Ethics Review System Research Articles

Chinese ethics review system and chinese medicine ethical review: Past, present, and future

The Chinese medical ethics committee and the ethical review system have made the following achievements: (1) enabled the institutionalization of medical ethics, (2) carried out the ethics review of Chinese medicine (CM) and integrative medicine extensively, (3) trained a large number of ethical professionals, (4) supported and protected the interests of patients and subjects, and (5) ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways: (1) to refine the relevant rules of ethical review, (2) to develop the relevant standards of the CM and integrative medicine ethical review, (3) to enhance the independence and authority of ethics committee, (4) to emphasize innovation and to discover and solve new problems, and (5) to increase international exchanges and improve relevant research.

Ethics, Kawa, and the Constitution: Transformation of the System of Ethical Review in Aotearoa New Zealand

New Zealand is a South Pacific nation with a history of British colonization since the 19th century. It has a population of over four million people and, like other indigenous societies such as in Australia and Canada, Māori are now a minority in their land, and their experience of colonization is that of being dominated by settlers to the detriment of their own systems of society.

Defending Rights or Defending Privileges?

Conducting research in public services organizations raises important but often neglected questions about the status of managers and staff as research subjects. An approach that prioritizes the protections and entitlements due to research subjects may thwart the public interest. An approach that grants laissez faire to researchers may threaten the legitimate rights and interests of managers and staff. Ethics review systems are currently poorly equipped to engage in useful debates about the drawing of appropriate boundaries for inquiry. We urge a recasting of the role of ethics review from research subject's sole protector to honest broker.

ARRIVE: new guidelines for reporting animal research

In 1980, Altman wrote that misuse of statistics in medical research was unethical (Altman, 1980). This article was the first of many, written to improve the standard of statistical analysis and reporting in medical journals, and the endeavour has been largely successful. Other factors have also been at play over these three decades. The regulation of ethical standards and approval increased, more control of data collection was required for the licensing of drugs, and ‘evidence based’ practice became popular. This approach to the analysis of information uses a structured process and allows later assembly of data from separate studies, impossible without full details. To allow these details to be reported in a consistent way, and accessible for further use, the CONSORT statement defined guidelines for reporting trials (Begg et al. 1996). The International Committee of Medical Journal Editors introduced guidelines for reporting, and in 2005 required that all clinical trials should be registered in a publicly accessible database. On occasion, these requirements may still not be properly met. For example, although studies may be registered, the end point for analysis may not be specified, leading to subsequent uncertainty and sometimes controversy (Leo, 2009). The practice of reporting of animal research has not advanced at the same rate. In a recent survey of our journals we found that omissions of relevant and important statistical details were common. Animal research in the UK has been legally regulated for many years, with a specific and exacting system of ethical review, and practical oversight of animal studies. However, after a parliamentary review, an independent but predominantly government-funded body was set up in 2004: the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). An important aim for this body has been to connect with the public, and government surveys now assess public attitudes to these topics. This body is also concerned with improving the quality of study design and reporting. The NC3Rs recently surveyed the standards of reporting on animal research (rats, mice and non-human primates) in studies carried out between 1999 and 2005. Out of about 170,000 relevant publications, a carefully selected sample of 271 studies was analysed for quality of reporting, and 48 in more detail for quality of study design and analysis. The prominent ‘errors’ in reporting were not exactly stating the hypothesis to be examined, the means of determining sample size, or the method of randomisation. These results were used to construct a set of exact guidelines on the conduct and reporting of animal studies, based on the previous CONSORT guidelines for human studies. The new guidelines have a new acronym: ARRIVE, which is Animal Research: Reporting In Vivo Experiments, and provide explicit and unequivocal instructions on reporting animal experiments. One of the authors of this editorial recently described The Journal of Physiology's advice to authors as ‘mild encouragement’, and wrote a firmer guide (Drummond, 2009). Despite the aim to be more exact, this firmer approach has been described as providing ‘little or no guidance on what information to report when describing in vivo research’. Thus, the new ARRIVE guidelines represent a new degree of stringency in requirements, which we fully endorse as a means of improving scientific reporting and ethical standards in animal research, although the latter aim has long been an aspiration of both The Journal of Physiology and Experimental Physiology. These guidelines are supported by other bodies such as the International Council of Medical Journal Editors (2008), the Council of Science Editors (2009), the Committee on Publication Ethics (2010), and the Nuffield Council for Bioethics (2005). In some fields, we would encourage even more detail. For example, the method of killing (not euthanasia) is often relevant, scientifically and legally, and the means of providing care after procedures, such as analgesia, may also be highly relevant. For animal studies performed under anaesthesia, blood pressure, heart rate and blood gases should be measured and recorded. The criteria for additional doses of anaesthetic should be stated and data on additional administration should be included in the Methods. Good science is best served if these principles are applied from the start of the study: the plan and design of the experiment should apply sound statistical principles. To that end, The Journal of Physiology hopes to publish a series of short editorials, specifically aimed at the non-expert, to aid good design, execution and presentation of experiments.

