Kaori_Muto

Research
 ethics
 commi-ees

Kaori
 Muto,
 Ph.D.
 
Department
 of
 Public
 Policy
 
The
 Ins;tute
 of
 Medical
 Science
 
The
 University
 of
 Tokyo

Outline

1.  Research
 ethics
 commiCees
 in
 Japan
 
2.  DoH
 and
 research
 ethics
 commiCees
 
3.  Discussions
 on
 RECs
 in
 30
 years
 
4.  Points
 to
 consider
 in
 revision
 of
 DoH
 
2

Defini4on

“research
 ethics
 commiCee”
 (ar;cle
 15)
 
 may
 include:
 
1.  CommiCee
 set
 by
 ins;tu;on
 
– Ins;tu;onal
 Review
 Boards
 (IRBs)
 
2.  CommiCee
 in
 community
 
– LRECs,
 Comité
 de
 protec;on
 des
 personnes,
 State
 IRBs
 
3.  Centralized
 commiCee
 
– Central/
 Joint
 IRBs
 
4.  Commercial
 en;ty
 
– commercial
 IRBs
 
5.  Others
 

3

4
 
Classifica4on
 of
 clinical
 research
 in
 Japan
 
Clinical
 Research
 
 includes
 most
 of
 clinical
 trials
 and
 observa;onal
 studies
 
using
 human
 samples
 and/or
 data
 derived
 from
 individuals
 
“Chiken”
 
 are
 legally
 regulated
 clinical
 trials,
 specially
 intended
 for
 
collec;ng
 evidence
 for
 applica;on
 to
 the
 regula;ve
 authority
 (PMDA)
 
for
 approval
 of
 produc;on
 and
 sales
 of
 drug
 or
 medical
 devices
 
Clinical Research
Clinical Trials
“Chiken”
Pharmaceutical
Affairs Law
ICH-GCP
Ethical
 Guidelines
 for
 Clinical
 
Research
 (MHLW*,
 2003)
 
5
 
Regula4on
 of
 Clinical
 Research
 in
 Japan:
 
Guideline
 
Clinical
Research
Ethical Guidelines for Clinical Research
(MHLW*)
Clinical
Trials
* MHLW, Ministry of Health, Labour and Welfare
** MEXT, Ministry of Education, Culture, Sports, Science and Technology
*** METI, Ministry of Economy, Trade and Industry
Ethical Guidelines for Human Genome/Genetic Analysis
Research (MEXT**, MHLW*, METI***)
Ethical Guidelines for Clinical Research on Gene Therapy
(MEXT, MHLW)
Ethical Guidelines for Clinical Research Using Human Stem
Cells (MHLW)
Ethical Guidelines for Epidemiological Research (MEXT**,
MHLW*)
6
 
RECs
 in
 Japan
 
•  GCP
 and
 all
 ethical
 guidelines
 require
 to
 establish
 
REC
 in
 each
 research
 ins;tu;on
 and
 govern
 all
 
protocols
 
•  No
 official
 registry
 to
 cover
 all
 RECs.
 How
 many?
 
3,000?
 (Sasaguri
 et
 al,
 2008)
 
•  So-­‐called
 “IRB
 offices”
 or
 “research
 ethics
 
consulta;on
 service”
 are
 slightly
 increasing
 for
 
quality
 assurance
 of
 RECs
 
•  No
 original
 accredita;on
 system
 
•  Central
 RECs—under
 discussion
 
How
 RECs
 have
 been
 discussed?

•  Found
 271
 papers
 between
 
 

 
 
 
 1978-­‐2013
 
•  Most
 papers
 from
 USA;
 
some
 from
 Europe,
 Asia
 and
 
Africa
 
•  Where
 to
 submit?
 

