POLICY STATEMENT

The MSU-GSC IERC shall only conduct an initial review procedure of submitted protocols after undergoing the technical review process. The Principal Investigator (PI) or his/her equivalent representative shall submit to the MSU-GSC IERC office three (3) hard copies of all the required and applicable, duly signed documents identified in the Review Checklist.

The soft copy of the submitted documents shall be also be sent to the MSU GSC IERC email (ierc@msugensan.edu.ph). Only complete submission shall be accepted for review. For incomplete submission, the Principal Investigator shall be given five working days to comply with the missing document/s as indicated in the Missing Document Form.

DETERMINATION OF TYPE OF REVIEW

The MSU-GSC IERC Staff shall inform the IERC Secretary to communicate with the Chairperson to determine the protocol of the study. The MSU-GSC IERC will be responsible for the identification and assignment of primary reviewers or independent consultants who will evaluate the research submissions, finalization of review results, and the communication of decision to the researcher.

For Full Board Review
For Expedited Review
Exempted from Review

To start the ethics review process, principal investigators are requested to submit a copy of the protocol dossier at the Institution's email (ierc@msugensan.edu.ph) which includes the following.

From MSU-GSC IERC

a. Review Checklist Form (Form 006)*

b. Registration and Application Form (Form 007)*

c. Study Protocol Assessment Form (Form 008)*

d. Informed Consent Assessment Form (Form 009)*

*Forms are downloadable at the Downloadable Forms Section

From Principal Investigators

a. Study Protocol/Manuscript

b. Curriculum Vitae of Principal Investigators (Researchers) and Study Adviser

c. Research Proposal Technical Result (Form 007b)

d. Sampled Informed Consent: English/Local Dialect (Form 009b)

e. Long Brown Folder

Study Specific Documents (if applicable to study)

a. Assent Form in English and Local Dialect (for studies involving minors and relevant populations deemed incompetent to sign and the informed consent form

b. Informed Consent Form for Genetic Studies in English and Local Dialect

c. Investigator's Brochure (for Clinical Trial Phase I, II, and III) or Basic Product Information

d. National Commission for Indigenous People (NCIP) clearance (for studies with indigenous populations)

e. Declaration of conflict of interest of the Principal Investigator/Co-Investigator

f. Disclosure for funding sources, sponsors, institutional affiliations, and other possible sources of conflict of interest

g. Recruitment advertisements (as needed by the study protocol)

h. Memorandum of Agreement

i. Materials Transfer Agreement (for any research involving the transfer of biological specimen)

The principal investigator/researcher shall submit three (3) sets of hard copies of the protocol dossier at the MSU-GSC IERC Office after evaluating the completeness based on the Review Checklist Form (Form 006). A Complete submission will be accepted and processed for review.

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