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National Children’s Hospital

INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE

CHAPTER 1. Structure and Composition

NCH IRB/IEC SOP/GUIDELINES

Effective Date: 05/04/2012

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STRUCTURE AND COMPOSITION

1.1. Constituting the NCH IRB/IEC

1.2. Confidentiality/Conflict of Interest Agreement

1.3. Training of Personnel and NCH IRB/IEC Members

1.4. Selection of Independent Consultants

1.5. Incentives for NCH IRB/IEC Members and Consultants

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1.1 Constituting the NCH IRB/IEC 1. Purpose

One purpose of this Standard Operating Procedure (SOP) is to describe the composition

and structure of the National Children’s Hospital Institutional Review Board/Independent

Ethics Committee in compliance with national and international guidelines in ethical

research.

Another purpose of this SOP is to define the Terms of reference for the NCH IRB/IEC related

to:

Confidentiality/Conflict of Interest Agreement

Training of Personnel and NCH IRB/IEC Members

Selection of Independent Consultants

Compensation of NCH IRB/IEC Members and Consultants

2. Scope

The NCH IRB/IEC is an independent body created by the National Children’s Hospital under

the Office of the Medical Center Chief II (MCC), whose responsibility is to ensure the

protection of the rights, safety and well-being of human subjects involved in health related

research and to provide public assurance of that protection. In accordance with

applicable national/international regulations, the NCH IRB/IEC has the authority to approve,

require modifications to, or disapprove research.

The NCH IRB/IEC reviews and monitors health researches that involve:

National Children’s Hospital patients, done within the National Children’s Hospital, or

using the National Children’s Hospital facilities, including those initiated by National

Children’s Hospital full-time staff (residents/fellows, consultants, other hospital staff),

outside agencies or non-affiliated parties.

Health research done by National Children’s Hospital full-time staff in areas outside of

National Children’s Hospital is covered by this SOP, except researches undertaken by

part time hospital staff done outside the National Children’s Hospital that has been

approved by another NCH IRB/IEC.

This SOP describes the Terms of Reference (TOR) which provide the framework for

constitution, responsibilities and activities of the NCH IRB/IEC. The TOR is further supported

by the SOPs of the National Children’s Hospital.

3. Responsibility

It is the responsibility of the NCH IRB/IEC members and secretariat to understand and

implement the SOPs of the NCH IRB/IEC.

4. Process Flow/Steps

NO. ACTIVITY RESPONSIBILITY

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1 Describe NCH IRB/IEC compliance with international

/national ethical standards

Members/Secretariat

2 Provide requirements for members and independent

consultants

Members/Secretariat

3 Nominate members and independent consultants

Members

4 Appoint NCH IRB/IEC members and provide conditions of

appointment

Medical Center Chief II

5 Provide terms for resignation, disqualification, and

replacement of members

Medical Center Chief II/

Members/Secretariat

6 Designate officers and describe their functions

Chair and Co-Chair

7 Designate secretariat staff and describe his/her functions

Secretariat

8 Describe roles and responsibilities of members Members/Secretariat

5. Detailed Instructions

5.1 Ethical basis

5.1.1 The NCH IRB/IEC is guided in its reflection, advice, and decision by the

ethical principles expressed in the Declaration of Helsinki (1964 and

subsequent revisions).

5.1.2 The NCH IRB/IEC seeks to fulfill the requirements for international assurances

and is established to function in accordance with the national law and

regulations.

5.1.3 It makes further reference to the National and International Ethical

Guidelines for Biomedical Research Involving Human Subjects like Council of

International Organizations for Medical Sciences (CIOMS), the Belmont

Report, and the European Convention on Human Rights and Biomedicine.

5.1.4 The NCH IRB/IEC establishes its own standard operating procedures based on

the Operational Guidelines for Ethics Committees that Review Biomedical

Research, the WHO & ICH Guidelines for Good Clinical Practice, National

Ethical Guidelines for Health Research and the local regulations such as the

Ethical Guidelines in AID Investigation in the Philippines.

5.1.5 The NCH IRB/IEC adheres to national and international ethical standards and

recognizes that the protocols it approves may also be approved by national

and/or local ethics committees prior to their implementation in specific

localities.

5.1.6 In evaluating protocols and ethical issues, the NCH IRB/IEC is aware of the

diversity of laws, cultures and practices governing research and medical

practices in various countries around the world.

