%0 Book %A National Research Council %T Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences %@ 978-0-309-29806-3 %D 2014 %U https://nap.nationalacademies.org/catalog/18614/proposed-revisions-to-the-common-rule-for-the-protection-of-human-subjects-in-the-behavioral-and-social-sciences %> https://nap.nationalacademies.org/catalog/18614/proposed-revisions-to-the-common-rule-for-the-protection-of-human-subjects-in-the-behavioral-and-social-sciences %I The National Academies Press %C Washington, DC %G English %K Behavioral and Social Sciences %P 182 %X 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. %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Controlled Human Inhalation-Exposure Studies at EPA %@ 978-0-309-45249-6 %D 2017 %U https://nap.nationalacademies.org/catalog/24618/controlled-human-inhalation-exposure-studies-at-epa %> https://nap.nationalacademies.org/catalog/24618/controlled-human-inhalation-exposure-studies-at-epa %I The National Academies Press %C Washington, DC %G English %K Environment and Environmental Studies %P 158 %X The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA’s pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA’s clinical research facility. %0 Book %A National Research Council %E Pool, Robert %T Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary %@ 978-0-309-28823-1 %D 2013 %U https://nap.nationalacademies.org/catalog/18383/proposed-revisions-to-the-common-rule-perspectives-of-social-and %> https://nap.nationalacademies.org/catalog/18383/proposed-revisions-to-the-common-rule-perspectives-of-social-and %I The National Academies Press %C Washington, DC %G English %K Behavioral and Social Sciences %K Education %P 110 %X 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. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Pool, Robert %E Rusch, Erin %T Principles and Obstacles for Sharing Data from Environmental Health Research: Workshop Summary %@ 978-0-309-37085-1 %D 2016 %U https://nap.nationalacademies.org/catalog/21703/principles-and-obstacles-for-sharing-data-from-environmental-health-research %> https://nap.nationalacademies.org/catalog/21703/principles-and-obstacles-for-sharing-data-from-environmental-health-research %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 114 %X On March 19, 2014, the National Academies of Sciences, Engineering, and Medicine held a workshop on the topic of the sharing of data from environmental health research. Experts in the field of environmental health agree that there are benefits to sharing research data, but questions remain regarding how to effectively make these data available. The sharing of data derived from human subjects—making them both transparent and accessible to others—raises a host of ethical, scientific, and process questions that are not always present in other areas of science, such as physics, geology, or chemistry. The workshop participants explored key concerns, principles, and obstacles to the responsible sharing of data used in support of environmental health research and policy making while focusing on protecting the privacy of human subjects and addressing the concerns of the research community. Principles and Obstacles for Sharing Data from Environmental Health Research summarizes the presentations and discussions from the workshop. %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Interim Report %@ 978-0-309-47209-8 %D 2018 %U https://nap.nationalacademies.org/catalog/25025/review-of-report-and-approach-to-evaluating-long-term-health-effects-in-army-test-subjects %> https://nap.nationalacademies.org/catalog/25025/review-of-report-and-approach-to-evaluating-long-term-health-effects-in-army-test-subjects %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 26 %X Between 1942 and 1975, the U.S. Army conducted tests with human subjects to study the effects of a variety of agents, including chemical warfare and biological agents. The potential long-term health effects on the test subjects from their exposures have been evaluated periodically, most recently in a report titled Assessment of Potential Long-Term Health Effects on Army Human Test Subjects of Relevant Biological and Chemical Agents, Drugs, Medications and Substances: Literature Review and Analysis (the Report), which was prepared by a contractor to assist the Army with making determinations about providing medical care to former test subjects. In response to a request by the Army, the National Academies of Sciences, Engineering, and Medicine formed a committee that was tasked with examining whether the Report appropriately identified potential long-term health effects from exposure to the test agents and whether an adequate weight-of-evidence approach was used to characterize the strength of the associations between the agents and their potential health effects. The committee was made aware at its first meeting on November 30, 2017, that the Army had already begun to receive applications for medical care and that some determinations may need to be made before the committee's evaluation of the Report was completed. Because of this urgency, the Army developed a process by which applications for medical care