ARRIVE: new guidelines for reporting animal research

In 1980, Altman wrote that misuse of statistics in medical research was unethical (Altman, 1980). This article was the first of many, written to improve the standard of statistical analysis and reporting in medical journals, and the endeavour has been largely successful. Other factors have also been at play over these three decades. The regulation of ethical standards and approval increased, more control of data collection was required for the licensing of drugs, and ‘evidence based’ practice became popular. This approach to the analysis of information uses a structured process and allows later assembly of data from separate studies, impossible without full details. To allow these details to be reported in a consistent way, and accessible for further use, the CONSORT statement defined guidelines for reporting trials (Begg et al. 1996). The International Committee of Medical Journal Editors introduced guidelines for reporting, and in 2005 required that all clinical trials should be registered in a publicly accessible database. On occasion, these requirements may still not be properly met. For example, although studies may be registered, the end point for analysis may not be specified, leading to subsequent uncertainty and sometimes controversy (Leo, 2009). The practice of reporting of animal research has not advanced at the same rate. In a recent survey of our journals we found that omissions of relevant and important statistical details were common. Animal research in the UK has been legally regulated for many years, with a specific and exacting system of ethical review, and practical oversight of animal studies. However, after a parliamentary review, an independent but predominantly government-funded body was set up in 2004: the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). An important aim for this body has been to connect with the public, and government surveys now assess public attitudes to these topics. This body is also concerned with improving the quality of study design and reporting. The NC3Rs recently surveyed the standards of reporting on animal research (rats, mice and non-human primates) in studies carried out between 1999 and 2005. Out of about 170,000 relevant publications, a carefully selected sample of 271 studies was analysed for quality of reporting, and 48 in more detail for quality of study design and analysis. The prominent ‘errors’ in reporting were not exactly stating the hypothesis to be examined, the means of determining sample size, or the method of randomisation. These results were used to construct a set of exact guidelines on the conduct and reporting of animal studies, based on the previous CONSORT guidelines for human studies. The new guidelines have a new acronym: ARRIVE, which is Animal Research: Reporting In Vivo Experiments, and provide explicit and unequivocal instructions on reporting animal experiments. One of the authors of this editorial recently described The Journal of Physiology's advice to authors as ‘mild encouragement’, and wrote a firmer guide (Drummond, 2009). Despite the aim to be more exact, this firmer approach has been described as providing ‘little or no guidance on what information to report when describing in vivo research’. Thus, the new ARRIVE guidelines represent a new degree of stringency in requirements, which we fully endorse as a means of improving scientific reporting and ethical standards in animal research, although the latter aim has long been an aspiration of both The Journal of Physiology and Experimental Physiology. These guidelines are supported by other bodies such as the International Council of Medical Journal Editors (2008), the Council of Science Editors (2009), the Committee on Publication Ethics (2010), and the Nuffield Council for Bioethics (2005). In some fields, we would encourage even more detail. For example, the method of killing (not euthanasia) is often relevant, scientifically and legally, and the means of providing care after procedures, such as analgesia, may also be highly relevant. For animal studies performed under anaesthesia, blood pressure, heart rate and blood gases should be measured and recorded. The criteria for additional doses of anaesthetic should be stated and data on additional administration should be included in the Methods. Good science is best served if these principles are applied from the start of the study: the plan and design of the experiment should apply sound statistical principles. To that end, The Journal of Physiology hopes to publish a series of short editorials, specifically aimed at the non-expert, to aid good design, execution and presentation of experiments.

Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal...

Identifying structures, processes, resources and needs of research ethics committees in Egypt

BackgroundConcerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges.MethodsWe distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data.ResultsWe obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics.ConclusionOur study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs.

The Current Status of Animal Use and Alternatives in Korean Veterinary Medical Schools

Two new Korean laws regulating animal welfare and the humane use of animals in science came into effect in 2008 and 2009. Both these laws impose ethical committee review prior to the performance of animal experiments in research, testing and education. This study briefly summarises the new Korean laws, and investigates the current status regarding the numbers of animals used, the alternatives to animals which are used, the curricula relating to the humane use of animals, and ethical review practices in Korean veterinary education. Approximately 4,845 animals, representing 20 different species, were used in veterinary medical education in Korea in 2007. Korea has begun to introduce formal courses on animal welfare for the humane treatment of animals used in experiments, and an ethical protocol review system prior to animal use in education. Korea is moving toward better animal welfare, by incorporating practices consistent with international standards. The information presented represents the first such data gathered in Korea, which should prove useful for monitoring the implementation of replacement, reduction, and refinement measures in animal use for education purposes.

A case study evaluation of ethics review systems for multicentre clinical trials

TO THE EDITOR: The evaluation by Hicks and colleagues of the centralised ethics review system in New South Wales codifies important additional time delays facing researchers conducting multicentre trials that include NSW. These delays have direct financial consequences that continue to limit the viability (especially when staff are on time-limited grants) and productivity of multisite research in Australia, without adding value to the ethical conduct of the research. There is also inconsistency between the approaches of the lead ethics committee (LEC) and site-specific ethics committees in the way they deal with protocol amendments and adverse event governance, further compounding the delays in initial review. Five multicentre clinical trials are currently being conducted by the Palliative Care Clinical Studies Collaborative (PaCCSC), a national initiative to improve the evidence for symptom therapeutics at the end of life. Submissions for ethics review occurred between May 2008 and July 2009 across nine sites in five states. As in the study by Hicks et al, ethics review submissions included the NSW LEC, but because these submissions were more recent than those reported by Hicks et al, they were submitted on the National Ethics Application Form (NEAF). Hicks and colleagues state there is benefit in standard documentation, but using the NEAF does not reduce the need for collating complete sets of documentation for each site-specific approval and any subsequent amendments or adverse events.4 For the PaCCSC, LEC and site-specific review in NSW achieved approval in a median of 119 days (range, 76–209), compared with 107 days (range, 6–172) for individual committees in other states. Hicks and colleagues did not quantify the costs generated by these delays. Given that staff are often employed to prepare ethics submissions and then retained for the definitive study, additional delays in approval are costly, especially with finite, competitive grants funding. Costs of multisite ethics review applications have previously been quantified in Australia, but the additional delays in NSW from the requirement for site-specific approval are estimated to have cost the PaCCSC about $4000 per study per site in salaries and on-costs. Across three NSW sites and five studies, $55 000 has been spent without measurable ethical or research governance benefits. Theoretically, LEC review should streamline protocol amendments and adverse events reporting, as they are the responsibility of the LEC. But although protocol amendments are supposed to be reviewed only by the LEC, some site-specific committees continue to insist on approving all amendments. Efforts to consolidate adverse event reporting have made some progress. All adverse events are reported to the LEC for review, and any required response should be shared with site-specific committees. Again, some non-lead sites continue to insist on separately reviewing adverse events rather than using the LEC as intended.