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5.1.7 It attempts to inform itself where possible of the requirements and conditions

of the various localities where proposed National Children’s Hospital research

is being considered.

5.1.8 The NCH IRB/IEC also seeks to be informed, as appropriate, by national/local

ethics committees and researchers of the impact of the research it has

approved.

5.2 Membership Requirements/Independent Consultants

5.2.1 NCH IRB/IEC Membership

5.2.1.1 The NCH IRB/IEC is composed of at least 10 members

5.2.1.2 Membership must be multidisciplinary and multisectoral. The members

should have various backgrounds to promote complete and efficient review

of research activities commonly conducted by the National Children’s

Hospital.

5.2.1.3 The members shall include at least one member whose primary concerns are

in medical science, at least one member who is a pediatrician, at least one

member whose primary concerns are in non-medical/non-scientific areas,

and at least a member from outside the institute.

5.2.1.4 Relevant expertise may include medicine and research, social or behavioral

science, law, philosophy, environmental science and public health. It is

recommended that the NCH IRB/IEC should include a person without

disciplinary constraints who will represent the interest and concerns of the

community.

5.2.1.5 The NCH IRB/IEC cannot consist entirely of men or entirely of women. It

should be gender sensitive and should ideally consider an equal

representation of men and women members.

5.2.1.6 The NCH IRB/IEC should have representatives from the older and younger

generations.

5.2.1.7 The committee should have an office and adequate support staff for

carrying out the NCH IRB/IEC responsibilities.

5.3 Nomination

5.3.1 The current NCH IRB/IEC members nominate candidates for new members to the

Chair

5.3.2 Independent consultant requested and identified by NCH IRB/IEC members is

nominated to the Medical Center Chief.

5.4 Appointment/Conditions of Appointment

5.4.1 Terms of Office

5.4.1.1 The appointing authority shall indicate the NCH IRB/IEC’s functions, terms of

office, the scope of work, conditions of appointment, system of replacement

or recall, and compensation, if any. Members are appointed for a period of

two (2) years ;

5.4.1.2 Their appointments may be renewed by the Medical Center Chief

II/Appointing Authority/ or head of the institution/agency for up to three (3)

consecutive terms.

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5.4.1.3 The NCH IRB/IEC will include some rotation after a period of two years up to

three consecutive terms, but it will also strive to ensure continuity, the

development and maintenance of expertise, and allows for innovations

(fresh ideas and approaches) within the NCH IRB/IEC.

5.4.2 Appointment of Members

5.4.2.1 The Medical Center Chief II of the National Children’s Hospital is responsible

for making the appointment of committee members upon the

recommendation of the NCH IRB/IEC Chair.

5.4.2.2 Members are selected in their personal capacities, based on their interest,

ethical and/or scientific knowledge and expertise, as well as on their

commitment and willingness to volunteer the necessary time and effort for

NCH IRB/IEC. Members are required to have prior training in Good Clinical

Practice, Research Methodology and Research Ethics, or if none, must be

willing to undergo such training during their membership. A good moral

character should be considered.

5.4.2.3 Members must disclose in writing any interest or involvement, financial,

professional or otherwise in a project or proposal under consideration, which

is in conflict with function as a reviewer or constitute a breach of

confidentiality.

5.4.2.4 Members should submit their curriculum vitae.

5.4.2.5 The NCH IRB/IEC will decide the extent to which members that might have a

conflict of interest may participate in committee deliberations/actions

regarding a particular protocol under a Confidentiality/Conflict of Interest

Agreement.

5.4.2.6 Members will be required to sign a confidentiality/conflict of interest

agreement at the start of their term. The agreement should cover all

applications, meeting deliberations, information on research participants

and related matters. Secretariat/administrative staff is likewise expected to

sign a similar confidentiality/conflict of interest agreement.

5.4.2.7 The confidentiality agreement protects the privacy and confidentiality of all

parties whose information may be disclosed to the NCH IRB/IEC in the course

of its work.

5.4.3 Conditions of Appointment of Members

5.4.3.1 Willingness to publicize his/her full name, profession, and affiliation;

5.4.3.2 All financial accountability, reimbursement for work and expenses, if any,

within or related to the NCH IRB/IEC should be recorded and made available

to the public upon request;

5.4.3.3 All NCH IRB/IEC Members and Independent Consultants must sign a

Confidentiality/Conflict of Interest Agreements regarding meeting

deliberations, applications, information on research participants, and related

matters.

