Frequently Asked Questions (FAQs)

I. Effects of COVID-19 Pandemic on UPMREB

1. Does UPMREB accept submissions for review?
The UP Manila Research Ethics Board (UPMREB) will continue normal operations during this time of COVID-19 pandemic However, to protect our members and staff from exposure, REB office is closed and we have adopted electronic processing of protocol applications.
2. Are the reviews done electronically?
All reviews are facilitated online, and panel actions are communicated to investigators through electronic mail used during submission.
3. Do I still need to submit hard copies?
No. Submission of hard copy is removed from the UPMREB SOP. We only process electronic submissions through iREB and email.
4. How do I contact UPMREB?
All inquiries are coursed through e-mail and we do not yet receive face-to-face inquiries. We suggest to indicate a clear subject heading so we could respond to you promptly.
5. What is the turn-around time of approval of protocols?
Standard review turnaround time remains and is dependent on the completeness of the protocol (you can refer to the study protocol assessment form [UPMREB form 2C] and informed consent assessment form [UPMREB form 2D], and the NEGHHR 2017 for the needed elements in the study documents). However, in view of the urgent nature of specific COVID-19 treatment-, diagnostic-, and vaccine-related protocols, UPMREB is implementing a flexible system to facilitate panel actions as quickly as possible.
6. Is there a schedule for processing submissions?
No. We screen and receive all types of submissions any day of the week.

II. APPLICATION

A. What type of studies should be submitted to UPMREB?
All research studies involving human participants (e.g. human data, material, biospecimen) and those that are for future publication should be submitted to UPMREB for ethical review. As per memo issued by the university, all research by UP Manila and its constituents should undergo REB review. As to the type of studies needing ethical approval, you may refer to the NEGHHR guidelines for exemption. Usually, meta-analysis studies are exempt. However, as per the same guideline, exemption is issued by an accredited REC and hence, will need submission to UPMREB prior to issuance of a certification of exemption.

B. How do I apply for initial review?

Register your study with RGAO (Research Grants Administration Office) at http://rgao.upm.edu.ph/registration. Accomplish the online forms (application information, endorsements, declaration of conflict of interest, protocol assessment, and informed consent assessment) at https://ireb.upm.edu.ph.

You can watch this short video made by our UPMREB Chair, Dr. Jacinto Blas V. Mantaring III, to guide you in navigating iREB and making your first initial submission for ethics review: https://www.youtube.com/watch?v=3UT2HhkJ-ZU

C. How do I upload the documents in iREB?
Upload basic and other study-related documents in PDF format. You can convert to pdf, and merge 2 or more pdf files online (e.g. www.ilovepdf.com).

D. How do I know the status of my application?
You will receive a system-generated email notification from UPMREB to address screening issues or a notification that your study protocol registration application has been accepted. Check status by visiting your iREB account and selecting “Pending Registrations”; status is in the third column.

E. How do I know the screening issues?
In case there are some screening issues noted, we will return the submission to the PI who may resubmit his application through iREB anytime. Click the “Draft Applications” in the Principal Investigator Module.

F. How would the Principal Investigator know if he already has a UP System Authentication and Directory Service (ADS) account or if he should be requesting for one?
ADS account is the same with the UP e-mail address that was issued to the Principal Investigator and the password will be the same one used in the UP email. If the Principal Investigator does not have an official UP email/account, he can request through the iREB website.

G. How to request an ADS account for iREB
i. Visit https://ireb.upm.edu.ph/login and click “request for an account”.
ii. Fill out the requested information and click submit. This will be queued in the system
iii. UPMREB staff will request an ADS account from IMS (within 1-2 days from receipt of your request).
iv. IMS will notify you through e-mail of your ADS account.
v. If the PI does not know of his/her ADS account, email UPMREB staff so we can request from IMS. Account will be only be activated if they have ADS account.
vi. IMS/ADS administrators will send an email notification to PI regarding ADS username and password to activate ADS account. IMS will send only ADS username to UPMREB staff to activate iREB account.

H. How much is the application fee?
For information on the application fee, please contact RGAO at rgao.upm@up.edu.ph. or (02)567-2054. UPMREB Review Fees are based on the schedule prescribed in Memorandum Order NO. CCDP-2016-081.

I. General Instructions on Resubmission and Post-approval Submission (read further details here http://reb.upm.edu.ph/node/119)

1. Download the required UPMREB form at http://reb.upm.edu.ph/sops-and-forms.
2. Submit your application and corresponding attachments to upmreb@post.upm.edu.ph using the following subject heading: __.
3. Wait for an email notification from UPMREB to submit the hard copies of your documents.
4. Submit four (4) complete sets of hard copy of accomplished UPMREB form and related document(s) to UPMREB office at Rm 126, NIH Bldg, UP Manila.