A case study evaluation of ethics review systems for multicentre clinical trials

A case study evaluation of ethics review systems for multicentre clinical trials

A case study evaluation of ethics review systems for multicentre clinical trials

A case study evaluation of ethics review systems for multicentre clinical trials

倫理審查的制度歷史、運行現狀與困境

LANGUAGE NOTE | Document text in Chinese; abstract also in English.西方文化和原則主義的生物醫學倫理審查制度大有“普惠全球”之勢，但是從國際文獻的制訂歷史追溯倫理審查要求的修改變化，會發現倫理審查要求的弱化和無窮倒退的現象。本文將結合當前西方倫理審查的運行現狀，對倫理審查制度面臨的理論和實踐困境進行分析。Since the 1970s, the ethics review system has become an important measure to protect human life. International organizations have ceaselessly revised and perfected the rules of several international ethics documents, carried out ability training for ethics reviews on a global scale, helped many countries to set up ethics committees, and attempted to promote the Western ethical culture and principle of “universal ethics.” However, if we investigate the history of the changes in the requirements of ethics reviews coded in the relevant international documents and enactments, we find that the requirements of ethics reviews for medical research have become weakened and have substantially regressed.The Western approach to the ethics review has no means of ensuring that investigators obey the ethics review system. It is also unable to secure common ground and set aside differences when confronted with a pluralist culture. This weakens its ability to review and supervise. The current state of the Western ethics review also displays some negative features, such as a loosely organized structure, commercialization stimulated by conflicts of interest, disagreement over conclusions (especially for research projects involving multiple research centers) due to pluralist cultures and systems of morality, the limited protection of human subjects due to poor review and supervision, and the imposition on researchers of very complex review processes.The system of ethics review is also beset by several dilemmas. The first is the suspicion of ethics imperialism. International documents attempt to provide a universal frame and impose the values of certain moral communities on others. Second, the ethics principles proposed by Beauchamp and Childress seem to be the foundation of many international documents, yet reflect only a small part of American morality, and cannot always be applied to other cultures and customs. They have been attacked by virtue theory, casuistry, feminism, and communitarianism alike. Third, the history of the revision of international ethics documents suggests that ethics reviews often fall into a vicious circle: scientific research must be reviewed by an ethics committee, and the ethics committee must be reviewed by an external institute, but who reviews the external institute?This essay contends that the Western ethics review system is based on Western human rights theory and the religious view of original sin, in that the review process must be enforced to prevent the evil in human nature. This epistemological foundation has caused many problems and dilemmas, as stated. To resolve these problems and dilemmas, we need to re-examine the foundations of ethics reviews. This essay argues that due to the reality of cultural and ethical pluralism, it is difficult, if not impossible, to seek a global or universal ethical theory that will guide all ethics review practices.Finally, this essay puts forward a proposal for reconstructing Chinese ethics reviews by drawing on intellectual and ethical thought in Confucian resources. Confucianism emphasizes the cultivation of virtue and self-improvement, which means that the good of the individual primarily derives from self-discipline. In a scientific research field, this suggests that investigators should do good voluntarily and conscientiously. This idea should be applied in the construction of a harmonious relationship between ethics committees and researchers.DOWNLOAD HISTORY | This article has been downloaded 114 times in Digital Commons before migrating into this platform.

Some Suggestions for Improving the Research Ethics Review System in Japan, Based on a Study Involving Interviews with Committee Members and Investigators Regarding Clinical Research Conducted in FY 2008 at an Institution

A research ethics committee (REC) is an appropriately constituted group that reviews and monitors biomedical research in order to protect the rights and welfare of human subjects. Although a number of studies have reported that Japanese institutions conducting biomedical research have established RECs, little is known about the quality of research protocols and the review process in these institutions. Using a checklist of 67 items, we reviewed 75 protocols that had been evaluated by the REC of an institution. Forty-six of 75 protocols did not clearly state the background of the study. In 25 of the 46 protocols, no committee members identified the absence of a stated background. Interviews with 18 investigators and 27 REC members revealed that some investigators and committee members did not understand the role of the REC. The results of this study suggest that about one-third of REC-approved protocols may contain shortcomings. The study implies that REC does not always function effectively to ensure that the research to be conducted is ethically sound. We suggest the following improvements: 1) education and training of investigators and committee members on how to conduct clinical research, 2) establishment of a research center to support and manage the conduct of clinical research, 3) improvement of relationship and communication between committee members, 4) introduction of a procedure whereby all committee members discuss each protocol until a consensus is reached, and 5) establishment of an organization to support efficient and effective operations of the RECs.

