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2014 PHREB Policies for

Registration and Accreditation of


RERCs

Updates on PHREB Accreditation

The policies promote standards in the establishment of


procedures and mechanisms that enable ethics review
committees to conduct quality scientific and ethical review of
research protocols and thereby ensure the safety and protection

Cecilia V. Tomas, M.D.


Chair, Sub-Com on Standards &
Accreditation, PHREB

of the rights and welfare of the participants in research.


Effective as of February 2, 2014

March 4, 2015
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PHREB Levels of Accreditation

PHREB Criteria for Accreditation

Level
1. Functionality of the structure & membership of the ERC
2. Adequacy of the Standard Operating Procedures and
consistency in its implementation.
3. Adherence to international, national and institutional
guidelines and policies.
4. Completeness of the review process
5. Adequacy of the after-review procedures
6. Adequacy of administrative support for ERC activities
7. Efficient and systematic recording and archiving

Features

Level 1

Qualifies an ERC to review researches


involving human participants except
clinical trials

Level 2
Qualifies an ERC to review clinical trials
not intended for registration of new drugs
(e.g. non industry trial by
residents/fellows/ consultants)

Demonstrates sufficient competency


and efficiency in ethical review
Adheres to a set of appropriate
standard operating procedures

But no office and staff of its own

Above features PLUS

Has adequate administrative


support office, standard
equipment and administrative staff
But no database or adequate
archiving system

PHREB Accreditation Visit Activities

PHREB Levels of Accreditation

Conduct Opening Meeting

Level

Tour ERC Office

Features

Review Membership & Training Files


Demonstrates sufficient competency
and efficiency in ethical review
Qualifies an ERC to review
Adheres to a set of appropriate
investigational new drugs (IND) or
device protocols for registration to FDA. standard operating procedures

Level 3

Qualifies an ERC as an Ethics Review


Resource of the FDA

Has adequate administrative support

Maintains an updated database of


reviewed protocols and has established
an informative archival system.

Review EC SOPs

Interview EC Representatives
Review Protocol Files, Meeting Agenda/Minutes
& Communication Records
Review EC SAE, Site Visit, Annual & Final Reports

Observe EC Board Meeting


Hold Summary Meeting
Conduct Closing Meeting

Level 3 Ethics Review Committees

Level 3 Ethics Review Committees


Name of Institution
1. Philippine Heart Center Ethics
Review Committee
2. The Medical City Institutional
Review Board
3. St. Lukes Medical Center
Institutional Ethics Review
Committee

Accreditation Effectivity Date


No.
12-001
01 August 2012

Name of Institution

Expiry Date
31 July 2015

13-003

01 March 2013

29 February 2016

13-004

01 March 2013

29 February 2016

4. Makati Medical Center


Institutional Review Board
5. Manila Doctors Hospital
Institutional Review Board
6. University of the Philippines
Manila Research Ethics Board
7. Department of Health XI
Cluster Ethics Review
Committee

Accreditation
No.
L3-2014-001-01

Effectivity Date

Expiry Date

14 March 2014

14 March 2017

L3-2014-002-01

14 March 2014

14 March 2017

L3-2014-003-02

14 March 2014

14 March 2017

L3-2014-004-01

14 March 2014

14 March 2017

Level 3 Ethics Review Committees


Name of Institution

8. Veterans Memorial Medical


Center Institutional Review Board
9.Davao Doctors Hospital
Institutional Ethics Review Board
10.Mariano Marcos Memorial
Hospital and Medical Center Ethics
Review Committee
11.Chong Hua Hospital Institutional
Review Board
12. Baguio General Hospital and
Medical Center Ethics Review
Committee

Accreditation No.

Effectivity Date

Expiry Date

L3-2014-005-01

14 March 2014

14 March 2017

L3-2014-006-01

25 Nov. 2014

25 Nov. 2017

L3-2014-007-01

25 Nov. 2014

25 Nov. 2017

L3-2014-008-01

25 Nov. 2014

25 Nov. 2017

L3-2014-009-01

25 Nov. 2014

25 Nov. 2017

Level 3 Ethics Review Committees


Name of Institution

Accreditation No.

