The American Journal of Bioethics, Volume 11, Issue 6, Page 25-27, June 2011.

Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...) of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal. (shrink)

Assent to medical research or treatment may be an intuitively attractive way to address the area between incapacity and capacity that might otherwise be subject to a best interests assessment. Assent has become a widely disseminated concept in law, research, and clinical ethics, but little conceptual work on assent has so far occurred. An exploration of use of assent in treatment and research in children and people with dementia suggests that at least five claims are made on behalf of assent. (...) Since at least some of these may lead to tensions with others, assent requires firmer conceptual underpinning. Whether assent remains primarily a local approach to research in children in the United States, where it appears to fit with legal background conditions, or develops its promise to overturn the dominant, binary, approach to (in)capacity will depend on the strength of future philosophical work to improve the theoretical foundations to assent. (shrink)

When science takes man as its subject, tensions arise between two values basic to Western society: freedom of scientific inquiry and protection of individual inviolability.... At the heart of this conflict lies an age-old question: When may a society, actively or by acquiescence, expose some of its members to harm in order to seek benefits for them, for others, or for society as a whole?

When science takes man as its subject, tensions arise between two values basic to Western society: freedom of scientific inquiry and protection of individual inviolability.... At the heart of this conflict lies an age-old question: When may a society, actively or by acquiescence, expose some of its members to harm in order to seek benefits for them, for others, or for society as a whole?

Definition of the problem: The development and use of drugs aimed at a positive influence on the cognitive decline in patients suffering from Alzheimer's disease raises a number of ethical issues. Arguments: Among other things, these issues are concerned with the significance of these drugs for the patient's subjective well-being and quality of life and with aspects of informed consent to the use of these drugs, particularly in connection with their use in scientific medical research. Conclusion: The value and significance (...) of antidementia drugs depends not only on their effect on cognitive decline, but also on their wider significance for patients' quality of life and their primary carers. The subjective experience of those directly involved deserves more attention in research and practice. (shrink)

This paper explores the use of advance directives in clinical dementia research. The focus is on advance consent to participation of demented patients in non-therapeutic research involving more than minimal risks and/or burdens. First, morally relevant differences between advance directives for treatment and care, and advance directives for dementia research are discussed. Then attention is paid to the philosophical issue of dementia and personal identity, and the implications for the moral authority of research advance directives. Thirdly, a number of practical (...) shortcomings of advance directives for non-therapeutic dementia research are explored and attention is paid to the role of proxies. It is concluded that upon a closer look the initial attractiveness of advance directives for dementia research is lessened, and that it is doubtful whether these instruments can compensate for the lack of subject consent in case of non-therapeutic dementia research involving more than minimal risks and/or burdens for the incompetent demented subject. (shrink)