research ethics board

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Introduction

In 1984, the National Ethics Committee (NEC) was organized by the Philippine Council for Health

Research and Development (PCHRD) through Special Order No. 84- 053 issued by then PCHRD

Executive Director, Dr. Alberto G. Romualdez, Jr. The NEC was created “to ensure that all health

research and development proposals conformed with ethical standards and to promote the

establishment of Ethics Review Committees (ERCs) in various localities and institutions”. The first

chair of the committee was Dr. Generoso Basa from the University of Santo Tomas Faculty of

Medicine and Surgery.

The first set of guidelines for the conduct of biomedical research in the country was published by

NEC in 1985. This underwent revisions in 1996 and 2000 to address various developments in health

research like global clinical trials, genetic research, and organ transplantation research.

In 2003, the Philippine Health Research Ethics Board (PHREB) was constituted as one of the working

committees in the Philippine National Health Research System (PNHRS) and was identified as the

national policymaking body in health research ethics. With this new development, the role of the

National Ethics Committee remained as a reviewing committee at the national level.

To enable the NEC to better discharge its functions as a review committee, the NEC Secretariat, Ms.

Imelda B. Mutuc and Ms. Charisma G. Cruz under the supervision of the NEC Chair, Dr. Marita V.T.

Reyes, developed and compiled a set of operating procedures (SOPs) in May-July 2008. This was

subsequently approved by the NEC during its meeting on August 21, 2008.

In 2010, with more than a 100 ERCs registered with PHREB database, a gradual phase-out of the

NEC was decided even while it still continued to do post-approval procedures for previously

approved protocols. In July 2010, the NEC no longer accepted new applications for review. It was

estimated that the ongoing studies would have ended by December 2012. This, however, did not

materialize as the Principal Investigators requested extensions of ethical approval until December

2013.

In the meantime, PCHRD referred 30 project proposals from the DOH-Health Systems Research

Management Program for review as an important step in processing the proposals for funding. This

referral led to a revisit of the decision on the NEC phase-out and to a realization that there was indeed

a need for a review committee at the national level specifically in the review of research proposals

that are not within the scope of existing Institutional Ethics Review Committees or where there are

none.

Thus, the present NEC is envisioned to be an essential component of the Philippine National Health

Research System (PNHRS) as depicted in the organogram below:

PHILIPPINE NATIONAL HEALTH RESEARCH SYSTEM

PHILIPPINE COUNCIL FOR HEALTH RESEARCH AND DEVELOPMENT

(Headed by PCHRD Executive Director

NATIONAL ETHICS

COMMITTEE

PHILIPPINE HEALTH RESEARCH ETHICS BOARD

Finance and Administrative Division

Research and Development

Management Division

Institution Development Division

Research Information, Communication, and Utilization Division

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The primary responsibility of the NEC is to safeguard the rights, dignity and welfare of human

participants in research proposals referred to it by PCHRD, PHREB or other national agencies or

directed to it by the Philippine Health Research Ethics Portal (PHREP). It shall also respond to

requests for assistance by Institutional ERCs in the resolution of difficult ethical issues. It shall advise

the PCHRD and other government agencies including Philippine Food and Drug Administration

(FDA), on identified ethical issues on relevant research activities. It shall provide appropriate

information to PHREB in the formulation of policies and guidelines on health research. Among its

activities, the NEC shall network with other national ethics bodies (i.e. DOH-National Ethics

Committee, Philippine Genomics Center-Ethical Legal Social Implications) in contributing to the

development of an ethical research environment in the Philippines.

The operations of the National Ethics Committee shall be supported by the PCHRD. It shall be

composed of a Chair and 8 members, who will all be appointed by the PCHRD Executive Director.

The responsibilities of a member are as follows:

1. Attend NEC meetings consistently.

2. Participate in the ethical review of research proposals and other related reports. The

non-scientific member shall give special attention to the Informed Consent Form and

process to ensure that these are comprehensible by ordinary persons and are considerate

of community values.

3. Participate in the after-review activities, e.g., continuing review, site visits, etc.

4. Declare any conflict of interest (COI) in the review of research proposals.

5. Maintain confidentiality of the documents and deliberations of the NEC meetings.

6. Attend continuing ethics education and other related activities.

On the other hand, the Chair:

1. Sets the meeting agenda and presides in regular and special NEC meetings.

2. Conducts a preliminary review of all proposals and decides on the type of review.

3. Assigns primary reviewers for specific research proposals for full review.

4. Assigns reviewers for expedited reviews.

5. Ensures an appropriate and timely decision/action on a proposal.

6. Invites and appoints independent consultants for the review of proposals requiring a

particular expertise.

7. Ensures that all NEC members undergo appropriate orientation and continuing training in

research ethics, concepts, and guidelines.

8. Submits annual reports to PHREB.

All NEC members are mandated to disclose any COI that may affect their decision-making. Each

member is required to sign a COI agreement and disclosure checklist prior to an appointment. The

NEC members must abide by a confidentiality agreement that shall limit their access and sharing of

any information that is deemed proprietary. This policy shall also apply to all resource persons,

external reviewers and other individuals who will be involved in the ethics review process.

A Secretariat designated by the Office of the Executive Director of PCHRD shall manage the daily

operations of the NEC. It shall consist of at least 2 individuals, one of whom must have supervisory

qualifications. The NEC Secretariat shall

1. Manage submissions of application for ethics review from study proponents.

2. Assign an NEC code to every protocol received by the NEC for review.

3. Organize NEC meetings.

4. Prepare NEC meeting agenda and minutes in consultation with the NEC Chair.

5. Prepare the protocol materials and distribute these for review.

6. Record and summarize deliberations and decisions of the NEC in consultation with the NEC

Chair.

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7. Prepare communications to proponents for approval and signature of the NEC Chair.

8. Inform the Chair of any incoming communications pertinent to NEC activities and

responsibilities.

9. Liaise with the PCHRD administration regarding NEC activities and requirements.

10. Organize the preparation, review, revision and distribution of SOPs to the NEC members.

11. Maintain and archive NEC documents and files, i.e. research protocols and related

documents, NEC minutes of the meetings, NEC membership files, etc.

12. Assist in the preparation of the Annual Report.

This set of Standard Operating Procedures is a revision of the 2008 SOPs. It takes into consideration

renewed mandate of the NEC and its participation in the Philippine Health Research Ethics Portal

(PHREP). The NEC is guided by the 2013 Helsinki declaration, 2009 CIOMS Guidelines and the

2011 National Ethical Guidelines in Health Research.

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NATIONAL ETHICS COMMITTEE

STANDARD OPERATING PROCEDURES

PREPARATION AND REVISION OF


SOP No. NEC SOP 01 Version No. 2 Version Date 15 July 2014 Effectivity 15 July 2014

1. POLICIES

All major activities of the National Ethics Committee must be guided by a set of Standard Operating

Procedures (SOP). A specific SOP may be proposed by any member of the National Ethics

Committee (NEC) and must be approved by the Committee before implementation. The set of SOPs

must be reviewed periodically for 1) internal and external consistency, 2) efficiency, and 3)

applicability.

2. PURPOSE OF THE ACTIVITY

The purpose of preparing SOPs is to ensure consistency and transparency of all major activities of the

National Ethics Committee thereby promoting quality assurance in review. SOPs need to be reviewed

and updated periodically to ensure that they remain consistent, effective and applicable.

3. SCOPE

This SOP is limited to the preparation and revision of the NEC SOPs.

4. ROLES AND RESPONSIBILITIES

4.1. Committee Chair/Members/Secretariat identifies new SOPs or SOPs for revision. They

prepare the draft SOP and participate in the deliberation of the proposed new or revised

SOP.

4.2. The Secretariat collates SOP proposals from members, prepares the materials for

discussion and finalizes the SOP based on the NEC template.

5. FLOWCHART

Flowchart 1. Preparation of Standard Operating Procedure

Individual Committee Members / Chair /Secretariat

Individual Committee Members / Chair /Secretariat

Committee

Committee

Secretariat

Approval of SOP

Start

Identification of new SOP

or SOP for revision

End

Formulation of SOP

Deliberation

Coding and Filing of new SOP

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6. DESCRIPTION OF PROCEDURES

6.1. Identifying SOPs

Any member of the NEC/Secretariat can propose the formulation of a new SOP/amendment to an

existing SOP in a regular meeting of the NEC as an item in the agenda.