5.5 Resignation, Disqualification, and Replacement of Members

5.5.1 Members may resign from their positions by submitting a letter of resignation to the

Chair.

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5.5.2 Members may be separated from the committee by disqualification upon valid

grounds as determined by the committee through a written complaint;

5.5.3 A member may also be disqualified from continuing with his/her membership after

the Chair or any other NCH IRB/IEC member/s has provided written position about

the incompetence/disqualification of the member and there has been unanimous

agreement/by a majority vote of its members.

5.5.4 Members who have resigned or have been disqualified may be replaced by the

appointing authorities.

5.5.5 The terms of replacement shall be limited to that of the remaining term of the

member that he/she has replaced.

5.6 NCH IRB/IEC Officers

5.6.1 The following officers through their respective responsibilities contribute to efficient

NCH IRB/IEC operation:

Chair Presides over the NCH IRB/IEC meetings and reports directly to

the Medical Center Chief;

Reports the meeting outcomes to the Medical Center Chief;

Invites independent consultants

Assigns primary reviewers

Co-Chair Presides over meetings in the absence of the Chair

Acts as vice-chair during meetings with the Chair

Secretary Manages administrative aspect of the NCH IRB/IEC

5.6.2 The officers are elected by the NCH IRB/IEC members for a two-year term. They

may be (reappointed) re-elected but not for more than three consecutive terms.

Should they resign or be disqualified, the NCH IRB/IEC members shall elect a

replacement to serve the remaining term.

5.7 NCH IRB/IEC Secretariat

5.7.1 The NCH IRB/IEC secretariat is composed of the Secretary and administrative

support staff who are employees of the National Children’s Hospital and appointed

by the Medical Center Chief II.

5.7.2 The Secretariat shall have the following functions:

Organizing an effective and efficient tracking procedure for each proposal

received

Preparation, maintenance and distribution of study files

Organizing NCH IRB/IEC meetings regularly

Preparation and maintenance of meeting agenda and minutes

Maintaining the NCH IRB/IEC documentation and Archiving

Communicating with the NCH IRB/IEC members and applicants

Arrangement of training for personnel and NCH IRB/IEC members;

Organizing the preparation, review, revision and distribution of SOPs and

guidelines;

Providing the necessary administrative support for NCH IRB/IEC-related

activities of the Chair of the NCH IRB/IEC

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Providing updates on relevant and contemporary issues related to ethics in

health research, as well as relevant contemporary literature to the Committee

members.

5.8 Roles and responsibilities of NCH IRB/IEC Members

Participate in the NCH IRB/IEC meetings;

Review, discuss research and consider proposals submitted for evaluation;

Monitor serious adverse event reports and recommend appropriate action(s) ;

Review the progress reports and monitor ongoing studies as appropriate

Evaluate final reports and outcome

Maintain confidentiality of the documents and deliberations of NCH IRB/IEC meetings

Declare any conflict of interest;

Participate in continuing education activities in biomedical ethics and biomedical

research

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LETTER OF APPOINTMENT OF NCH IRB/IEC MEMBER

Date

______________________

______________________

______________________

Dear ___________________,

This is to welcome you to the NCH IRB/IEC and to congratulate you on your new position as a

Member.

Membership shall for the duration of two (2) years, with possible renewal for up to three (3)

consecutive terms. As a member, you will have the following roles and responsibilities:

1. Participate in the NCH IRB/IEC meetings

2. Review, discuss and consider research proposals submitted for evaluation;

3. Monitor serious adverse event reports and recommend appropriate action(s) ;

4. Review the progress reports and monitor ongoing studies as appropriate

5. Evaluate final reports and outcome

6. Maintain confidentiality of the documents and deliberations of NCH IRB/IEC meetings

7. Declare any conflict of interest;

8. Participate in continuing education activities in biomedical ethics and biomedical

research

You will likewise be required to sign a confidentiality and conflict of interest agreement (refer to

attached document). Please sign the confirm below and return to the NCH IRB/IEC Secretariat

along with the confidentiality and conflict of interest agreement and latest curriculum vitae as soon

as possible.

Looking forward to your participation and again, welcome.

