The Needs for Research Ethics Consultation Service
(
RECS
)
in Japan
Kuniko Aizawa, Haruka Nakada, Kaori Doi, Taketoshi Okita, Waki Toya, Kenji Matsui
Office for Research Ethics & Bioethics, National Cerebral & Cardiovascular Center, Osaka, Japan
A preliminary questionnaire survey
Method
•
Design:
An anonymous self-administered
questionnaire survey on site or by mail.
•
Participants:144
institutional review board (
IRB
)
members
and clinical
research coordinators
from
78
institutions
participated in four
research ethics
seminars
we held in three cities
from 2012 to 2014.
•
Survey period:
Dec. 2013 to Feb. 2014.
•
Measurements:
Questionnaire with 11
multiple-choice questions.
•
Analysis:
Cross tabulation
•
Role: CRC/IRB member etc.
•
Affiliation: Medical school/Hospital etc.
•
Prefered RECS type: Institutional/External etc.
Return rate
:
119
/144 (82.6%)
Respondent characteristics
A. Role
B. Affiliation
C. Is there a research ethics
expert
at
your institution?
D. Is there any
person or division
responding to
research ethics
inquiry
?
E.
Who
responds to the inquiry?
G. What
type
of RECS is
the most preferable?
H. Should requestors
pay
for RECS?
I. What is the biggest
obstacle
for requesting RECS?
UNESCO Chair in Bioethics 11th World Conference, Naples, Italy, Oct. 20-22, 2015
54.6
Med school 62.1
34.4
27.7 18.4
Hospital 53.1
9.2
11.5
3.1 8.4
8.0
9.4
0% 20% 40% 60% 80% 100% Total (n=119)
IRB member etc. (n=87) Research coordinator (n=32)
Med school Hospital Public research institute Other
42.9
42.5
43.8
53.8
29.6 14.3
18.4
3.1
12.3
16.7 23.5
26.4
15.6
12.3
37.0
22.7
18.4
34.4
24.6
20.4 1.7
2.3
0.0
3.1
0.0 0.8
0.0
3.1
1.5
0.0
0% 20% 40% 60% Total (n=119)
IRB member etc. (n=87)
Research coordinator (n=32)
Med school (n=65)
Hospital etc. (n=54)
Research and educational staff External IRB member None
I don't know Other
No reply
60.9
68.6
38.9
63.2 58.1
40.6
43.1
33.3
50.0
29.0
15.9
11.8
27.8
7.9
25.8 7.2
3.9
16.7
5.3
9.7
0% 20% 40% 60% Total (n=69)
IRB member etc. (n=51) Research coordinator
(n=18)
Med school (n=38) Hospital etc. (n=18)
IRB
Research
support division Other
I don't know
Very much
necessary,
43.7
Necessary,
54.6
Unnecessary,
1.7
Very much
want to use
RECS, 27.7
Want to use
RECS, 67.2
Don’t want to
use RECS, 3.4
No reply, 1.7
37.0
Institutional 44.6
27.8
22.7
18.5
27.8
22.7
18.5
27.8
14.3
13.8
14.8
2.5
4.6
0% 20% 40% 60% 80% 100%
Total (n=119)
Med school (n=65)
Hospital etc. (n=54)
Institutional
Regional
By research type or field Nationwide
Other
No reply
42.9
27.3
Some expenses
52.0
46.3
34.4
54.6
No expenses 72.7
44.0
48.1
59.4
2.5
0.0
4.0
5.6
6.3
0% 20% 40% 60% 80% 100%
Total (n=119)
Prefer institutional RECS (n=44)
Prefer external RECS (n=75)
Hospital etc. (n=54)
Research coordinator (n=32)
Some expenses No expenses No reply
21.1
21.5
20.0
20.5
21.4
20.2
19.0
23.3
15.4
22.9
14.7
19.0
3.3
7.7
18.6
13.8
11.4
20.0
20.5
10.0
12.8
13.9
10.0
17.9
10.0
12.8
12.7
13.3
15.4
11.4
4.6
2.5
10.0
2.6
5.7
0% 20% 40% 60% 80% 100%
Total (n=109)
IRB member etc. (n=79)
Research coordinator (n=30)
Prefer institutional RECS (n=39)
Prefer external RECS (n=70)
Difficulty conveying the specific situation to the consultant
Lack of confidence that the issue at hand is being met by the consultation
Uncertainty of confidentiality
The expenses
Unfamiliarity with the consultant
Other
No reply
Summary
•
Institutional research ethics
resources are insufficient
. (
C~E
)
•
Respondents
want to use RECS
. (
F
)
•
External RECS
(i.e., regional and by
study type or field) is needed. (
G
)
Challenges
•
To provide
more research ethicists
and to respond the needs for
RECS
.
(
C,
F~I
)
Proposal
•
To develop
public RECS
at
15 or more
core research institutions.
Our new public RECS
•
We started an
online public RECS
this
year. 11 bioethicists across Japan join
hands with us.
•
We also opened a RECS
case study
website
.
We continue working to
improve
the
public RECS.
Do you think RECS is necessary?
(inside)
Do you want to use RECS?
(outside)
F.
E-mail: [email protected]
This study is supported by JSPS KAKENHI Grant Numbers 25750101 and 15H02518;
MHLW Project for Structure Improvement to Execute Early-Phase & Exploratory Clinical Trial; and Cardiovascular Disease R&D Fund H25-6-26 for Young Scientist and H25-5-1.
IRB member
45.4
IRB administ
rator 16.8
Research coordina
tor 26.9
Other 10.9
(%)
A person or division
with publicity,
41.2
A person or division
without publicity,
16.8 No person
or division,
32.8
I don't know, 8.4
No reply, 0.8
(%)
5 ~ 10 regions: 56% (5 ~ 85 regions)
2 ~ 10 study types or fields
