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National Children’s Hospital INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE

CHAPTER 2. Initial Review Procedures

NCH IRB/IEC SOP/GUIDELINES

Effective Date: 05/04/2012

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INITIAL REVIEW PROCEDURES

2.1. Management of Protocol Submissions

2.2. Use of Study Assessment Forms

2.3. Expedited Review

2.4. Full Board Review Of Submitted Protocols

2.5. Preparation of Meeting Agenda

2.6. Preparation of Meeting Minutes

2.7. Review of a Medical Device Study

2.8. Review of Protocols that Involve Genetic Materials

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2.1 Management of Protocol Submission

1. Scope

This SOP describes how the NCH IRB/IEC Secretariat manages initial protocol submissions to

NCH IRB/IEC. It covers the actions to be done from the time of submission to the filing of the

original protocol package in the Active Study File cabinet and the preparation of copies of

the package for distribution to the reviewers.

The NCH IRB/IEC accepts all protocols for review to be done by NCH staff and outside

investigators/researchers within and outside NCH.

Specifically researches referred from the PNHRS, DOH with the provision that non-NCH

institutions who submit proposals for NCH review need to have a MOA with NCH. The MOA

should stipulate that the institution agrees to abide by the rules and regulations that the

NCH IRB/IEC follows (which in turn follow PHREB and FERCAP rules); they will provide the

necessary environment to ensure the safe and ethical conduct of the research, including

oversight and stewardship functions as necessary; they will agree to monitoring procedures

that the Committee may deem necessary.

2. Flow chart

Activity Responsibility

1. Receives the initial protocol package for review and

checks the completeness of the “Research Project

Proposal Format”

Secretariat

2. Assigns a permanent code to the package

Secretariat

3. Makes a duplicate of the application form and gives the

duplicate to the person submitting the package.

Attaches original to the protocol package.

Secretariat

4. Have the Principal Investigator sign documents in the

submitted package using the “ Document Receipt Form”

Secretariat

5. Makes a copy of the duly filled up, signed and dated

acceptance form and attaches this copy to the protocol

package

Secretariat

6. Gives the original “Document Receipt Form” to the

principal investigator

Secretariat

7. Log the received protocol in the “Log of Submitted

Protocols”

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8. Makes copies of the protocol package and prepares

them for distribution to the reviewers

Secretariat

9. Files the original package in a properly coded Protocol

File folder and places it in the Active Study File cabinet

Secretariat

3. Detailed Instructions

Note: All protocols need technical approval prior to ethical review. For National Children’s

Hospital-funded protocols, the Technical Review Committee should have addressed

the technical issues apparent to the study protocol. For non- National Children’s

Hospital funded protocols, a document stating that the research protocol has

undergone and passed technical review should be attached to the study protocol

submitted for ethical review.

Upon submission of the initial protocol for NCH IRB/IEC review, let the principal

investigator or his/her representative fill out a Registration and Application Form

(NCH IRB/IEC-2012-05-2A-RAF and NCH IRB/IEC-2012-05-2B-RAF).

3.1. Make a copy of the filled-in application form and give original to the principal

investigator or his/her representative. Attach the copy to the package.

3.2. Assign a code to the package. The code will be communicated to the principal

investigator in subsequent communications regarding the protocol.

3.3. Fills out and makes a duplicate copy of the Registration & Application Form (NCH

IRB/IEC-2012-05-2A-RAF or NCH IRB/IEC-2012-05-2B-RAF) in the presence of the

principal investigator or his/her representative and checks the documents being

submitted and marks the submitted documents on the checklist that is found on the

form. The duplicate copy of the NCH IRB/IEC-2012-05-2A-RAF or NCH IRB.IEC-2012-05-

2B-RAF) will be attached to the protocol package, while the original is given to the

principal investigator or his/her representative.

3.4. A protocol package has to include the following:

3.4.1. For Full Board Review

1) Accomplished registration and application form

2) Full protocol

3) Research project proposal format

4) Executive summary

5) Declaration of no conflict of interest

6) Data collection form/s /Questionnaires etc.

7) Informed Consent form (English and local dialect)

8) Assent form (as necessary)

9) Budget

10) CV of proponent and co-investigators and their GCP Certificate (as

necessary but mandatory for sponsor-initiated studies)

11) GANTT Chart (as necessary)

12) Ads for recruitment, if applicable

13) Technical approval document

14) Ethics Review Board Fee

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15) Institutional Fee payable upon approval of research

3.4.2. For Social and Behavioral Research

1) Letter of intent by the reserachers addressed to the Medical Center

Chef (MCC) through NCH IRB/IEC Chairman

2) Research title page, Table of contents

3) Research paper – Chapter I to III

4) Validated Survey Questionnaire

5) Result/Certification of Validation of survey questionnaire from a

statistician

6) Ethics Review Board Fee

7) Institutional Fee payable upon approval of research

Note: That both the Secretariat and the principal investigator or his/ her

representative should sign after the description or name of each document in the

protocol package.

3.5. Make a duplicate of the filled out form and ensure that the date is stated and is

signed. Attach the duplicate acceptance form to the received package.

3.6. Give the original copy of the acceptance form to the principal investigator or

his/her representative.

3.7. Log the protocol in the logbook for submitted protocols.

3.8. Manage the protocol package:

3.8.1. For protocols requiring a full board review,

3.8.1.1. Makes copies of the protocol package for file, for each reviewer, and

for each NCH IRB/IEC member. Puts the original copies in a file folder.

3.8.1.2. Puts the code of the protocol in front of the file folder.

3.8.1.3. Files the folder in the Ongoing Review Files cabinet

3.8.2. For protocols that can be subjected to expedited review,

3.8.2.1. Make 4 copies of the protocol package for file and for each

reviewer. Put the original copies in a file folder.

3.8.2.2. Puts the code of the protocol in front of the file folder.

3.8.2.3. File the folder in the On-going Review Files cabinet.

3.9. Prepare the copies of protocol for distribution to the reviewers. Include blank copies

of the Study Protocol Assessment Form (NCH IRB/IEC-2012-05-2C-SPAF) and the

Informed Consent Assessment Form (NCH IRB/IEC-20120-05-2D-ICAF) in the package.

3.10. Enter in the Log of Received Protocols the names of the reviewers to whom the

packages are to be delivered, the date of actual delivery, the name of the person

who delivers them, and the names of the recipients of the packages.

NOTE:

1. All protocols shall need technical approval prior to ethical review.

2. Reviewers are selected on the basis of their expertise. Research proposals

are given to both institutional and lay/non-institutional members for review.

The institutional members analyze the ethical procedures of the proposal

while the lay/ non-institutional members assess the informed consent form.

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4. Relevant Forms

NCH IRB/IEC-2012-05-2A-RAF Registration and Application Form

NCH IRB/IEC-2012-05-2B-RAFSBBR Registration and Application

Form for Social and Behavioral Basic

Research

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NCH IRB/IEC-2012-05-2A-RAF

REGISTRATION AND APPLICATION FORM For Initial Review and Resubmission

SECTION I: APPLICATION INFORMATION

1. Study Protocol Code: 1.1 NCH IRB/IEC CODE:

2. Type of Submission 2.1 Initial Review

2.2 Resubmission (responses to initial review recommendations or

submission of studies with investigator-initiated changes prior to

ethics approval). NOTE: version and date of version must be

inserted as a document footer for all resubmissions

3. Date of Submission: <dd/mm/yyyy>

4. Study Category 4.1 Research involving human participants

4.2 Research involving non-human living vertebrates

4.3 Others (indicate):

5. Type of study: 5.1 Pre-clinical Research

5.2 Non-clinical trial, specifically (choose one):

5.2.1 Diagnostics

5.2.2 In vitro study

5.2.3 Genetic or genomic research

5.2.4 Stem Cell Research

5.2.5 Herbal Research

5.2.6 Complementary and Alternative Medicine Research

5.2.7 Research on Assisted Reproductive Technology

5.2.8 Research on Indigenous Materials

5.2.9 Review of medical records

5.2.10 Epidemiological study

5.2.11 Socio-behavioral Research

5.2.13 Health informatics

5.2.14 Operations/process research

5.3 Clinical Trial Type 1 (drug or pharmaceutical trials,

diagnostic trials, trials on devices, and other therapy trials)

intended for marketing registration

5.4 Clinical Trial Type 2 (drug or pharmaceutical trials,

diagnostic trials, trials on devices, and other therapy trials) NOT

intended for marketing registration

5.5 Post Marketing Surveillance

5.6 Others, please indicate:_________________________________

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6. Category of Investigator 6.1 NCH Faculty/REPS