6.2. Formulating the SOP

6.2.1. The Chair shall assign the responsible person/s for drafting the proposed

new/amended SOP.

6.2.2. The new/amended SOP shall be included in the agenda in the following

meeting.

6.3. Deliberation

The formulation/revision must be justified during the presentation in the meeting among the members.

6.4. Approval

6.4.1. The new/amended SOP must be formally approved by consensus in a regular

meeting.

6.4.2. The new/amended SOP shall take effect as soon as it is signed by the Chair

unless the NEC decides that a different effectivity date is justified.

6.5. SOP Coding and filing

6.5.1. Upon approval, it shall be assigned an NEC SOP number.

6.5.2. The new/amended SOP shall be incorporated in the SOP file with the

signature of the Chair signifying approval and the date of the meeting when it

was approved.

DOCUMENT HISTORY

NEC SOP version 1 SOP Authors Ms. Imelda B. Mutuc and Ms. Charisma G. Cruz Page 2 Reviewed by Dr. Marita V.T. Reyes Review Date 7 August 2008 Approved by NEC Committee Approval Date 21 September 2008

NEC SOP version 2

Prepared by NEC Secretariat Pages 4-5

Reviewed and approved by NEC Committee Date 15 July 2014

Signed for effectivity by Marita V.T. Reyes NEC Chair

Date 15 July 2014

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CONSTITUTING THE NATIONAL ETHICS

COMMITTEE

SOP No. NEC SOP 02 Version No. 2 Version Date 15 July 2014 Effectivity 15 July 2014

1. POLICY

The National Ethics Committee shall be constituted in accordance with international and national

guidelines. It shall be multidisciplinary, multi-sector, gender-balanced and age-balanced with

representatives from relevant health disciplines (i.e. medical and nonmedical, scientific and non-

scientific), with at least 9 members.

NEC members are selected on the basis of their (1) disciplinal and sector representation, (2) interest in

research ethics and (3) willingness to commit time and effort for NEC activities.

Selection of members shall be through nominations from current committee members and other

sources identified by PCHRD and DOST. Final appointment shall be approved by the Executive

Director of PCHRD. The NEC Chair is designated by the PCHRD Executive Director.


Prompt constitution of the Committee prevents quorum problems and facilitates decision making. The

activity also ensures that the membership of the Committee adheres to international and national

guidelines.

3. SCOPE

This SOP applies to the selection of members and designation of officials of the National Ethics

Committee.


Compliance with this SOP rests on the Executive Director of the PCHRD as the appointing authority.

The Chair, members and the Secretariat shall be active participants in the nomination process. All

members shall sign the Conforme, and the Confidentiality and Conflict of Interest Agreements.

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5. FLOWCHART

Flowchart 2: Selection of New Members

Chair

PCHRD Executive Director

NEC Members and other identified agencies

Secretariat

Chair

PCHRD Executive Director

Secretariat

New NEC Member

Secretariat


6.1. Report of vacant positions

The Chair identifies the vacant positions, notes the disciplinal, sectoral scientific/non-scientific,

medical/non-medical requirements and reports these to the PCHRD Executive Director

6.2. Call for nominations

The PCHRD Executive Director calls for nominations from the NEC members, PCHRD personnel

and other consultants. Nomination letters must include an acceptance of the nomination by the

prospective member and a copy of their respective curriculum vitae. A deadline is set for the

submission of nominees.

6.3. Submission of nominations

Nominations must include the latest curriculum vitae (signed and dated) and a justification why the

nominee is a suitable as Medical/ non-medical, scientific/non-scientific member of the National Ethics

Committee.

6.4. Collation of nominations

Start

Report of vacant positions

Call for nominations

Submission of nominations

Collation of nominations

Submission of list of nominees

Selection and appointment of new member/s

End

Communication with the new member/s

Signing of COI and Confidentiality Agreements

Filing of appointment documents

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6.4.1. The Secretariat collates the nominations received and verifies acceptance of

nominations from the nominees.

6.4.2. The Secretariat prepares a final list with the supporting documents and forwards them to

the NEC Chair.

6.5. Submission of list of nominees

The NEC Chair evaluates the qualifications of the nominees and submits the final list of nominees to

the PCHRD Executive Director.

6.6. Selection and appointment of new member/s 6.6.1. The PCHRD Executive Director, in consultation with the NEC Chair, selects the new

member/s of the NEC Committee. 6.6.2. The PCHRD Executive Director directs the preparation of and signs the relevant

PCHRD Special Order for the appointment of the new member/s.

6.7. Communication with the new member/s

6.7.1. The Secretariat prepares the appointment documents of the selected new member/s that

include the terms of reference including roles and responsibilities of NEC members.

6.7.2. The Secretariat sends the appointment documents to the new member/s.

6.8. Signing of COI and Confidentiality Agreements

The Secretariat provides copies of the Conflict of Interest and Confidentiality Agreements to the new

member/s in the first NEC meeting that they will attend. They will be given enough time to study the

documents for their signature.

6.9. Filing

The Secretariat collects and keeps the signed COI and Confidentiality Agreements in the membership

file together with the appointment papers.

ANNEXES

NEC Form 1: Confidentiality Agreement, p43

NEC Form 2: Conflict of Interest Agreement, p44

DOCUMENT HISTORY

NEC SOP version 1

SOP Authors Ms. Imelda B. Mutuc and Ms. Charisma G. Cruz Page 4

Reviewed by Dr. Marita V.T. Reyes Review Date 7 August 2008

Approved by NEC Committee Approval Date 21 August 2008

NEC SOP version 2

Prepared by NEC Secretariat Page 6-8


Signed for effectivity by

Marita V.T. Reyes NEC Chair

Date 15 July 2014

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DISQUALIFICATION OF MEMBERS

SOP No. NEC SOP 03 Version No. 1 Version Date 17 April 2015 Effectivity 17 April 2015

1. POLICY

Disqualification of a member may be considered on the following grounds: 1. failure to attend three

(3) consecutive regular meetings without a justifiable reason; 2. willful nondisclosure of a Conflict of

Interest; and 3. conduct unbecoming of a member of the NEC.


Establishment of the process for disqualification of members is important to sustain an active and

efficient Committee. The process ensures that the proceedings will be fair and transparent.

3. SCOPE

This SOP shall apply to incumbent members of the NEC.


4.1. The Secretariat:

4.1.1. informs members regarding consecutive absences in regular meetings;

4.1.2. includes information on regrets in the attendance during meetings; and

4.1.3. logs and files pertinent records and documents.

4.2. The Members:

4.2.1. inform the secretariat of their reason/s for not being able to attend a meeting

4.2.2. participate in the deliberations regarding the disqualification of a member; and

4.3. The Chair:

4.3.1. presides over the deliberations on disqualification of members.

5. FLOWCHART

Flowchart 3: Disqualification of Members

NEC Member/s

NEC Member/s

Secretariat

Notification of concerned member

Start

Deliberation and decision

Communication of decision

End

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6. DETAILED PROCEDURES

6.1. Notification of the concerned member regarding consecutive absences or other possible

grounds for disqualification

If the member still fails to attend the next regular meeting, which will mark his 4th

consecutive nonattendance, he will be asked to resign from his position as NEC Member

through a formal letter. Aside from nonattendance, a member may still be disqualified from

the position based on willful nondisclosure of a conflict of interest and conduct unbecoming

of a member of the NEC.

6.2. Deliberation and decision

6.2.1. The concerned member will be given the opportunity to explain his/her side of the issue.

6.2.2. The disqualification issue will be included as an item in the agenda of a regular meeting.

6.2.3. The Committee shall deliberate on the matter in a judicious manner, ensuring that the

interest of the concerned member is balanced with that of the NEC.

6.3. Communication of the Committee’s decision

In the event that the final decision of the committee is to disqualify the member, a formal letter will be

prepared and sent to the concerned member containing the reason for disqualification.

DOCUMENT HISTORY

NEC SOP version 1


Reviewed and approved by NEC Committee Date 17 April 2015


Date 17 April 2015

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MANAGEMENT OF RESEARCH

DOCUMENTS FOR INITIAL REVIEW

SOP No. NEC SOP 04

Version No. 3

Version Date 19 October 2017

Effectivity 19 October 2017

1. POLICY

The NEC shall review protocols directed to it by government agencies including the Philippine Health

Research Ethics Board (PHREB), PCHRD, DOH, and UP Manila Research Ethics Board. All

submitted protocols shall be assigned its NEC code and logged accordingly.

