In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
The past half-century has witnessed a dramatic increase in the scale and complexity of scientific research. The growing scale of science has been accompanied by a shift toward collaborative research, referred to as "team science." Scientific research is increasingly conducted by small teams and larger groups rather than individual investigators, but the challenges of collaboration can slow these teams' progress in achieving their scientific goals. How does a team-based approach work, and how can universities and research institutions support teams? Enhancing the Effectiveness of Team Science synthesizes and integrates the available research to provide guidance on assembling the science team; leadership, education and professional development for science teams and groups. It also examines institutional and organizational structures and policies to support science teams and identifies areas where further research is needed to help science teams and groups achieve their scientific and translational goals. This report offers major public policy recommendations for science research agencies and policymakers, as well as recommendations for individual scientists, disciplinary associations, and research universities. Enhancing the Effectiveness of Team Science will be of interest to university research administrators, team science leaders, science faculty, and graduate and postdoctoral students.
In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
The identification of gaps from systematic reviews is essential to the practice of ''evidence-based research.'' Health care research should begin and end with a systematic review. A comprehensive and explicit consideration of the existing evidence is necessary for the identification and development of an unanswered and answerable question, for the design of a study most likely to answer that question, and for the interpretation of the results of the study. In a systematic review, the consideration of existing evidence often highlights important areas where deficiencies in information limit our ability to make decisions. We define a research gap as a topic or area for which missing or inadequate information limits the ability of reviewers to reach a conclusion for a given question. A research gap may be further developed, such as through stakeholder engagement in prioritization, into research needs. Research needs are those areas where the gaps in the evidence limit decision making by patients, clinicians, and policy makers. A research gap may not be a research need if filling the gap would not be of use to stakeholders that make decisions in health care. The clear and explicit identification of research gaps is a necessary step in developing a research agenda. Evidence reports produced by Evidence-based Practice Centers (EPCs) have always included a future research section. However, in contrast to the explicit and transparent steps taken in the completion of a systematic review, there has not been a systematic process for the identification of research gaps. We developed a framework to systematically identify research gaps from systematic reviews. This framework facilitates the classification of where the current evidence falls short and why the evidence falls short. The framework included two elements: (1) the characterization the gaps and (2) the identification and classification of the reason(s) for the research gap. The PICOS structure (Population, Intervention, Comparison, Outcome and Setting) was used in this framework to describe questions or parts of questions inadequately addressed by the evidence synthesized in the systematic review. The issue of timing, sometimes included as PICOTS, was considered separately for Intervention, Comparison, and Outcome. The PICOS elements were the only sort of framework we had identified in an audit of existing methods for the identification of gaps used by EPCs and other related organizations (i.e., health technology assessment organizations). We chose to use this structure as it is one familiar to EPCs, and others, in developing questions. It is not only important to identify research gaps but also to determine how the evidence falls short, in order to maximally inform researchers, policy makers, and funders on the types of questions that need to be addressed and the types of studies needed to address these questions. Thus, the second element of the framework was the classification of the reasons for the existence of a research gap. For each research gap, the reason(s) that most preclude conclusions from being made in the systematic review is chosen by the review team completing the framework. To leverage work already being completed by review teams, we mapped the reasons for research gaps to concepts from commonly used evidence grading systems. Our objective in this project was to complete two types of further evaluation: (1) application of the framework across a larger sample of existing systematic reviews in different topic areas, and (2) implementation of the framework by EPCs. These two objectives were used to evaluate the framework and instructions for usability and to evaluate the application of the framework by others, outside of our EPC, including as part of the process of completing an EPC report. Our overall goal was to produce a revised framework with guidance that could be used by EPCs to explicitly identify research gaps from systematic reviews.
The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.
In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