 
 
 
 “IRB”
 
 
 
 
 

7

0
 
5
 
10
 
15
 
20
 
25
 
•  PubMed
 Search=
 (ins;tu;onal
 review
 board[Title])
 OR
 (research
 
ethics
 commiCee
 [Title])
 

 
 
 “Bulle;n
 of
 Medical
 Ethics”
 
 “Journal
 of
 Medical
 Ethics”
 
 

 
 
 “PLoS
 ONE”
 
 “BMC
 Medical
 Ethics”
 

 
 
 
 ”Journal
 of
 Empirical
 Research
 on
 Human
 Research
 Ethics”
 
 
30
 years
 ago…
 1978-­‐1983
 
Informed
 consent
 in
 a
 university
 hospital
 Sorensen
 AA.
 1978.
 
The
 IRB
 as
 deputy
 sheriff
 Huff
 TA.
 Clin
 Res.
 1979.
 
 
The
 costs
 of
 IRBs
 Brown
 JH
 et
 al.
 J
 Med
 Educ.
 1979.
 
Pharmacists’
 role
 Donehew
 GR
 et
 al.
 Hosp
 Pharm.
 1979.
 
The
 responsibility
 of
 IRBs
 Holloway
 PJ
 and
 Worthington
 HV.
 J
 Dent
 Res.
 1980.
 
The
 philosophy
 of
 IRBs
 Brown
 JH
 et
 al.
 J
 Med
 Educ.
 1980.
 
The
 roles
 of
 IRBs
 Bosso
 JA.
 Drug
 Intell
 Clin
 Pharm.
 1983.
 
IRB
 inconsistency
 Veatch
 RM.
 JAMA.
 1982.
 
Ethical
 issues
 in
 nursing
 research
 Davis
 AJ.
 West
 J
 Nurs
 Res.
 1979.
 
A
 case
 study
 of
 no-­‐risk
 decisions
 in
 health-­‐related
 
research
 Gortner
 SR
 et
 al.
 Nurs
 Res.
 1982.
  8

20
 years
 ago…
 1992-­‐93
 
Pharmacist’
 role
 Mutnick
 AH,
 Miller
 LS.1983.
 
Standards
 of
 opera;on
 procedures
 Reynolds
 MB.
 1992;
 Castronovo
 
FP
 Jr.
 1993;
 Rosnow
 RL
 et
 al.
 1993;
 
 
Reflec;on
 of
 ac;vi;es
 of
 IRBs
 Bartolo.1992;
 
Readability
 of
 consent
 forms
 Hammerschmidt
 DE,
 Keane
 MA.
 1992.
 
Understanding
 IRBs
 Lovell
 SL.
 1992.
 
Audi;ng
 Cookson
 JB.
 1992.
 
 
IRB
 chair
 perspec;ves
 on
 ethical
 issues
 in
 phase
 I
 
oncology
 research
 Kodish
 E
 et
 al.
 1992.
 

  9

10
 years
 ago…2002-­‐03
 
The
 cost
 of
 the
 IRBs
 Humphreys
 K
 et
 al.
 2003.
 
Court
 decision
 and
 IRBs
 Maloney
 DM.
 2003;
 
 
Roles
 of
 RECs
 in
 follow
 up
 Mar;ni
 N
 et
 al.
 2003;
 Suñe-­‐Mar;n
 P
 and
 Montoro-­‐Ronsano
 JB.
 2003.
 
Conflict
 of
 Interests
 Weber
 LJ,
 Bissell
 MG.2003.
 
Variety
 of
 review
 process
 in
 minimal
 risk
 Hirshon
 JM
 et
 al.
 2003.
 
IRB
 reform
 Paasche-­‐Orlow
 MK,
 Taggart
 JC.2002;
 Mann
 H.2002;
 Kornfeld
 DS.2002;
 Emanuel
 EJ.2002.
 
Research
 administrators
 shouldn’t
 serve
 IRBs
 Maloney
 DM.
 2002.
 
Central
 IRBs
 Chris;an
 MC
 et
 al.2002.
 
Research
 on
 stored
 blood
 and
 ;ssue
 samples
 White
 MT
 &
 Gamm
 J.2002.
 
