Human Biomonitoring for Environmental Chemicals

by National Research Council, Division on Earth and Life Studies, Board on Environmental Studies and Toxicology, Committee on Human Biomonitoring for Environmental Toxicants

2006 · National Academies Press

Biomonitoring—a method for measuring amounts of toxic chemicals in human tissues—is a valuable tool for studying potentially harmful environmental chemicals. Biomonitoring data have been used to confirm exposures to chemicals and validate public health policies. For example, population biomonitoring data showing high blood lead concentrations resulted in the U.S. Environmental Protection Agency's (EPA's) regulatory reduction of lead in gasoline; biomonitoring data confirmed a resultant drop in blood lead concentrations. Despite recent advances, the science needed to understand the implications of the biomonitoring data for human health is still in its nascent stages. Use of the data also raises communication and ethical challenges. In response to a congressional request, EPA asked the National Research Council to address those challenges in an independent study. Human Biomonitoring for Environmental Chemicals provides a framework for improving the use of biomonitoring data including developing and using biomarkers (measures of exposure), research to improve the interpretation of data, ways to communicate findings to the public, and a review of ethical issues.

Protecting Participants and Facilitating Social and Behavioral Sciences Research

by National Research Council, Division on Behavioral and Social Sciences and Education, Board on Behavioral, Cognitive, and Sensory Sciences, Committee on National Statistics, Panel on Institutional Review Boards, Surveys, and Social Science Research

2003 · National Academies Press

Institutional review boards (IRBs) are the linchpins of the protection systems that govern human participation in research. In recent years, high-profile cases have focused attention on the weaknesses of the procedures for protecting participants in medical research. The issues surrounding participants protection in the social, behavioral, and economic sciences may be less visible to the public eye, but they are no less important in ensuring ethical and responsible research. This report examines three key issues related to human participation in social, behavioral, and economic sciences research: (1) obtaining informed, voluntary consent from prospective participants: (2) guaranteeing the confidentiality of information collected from participants, which is a particularly challenging problem in social sciences research; and (3) using appropriate review procedures for "minimal-risk" research. Protecting Participants and Facilitating Social and Behavioral Sciences Research will be important to policy makers, research administrators, research sponsors, IRB members, and investigators. More generally, it contains important information for all who want to ensure the best protectionâ€"for participants and researchers alikeâ€"in the social, behavioral, and economic sciences.

Governance of Dual Use Research in the Life Sciences

by National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Life Sciences

2018 · National Academies Press

Continuing advances in science and technology offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances have the potential to challenge the oversight systems for responsible conduct of life sciences research with dual use potential â€" research that may have beneficial applications but that also could be misused to cause harm. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, to promote global dialogue and increased common understandings of the essential elements of governance for such research. Hosted by the Croatian Academy of Sciences and Arts in Zagreb, Croatia, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop.

Proposed Revisions to the Common Rule

by National Research Council, Division of Behavioral and Social Sciences and Education, 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

2013 · National Academies Press

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas: 1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions. 2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk. 3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data). 4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data. 5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight.

Cross-Sector Responses to Obesity

by Institute of Medicine, Food and Nutrition Board, Roundtable on Obesity Solutions

2015 · National Academies Press

Obesity affects 17 percent of children and adolescents and almost 36 percent of adults in the United States. Conservative estimates suggest that obesity now accounts for almost 20 percent of national health care spending. Until the obesity epidemic is reversed, obesity will continue to drive rates of chronic diseases such as heart disease, stroke, type 2 diabetes, and certain types of cancer. Cross-Sector Responses to Obesity is a summary of a workshop convened by the Institute of Medicine Roundtable on Obesity Solutions in September 2014 to explore models of cross-sector work that may reduce the prevalence and consequences of obesity. This report identifies case studies of cross-sector initiatives that engage partners from diverse fields, and lessons learned from and barriers to established cross-sector initiatives.

An Assessment of Balance in NASA's Science Programs

by National Research Council, Division on Engineering and Physical Sciences, Space Studies Board, Committee on an Assessment of Balance in NASA's Science Programs

2006 · National Academies Press

When the space exploration initiative was announced, Congress asked the NRC to review the science NASA proposed to carryout under the initiative. It also asked the NRC to assess whether this program would provide balanced scientific research across the established disciplines supported by NASA in addition to supporting the new initiative. In 2005, the NRC released three studies focusing on a portion of that task, but changes at NASA forced the postponement of the last phase. This report presents that last phase with an assessment of the health of the NASA scientific disciplines under the budget requests imposed by the exploration initiative. The report also provides an analysis of whether the science budget appropriately reflects cross-disciplinary scientific priorities.