Vaccine Safety Research, Data Access, and Public Trust

by Institute of Medicine, Board on Health Promotion and Disease Prevention, Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program

2005 · National Academies Press

The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database. In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

Sharing Clinical Research Data

by Forum on Drug Discovery, Development, and Translation, Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, Roundtable on Translating Genomic-Based Research on Health, Board on Health Sciences Policy, Board on Health Care Services, Institute of Medicine

2013 · National Academies Press

Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences

by National Research Council, Division of Behavioral and Social Sciences and Education, Committee on Population, Committee on National Statistics, Board on Behavioral, Cognitive, and Sensory Sciences, Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences

2014 · National Academies Press

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences examines how to update human subjects protections regulations so that they effectively respond to current research contexts and methods. With a specific focus on social and behavioral sciences, this consensus report aims to address the dramatic alterations in the research landscapes that institutional review boards (IRBs) have come to inhabit during the past 40 years. The report aims to balance respect for the individual persons whose consent to participate makes research possible and respect for the social benefits that productive research communities make possible. The ethics of human subjects research has captured scientific and regulatory attention for half a century. To keep abreast of the universe of changes that factor into the ethical conduct of research today, the Department of Health and Human Services published an Advance Notice of Proposed Rulemaking (ANPRM) in July 2011. Recognizing that widespread technological and societal transformations have occurred in the contexts for and conduct of human research since the passage of the National Research Act of 1974, the ANPRM revisits the regulations mandated by the Act in a correspondingly comprehensive manner. Its proposals aim to modernize the Common Rule and to improve the efficiency of the work conducted under its auspices. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences identifies issues raised in the ANPRM that are critical and feasible for the federal government to address for the protection of participants and for the advancement of the social and behavioral sciences. For each identified issue, this report provides guidance for IRBs on techniques to address it, with specific examples and best practice models to illustrate how the techniques would be applied to different behavioral and social sciences research procedures.

Advancing Strategic Science

by National Research Council, Division on Earth and Life Studies, Board on Earth Sciences and Resources, Mapping Science Committee, Committee on Spatial Data Enabling USGS Strategic Science in the 21st Century

2012 · National Academies Press

Science is increasingly driven by data, and spatial data underpin the science directions laid out in the 2007 U.S. Geological Survey (USGS) Science Strategy. A robust framework of spatial data, metadata, tools, and a user community that is interactively connected to use spatial data in an efficient and flexible way-known as a spatial data infrastructure (SDI)-must be available for scientists and managers to find, use, and share spatial data both within and beyond the USGS. Over the last decade, the USGS has conducted breakthrough research that has overcome some of the challenges associated with implementing a large SDI. Advancing Strategic Science: A Spatial Data Infrastructure Roadmap for the U.S. Geological Survey is intended to ground those efforts by providing a practical roadmap to full implementation of an SDI to enable the USGS to conduct strategic science.