13. National Kidney Transplant


Institute Research Ethics
Committee
14.Lung Center of the
Philippines Ethics Review
Committee
15. Far Eastern UniversityNicanor Reyes Medical
Foundation Institutional Ethics
Review Committee

Effectivity Date

Expiry Date

L3-2014-010-01

25 Nov. 2014

25 Nov. 2017

L3-2014-011-01

25 Nov. 2014

25 Nov. 2017

L3-2014-012-01

25 Nov. 2014

25 Nov. 2017

Level 3 Ethics Review Committees


Name of Institution

16. Univ. of the East Ramon


Magsaysay Memorial Medical Center
Inc. Research Institute for Health
Institutional Ethics Review Board
17. Research Institute of Tropical
Medicine Institutional Review Board
18. University of Perpetual Help
System DALTA Institutional Review
Board
19. Manila Med Ethics Review
Committee

Accreditation No.

Effectivity Date

10

Level 2 Ethics Review Committees


Expiry Date

L3-2014-013-01

25 Nov. 2014 25 Nov. 2017

Name of Institution
Accreditation No. Effectivity Date
Expiry Date
1. Our Lady of Fatima
L2-2014-001-01
25 Nov. 2014
25 Nov. 2017
University Institutional
Ethics Review Committee

L3-2014-014-01

25 Nov. 2014 25 Nov. 2017

L3-2014-015-01

25 Nov. 2014 25 Nov. 2017

2. Pacific Eye and Laser


Institute Institutional
Review Board

L3-2014-016-01

25 Nov. 2014 25 Nov. 2017

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L2-2014-002-01

25 Nov. 2014

25 Nov. 2017

3. Asian Eye Institute


L2-2014-003-01
Ethics Review Committee

25 Nov. 2014

25 Nov. 2017

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2014 PHREB Requirements for Registration and


Accreditation of Research Ethics Review Committees
Section III
2. All research ethics review committees (RERCs) which currently
conduct review for ethical soundness of research proposals (or
intend to review) researches involving human participants must
register and undergo accreditation by PHREB by 30 December 2015.

2014 PHREB Requirements for Registration and


Accreditation of Research Ethics Review Committees
Section III
4. Different procedures shall be required based on the present registration
status of the RERCs as follows:
4.1. Newly constituted RERC : a RERC that is newly organized and has
functioned for not more than 12 months.
4.2. Unregistered RERC: a RERC that has been functional for more than a year
but has not registered yet.
4.3. Registered but non-compliant RERC: a previously registered RERC but has
not complied with the submission of the required annual reports.
4.4. Registered and compliant RERC: a previously registered RERC which has
dutifully complied with the submission of annual reports.

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2014 PHREB Requirements for Registration and


Accreditation of Research Ethics Review Committees
Section III

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PHREB Memo February 27, 2015


In order to review clinical trials research protocols of drugs and

11. PHREB accreditation is mandatory for all RERCs in the


Philippines. Any other accreditation, international or national, is at the

devices for FDA registration, RERCs need to have Level 3


accreditation.

discretion of the RERCs but there is no PHREB reciprocity of


accreditation with other bodies or organizations.

ERCs which qualify as Level 3 should submit their applications by

30 April 2015.

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PHREB Memo February 27, 2015

April 30, 2015 submission of applications for Level 3 ERC.

The acceptance of applications for Level 1 or Level 2


accreditation is ongoing. Interested RERCs should send their
applications and required documents as early as possible in
order for the PHREB

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Sub-Committee on Standards and

Accreditation to evaluate the submitted documents before 30


December 2015.

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Only those which comply and will qualify will be processed in 2015. If ERC is
accredited before December 30, 2015, they continue reviewing new CTs. Awarding of
certificate: March 2016.
Applicant ERCs if still being processed, can continue to review Clinical Trials till the
end of December 30 2015. If accreditation process is not completed by January 01
2016, ERCs shall stop accepting new CTs (for FDA registration) but continue to
monitor previously approved CTs.
ERCs which apply but do not qualify for Level 3 can no longer accept clinical trials for
review after April 30 and they can apply again for Level 3 in 2016. They should apply
for Level 1 or 2 before December 30, 2015.