All submissions are submitted through the Philippine Health Research Ethics Portal (PHREP) or by

email ([email protected]).

An application and review fee shall be paid by the proponent to the PCHRD Cashier.


Management of research documents for initial review ensures that all documents are properly

identified, codified, logged and acted upon appropriately.

3. SCOPE

This SOP refers to new protocols submitted for review. It starts with the receipt of research

documents until the type of review is determined.


4.1. The Secretariat:

4.1.1. Receives protocol documents through PHREP (with auto-generated code) or by email;

4.1.2. Assigns NEC code specific for the new submission; and

4.1.3. Checks that the submission is complete based on the fully accomplished NEC Form 03:

Application for Review.

4.2. The Chair:

4.2.1. determines the category to which the research proposal belongs;

4.2.2. decides if there are any additional documents needed for the review, i.e. institutional

endorsements, NCIP clearances, etc.

mailto:[email protected]

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5. FLOWCHART

Flowchart 4: Management of Protocol Submission for initial review

Secretariat

Secretariat

Chair and Secretariat

Secretariat




6.1. Receipt of Protocol documents for Initial Review

The NEC secretariat receives the proposal through PHREP or by email. PHREP manager

automatically assigns an auto-generated code specific to the submission. The submission should

include the appropriate endorsement letter from a recognized government agency for the submission

process to proceed. The researcher shall pay a processing fee of Php 5,000.00 to the Philippine

Council for Health Research and Development (PCHRD) Cashier, and present a copy of the receipt to

the secretariat for verification.

No

Yes

Determination of Type of Review

With more than

minimal risk?

or

With vulnerable

participants?

SOP

6

Expedited

Review

No

Full

Review

SOP

5

Yes

Inform proponent

of deficiency Complete?

Receipt of protocol documents

for initial review

Start

Screening for completeness of

submissions

Start

Assignment of Protocol Codes

Require Review?

No Exempted from

Review

Inform proponent

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6.2. Assignment of NEC Code

An NEC code will be assigned that indicates

a. Year of submission

b. Series number for the year

c. Proponent’s Surname

d. Short Title/Topic

as follows:

- - - Year - Series No. - PI Surname - Short Title/Topic

For example, proponent Juan dela Cruz submitted a protocol on HIV in 2014 and was the 5th proposal

submitted in that year, it will be coded as:

NEC Code: 2014 – 005 – dela Cruz – HIV

6.3. Screening for completeness of submissions

6.3.1. The Secretariat assesses whether the basic requirements for submission as listed in NEC

Form 03: Application for Review (Section 3: Checklist of Document) are complete

6.3.2. If protocol documents are complete and satisfactory, it is filed and logged into the

database. The researcher will then be asked to pay the review fee of Php 10,000.00 to

the Philippine Council for Health Research and Development (PCHRD) Cashier, and

present a copy of the receipt to the secretariat for verification.

6.3.3. If protocol documents are incomplete, the researcher is notified of the lacking

documents. Submission process will continue when the indicated documents are

received.

6.4. Determination of category of proposal

6.4.1. The Secretariat assesses the proposal and recommends to the Chair whether the

proposal falls under exemption from review or requires full or expedited review.

6.4.2. The NEC Chair decides on the category of the proposal and instructs the Secretariat to

proceed accordingly.

6.5. Exemption from Review

A Certificate of Exemption from Review (NEC Form 15c) shall be issued by the

committee, signed by the Chair when the research proposal -

6.5.1 does not involve human participants nor identifiable human materials and data, or

6.5.2. involves minimal interaction with participants like surveys, brief interviews or

observation of public behavior, where privacy and confidentiality are protected adequately

and it does not place the participants at risk of criminal or civil liability nor damage to

financial standing or reputation; or

6.5.3. is for institutional quality assurance or public health program evaluation or consumer

acceptability testing, or involves the use of publicly available data or information, and does

not entail more than minimal risks or harms.

6.6. Full/Expedited Review (SOP 5 and 6 respectively)

6.6.1. The Secretariat shall proceed to prepare for either full or expedited review by referring

to SOPs 5 or 6.

ANNEX:

NEC Form 3: Application Form for Ethics Review, p46

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DOCUMENT HISTORY

NEC SOP version 1

SOP Authors Ms. Imelda B. Mutuc and Ms. Charisma G. Cruz Page 2 Reviewed by Dr. Marita V.T. Reyes Review Date 7 August 2008 Approved by NEC Committee Approval Date 21 September 2008

NEC SOP version 3

Nature of Revisions

1.Processing and review fee were included

2. Determination of the category of review

3. Inclusion of the criteria for exemption from

review

4. Inclusion of the corresponding Form 15c: Certificate

of Exemption from Review

Prepared by NEC Committee Pages 11-14

Reviewed and approved by NEC Committee Date 19 October 2017

Signed for effectivity by Filipinas F. Natividad NEC Chair

Date 19 October 2017

NEC SOP version 2





Date 15 July 2014

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FULL REVIEW

SOP No. NEC SOP 05

Version No. 3

Version Date 21 February 2017

Effectivity 21 February 2017

1. POLICY

Proposals that 1. involve vulnerable participants, 2. entail more than minimal risk 3. use stem cell

technology and other emerging technologies shall undergo the full review process. Proposals shall be

evaluated for scientific and social value, scientific validity and ethical soundness using international

and national ethical guidelines.

The process of Full Review makes use of the primary reviewer system where one member with

scientific/medical interests and one with non-scientific/non-medical interest shall be assigned as

primary reviewers who will make a comprehensive ethical review report for presentation during a

committee meeting. The NEC may seek the help of independent consultants in the review. However,

only the members of the Committee participate in the final decision.

The reviewers of the proposals for full review must be present during the meeting. Decisions are made

by consensus.

Actions of the Committee shall include any of the following:

- No decision: Proponent needs to submit additional information or documents prior to an

ethical review decision

- Ethics review decision: Approved, Disapproved, Minor Revisions needed or Major

Revisions needed

The whole review process shall be completed within 7 weeks from receipt of a complete set of

documents. Only proposals submitted with complete documentation at least 2 weeks prior to the

scheduled regular quarterly meeting shall be included in the ongoing review cycle.

The proponent may appeal any decision of the NEC by submitting a letter containing the justification

for the appeal addressed to the Chair. All appeals will be discussed in a regular committee meeting.


Full review of pertinent research documents ensures that all members of the Committee are able to

participate in the assessment of and deliberation on a study that is of more than minimal risk and/or

one that involves vulnerable participants.

3. SCOPE

This SOP applies to the ethical evaluation of all research proposals that require a full review.


4.1. The Chair has the primary responsibility of

4.1.1. assigning the primary reviewers;

16 | 78

4.1.2. ensuring that the NEC obtains from the Researcher all the necessary information

pertinent to decision-making;

4.1.3. deciding if the researcher is required to attend the meeting to give clarifications and/ or

answer queries of the Committee;

4.1.4. inviting an external consultant as a resource in the review; and

4.1.5. ensuring that the Committee arrives at a decision.

4.2. The Secretariat

4.2.1. Ensures that relevant documents are available to and accessible by all NEC members.

4.3. The Primary Reviewers (PR)

4.3.1. Both members make an evaluation of the research proposals prior to the meeting using

the NEC Form 4: Reviewer’s Worksheet and/or NEC Form 5: ICF Checklist.

4.3.2. The member with non-scientific and non-medical interests will focus on the review of

the informed consent form and process.

4.3.3. Both members present their evaluation during the meeting.

4.4. Committee members

4.4.1. evaluate the research proposals based on review guidelines; and

4.4.2. actively participate in the deliberation of every proposal.

5. FLOWCHART

Flowchart 5: Full review process

Chair

Secretariat

Secretariat

Secretariat

Chair

Primary Reviewers

Committee

Committee


Secretariat

Conduct of Meeting (SOP 08)

Inclusion of the proposal in the agenda of

the next NEC Meeting

Start

Assignment of Primary

Reviewers (PR)

Forwarding of documents for review

and evaluation forms to PR

Forwarding of documents to committee

members

Presentation of Reports

NEC Form

4 & 5

Discussion

Deliberation and Formulation of decision

Communicating the decision and post-

approval requirements (SOP 11)

Filing of decision letter and excerpts of

minutes (SOP 12)

17 | 78


6.1. Assignment of Primary Reviewers

6.1.1. The Chair assigns the Primary Reviewers

6.1.2. The PRs will be selected based on their expertise in the light of the type of research to

be reviewed.