J. For approved protocols, is the Principal Investigator required to upload the post-approval submissions in iREB?

Not yet. We will be issuing another memorandum once iREB caters to all submissions. Submit post-approval submissions via email.

K. How to submit if qualified for SJREB?
Follow our usual process of submission and confirm whether the protocol will/is submitted to SJREB. Email the SJREB approval as well as the SJREB approved documents once available. For post-approval submissions (e.g. continuing review, amendment, etc), we will accept the submission once with SJREB approval.

L. What happens to my proposal if I fail to resubmit within 90 days?
The deadline for resubmission is 90 days after the date of decision letter, so if the principal investigator fails to resubmit within such time, the protocol will be archived.

III. REVIEW

A. Does UPMREB review studies outside UPM/PGH?
Yes. Its oversight applies to faculty, personnel, and students doing research in UP Manila; non-UP Manila researchers doing research in UP Manila; and non-UP Manila researchers doing research in non-UP Manila sites with no local ethics review committee (as mandated by the Philippine Health Research Ethics Board). For Non-UPM investigators who wish to conduct a research study in UP Manila and PGH, it is imperative to identify a collaborator assigned in that specific UPM unit/department/site.

B. Does UPMREB review Serious Adverse Events (SAEs)?
Yes. The UPMREB SAE Committee reviews onsite SAE and SUSAR reports only which are reported during the panel meeting. Meanwhile, offsite SAEs and SUSARs are filed in the study protocol and serve as reference when reviewing onsite SAE/SUSAR.

C. When should I submit SAE?
Onsite fatal and non-life threatening but unexpected serious adverse reactions coincide reporting requirement with FDA while onsite expected and other offsite reports are reported as a summary with an annual report or final report, whichever will be submitted earlier. For further information, refer to the Guideline on Reporting Serious Adverse Events (ver 2020) which is downloadable under SOPs and Forms tab.

D. How long does it take for a study to be approved?
If there are no further modifications to the protocol, approval may be issued at least four weeks after receipt of the initial submission package by the office if it is classified as full board. If the protocol is classified as expedited and there are no further modifications to it, the approval may be issued 14 days after receipt of the submission.

E. When do the Panels meet?

Panel

Monthly

1

1st Thursday

2

3rd Tuesday

3

4th Monday

4

2nd Thursday

5A

No Full Board Meeting

5B

No Full Board Meeting

5C

No Full Board Meeting

Panel 1 meets every first Thursday of the month while Panel 2 meets every third Tuesday of the month. Panel 3 meets every 4th Monday of the month while Panel 4 meets every 2nd Thursday of the month. Panel 5A and 5B do not hold full board meetings. Special meetings may be organized to discuss COVID-19 treatment, diagnostic, or vaccine-related protocols.

IV. SUBMISSIONS & PANEL ACTION

A. When is the deadline of submissions for full board review?

Type of Submission

Panel 1 and 2

Panel 3 and 4.

Panel 5a, 5b, 5c

Initial Review

17 days before the meeting

17 days before the meeting

N/A

Post-Approval Review

(Continuing Review, Amendment, Deviation, Final Report, Early Study Termination)

14 days before the meeting

14 days before the meeting

N/A

For the initial submission to be included in the Panel meeting, it must be submitted at least 17 days prior to the meeting.

B. Where do I claim the panel action?
RGAO is responsible for releasing the Certificates of Approval and Archiving Notifications, endorsed by UPMREB, to the investigators upon confirmation of payment or waiver thereof:
Certificates of Approval - initial reviews, continuing review applications
Archiving Notification for early termination reports, final report, and exempted protocols

V. FORMS

A. Who may sign the Scientific/Technical Review Approval Endorsement Section (Section II)?
1. For thesis dissertations and clinical trials, the thesis adviser, thesis panel chair, or the department chair may serve as the signatory official.
2. For clinical trials, the signatory official is the person with direct oversight to the department or institution of the principal investigator.
(NOTE: To eliminate conflict of interest, the principal investigatorI or any of the co-investigators should not be the signatory for section II)

B. Who may sign the Institutional Endorsement Section (Section III)?

The signatory official for this section is the person with direct oversight to the department or institution of the principal investigator.
(NOTE: To eliminate conflict of interest, the principal investigatorI or any of the co-investigators should not be the signatory for section III)

VI. OTHERS

A. Do I need UPMREB review and approval if I am a UPM Faculty doing a research in another institution?
Yes.

B. What should I do if I am a non-UPM investigator who wants to conduct research with human subjects in PGH?
The non-UPM investigator must get a collaborator from UP Manila.

C. Is the Principal Investigator required to be present at the Panel meeting where the protocol will be discussed?
No, but the PI may be advised to be present during the Panel meeting to answer the questions and clarifications raised by the Board. In this way, the duration of review may be shortened.