Alfonso Farnós Iciar, Hernández Gil Arantza, Rodríguez Velasco María
Rev Derecho Genoma Hum. 2013 Jul-Dec(39):173-203.
Research on human genome and its applications open great perspectives to improve human beings' health. However, these advances must never endanger the respect of dignity, freedom and rights of the participants in medical research, assuring prohibition of any way of discrimination because of genetic features. The Independent Research Boards (IRB), responsible for safeguarding rights, safety and well-being of the subjects taking part in the biomedical research, assess independently submitted genetic studies, clinical trials whose primary objective is obtaining genetic information and genetic sub-studies of clinical trials with drugs. Biobanks, as safeguarding means to preserve biological samples in suitable quality conditions, must be assigned to two external committees, a scientific one and an ethics one. External ethics committees of biobanks have to make the ethical assessment of the submissions of samples transfers and associated data, in order to carry out research projects. On the other hand, they have to advise biobanks on the compliance of ethical and legal principles, which, in many committees, has turned into the performance of informed consent forms which are in accordance with current laws.
对人类基因组及其应用的研究为改善人类健康开辟了广阔前景。然而,这些进展绝不能危及对医学研究参与者尊严、自由和权利的尊重,确保禁止因基因特征而进行的任何形式的歧视。负责保障参与生物医学研究的受试者的权利、安全和福祉的独立研究委员会(IRB),独立评估提交的基因研究、主要目标是获取基因信息的临床试验以及药物临床试验的基因子研究。生物样本库作为在合适质量条件下保存生物样本的保障手段,必须交由两个外部委员会,一个科学委员会和一个伦理委员会。生物样本库的外部伦理委员会必须对样本转移及相关数据的提交进行伦理评估,以便开展研究项目。另一方面,它们必须就伦理和法律原则的遵守情况向生物样本库提供建议,在许多委员会中,这已转变为按照现行法律填写知情同意书。