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 I. VISION

 

An exemplary Dr. PJGMRMC-IRB to mandate highly ethical and sound research design, scientific integrity and standards.

 

II. MISSION

 

The Dr. Paulino J. Garcia Memorial Research and Medical Center Institutional Review Board is committed to deliver quality, efficient and effective review processes ensuring that all health and health-related researches involving human participation adheres to existing international, national, local and institutional ethical guidelines.

 

III. OBJECTIVES

 

To safeguard the rights, wellbeing, and safety of all participants in researches being undertaken in the institution by following local and international ethical guidelines for research and with utmost regard for the principles of: respect for person, beneficence and justice.

 

IV. ORGANIZATIONAL STRUCTURE

 Organizational Structure

 

 

 WORKFLOW DESCRIPTION OF PROCEDURES FOR MANAGEMENT OF INITIAL SUBMISSION AND RESUBMISSION

 



STEP

PROCESS

DESCRIPTION OF PROCEDURE

RESPONSIBLE PERSON

1.

Receipt of study documents for initial review and determination of completeness of submission or resubmission

The staff secretariat receives the study documents and determines the completeness of the submission using the Review Checklist Form (PJG-MCC-IRB-Form-001) The staff secretariat returns all incomplete submissions to the researcher.

Staff Secretariat

2.

Coding of Documents

The staff secretariat assigns a code according to the following information: (a) the year it was submitted, (b) the chronological number of DR. PJGMRMC-IRB received protocols, (c) first letter of first name followed by middle initial then surname, (d) keyword of the study. (For example, Mr. Melvin R. Estolano submits a protocol on statistics which is the first to be received in 2018 then the protocol will be coded as follows: 2018-001-MRESTOLANO-Statistics)

Staff Secretariat

3.

Entry into logbook/database

The staff secretariat enters in a logbook and an electronic database the following information: (1) study code, (2) title of the study, (3) name of proponent, (4) date of submission and resubmission, (5) name of receiver. These items are initial entries.

Staff Secretariat

4.

Determination of type of Review/Action

The DR. PJGMRMC-IRB Chairperson determines the type of review expedited (SOP on Expedited Review (SOP 6.4.1))or full review (SOP on Full Review (SOP 6.4.2)) or exemption form review (SOP on Communicating IRB Decisions (SOP 6.6.2))

DR. PJGMRMC-IRB Chairperson or Co-Chairperson

 

 

 

 

WORKFLOW DESCRIPTION OF PROCEDURES FOR MANAGEMENT OF RESEARCHES FROM OUTSIDERS

 



STEP

PROCESS

DESCRIPTION OF PROCEDURE

RESPONSIBLE PERSON

1

PI submits letter of request to MCC                 

The primary investigator submits letter of request   for ethical review or data collection to IRB                                                                            

 

PI

2

MCC forwards letter to IRB                                

The MCC forwards letter of request to IRB

Medical Center Chief (MCC)

3

IRB request submission of requirements         

The IRB request submission of requirements on                                                                                        Checklist (PJG-IRB-FORM01-

3.1   If requirements complete, coded and listed in logbook/database of research proposals

3.2   If without technical review, paper forwarded to research committee for technical review

3.3   If incomplete, study returned for completion of requirements

Staff Secretariat

4

Entry in the logbook/database

Once coded and included in proposal              logbook/database

4.1   PI signs commitment letter together with research adviser

4.2   Fees for IRB review if applicable

DR. PJGMRMC-IRB Chairperson

 

Policy Statement

The DR. PJGMRMC-IRB shall require a set of documents listed in a checklist for initial submission. Submissions with complete requirement shall be accepted every first Monday of the month (in case the first Monday falls on a holiday, submissions will be accepted the next working day).