Trudo Lemmens

The declaration of Helsinki

Mosaic tablet, dynamic document, or dinosaur?

Research Ethics Recommendations for Whole-Genome Research: Consensus Statement

Interest in whole-genome research has grown substantially over the past few months. This article explores the challenging ethics issues associated with this work.

Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards

Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules are essential because of the absence of clear substantive rules in research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process.

Guinea Pigs on the payroll: The ethics of paying research subjects

Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or “undue influence,”; on the subjects free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit‐driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subjects safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.

Justice for the Professional Guinea Pig

(2001). Justice for the Professional Guinea Pig. The American Journal of Bioethics: Vol. 1, No. 2, pp. 51-53.

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene

Recent controversies surrounding the safety and efficacy of approved drugs show how commercial interests impact on medical research and raise not only specific research ethics concerns, but also more fundamental concerns about research integrity and the reliability of scientific evidence. These concerns go beyond the strict context of medical research, since scientific integrity underlies the drug regulatory process and the practice of medicine itself. This article first uses some of the recent controversies to illustrate how commercialization affects different stages in the production, sharing and publication of scientific findings. Various mechanisms are then scrutinized that could arguably provide some safeguards: competition in the market; independent scrutiny by peers; research ethics review; registration of clinical trials; and review by drug regulatory agencies. The author discusses, however, why none of these regulatory mechanisms deals sufficiently with the negative impact of commercial interests and how these mechanisms are themselves affected by the problem they are supposed to address. While medical research is fully integrated within a lucrative industry, to some extent it continues to be regulated as if it were a charitable practice with a pure humanitarian mission. Because of the interaction between the various regulatory regimes, and because scientific integrity is a crucial component at all levels, a more fundamental structural change is needed. The author supports recommendations to establish an independent drug testing agency which would create a healthy separation between those with financial interests in research from those conducting the research.

Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles

Ghostwriting and guest authorship of medical journal articles raise serious ethical and legal concerns, bearing on the integrity of medical research and evidence used in legal disputes. Ghostwriting involves undisclosed authorship, usually by medical communications agencies or a pharmaceutical sponsor of the published research; guest authorship involves taking authorial credit for the published work without making a substantial contribution to it. Commentators have objected to these practices because of concerns involving bias in ghostwritten clinical trial reports and review articles. We also note the effects of ghostwritten articles on questions involving the legal admissibility of scientific evidence. Efforts to curb ghostwriting practices, undertaken by medical journals, academic institutions, and professional disciplinary bodies, have thus far had little success and show little promise. These organizations have had difficulty adopting and enforcing effective sanctions, for specific reasons relating to the interests and competencies of each kind of organization. Because of those shortcomings, a useful deterrent in curbing the practice may be achieved through the imposition of legal liability on the ‘guest authors’ who lend their names to ghostwritten articles. We explore the doctrinal grounds on which such articles might be characterized as fraudulent. A guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO). The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This doctrine has been used by the U.S. Supreme Court to impose sanctions on the authors and corporate sponsors of a ghostwritten article. We discuss the potential penalties associated with each of these varieties of fraud.

The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives

Offers to health-care professionals of finders fees ranging between

Does the FDA have the authority to trump the Declaration of Helsinki

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