糖尿病肾病中药临床试验伦理调查与思考

Ethical Investigations and Considerations of Clinical Trials of TCM in Diabetic Nephropathy Management

随着糖尿病肾病的发病率日益升高,目前有关糖尿病肾病的中药临床试验越来越多。因此在遵循医学伦理原则前提下,如何充分了解糖尿病肾病临床研究伦理审查的专业需求,保障受试者权益,是糖尿病肾病中药临床研究亟需解决的问题。本课题分别对糖尿病肾病领域专家和患者进行有关中药临床试验的伦理研究调查,并对结果进行了讨论与思考,在此基础上制定了更为规范完善的糖尿病肾病中药临床试验知情同意书模板。

With the high incidence of diabetic nephropathy,the clinical trials of traditional Chinese medicine（TCM） in diabetic nephropathy area play an important role in the development of this subject.Therefore,following the principles of medical ethics,issues of fully understanding professional requirements of ethics review for clinical research of diabetic nephropathy and the protection of patients＇ rights are questions which should be solved.This article was based on the investigations on ethical needs of experts and patients in diabetic nephropathy area of TCM clinical trials.Discussions and considerations were made on results.A the more perfect and regulated medical informed consent formwork for diabetic nephropathy of TCM clinical trials was made based on these consultations.