6.2 NCH Undergraduate Student

6.3 NCH Graduate Student (MS, PhD, Medical Student)

6.4 NCH/Study Group Researcher, Faculty, UR, URA

6.5 NCH Fellows, Residents, Nursing staff, Researcher

6.6 Non-NCH (NOTE: This category requires completion of

PART III: AUTHORIZATION AND ACKNOWLEDGEMENT OF REVIEW

below)

6.7 Others, please specify: __________________________________

7. Purpose of study 7.1 Academic requirement (Thesis, Dissertation, Training

Requirement)

7.2 Independent research work

7.3 Multi-institutional or multi-country collaboration


8. Study Title

9. Study Protocol Synopsis Please write a synopsis (maximum 500 words) of the study in the space

provided below based on the specified components, and indicate

page where such components may be found in the full study protocol

or in annexes/appendices. If items are not applicable, indicate by

N/A. Attach the full study protocol to this application.

1. Technical Synopsis

a. Objectives/Expected output

b. Literature review rationalizing the design

c. Research design

d. Sampling design, sample size

e. Inclusion criteria, exclusion criteria, withdrawal criteria

f. Data collection plan

g. Specimen collection and processing plan (including plans for

specimen storage and duration of storage)

h. Data analysis plan (including statistical basis for design, as

applicable)

i. Rationalization for choice of study site (including capacity of site

to address known risks of study protocol, such as availability of

equipment and facilities, as applicable) (Cross reference

information with statements provided in the informed consent)

2. Ethical Considerations Section

a. Protection of privacy and confidentiality of research information

including data protection plan

b. Vulnerability of research participants

c. Risks of the study (including social risks)

d. Benefits of the study

e. Patient-related compensations/reimbursements/entitlements

f. Informed consent process and recruitment procedures

g. Terms of reference of collaborative study (as applicable, such as

intellectual property agreements and similar concerns)

h. Terms of available study-related insurance

10. Study Duration (in months)

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11. Use of special

populations or

vulnerable groups

11.1 Children (under 18)

11.2 Indigenous People

11.3 Elderly

11.4 People on welfare/social assistance

11.5 Poor and unemployed

11.6 Patients in emergency care

11.7 Homeless persons

11.8 Refugees or displaced persons

11.9 Patients with incurable diseases


11.11 Not applicable

12. Endorsing/College/ Unit/

Institution

12.1 College of Allied Medical Professions

12.2 College of Arts and Sciences

12.3 College of Dentistry

12.4 College of Medicine

12.5 College of Nursing

12.6 College of Pharmacy

12.7 College of Public Health

12.8 National Teacher Training Center for the Health

Professions

12.9 School of Health Sciences

12.10 NCH (Put institute or office): <name of institute or office>

12.11 NCH (Put department and section): <name of

department & section>

12.12 NCH (local): <name of institution>

12.13 NCH (foreign institution): <name of institution>

13. Study site 13.1 NCH unit

13.2 Non-NCH with local IRB/ERB/ERC

13.3 Non-NCH without local IRB/ERB/ERC

14. Funding agency: 14.1 (NAME):

TYPE OF FUNDING AGENCY

14.1 NCH unit

14.2 Investigator

14.3 PHL Government agency/office/entity

14.4 Multilateral Agency (UN agencies and other

intergovernmental agencies)

14.5 Private company or Non-governmental organization

(NGO)


15. Study Budget NOTE: This refers to line item amounts. However, if a separate budget

sheet is available, just indicate total amount and attach budget sheet

16. Previous ethics approval

or clearance issued by

other sites

16.1 Name of Institutional Review Board or Ethics Review

Committee:

16.2 Date of ethics approval:

16.3 Date of expiration of ethics approval:

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16.4 Not applicable

17. Principal Investigator <Title, First Name, Last Name>

18. Birthday <dd/mm/yyyy>

19. PI Address <Institutional Address>

20. PI Telephone:

21. PI Facsimile:

22. PI Mobile:

23. PI Email:

24. Other Ongoing studies 24.1 Title:

24.1.1 NCH IRB/IEC Code (if

applicable):

24.3 Title:

24.3.1 NCH IRB/IEC Code

(if applicable):

24.2 Title:

24.2.1 NCH IRB/IEC Code (if

applicable):

24.4 Title:

24.4.1NCH IRB/IEC Code

(if applicable):

25. Declaration of Conflict of

Interest of PI

25.1 I have no conflict of interest in any form (financial, proprietary,

professional) with sponsor, the study, Co-Investigators, or the site

25.2 I have personal/family financial interest in the results of the

study

NATURE: 25.3 I Have proprietary interest in the research (patent, trademark,

copyright, licensing)

NATURE: 26. Other investigators with

corresponding task

description (add

additional rows as

applicable)

Co-Investigator:

Task description:

Co-Investigator:

Task description:

Co-Investigator:

Task description:

27. Submitted by: <Title, First Name, Last Name>

Study

designation

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SECTION II: SCIENTIFIC/TECHNICAL REVIEW APPROVAL ENDORSEMENT This section should be signed by the Chair/Head of the Scientific/Technical Review committee/office that

reviewed the scientific soundness of the study and issued the appropriate approval. Alternatively, results of

Scientific/Technical Review disposition may be appended to this application, instead of completing this section,

provided that the information required below had been appropriately addressed. STUDY PROTOCOL TITLE: <with Version Number and Date>

Principal Investigator: <Title, First Name, Last Name>

I confirm that the(NAME OF SCIENTIFIC/TECHNICAL REVIEW COMMITTEE/OFFICE) has reviewed and approved the

following study protocol-related information: Objectives/Expected output supported by literature review; overall

research design; sampling design, sample size, Inclusion/exclusion/ withdrawal criteria; data collection plan and

specimen collection, processing, and storage as applicable; data analysis plan including statistical

design/framework, as applicable.

Issuing committee/office: Head of committee/office: <Title, First Name, Last Name>

Signature: Date of Signature: <dd/mm/yyyy>

SECTION III: INSTITUTIONAL ENDORSEMENT This section should be signed by the head of unit (administrative authority legally empowered to sign on behalf the

unit such as Dean, Director, and the like) of the Principal Investigator. This section is required only for initial

submission, provided there are no changes in study protocol information below. STUDY PROTOCOL TITLE: Principal Investigator: <Title, First Name, Last Name>

I confirm that I have read this Application and that the research will be implemented under the oversight of this

Department/Institution in accordance with the conditions of approval by the National Children’s Hospital

Institutional Review Board/Independent Ethics Committee. I also confirm that the Principal Investigator has a

regular appointment in this institution.

Issuing unit/college:

Head of unit: <Title, First Name, Last Name>

Signature: Date of Signature: <dd/mm/yyyy>

SECTION IV: AUTHORIZATION AND ACKNOWLEDGEMENT OF REVIEW This section should be completed by the signatory official who can sign on behalf of the institution that has

oversight on the research site, IF the research site is OUTSIDE the scope of authority of NCH and the PI is non NCH

personnel. If not applicable, put N/A in all fields. This section is required only for initial submission, provided there

are no changes in study protocol information below. STUDY PROTOCOL TITLE: Principal Investigator: <Title, First Name, Last Name>

This is to certify that the <NAME OF RESEARCH SITE>:

1) Has no local Institutional Review Board/ Ethics Review Committee; and

2) Authorizes and acknowledges the National Children’s Hospital Institutional Review Board/Independent Ethics

Committee (NCH IRB/IEC), located at the 264 E. Rodriguez Sr. Blvd., Quezon City, to perform the ethical review

of the abovementioned study protocol in accordance with international ethical standards and national

regulatory requirements, and oversee the conduct of the research study which includes progress monitoring,

adverse event monitoring, and site visits.

