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A culture of accountability
Cardiovascular Pathology 14 (2005) 283 – 284
Editorial
A culture of accountability As biomedical science and clinical health care move forward at an ever more rapid pace, especially in the cardiovascular sciences, community interest has increased significantly and issues around accountability have emerged. The public wants to know how biomedical science is disseminated, to both the professional and lay communities. They want to know how the social issues of diversity, conflict of interest, bioethics, and codes of behavior are developed and utilized and how accountability is addressed. The issue of cost/benefit is also questioned. This interest is in part due to the fact that the community is better educated and informed in matters of science and medicine, and that it is the community that is paying for the new knowledge that is being generated. Their tax dollars support government spending on research and teaching. Through volunteer donations they support not-for-profit advocacy and funding agencies. Through cost of drugs, medical devices, and diagnostic and therapeutic agents they pay indirectly for industry research. The community expects that the biologic and biomedical enterprise must have transparent mechanisms in place that are effective in addressing these important issues. Governments are now being asked to be accountable as well in how they manage the funding of the biologic and biomedical science enterprise. Perhaps more important to the community is how governments manage the health care system in general. Thus, to maintain accountability, an oversight infrastructure needs to be developed. How does oversight become part of any initiative? It needs to be clearly developed with a mandate, a set of operative procedures, and a transparent reporting mechanism. Opportunities are required to provide recommendations to adjust the oversight as conditions change and to have wide consultation throughout all decision-making processes. An important issue that arises when oversight is put into place is how to effectively separate science from politics so that management and oversight discussions result in informed decisions made by careful analysis of all available data and are not responses to political pressures and expediencies. Essential in these processes is transparency and excellent governance. This will occur best when oversight is proactive and not carried out in reaction to an acute event that results in hurried oversight decisions that 1054-8807/05/$ – see front matter D 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.carpath.2005.08.008
do not allow for adequate information gathering, analysis, and consultation. Thus, the adage that bif it ain’t broke, don’t fix itQ needs to be replaced by bfix it before it breaks.Q The goal is not to bclean up the messQ but indeed to prevent the mess from occurring. Oversight is a very powerful tool that needs to be used in a careful, well-informed, and transparent manner, following enforceable rules of governance. The process of oversight can in fact easily become conflicted. For example, if the oversight group formulates planning, regulates performance directives, and exerts fiduciary control while at the same time evaluating outcomes, this will by its very nature open the body to, at the very least, the perception of conflict of interest. Oversight processes have the potential to place restrictions on institutional and individual academic freedom. This must be carefully guarded against! The oversight bodies may be constituted to support a vision and a mission that may be substantially different from that of the institutions they oversee. Influence on the size and scope of educational and research programs may be the result of political agendas rather than educational and societal needs. Outcomes may indeed be set in a way that limits program initiatives and stifles development and growth. Planning processes driven by oversight bodies may respond to short-term goals, which are politically driven, while long-range goals are given much less support. Oversight may rely on internal processes, external processes, or a mixture of the two. One solution is to create a sustainable bculture of accountabilityQ and then develop appropriate internal oversight processes that support and enforce accountability. To achieve meaningful proactive self-regulation, members of the biologic and biomedical science enterprise and of the heath care enterprise must cooperate fully in self-regulation. There are numerous examples of this, but much more must in fact be developed and effectively utilized. For example, scientists are carrying out studies on the bioethics of scientific activity and are investigating major fraud and minor indiscretions. Numerous accreditation bodies have been constituted, most often by the discipline itself, to evaluate hospital performance, educational programs, animal experimentation, and human clinical trials and research. Accountability
284
Editorial / Cardiovascular Pathology 14 (2005) 283 – 284
is becoming an essential component of doing business and this can only benefit biomedical research, health care, and the population at large. The regulatory process can rapidly escalate in size and cost. The self-regulation process must remain cost-effective and not become a resource burden. Realistic goals can result in the achievement of maximum value in assessment, benchmarking, and accountability. Methods of assessment, benchmarks, and categories of accountability should be built into new initiatives. Ongoing initiatives require similar approaches, although it is usually more difficult to introduce oversight into ongoing projects. In this case, communications must be used effectively to explain the oversight, especially why it is being carried out, when a system has been working well without oversight in place. Once a rigorous culture of accountability is achieved, then accountability becomes second nature for members of the organization. If accountability is not achieved through internal self-regulation, then external agencies will impose
accountability. This has the potential to interfere with the vision, mission, and operation of our biomedical enterprise. Thus, the challenge for the biomedical community is to continue to implement self-regulation that will by its transparency and effectiveness be regarded as appropriate and trustworthy. Thus, arms-length oversight bodies need to be able to operate free of coercion to oversee policies and behaviors that have been established and carried out by members of the organization based on ethical and moral principles and utilizing transparent, fair, and judicially sound principles. The cardiovascular medical community needs to adopt a culture of accountability and put in place processes that achieve optimum self-regulation.