will be reviewed, and as a result, the committee was given the additional task of reviewing the Army's Memorandum that describes the approach that will be used by the Army to evaluate agent- and outcome-specific associations. This interim report was prepared to facilitate the Army's deliberations. A review of the Report is presented first, followed by a review of the Memorandum. %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects %@ 978-0-309-47418-4 %D 2018 %U https://nap.nationalacademies.org/catalog/25065/review-of-report-and-approach-to-evaluating-long-term-health-effects-in-army-test-subjects %> https://nap.nationalacademies.org/catalog/25065/review-of-report-and-approach-to-evaluating-long-term-health-effects-in-army-test-subjects %I The National Academies Press %C Washington, DC %G English %K Conflict and Security Issues %K Health and Medicine %P 66 %X Between 1942 and 1975, the U.S. Army conducted tests on human subjects to study the effects of a variety of agents, including chemical warfare agents, biological agents, medications, vaccines, and other substances. The tests investigated the immediate or short-term health effects from acute exposure to understand vulnerabilities to attack. Whether the exposures could have resulted in long-term health consequences to the test subjects has been assessed periodically, and the Army is required to notify subjects of information relating to potential health effects associated with exposure to the test agents. Most recently, a 2016 court injunction directed the Army to provide test subjects with new information about potential long-term health effects associated with their exposures, and to provide medical care if an injury or illness could be attributed to their participation in an Army chemical or biological testing program. In support of the first requirement, the Army contracted a report, Assessment of Potential Long-Term Health Effects on Army Human Test Subjects of Relevant Biological and Chemical Agents, Drugs, Medications and Substances: Literature Review and Analysis (the Report), to determine whether new information published since 2006 should be provided to the veterans. At the request of the Army, the National Academies of Sciences, Engineering, and Medicine formed an ad hoc committee that was tasked with conducting an independent review of the Report. The committee assessed whether the Report appropriately identified potential long-term health effects that could have resulted from test exposures using an adequate weight-of-evidence approach. The general approach for evaluating agent- and outcome-specific associations as outlined in the Army Memorandum was also reviewed. An interim report of its overarching findings and their supporting evidence was prepared in February 2018. This final report provides additional detail about the basis of the committee’s findings and recommendations. No new findings or recommendations have been added to this report. %0 Book %A Institute of Medicine %T Future Uses of the Department of Defense Joint Pathology Center Biorepository %@ 978-0-309-26065-7 %D 2012 %U https://nap.nationalacademies.org/catalog/13443/future-uses-of-the-department-of-defense-joint-pathology-center-biorepository %> https://nap.nationalacademies.org/catalog/13443/future-uses-of-the-department-of-defense-joint-pathology-center-biorepository %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 200 %X Founded during the Civil War as the Army Medical Museum, the Armed Forces Institute of Pathology (AFIP) amassed the world's largest collection of human pathologic specimens and was considered a premier consultation, education, and research facility by the end of the 20th century. Samples from the AFIP were instrumental in helping to solve public health mysteries, such as the sequence of the genome of the 1918 influenza virus that killed more than 40 million people worldwide. In 2005, the federal Base Realignment and Closure Commission recommended that the AFIP be closed, and its biorepository was transferred to the newly created Joint Pathology Center. During the transition, the Department of Defense asked the IOM to provide advice on operating the biorepository, managing its collection, and determining appropriate future use of specimens for consultation, education, and research. Future Uses of the Department of Defense Joint Pathology Center Biorepository, the IOM proposes a series of protocols, standards, safeguards, and guidelines that could help to ensure that this national treasure continues to be available to researchers in the years to come, while protecting the privacy of the people who provided the materials and maintaining the security of their personal information. %0 Book %A Institute of Medicine %T Protecting Data Privacy in Health Services Research %@ 978-0-309-07187-1 %D 2000 %U https://nap.nationalacademies.org/catalog/9952/protecting-data-privacy-in-health-services-research %> https://nap.nationalacademies.org/catalog/9952/protecting-data-privacy-in-health-services-research %I The National Academies Press %C Washington, DC %G English %K Computers and Information Technology %P 208 %X