6.1.3. External consultants may be identified to act as resource in the review.

6.2. Forwarding of Proposal and Evaluation forms to Primary Reviewers

6.2.1. The Secretariat informs the PRs about their selection. The PRs must notify the

Secretariat if they are able to do review. In case a PR is not available, he/she must notify

the Secretariat and Chair so that another PR will be appointed.

6.2.2. The Secretariat forwards the proposal and supplementary documents to the PRs

including the review forms (NEC Form 04 and 05 or NEC Form 6.1 and 6.2 ), which

they will use in the review.

6.2.3. The review will include:

6.2.3.1. technical/scientific assessment, especially on the methodology, appropriateness

of study site, inclusion/exclusion criteria, relevant policies, study tools,

questionnaires, etc.

6.2.3.2. ethical assessment especially on vulnerability of participants, risks involved,

balancing of risks and benefits, protection of privacy, management of conflict of

interest, protection of patients’ rights, etc.

6.2.3.3. assessment of the informed consent/assent form and process including

appropriateness of translation to local language/dialect

6.2.3.4. appropriateness of qualifications of researchers and co-researchers

6.3. Inclusion of the proposal in the agenda of the next NEC Meeting

6.3.1. The research proposal will be included in the next meeting agenda by the Secretariat in

consultation with the Chair (SOP 7, Section 6.2).

6.3.2. The Primary Reviewers will be notified of the date of the meeting when the proposal

will be discussed.

6.4. Forwarding of documents to committee members

The Secretariat forwards the submission documents to the committee members in preparation for

discussion during the meeting. Best effort will be exerted to do this at least one (1) week before the

meeting.

6.5. Conduct of Meeting (SOP 08)

The meeting agenda will be followed as per notice of meeting and its approval.

6.6. Presentation of Reports

On the appropriate agenda item, the PRs present their review report that includes a summary of the

protocol and their comments and recommendations.

6.7. Discussion

6.7.1. The Chair acknowledges the report and invites the members to contribute their own

findings to generate a comprehensive review for decision making.

6.7.2. The Chair carefully moderates the discussion in an orderly manner following the

sequence of topics in the evaluation form, seeing to it that important ethical concerns are

addressed.

6.8. Deliberation and Formulation of decision

End

18 | 78

6.8.1. The Chair summarizes the issues and their resolution in preparation for decision

making.

6.8.2. The Committee decides by consensus. The decision of the committee may be any of the

following for specific submissions.

6.8.2.1. Initial submissions

A. Approved

The proposal is approved and will be granted an ethical clearance as written.

B. Disapproved

The proposal is not granted an ethical clearance because of major ethical and scientific problems. The

reasons for the disapproval should be clearly identified and included in the NEC evaluation letter to

researcher.

C. Minor Revisions Required

The proposal is not granted an ethical clearance until the minor revisions to the proposal are received

and approved. These minor revisions may include a change in the title, improvements in the language

of the Informed Consent Form or other alterations that do not alter the favorable benefit-risk

assessment. Subsequent submissions may undergo expedited review through SOP 4 and SOP 6)

D. Major Revisions Required

The proposal is not granted an ethical clearance until major revisions to the proposal are received and

approved. Major revisions include change in the research objectives, change in the research design,

or any change that will alter the favorable benefit-risk assessment. Subsequent submissions must

undergo full review through SOP 4 and SOP 5.

6.8.2.2. Progress reports

A. Accepted

The report is accepted and found satisfactory e.g. report submitted on time, information on

recruitment status, adverse events, protocol deviation, amendments, other challenges and issues,

courses of action.

B. Need for additional Information

The report needs additional information regarding issues identified by the Committee.

C. Action required

The Committee decides that the researcher needs to act on certain issues identified by the Committee

in order to protect participants.

6.8.2.3. Final reports

A. Accepted

The report is accepted and found satisfactory e.g. report submitted on time, title and objectives of the

study consistent with the original proposal unless with prior approved amendment/s, reported adverse

events resolved appropriately with summary of results.



C. Action required

The Committee decides that the researcher needs to act on certain issues identified by the Committee

in order to protect participants.

D. Not accepted

19 | 78

The Committee finds certain aspects of the report that have implications on veracity and consistency.

The Committee requires resubmission of the corrected report.

6.8.2.4. Amendment

A. Approved

The Amendment is approved and can be implemented as written.

B. Need for additional information

The Committee finds that the amendment requires justification.

C. Revision of the Consent form and/or reconsent of participants

The Committee finds that the amendment is major so that the consent form has to be revised

accordingly. Reconsent may also be required.

6.8.2.5. Early Termination Report

A. Acknowledgment

The Committee finds that the early termination of the study by either the sponsor/funder or the

researcher is justified and that the participants’ welfare has been looked into properly.


The Committee finds the justification for early termination unclear and needs further explanation.

C. Action needed

The report does not describe an acceptable management of the welfare of the participants.

6.8.2.6. SAEs and SUSARs

A. Acknowledgment

The SAEs are deemed not related to the study while the SUSARs have been managed satisfactorily.


The details of the report are inadequate or there is a need for justification for a late report.

C. Action needed

The report does not describe an acceptable management of the welfare of the participants.

6.8.2.7. Protocol deviations/violations

The source/cause of the deviation (whether it is from the participant, researcher, or others) is

determined from the protocol deviation report in order to recommend appropriate corrective action.

A. Notation

Protocol deviations/violations are minor and there is no negative impact on the risk-benefit ratio and

integrity of data.


The details of the deviation/violation are inadequate or there is a need for an explanation of why and

how the deviation/violation happened.

C. Need for Corrective Action

The Committee requires the researcher to implement corrective action so that the deviation/violation

will not be repeated, well-being of the participants is promoted and integrity of data is protected.

6.9. Alert for Continuing Review

20 | 78

Alerts will be calendared by the Secretariat to serve as reminders to the NEC directly and to the

researchers/investigators indirectly, for submissions which are due, whenever possible, e.g. contingent

on specified dates

6.10. Communicating the NEC Decision and post-approval requirements

The decision of the NEC will be communicated to the researcher following SOP 11: Management of

Communications.

The requirement for and frequency of submission of reports (i.e. progress and final reports,

SAEs/SUSARs, protocol deviations/violations, and early termination report) are stated in the approval

letter that is sent to the proponent after the initial review of the study. The frequency of

submissions for continuing review is determined based on the level of risk and duration of the study.

The letter is prepared by the Secretariat and signed by the Chair.

6.11. Filing of decision letter and excerpts of minutes

The Secretariat updates the protocol files and database accordingly (SOP 12). The research will be

logged using the NEC Form 10: Log of Research Submissions.

ANNEX:

NEC Form 4: Reviewer’s Worksheet, p48

NEC Form 5: ICF Checklist, p50

NEC Form 6.1: Reviewer’s Worksheet for Stem Cell Researches, p53

NEC Form 6.2: ICF Checklist for Stem Cell Researches, p57

NEC Form 9: Continuing Review Form, p63

NEC Form 10: Log of Research Submissions, p.65

DOCUMENT HISTORY

NEC SOP version 4

Nature of Revision

1. Change of title from Full Review of Research Proposals to Full Review


Reviewed and approved by NEC Committee Date 19 October2017


Date 19 October2017

NEC SOP version 3

Nature of Revision

1. Addition of mechanism for appeals in the policy statement

2. Criteria for decision points on Progress and Final reports

3. Management of Protocol deviations/violations


Reviewed and approved by NEC Committee Date 21 February 2017


Date 21 February 2017

21 | 78

NEC SOP version 1

SOP Authors Ms. Imelda B. Mutuc and Charisma G. Cruz Page 14



NEC SOP version 2





Date 15 July 2014

22 | 78



EXPEDITED REVIEW

SOP No. NEC SOP 06

Version No. 4

Version Date 19 October 2017

Effectivity 19 October 2017

1. POLICY

Proposals/reports that do not involve vulnerable populations or have no vulnerability issues and/or do

not entail more than minimal risk shall undergo Expedited Review. Proposals shall be evaluated for

scientific and social value, scientific validity and ethical soundness using international and national

ethical guidelines.

