Strode A, Singh P P
S Afr Med J. 2014 Nov;104(11):759-61. doi: 10.7196/samj.8596.
The issue of what type of compensation a research participant would be entitled to in a clinical trial when they have signed an informed consent document excluding certain forms of compensation recently came before our courts in the matter of Venter v Roche Products (Pty) Limited and Others (Case No. 12285/08). In this case, the court had to consider whether the plaintiff, Mr Venter, was entitled to claim for non-medical costs such as pain and suffering, loss of income and general damages, even though the informed-consent document expressly excluded such claims.
To set out the facts, issues and judgment in the case, concluding with a discussion of the implications of the judgment for research ethics committees (RECs).
Critical review of a judgment of the Western Cape High Court.
The court concluded that Mr Venter's application for damages should be dismissed because he had voluntarily agreed to the limited compensation as set out in the informed consent form that had been approved by both the local RECs and the Medicines Control Council.
The Venter case has shown that delictual claims for research-related injuries will not be successful if plaintiffs have agreed to limit their own rights through signing an informed-consent form that limits compensation. This places an important obligation on RECs to ensure that they carefully review compensation clauses in informed-consent documents and that these are made clear to potential research participants.
在“文特尔诉罗氏产品（私人）有限公司及其他方”（案件编号：12285/08）一案中，近期我们的法院面临这样一个问题：当研究参与者签署了一份排除某些形式补偿的知情同意书后，他们在临床试验中有权获得何种类型的补偿。在该案件中，法院必须考虑原告文特尔先生是否有权主张诸如疼痛与痛苦、收入损失及一般损害赔偿等非医疗费用，即便知情同意书明确排除了此类索赔。
阐述该案件的事实、问题及判决结果，并以讨论该判决对研究伦理委员会（RECs）的影响作为结尾。
对西开普高等法院的一项判决进行批判性审查。
法院得出结论，文特尔先生的损害赔偿申请应被驳回，因为他已自愿同意接受当地研究伦理委员会和药品控制委员会批准的知情同意书中规定的有限补偿。
文特尔案表明，如果原告通过签署限制补偿的知情同意书而自愿同意限制自己的权利，那么因研究相关伤害提出的侵权索赔将不会成功。这给研究伦理委员会带来了一项重要义务，即确保他们仔细审查知情同意书中的补偿条款，并向潜在的研究参与者明确说明这些条款。
