We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

This paper explores a framework for thinking about risks inherent in emerging technologies; given uncertainty about the magnitude—or even nature—of those risks, deliberation about those technologies is challenged. §1 develops a conceptual framework for risk, and §2 integrates that conception into cost-benefit analysis. Given uncertainty, we are often pushed toward precautionary approaches, and such approaches are explored in §3. These first three sections are largely literature review, and then a positive argument for how to think about the relationship between risk, (...) precaution, and uncertainty is offered in §4. (shrink)

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of (...) separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study’s science, but that they have anobligation do so. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.

The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

The recent in vitro derivation of gamete‐like cells from mouse embryonic stem (mES) cells is a major breakthrough and lays down several challenges, both for the further scientific investigation and for the bioethical and biolegal discourse. We refer here to these cells as gamete‐like (sperm‐like or oocyte‐like, respectively), because at present there is still no evidence that these cells behave fully like bona fide sperm or oocytes, lacking the fundamental proof, i.e. combination with a normally derived gamete of the opposite (...) sex to yield a normal individual. However, the results published so far do show that these cells share some defining features of gametes. We discuss these results in the light of the bioethical and legal questions that are likely to arise would the same process become possible with human embryonic stem (hES) cells. (shrink)

Recent legal rulings concerning the status of advance statements have raised interest in the topic but failed to provide any definitive general guidelines for their enforcement. I examine arguments used to justify the moral authority of such statements. The fundamental ethical issue I am concerned with is how accounts of personal identity underpin our account of moral authority through the connection between personal identity and autonomy. I focus on how recent Animalist accounts of personal identity initially appear to provide a (...) sound basis for extending the moral autonomy of an individual - and hence their autonomous wishes expressed through an advance directive - past the point of severe psychological decline. I argue that neither the traditional psychological account nor the more recent Animalist account of personal identity manage to provide a sufficient basis for extending our moral autonomy past the point of incapacity or incompetence. I briefly explore how analogies to similar areas in law designed to facilitate autonomous decision, such as wills and trusts, provide at best only very limited scope for an alternative justification for granting advance statements any legal or moral authority. I conclude that whilst advance statements play a useful role in formulating what treatment is in a patient’s best interests, such statements do not ultimately have sufficient moral force to take precedence over paternalistic best interest judgements concerning an individual’s care or treatment. (shrink)

David Wiggins; IV*—Moral Cognitivism, Moral Relativism and Motivating Moral Beliefs, Proceedings of the Aristotelian Society, Volume 91, Issue 1, 1 June 1991, P.

The paper defends the permissibility of paying inducements to research subjects against objections not covered in an earlier paper in Bioethics. The objections are that inducements would cause inequity, crowd out research, and undesirably commercialize the researcher‐subject relationship. The paper shows how these objections presuppose implausible factual and/or normative claims. The final position reached is a qualified defence of freedom of contract which not only supports the permissibility of inducements but also offers guidance to ethics committees in dealing with practical (...) problems that might arise if inducements are offered. (shrink)

Due to modern biochemistry and, in particular, recent developments in genomics, proteomics, and bioinformatics, human samples have become the most important raw materials for advancement in the health sciences. Such material has been at the center of fundamental biomedical research for a long time. What is new is its increased usefulness in research with direct clinical relevance, such as the development of drugs. Because of the larger commercial involvement in such research, this has also led to greater economic interests in (...) human biological material and in the information that can be extracted from it. (shrink)

Opposition to inducement payments for research subjects is an international orthodoxy amongst writers of ethics committee guidelines. We offer an argument in favour of these payments. We also critically evaluate the best arguments we can find or devise against such payments, and except in one very limited range of circumstances, we find these unconvincing.

The idea of splitting off cells from embryos to clone human beings sounds so bizarre and dangerous that one would think the practice should not be permitted. A closer look reveals its ethical acceptability.