The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The (...) current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)

The development of cancer therapies is a long and arduous process. Because it can take several years for a cancer agent to pass clinical testing and be approved for use, terminal cancer patients rarely have the time to see these experimental therapies become widely available. For most terminal cancer patients the only opportunity they have to access an experimental drug that could potentially improve their prognosis is by joining a clinical trial. Unfortunately, several aspects of clinical trial methodology that are (...) set in place in order to optimise drug development for the benefit of future generations of cancer patients, pose significant limitations to current patient participation. Therefore, several terminal cancer patients believe that they should have the right to access experimental agents that have passed initial safety testing without having to participate in clinical trials. However, granting off-trial access to patients could be detrimental to the scientific process of drug development, and thus could pose significant risks to the health of future patients relying on sound research. Examining this matter through two divergent ethical lenses, rights-based ethics and communitarian ethics, may provide new insight into the issues surrounding the balance between the autonomous rights of current terminal cancer patients, and the needs of future patients and the values of society. (shrink)

Die Sekundärnutzung klinischer Daten für Forschungs- und Lernaktivitäten hat das Potenzial, medizinisches Wissen und klinische Versorgung erheblich zu verbessern. Zur Realisierung dieses Potenzials bedarf es einer ethischen und rechtlichen Grundlage für die Datennutzung, vorzugsweise in Form der Einwilligung von Patient*innen. Damit stellt sich die grundsätzliche Frage: Haben Patient*innen eine moralische Pflicht, ihre klinischen Daten für Forschungs- und Lernaktivitäten zur Verfügung zu stellen?Auf Basis eines ethischen Ansatzes, der als „sorgender Liberalismus“ bezeichnet werden kann, werden folgende Argumente zur Begründung einer Pflicht von (...) Patient*innen zur Bereitstellung ihrer klinischen Daten für Forschungs- und Lernaktivitäten auf Plausibilität und moralisches Gewicht untersucht: die allgemeine Hilfspflicht; Solidarität; die Pflicht zu gemeinwohlförderlichem Handeln; das Trittbrettfahrerargument; transgenerationale Gerechtigkeit; das Prinzip des Zurückgebens; das Prinzip des Nicht-Schädigens; die Forschungsfreiheit und der Wert der Wissenschaft.Die allgemeine Hilfspflicht und die Pflicht zu gemeinwohlförderlichem Handeln sind gewichtige Gründe für eine moralische Pflicht von Patient*innen zur Bereitstellung ihrer klinischen Daten für Forschungs- und Lernaktivitäten. Das Argument der transgenerationalen Gerechtigkeit und das Prinzip des Zurückgebens sind ethisch schwache Gründe für eine solche Pflicht, können jedoch eine motivationale Rolle spielen. Die anderen Gründe sind nicht geeignet, eine Pflicht zu begründen. Das Ergebnis ist in mehrfacher Hinsicht relevant: für Patient*innen, die um die Einwilligung in die Sekundärnutzung ihrer klinischen Daten gebeten werden; für die ethische Diskussion der Frage, ob und inwieweit Abstriche von der klassischen spezifischen Einwilligung unter bestimmten Bedingungen ethisch akzeptabel sind; für die rechtwissenschaftliche Diskussion der Bedingungen für eine juristisch verhältnismäßige Sekundärnutzung klinischer Daten für Forschungs- und Lernaktivitäten. (shrink)

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, (...) this article shows that decontextualized discussions of this putative moral obligation are problematic. (shrink)

BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of (...) a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB. (shrink)

Several years ago, the University of Minnesota hosted a lecture by Alan Milstein, a Philadelphia attorney specializing in clinical trial litigation. Milstein, who does not mince words, insisted on calling research studies “experiments.” “Don't call it a study,” Milstein said. “Don't call it a clinical trial. Call it what it is. It's an experiment.” Milstein's comments made me wonder: when was the last time I heard an ongoing research study described as a “human experiment”? The phrase is now almost always (...) associated with abuses. Asking a prospective subject to sign up for a medical experiment would probably get roughly the same response as asking him or her to sign up for a police interrogation. It wasn't always this way. In the early days of American bioethics, scholars used the word “experimentation” in the same neutral way that they later began to use “research study” and “clinical trial.”. (shrink)

The importance of having ethical oversight in research that is carried out on humans is well established. Research ethics, which is mainly influenced by a biomedical ethical framework, aims to ensure that the well-being and the rights of research participants are upheld and that any potential risks and harms are reduced. However, research is also considered to be a social activity with social effects. Therefore the principles of Catholic Social Teaching as a framework for research ethics may be significant. This (...) paper outlines those principles and demonstrates how these principles may be used for: reflecting ethically on research , judging a research ethics proposal and providing guidelines for action in research. (shrink)

It is generally assumed in research ethics that research participants have an unconditional right to withdraw from research without any detriment or reprisal. This paper analyses this right in the context of biobank research and argues that the traditional shape of the right in clinical research can be modified in biobank research without incurring significant ethical cost. The paper falls in three parts. The first part is a brief explication of the philosophical justification of the right to withdraw. The second (...) part presents a number of extant criticisms of the right. And the third and final part argues that although a right to withdraw is crucial in relation to biobank research, such a right has to be specified in a different way to the similar right in relation to clinical research. (shrink)