1.

Record Nr.

UNINA9910795111703321

Autore

Babb Sarah L.

Titolo

Regulating human research : IRBs from peer review to compliance bureaucracy / / Sarah Babb

Pubbl/distr/stampa

Stanford, California : , : Stanford University Press, , 2020

©2020

ISBN

1-5036-1123-X

Descrizione fisica

1 online resource (185 pages)

Classificazione

AK 24400

Disciplina

174.28

Soggetti

Institutional review boards (Medicine) - United States

Human experimentation in medicine - Law and legislation - United States

Medical ethics committees - United States

Bureaucracy - United States

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Frontmatter -- Contents -- Acknowledgments -- Introduction -- 1. The federal crackdown and the twilight of approximate compliance -- 2. Leaving it to the professionals -- 3. Organizing for efficiency -- 4. Ethics review, inc. -- 5. The common rule and social research -- 6. Varieties of compliance -- Conclusion -- Appendix: research informants -- Notes -- Bibliography -- Index

Sommario/riassunto

Institutional review boards (IRBs) are panels charged with protecting the rights of humans who participate in research studies ranging from biomedicine to social science. Regulating Human Research provides a fresh look at these influential and sometimes controversial boards, tracing their historic transformation from academic committees to compliance bureaucracies: non-governmental offices where specialized staff define and apply federal regulations. In opening the black box of contemporary IRB decision-making, author Sarah Babb argues that compliance bureaucracy is an adaptive response to the dynamics and dysfunctions of American governance. Yet this solution has had unforeseen consequences, including the rise of a profitable ethics review industry.