1.

Record Nr.

UNINA9910817238103321

Autore

Tereskerz Patricia M

Titolo

Clinical research and the law / / Patricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, Jr

Pubbl/distr/stampa

Chichester, West Sussex, : John Wiley & Sons, 2012

ISBN

9781299313712

129931371X

9781118272169

1118272161

9781118272152

1118272153

9781118272183

1118272188

Edizione

[1st ed.]

Descrizione fisica

1 online resource (282 p.)

Altri autori (Persone)

EdelmanRobert <1936->

McKinneyRoss

Disciplina

344.04/196

Soggetti

Biology - Research - Law and legislation - United States

Medicine - Research - Law and legislation - United States

Clinical trials - Law and legislation - United States

Human experimentation in medicine - Law and legislation - United States

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Research malpractice & negligence -- Duty of care : understanding the legal differences between medical treatment and medical research -- Establishing standard of care & violation of standard of care -- Informed consent in clinical research -- Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs) -- Legal aspects of financial conflicts of interest in clinical trials -- Disclosure of clinical trial information : legal ramifications of withholding study results -- Clinical trials & insider trading -- Clinical trials and criminal law -- Clinical trial contracts.

Sommario/riassunto

This book provides a comprehensive resource for medical professionals



on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.