The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected. %0 Book %A Institute of Medicine %E Lenzi, Rebecca N. %E Altevogt, Bruce M. %E Gostin, Lawrence O. %T Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee %@ 978-0-309-29662-5 %D 2014 %U https://nap.nationalacademies.org/catalog/18577/oversight-and-review-of-clinical-gene-transfer-protocols-assessing-the %> https://nap.nationalacademies.org/catalog/18577/oversight-and-review-of-clinical-gene-transfer-protocols-assessing-the %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 134 %X Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes. %0 Book %A Institute of Medicine %E Nass, Sharyl J. %E Patlak, Margie %T Contemporary Issues for Protecting Patients in Cancer Research: Workshop Summary %@ 978-0-309-30666-9 %D 2014 %U https://nap.nationalacademies.org/catalog/18823/contemporary-issues-for-protecting-patients-in-cancer-research-workshop-summary %> https://nap.nationalacademies.org/catalog/18823/contemporary-issues-for-protecting-patients-in-cancer-research-workshop-summary %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 92 %X In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. %0 Book %A National Academy of Sciences %A National Academy of Engineering %A Institute of Medicine %E Sloan, Susan Sauer %E Alper, Joe %T Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop %@ 978-0-309-30895-3 %D 2014 %U https://nap.nationalacademies.org/catalog/18849/culture-matters-international-research-collaboration-in-a-changing-world-summary %> https://nap.nationalacademies.org/catalog/18849/culture-matters-international-research-collaboration-in-a-changing-world-summary %I The National Academies Press %C Washington, DC %G English %K Policy for Science and Technology %P 98 %X In an increasingly interconnected world, science and technology research often transects international boundaries and involves researchers from multiple nations. This paradigm provides both new opportunities and new challenges. As science and technology capabilities grow around the world, United States-based organizations are finding that international collaborations and partnerships provide unique opportunities to enhance research and training. At the same time, enhancing international collaboration requires recognition of differences in culture, legitimate national security needs, and critical needs in education and training. Culture Matters is the summary of a workshop convened by the Government-University-Industry Research Roundtable (GUIRR) in July 2013 to address how culture and cultural perception influence and impact the process by which research agreements are made and negotiated across international boundaries. In this workshop, "Culture Matters: An Approach to International Research Agreements", representatives from around the world and from GUIRR's three constituent sectors - government, university, and industry - gathered to provide input into four specific meeting tracks or domains. The tracks focused on research and agreements affecting or involving people/human subjects; environmental and natural resources; science, engineering, and manufacturing; and agriculture and animal issues. This report examines each of these domains and the role that culture and cultural expectations may have in the forging and implementation of international research agreements. %0 Book %A Institute of Medicine %E Alper, Joe %T Informed Consent and Health Literacy: Workshop Summary %@ 978-0-309-31727-6 %D 2015 %U https://nap.nationalacademies.org/catalog/19019/informed-consent-and-health-literacy-workshop-summary %> https://nap.nationalacademies.org/catalog/19019/informed-consent-and-health-literacy-workshop-summary %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 192 %X Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop. %0 Book %A Institute of Medicine %T Ethical and Scientific Issues in Studying the Safety of Approved Drugs %@ 978-0-309-21813-9 %D 2012 %U https://nap.nationalacademies.org/catalog/13219/ethical-and-scientific-issues-in-studying-the-safety-of-approved-drugs %> https://nap.nationalacademies.org/catalog/13219/ethical-and-scientific-issues-in-studying-the-safety-of-approved-drugs %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 292 %X An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups. %0 Book %A Institute of Medicine %E Gostin, Lawrence O. %E Vanchieri, Cori %E Pope, Andrew %T Ethical Considerations for Research Involving Prisoners %@ 978-0-309-10119-6 %D 2007 %U https://nap.nationalacademies.org/catalog/11692/ethical-considerations-for-research-involving-prisoners %> https://nap.nationalacademies.org/catalog/11692/ethical-considerations-for-research-involving-prisoners %I The National Academies Press %C Washington, DC %G English %K Policy for Science and Technology %P 284 %X In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations&#8212racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis&#8212are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: &#8226 expand the definition of "prisoner"; &#8226 ensure universally and consistently applied standards of protection; &#8226 shift from a category-based to a risk-benefit approach to research review; &#8226 