Expedited Review is also applicable to minor revisions or amendments to an approved protocol e.g.

decrease in the amount of blood to be extracted, change in site, change of contact person, addition of

Principal Investigator/s or sub-investigator/s, change in contact numbers and similar actions that have

minimal impact on patient safety and risks.

The review shall be conducted by at least two reviewers, one scientific/medical and one non-

scientific/non-medical. The summary and status of Expedited Reviews shall be presented during the

next NEC Meeting.

The whole review process shall be completed within 6 weeks from receipt of a complete set of

documents.

The proponent may appeal any decision of the NEC by submitting a letter containing the justification

for the appeal addressed to the Chair. All appeals will be discussed in a regular committee meeting.


Expedited Review aims to make the work of the Committee efficient by assigning the comprehensive

review of pertinent researches that entail minimal risk and which do not involve vulnerable

participants to a few experts and thus relieving the agenda of the Committee meeting.

3. SCOPE

This SOP applies to the ethical evaluation of proposals (e.g., new protocols, resubmissions,

amendments) which are deemed subject to Expedited Review. It starts with the assignment of

reviewers and ends with the inclusion of the review report in the agenda of the next regular meeting.


4.1. The Chair

4.1.1. assigns the appropriate reviewers;

4.1.2. reviews the summary of evaluation results; and

4.1.3. finalizes review outcome in consideration of the reviewers’ evaluation.


4.2.1. ensures that relevant documents are complete and available to the reviewers;

4.2.2. collates the evaluation reports of reviewers and forwards the summary of evaluation to

the Chair; and

23 | 78

4.2.3. drafts communication letter to the researcher.

4.3. The Reviewers

4.3.1. evaluate the research proposals using the NEC Form 4: Reviewer’s Worksheet and/or

NEC Form 5: ICF Checklist, depending on their disciplinal/sector representation

(scientific or non-scientific/medical or non-medical); and

4.3.2. submit the fully accomplished Evaluation Forms to the Secretariat.

5. FLOWCHART

Flowchart 6: Expedited review process

Chair

Secretariat

Secretariat

Reviewers

Secretariat

Secretariat

Chair and PRs

Secretariat and Chair

Secretariat

Secretariat

Secretariat


NEC Form

4 & 5

Start

Assignment of reviewers

Forwarding of documents and

evaluation forms to assigned Reviewers

Submission of evaluation report to

Secretariat

Forwarding of summary of

evaluations to Chair

Review of proposal and

supplementary documents

Yes

Re-evaluation

of documents

No Are

recommendations

compatible?

Preparation of decision letter

Communicating decision to

researcher (SOP 11)

Filing of decision letter and excerpts of minutes

Inclusion of the Expedited Review Report in

the Agenda of the next meeting

End

24 | 78

6.1. Assignment of Reviewers

6.1.1. The Chair assigns the Reviewers

6.1.2. The Reviewers will be selected based on their expertise in the light of the type of

research to be reviewed.

6.1.3. External consultants may be identified to act as resource in the review.

6.2. Forwarding of the Proposal/Report to the Reviewers

6.2.1. The Secretariat notifies the assigned reviewers. The assigned reviewers must notify the

Secretariat if they are able to do review so that other members can be assigned if

necessary.

6.2.2. The secretariat sends the reviewers copies of the research submissions together with the

review forms (NEC Form 04 and 05 or NEC Form 6.1 and 6.2).

6.3. Review of Proposal and Supplementary Documents

6.3.1. The reviewers accomplish the review forms and write their comments and

recommendations.

6.3.2. The review will include:

6.3.2.1. technical/scientific assessment, especially on the methodology, appropriateness

of study site, inclusion/exclusion criteria, relevant policies, study tools,

questionnaires, etc.

6.3.2.2. ethical assessment especially on vulnerability of participants, risks involved,

balancing of risks and benefits, protection of privacy, management of conflict of

interest, protection of patients’ rights, etc.

6.3.2.3. assessment of the informed consent/assent form and process including

appropriateness of translation to local language/dialect

6.3.2.4. appropriateness of qualifications of researchers and co-researchers

6.4. Submission of Evaluation Results to Secretariat

6.4.1. The reviewers submit their evaluation results to the Secretariat with their

recommendations. The recommendation of the NEC reviewer may be any of the

following for specific submissions as follows:

6.4.1.1. Initial submission

A. Approved

The protocol is approved and will be granted an ethical clearance as written.

B. Disapproved

The proposal is not granted an ethical clearance because of major ethical and scientific

problems. The reasons for the disapproval should be clearly identified and included in the

NEC evaluation letter to researcher.

C. Minor Revisions Required

The proposal is not granted an ethical clearance until the minor revisions to the protocol are

received and approved. These minor revisions may include a change in the title,

improvements in the language of the Informed Consent Form or other alterations that do not

alter the favorable benefit-risk assessment. Subsequent submissions may undergo Expedited

Review through SOP 4 and SOP 6)

D. Major Revisions Required

The proposal is not granted an ethical clearance until major revisions to the protocol are

received and approved. Major revisions include change in the research objectives, change in

25 | 78

the research design, or any change that will alter the favorable benefit-risk assessment.

Subsequent submissions must undergo Full Review through SOP 4 and SOP 5.

6.4.1.2. Progress reports

A. Accepted

The report is accepted and found satisfactory.



C. Action required

The researcher needs to act on certain issues identified by the Committee in order to protect

participants.

6.4.1.3. Final reports

A. Accepted

The report is accepted and found satisfactory e.g. report submitted on time, title and

objectives of the study consistent with the original proposal unless with prior approved

amendment/s, reported adverse events resolved appropriately with summary of results.



C. Action required

The Committee decides that the researcher needs to act on certain issues identified by the

Committee in order to protect participants.

D. Not accepted

The Committee finds certain aspects of the report that have implications on veracity and

consistency. The Committee requires resubmission of the corrected report.

6.4.1.4. Amendment

A. Approved

The Amendment is approved and can be implemented as written.


The Committee finds that the amendment requires justification.

C. Revision of the Consent Form and/or reconsent of participants

The Committee finds that the amendment is major so that the Consent Form has to be revised

accordingly. Reconsent may also be required.

6.4.1.5. Early Termination Report

A. Acknowledgment

The Committee finds that the early termination of the study by either the sponsor/funder or

the researcher is justified and that the participants’ welfare has been considered properly.


The Committee finds the justification for early termination unclear and needs further

explanation.

C. Action needed

The report does not describe an acceptable management of the welfare of the participants

26 | 78

6.4.1.6. SAEs and SUSARs

A. Acknowledgment of the Report

The SAEs are deemed not related to the study while the SUSARs have been managed

satisfactorily. No further action is required.


The details of the report are inadequate or there is a need for justification for a late report.

C. Action needed

The report does not describe an acceptable management of the welfare of the participants

6.4.1.7. Protocol deviations/violations

The source/cause of the deviation (whether it is the responsibility of the participant, researcher, or

others) is determined from the protocol deviation report in order to recommend appropriate

corrective action.

A. Notation

Protocol deviations/violations are minor and there is no negative impact on the risk-benefit

ratio and integrity of data. No further action is required.


The details of the deviation/violation are inadequate or there is a need for an explanation of

why and how the deviation/violation happened.

C. Need for Corrective Action

The Committee requires the researcher to implement corrective action so that the

deviation/violation will not be repeated.

6.5. Forwarding of Summary of Evaluations to Chair

6.5.1. The Secretariat collates the review results and forwards the summary to the Chair.

6.5.2. The Chair evaluates the review reports for compatibility and consistency. He/She

makes the final decision taking into consideration the reviewers’ recommendations and

his/her own findings and assessment.

6.6. Preparation of evaluation letter

The Secretariat and Chair prepare the evaluation letter that will contain the decision of the NEC, and

the comments and recommendations of the reviewers, if any.

6.7. Alert for Continuing Review

Alerts will be calendared by the Secretariat to serve as reminders to the NEC directly and to the

researchers/investigators indirectly, for submissions which are due, whenever possible, e.g.,

contingent on specified dates.

6.8. Communicating the NEC decision and post-approval requirements The decision of the NEC will be communicated to the researcher following SOP 11: Management of

Communications.

The requirement for and frequency of submission of reports (i.e. progress and final reports,

SAEs/SUSARs, protocol deviations/violations, and early termination report) is stated in the approval

letter that is sent to the proponent after the initial review of the study. The frequency of submissions

for continuing review is determined based on the level of risk and duration of the study. The letter is

prepared by the Secretariat and signed by the Chair.