Pediatric
 research
 Smith
 DE.2002.
 
Assessment
 of
 the
 risk/benefit
 ra;o
 of
 phase
 II
 cancer
 clinical
 trials
 
 
Van
 Luijn
 HE
 et
 al.
 200210

Recent
 topics:
 papers
 in
 2011-­‐12

Need
 for
 IRB
 registry
 
Quality
 assurance
 
Quality
 improvement
 
Roles
 of
 community
 IRB
 
 
Conflict
 of
 interests
 
Who
 are
 IRB
 members?
 
 
Who
 should
 be
 members?
 
Successful
 examples
 
Training
 workshops
 

 
Observa;on
 of
 review
 process
 
Variety
 of
 review
 process
 in
 
mul;center
 studies
 
Variety
 of
 review
 process
 in
 
minimal
 risk
 
Variety
 of
 review
 results
 on
 
surrogate
 consent
 

11

Recent
 topics:
 papers
 in
 2011-­‐12

Anesthesia
 and
 informed
 consent
Medical
 educa;on
 research
 
Facial
 transplanta;on
 
Community-­‐based
 par;cipatory
 
research
 

Tissue
 research
 
Incidental
 findings
 in
 genome
 
research
 
Pediatric
 drug-­‐trial
 recruitment
 
Interna;onal
 research
 (HIV/
AIDS)
 
Different
 views
 of
 chairs:
 data
 
sharing
 in
 gene;c
 research
 

12

DoH
 and
 REC

Tokyo
 (1975):
 Protocols
 ‘should
 be
 transmiCed
 to
 a
 specially
 
appointed
 independent
 commiCee’.
 
 
Hong
 Kong
 (1989):
 ‘transmiCed
 for
 considera;on,
 comment
 and
 
guidance’,
 ‘
 independent
 of
 the
 inves;gator
 and
 the
 sponsor’
 
Edinburgh
 (2000):
 ‘ethical
 review
 commiCee’,
 independent
 of
 
‘any
 other
 undue
 influence’
 ‘the
 right
 to
 monitor
 ongoing
 studies’
 
Seoul
 (2008):
 ‘research
 ethics
 commiCee’,
 ‘where
 consent
 would
 
be
 impossible
 or
 imprac;cal
 to
 obtain,
 the
 research
 using
 
iden;fiable
 human
 material
 or
 data
 may
 be
 done
 only
 awer
 
considera;on
 and
 approval
 of
 a
 REC’,
 ‘take
 into
 considera;on
 the
 
laws
 and
 regula;ons
 of
 the
 country
 or
 countries’
 

  13

Points
 to
 consider
 in
 revision
 of
 DoH

1. Rela;onships
 between
 DoH
 and
 RECs
 
2. Interna;onal
 Research
 
3. Who
 should
 be
 members?
 
4. Educa;on
 for
 REC
 chair
 and
 members
 
5. Quality
 assurance
 

 
14

1.
 Rela4onships
 between
 
 
DoH
 and
 RECs

•  Although
 the
 Declara;on
 is
 addressed
 primarily
 to
 
physicians,
 the
 WMA
 encourages
 other
 
par;cipants
 in
 medical
 research
 involving
 human
 
subjects
 to
 adopt
 these
 principles.(Ar;cle.2)
 

15

Should
 DoH
 make
 more
 recommenda;ons
 about
 RECs?
 
2.
 Interna4onal
 Research

•  HIV/AIDS
 research
 sponsored
 by
 a
 developed
 
country,
 but
 conducted
 in
 a
 developing
 country
 
conducted
 in
 one
 of
 four
 developing
 countries
 
•  Among
 papers
 on
 PubMed
 published
 in
 2007
 (N
 =
 
154)
 ,
 only
 52%
 men;oned
 dual
 approval.
 
 
•  “the
 need
 for
 clearer
 and
 more
 universally
 accepted
 
guidelines”.
 