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Procedures: (Level 3 ERCs should have reviewed at least


20 protocols/year and at least 10 protocols with latest SOP)

Procedures: (Level 3 ERCs should have reviewed at least


20 protocols/year and at least 10 protocols with latest SOP)

Qualified ERCs
have to apply for
Level 3
accreditation by
April 30 , 2015

Qualified ERCs
have to apply for
Level 3
accreditation by
April 30 , 2015

If the ERC qualifies,


it is scheduled for
visit

Awarding of
accreditation certificate
in March or August

ERC can continue to


accept new CTs till
December 30, 2015

If accreditation requirements
are satisfied (including
approval/implementation of
action plan), ERC can accept
new CTs in 2016.

If the ERC qualifies,


it is scheduled for
visit

Monitoring of approved
protocols shall be
continued by the ERC
until completion

ERC can continue to


accept new CTs till
December 30, 2015

If processing is not completed


by Dec. 30 2015, ERC shall not
accept new CTs in 2016 and
wait for completion of
accreditation

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Procedures (Level 3):


ERCs that do not qualify
for Level 3 accreditation
(at least 20 protocols) by
April 30 , 2015
Monitoring of protocols
approved prior to April 30,
2015 shall be continued by
the ERC until completion

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Procedures (Level 3):


Qualified ERCs that do
not apply for Level 3
accreditation by April 30
2015

ERC shall not accept


new CTs after April 30
2015

ERC shall apply for Level


1 or Level 2 before or by
Dec 2015; otherwise
they cannot review
protocols in 2016

ERC shall apply for


Level 1 or Level 2

ERC shall not accept


new CTs after April
30 2015
Monitoring of
previously approved
protocols shall be
continued till
completion

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ERC Application for Level 1 or Level 2

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Procedures: Level 1 and Level 2 ERCs

1. Submission of documents and proof of evidence & compliance as per requirements


stated in 2014 PHREB accreditation procedures.
Note: To facilitate processing of application, ensure that submission of required
documents is complete
2. SSA assessment of documents
If requirements are fully met, PHREB will issue certificate of accreditation
If there are areas for improvement recommended by SSA, ERC shall submit action

plan within
30 days and report its implementation. When these are complied with, PHREB
will issue certificate of accreditation.

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ERCs for Level 1 or Level


2 accreditation should
apply now till December
30, 2015

SSA assesses the


documents

Monitoring of previously
approved protocols shall
be continued till
completion

SSA approves &


awards Level 1 or
Level 2 accreditation

ERC continues to
accept new protocols
until expiry of
accreditation

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Procedures: For Level 1 or 2 ERC when SSA finds


significant areas for improvement
ERC submits action
plan to address
these areas for
improvement and
submits to SSA
within 30 days

While waiting for


implementation
ERC action plan

SSA assesses &


approves the
action plan

SSA approves
& awards Level
1 or Level 2
accreditation
ERC can continue
to accept new
protocols until
December 30, 2015

ERC submits
report on
implementation

SSA assesses
implementation of
ERC action plan
Monitoring of previously
approved protocols shall
be continued till
completion

Summary:
1. PHREB Requirements for Registration and Accreditation of RERCs (Feb. 2 2014)
1.1 PHREB Criteria for Accreditation - 7 standards
1.2 Accreditation Levels 1, 2, 3
1.3 Kinds of existing ERCs at present time
2. List of Accredited ERCs - Level 3 (19), Level 2 (3)
3. PHREB Memo to ERCs February 27, 2015 - application deadline (April 30, 2015) for
Level 3 ERCs. Level 1 and 2 applications are on-going till December 30 2015
4. Procedures to follow for Level 1,2 and 3 ERCs
Reference: PHREB Requirements for Registration and Accreditation of RERCs
(Feb. 2 2014) - Please review document for complete information.

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