Ethical Conduct of Clinical Research Involving Children
Title | Ethical Conduct of Clinical Research Involving Children PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Total Pages | 445 |
Release | 2004-07-09 |
Genre | Medical |
ISBN | 0309133386 |
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.
Research Involving Children
Title | Research Involving Children PDF eBook |
Author | United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Publisher | |
Total Pages | 184 |
Release | 1977 |
Genre | Children |
ISBN |
Doing Research with Children and Young People
Title | Doing Research with Children and Young People PDF eBook |
Author | Sandy Fraser |
Publisher | SAGE |
Total Pages | 308 |
Release | 2004 |
Genre | Medical |
ISBN | 9780761943815 |
Doing Research with Children and Young People introduces researchers to the key considerations involved in working with children and young people.
Children in Medical Research
Title | Children in Medical Research PDF eBook |
Author | Lainie Friedman Ross |
Publisher | OUP Oxford |
Total Pages | 300 |
Release | 2006-02-09 |
Genre | Philosophy |
ISBN | 0191534218 |
Lainie Ross presents a rigorous critical investigation of the development of policy governing the involvement of children in medical research. She examines the shift in focus from protection of medical research subjects, enshrined in post-World War II legislation, to the current era in which access is assuming greater precedence. Infamous studies such as Willowbrook (where mentally retarded children were infected with hepatitis) are evidence that before the policy shift protection was not always adequate, even for the most vulnerable groups. Additional safeguards for children were first implemented in many countries in the 1970s and 1980s; more recent policies and guidelines are trying to promote greater participation. Ross considers whether the safeguards work, whether they are fair, and how they apply in actual research practice. She goes on to offer specific recommendations to modify current policies and guidelines. Ross examines the regulatory structures (e.g. federal regulations and institutional review boards), the ad hoc policies (e.g. payment in pediatric research and the role of schools as research venues), the actual practices of researchers (e.g. the race/ethnicity of enrolled research subjects or the decision to enroll newborns) as well as the decision-making process (both parental permission and the child's assent), in order to provide a broad critique. Some of her recommendations will break down current barriers to the enrolment of children (e.g. permitting the payment of child research subjects; allowing healthy children to be exposed to research that entails more than minimal risk without requiring recourse to 407 panels); whereas other recommendations may create new restrictions (e.g., the need for greater protection for research performed in schools; restrictions on what research should be done in the newborn nursery). The goal is to ensure that medical research is done in a way that promotes the health of current and future children without threatening, to use the words of Hans Jonas, 'the erosion of those moral values whose loss . . . would make its most dazzling triumphs not worth having'.
Research Involving Children
Title | Research Involving Children PDF eBook |
Author | United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Publisher | |
Total Pages | 630 |
Release | 1977 |
Genre | Children |
ISBN |
Research Involving Children
Title | Research Involving Children PDF eBook |
Author | United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Publisher | |
Total Pages | 182 |
Release | 1977 |
Genre | Children |
ISBN |
Appendix to Report and Recommendations, Research Involving Children
Title | Appendix to Report and Recommendations, Research Involving Children PDF eBook |
Author | United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Publisher | |
Total Pages | 448 |
Release | 1977 |
Genre | Children |
ISBN |