The impact of clinical trials legislation on clinical pharmacology: problems and solutions

The article by Morris Brown on the impact of clinical trials legislation on clinical pharmacology [1]makes very sorry reading, as does the editorial appearing in the same issue, although less so than the Brown article. There is so much that is inaccurate in this article that it compromises the legitimate validity of his argument that bureaucracy in this country hampers clinical research. It so happens that, in my so-called retirement, I am closely involved with the research ethics review process throughout Europe, being co-chairman of the European Forum for Good Clinical Practice (EFGCP) Ethics Working Party and the EFGCP Ethics Officer, as well as having served on UK research ethics committees (RECs) for over 12 years, now being the alternate vice-chairman of Cambridgeshire 4 REC, which used to be the former East of England MREC. I was responsible for initiating the report on the structure and function of RECs published in the International Journal of Pharmaceutical Medicine in February 2007 and kept up to date on an annual basis on our EFGCP website (http://www.efgcp.be). I am therefore in a very strong position to maintain that the UK can be proud that it has as good a grasp of research ethics as any other European state, and I would be willing to debate that vigorously in public. Sadly, Brown has not acknowledged the efficiency that now demonstrably pervades the research ethics review system in this country, allowing himself to be overwhelmed by the deficiencies of the R&D Governance process in this country, with which the National Health Service has lumbered itself. This, I freely acknowledge, is a nightmare that only recently might have shown a first sign of waking itself up. Coupled with academic regulations, with which clinical pharmacologists might well be encumbered, too, I can therefore understand the frustration that Brown demonstrates, though it is partially misdirected. Without wishing to be personal in a letter to the Journal, I would remind Brown and his clinical pharmacology colleagues that one of the most irritating aspects of an application to a REC is the inadequacy of many patient information sheets, whether they come from pharmaceutical companies or academic departments. By and large, clinical pharmacologists ought to be as good as any group in the production of comprehensive yet comprehensible patient information sheets that, above all, are able to be understood by the patients who are the intended subjects of research projects. Time taken to produce a really good patient information sheet must be time well spent, as the time needed to take on board the concerns of a REC may well be much greater than for the drafting of a decent document in the first place. Referral back by a REC must be frustrating to an investigator, but the time taken to deal with the REC concerns can be minimized, and it is not right to accuse RECs of delaying tactics when the time taken for a response by an investigator may well be very protracted. Of more fundamental concern is Brown's clear lack of understanding of what research ethics are all about. No doubt Brown is a very sound medical ethicist and he tells us that medical ethics was his first academic interest. But research ethics is quite different from mainstream medical ethics. It is because RECs are established to look after the interests of patients who are the subjects of clinical research projects that they include in their membership lay persons as well as experts. The National Research Ethics Service (NRES) has ensured that all the members of RECs are properly trained in the principles of research ethics, and Brown's comments on the membership of RECs in his article are insulting in the extreme. It is the intelligent lay persons as well as the doctors, nurses, lawyers, statisticians, pharmacists, teachers and so on who are found on RECs that safeguard the interests of patients—and at Cambridgeshire 4 we operate to strict deadlines. I hope that readers of your Journal will recognize the efficiency with which research projects are dealt with by the NRES, through its research ethics committees, and will all contribute to putting pressure on other aspects of the research approval process that are still deficient. None declared.

A case study evaluation of ethics review systems for multicentre clinical trials

To evaluate the difference in time taken for ethics and site governance approval for multicentre clinical trials using two different systems of ethics review. We evaluated the times to final ethics and governance approval for two international, multicentre clinical trials of treatment for metastatic colorectal cancer: the MAX trial, using a non-centralised ethics review system, and the CO.20 trial, using the new New South Wales centralised ethics review system. Time from trial submission to overall study approval. The median time taken to obtain ethics approval for the MAX trial at 16 NSW sites was 100 days (range, 36-161 days). The median time to obtain central ethics approval for the CO.20 trial at 14 NSW sites was 77 days, with an additional 60 days (range 20-79 days) required to obtain site-specific research governance approval. Any difference in time to approval between the review systems was outweighed by the overall time taken. However, the time spent by both the coordinating centre and local sites in collation, submission and correspondence was greatly reduced, and the centralised process allowed for standardised documentation at all study sites.

