Rebalancing commercial and public interests in prioritizing biomedical, social and environmental aspects of health through defining and managing conflicts of interest.

Biomedical research is intended to benefit human beings and their health. Toward that end, scientific norms involve examining and criticizing the work of others and prioritizing questions that should be studied. Yet, in areas of health research where industry is active, it has often utilized well-honed strategies aimed at evading scientific standards and at dominating the research agenda, largely through its financial support and lack of transparency of its research practices. These tactics have now been documented to uniformly support industry products. Commercial entities are aided in this pursuit by public policy that has significantly embedded commercial interests and agendas into federal research funding and infrastructure. Therefore, to understand the resulting landscape and its effect on priority in health research agendas, traditional definitions of individual conflicts of interest (COI) and the less well developed institutional COI must be supplemented by a new construct of structural COI, largely operating as intellectual monopolies, in support of industry. These arrangements often result in financial and reputational resources that assure dominance of commercial priorities in research agendas, crowding out any other interests and ignoring justified returns to the public from investment of its tax dollars. There is no sustained attention to mechanisms by which public interests can be heard, normative issues raised, and then balanced with commercial interests which are transparently reported. Focus on research supporting approval of commercial products ignores social and environmental determinants of health. Commercial bias can invalidate regulatory research protections through obscuring valid risk-benefit ratios considered by IRBs.

Correctable Myths About Research Misconduct in the Biomedical Sciences.

A recent National Academy report on research integrity noted that policies are not evidence-based, with no formal entity responsible to attend to this deficit. Here we describe four areas of research misconduct (RM) regulations governing Public Health Service funded research that are empirically and/or ethically questionable. Policies for human subject protection, RM and conflict of interest are not harmonized, making it extremely difficult to deal with complex cases which often contain allegations in all of these areas. Second, detection of RM has depended entirely on whistleblowers in spite of evidence of significant under-reporting. Third, the scientific record is far from cleansed of the effects of falsified/fabricated work through current mechanisms of retraction. Finally, lack of fairness in the regulations may reflect lack of a Belmont Report-like document to guide ethics of RM policy. These issues are likely common in other countries. RM regulations should be harmonized with related regulations and their effectiveness tracked, open access to data for independent replication and improved statistical tests are an essential supplement to whistleblowers, correction of the scientific record will require a major effort, and further ethical analysis and guidance are as important as is empirical study for the improvement of RM regulations. Further consideration should be given to assigning current regulations for human subjects protection, RM and conflict of interest to a single authority and to the further development of a Belmont-like report of essential principles, for RM.

Ethics of patient education and how do we make it everyone's ethics.

Patient education has long been central to nursing's philosophy of practice, and, because of this commitment, nurses in all practice settings have been deeply distressed with the careless and generally incomplete manner in which it is practiced in the health care system. This article examines the ethical underpinning of this distress and of this neglect in patient education and what actions nurses can take to correct this situation.

Responsibility for control; ethics of patient preparation for self-management of chronic disease.

Patient self-management (SM) of chronic disease is an evolving movement, with some forms documented as yielding important outcomes. Potential benefits from proper preparation and maintenance of patient SM skills include quality care tailored to the patient's preferences and life goals, and increase in skills in problem solving, confidence and success, generalizable to other parts of the patient's life. Four central ethical issues can be identified. 1) insufficient patient/family access to preparation that will optimize their competence to SM without harm to themselves, 2) lack of acknowledgement that an ethos of patient empowerment can mask transfer of responsibility beyond patient/family competency to handle that responsibility, 3) prevailing assumptions that preparation for SM cannot result in harm and that its main purpose is to deliver physician instructions, and 4) lack of standards for patient selection, which has the potential to exclude individuals who could benefit from learning to SM. Technology assessment offers one framework through which to examine available data about efficacy of patient SM and to answer the central question of what conditions must be put in place to optimize the benefits of SM while assuring that potential harms are controlled.

Off with their heads: the need to criminalize some forms of scientific misconduct.

Improvement in policy for the management of scientific misconduct has been slow. While assurance of due process at the ORI level is now in place, similar protections at the institutional level and institutional responsibility for further oversight and a workplace where the responsible conduct of research can be practiced have not yet been addressed. In contrast, policy regarding human subject protection has evolved rapidly to reflect firmer norms, with decisive priority given to subject protection over scientific or social needs. Perhaps because scientific misconduct policy has the potential to harm the careers of individual scientists and harms to individual subjects are thought to be indirect, the scientific community has been successful in blocking every move toward testing more rigorous regulation. The mantras that scientists can discipline their own, and the price of competitive science is some level of scientific misconduct are not persuasive. The standards by which science is judged should not be an exception to those governing others who deal with the public's money and have a duty to the public interest.

The ethics of self-management preparation for chronic illness.

While nearly all patients with a chronic disease must self-manage their condition to some extent, preparation for these responsibilities is infrequently assured in the USA. The result can be significant harm and the undermining of a patient's ability to take advantage of life opportunities and be productive. Agreeing to care for a patient involves a moral responsibility to see that she or he receives the essential elements of care, including the ability to manage the disease on a daily basis. The research base for the efficacy of self-management and for how patients can be prepared to assume it is sufficiently strong that health care professionals must advocate for its inclusion in the routine evidence-based care of individuals with chronic disease. Because patient education is central to nursing's philosophy and practice, the profession should play a major role in removing structural barriers to self-management preparation and assuring its provision to a high standard of quality.

Evaluating the oversight of scientific misconduct.

The Office of Research Integrity has proposed a new definition of scientific misconduct that will substantively reduce the federal government's role of oversight of scientific practices. The standard is being changed despite the lack of evidence about the effects of current policies or understanding of why research misconduct occurs, how it can be detected and prevented, and the nature and effectiveness of sanctions. Given this lack of knowledge and the perception that the integrity of science is falling, we believe it would be unwise for the academic and scientific community to adopt this new standard.