Name of Research Site Address of Research Site Signatory Official <Title, First Name, Last Name>

Position of Official Signature Date of Signature:<dd/mm/yyyy>

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NCH IRB/IEC-2012-05-2B-RAFSBBR

SOCIAL AND BEHAVIORAL BASIC RESEARCHES

REGISTRATION AND APPLICATION FORM For Initial Review

SECTION I: APPLICATION INFORMATION

1. NCH IRB/IEC Code

2. RESEARCH TITLE

3. Researcher/s 3.1. _____________________________

3.2. _____________________________

3.3. _____________________________

3.4 _____________________________

3.5. _____________________________

3.6. _____________________________

4. Degree & School

5. Description of

respondents including

their characteristics and

age range

6. Number of Projected

Respondents in our

institution

7. Study Duration/

Respondents

participation

8. Description of Data

Gathering Procedure:

9. Please describe safety

measures taken to

protect respondent’s

privacy during

identification of

respondents and

collection of data

10. Please indicate the type

of Informed

Consent/Assent to be

used in the research NOTE: (Informed

Consent/Assent must utilize

language understandable

to the respondents)

11. Submitted by 12. Phone Number &

E-mail Address

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2.2 Use of Study Assessment Forms

1. Scope

There are two (2) NCH IRB/IEC Assessment Forms for protocol review (see Annex for

samples):

1.1. Study Protocol Assessment Form (NCH IRB/IEC-2012-05-2C-SPAF)

1.2. Informed Consent Assessment Form (NCH IRB/IEC-2012-05-2D-ICAF)

These SOP apply to the use of the Study Assessment Forms in the review and assessment of

protocols submitted to NCH IRB/IEC for initial review and approval by the NCH IRB/IEC. The

NCH IRB/IEC uses two study assessment forms. The two assessment forms, namely the (1)

Study Protocol Evaluation Form and the (2) NCH IRB/IEC Checklist for Informed Consent, are

in the form of checklists and these are accomplished by individual reviewers. Any

comments, evaluation, recommendations and the initial decision of each reviewer

regarding a protocol are all noted in these two forms.

The Study Assessment Forms are designed to standardize the review process and to

facilitate reporting of recommendation and comments given to each individual protocol.

It is the responsibility of the NCH IRB/IEC reviewers to individually fill-in the assessment forms

(the checklists) after reviewing each study protocol. The Secretariat is responsible for

recording and filing the NCH IRB/IEC’s action, relevant points and deliberation about a

particular protocol, including the reason for said action. The consensus regarding the

decisions on each reviewed protocol will be reflected in the Minutes of the meeting.

2. Flow Chart

Activity

Responsibility

1. Look for Study Protocol Assessment Forms (NCH IRB/IEC-2012-05-2C-

SPAF) (checklists) that should come together with the protocol

Reviewer

2. Fill up the Study Protocol Assessment Forms (NCH IRB/IEC-2012-05-

2C-SPAF)as you review the study protocol

Reviewer

3. Submit accomplished Study Protocol Assessment Forms (NCH

IRB/IEC-2012-05-2C-SPAF) for next NCH IRB/IEC meeting

Secretariat

4. The compiled checklists and forms are reproduced for inclusion in

the agenda of the meeting; the decision of the NCH IRB/IEC is

included in the Minutes

Secretariat

5. Inform the principal investigator of NCH IRB/IEC decision through a

letter from the Chair

Chair/Secretariat

6. File copies of duly accomplished forms in the Study File folder of the

particular protocol

Secretariat

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3.1. The NCH IRB/IEC reviewer checks if the two Study Assessment Forms (Study Protocol

Assessment Form (NCH IRB/IEC-2012-05-2C-SPAF)and Informed Consent Assessment

Form (NCH IRB/IEC-2012-05-2D-ICAF) are attached with each protocol received for

review.

3.2. The NCH IRB/IEC reviewer individually fills out both forms for each protocol.

3.3. The Study Protocol Assessment Form has 25 items, while the Informed Consent

Assessment Form has 33 items. Examples of these forms are found in the Annexes. The

important items in the checklists are:

3.3.1. Need for human study participants for study/rationale and significance of

the study

3.3.2. Objectives of the study

3.3.3. Review of literature

3.3.4. Sample size

3.3.5. Methodology and data management

3.3.6. Inclusion/exclusion criteria

3.3.7. Control arms (placebo, if any)

3.3.8. Withdrawal or discontinuation criteria

3.4. The reviewer signs and submits the checklists together with the reviewed protocol

back to the Secretariat. He/she makes sure that the Secretariat signs for receipt of

both forms and reviewed protocol.

3.5. The Secretariat compiles the checklists and submits these to the Chair.

3.6. The Chair reviews the compiled checklists.

3.7. If the protocol is not approved, the Chair through the Secretariat communicates the

reason/s to the principal investigator for revision.

The Chair also informs the principal investigator that the comments/suggestions

stated in the letter are the results of initial review and after he/she has made the

necessary revisions the protocol will still undergo another review to be conducted by

other NCH IRB/IEC members in an en banc meeting prior to its approval.

3.8. If the protocol is approved by the reviewers, the Chair includes the protocol in the

agenda of the next NCH IRB/IEC meeting.

3.9. The Secretariat includes the compiled checklist in the agenda of the next meeting.

3.10. The protocol and consent is discussed in the NCH IRB/IEC meeting for final decision.

3.11. The checklists are returned to the corresponding protocol’s file folder.

3.11.1. The NCH IRB/IEC decision is communicated to the principal investigator

through a letter, which is signed by the Chair. A copy of the signed letter is

retained in the study file folder of that protocol. On the latter copy, the date

on which the notification has been delivered is noted before being filed.

NOTE: The principal investigator should be informed regarding the review

process his/her protocol will undergo. The protocol will first undergo a

review by the two members of the NCH IRB/IEC. The necessary

revisions to the protocol will then be communicated to the principal

investigator. If the two reviewers have approved the protocol, the

protocol will then be included by the Chair in the agenda for the next

meeting for an en banc review. The protocol will only be given full

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approval once it has been approved by all members of the NCH

IRB/IEC in an en banc meeting.

4. Relevant Forms

4.1. NCH IRB/IEC-2012-05-2C-SPAF Study Protocol Assessment Form

4.2. NCH IRB/IEC-2012-05-2D-ICAF Informed Consent Assessment Form

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NCH IRB/IEC-2012-05-2C-SPAF

STUDY PROTOCOL ASSESSMENT FORM STUDY PROTOCOL INFORMATION

NCH IRB/IEC Code:

Study Protocol Title:

Principal Investigator:

Study Protocol Submission Date:

INSTRUCTIONS To the Principal Investigator: Please indicate in the space provided below whether or not the

specified assessment point is addressed by your study protocol. To

facilitate the evaluation of the assessment point, indicate the page

and paragraph where this information can be found.

To the Primary Reviewer: Please evaluate how the assessment points outlined below have been

appropriately addressed by the study protocol, as applicable, by

confirming the submitted information and putting your comments in the

space provided under “REVIEWER COMMENTS.” Finalize your review by

indicating your conclusions under “RECOMMENDED ACTION” and

signing in the space provided for the primary reviewer.

