidelines for research involving human ific research has produced substantial social benefits. Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the second world war. This code became the prototype of many later codes[1] intended to assure that research involving human subjects would be carried out in an ethical codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in their work. Broader ethical principles will provide a basis on which specific rules may be formulated, criticized and principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles. Boundaries between practice and is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research. The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called "experimental" when the terms "experimental" and "research" are not carefully the most part, the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. By contrast, the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project [3]. And practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human b: basic ethical principles.
Basic ethical expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do r, not every human being is capable of self-determination. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics. Claude bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children -- even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in nazi concentration camps was condemned as a particularly flagrant injustice. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally t this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the ations of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research. Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, r, a simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care.
Special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the hension. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject's best ariness. The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. However, when expressions such as "small risk" or "high risk" are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned term "benefit" is used in the research context to refer to something of positive value related to health or welfare. While the most likely types of harms to research subjects are those of psychological or physical pain or injury, other possible kinds should not be and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). Previous codes and federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects' rights have been protected. Only on rare occasions will quantitative techniques be available for the scrutiny of research protocols. This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible. It should also be determined whether an investigator's estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available y, assessment of the justifiability of research should reflect at least the following considerations: (i) brutal or inhumane treatment of human subjects is never morally justified. It should be determined whether it is in fact necessary to use human subjects at all. Iii) when research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation). Iv) when vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research e is relevant to the selection of subjects of research at two levels: the social and the individual.
Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. The institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain ice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus, even if individual researchers are treating their research subjects fairly, and even if irbs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider distributive justice in selecting research populations, especially institutionalized ones, are already burdened in many ways by their infirmities and environments. When research is proposed that involves risks and does not include a therapeutic component, other less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved. Also, even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the recipients of the special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition. 1] since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have been adopted by different organizations. Department of health, education, and welfare codes for the conduct of social and behavioral research have also been adopted, the best known being that of the american psychological association, published in 1973. The fact that some forms of practice have elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the general distinction between research and practice. Even when a procedure applied in practice may benefit some other person, it remains an intervention designed to enhance the well-being of a particular individual or groups of individuals; thus, it is practice and need not be reviewed as research. 3] because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the commission specifically declines to make any policy determination regarding such research at this time. Rather, the commission believes that the problem ought to be addressed by one of its successor t created by office for human research protectionscontent last reviewed on march 15, up for ohrp sign up for updates, please click the sign up button for human research protections. Wootton parkway, suite crimination l > research methods & cting / sion journal of empirical research on human research ethics (jerhre) publishes empirical research and reviews of empirical literature on human research ethics. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research is the only journal in the field of human research ethics dedicated exclusively to empirical research. Topics of recent articles include the following:communication issues: recruitment; informed consent; deception; relationships as a source of data; community consultation and outreach; language and meaning across cultures and contextsacquisition and use of data: privacy; confidentiality; uses of data: privacy; confidentiality; uses of datarisk and benefit: risk, wrong and harm; benefit, incentive, promise of social value; risk/benefit assessment: risk, wrong and harm; benefit, incentive, promise of social value; risk/benefit assessmenttheory, method and design: validity; modeling; equitable treatment of participants; technology, efficiency and sampling; beliefs about knowledge: validity; modeling; equitable treatment of participants; technology, efficiency and sampling; beliefs about knowledgeother influences on research: research ethics committees; other institutional-governance influences; perceptions that influence research; taboo, questionable and controversial topics of research; scientific integrity and responsibility; ethics and politics; government and agency regulations and policies; human-research literacy; education in the responsible conduct of research (rcr): recruitment; informed consent; deception; relationships as a source of data; community consultation and outreach; language and meaning across cultures and contexts: privacy; confidentiality; uses of data: risk, wrong and harm; benefit, incentive, promise of social value; risk/benefit assessment: validity; modeling; equitable treatment of participants; technology, efficiency and sampling; beliefs about knowledgeinstitutions and their researchers share concern about the responsible conduct of research (rcr), but can experience difficulty finding common ground around the interpretation of ethical principles and regulations. Jerhre seeks to create collaboration among these stakeholders by stimulating research and disseminating knowledge to foster the intelligent application of ethical principles in research contexts basic aim of jerhre is to improve ethical problem solving in human research. Jerhre creates collaboration among stakeholders, stimulates research, and disseminates knowledge to foster intelligent application of ethical principles in research contexts sity of kwazulu-natal, south university chicago, nbosch university, south sity of wisconsin, stout, sity of oxford, university school of medicine, ia university, sity of windsor, of medicine, case western reserve university, ter medical school, wellcome trust research programme, -copernicus group, sity of ottawa, sity of pittsburgh, sity of north carolina, rnia state university, east bay, -jo van den estern university, al institutes of health, university of chicago, van den sity of new brunswik, mawr college, sity of minnesota, uth college, sity of wisconsin, stout, sity of michigan, louis university, university medical center, an association for the advancement of science, sity of chicago, university of melbourne, al institutes of health, sity of windsor, bilt university, university, saudi nati children's hospital medical center, sity of minnesota, a university, al institutes of health, sity of massachusetts medical school, college of medicine, sity of tulsa, ut de recherché cliniques de montreal, sity of maryland, hopkins bloomberg school of public health, al institutes of health, a state university, graphy of ’s directory of publishing opportunities in psychiatry and ate analytics: social science citation ationale bibliographie der geistes- und ationale bibliographie der rezensionen wissenshcaftlicher n-reuters journal citation n-reuters science citation n-reuters web of following is intended to guide and expand, not limit, the scope of articles. Articles should be concise, useful and interesting to jerhre’s target audience: researchers, research administrators and members of ethics committees. Relevant aspects are described ct of interest (coi) - authors are required to declare to the editor any conflicts of interest (any financial or other arrangements or commitments that could reasonably be perceived as sources of bias in the design, interpretation, or reporting of the results of the research) upon acceptance in the journal. Undisclosed conflicts later identified by a third party will be published in an "errata" if the editors feel the readers should know about such tion of human subjects - manuscripts reporting data from human subjects research must state, in the method section, what formal review and approval or waiver was granted by appropriate research ethics committee(s). The treatment of research participants must be in accord with ethical and other requirements, as set forth in the country in which the research was conducted and as specified by the sponsoring ed consent - the approach(es) and method(s) of obtaining informed consent should be described, including the reasons why any unconventional approaches or waivers were deemed more ethical and respectful in the particular culture and context. This discussion of the informed consent processes and rationales should be more than perfunctory, given that research published in jerhre derives from a wide range of cultures that may require unconventional approaches to informed consent (e. Considerable ethical problem solving often must enter into the development of effective research procedures including the establishment of a respectful relationship with the research participants and others in their community.
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