6.9. Filing of decision letter and excerpts of minutes

27 | 78

The Secretariat updates the protocol files and database accordingly (SOP 12). The research will be

logged using the NEC Form 10: Log of Research Submissions.

6.10. Inclusion of the Expedited Review Report in the next Meeting Agenda 6.10.1. The Secretariat prepares the report on Expedited Reviews of research proposals for

initial review using the NEC Form 10: Log of Research Submissions.

6.10.2. The report will be included in the next meeting agenda (SOP 7).

6.10.3. The Chair and Secretariat present the report during the next NEC meeting.

ANNEX:

NEC Form 4: Reviewer’s Worksheet, p48

NEC Form 5: ICF Checklist, p51

NEC Form 6.1: Reviewer’s Worksheet for Stem Cell Researches, p53

NEC Form 6.2: ICF Checklist for Stem Cell Researches, p57

NEC Form 9: Continuing Review Form, p63

NEC From 10: Log of Research Submissions, p.

DOCUMENT HISTORY

NEC SOP version 4

Nature of Revision

1. Expansion of the criteria for expedited review to include proposals that

have “vulnerability issues”.

2. Clarification of the Scope of the SOP as starting “with the assignment of

reviewers” and ending “with the inclusion of the review report in the agenda

of the next regular meeting”.

3. Clarification of an Acknowledgment decision. “The SAEs not are related

to the study while the SUSARs have been managed satisfactorily. No

further action is required.

4. Clarification of the notation decision for minor deviations

5. Minor edits;

5.1 Change of title from Expedited review of Proposals to Expedited Review

5.2 Protocol submissions to Proposals/Reports


Reviewed and approved by NEC Committee Date 19 October 2017


Date 19 October 2017

NEC SOP version 3

Nature of Revision

1. Addition of mechanism for appeals in the policy statement

2. Criteria for decision points on Progress and Final reports

3. Management of Protocol deviations/violations





28 | 78

NEC SOP version 1


NEC SOP version 2




Date 15 July 2014

Yes

No

Review of

proposal

and

supplement

29 | 78



PREPARATIONS FOR A MEETING

SOP No. NEC SOP 7 Version No. 2 Version Date 13 June 2016

Effectivity 13 June 2016

1. POLICY

The NEC shall have regular quarterly meetings preferably on the 2nd

Friday of March, June,

September, and December of the year. Schedule of meeting may be moved depending on the

availability of the members. Special meetings may also be scheduled in between regular meetings if

there are urgent matters; when time considerations may impact negatively on research conduct and

ethical concerns that need the Committee’s decision.

All meetings shall have a quorum of at least 4 members from the scientific, and 1 from the non-

scientific community. If quorum is not achieved during the meeting, the meeting may proceed as a

caucus that shall be appropriately documented. Confirmation of attendance prior to the meeting is

obtained to determine possibility of quorum.

The meeting agenda shall be prepared to ensure that all proposals, reports and other concerns will be

discussed in the meeting. For an orderly conduct of the meeting, a standardized template of the

agenda shall serve as a guide to the presiding officer and all the meeting attendees.

The meeting shall take place in a closed venue to maintain confidentiality especially in the review of

researches. The Secretariat shall manage preparations for the meeting

2. PURPOSE

This SOP aims to describe the processes required in scheduling NEC meetings and ensuring that the

preparations before the meeting are properly done.

3. SCOPE

This SOP applies to, and describes, all processes to be followed in scheduling and preparing for,

NEC meetings.

4. ROLES AND RESPONSIBILITES

4.1. The Chair

4.1.1. Sets date of meeting


4.2.1. coordinates with the NEC Chair regarding agenda of the meeting

4.2.2. notifies members of the meeting and check their availability on the date of the meeting;

4.2.3. checks for quorum before meeting to determine if meeting will push through;

4.2.4. prepares physical arrangements and meeting materials; and

4.2.5. distributes meeting materials to the Chair and members, and invited guests when

applicable

4.3. The Members

4.3.1. confirm their availability to attend the scheduled meeting to the Secretariat

30 | 78

5. FLOWCHART

Flowchart 7: Preparations before the meeting

Chair

Secretariat

Secretariat

Members

Secretariat

Secretariat


6.1. Setting date of NEC meeting

6.1.1. Regular meetings of the NEC are held every 2nd

Friday of the months of March, June,

September and December. However, depending on the availability of the Chair and

Members, the meeting may be set on another date.

6.1.2. The Chair may call for a special meeting using Table 1: Timetable for scheduling

special meetings.

6.1.3. The proponents of proposals for review shall be informed of the meeting date and shall

be asked to make themselves available on the date to respond to possible queries.

6.2. Preparation of the tentative meeting agenda

6.2.1. The Secretariat drafts a tentative agenda of the meeting in consultation with the Chair

using NEC Form 7: Agenda of the Meeting Template

6.3. Notification of the members and invited guests

6.3.1. The Secretariat notifies the NEC members of the meeting date and venue through phone

call, text message or email.

6.3.2. Upon instructions of the Chair, the Secretariat may invite guests to the meeting with a

clear explanation of their role in the meeting.

6.4. Confirmation of attendance

6.4.1. Members confirm their attendance to the meeting prior to the meeting date. If quorum

cannot be achieved, the meeting may be moved to another date when majority of

members can attend.

6.4.2. Members who cannot attend the meeting shall duly inform the Secretariat of the reason

of their nonattendance.

Start

Preparation of tentative meeting

agenda

Notification of Members and invited

guests

Confirmation of attendance

End

Physical arrangements

Checking for quorum

Setting date of the meeting

31 | 78

6.5. Checking for quorum

6.5.1. The Secretariat takes note of the members who confirmed their attendance and checks

for quorum.

6.5.2. The Secretariat informs the Chair of the presence or absence of a quorum and gives the

names of members who will attend the meeting.

6.6. Physical arrangements and preparation of meeting materials

The Secretariat reserves the venue for the meeting and prepares the materials needed.

ANNEX:

NEC Form 07: Agenda of the Meeting Template, p59

DOCUMENT HISTORY

NEC SOP version 1


NEC SOP version 2

Prepared by Dr. Marita V.T. Reyes, Dr. Filipinas Natividad and NEC

Secretariat Pages 28-30

Reviewed and approved by NEC Committee Date 13 June 2016


Date 13 June 2016

32 | 78



CONDUCT OF MEETING

SOP No. NEC SOP 08

Version No. 2 Version Date 28 May 2015


1. POLICY

The meeting shall be presided by the Chair and shall start when the Chair calls the meeting to order.

The Tentative Agenda of the meeting shall be approved by the Committee at the start of the meeting.

Any member can propose items in the agenda that are deemed important for deliberation or

discussion. The meeting shall be conducted in accordance with the approved agenda.

A quorum is declared when five (5) members including one (1) whose interest is non-scientific are

present.

All issues should have been properly discussed and decisions properly documented at the end of the

meeting. The meeting ends upon adjournment by the Chair.


Regular NEC meetings are held to be able to discuss, deliberate and update on important matters

involving NEC, and to conduct full review, as well as continuing review of researches. Proper

conduct of a meeting will ensure that topics in the agenda are thoroughly discussed; conflict of

interest issues are managed; recommendations, ideas and suggestions of the members are heard; and

decisions and deliberations are documented.

3. SCOPE

This SOP applies to the process involved in the conduct of the NEC meeting.


4.1. The Chair

4.1.1. presides over the meeting;

4.1.2. asks members if there are any conflicts of interests; and

4.1.3. summarizes the issues, recommendations and decisions made during the meeting.


4.2.1. notes attendance of members;

4.2.2. assists the Chair and the members during the meeting; and

4.2.3. documents the deliberations and decisions made during the meeting.

4.3. The Members participate in the deliberation of every item in the agenda especially those that

require decisions to be made.

4.4. The Primary Reviewers present their evaluation of the researches assigned to them to serve

as basis for discussion and enable the Committee to come up with a sound decision.

33 | 78

5. FLOWCHART

Flowchart 12: Conduct of the NEC Meeting

Chair

NEC

Members

Secretariat

NEC

NEC

Chair

Chair

6. PROCEDURES

6.1. Call to order

The meeting will start when the Chair calls it to order, taking note that all, if not majority, of the

members are already present.

