The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection

Journal of Law, Medicine and Ethics 30 (3):411-419 (2002)
  Copy   BIBTEX

Abstract

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 91,069

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

What’s Wrong with Invisible-Hand Explanations?David L. Hull - 1997 - Philosophy of Science 64 (4):126.
A plea for pragmatism in clinical research ethics.David H. Brendel & Franklin G. Miller - 2008 - American Journal of Bioethics 8 (4):24 – 31.

Analytics

Added to PP
2016-02-04

Downloads
20 (#669,591)

6 months
9 (#158,930)

Historical graph of downloads
How can I increase my downloads?

References found in this work

Add more references