2016 Fiscal Year Final Research Report
A study on informed assent of children participate in medical research
| Project/Area Number |
25500012
|
|---|
| Research Category |
Grant-in-Aid for Scientific Research (C)
|
| Allocation Type | Multi-year Fund |
|---|
| Section | 一般 |
|---|
| Research Field |
Bioethics
|
|---|
| Research Institution | Tokoha University (2015-2016)
Teikyo Gakuen Junior College (2013-2014) |
|---|
Principal Investigator |
|
|---|
| Project Period (FY) |
2013-04-01 – 2017-03-31
|
| Keywords | インフォームド・アセント / 子ども / 医学研究 / 研究倫理 / 面接調査 |
|---|
| Outline of Final Research Achievements |
When a potential research subject is able to give assent to decisions about participation in research, the researcher must seek that assent in addition to the consent of the legally authorized representative. These were declared in Japanese Ethical Guidelines for Medical and Health Research in 2015.
We researched on informed assent of children by (1) literature research of official guidelines, (2) a nationwide survey touward peoples (age; 20-69) in Japan, (3) a focus group study toward experts, and (4) an empirical study toward children (age; 4-9). In the empirical study, we targeted healthy children and medical research with no invasion or intervention. At the first interview, a child received clear explanations about the second interview from a researcher using scenarios and figures. 5-year children signed with marks or first name and 6-year or over children; in elementary school children, signed with full name. It was suggested a 5-year child might have capacity for assent.
|
| Free Research Field |
生命倫理
|
