Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact (the fact that the action the rule prescribes is ethically obligatory), whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that the actions (...) prescribed by the rules are ethically obligatory, and consequently we should focus our attention on how to craft the rules so as to promote the legitimate goals of human subjects research. Unfortunately, this cannot be done without evidence about the likely effects of various candidate policies—evidence we currently lack. Therefore, we should take the rules as mere starting points, subject to revision as the evidence comes in. (shrink)

Research ethics committees are charged with providing an opinion on whether research proposals are ethical. These committees are overseen by a central office that acts for the Department of Health and hence the State. An advisory group has recently reported back to the Department of Health, recommending that it should deal with inconsistency in the decisions made by different RECs. This article questions the desirability and feasibility of questing for consistent ethical decisions.

ABSTRACT Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to ‘harmonise’ their judgements. Some inconsistencies are bad because they are due to irrationality, or carelessness, or the operation of conflicting interests, and so should be reduced or removed. Other inconsistencies, we argue, are not bad and should be left or even encouraged. In this paper we examine three arguments to reject the view that we should strive for complete (...) consistency between committees. The first argument is that differences in judgement are not necessarily incompatible with ideas of justice for patients who are potential participants of research reviewed by different committees. We call this ‘the justice argument.’ The second argument is that such committees do not have access to a single moral truth, to which their judgement is supposed to correspond. We call this the ‘moral pluralism argument.’ The third argument is that the process of ethics committee review is also morally relevant and not solely the outcome. We call this the ‘due process argument.’ While we fall short of establishing exactly how much variation and on what substantive issues would be ethically permissible, we show that it is largely inevitable and that a certain amount of variation could be seen as a desirable part of the institution of medical research. (shrink)

A distinction is made between two models of ethics committees. According to the Mirror Model, ethics committees ought to reflect the values of society. The Critical Model says committees are to critically examine these standards rather than merely reflect them. It is argued that the Critical Model should be accepted because a society's ethical standards can be mistaken and a society that has Critical rather than merely Mirror ethics committees is more likely to have such mistakes revealed. Some implications of (...) the Critical Model are discussed. (shrink)

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively (...) identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. (shrink)

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.

One role of research ethics committees is to assess the ethics of proposed health research. In some countries, RECs are also instructed to assess its legality. However, in other countries they are explicitly instructed not to do so. In this paper, I defend the claim that public policy should instruct RECs not to assess the legality of proposed research . I initially defend a presumption in favour of the Claim, citing reasons for making research institutions solely responsible for assessing the (...) legality of their own research. I then consider three arguments against the Claim which may over-ride this presumption—namely, that policy should instruct RECs to assess the legality of research because doing so would minimise the costs of assessing the legality of research, whether research is legal may partly determine whether it is ethical and whether research is legal may constitute evidence for whether it is ethical. I reject the first two arguments and note that whether the third succeeds depends on the answer to a more fundamental question about the appropriate nature of REC ethical deliberation. I end with a brief discussion of this question, tentatively concluding that the third argument also fails. (shrink)

ABSTRACTSome people might argue that there are already too many different documents, guidelines, and regulations in bioethics. Some overlap with one another, some are advisory and lack legal force, others are legally binding in countries, and still others are directed at narrow topics within bioethics, such as HIV/AIDS and human genetics. As the latest document to enter the fray, the UNESCO Declaration has the widest scope of any previous document. It embraces not only research involving human beings, but addresses broader (...) concerns in medicine and healthcare. The UNESCO draft declaration has some minor weaknesses, but on the whole, the strengths outweigh the weaknesses. One weakness is that some items in the draft are stated in a way that is too restrictive, thereby appearing to rule out legitimate activities. A strength of the Declaration is that it is relatively brief, yet at the same time contains sufficient detail to make it something more than a rehearsal of mere pieties. As the most recent of the numerous bioethics and human rights documents, the UNESCO draft draws on many of the earlier documents and also includes some of the most recent thinking about ethical norms and obligations. Perhaps its greatest strength lies not in details of the principles or their implementation, but rather in its stature as an international declaration issued by a United Nations organization. (shrink)