,

 (1)

, ,
,

(, ,
)- .
--

 (2)

, ,

.

 (1)
1)

2)
.

 (2)

1.
2.
3. , ,
( )
4.
5.
6.
7. / /
8.
9.
10.

 (3)

11. /
12. , ,
13. ,
14. URLs
15. (IP)
16. - , ,
17. ,
18. , , .

(privacy)

.
Dunn and Chadwick, 2004

(confidentiality)

.
Dunn and Chadwick, 2004

."
- ( )

 (1)
(CIOMS)-

.
,

.
18

 ,
(1)
1.

2.

3.



,

.

( , CIOMS , ICH-GCP,

, - )

, ,

(
)
- .

C. Torres.
.
, . 2014.9.22

European textbook on ethics in research. (2010) DirectorateGeneral for Research Science, Economy and Society, pp. 75-96


, PhD

?
?

70%


Defect in Informed Consent Form

 ?



.
ICH GCP.1.28

What is informed consent?

A process by which a subject voluntarily confirms his or her

own willingness to participate in particular trial, after
having been informed of all aspect of the trial that are
relevant to the subjects decision to participate

ICH GCP.1.28

 XX



.
,
.
.

, ,
,



,
.


?
1:
: ,
, , ?
2:

3:

4:

 (1)

, ,

,
/ , ,
,
,

, ,
, .
, , ,

 (2)

:
,

: ,


:
1. 4-
2. -

18-75

A-

, :
(
)

- /
-
-
-

:
-
-

-
-
, ,

:
-
-
-

:
-
-
-
-
-
- /

 ...
( ,
, , )-

CIOMS 2002

...

...

J. Karbwang. .
, . 2014.9.22

. . .
. 2014

European textbook on ethics in research. (2010) DirectorateGeneral for Research Science, Economy and Society, pp.34-48