Frequently Asked Questions (FAQs)

I. APPLICATION

A. What type of studies should be submitted to UPMREB?

All researches involving human participants and those that are for future publication should be submitted to UPMREB for ethical review.

B. How do I apply for initial review?

1. Register your study with RGAO (Research Grants Administration Office) at http://rgao.upm.edu.ph/registration. You may also contact them at 567-2054.

2. Accomplish the required UPMREB forms (2A, 2B, 2C, and 2D) which can be downloaded at http://reb.upm.edu.ph.

3. Submit your application and corresponding attachments to upmreb@post.upm.edu.ph using the following subject heading: <Type of submission>_<PI Last Name>_<Code: RGAO/UPMREB. Basic documents are listed in the UPMREB Form 2(A) Review Checklist.

4. Wait for an email notification from UPMREB to submit the hard copies of your documents.

5. Submit four (4) complete sets of hard copy of accomplished UPMREB forms to UPMREB office at Rm 126, NIH Bldg, UP Manila. Please include an originally signed Section II-IV (last page of UPMREB Form 2B) in your initial submission package.

Note: UPMREB is accepting submissions for initial review during Mondays and Wednesdays, 9:00AM-12:00PM and 1:00-3:00PM ONLY.

C. How much is the application fee?

For information on the application fee, please contact RGAO at rgao.upmanila@yahoo.com or (02)567-2054. UPMREB Review Fees are based on the schedule prescribed in Memorandum Order NO. CCDP-2016-081.

II. RESUBMISSIONS

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 the 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).

B. Does UPMREB review Adverse Events (AEs)?

No. The UPMREB SAE Subcommittee only requires the expedited reporting of Serious Adverse Events (SAEs).

C. 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 10 days after receipt of the submission.

D. When do the Panels meet?

Panel.................................Monthly Meeting Schedule
1......................................1st Thursday
2......................................3rd Tuesday
3 ......................................4th Monday
4......................................2nd Thursday
5A....................................No Full Board Meeting
5B.....................................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.

IV. SUBMISSIONS

A. What is the schedule for each type of submission (hard copy)?

Type of Submission..................................Submission Schedule
Initial Review...........................................Monday and Wednesday
Resubmission..........................................Monday and Wednesday
Post-approval Review..............................Tuesday and Thursday
(Continuing Review, Amendment, Deviation, Final Report, Early Study Termination)
Notifications............................................Tuesday and Thursday
Safety reports (SAE and SUSAR)................Monday to Friday

Receiving is from 9:00 AM to 12:00 PM and from 1:00 PM to 3:00 PM.

B. How many copies are required for each type of submission?

For initial and post-approval submissions, four copies are required. The submitter must use a fastener, or a binder (for clinical trials) to secure the pages of each copy. For SAE, SUSARs, and other safety reports, only two copies of the submission are required. The submitter must furnish an extra copy if he/she needs a receiving copy.

C. Do I have to submit a soft copy of the reports?

Yes. The soft copy of the reports must be submitted through iREB prior to the submission of the hard copy. Submission through iREB can be done any day and anytime.

D. What if the SAE reports cannot be submitted within 24 hours?

There is no requirement for a report to be submitted within 24 hours. Onsite reports must be submitted within seven days upon awareness of the event.

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

Type of Submission......................Panel 1 and 2.....................Panel 3 and 4..................Panel 5a and 5b
Initial Review.................17 days before the meeting.....17 days before the meeting...........N/A

Post-Approval Review....14 days before the meeting.....14 days before the meeting...........N/A
(Continuing Review, Amendment, Deviation, Final Report, Early Study Termination)

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

V. DECISION LETTERS

Where do I claim the decision letter?

Decision letters such as initial review approval, continuing review approval, inactivation and exemption are endorsed to RGAO. RGAO is responsible for releasing the decision letters to the investigators upon confirmation of payment or waiver thereof.

Decision letters with minor or major modifications will be released to the investigator by the UPMREB secretariat. You can check details of your protocol submission in the 'Status of Submission' Tab.

VI. 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.

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.

VII. OTHERS

A. Do I need UPMREB review and approval if I am a 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.