6.2. Approval of the Meeting Agenda

The present members revise and/or approve the Tentative Meeting Agenda prepared by the Secretariat

and Chair

6.3. Declaration of Conflict of Interest (COI)

The members declare if there is COI prior to a full review of research. Those with COI shall be

exempted from giving their decision in the review of the research.

6.4. Determination of quorum

6.4.1. The Secretariat states if there is quorum during meeting and reports the reasons for non-

attendance of the members who cannot make it to the meeting. If quorum is not

achieved the meeting will continue as a caucus and the Secretariat shall document it

accordingly in the minutes of the meeting.

6.4.2. The Secretariat takes note that quorum is maintained throughout the meeting, especially

when a member/s declares a COI for a certain research for review.

6.5. Approval of the minutes of the previous meeting

The Chair and Members review and approve the minutes of the previous meeting. Businesses arising

from the minutes shall be included in the discussion.

Call to Order

Start

Determination of quorum

Approval of the Meeting Agenda

Declaration of Conflict of Interest

Discussion on each topic in the

approved agenda

Summary of decisions

Adjournment

End

Approval of the minutes of the

previous meeting

34 | 78

6.6. Discussion/deliberation on each topic in the approved agenda

6.6.1. The meeting shall progress according to the approved agenda.

6.6.2. The Secretariat shall document the deliberations during each topic/issue and shall

include these in the minutes of the meeting.

6.6.3. During review of proposals, the primary reviewers will present their findings and

recommendations to the group. They members will then deliberate on the research to

come up with a decision (refer to SOP 5 Section 6.8).

6.7. Summary of decisions

The Chair summarizes the decisions, actions and resolutions that the group came up with for each

topic in the agenda.

6.8. Adjournment

The Chair adjourns the meeting when all topics in the agenda have been discussed.

DOCUMENT HISTORY

NEC SOP version 1

SOP Authors Ms. Imelda B. Mutuc and Ms. Charisma G. Cruz Page


Approved by NEC Committee Approval Date 21 September 2008

NEC SOP version 2



Signed for effectivity by Marita V.T. Reyes

NEC Chair

Date 19 June 2015

35 | 78



PREPARATION OF MINUTES OF THE

MEETING

SOP No. NEC SOP 09

Version No. 2

Version Date 18 May 2015


1. POLICY

The Minutes of the Meeting shall be based on the approved agenda. It shall reflect the nature of the

issues raised, how these were resolved, and the corresponding decisions made during the meeting. It

shall also contain the names of the members present, who participated in the deliberations of certain

researches, and those who did not participate in the review of researches due to conflict of interest.

The minutes of the meeting shall be prepared two weeks before the next Committee meeting and

approval will be done in that meeting.


The minutes of the meeting are carefully prepared to ensure that all decisions made are accurately

recorded for reference.

3. SCOPE

This SOP covers the processes in the preparation of minutes of the meeting, the persons responsible

for drafting and approval of the document, and the information included in the minutes.


4.1. The Secretariat prepares draft of minutes of the meeting and submits it to the Chair for

review;

4.2. The Chair reviews and approves the draft minutes of the meeting; and

4.3. The NEC Members including the Chair review and approve the Minutes of the Meeting in

the next NEC Meeting.

5. FLOWCHART

Flowchart 9: Preparation of the Minutes of the Meeting

Secretariat

Chair and Members

NEC Members and Chair

Preparation of the draft minutes of the

meeting

Start

Review of the draft minutes of the meeting

Approval of the minutes of the meeting

End

36 | 78


6.1. Preparation of the draft minutes of the meeting

6.1.1. The Secretariat prepares draft of the minutes using NEC Form 08: Minutes of the

Meeting, within two weeks after the meeting.

6.1.2. The Secretariat ensures that the minutes contain the attendance and presence of

quorum, the identity of the presiding officer, the agenda, the management of conflict of

interest, issues discussed, proposed management/resolutions and final

recommendation/s. The actions on specific issues and the persons responsible are

summarized at the end of the document.

6.1.3. The draft of the minutes is sent to the Chair for revision/correction.

6.2. Review of the draft minutes of the meeting

6.2.1. During the subsequent NEC meeting, the Committee reviews the draft minutes and

gives comments, clarifications and suggestions.

6.2.2. The Secretariat incorporates the suggestions and revisions on the minutes.

6.3. Approval of the minutes of the meeting

6.3.1. The corrected minutes are finalized and approved formally by the Committee during

the meeting.

ANNEX:

NEC Form 08: Minutes of the Meeting Template, p60

DOCUMENT HISTORY

NEC SOP version 1


NEC SOP version 2




Date 19 June 2015

37 | 78



MONITORING AND CONTINUING

REVIEW

SOP No. NEC SOP 10

Version No. 4 Version Date 21 February 2017

Effectivity 21 February 2017

1. POLICY

All research projects approved for implementation shall undergo monitoring and continuing review

until completion or termination. Monitoring review shall include the submission of interim or

progress reports (quarterly, semi-annually or annually, as determined by the NEC), serious adverse

events (SAEs), adverse drug reactions and suspected unexpected serious adverse reactions (SUSAR),

protocol deviations/violations, amendments to the protocol, and early termination decision. Final

reports shall be submitted two months after the completion of the study.

Continuing review refers to request for extension and renewal of ethical clearance. The requirement

for continuing review shall be stated in the NEC approval letter. The schedule of submissions for

continuing review is determined based on the level of risk and duration of the study.

The frequency of reports is indicated in the approval letter using NEC SOP 08, Item 4.2.

The researcher shall be given sanctions for non-compliance with continuing review requirements.

After thorough deliberation on the impact on participant safety and rights, the NEC shall decide on

any of the following actions:

Closer monitoring of study implementation

Suspension of recruitment of study participants

Withdrawal of ethical clearance for the study

The researcher shall be given 30 days to appeal the NEC decision.


Continuing review is a means of monitoring the study implementation. It ensures that the study

procedures are done according to the approved protocol and that the safety and well-being of the

study participants are addressed consistently.

3. SCOPE

Continuing review is conducted for each report submitted and for a request for extension of ethical

clearance. It starts upon submission of the required reports or request for extension of ethical

clearance and ends with communicating with the researcher regarding acceptance of the reports

without any required further action or approval of the application for extension of ethical clearance.


4.1. The Chair

4.1.1. Determines type of review;

4.1.2. Instructs the Secretariat to proceed accordingly; and

4.1.3. Communicates the decision of the NEC to the researcher.


4.2.1. Receives and records the report and/or the application for extension of ethical clearance;

38 | 78

4.2.2. Informs NEC Chair about the submission; and

4.2.3. Forwards the report and/or application together with the pertinent original documents to

the designated reviewers either for expedited review or for full review.

5. FLOWCHART

Flowchart 10: Submission of reports/amendments for continuing review

Secretariat

Secretariat

Secretariat

Secretariat

Chair

Chair, Members, and Secretariat


6.1. Receipt of report/request for extension of ethical clearance

The Secretariat receives the report and/or request for extension of ethical clearance and checks the

timeliness of the report and/or application and notes the information accordingly. The appropriate

application form for review shall be accomplished as follows:

Request for extension or renewal of ethical clearance:

o NEC Form 9 (Continuing review)

o NEC Form 11 (Log of Post-Approval Submissions)

Request for Review of Progress Report: NEC Form 12

Request for Review of Amendments: NEC Form 13

Request for Final Report: NEC Form 14

6.2. Logging of submitted document

The Secretariat enters the study information in the protocol logbook.

6.3. Retrieval of pertinent related documents

Start

Receipt or report and/or request for

extension of ethical clearance

Retrieval of pertinent related

documents

SOP 6

Determination of type of review

Expedited review Full review

SOP 5

Informing the NEC Chair of the report

and/or application

Logging of submitted document

39 | 78

The Secretariat retrieves study records, e.g., approved protocol and ICF or latest versions of the

protocol and ICF, earlier progress reports, etc., whichever is relevant to the present submission.

6.4. Informing the NEC Chair of the report and/or application

The Secretariat informs the Chair about the submission and forthwith submits the accompanying

documents and the pertinent previous documents.

6.5. Determination of type of review The Chair decides the type of review based on the degree of risk to participants.

6.6. Full or Expedited Review

The NEC Chair instructs the Secretariat to proceed with the applicable SOP, i.e., SOP 06 for

expedited review and SOP 05 for full review.

