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ARS Home » Plains Area » Houston, Texas » Children's Nutrition Research Center » Research » Publications at this Location » Publication #198608
Title: ETHICAL ISSUES, SAFETY, AND DATA INTEGRITY IN CLINICAL TRIALS

Author
item TREMAIN, WILLIAM - MAYO CLINIC COLLEGE OF ME
item CARLSON, MARILYN - ENTREMEDICA INC ENCINITAS
item ISAAKS, KIM - UNIV. OF NORTH CAROLINA
item Motil, Kathleen
item ROBUCK, PATRICIA - NAT INST OF DIABETES AND
item WURZELMAN, JOHN - GLAXOSMITHKLINE NORTH CAR

Submitted to: Inflammatory Bowel Diseases
Publication Type: Review Article
Publication Acceptance Date: 8/26/2005
Publication Date: 11/5/2005
Citation: Tremain, W.J., Carlson, M.R., Isaaks, K.L., Motil, K.J., Robuck, P.R., Wurzelman, J.I. 2005. Ethical issues, safety, and data integrity in clinical trials. Inflammatory Bowel Diseases. 11(Supplement1):S17-S21.

Interpretive Summary:

Technical Abstract: Published in 1974, the Belmont Report established the ethical principles for conducting clinical research in the United States. The essential concepts are respect for the research participant, beneficence for society at large, and justice (equal access to participation and equal treatment) toward subjects in a research study. These principles are applied through the use of informed consent, risk/benefit assessment, and the impartial selection of study subjects. Strict adherence to these criteria often results in conflicts of interest, which the investigator must anticipate and manage. Investigation must also be thoroughly acquainted with the principles of Good Clinical Practice and regulatory requirements. Recent implementation of the Privacy Rule now requires the investigator to protect not only the safety but the privacy of the research subject. While the regulatory obligations can appear onerous, strict compliance results in clinical research that is safe, scientifically sound, and ethical.