Online research in philosophy

Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize.

The concept of minimal risk plays a key role in federal regulations on the protection of human research subjects. Although there has been considerable discussion of the meaning of minimal risk, the question of how this concept should be interpreted in research involving pregnant women and fetuses has not been addressed. This essay reviews the literature on minimal risk and argues for an interpretation of that concept in the context of research involving pregnant women and fetuses.

An approach to describing risk analysis, risk perception and risk interpretation under a single umbrella starting with a general definition of risk as "adverse consequences under uncertainty." The idea of risk representation is introduced as an omnibus term for many different ways of conceptualizing risk and deploying risk messages in science, government or society.

Preventing exploitation in human subjects research requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market to human subjects research, and Ballantyne's criticisms of both the ideal market and the resulting benchmark of fairness. It argues that the criticism of this particular benchmark is on point, but the rejection of the ideal market is mistaken. After presenting a complete account of the ideal market, this paper proposes a new method for applying the ideal market to human subjects research and illustrates the proposal by considering a sample case.

The 2006 Institute of Medicine (IOM) report, 'Ethical Considerations for Research Involving Prisoners', recommended five main changes to current US Common Rule regulations on prisoner research. Their third recommendation was to shift from a category-based to a risk-benefit approach to research review, similar to current guidelines on pediatric research. However, prisoners are not children, so risk-benefit constraints on prisoner research must be justified in a different way from those on pediatric research. In this paper I argue that additional risk-benefit constraints on prisoner research are unnecessary: the current Common Rule regulations, omitting category-based restrictions but conjoined with the IOM report's other four main recommendations, ensure that prisoner research is as ethical as non-prisoner research is. I explain why four problems which which may be more prevalent in prisons and which risk-benefit constraints may seem to address – coercion, undue inducements, exploitation, and protection from harm – are in fact not solved by adding further risk-benefit constraints on prisoner research.

This paper investigates board judgment in response to management led buyouts (MLBs). Board response is suggested to be guided by the business judgment rule and its dual duties of care and loyalty. The duty of loyalty is seen to be evolving into a specification of fair dealing. With this trend, the current interpretation of the business judgment rule emphasizes the role of care and relies on the market to insure fairness. Possible failures in the MLB market which limit its effectiveness in assuring fairness are discussed. Recommendations to counteract these failures are suggested.

One of the central problems concerning research with children is the delineation of appropriate levels of risk exposure. In the U.S. Code of Federal Regulations, the "minimal risk" concept serves as an anchoring measure for allowable risk. While the regulations sought to promote a balance between scientific advances and the protection of children's vulnerable status, ambiguities in the language of the regulations and the regulatory definition of "minimal risk" have given rise to a great deal of confusion. Research ethics boards and the medical community espouse a multitude of varying opinions regarding the interpretation and application of the federal regulations with more recent research demonstrating an apparent increase in risk without corresponding benefit in pediatric research. Informed by ethical theory, law, and science, this project analyzes the apparent increase in allowable risk, calls for a reassessment of the concept of "minimal risk," and recommends modifications to the federal regulations.

This paper challenges the fitness of Angela Ballantyne's proposed theory of exploitation by situating her ‘fair risk account’ in an ongoing dialogue about the adequacy conditions for benchmarks of fairness. It identifies four adequacy conditions: (1) the ability to focus on level rather than type of benefit; (2) the ability to focus on micro-level rather than macro-level fairness; (3) the ability to prevent discrimination based on need; and (4) the ability to prescribe a certain distribution as superior to all others. While the fair risk account satisfies the first condition, this paper argues that it has difficulty satisfying the last three conditions. Ballantyne's proposal includes several new and promising features, but in order for the fair risk account to be useful in identifying and preventing exploitation, Ballantyne must either clarify and augment her theory or challenge the relevance of the adequacy conditions it fails to meet.

Hertwig and Ortmann suggest paying participants contingent upon performance in order to increase the thoroughness they devote to a decision task. We argue that monetary incentives can yield a number of unintended effects including distortions of the subjective representation of the task and impaired performance. Therefore, we conclude that performance-contingent payment should not be generally employed in judgment and decision research.

There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. But there are some instances where it is not. Specifically, incentives become problematic when conjoined with the following factors, singly or in combination with one another: where the subject is in a dependency relationship with the researcher, where the risks are particularly high, where the research is degrading, where the participant will only consent if the incentive is relatively large because the participant's aversion to the study is strong, and where the aversion is a principled one. The factors we have identified and the kinds of judgments they require differ substantially from those considered crucial in most previous discussions of the ethics of employing incentives in research with human subjects.