To be filled out by the

PI

ASSESSMENT

POINTS

Indicate if the

study protocol

contains the

specified

assessment

point

Page and

paragraph

where it is

founded

REVIEWER COMMENTS

1. SCIENTIFIC DESIGN YES N/A

1.1. Objectives Review of viability of

expected output

1.2. Literature review Review of results of

previous animal/human

studies showing known risks

and benefits of

intervention, including

known adverse drug

effects, in case of drug

trials

1.3. Research design Review of appropriateness

of design in view of

objectives

1.4. Sampling design

Review of

appropriateness of

sampling methods and

techniques

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1.5. Sample size Review of computation of

sample size

1.6. Statistical analysis

plan (SAP) Review of the

appropriateness of

statistical methods to be

used and how participant

data will be summarized

1.7. Data analysis plan Review of appropriateness

of statistical and non-

statistical methods of data

analysis

1.8. Inclusion criteria Review of precision of

criteria both for scientific

merit and safety concerns;

and of equitable selection

1.9. Exclusion criteria Review of criteria precision

both for scientific merit and

safety concerns; and of

justified exclusion

1.10. Withdrawal criteria Review of criteria precision

both for scientific merit and

safety concerns

2. CONDUCT OF STUDY

2.1. Specimen handling Review of specimen

storage, access, disposal,

and terms of use

2.2. PI qualifications Review of CV and relevant

certifications to ascertain

capability to manage

study related risks

2.3. Suitability of site Review of adequacy of

qualified staff and

infrastructures, including

applicability of UPMREB

FORM2(E)2012 and UPMREB

FORM2(F)2012

2.4. Duration Review of length/extent of

human participant

involvement in the study

3. ETHICAL

CONSIDERATIONS

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3.1. Conflict of interest Review of management of

conflict arising from

financial, familial, or

proprietary considerations

of the PI, sponsor, or the

study site

3.2. Privacy and

confidentiality Review of measures or

guarantees to protect

privacy and confidentiality

of participant information

as indicated by data

collection methods

including data protection

plans

3.3. Informed consent

process Review of application of

the principle of respect for

persons, who may solicit

consent, how and when it

will be done; who may give

consent especially in case

of special populations like

minors and those who are

not legally competent to

give consent, or indigenous

people which require

additional clearances

3.4. Vulnerability Review of involvement of

vulnerable study

populations and impact on

informed consent (see 3.3).

Vulnerable groups include

children, the elderly, ethnic

and racial minority groups,

the homeless, prisoners,

people with incurable

disease, people who are

politically powerless, or

junior members of a

hierarchical group

3.5. Recruitment Review of manner of

recruitment including

appropriateness of

identified recruiting parties

3.6. Assent Review of feasibility of

obtaining assent vis à vis

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incompetence to consent;

Review of applicability of

the assent age brackets in

children:

0-under 7: No assent

7-under 12: Verbal Assent

12-under15: Simplified

Assent Form

15-under18:Co-sign

informed consent form with

parents

3.7. Risks Review of level of risk and

measures to mitigate these

risks (including physical

,psychological, social,

economic), including plans

for adverse event

management; Review of

justification for allowable

use of placebo as detailed

in the Declaration of

Helsinki (as applicable)

3.8. Benefits Review of potential direct

benefit to participants; the

potential to yield

generalizable knowledge

about the participants’

condition/problem; non-

material compensation to

participant (health

education or other

creative benefits), where

no clear, direct benefit

from the project will be

received by the participant

3.9. Incentives or

compensation Review of amount and

method of compensations,

financial incentives, or

reimbursement of study-

related expenses

3.10. Community

considerations Review of impact of the

research on the

community where the

research occurs and/or to

whom findings can

be linked; including issues

like stigma or draining of

local capacity; sensitivity to

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cultural traditions, and

involvement of the

community in decisions

about the conduct of

study

3.11. Collaborative

study terms of

reference Review of terms of

collaborative study

especially in case of multi-

country/multi-institutional

studies, including

intellectual property rights,

publication rights,

information and

responsibility sharing,

transparency, and

capacity building

RECOMMENDED ACTION

APPROVAL

MINOR MODIFICATIONS

MAJOR MODIFICATIONS

DISAPPROVAL

JUSTIFICATION FOR RECOMMENDATION

PRIMARY REVIEWER Name

Date: Signature

PANEL SECRETARY Name

Date: Signature

PANEL CHAIR Name

Date: Signature

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NCH IRB/IEC-2012-05-2B-ICAF

INFORMED CONSENT ASSESSMENT FORM

STUDY PROTOCOL INFORMATION NCH IRB/IEC Code:

Study Protocol Title:

Principal Investigator:

Study Protocol Submission Date:

INSTRUCTIONS: To the Principal Investigator: Please indicate in the space provided below whether or not the

specified element is addressed by the informed consent form (ICF). To

facilitate the evaluation of the assessment point, indicate the page and

paragraph where this information can be found.

To the Primary Reviewer: Please evaluate how the elements outlined below have been

appropriately addressed by the informed consent form (ICF), as

applicable, and by confirming the submitted information and putting

your comments in the space provided under “REVIEWER

COMMENTS.”Finalize your review by indicating your conclusions under

“RECOMMENDED ACTION” and signing in the space provided for the

primary reviewer.

To be filled out by

the PI

ESSENTIAL ELEMENTS (As applicable to the study)

Indicate if the ICF

has the specified

element

Page and

paragraph

where

element is

found

REVIEWER COMMENTS

YES N/A 4. A statement that the study

involves research

5. The statement describes the

purpose of the study

6. Study-related treatments and

probability of random assignment

7. Study procedures including all

invasive procedures

8. Responsibilities of the participant 9. Expected duration of

participation in the study

10. Approximate number of

participants in the study

11. Study aspects that are

experimental

12. Foreseeable risks to

participant/embryo/

fetus/nursing infant; including

pain, discomfort, or

inconvenience associated with

participation including risks to

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spouse or partner;

13. Risks from allowable use of

placebo (as applicable)

14. Reasonably expected benefits; or

absence of direct benefit to

participants, as applicable

15. Expected benefits to the

community or to society, or

contributions to scientific

knowledge

16. Description of post-study access

to the study product or

intervention that have been

proven safe and effective

17. Alternative procedures or

treatment available to

participant

18. Compensation or insurance or

treatment entitlements of the

participant in case of study-

related injury

19. Anticipated payment, if any, to

the participant in the course of

the study; whether money or

other forms of material goods,

and if so, the kind and amount

20. Compensation (or no plans of

compensation) for the

participant or the participant’s

family or dependents in case of

disability or death resulting from

study-related injuries

21. Anticipated expenses, if any, to

the participant in the course of

the study

22. Statement that participation is

voluntary, and that participant

may withdraw anytime without

penalty or loss of benefit to which

the participant is entitled

23. Stating that the study monitor(s),

audit(s), the NCH IRB/IEC Ethics

Review Panel, and regulatory

authorities will be granted direct

access to participant’s medical

records for purposes ONLY of

verification of clinical trial

procedures and data

24. A statement that the records

identifying the participant will be

kept confidential and will not be

made publicly available, to the

extent permitted by law; and that

the identity of the participant will

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remain confidential in the event

the study results are published;

including limitations to the

investigator’s ability to guarantee

confidentiality

25. Description of policy regarding

the use of genetic tests and

familial genetic information, and

the precautions in place to

prevent disclosure of results to an

immediate family relative or to

others without consent of the

participant

26. Possible direct or secondary use

of participant’s medical records

and biological specimens taken

in the course of clinical care or in

the course of this study

27. Plans to destroy collected

biological specimen at the end

of the study; if not, details about

storage (duration, type of storage

facility, location, access

information) and possible future

use; affirming participant’s right

to refuse further use, refuse

storage, or have the materials

destroyed

28. Plans to develop commercial

products from biological

specimens and whether the

participant will receive money or

other benefit from such

development

29. A statement that the participant

or participant’s legally

acceptable representative will

be informed in a timely manner if

information becomes available

that may be relevant to the

willingness of the participant to

continue to participate

30. The statement describes the

access of participant to the result

of the study

31. A statement describing the

extent of the participant’s right to

access his/her records (or lack

thereof is à this pending request

for approval of non or partial

disclosure)

32. Foreseeable circumstances and

reasons under which

participation in the study may be

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terminated

33. Sponsor, institutional affiliation of

the investigators, and nature and

sources of funds

34. A statement whether the

investigator is serving only as an

investigator or as both

investigator and the participant’s

health care provider

35. Person(s) to contact with the

study team for further information

regarding the study and whom to

contact in the event of study-

related injury

36. A statement that the NCH IRB/IEC

Ethics Review Panel (specify) has

approved the study, and may be

reached through the following

contact for information regarding

rights of study participants,

including grievances and

complaints:

Name of NCH IRB/IEC Chair

Address: 264 E. Rodriguez Sr. Blvd.,

Quezon City 1102

Email: nch.irbiec.com.ph

Tel: +63 2 7240656 to 59 loc. 114

RECOMMENDED ACTION APPROVAL

MINOR MODIFICATIONS

MAJOR MODIFICATIONS

DISAPPROVAL Reasons for

disapproval:

PRIMARY REVIEWER Name

Date: Signature

PANEL SECRETARY Name

Date: Signature

PANEL CHAIR Name

Date: Signature

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2.3. Expedited Review

1. Scope

These SOP apply to the review and approval of study proposals with minimum risk to study

participants, protocol amendments or informed consent changes of currently approved

studies. The acceptance procedure is the same as for any protocol submitted for the first

time to NCH IRB/IEC for review (i.e. The protocol will have to undergo technical review prior

to ethical review). For proposals that are not NCH-funded, the NCH IRB/IEC will require

evidence of technical review or reserves the right to submit the proposal to the TRC for

review, or will have to address both technical and ethical issues.

