Ann C. Bonham

Moving Comparative Effectiveness Research Into Practice: Implementation Science And The Role Of Academic Medicine

The success of the federal investment in comparative effectiveness research will hinge on using the power of science to guide reforms in health care delivery and improve patient-centered outcomes. Translating the results of comparative effectiveness research into practice calls for the rigors of implementation science to ensure the efficient and systematic uptake, dissemination, and endurance of these innovations. Academic medicine can help answer the call by thoroughly integrating its research and training missions with clinical care that is focused on patient-centered outcomes; building multidisciplinary teams that include a wide range of experts such as clinicians, clinical and implementation scientists, systems engineers, behavioral economists, and social scientists; and training future care providers, scientists, and educators to carry innovations forward.

Recommendations concerning the new U.S. National Institutes of Health initiative to balance the sex of cells and animals in preclinical research

The U.S. National Institutes of Health (NIH) announced last May that steps will be taken to address the over‐reliance on male cells and animals in preclinical research. To further address this announcement, in September 2014, scientists with varying perspectives came together at Georgetown University to discuss the following questions. (1) What metrics should the NIH use to assess tangible progress on policy changes designed to address the over‐reliance on male cells and animals in preclinical research? (2) How effective can education be in reducing the over‐reliance on male cells and animals in preclinical research and what educational initiatives sponsored by the NIH would most likely effect change? (3) What criteria should the NIH use to determine rigorously defined exceptions to the future proposal requirement of a balance of male and female cells and animals in preclinical studies? (4) What additional strategies in addition to proposal requirements should NIH use to reduce the overreliance of male cells and animals in preclinical research? The resulting consensus presented herein includes input from researchers not only from diverse disciplines of basic and translational science including biology, cell and molecular biology, biochemistry, physiology, pharmacology, neuroscience, cardiology, endocrinology, nephrology, psychiatry, and obstetrics and gynecology, but also from recognized experts in publishing, industry, advocacy, science policy, clinical medicine, and population health. We offer our recommendations to aid the NIH as it selects, implements, monitors, and optimizes strategies to correct the over‐reliance on male cells and animals in preclinical research.—Sandberg, K., Umans, J. G., Georgetown Consensus Conference Work Group. Recommendations concerning the new U.S. National Institutes of Health initiative to balance the sex of cells and animals in preclinical research. FASEB J. 29, 1646‐1652 (2015). www.fasebj.org

Ethical oversight of research on patient care.

The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOMs vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void.

Issues and Challenges of Non-Tenure-Track Research Faculty: The UC Davis School of Medicine Experience

Nationally, medical schools are appointing growing numbers of research faculty into non-tenure-track positions, paralleling a similar trend in universities. The American Association of University Professors (AAUP) issued a statement expressing concern that the marked growth in non-tenure-track faculty can undermine educational quality, academic freedom, and collegiality. Like other medical schools, the UC Davis School of Medicine has had a rise in non-tenure-track faculty in order to enhance its research mission, in particular in the Salaried Adjunct faculty track (SalAdj). SalAdj faculty have more difficulty in achieving promotion, report inequitable treatment and less quality of life, have less opportunity to participate in governance, and feel second-class and insecure. These issues reflect those described by the AAUP. The authors describe the efforts at UC Davis to investigate and address these issues, implementation of a plan for improvement based on task force recommendations, and the lessons learned. Supporting transfer to faculty tracks in the academic senate, enhancing financial support, ensuring eligibility for internal grants, and equitable space assignments have contributed to an improved career path and more satisfaction among SalAdj faculty. Challenges in addressing these issues include limited availability of tenure-track positions, financial resources, adequate communication regarding change, and compliance with existing faculty search policies.

The U.S. Public׳s Investment in Medical Research: An Evolving Social Contract

Medical researchers and their institutions are operating under extraordinary financial stress. More than a decade after completion of the 5-year doubling of the National Institutes of Health budget, the medical research community must confront a significant loss in National Institutes of Health purchasing power and downward pressures in federal discretionary spending. In part, this trend results from a federal budget stalemate over the growth in entitlement programs, particularly spending on medical care. This article considers the changing nature of the federal investment in medical research and the potential for medical researchers and institutions conducting the full spectrum of research to improve health system performance and health equity. In our view, continued federal investments reflect an evolving social contract for research serving the public good; the term contract is used metaphorically to represent a figurative, implicit agreement between the scientific community and the publics representatives in government. Under this conceptual contract, the American people--who are ultimately the funders of research, research training and infrastructure--expect outcomes that lead to better health, security or other benefits. The evolving contract includes expectations for more accountability, transparency, sharing of results and resources, and better integration of research systems and cultures that used to take pride in boundaries and distinctions. We outline here some of the major movements of organizations realigning to social support, which are increasingly essential to sustain public investment in medical research.