Sincerely,

EPIFANIA S. SIMBUL, MD, FPPS, CEO VI


Conforme:

_______________________ ____________________

(PRINT NAME) Date

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LETTER OF APPOINTMENT OF NCH IRB/IEC CHAIR

Date

______________________

______________________

______________________

Dear ________________,

This is to welcome you to the NCH IRB/IEC and to congratulate you on your new position as Chair.

Term of office is two (2) years, with possible renewal for up to three (3) consecutive terms. As Chair

of the NCH IRB/IEC, your specific responsibilities include:

1. Preside over NCH IRB/IEC meetings and report directly to the Medical Center Chief

2. Report the meeting outcomes to the Medical Center Chief

3. Invite independent consultants to provide special expertise to the NCH IRB/IEC on a

proposed research protocol as needed

4. Assign primary reviewers

These are in addition to your roles and responsibilities as a member, as mentioned below:





5. Maintain confidentiality of the documents and deliberations of NCH IRB/IEC meetings



research




as possible.


Sincerely,



Conforme: _________________________ _______________

(PRINT NAME) Date

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LETTER OF APPOINTMENT OF NCH IRB/IEC CO-CHAIR

Date

______________________

______________________

______________________

Dear _____________________,

This is to welcome you to the NCH IRB/IEC and to congratulate you on your new position as Co-

Chair.

Term of office is two (2) years, with possible renewal for up to three (3) consecutive terms. As Vice-

Chair of the NCH IRB/IEC, your specific responsibilities include:

1. Preside over NCH IRB/IEC meetings in the absence of the Chair

2. Act as vice-chair during meetings with the Chair

These are in addition to your roles and responsibilities as a member, as mentioned below:

1. Participate in the NCH IRB/IEC meetings;





6. Maintain confidentiality of the documents and deliberations of NCH IRB/IEC

meetings



research




as possible.


Sincerely,



Conforme: _________________________ _______________

(PRINT NAME) Date

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LETTER OF APPOINTMENT OF NCH IRB/IEC SECRETARY Date

______________________

______________________

______________________

Dear ____________________,

This is to welcome you to the NCH IRB/IEC and to congratulate you on your new position as Secretary.

Membership shall for the duration of two (2) years, with possible renewal for up to three (3) consecutive terms.

As Secretary of the NCH IRB/IEC, your specific responsibility entails the administration of the Secretariat and will

be supported by an administrative staff appointed by the Director. The Secretariat has the following functions:

1. Organizing an effective and efficient tracking procedure for each proposal received

2. Preparation, maintenance and distribution of study files

3. Organizing NCH IRB/IEC meetings regularly

4. Preparation and maintenance of meeting agenda and minutes

5. Maintaining the NCH IRB/IEC documentation and Archiving

6. Communicating with the NCH IRB/IEC members and applicants

7. Arrangement of training for personnel and NCH IRB/IEC members;

8. Organizing the preparation, review, revision and distribution of SOPs and guidelines;

9. Providing the necessary administrative support for NCH IRB/IEC-related activities of the

Chair of the NCH IRB/IEC

This is in addition to your roles and responsibilities as a member, as mentioned below:

1. Participates in the NCH IRB/IEC meetings;

2. Reviews, discusses and considers research proposals submitted for evaluation;

3. Monitors serious adverse event reports and recommend appropriate action(s) ;

4. Reviews the progress reports and monitor ongoing studies as appropriate

5. Evaluates final reports and outcome

6. Maintains confidentiality of the documents and deliberations of NCH IRB/IEC meetings

7. Declares any conflict of interest;

8. Participates in continuing education activities in biomedical ethics and biomedical

research

You will likewise be required to sign a confidentiality and conflict of interest agreement (refer to attached

document). Please sign the confirm below and return to the NCH IRB/IEC Secretariat along with the

confidentiality and conflict of interest agreement and latest curriculum vitae as soon as possible.


Sincerely,



Conforme:

_________________________ _______________

(PRINT NAME) Date

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LETTER OF INVITATION TO INDEPENDENT CONSULTANT

Date

______________________

______________________

______________________

Dear _________________,

The NCH IRB/IEC would like to invite you to be an Independent Consultant for a research protocol

that has been submitted to our committee for approval. The research protocol is entitled

“__________________________________________”.