Avrum I. Gotlieb Jagdish Butany Editors
Editorial
A culture of accountability As biomedical science and clinical health care move forward at an ever more rapid pace, especially in the cardiovascular sciences, community interest has increased significantly and issues around accountability have emerged. The public wants to know how biomedical science is disseminated, to both the professional and lay communities. They want to know how the social issues of diversity, conflict of interest, bioethics, and codes of behavior are developed and utilized and how accountability is addressed. The issue of cost/benefit is also questioned. This interest is in part due to the fact that the community is better educated and informed in matters of science and medicine, and that it is the community that is paying for the new knowledge that is being generated. Their tax dollars support government spending on research and teaching. Through volunteer donations they support not-for-profit advocacy and funding agencies. Through cost of drugs, medical devices, and diagnostic and therapeutic agents they pay indirectly for industry research. The community expects that the biologic and biomedical enterprise must have transparent mechanisms in place that are effective in addressing these important issues. Governments are now being asked to be accountable as well in how they manage the funding of the biologic and biomedical science enterprise. Perhaps more important to the community is how governments manage the health care system in general. Thus, to maintain accountability, an oversight infrastructure needs to be developed. How does oversight become part of any initiative? It needs to be clearly developed with a mandate, a set of operative procedures, and a transparent reporting mechanism. Opportunities are required to provide recommendations to adjust the oversight as conditions change and to have wide consultation throughout all decision-making processes. An important issue that arises when oversight is put into place is how to effectively separate science from politics so that management and oversight discussions result in informed decisions made by careful analysis of all available data and are not responses to political pressures and expediencies. Essential in these processes is transparency and excellent governance. This will occur best when oversight is proactive and not carried out in reaction to an acute event that results in hurried oversight decisions that 1054-8807/05/$ – see front matter D 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.carpath.2005.08.008
do not allow for adequate information gathering, analysis, and consultation. Thus, the adage that bif it ain’t broke, don’t fix itQ needs to be replaced by bfix it before it breaks.Q The goal is not to bclean up the messQ but indeed to prevent the mess from occurring. Oversight is a very powerful tool that needs to be used in a careful, well-informed, and transparent manner, following enforceable rules of governance. The process of oversight can in fact easily become conflicted. For example, if the oversight group formulates planning, regulates performance directives, and exerts fiduciary control while at the same time evaluating outcomes, this will by its very nature open the body to, at the very least, the perception of conflict of interest. Oversight processes have the potential to place restrictions on institutional and individual academic freedom. This must be carefully guarded against! The oversight bodies may be constituted to support a vision and a mission that may be substantially different from that of the institutions they oversee. Influence on the size and scope of educational and research programs may be the result of political agendas rather than educational and societal needs. Outcomes may indeed be set in a way that limits program initiatives and stifles development and growth. Planning processes driven by oversight bodies may respond to short-term goals, which are politically driven, while long-range goals are given much less support. Oversight may rely on internal processes, external processes, or a mixture of the two. One solution is to create a sustainable bculture of accountabilityQ and then develop appropriate internal oversight processes that support and enforce accountability. To achieve meaningful proactive self-regulation, members of the biologic and biomedical science enterprise and of the heath care enterprise must cooperate fully in self-regulation. There are numerous examples of this, but much more must in fact be developed and effectively utilized. For example, scientists are carrying out studies on the bioethics of scientific activity and are investigating major fraud and minor indiscretions. Numerous accreditation bodies have been constituted, most often by the discipline itself, to evaluate hospital performance, educational programs, animal experimentation, and human clinical trials and research. Accountability
284
Editorial / Cardiovascular Pathology 14 (2005) 283 – 284
is becoming an essential component of doing business and this can only benefit biomedical research, health care, and the population at large. The regulatory process can rapidly escalate in size and cost. The self-regulation process must remain cost-effective and not become a resource burden. Realistic goals can result in the achievement of maximum value in assessment, benchmarking, and accountability. Methods of assessment, benchmarks, and categories of accountability should be built into new initiatives. Ongoing initiatives require similar approaches, although it is usually more difficult to introduce oversight into ongoing projects. In this case, communications must be used effectively to explain the oversight, especially why it is being carried out, when a system has been working well without oversight in place. Once a rigorous culture of accountability is achieved, then accountability becomes second nature for members of the organization. If accountability is not achieved through internal self-regulation, then external agencies will impose
accountability. This has the potential to interfere with the vision, mission, and operation of our biomedical enterprise. Thus, the challenge for the biomedical community is to continue to implement self-regulation that will by its transparency and effectiveness be regarded as appropriate and trustworthy. Thus, arms-length oversight bodies need to be able to operate free of coercion to oversee policies and behaviors that have been established and carried out by members of the organization based on ethical and moral principles and utilizing transparent, fair, and judicially sound principles. The cardiovascular medical community needs to adopt a culture of accountability and put in place processes that achieve optimum self-regulation.
Avrum I. Gotlieb Jagdish Butany Editors