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Research misconduct (RM) remains an important problem in health research despite decades of local, national, regional, and international efforts to eliminate it. The ultimate goal of every health research project, irrespective of setting, is to produce trustworthy findings to address local as well as global health issues. To be able to lead or participate meaningfully in international research collaborations, individual and institutional capacities for research integrity (RI) are paramount. Accordingly, this paper concerns itself not only with individuals' research skills but also with institutional and national policies and governance. Such policies and governance provide an ethical scaffold for the production of knowledge and structure incentives. This paper's operational definition of research therefore draws from Institute of Medicine's articulation of health research as an inquiry that aims to produce knowledge about the structure, processes, or effects of personal health services; and from an existing health systems framework. The paper reviews the research regulatory environment and the ethics apparatus in Ghana, and describes a project jointly undertaken by Ghanaian researchers in collaboration with New York University to assess the perceived adequacy of current institutional practices, opportunities, and incentives for promoting RI. [ABSTRACT FROM AUTHOR]

Institutional review boards (IRBs) have become beleaguered by a growth in responsibilities related to research oversight in the past several decades. A number of regulatory bodies have appeared in response to these novel and complex responsibilities, seeking to respond to among other issues, conflicts of interest, new technologies, and the potential misuse of research findings. Here, we examine several examples of these novel regulatory bodies as well as a number of concerns related to them that have been largely unacknowledged. Evidence suggests that there can be disharmony and conflicts between these regulatory bodies and IRBs, a lack of clarity with regard to their roles and responsibilities, as well as shortcomings within these entities that, at times, look a lot like the worries that have long been raised in relation to IRBs. We offer a brief discussion of how some of these concerns might be ameliorated, either through a significant restructuring of the system of research oversight, or perhaps through smaller changes to these regulatory bodies. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

20 years ago, the Report of the Commission on Research Integrity (also known as the Ryan Commission after its chair) was submitted to the Secretary of the Department of Health and Human Services and to House and Senate Committees. As directed in enabling legislation, the Commission had provided recommendations on a new definition of research misconduct, oversight of scientific practices, and development of a regulation to protect whistleblowers. Reflecting the ethos of the time, the Commission recommended that institutions receiving Public Health Service research funding should provide oversight of all but the most egregious misconduct. The suggested definition of research misconduct was organized around misappropriation, interference and misrepresentation, which would have addressed collaborative/authorship disputes and sabotage in scientific laboratories, both of which remain unaddressed in current policy. The Commission also recommended the Whistleblower Bill of Rights and Responsibilities which would have authorized remedies for whistleblowers who experienced retaliation and sanctions against retaliators. Response from the scientific community was highly critical, and none of the Commission's recommendations was accepted. No new body has examined issues within the Commission's charge, there has been no significant Congressional or public pressure to do so, institutions have not been able to sustain standards that would have avoided current concerns about bias and irreproducibility in research, and there is still no entity in science capable of addressing issues assigned to the Commission and other urgent issues. [ABSTRACT FROM AUTHOR]

Whistleblowers remain essential as complainants in allegations of research misconduct. Frequently internal to the research team, they are poorly protected from acts of retribution, which may deter the reporting of misconduct. In order to perform their important role, whistleblowers must be treated fairly. Draft regulations for whistleblower protection were published for public comment almost a decade ago but never issued (). In the face of the growing challenge of research fraud, we suggest vigorous steps, to include: organizational responsibility to certify the accuracy of research including audit, required whistleblower action in the face of imminent or grave harm to subjects, strengthened legal protections against retaliation including prompt enactment of Federal whistleblower protections and consideration of criminalizing the most egregious cases of research misconduct. [ABSTRACT FROM AUTHOR]

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations. [ABSTRACT FROM AUTHOR]

Institutional review boards (IRBs) are one of the bodies charged with prospectively reviewing compassionate use, the hopefully therapeutic use of an unapproved drug in a seriously ill or dying patient who has no other treatment options. However, there are ethical issues in assigning this role to a body whose primary purpose is to review research proposals. The role of IRBs with regard to compassionate use must be examined and potentially revised. [ABSTRACT FROM AUTHOR]