GCM Research Ethics Committee

FAQ guide for the Research Ethics Committee (REC) at the Gullas College of Medicine, designed to align with national health research frameworks ( like the Philippine Health Research Ethics Board – PHREB) and global institutional guidelines.

1. What is the purpose of the UV Gullas College of Medicine Research Ethics Committee (REC)
   • The REC is an independent body tasked with reviewing, approving, and monitoring research protocols involving human participants. As per memo issued by GCM, all research by GCM and the VGMH should undergo REC review. Kindly refer to the study can be exempted by the GCM REC. Its primary goal is to protect the rights, safety, dignity, and well-being of all research participants, while ensuring that the data collected is scientifically valid and ethical.
2. Does my study really need ethical review?
   • Yes, if it involves human participants, their identifiable data, or biological samples. This includes:
     • Clinical trials and biomedical studies.
     • Epidemiological and public health research.
     • Social science surveys, questionnaires, or interviews involving patients, students, or community members.
     • Retrospective chart reviews using medical records.
   • Crucial Rule:  You must secure REC approval before  any participant recruitment or data collection begins. Ethical approval cannot be granted retroactively.
3. What documents do I need to submit for an initial interview?
   • To initiate a review, researchers generally need to provide a complete submission packet. Ensure all tools, questionnaires, and consent forms have explicit version numbers and dates.
     • Application Form (Form 4.0) addressed to the REC chair.
     • Notice to Proceed from the CHRI (proof that your research has already been vetted and approved for scientific merit by your technical service panel
     • The Full Research Proposal: Must include (Title, abstract, methodology, inclusion/exclusion criteria, data analysis plan, and clear ethical considerations)
     • Informed Consent Forms (ICF): Provided in English and translated into the local dialect (typically Cebuano/Bisaya) depending on your target study population. This is incorporated in the proposal and must conform with the latest proposal template of the Research Department.
     • Data Collection Tools: Questionnaires, case report forms (CRFs), or interview guides.
     • Researcher Credentials: Updated, signed, and dated Curriculum Vitae (CV) of the Principal mInvestigator (PI) and co-investigators. This is included in the proposal.
     • Certification of QQ validity/reliability
     • Protocol Summary Sheet (Form 4.8)
     • REC review checklist (Form 4.4)
     • Informed Consent Form Worksheet (Form 4.5)
4. How are protocols classified for review?
   • When you submit your study, the REC filters it into one of three review pathways based on the level of risk to participants:

5. How long does the ethical review process take?
   • Expedited Reviews: Typically take 3 to 4 weeks, as they are evaluated by selected committee reviewers rather than waiting for a full monthly meeting.
   • Full Committee Reviews: Can take 4 to 6 weeks depending on the meeting schedule, the complexity of the study, and how quickly the investigator responds to clarifications.
6. What are the possible decisions the REC can make?
   • Following a review, you will receive an official notification with one of the following outcomes:
     • Approved: You are clear to begin your study immediately.
     • Approved with Minor Modifications: The study is fundamentally sound, but you need to tweak minor language elements (usually in the Informed Consent Form) before final sign-off.
     • Major Revisions Required: The protocol needs significant safety or methodological restructuring. You must resubmit the updated version for another review.
     • Disapproved: The study presents ethical risks that outweigh its scientific benefits or violates critical protections.
7. What must I do once my study is approved?
   • Approval does not mean your communication with the REC is over. As the investigator, you are required to:
     • Stick to the Protocol: You cannot change your methodology, survey questions, or team members without submitting a Protocol Amendment to the REC for approval.
     • Report Adverse Events: Any unexpected harm, side effects, or breach of data privacy must be reported to the committee immediately.
     • Submit Progress/Final Reports: For long-term studies, you will need to submit annual progress reports for continuing review. A final closure report is mandatory upon study completion.
8. Does GCM REC review studies outside UPM/PGH?
   • No, the GCM REC does not review studies from medical schools outside GCM. For non-GCM investigators who wish to do a research study in GCM or VGMH, the PI must identify a collaborator assigned in that specific unit/department/site.
9. Are the reviews done electronically?
   • All reviews are conducted on a hybrid basis. Panel actions are sent to investigators through electronic mail and by hand during submission.
10. Do I still need to submit hard copies?
    • Yes. Submission of hard copy is required by the GCM REC. However the GCM REC also handle electronic submissions only.
11. How do I contact GCM REC?
    • Inquiries can be coursed through e-mail and/or face-to-face at the REC office on the 2/F of the GCM main building. Guests are encouraged to prepare documents needed during their inquires or visit so we can respond promptly.
12. How do I know the status of my application?
    • You will receive a decision letter from the REC office and an email notifying you that your study protocol registration application has been accepted. For follow-ups or inquiries you ay visit the REC office or send an email to the address provided below sduran@gcm.edu.ph
13. How do I apply for initial review?
    • Register your study with REC office using Form 4.0 and other required forms or get the same forms at CHRI Office
14. How would the Principal Investigator know if he already has an approved GCM REC ethics review application?
    • The GCM REC will give you an REC code through email or hand carry. If the Principal Investigator does not have an official REC code, s/he can request through the REC office or REC website.
15. How much is the application fee?
    • To know the cost of the ethics review of your study, kindly visit the REC office and present Form 4.0 (Ethics Review application) to the REC administrative secretary. S/he will issue a slip containing the cost of your ethics review. This depends on the level of REC meeting (Exempted, Expedited or Full committee hearing).
16. Can u submit anytime?

    • No, you should submit only at least 1 week before the 2nd Wednesday of every month during office hours (Monday to Thursday, 8:00 AM to 6:00 PM, and Friday, 8:00 AM to 5:00 PM) which are scheduled cut-off dates. Kindly see cut-offs dates/meetings.