As an Independent Consultant, we recognize your expertise in the field of the research that is being

proposed and appreciate your insights as well as any recommendations.

As the Independent Consultant, you are required to complete a consultative report to be reviewed

by the NCH IRB/IEC on the research protocol. You may also attend the NCH IRB/IEC meeting,

present the report, and participate in the discussion but without the right to vote. Your report

becomes part of the study file.

Please sign the confirm below if you accept our invitation. Likewise, please go over and sign the

Confidentiality/Conflict of interest Agreements (refer to attached agreement) and return to the

NCH IRB/IEC Secretariat along with the confidentiality and conflict of interest agreement and latest

curriculum vitae as soon as possible.

For any questions, please feel free to contact the NCH IRB/IEC Chair at 724-0656 to 59 local 114.

Thank you for your attention and hoping for your favorable response.

Sincerely,

MYRNA T. VALENCIA, M.D., F.P.P.S.

Chair, NCH IRB/IEC

Conforme:

___________________________ _____________

Name of Consultant Date

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NCH IRB/IEC-2012-1A-CV CV of NCH IRB/IEC Member

CURRICULUM VITAE

Last name: First name:

Position:

Date of 1st Appointment:

Term of Office:

Address:

Contact No.

E-mail:

Education Background:

Work Experience

A. Previous experience

B. Present Work

experience

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1.2 Confidentiality/Conflict of Interest Agreement 1. Scope

The purpose of this section is to provide a form for Confidentiality/Conflict of Interest

Agreement and identify who should read, understand, accept, keep in mind, sign and date

the form. The procedures provide details when and where to sign as well as how the signed

document should be kept.

The SOP covers the Agreements on both Confidentiality and Conflict of Interest concerning

information and procedures followed by the NCH IRB/IEC.

It is the responsibility of all newly-appointed NCH IRB/IEC members to read, understand,

accept and sign the agreement contained in the Confidentiality/Conflict of Interest form

before beginning their ethical review tasks with the NCH IRB/IEC to protect the rights of

study participants.

If a member refuses to sign such agreement, this may be a ground for his/her

disqualification to serve in the NCH IRB/IEC or to be disallowed in the deliberations of certain

protocols.

2. Flow chart


1 Give the form Secretariat

2 Read the text carefully and thoroughly Members

3 Ask questions, if any Members

4 Sign to indicate consent; otherwise Members

5 Return unsigned form Members

6 Keep the Agreement in mind Members

3. Detailed instructions

3.1. Give the form

The Secretariat provides a copy of the Confidentiality and Conflict of Interest

Agreement Form (NCH IRB/IEC 2012-05-1B-CCIA) to new members of the NCH

IRB/IEC together with the letter from the Medical Center Chief II about his

appointment as a member.

3.2. Read the text carefully and thoroughly

3.2.1. Newly appointed members obtain two copies of the Confidentiality and

Conflict of Interest Agreement Form (NCH IRB/IEC 2012-05-CCIA-1(B).

3.2.2. Read through the text of the form very carefully.

3.2.3. The members fill in their names and their office in the blanks

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3.3. Ask questions, if any

3.3.1. Direct questions to the Secretariat, if any part or sentences is not clear.

3.3.2. Let the member of the Secretariat explain or clarify the contents of the

document.

3.4. Return unsigned form

Member/Guest returns unsigned Confidentiality and Conflict of Interest Agreement

Form (NCH IRB/IEC 2012-05-1B-CCIA) with a written explanation to the Secretariat

3.5. Sign to indicate consent

3.5.1. Sign and date both copies of the document before a member of the

Secretariat.

3.5.2. Give the forms back to the Secretariat to sign and date.

3.5.3. The members keep a copy as their records.

3.6. Keep the Agreement in mind

3.6.1. The Secretariat keeps a copy of the signed Confidentiality and Conflict of

Interest Agreement Form (NCH IRB/IEC 2012-05-1B-CCIA) as the Institute’s

records.