Chin
 LJ
 et
 al.
 J
 Empir
 Res
 Hum
 Res
 Ethics:
 6(3):83-­‐91,
 2011.
 
 
16

2.
 Interna4onal
 Research

“It
 [This
 commiCee]
 must
 take
 into
 considera;on
 the
 laws
 
and
 regula;ons
 of
 the
 country
 or
 countries
 in
 which
 the
 
research
 is
 to
 be
 performed
 as
 well
 as
 applicable
 
interna;onal
 norms
 and
 standards
 but
 these
 must
 not
 be
 
allowed
 to
 reduce
 or
 eliminate
 any
 of
 the
 protec;ons
 for
 
research
 subjects
 set
 forth
 in
 this
 Declara;on”.(Ar;cle
 15)
 
17

What
 should
 RECs
 in
 sponsored
 countries
 do?
 
What
 should
 RECs
 in
 developing
 countries
 do?
 
In
 cases
 like
 global
 (mul;-­‐na;onal)
 clinical
 research
 
collabora;on?
 
 
3.
 Who
 should
 be
 members?

•  No
 descrip;on
 on
 requirement
 on
 members
 
•  Minimum
 requirement
 is
 “diversity”
 
– Age
 
– Gender
 
– Ethnic
 background
 
– Academic
 background
 
– Pa;ents/par;cipants
 
18

Should
 DoH
 make
 any
 sugges;ons
 about
 members?
 
4.
 Training
 for
 REC
 chair
 and
 
members

“Medical
 research
 involving
 human
 subjects
 must
 be
 
conducted
 only
 by
 individuals
 with
 the
 appropriate
 scien;fic
 
training
 and
 qualifica;ons.”
 (Ar;cle
 16)
 
•  “[…]the
 report
 recommends
 that
 IRB
 members
 and
 staff
 
complete
 educa;onal
 and
 cer;fica;on
 programs
 on
 
research
 ethics
 before
 being
 permiCed
 to
 review
 research
 
studies”
 (NBAC
 2001)
 
19

Should
 REC
 chair
 or
 members
 have
 the
 appropriate
 training
 
and
 qualifica;ons
 to
 review
 new
 and
 complicated
 maCers?
 
Incen;ves
 to
 be
 trained?
 
5.
 Quality
 assurance

•  Accredita;on/
 recogni;on
 system
 would
 provide
 mutually
 
reliable
 standards
 to
 global
 community.
 
ü USA:
 The
 Associa;on
 for
 the
 Accredita;on
 of
 Human
 
Research
 Protec;on
 Programs,
 Inc.
 (AAHRPP)
 
 
ü Asian
 countries:
 AAHRPP
 and/or
 The
 Strategic
 Ini;a;ve
 
for
 Developing
 Capacity
 in
 Ethical
 Review
 (SIDCER)
 
ü UK:
 Accredita;on
 Scheme
 for
 the
 Na;onal
 Research
 
Ethics
 Service
 
20

Should
 DoH
 recommend
 any
 registry,
 accredita;on
 or
 
recogni;on
 to
 keep
 minimum
 quality
 of
 RECs?
 
Should
 RECs
 conduct
 self-­‐monitoring
 and
 improvement
 ?
 
Thank
 you
 very
 much
 for
 your
 a-en4on!

Doshisha
 University
 
•  Ryuichi
 IDA
 
Na4onal
 Cerebral
 Cardiovascular
 
Center
 
 
•  Kenji
 MATSUI
 
SHOWA
 UNIV
 
•  Shimon
 TASHIRO
 
Osaka
 University
 
•  Kazuto
 KATO
 

 
University
 of
 Tokyo
 
•  Masamine
 JIMBA
 
•  Yusuke
 INOUE
 
•  Hyongsoo
 HONG
 
•  Chiunfang
 CHANG
 
•  Mayumi
 KUSUNOSE
 

Acknowledgement to our colleagues and friends

2011.03.11.
Tohoku Disaster