The following are types of protocols that can be subjected to expedited review:

1.1. Protocols of a non-confidential nature (not of a private character, e.g. relate to

sexual preference etc., or not about a sensitive issue that may cause social stigma),

not likely to harm the status or interests of the study participants and not likely to

offend the sensibilities nor cause psychological stress of the people involved.

1.2. Protocols not involving vulnerable subjects (individuals whose willingness to volunteer

in a clinical trial may be unduly influenced by the expectation of benefits associated

with participation or of a retaliatory response in case of refusal to retaliate, patients

with incurable diseases, persons in nursing homes, unemployed or impoverished

persons, patients in emergency situations, ethnic minority groups, homeless persons,

nomads, refugees, minors and those incapable of giving consent).

1.3. Protocols that involve collection of small amounts of blood samples (and not too

frequent) e.g. by finger, heel or ear stick.

1.4. Protocols that involve collection of biological specimens for research purposes by

non-invasive means (e.g. collection of body fluids or excreta non-invasively,

collection of hair or nail clippings in a non-disfiguring or non-threatening manner).

1.5. Collection of data for research purposes through non-invasive procedures (not

involving general anesthesia or sedation) routinely employed in clinical practice and

using medical devices which have been already approved for use. Examples of

such procedures include collection of data through application of EEG or ECG

electrodes, acoustic testing, tests using the Doppler principle, non-invasive blood

pressure and other routine clinical measurements, exercise tolerance etc.

However, procedures involving the use of x-rays or microwaves are not

recommended for expedited review.

1.6. Research involving data, documents or specimens that have been already

collected or will be collected for on-going medical treatment or diagnosis

1.7. Proposed continuing reviews, protocol amendments and end of study reports that

have minor modifications and no significant risk to study participants.

2. Flow Chart


1. Receives the submitted documents

and forwards to the Chair

Secretariat

2. Determines that the protocol is for

expedited review

Chair

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3. Assigns reviewers for the expedited

review

Chair

4. Reviewers will do the expedited

review and submit the decision to the

Secretariat

Members / Chair

5. The decision is communicated to the

NCH IRB/IEC members for comments

Approval

No

Yes

Secretariat

6. The decision is communicated with

the principal investigator and

requests for revision and resubmission

of protocol

Notifies the

principal

investigator

and reports

the

approval to

en banc

NCH

IRB/IEC

Secretariat

7. File documents in study file folder of

protocol

Secretariat


3.1. The Secretariat receives the submitted documents.

3.1.1. Receive the application documents submitted by investigators.

3.1.2. Check items received using checklist as guide.

3.1.3. Stamp the receiving date on the letter of application and on all the

documents received.

3.1.4. Sign on the “receiver’s name” and put the date on the receiving document

form.

3.2. Criteria for Expedited Review of Amendments/ Revisions

3.2.1. Administrative revisions, such as correction of types

3.2.2. Addition or deletion of non-procedural items, such as the addition of study

personnel names, laboratories, etc.

3.2.3. The research activity includes only minor changes from previously approved

protocol.

3.3. The Chair nominates two or more NCH IRB/IEC members to review the protocol. The

selected members are normally those who reviewed and recommended the

previous version of that protocol, if it is not submitted for the first time.

3.4. The Secretariat sends the revised protocol to the selected members.

3.5. The NCH IRB/IEC members carry out the expedited review on the complete proposal

(study protocol with all the attached documents as mentioned in the guidelines for

submission of proposals).

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3.6. If consensus cannot be reached, the Chair will refer the proposal back to the NCH

IRB/IEC for full review.

3.7. The Secretariat informs the NCH IRB/IEC members of the proposals approved by

expedited review. If any NCH IRB/IEC member raises concern about any of the

proposals presented to it, then that proposal shall undergo a regular review.

3.8. The Secretariat communicates with the NCH IRB/IEC and the principal investigator.

3.8.1. The reviewers forward their comments to the Secretariat.

3.8.2. Full board notification of items approved through expedited review by the

Chair or the designate is accomplished by providing notification and source

documentation of the items in the meeting agenda/notes.

3.8.3. The Secretariat communicates the decision to the principal investigator.

3.9. The Secretariat files the documents in the study file folder of the protocol.

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2.4 Full Board Review of Submitted Protocols

1. Scope

These SOP describe how the NCH IRB/IEC reviewers evaluate a study protocol submitted to

NCH IRB/IEC for the first time.

The Secretariat is responsible for receiving, verifying and managing the contents of both the

hard copies and the electronic version (if any) of the submitted protocol package. In

addition, the Secretariat should create a specific protocol file, make copies of the file and

then distribute the copies to the NCH IRB/IEC reviewers, together with a cover letter where

the due date for returning the reviewed protocol is indicated (See NCH IRB/IEC SOP 2012).

It is the responsibility of the assigned reviewers to thoroughly review the study protocols

delivered to them, give their decision, observation and comments and put all of this in the

Study Assessment Forms before returning the reviewed protocol and assessment form to the

Secretariat on the due date.

2. Flow Chart

Activity

Responsibility

1. Receives the distributed protocol

package

Reviewers

2. Verifies the contents of the package

Reviewers

3. Reviews the protocol and fills out and

sign individual Study Assessment Forms

Reviewers

4. Discuss/es in an en banc meeting of NCH

IRB/IEC if needed

Members/Chair

5. Communicates NCH IRB/IEC decision to

the principal investigator

Approval

No

6. The decision is communicated with the

principal investigator and requests for

revision and resubmission of protocol

Yes

Notifies the

principal

investigator and

reports the

approval to en

banc NCH IRB/IEC

Secretariat/Chair

Secretariat

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3. Detailed Instructions for Reviewers

3.1. Receive the protocol packages

3.1.1. Check the distributed packages.

3.1.2. Fill in the Document Receipt Form (NCH IRB/IEC-2012-05-2E-DRF) upon

receiving the packages, indicate the date and affix reviewer's signature.

3.1.3. Return the signed acknowledgment form back to the delivery

person/Secretariat.

3.2. Verify the contents of the package

3.2.1. Look for the Study Protocol Assessment Forms (NCH IRB/IEC-2012-05-2C-SPAF).

3.2.2. Note the due date for submitting results (accomplished checklists) and the

protocols back to NCH IRB/IEC Secretariat.

3.3. Review the Protocol

3.3.1. Using the requirements for review, take note if there are missing/lacking items

in the protocol and which you feel should be included in the protocol.

3.3.2. Look for the CV or information about the principal investigator/s, study sites

and other documents which you feel should be included or necessary in

order to review the protocol.

3.3.2.1. Consider whether study and training background of the principal

investigator/s relate to the study.

3.3.2.2. Look for disclosure or declaration of potential conflicts of interest.

3.3.2.3. Non-physician principal investigators should be advised by a

physician when necessary.

3.3.2.4. Determine if the facilities and infrastructure at study sites can

accommodate the study.

3.3.3. Using the checklist for Informed Consent Assessment Form (NCH IRB/IEC-2012-

05-2D-ICAF), review the Informed Consent and note any item on the

checklist that is lacking in the Informed Consent document and which you

feel should be added or elaborated.

3.3.4. Look for Assent Form if the protocol calls for children 12 years to under 15

years old (Simplified Assent Form) as study participants. The procedure for

getting the assent of minor-aged study participants should be clear (the

objective of the study and the procedures to be done should be explained

to the child separately, for example).