3.6.2. Keep the copies in a Confidentiality/Conflict of Interest Agreement file.

3.6.3. Store the file in a secure cabinet with limited key holders.

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NCH IRB/IEC-2012-05-1B-CCIA Confidentiality and Conflict of Interest Agreement Form

CONFIDENTIALITY AND CONFLICT OF INTEREST AGREEMENT

Know all Men by these Presents:

In view of the appointment of NATIONAL CHILDREN’S HOSPITAL, as a member of the NCH IRB/IEC, and

hereinafter referred to as the Undersigned, and whereas:

The Undersigned has been asked to assess research studies and protocols involving human subjects in

order to ensure that the same are conducted in a humane and ethical manner, with the highest standards of

care according to the applied national and local laws and regulations, institutional policies and guidelines;

The appointment of the Undersigned as a member of the NCH IRB/IEC is based on individual merits

and not as an advocate or representative of a home province/ territory/ community nor as the delegate of

any organization or private interest;

The fundamental duty of an NCH IRB/IEC member is to independently review both scientific and

ethical aspects of research protocols involving human subjects and make a determination and the best

possible objective recommendations, based on the merits thereof under review; and

The NCH IRB/IEC must meet the highest ethical standards in order to merit the trust and confidence of

the communities in the protection of the rights and well-being of human subjects;

The following terms and conditions covering Confidentiality and Conflict of Interest arising in the

discharge of said appointed NCH IRB/IEC member functions, are hereby stipulated in this Agreement for

purposes of ensuring the same high standards of ethical behavior necessary for the NCH IRB/IEC to carry out its

mandate.

Confidentiality

This Agreement thus encompasses any information deemed Confidential, Privileged, or Proprietary

provided to and/or otherwise received by the Undersigned in conjunction with and/or in the course of the

performance of his/her duties as a member/Independent Consultant of the NCH IRB/IEC.

Any written information provided to the Undersigned that is of a Confidential, Privileged, or Proprietary

in nature shall be identified accordingly. Written Confidential information provided for review shall not be

copied or retained. All Confidential information (and any copies and notice thereof) shall remain the sole

property of the NCH IRB/IEC.

As such, the Undersigned agrees to hold in trust and in confidence all Confidential, Privileged or

Proprietary information, including trade secrets and other intellectual property rights (hereinafter collectively

referred to as the “information”). Moreover, the Undersigned agrees that the information shall be used only for

contemplated purposes and none other. Neither shall the said information be disclosed to any third party.

The Undersigned further agrees not to disclose or utilize, directly or indirectly, any information

belonging to a third party, in fulfilling this agreement. Furthermore, the Undersigned confirms that her

performance of this agreement is consistent with National Children’s Hospital’s policies and any contractual

obligations owed to third parties.

Conflict of Interest

It is recognized that the potential for conflict of interest will always exist; however, there is concomitant

faith in the ability of the NCH IRB/IEC to manage these conflict issues, if any, in such a way that the ultimate

outcome of the protection of human subjects remains.

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It is the policy of the NCH IRB/IEC that no member/consultant may participate in the review, comment

or approval of any activity in which he/she has a conflict of interest except to provide information as

requested by the NCH IRB/IEC.

The Undersigned will immediately disclose to the Chair of the NCH IRB/IEC any actual or potential

conflict of interest that he/she may have in relation to any particular proposal submitted for review by the NCH

IRB/IEC, and to abstain from any participation in discussions or recommendations in respect of such proposals.

If an applicant submitting a protocol believes that an NCH IRB/IEC member has a potential conflict,

the investigator may request that the member be excluded from the review of the protocol.

The request must be in writing and addressed to the Chair. The request must contain evidence that

substantiates the claim that a conflict exists with the NCH IRB/IEC member(s) in question. The NCH IRB/IEC may

elect to investigate the applicant’s claim of the potential conflict.

When a member/consultant has a conflict of interest, the member should notify the Chairperson and

may not participate in the NCH IRB/IEC review or approval except to provide information requested by the

Board.

Examples of conflict of interest cases may include but is not limited to any of the following:

A member/consultant is involved in a potentially competing research program.

Access to funding or intellectual information may provide an unfair competitive advantage.

A member’s/consultant’s personal biases may interfere with his or her impartial judgment.

Agreement on Confidentiality and Conflict of Interest

[To the Undersigned: Please sign and date this Agreement, if you agree with the terms and conditions set forth above. The

original (signed and dated Agreement) will be kept on file in the custody of the NCH IRB/IEC. A copy will be given to you

for your records.]

