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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309084881 Category : Medical Languages : en Pages : 313
Book Description
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309084881 Category : Medical Languages : en Pages : 313
Book Description
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309171091 Category : Medical Languages : en Pages : 232
Book Description
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.
Author: Lee O. Jastone Publisher: Nova Publishers ISBN: 9781594547256 Category : Law Languages : en Pages : 120
Book Description
The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations. In 1974, 45 CFR 46 was published following some cases of harm to human subjects, such as those caused by thalidomide drug trials and the United States Public Health Service syphilis study in Tuskeegee, Alabama. The regulations had their roots in numerous international agreements, such as the Nuremberg Code and the Declaration of Helsinki, and domestic policies, such as those put forth by the Department of Health, Education and Welfare (DHEW; now the Department of Health and Human Services, HHS). In 1991, 16 federal agencies adopted 45 CFR 46, Subpart A, which then became known as the Common Rule. Since the Common Rule took effect, events like the death of Jesse Gelsinger in 1999 due to his participation a clinical trial have prompted scrutiny of the Rule and its ability to protect research subjects. In order to help enhance research subject protections, in 2000 HHS removed the Office for Protection from Research Risks (OPRR) from the National Institutes of Health (NIH), and created a new office -- the Office for Human Research Protections (OHRP) -- in an elevated position in HHS. In addition, groups like the National Bioethics Advisory Commission and the National Academies raised the following policy questions: (1) Should the Common Rule be applied to non-federally funded research, social and behavioural research, international clinical trials, and research with human biological materials? (2) Do existing provisions ensure the participation and protection of children, prisoners, minorities, those with diminished capacity, pregnant women, foetuses, neonates, and people in emergency situations? (3) What should be the requirements regarding IRBs' membership, responsibilities, training, and registration? (4) How should conflicts of interest, accreditation, ongoing research, and adverse event reporting be handled? (5) How should basic and research-related medical care's cost, and IRB liability for harm be handled? (6) How should the human subjects protection system be reassessed, adequate resources ensured, and the burdens and benefits of amending regulations appropriately weighed? (7) How does 45 CFR 46 interact with the Food and Drug Administration (FDA) regulations for the protection of human subjects (21 CFR 50 and 56), and the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (45 CFR 146)?
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309071879 Category : Computers Languages : en Pages : 208
Book Description
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.
Author: David B. Resnik Publisher: Springer ISBN: 3319687565 Category : Philosophy Languages : en Pages : 316
Book Description
This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309133386 Category : Medical Languages : en Pages : 445
Book Description
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Author: Robin Levin Penslar Publisher: U.S. Government Printing Office ISBN: Category : Body, Human Languages : en Pages : 516
Book Description
2d edition. Issued in looseleaf form with index dividers and a spinelabel. Prepared under contract by Robin Levin Penslar, at IndianaUniversity, Poynter Center for the Study of Ethics and AmericanInstitutions. Includes sections on: institutional administration (ofthe Institutional Review Board, the IRB); regulations and policies;biomedical and behavioral research, an overview; special classes ofsubjects (such as fetuses, women, children, prisoners, comatosepatients, and volunteers); bibliography; glossary; texts ofinternational human rights documents (Nuremburg, Helsinki, andBelmont); lists of contacts; Federal regulations; and otherinformation.
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher: ISBN: Category : Human experimentation in medicine Languages : en Pages :
Author: Robin Levin Penslar Publisher: U.S. Government Printing Office ISBN: Category : Body, Human Languages : en Pages : 486
Book Description
2d edition. Issued in looseleaf form with index dividers and a spinelabel. Prepared under contract by Robin Levin Penslar, at IndianaUniversity, Poynter Center for the Study of Ethics and AmericanInstitutions. Includes sections on: institutional administration (ofthe Institutional Review Board, the IRB); regulations and policies;biomedical and behavioral research, an overview; special classes ofsubjects (such as fetuses, women, children, prisoners, comatosepatients, and volunteers); bibliography; glossary; texts ofinternational human rights documents (Nuremburg, Helsinki, andBelmont); lists of contacts; Federal regulations; and otherinformation.
Author: Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research Publisher: National Academies Press ISBN: 0309164605 Category : Political Science Languages : en Pages : 284
Book Description
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—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are 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: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.
Author: Institute of Medicine
Author: Institute of Medicine
Author: Institute of Medicine
Author: Lee O. Jastone
Author: Institute of Medicine
Author: David B. Resnik
Author: Institute of Medicine
Author: Robin Levin Penslar
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Author: Robin Levin Penslar
Author: Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research