3.4. The reviewer is advised to note the following Review Guidelines:

3.4.1. In assessing the degree of risk against the benefit, determine whether the risks

are reasonable in relation to anticipated benefits; and/or if the risks can be

minimized.

3.4.2. Study participants are selected equitably especially if randomization is not to

be used. Study participant's information sheet should be clear and adequate

3.4.3. There is voluntary, non-coercive recruitment of study participants.

3.4.4. The Informed Consent is adequate, easy to understand and properly

documented.

3.4.5. There should be a translation of the Informed Consent document into the

local dialect which should be plain and comprehensible by the general

public.

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3.4.6. The procedure for getting the Informed Consent is clear and unbiased.

3.4.7. The persons who are responsible for getting the Informed Consent are

named and introduced to the study participants.

3.4.8. The research plan makes adequate provision for monitoring the data

collected to ensure the safety of study participants, where appropriate.

3.4.9. There are adequate provisions to protect the privacy of study participants

and to maintain the confidentiality of data, where appropriate.

3.4.10. There is provision for compensation to study participants. This should be

reasonable provision for medical/psychosocial support; treatment for study

related injuries, as well as compensation for participation to cover

reasonable expenses like transport and lost wages because of participation.

3.4.11. There are appropriate safeguards included to protect vulnerable study

participants.

3.4.12. Contact persons with address and phone numbers are included in the

Informed Consent.

3.4.13. There is clear justification for the use of biological materials (note SOP on

review of protocols using genetic and/or biological materials which have

potential for genetic research).

3.4.14. There are appropriate contracts or memoranda of understanding especially

in collaborative studies (see SOP on Review of Collaborative Studies).

3.5. Examine community involvement and impact/benefit of the study to community

and/or the institution. If relevant, the reviewer looks for the following in the protocol:

3.5.1. Community consultation

3.5.2. Involvement of local researchers and institutions in the protocol design,

analysis and publication of the results

3.5.3. Contribution to development of local capacity for research and treatment

3.5.4. Benefit to local communities

3.5.5. Availability of study results

3.6. After reviewing the protocol and the documents, the reviewer makes a decision.

3.6.1. Record the decision by marking in the desired block at the back of the

Informed Consent Assessment Form: Approved, Approved with

recommendation, Resubmitted, or Disapproved.

3.6.2. Include comments, suggestion and reason for disapproval.

3.6.3. Check the completeness and correctness of the assessment forms. Indicate

the date and affix the reviewer's signature in the decision form. Submit the

completed forms to the Secretariat together with the protocols.

3.7. Submit the completed forms to the Secretariat together with the protocols.

3.8. Attend and participate actively in the en banc meeting regarding the reviewed

protocol/s.

3.9. For NCH-funded proposals, a member of the Techincal Review Committee (TRC)

shall sit in the en banc meeting as a consultant to address technical issues.

3.10. The NCH IRB/IEC en banc then makes a decision on the protocol either to approve

or approve with modifications or disapprove.

3.11. If the study is approved, the NCH IRB/IEC determines the frequency of continuing

review from each investigator.

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3.11.1. The Secretariat sends an Action Letter/Approval Letter along with the

approved documents to the principal investigator.

3.11.2. The letter contains identification of the document approved, the date set by

the NCH IRB/IEC for frequency of continuing review, and a review of other

obligations and expectations from the principal investigator throughout the

course of the study.

3.11.3. An approval is placed on every page of each consent form approved by

the NCH IRB/IEC.

3.12. For non-NCH-funded proposals, NCH IRB/IEC may request the Techincal Review

Committee (TRC)to provide additional technical input as deemed necessary.

3.13. If the NCH IRB/IEC votes not to approve the study, the Secretariat immediately

notifies the principal investigator in writing about the decision and the reason for not

approving the study.

3.14. If the principal investigator wishes to appeal regarding the decision, he/she may do

so through written request submitted to the NCH IRB/IEC.

3.15. If the NCH IRB/IEC requires modifications to any of the documents, the Secretariat

either generates the revisions to the documents or sends a written request of the

specific changes to the Principal Investigator asking him/her to make the necessary

changes and re-submit the documents to the NCH IRB/IEC.

3.16. The final recommendations of the NCH IRB/IEC should be written on the approval

letter.

3.17. The Secretariat drafts the approval letter, gives to the Chair to sign, then sends it to

the principal investigator. There should be a file/received copy with specific date. All

information regarding the date of the NCH IRB/IEC decision such as the date when

decision was written and signed by the Chair, and date when it was delivered

to the principal investigator, are entered in the “Log of Submitted Protocols”.

3.18. All documented deliberations regarding a protocol are filed in the study file of that

protocol. Keep a copy of the "Notice of NCH IRB/IEC Decision" in the corresponding

file. Place the original documents of the application review and the assessment

forms in sequence of approval number in the study file folder of the protocol.

4. Relevant Form

NCH IRB/IEC-2012-05-2E-DRF Document Receipt Form

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NCH IRB/IEC-2012-05-2E-DRF

DOCUMENT RECEIPT FORM DATE

RECEIVED NCH IRB/IEC

CODE TITLE PRINCIPAL

INVESTIGATOR RECEIVED BY TYPE OF

SUBMISSION E – Expedited

FR-Full Review

REMARKS

Prepared by:

_________________________________

Secretary, NCH IRB/IEC

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2.5 Preparation of Meeting Agenda

1. Purpose:

This Section is aimed at describing the process of preparation and distribution of the

agenda for NCH IRB/IEC meetings.

2. Scope

2.1. This SOP provides instructions for the preparation, review, approval, and distribution

of meeting agenda prior to the regular NCH IRB/IEC meeting.

2.2. It is the responsibility of the Secretariat to consult with the NCH IRB/IEC Chair

regarding matters to be taken up in a meeting, preparation and approval of the

agenda, and distribution to NCH IRB/IEC members one week before the scheduled

meeting.

3. Workflow


1. Prepare meeting agenda

Secretariat

2. Have agenda approved by the Chair

Secretariat

3. Distribute notice of meeting and agenda to

NCH IRB/IEC members

Secretariat

4. File the notice of meeting and agenda Secretariat

4. Detailed instructions

4.1. Preparation of meeting agenda before each NCH IRB/IEC meeting

4.1.1. The NCH IRB/IEC has a standard agenda format for its monthly meetings (NCH

IRB/IEC-2012-05-2G-MM). However, the Secretariat should still consult the Chair on

the agenda for the particular month before finalizing the agenda.

4.1.2. The regular agenda items are:

4.1.2.1 Review of previous meeting Minutes

4.1.2.2 Approval of Minutes

4.1.2.3 Business arising from the Minutes

4.1.2.4 Reports on protocols/amendments reviewed for the month

4.1.2.4.1 New protocols

4.1.2.4.2 Resubmitted protocols

4.1.2.4.3 Amendments/revisions

4.1.2.4.4 Terminated/completed protocols

4.1.2.4.5 Clarifications on particular protocols to be made by Principal

investigator/s, if any

4.1.2.4.6 Report on SAEs

4.1.2.5 Administrative matters

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4.1.2.6 Others

4.1.2.7 Setting of date of next meeting

4.1.2.8 Adjournment

4.1.3 Recommendations on protocols requiring clarifications in an en banc NCH

IRB/IEC meeting are made by NCH IRB/IEC reviewer/s, who inform/s the

Secretariat accordingly. The Chair instructs the Secretariat to inform the principal

investigator/s, in writing and by phone, at least a week before the meeting. The

reason/s for inviting them is/are stated in the letter. The time slot for their

appearance at the NCH IRB/IEC meeting is also communicated in the letter.

4.1.4 The Secretariat arranges the venue and other logistics for the meeting at least a

week before the scheduled meeting.

4.1.5 The Secretariat makes copies of the final agenda and sends them, together with

the notice of meeting to the NCH IRB/IEC members, at least one week before

the meeting.

4.1.6 The Secretariat files a copy of the agenda in the NCH IRB/IEC administrative files.

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2.6 Preparation of Meeting Minutes

1. Purpose

This Section is aimed at describing the process of preparation and distribution of the minutes

of NCH IRB/IEC meetings.