In the course of my activities as a member of the NCH IRB/IEC, I will be provided with confidential

information and documentation (which we will refer to as the "Confidential Information"). I agree to take

reasonable measures to protect the Confidential Information, subject to applicable legislation, not to disclose

the Confidential Information to any person; not to use the Confidential Information for any purpose outside the

Board's mandate, and in particular, in a manner which would result in a benefit to myself or any third party;

and to return all Confidential Information (including any minutes or notes I have made as part of my Board

duties) to the Chair upon termination of my functions as an NCH IRB/IEC member.

Whenever I have a conflict of interest, I shall immediately inform the Chair not to count me toward a

quorum for voting.

I have read and accept the aforementioned terms and conditions as explained in this Agreement.

_____________________________________ __________________________

Title/Name Date

EPIFANIA S, SIMBUL, MD, FPPS, CEO VI __________________________

Medical Center Chief II Date

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1.3 Training of Personnel and NCH IRB/IEC Members

1. Purpose

The purpose of this section is to inform the NCH IRB/IEC personnel and members why training

is necessary and how the members should seek to occasionally attend training or workshop

programs to up-date themselves on the progress of technology, information and ethics.

The National Children’s Hospital recognizes the importance of training and continuing

professional development, therefore the institution will allocate an annual budget for

specific training and study visits for NCH IRB/IEC personnel and members. New NCH IRB/IEC

members should fulfill the requirements for membership.

The SOP applies to all personnel of the NCH IRB/IEC. It is the responsibility of the NCH IRB/IEC

members to have them educated and trained periodically.


NO ACTIVITY RESPONSIBILITY

1 Provide list of required training

Chair/Secretariat

2 Keep track of training opportunities Members/Secretariat

3 Signify intention to attend (to MCC or to Chair) and

wait for recommendation of the Chair

Member/Secretariat

4 Attend training and keep the training record

Member/Secretariat

5 Keep the proof of attendance of the training records in

the NCH IRB/IEC documents folder under “Training of

Members”

Secretariat

3. Detailed instructions

3.1. Topics for training

3.1.1. NCH IRB/IEC members should maintain competence by ensuring currency of

their knowledge of:

Good Clinical Practice (GCP)

Declaration of Helsinki

CIOMS

Ethical Issues

Relevant laws

Developments in relevant science, technical and environmental, health

and safety aspects

Relevant requirements of health, safety and environmental laws ,

regulations, and related documents

Audit procedures

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3.1.2. An interchange of ideas, information and experiences with overseas

institutions and organizations related to research ethics is also being carried

out. International cooperation is also necessary to discuss ways of tackling

harmful information distribution and joint efforts to tackle such distribution

patterns. Efforts are being made to collect information on overseas trends

and to attend international specialist meetings organized for the exchange

of experience and information.

3.2. Keep track of training opportunities

3.2.1. Get information about training courses, workshops, conferences, etc. which

are periodically announced on websites, bulletin boards and various media

channels in coordination with the Secretariat

3.2.2. Select the ones you need

3.2.3. Submit an official request to the MCC endorsed by the Chair

3.2.4. Register to attend upon approval

3.2.5. Keep the receipt

3.2.6. Reimburse the training expense up to the maximum of PHP 1,500.00 per

training seminar

3.3. Keeping the training records

3.3.1. Fill in the Training Record of NCH IRB/IEC Member (NCH IRB/IEC-2012-05-1C-

TR) to record the training/workshop/conference activities in chronological

order.

3.3.2. Make a copy of the form.

3.3.3. Keep the original form as your record.

3.3.4. Give the copy to the Secretariat staff to keep in the National Children’s

Hospital file.

3.3.5. Update CV to reflect the training

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NCH IRB/IEC 2012-05-1C-TR Training Record of NCH IRB/IEC Members

TRAINING RECORD OF NCH IRB/IEC MEMBERS

LAST NAME: FIRST NAME:

BASIC COURSES Organizer Venue Date Funding

Source

1 GCP Training

2 Research Ethics

3 EC Standard Operating

Procedures (SOP)

CONTINUING ETHICS EDUCATION:

Research Ethics Workshops,

Conferences, Meetings, Lectures

Organizer Venue Date Funding

Source

1

2

3

4

5

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1.4 Selection of Independent Consultants

1. Scope

This SOP describes the procedures for engaging the services of a professional/expert as a

consultant to the NCH IRB/IEC. If the Chair of the NCH IRB/IEC determines that a study

involves procedure(s) that are not within the area of competence or expertise of the NCH

IRB/IEC members, the Chair may invite individuals with expertise in special areas to assist in

the review of protocols that require such expertise beyond or in addition to those available

within the NCH IRB/IEC.