update the ethical framework to include collaborative responsibility; and &#8226 enhance systematic oversight of research involving prisoners. %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century %@ 978-0-309-37948-9 %D 2016 %U https://nap.nationalacademies.org/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory %> https://nap.nationalacademies.org/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory %I The National Academies Press %C Washington, DC %G English %K Policy for Science and Technology %K Education %P 282 %X Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people. %0 Book %A National Research Council %T Scientific and Medical Aspects of Human Reproductive Cloning %@ 978-0-309-07637-1 %D 2002 %U https://nap.nationalacademies.org/catalog/10285/scientific-and-medical-aspects-of-human-reproductive-cloning %> https://nap.nationalacademies.org/catalog/10285/scientific-and-medical-aspects-of-human-reproductive-cloning %I The National Academies Press %C Washington, DC %G English %K Biology and Life Sciences %K Health and Medicine %P 294 %X Human reproductive cloning is an assisted reproductive technology that would be carried out with the goal of creating a newborn genetically identical to another human being. It is currently the subject of much debate around the world, involving a variety of ethical, religious, societal, scientific, and medical issues. Scientific and Medical Aspects of Human Reproductive Cloning considers the scientific and medical sides of this issue, plus ethical issues that pertain to human-subjects research. Based on experience with reproductive cloning in animals, the report concludes that human reproductive cloning would be dangerous for the woman, fetus, and newborn, and is likely to fail. The study panel did not address the issue of whether human reproductive cloning, even if it were found to be medically safe, would be—or would not be—acceptable to individuals or society. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Keusch, Gerald %E McAdam, Keith %E Cuff, Patricia A. %E Mancher, Michelle %E Busta, Emily R. %T Integrating Clinical Research into Epidemic Response: The Ebola Experience %@ 978-0-309-45776-7 %D 2017 %U https://nap.nationalacademies.org/catalog/24739/integrating-clinical-research-into-epidemic-response-the-ebola-experience %> https://nap.nationalacademies.org/catalog/24739/integrating-clinical-research-into-epidemic-response-the-ebola-experience %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 342 %X The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014–2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events. %0 Book %A Institute of Medicine %E Olson, Steve %E Downey, Autumn S. %T Sharing Clinical Research Data: Workshop Summary %@ 978-0-309-26874-5 %D 2013 %U https://nap.nationalacademies.org/catalog/18267/sharing-clinical-research-data-workshop-summary %> https://nap.nationalacademies.org/catalog/18267/sharing-clinical-research-data-workshop-summary %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %K Policy for Science and Technology %P 156 %X 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. %0 Book %A National Research Council %E Finch, Caleb E. %E Vaupel, James W. %E Kinsella, Kevin %T Cells and Surveys: Should Biological Measures Be Included in Social Science Research? %@ 978-0-309-07199-4 %D 2001 %U https://nap.nationalacademies.org/catalog/9995/cells-and-surveys-should-biological-measures-be-included-in-social %> https://nap.nationalacademies.org/catalog/9995/cells-and-surveys-should-biological-measures-be-included-in-social %I The National Academies Press %C Washington, DC %G English %K Behavioral and Social Sciences %P 388 %X What can social science, and demography in particular, reasonably expect to learn from biological information? There is increasing pressure for multipurpose household surveys to collect biological data along with the more familiar interviewer-respondent information. Given that recent technical developments have made it more feasible to collect biological information in non-clinical settings, those who fund, design, and analyze survey data need to think through the rationale and potential consequences. This is a concern that transcends national boundaries. Cells and Surveys addresses issues such as which biologic/genetic data should be collected in order to be most useful to a range of social scientists and whether amassing biological data has unintended side effects. The book also takes a look at the various ethical and legal concerns that such data collection entails. %0 Book %A Institute of Medicine %T Preserving Public Trust: Accreditation and Human Research Participant Protection Programs %@ 978-0-309-07328-8 %D 2001 %U https://nap.nationalacademies.org/catalog/10085/preserving-public-trust-accreditation-and-human-research-participant-protection-programs %> https://nap.nationalacademies.org/catalog/10085/preserving-public-trust-accreditation-and-human-research-participant-protection-programs %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 232 %X Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements. In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.