Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact (the fact that the action the rule prescribes is ethically obligatory), whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that the actions (...) prescribed by the rules are ethically obligatory, and consequently we should focus our attention on how to craft the rules so as to promote the legitimate goals of human subjects research. Unfortunately, this cannot be done without evidence about the likely effects of various candidate policies—evidence we currently lack. Therefore, we should take the rules as mere starting points, subject to revision as the evidence comes in. (shrink)

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, (...) talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying (...) legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. (shrink)

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.

As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.