A Survey of United Kingdom Independent Ethics Committees (IECS): Acceptance of and Readiness to Implement International Conference on Harmonization Good Clinical Practice

Abstract

The International Conference for Harmonization (ICH) Good Clinical Practice (GCP) draft guideline was formally adopted by the European Council in 1997 and is expected to become a legal requirement in the United Kingdom by 2003. The guideline includes a chapter outlining independent ethics committee (IECs) operations and ethical principles. This article presents the key results of an independent survey, conducted between 1998 and 1999, of the United Kingdom's 245 IECs to assess their acceptance of the ICH GCP guideline and their readiness to implement it. A total of 180 IECs responded to the survey with between 49% and 67% of respondents completing each question. Approximately half of all respondents agreed with 13 statements outlining the ethical principles of ICH GCP. However, only between 18% and 52% stated that specified ICH GCP procedural requirements were already reflected in their written procedures, indicating that although some IECs appear ready to implement certain aspects of the guideline, many are not yet prepared for its full introduction into domestic primary legislation.

Keywords

ICH GCP Good Clinical Practice Independent ethics committee Regulatory guidelines Standard operating procedure

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References

ICH Harmonised Tripartite Guideline for Good Clinical Practice. Richmond, Surrey, United Kingdom: Brookwood Medical Publications; 1996.

ICH Topic E6: Guideline to Good Clinical Practice: Note for Guidance on Good Clinical Practice. London, UK: The European Agency for the Evaluation of Medicinal Products (EMEA); 1997.

Foster

Manual for Research Ethics Committees. London, UK: King's College University Press; 1997: V2.3.1-V2.3.3.

Foster

Manual for Research Ethics Committees. London, UK: King's College University Press; 1997: V 2.1.

Foster

Manual for Research Ethics Committees. London, UK: King's College University Press; 1997: V 4.1-V4.4.1.

Foster

Overview of the mandatory requirements for ethics committee approval of multicentre studies in the UK. Presented at: All You Need to Know About MRECs; Brookwood International Academy of Healthcare Research; November 4, 1997, Surrey, UK.

Sumner

MREC Training on Research Ethics Committees. Presented at: Ethics Forum Meeting; Association of Clinical Research for the Pharmaceutical Industry; February 10, 2000, London, UK.