Ethical Issues for Clinical Research Managers
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Ethical Issues for Clinical Research Managers Adll E. Shamoo, PhD, CIP University of Maryland, School of Medicine, Baltimore, Maryland
David B. Resnik, PhD, JD
National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina
Clinical research managers have many scientific, legal, institutional, financial, and ethical responsibilities, such as ensuring the quality and integrity of theresearch process, protecting human subjects, complying with regulations, and using resources effectively. To fulfill these responsibilities, clinical research managers must exhibit leadership and moral integrity. In this
Key Words
Clinical research; Managers; Ethics; Principles
Correspondence Address
Adil E. Shamoo, PhD, CIP, University of Maryland, School of Medicine, 108 North Greene Street, Baltimore. MD 21201 (e-mail: [email protected]).
Disclaimer
Theideas atIdopinions expressed in this arlicledo /lOt represent the views of the NIEHS. the NIH. Dr the US ;::ovemment.
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INTRODUCTION Biomedical research and development (R&D) is a major factor in the US and world economy. In 2004, the pharmaceutical industry spent $38.8 billion on R&D. the biotechnology industry spent approximately $18 billion, and the Nationallnstitutes of Health (NIH) spent approximately $27 billion (1-3). According to Center Watch, there were approximately 41,000 registered clinical trials worldwide in 2004 and 30.000 in the United States (4). The pharmaceutical industry spent approximately $22 billion on clinical trials in 2004 (1). Approximately 20 million people per year participate as subjects in research studies (5). Clinical research takes places in hospitals, academic medical centers, and medical clinics. It helps to create or sustain many different types of white collar jobs related to R&D. The size of a typical clinical trial ranges from 20 subjects in a small phase I study to thousands and at times tens of thousands of subjects in phase 11\ or phase IV studies. Most clinical trials take place at multiple research sites, and many involve collaborations between academia, government. and private industry. Management of clinical research requires a great deal of skill, judgment, knowledge. and competence because clinical research is highly complex, intellectually demanding, and dynamic. Clinical research encompasses such areas as basic research, toxicology, pathology, drug development, and phase I, II. III. and IV clinical trials. Dmg Informnuou.Ionrnnl, Vol. 40. pp. 371-383,2006' 0092-8615/2006
article, we examine theethics of clinical research managers, We explicate ethical concepts and principles that apply to managing clinical research, identify the ethical duties of managers, explore ethical issues that arise in clinical research management at the trenches, describe a process for making ethical decisions, and analyze a hypothetical case scenario.
People who are involved in managing clinical research may have different titles. ranging from clinical investigators. managers, to d
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