2. Scope

This SOP describes how the Minutes of the NCH IRB/IEC meetings are to be prepared, used,

distributed and filed. As a rule, not all matters discussed during the meeting are included in

the Minutes. Only those pertinent and relevant comments, recommendations and decisions

are summarized in chronological order or other appropriate sequence.

3. Flow Chart


1. Organization of notes taken during the meeting and

tape proceedings

Secretariat

2. Preparation and drafting of the Minutes of Meeting

(NCH IRB/IEC-2012-05-2G-MM)according to the

sequence

Secretariat

3. Approval of the draft of the Minutes of Meeting

Chair/designated

member

4. Preparation and signing of approved Minutes of

Meeting

Secretariat and Chair

5. Filing of Minutes Meeting in NCH IRB/IEC members’

folders and NCH IRB/IEC documents file

Secretariat


4.1. The Minutes of the meeting shall be prepared within 2 weeks after its conduct.

4.2. Organization of notes

4.2.1. The Secretariat organizes the notes from the proceedings based on the

agenda of the meeting, using the audio tape of the meeting for verification if

needed. For each item, the following shall be noted:

4.2.1.1. Title of item or issue discussed

4.2.1.2. Important comments about the issue (name of member who made

the comment should be cited)

4.2.1.3. Conclusions/recommendations/decisions regarding the issue (if there

is consensus, there is no need to name those who made the decision)

4.3. Draft of the Minutes

4.3.1. The notes, as organized, are entered in the computer. Grammatical errors

are corrected. A draft copy is prepared using the following format:

4.3.1.1. Date and venue of meeting

4.3.1.2. Minutes of the meeting (NCH IRB/IEC-2012-05-2G-MM)

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4.3.2. Forward a copy of the draft of Minutes to the Chair, for corrections and

approval. The Chair ensures the accuracy of the minutes of the previous

meeting.

4.3.3. Once approved, a final copy of the minutes of the meeting (NCH IRB/IEC-

2012-0-2G-MM)is prepared using the following format:

4.3.3.1. Date and venue of meeting

4.3.3.2. NCH IRB/IEC members and guests who attended the meeting

4.3.3.3. NCH IRB/IEC members who were absent

4.3.3.4. Person presiding

4.3.3.5. Time that the meeting was opened

4.3.3.6. Items discussed as per agenda

4.3.3.7. Name and signature of person who prepared the minutes

4.3.3.8. Date and approval of the Chair

4.3.4 Make copies of approved minutes and enclose a copy in the NCH IRB/IEC

members’ meeting folders.

4.3.5 File original copy of Minutes in the NCH IRB/IEC Minutes folder.

4.3.6 Copies of the Minutes are also distributed to NCH IRB/IEC members during

the next meeting. If a member is absent, the approved Minutes are sent to

him/her.

5. Relevant Form(s)

NCH IRB/IEC-2012-05-2F-NOM Notice of Meeting

NCH IRB/IEC-2012-05-2G-MM Minutes of the Meeting

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NCH IRB/IEC-2012-05-2F-NOM

Date of issuance: ______

NOTICE OF MEETING

TO: <NAME OF NCH IRB/IEC PANEL> Members:

Name 1

Name 2

Name 3

Name 4

Name 5

Name 6

Name 7

Name 8

DATE OF MEETING

TIME OF MEETING

VENUE OF MEETING

AGENDA:

1. Call to order

2. Determination of quorum and presence of non-institutional members

3. Conflict of interest disclosure

4. Reading and approval of the Minutes of the last meeting

5. Business arising from the Minutes

6. Protocol review

6.1. FULL REVIEW

6.1.1. Study Protocols for Initial Review

NCH IRB/IEC Code

Study Protocol Submission

Date

<dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.2. Resubmissions or Study Protocols for Modification

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.3. Study Protocols for Clarificatory Interview

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NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.4. Application for Protocol Withdrawal

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Withdrawal Application

Date

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.5. Study Protocol Amendments Applications

NCH IRB/IEC Code

Study Protocol Approval

Date

<dd/mm/yyyy>

Amendment Submission

Date

<dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.6. Continuing Review Applications

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Application Date <dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.7. Final Reports

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Report Date <dd/mm/yyyy>

Title

Name of PI

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Sponsor

Type of Review

Primary Reviewers

6.1.8. AE and SUSAR Reports

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Report Date <dd/mm/yyyy> (Organize AEs under one protocol by date)

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.9. Site Visit Reports:

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Site Visit Date <dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.10. Protocol Deviation/Non-Compliance/Violation Reports:

NCH IRB/IEC Code


Date

<dd/mm/yyyy>


Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.11. Early Study Termination Application

NCH IRB/IEC Code


Date

<dd/mm/yyyy>


Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.1.12. Conduct of Study Queries, Complaints, or Grievance Reports

NCH IRB/IEC Code


Date

<dd/mm/yyyy> NCH IR

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Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

6.2. REPORT OF PROTOCOL SUBMISSIONS FOR EXPEDITED REVIEW AND FULL BOARD

PROTOCOLS WITH MODIFICATION EXPEDITED AT THE LEVEL OF THE CHAIR


NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

ACTION

6.2.2. Study Protocols for Modification (or Resubmissions)

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

ACTION

6.2.3. Study Protocol Amendments

NCH IRB/IEC Code


Date

<dd/mm/yyyy>

Amendment Submission

Date

<dd/mm/yyyy>

Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

ACTION

6.2.4. Continuing Review Applications

NCH IRB/IEC Code


Date

<dd/mm/yyyy>


Title

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Name of PI

Sponsor

Type of Review

Primary Reviewers

ACTION


NCH IRB/IEC Code


Date

<dd/mm/yyyy>


Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

ACTION

6.2.6. Protocol Deviation/Non-Compliance/Violation Reports

NCH IRB/IEC Code


Date

<dd/mm/yyyy>


Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

ACTION

6.2.7. Early Study Termination Applications

NCH IRB/IEC Code


Date

<dd/mm/yyyy>


Title

Name of PI

Sponsor

Type of Review

Primary Reviewers

ACTION

7. Other Matters

8. Adjournment

<TITLE, FIRST NAME, LAST NAME> and SIGNATURE

Chair, NCH IRB/IEC Review Panel

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NCH IRB/IEC-2012-05-2G-MM

National Children’s Hospital

I N S T I T U T I O N A L R E V I E W B O A R D / I N D E P E N D E N T E T H I C S

C O M M I T T E E 264 E. Rodriguez Sr. Blvd., Quezon City, 1102

Telephone: +63 2 7240656 to 59 local 114; Mobile: +63 ____________; Email: ___________________

Minutes of the NCH IRB/IEC

REGULAR MEETING

<Date>, <Place>, <Time>

1. ATTENDANCE

PRESENT ABSENT <Member>

<Member>

<Member>

<Member>

<Member>

<Member>

<Member>

<Member>

Others:

Panel Staff

<Name>

<Name>

<Name>

2. CALL TO ORDER

3. DETERMINATION OF QUORUM

4. DISCLOSURE OF CONFLICT OF INTEREST

5. READING AND APPROVAL OF THE MINUTES OF THE LAST MEETING

6. BUSINESS ARISING FROM THE MINUTES OF THE LAST MEETING

6.1. Corrections in the Minutes

6.2. Matters requiring NCH Panel action

7. STUDY PROTOCOL REVIEW

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7.1. FULL REVIEW


NCH IRB/IEC Code

Study Protocol Submission Date

Study Protocol Title

Principal investigator

Type of review

Primary reviewers

Technical Review

Sponsor

Quorum status

Conflict of interest

Assessment of scientific soundness

1. Objectives/Expected output 2. Literature review 3. Research design 4. Sampling design, sample size 5. Inclusion criteria, exclusion criteria, withdrawal criteria 6. Specimen collection and processing 7. Statistical and data analysis plan 8. PI qualifications 9. Suitability and choice of site 10. Translation of research instruments

Assessment of ethical issues 1. Conflict of Interest: 2. Privacy and confidentiality including data protection plan 3. Vulnerability 4. Risks 5. Benefits 6. Informed consent process and recruitment: 7. Informed Consent Form (ICF) (including translation) 8. Documentation of collaborative study TOR