Upon the advice or recommendation of the Secretariat or any NCH IRB/IEC member, it is

the responsibility of the NCH IRB/IEC to nominate and approve the name of the

independent consultants to be endorsed by the Chair.


No. Activity Responsibility

1 Request for an independent consultant/s Chair/Members

2 Select and recommend consultant to MCC/ Chair

Chair

3 Consultant signs Confidentiality Agreement Secretariat/

Consultation Services Agreement Consultant

4 Consultant renders services Consultant

5 Terminate Services Consultant/Chair

6 Store documents in NCH IRB-EC documents Secretariat

folder under Independent Consultants


3.1. Request for Independent Consultant

3.1.1. An NCH IRB/IEC member or the Chair may decide that a protocol received

should also be reviewed by an independent consultant.

3.1.2. The NCH IRB/IEC decides to obtain the independent consultant via a

majority vote.

3.2. Selection of Independent Consultants

3.2.1. NCH IRB/IEC member identifies the expert/s.

3.2.2. NCH IRB/IEC member nominates the expert/consultant.

3.2.3. NCH IRB/IEC conducts a qualification review of the prospective consultant.

3.2.4. NCH IRB/IEC makes decisions based on expertise, availability, and

independent criteria.

3.2.5. Chair endorses approval to the Medical Center Chief II who will make the

final approval and appointment of the independent consultant.

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3.3. Consultant Signs Agreements

3.3.1. Contact the consultant, who will be asked to provide:

A Curriculum Vitae (NCH IRB/IEC-2012-05-1A-CV)

A signed Terms of Reference

A signed Confidentiality/Conflict of Interest (NCH IRB/IEC-2012-05-1B-

CCIA)

3.3.2. Keep the pertinent documents in a consultant’s file.

3.3.3. Prepare a roster of consultants and the areas of their expertise

3.4. Consultant Renders Services

3.4.1. The NCH IRB/IEC Secretariat provides study protocol documents to the

concerned consultant for review, after the latter has signed the Terms of

Reference and the Confidentiality/ Conflict of Interest Agreement

3.4.2. The consultant must complete a consultative report to be reviewed by the

NCH IRB/IEC at the time the study is reviewed.

3.4.3. The consultant may attend the NCH IRB/IEC meeting, present the report, and

participate in the discussion but without the right to vote. The report

becomes a permanent part of the study file.

3.5. Termination Of Services

3.5.1. Consultant's services may be terminated by either the consultant or by the

NCH IRB/IEC.

3.5.2. Upon termination of the consultant’s services, the Secretariat shall ensure

that all the necessary documentation is filed with the other administrative

documents.

3.6. Store documents in NCH IRB/IEC folder under Independent Consultants File in

alphabetical order.

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1.5 Incentives for the NCH IRB/IEC Members and Consultants

1. Scope

This SOP describes how NCH IRB/IEC members and consultants are given an honorarium for

their work in the NCH IRB/IEC. The NCH IRB/IEC members are given an honorarium through

the National Children’s Hospital. The Executive Director, approves the honorarium package,

honorarium increase, and allowances for training.



1 Recommends honorarium for Chair

Members/Consultants

2 Meets on recommendation Members/Chair

3 Endorses NCH IRB/IEC Chair

recommendation to MCC

4 Approval Medical Center Chief

5 Dispensation of honorarium Secretariat

6 Acknowledgement of honorarium Member/Consultant


3.1. The Chair initiates the recommendation of honorarium or honorarium increase either

after a dialogue with NCH IRB/IEC members or with the Medical Center Chief II.

3.2. The NCH IRB/IEC includes the recommendation in the agenda of the NCH IRB/IEC

meeting.

3.3. The NCH IRB/IEC may endorse right away or modify the recommendation, then

endorse the honorarium/increase to the Medical Center Chief II.

3.4. The Medical Center Chief II may approve or disapprove the recommendation.

3.5. The NCH IRB/IEC members are informed of the decision.

3.6. NCH IRB/IEC members or consultants acknowledge in writing any honorarium

received from the NCH IRB/IEC.

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