Clinical Trials

Clinical research in children to be prohibited in Turkey

From 1 April 2005, clinical research in children will be prohibited in Turkey, as a result of an amendment to the Turkish Regulation on Drug Research, published on 12 October 2004¹. The amendment, introduced through the Turkish Criminal Law (TCK), adds text to Article 90 of the regulation (Offences Against the Immunity of the Body), stating that ‘under no condition may children be subjected to scientific experimenting’. Table 1 sets out the full text of the article, including the amendment.

The original Regulation on Drug Research is intended to transpose the EU Clinical Trials Directive (Directive 2001/20/EC) into Turkish law, as part of the Turkish national programme to transpose the Acquis Communautaire of the European Union. It has yet to come into effect.

Table 1. Translation of Article 90 of the Turkish Regulation on Drug Research, including a recent amendment to prohibit research in children, October 2004

Article 90 - Offences Against the Immunity of the Body

 

(1) A person conducting scientific research on a human being will be penalised by incarceration for a period ranging from one to three years.

 

(2) In order to be exempted from criminal liability in cases of scientific experimenting under consent of the subject, the following conditions must be met:

• (a) the requisite permissions must be obtained from the authorised boards and agencies;
• (b) in vitro or animal studies must have been previously conducted;
• (c) scientific data collated as a result of these experiments must necessitate performance of clinical studies;
• (d) the experiment must not cause any foreseeable harmful or residual effect on human health;
• (e) the experiment must not cause the subjects pain or be inconsistent with human dignity;
• (f) the purpose of the experiment must outweigh the burden assumed by the subjects and the risk to which he/she is subjected; and
• (g) written consent must be obtained from subjects based on sufficient information on the nature and results of the experiment, and performance of the experiment must not be for treatment of the subject.

 

(3) Under no condition may children be subjected to scientific experimenting.

 

(4) A person conducting an experiment on a patient without his/her consent will be punished with incarceration for up to one year. However, an experiment for treatment based on scientific methods is permitted under the consent of the patient, provided that there is no known medical intervention available. The consent of the patient, upon having received sufficient information on the nature and results of the experiment, should be in written form, and the therapy should be conducted by a specialist physician in a hospital environment.

 

(5) Where an offence cited in paragraph 1 results in injury to or death of the patient, provisions on causing premeditated injury or death become applicable.

 

(6) Where the offences cited in this article are perpetrated within the frame of the activities of a legal person, security measures pertaining to such persons will be in order.

 

MELEK BOSTANCI ÖNOL

References

1. Turkish Official Gazette, 12 October 2004, Issue 25611