Conclusion and recommendations

Major revision

Action taken Decision (Major Modification, which require full board deliberation)

Reasons

7.1.2. Resubmissions or Study Protocols for Modification:

7.1.3. Study Protocols for Clarificatory Interview:

7.1.4. Withdrawal of Study Protocol Applications:

7.1.5. Study Protocol Amendment Applications:

7.1.6. Continuing Review Applications:

7.1.7. Final Reports -

7.1.8. AE and SUSAR Reports -

7.1.9. Site Visit Reports -

7.1.10. Study Protocol Deviation/Non-Compliance/Violation Reports:

7.1.11. Early Study Termination Applications -

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7.1.12. Queries from Various Stakeholders -

7.2. REPORT OF PROTOCOL SUBMISSIONS FOR EXPEDITED REVIEW AND FULL

BOARD PROTOCOLS WITH MODIFICATION EXPEDITED AT THE LEVEL OF THE

CHAIR -

7.2.1. Study Protocols for Initial Review -

7.2.2. Resubmissions (study protocols for modification)-

7.2.3. Study Protocol Amendments -

7.2.4. Continuing Review Applications -


NCH IRB/IEC Code

Study Protocol Approval Date

Date of Report

Study Protocol Title

Principal Investigator

Type of Review

Primary Reviewers

Technical Review

Sponsor

Results reported

Action Decision Points (Approval)

7.2.6. Study Protocol Deviation/Non-Compliance/Violation Reports -

7.2.7. Early Study Termination Applications -

8. OTHER MATTERS

9. ADJOURNMENT

Prepared by:

DATE: 11/05/2012 SECRETARIAT STAFF

Checked by: Signature over <Title, First Name, Last Name>

DATE: 11/05/2012 PANEL SECRETARY

Approved by:

DATE: 11/05/2012 PANEL CHAIR

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2.7 Review of Medical Device Study

1. Scope

The purpose of these SOP is to provide instructions for review and approval of medical

device studies submitted to the NCH IRB/IEC. These SOP apply to the submission and the

review processes of protocols involving the study of new medical devices on human

subjects.

During the review of medical device studies, the NCH IRB/IEC may decide differently from

the way it does in the review of general category studies, clinical drug trials, animal studies,

or studies on the environment. The NCH IRB/IEC must determine if the proposed

investigation has Significant Risk (SR) or Non-significant Risk (NSR), and then the NCH IRB/IEC

should decide if the investigation is approved or not. In determining Significant Risk (SR) or

Non-significant Risk (NSR), the NCH IRB/IEC must review all information submitted by the

principal investigator.

The NCH IRB/IEC should consider the nature of the harm that may result from the use of the

device. If a device being investigated might cause significant harm to any one of the study

participants, the study will be considered Significant Risk (SR). In deciding if a device

presents significant or non-significant risks, the NCH IRB/IEC should consider the device’s

total risks, not those compared with the risks of alternative devices or procedures. If the

device is used in conjunction with a procedure involving risk, the NCH IRB/IEC should

consider the risks of the procedure in conjunction with the risks of the device. The NCH

IRB/IEC may also consult with the regulatory agency or an outside consultant to form its

opinion.

The NCH IRB/IEC may agree or disagree with the sponsor’s initial NSR assessment. If the NCH

IRB/IEC agrees with the sponsor’s initial Non-significant Risk assessment and approves the

study, the study may begin without submission of an IDE (Investigational Device Exemption)

application to the regulatory agency. If the NCH IRB/IEC disagrees, the sponsor must notify

the regulatory agency that an SR determination has been made. The study can be

conducted as an SR investigation following regulatory approval of an IDE application.

2. Flow Chart


1. Submits protocol package


2. Manages submitted protocol package

Secretariat

3. Conducts individual review

Reviewer

4. Conducts en banc review

Member

5. Notifies the principal investigator on NCH IRB/IEC

decision

Secretariat

6. Store documents Secretariat

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3.1 The same procedure is followed when the protocol is submitted for initial review as in

the submission of any protocol for NCH IRB/IEC review see NCH IRB/IEC SOP 2012.

3.2. When reviewing a protocol on a medical device, the reviewer must look for the

following:

3.2.1. Proposed investigational plan

3.2.2. Informed consent form

3.2.3. Description of the device

3.2.4. Description of study participant selection criteria

3.2.5. Monitoring procedures

3.2.6. Reports of prior investigations conducted with the device

3.2.7. Principal investigator’s curriculum vitae

3.2.8. Principal investigator’s professional license (s)

3.2.9. Risk assessment data / information

3.2.10. Statistics used in making the risk determination

3.2.11. Copies of all labelling for investigational use only

3.3. The reviewer also looks for information/communication from the principal

investigator, if any, whether other NCH IRB/IECs have reviewed the proposed study

and what decision was made especially with regards to the device’s risk.

3.4. A medical device study should always be submitted for an en banc review after

individual reviews are conducted. The NCH IRB/IEC en banc decides whether the

device study poses No Significant Risk (NSR) or poses Significant Risk (SR) to study

participants.

3.5. The principal investigator of a medical device study should always be present during

the en banc NCH IRB/IEC review of his proposal.

3.6. The NCH IRB/IEC decides whether or not the study should be approved.

3.7. The Chair calls for a vote on the medical device study. The NCH IRB/IEC votes to

any of the following:

3.7.1. Approve the study to start as presented with no modifications

3.7.2. Approve the study to start with minor modifications to item/s noted at the

convened meeting and to be followed-up by the Secretariat and Chair after

receiving the requested modifications

3.7.3. Require major modifications and/or request further information to be

resubmitted and subjected to review in the next full board meeting

3.7.4. Disapprove the study and state the reason.

3.7.5. Record the vote of risk assessment in the decision form and the meeting

minutes.

3.7.6. Determine the frequency of continuing review for the approved study.

3.7.7. The principal investigator is notified about the decision of the NCH IRB/IEC

thru the “Notice of NCH IRB/IEC Decision Form.”

If the NCH IRB/IEC votes not to approve the study, the Chair or Secretariat

notifies the principal investigator of the decision and the reason for

disapproving the study in written form. If the principal investigator wishes to

appeal for this decision, he/she may do so by writing to NCH IRB/IEC and

stating the reason for the appeal. This process is stated in the action letter

provided to the principal investigator.

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If the NCH IRB/IEC votes to require modifications to any of the documents,

the Secretariat either generates the revisions to the documents, or sends a

written request of the specific changes to the principal investigator, asking

him/her to make the necessary changes and resubmit the documents to the

NCH IRB/IEC.

3.8. The documents are stored in the active study files.

3.8.1. Prepare an appropriate label.

3.8.2. Store the document packages in the shelf for active files.

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2.8. Review of Protocols that Involve Genetic Materials

1. Scope

These SOP describe the special review that is necessary when a protocol involves the use of

genetic materials. The initial procedures of submission and processing of the submitted

documents do not differ from those used when protocol is submitted to NCH IRB/IEC.

However, when it comes to the individual review of such protocol, some documents

specifically referable to genetic studies are required. In addition, an independent

consultant may be requested to review the study.

2. Flow Chart

Activity

Responsibility

1. Submits protocol package


2. Manages submitted protocol package

Secretariat

3. Conducts Individual and/or independent

consultant’s review

Reviewer

4. Conducts en banc review with presence of

independent consultant

Member

5. Notifies the principal investigator on NCH IRB/IEC

decision

Secretariat

6. Stores documents Secretariat


3.1. The study protocol is processed using the SOP on Management of Submissions.

3.2. If not submitted with the protocol, a separate Informed Consent for the tissues to be

obtained from the study participant, which will be used for genetic studies, should

be submitted for review.

3.3. Copies of documents are given to reviewers for individual review.

3.4. A copy is given to an independent consultant who is identified by the Chair or

recommended by the members.

3.5. After individual review of the protocol, the protocol is discussed in an en banc NCH

IRB/IEC meeting with the independent consultant preferably present.

3.6. The decision of the NCH IRB/IEC is communicated to the principal investigator.

3.7. The files of the protocol are filed in the study file folder of the protocol.

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