Centralized National Ethical Review of Clinical Trials in Croatia

To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee. Clinical trial applications reviewed by the Croatian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices, were retrospectively analyzed from May 2004 to the end of 2008 according to the number, research area, and type of opinion issued. Applications from 2008 were analyzed separately according to the study phase, participants (adult trials vs pediatric trials), and sponsor (commercial trials vs academic trials). Data were analyzed by descriptive statistics. Since its establishment in 2004, the Croatian Central Ethics Committee has reviewed 407 trials. The greatest number of clinical trials was in the field of oncology (n = 69), mental and behavioral disorders (n = 52), and endocrine, nutritional, and metabolic diseases (n = 50). In the initial assessment of clinical trials, 60% applications received a conditionally positive opinion. In 28% of applications, the opinion had to be postponed because additional documentation or explanations were required. In 2008, the Croatian Central Ethics Committee reviewed 99 trials, most of which were phase III trials (n = 57). Five clinical trials included pediatric population and 3 were academic clinical trials. The model of centralized clinical trial review seems to be appropriate for the current number of clinical trials conducted in Croatia. The efficient and standardized review process of clinical trials by the Central Ethics Committee may positively affect the increasing number of clinical trials conducted in Croatia. Future development includes the transparency of the clinical trials through a publically available database and establishing the basis for conducting academic clinical trials.

Think globally, act locally: collective consent and the ethics of knowledge production

Ethical review is an integral part of the process of developing research and considering issues associated with the production of knowledge. It is part of a system that primarily legitimises western traditions of inquiry and reinforces western assumptions about knowledge and its benefit to society. Around the world the process of colonisation has excluded indigenous understandings. In New Zealand, Māori (indigenous) knowledge has been similarly marginalised; this pattern is also reflected within ethical review. Māori values, while acknowledged, are not yet considered to have equal weight in ethical deliberations. The notion of collective rights and the possibility of developing processes to allow collective consent to be recognised and mandated by ethics committees have been raised by communities but largely ignored by the ethical review system. While kaupapa Māori researchers espouse the benefits of closer community involvement, policy makers and ethics committees have focused on “consultation” as the mechanism which confirms proof of engagement, the establishment of community support, and the relevance of the project. This article highlights the potential of the concept of collective consent in negotiations between researchers and communities.

Un-ethical review? Why it is wrong to apply the medical model of research governance to human geography

The Economic and Social Research Council, the body which funds much social science in the UK, recently imposed on UK social science a system of research ethics governance already well established in other areas of research and in much of the rest of the developed world. This system requires that research involving human subjects receive prior ethical approval from a committee made up of, typically, multidisciplinary researchers and lay people. Our aim in this paper is to prompt debate about the purpose and practice of such an anticipatory ethical review. We begin by describing the rich and varied ethical and political debates ongoing in human geography. We argue that these are, at best, ignored and, at worst, threatened by this system of ethical review by committee. We describe the emergence of these formal mechanisms of research governance and important differences between the ethical contexts, history, and demands of research in the medical and social sciences. The paper draws on empirical research investigating National Health Service (NHS) research ethics committees to propose three salutary lessons geographers would do well to consider from experience elsewhere with ethical review. We argue that in review by committee deliberations extend beyond the ethical to include the methodological, that the system is a self-perpetuating and increasingly rule-bound mechanism, and that despite a rhetoric of accountability it is a system as obscure to outsiders as professional ethics.

Ethics in Social Research: challenges to the biomedical model

This article analyzes the main challenges involved in the ethical review of social research projects that use qualitative techniques for gathering data. The Brazilian ethical review system was constructed having biomedical sciences as the main reference. This article goes over some of the main points of ethical tension in social research by discussing five classic cases in human and social sciences. It supports the possibility of social research being included in the current ethical review system, as long as there is a sensitization of the ethics committees regarding the methodological particularities imposed by qualitative techniques. Finally, the need for specific ethical guidelines for social research is also considered.

Ética na Pesquisa Social: desafios ao modelo biomédico

This article analyzes the main challenges involved in the ethical review of social research projects that use qualitative techniques for gathering data. The Brazilian ethical review system was constructed having biomedical sciences as the main reference. This article goes over some of the main points of ethical tension in social research by discussing five classic cases in human and social sciences. It supports the possibility of social research being included in the current ethical review system, as long as there is a sensitization of the ethics committees regarding the methodological particularities imposed by qualitative techniques. Finally, the need for specific ethical guidelines for social research is also considered.