Introduction: Ethical Obligations for global clinical trials must meet a standard, such as those defined in the Declaration of Helsinki, or as outlined in the International Conference on Harmonization (ICH) E6 Good Clinical Practices (GCP). Objective: The purpose of this study was to determine the baseline knowledge of GCP’s and procedures for protecting the welfare, rights and safety of human subjects by an investigative team conducting a global clinical trial. Design: The design of this study was a test – retest knowledge assessment. The test was designed as a series of questions and answers incorporated into a keypad interactive response system. Population, Sample, Setting, Years: The population consisted of a convenience sample of Investigators (MDs), Study Coordinators (RNs) and Clinical Research Associates (CRA’s) (n = 250). The setting was a classroom style-training course offered in October 2001 (n = 102), with follow-up in April 2002 (n = 148). Intervention and Outcome Variables: Clinical Quality Assurance RNs offered various interventions between the two test periods. These consisted of GCP training sessions, audits, and included FDA Inspections. The Outcome Variables, knowledge of ethical principles pertaining to clinical research were measured in the second test session. Methods: Descriptive and Inferential Statistics were used. Findings: There was an increase in knowledge in the area of welfare, and safety of human subjects. However, there was a decline in correct answers concerning subject rights. Conclusions: The responses indicate a general lack of knowledge concerning GCPs and ethical research obligations. Investigative teams should be offered GCP training prior to conducting human research. Implications: Nurses in this sample, currently working in clinical research did not have knowledge of GCPs and basic ethical research obligations. There is a need for this basic training which, could be added to the curriculum of nursing schools.
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Back to 14th International Nursing Research Congress
Sigma Theta Tau International
10-12 July 2003