Protection of children′s rights and interests in translational medical research
10.13699/j.cnki.1001-6821.2015.22.028
- VernacularTitle:转化医学研究中儿童受试者权益保障
- Author:
Shu-Sen YAO
1
;
Zhen FAN
Author Information
1. 解放军总医院 医务部 器械处
- Keywords:
research involving children;
clinical trial;
assent;
informed consent
- From:
The Chinese Journal of Clinical Pharmacology
2015;31(22):2263-2265
- CountryChina
- Language:Chinese
-
Abstract:
Children who are seven years age or older are generally capa-ble of understanding the procedures and general purpose of research and of indicating their wishes regarding participation.Their assent should be required in addition to parental permission.In general, it is preferable to recruit older children rather than younger ones as participants where more understanding is likely but it must be remembered that younger children may react very differently to both illness and treatment compared with ol-der children.An articulated refusal of a child to participate or continue in research should always be respected.Evidence of significant upset should be accepted as a valid refusal.Consideration should be given to presen-ting data in innovative and nontraditional ways, eg, narrative accounts of projects or cartoons.