6.7. Communication with the Researcher

The result of the evaluation is communicated to the researcher according to SOP 11 (communicating

with the researcher)

ANNEX:

NEC Form 9: Continuing review, p63

NEC Form 11: Log of Post-Approval Submissions, p66

NEC Form 12: Progress Reports, p67

NEC Form 13: Amendments, p68

NEC Form 14: Final Report, p69

DOCUMENT HISTORY

NEC SOP version 4

Prepared by Secretariat Pages 36-39



Filipinas F. Natividad

NEC Chair


NEC SOP version 3

Prepared by Dr. Sonny Matias E. Habacon and Dr.

Marita V.T. Reyes

Pages 35-37

Reviewed and approved by NEC Committee Date 24 April 2016


Marita V.T. Reyes

NEC Chair

Date 24 April 2016

NEC SOP version 2

SOP Authors NEC Secretariat and Chair

40 | 78

Reviewed by Dr. Marita V.T. Reyes Review Date 19 June 2015

Approved by NEC Committee Approval Date 19 June 2015

NEC SOP version 1

SOP Authors Ms. Marie Jeanne Berroya and Ms. Anthea Maliz Cortes

Reviewed by Dr. Marita V.T. Reyes Review Date 02 April 2013

Approved by NEC Committee Approval Date 02 April 2013

41 | 78

NATIONAL ETHICS COMMITTEE STANDARD OPERATING PROCEDURES

MANAGEMENT OF COMMUNICATIONS

SOP No. NEC SOP 11 Version No. 1 Version Date 18 May 2015


1. POLICY

NEC Communications are classified as incoming and outgoing communications.

Incoming communications include applications for initial review, post-approval reports, requests for

extension of ethical clearance and inquiries. Initial review and post-approval reports are covered by

SOPs 4 and 10, respectively. Outgoing communications include decisions on initial review,

continuing review, and responses to requests for extension of ethical clearance.

The Committee shall communicate its initial review decisions within 7 weeks after receipt of the

complete set of documents for full review and within 6 weeks for expedited review. All responses to

requests and inquiries shall be sent within 2 weeks from date of receipt.

Decisions on requests for formal extension of ethical clearance shall be based on the NEC record of

submission of progress and other reports pertinent to continuing review.

All official outgoing communications must be signed by the Chair. Communications sent through

email shall be saved and documented for future references. All study-related communications shall be

treated with confidentiality.


Management of Communications aims to make the process efficient and responsive to the needs of

the NEC stakeholders.

3. SCOPE

This SOP covers that steps required in the management of incoming (i.e. requests for extension of

ethical clearances and inquiries) and outgoing communications.


4.1. The Chair reviews and signs all NEC letters and correspondences.


4.2.1. Prepares drafts of responses and other relevant communications; and

4.2.2. Stamps and logs all NEC letters and correspondences released.

42 | 78

5. FLOWCHART

Flowchart 11.1: Incoming Communications

Secretariat

Secretariat/Chair

Secretariat

Flowchart 11.2: Outgoing Communications

Secretariat

Secretariat and Chair

Secretariat


6.1. Incoming Communications

6.1.1. Entry to Logbook

The Secretariat logs the date, name of sender and nature of communication/inquiry.

6.1.2. Preparation of response

The Secretariat answers directly all inquiries on the type of researches reviewed by the NEC, the

schedule of review and other administrative issues. and refers requests for extension of ethical

clearance to the Chair with information on post-approval reports. The Chair asks the Secretariat to

draft either a positive or a negative response.

6.1.3. Release of NEC Response

The Chair signs the formal response and the Secretariat informs the addressee of the availability of the

letter for pick-up.

6.2. Outgoing Communications

6.2.1. Preparation of Draft

The Secretariat prepares the Draft of decision letter on initial and post-approval reviews based on

review reports and minutes of the meeting using NEC Form 15a: Decision Letter Template and NEC

Form 15b: Ethical Clearance Template.

Draft of communication

Review and finalization of

communication

Release of NEC response to the

recipient

End

Start

Start

Entry to logbook

Preparation of response

Release of response

End

43 | 78

6.2.2. Review and finalization of Communication

6.2.2.1. The Chair reviews the draft and makes the appropriate revisions for finalization.

6.2.2.2. The Chair signs the final version of the letter.

6.2.3. Release of NEC Response

The Chair signs the formal response and the Secretariat informs the addressee of the availability of the

letter for pick-up.

ANNEX:

NEC Form 15a: Decision Letter Template, p70

NEC Form 15b: Ethical Clearance Template, p71

DOCUMENT HISTORY

NEC SOP version 1

Prepared by NEC Secretariat Page 40-42



Date 19 June 2015

44 | 78



MANAGEMENT OF NEC FILES

SOP No. NEC SOP 12

Version No. 2

Version Date 18 May 2015


1. POLICY

The NEC files shall be kept properly as study files or administrative files. All study files must be

identified through codification and kept in the database. Access to files must be regulated and limited.

The NEC shall endeavor to maintain a paperless filing and archival system.

Files are classified as active or inactive. Active files pertain to approved and ongoing studies, and

current administrative files. Inactive files pertain to completed, terminated, and withdrawn and “lost”

studies. The latter refers to studies where no communications have been received for at least one year.

Hard copies of study files that have been completed/ terminated shall be archived for five years

beyond which they are discarded by shredding.

All other files (membership file, staff file, and minutes of meeting) shall be kept for ten years before

they are discarded by shredding provided that the soft copies of minutes of meeting and database are

maintained indefinitely.

Only the Secretariat and members of the NEC can access study files and only in relation to the review

process. They are bound by the confidentiality agreement to ensure the security and confidentiality of

these copies.


The files of the Committee must be properly managed so that identification, security, confidentiality,

easy retrieval and efficient review and reporting are ensured.

3. SCOPE

This SOP covers the management of active and inactive files, both study and administrative, and the

process by which they will be kept.


Compliance to this SOP lies in the Secretariat. The Secretariat will be responsible for the proper

coding of documents for filing, management of the database and documents to be archived and

maintenance and updating of the NEC monitoring system for ongoing researches.

5. FLOWCHART

45 | 78

Flowchart 9: Management of NEC Files

Secretariat

Secretariat

Secretariat


6.1. Identification of the type of file

6.1.1. Files will be classified as study or administrative, active or inactive. Study files, which

include protocols, are kept in separate folders which are labelled with their initial codes.

Administrative files include the following folders: agenda, minutes of meetings,

meeting documents, membership files, SOPs, National and International Guidelines,

secretariat files, etc.

6.1.2. The filing system shall be classified as follows:

Membership and Secretariat files

a. Updated (and signed) curriculum vitae of members

b. Appointment letters and terms of reference

c. Record of trainings in ethics review

d. Confidentiality agreement

e. Conflict of interest agreement

Study files

a. Protocol versions

b. Reports

c. Communications and responses

d. Researchers’ CV

Minutes of Meetings

6.1.2.1. Minutes of meetings

6.1.2.2. Annexes of documents used in the meeting

6.1.2.3. Attendance during meeting

Administrative Files

a. NEC Standard Operating Procedures

b. DOST Administrative Orders, PCHRD Special Orders, Memorandum of Agreement

and Circulars

Regulatory references

a. National Ethical Guidelines

b. PNHRS Law and Implementing Rules and Regulations

c. International Guidelines (WHO, ICH, CIOMS, Helsinki Declaration, etc)

Filing of documents in the appropriate folders

End

Start

Identification of the type of file

Logging of the document files in the log

46 | 78

6.2. Logging of study documents

Each study shall contain a log record that includes the following information:

6.2.1.1. the date of submission

6.2.1.2. title of the study

6.2.1.3. NEC Code

6.2.1.4. name of the proponent

6.2.1.5. contact details of proponent

6.2.1.6. review date

6.2.1.7. name/s of reviewer/s

6.2.1.8. type of review

6.2.1.9. approval date

6.2.1.10. documents submitted

6.2.1.11. progress reports, SAEs and submission of final report with date of

submission

6.2.1.12. decisions made regarding said study

6.2.1.13. completion date

6.3. Filing of documents in the appropriate folders

ANNEX:

NEC Form 10: Log of Research Submissions, p65

NEC Form 11: Log of Post-Approval Submissions, p66

DOCUMENT HISTORY

NEC SOP version 1

SOP Authors Ms. Imelda B. Mutuc and Charisma G. Cruz Page 42-44



NEC SOP version 2




Date 19 June 2015