Ethical conduct of clinical research involving children / Marilyn J. Field and Richard E. Behrman, editors ; Committee on Clinical Research Involving Children, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

Format:

Book

Contributor:

Field, Marilyn J. (Marilyn Jane)

Behrman, Richard E., 1931-

Institute of Medicine (U.S.). Committee on Clinical Research Involving Children.

Language:

English

Subjects (All):

Pediatrics--Research--Moral and ethical aspects.

Pediatrics.

Human experimentation in medicine.

Physical Description:

1 online resource (445 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academies Press, c2004.

Language Note:

English

Summary:

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.

Contents:

The necessity and challenges of clinical research involving children

Regulatory framework for protecting child participants in research

Defining, interpreting, and applying concepts of risk and benefit in clinical research involving children

Understanding and agreeing to children's participation in clinical research

Payments related to children's participation in clinical research

Regulatory compliance, accreditation, and quality improvement

Responsible research involving children.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

9786610208715

9780309133388

0309133386

9781280208713

1280208716

9780309531252

030953125X

OCLC:

923267203