Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016:35:491-508.

MAIN ETHICAL BREACHES IN MULTICENTER CLINICAL TRIALS REGULATIONS OF TURKEY

P Elif Ekmekci  1
Affiliations

MAIN ETHICAL BREACHES IN MULTICENTER CLINICAL TRIALS REGULATIONS OF TURKEY

P Elif Ekmekci. Med Law. 2016.

Abstract

Turkey has been a growing market for multicenter clinical trials for the last ten years and is considered among the top ten countries in terms of potential study subject populations. The objective of increasing the share of Turkey in multicenter clinical trials is strongly supported. This ambitious goal of Turkey raises the need to have regulations in compliance with other leading countries conducting clinical trials. The latest published Turkish regulations on clinical trials are structured in compliance with the International Conference on Harmonization (ICH) Guidelines and in harmony with the regulations of other leading countries in clinical research, such as the US. There are still flaws in Turkish regulation with the risk of violating human subjects' rights and issues with responsible conduct of research. The aim of this article is to compare Turkish clinical trials regulations with those of the US, to determine if there exists any incompatibility between the countries' regulations and, if so, how to ameliorate these. The main flaws in Turkish clinical trials regulations are identified as follows: lack of definition of the term "human subject; absence of explicit referral to the unacceptability of Conflict of Interest (COI) and taking measures to avoid it; exiguity of emphasis on plurality of the IRB members; nonexistence of a clear expression that this is research; and clinical equipoise, regarding the treatment of the existing clinical problem and lack of integration with international accreditation systems for Institutional Review Boards.

Keywords: Clinical Trials; Institutional Review Board; Multicenter; Regulations; Research Ethics Committee; Turkey.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

References

    1. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 2013 Available at: http://www.wma.net/en/30publications/10policies/b3/ [Accessed 11.8.2016] - PubMed
    1. The Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002 Available at: http://www.doms.ch/ [Accessed 11.8.20161] - PubMed
    1. The International Council for Harmonisation. Harmonized tripartite guideline for good clinical practice E6. 1996 Available at: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/... [Accessed 11.8.2016]
    1. World Health Organization. Handbook for good clinical research practice (GCP) guidance for implementation. 2002 Available at: http://apps.who.int/prequal/info_general/documents/gcp/gcp1.pdf [Accessed 11.8.20161]
    1. Ilbars H, Kavakli K, Akan H, Irmak DK. Clinical Trials Journey of Turkey-Long and Thin Road. J Clin Trials. 2015;5:211–215.

LinkOut - more resources