Common Issues in Registration and Application Form - updated 17 Dec 2020

These are the common issues in accomplishing Registration and Application Form.

I. Type of Submission
a. Initial Review - This is the first application for ethical clearance.
b. Resubmission - This is the response to initial review or recommendations from the panel communicated through a decision letter.

II. Study Category
a. Research involving human participants - Researches involving direct human interaction, human material, and data (e.g. records review, anonymized population data, etc.)
b. Research involving non-human living vertebrates - Researches involving non-human materials.
c. Others - any other research not cited above (e.g. meta-analysis, institutional quality audit)

III. Type of Study
a. Pre-Clinical Research
b. Non-clinical trial type includes non-clinical studies on diagnostics, in-vitro, genetic or genomic, stem cell, herbal, complementary and alternative medicine, assisted reproductive technology, indigenous materials, review of medical records, epidemiological studies (observational, descriptive, etc.), sociobehavioral, health informatics, and operations/process research.
c. Clinical Trial Type 1 includes drug or pharmaceutical trials, diagnostic trials, trials on devices, and other therapy trials) intended for marketing registration
d. Clinical Trial Type 2 includes drug or pharmaceutical trials, diagnostic trials, trials on devices, and other therapy trials) NOT intended for marketing registration
e. Post-Marketing Surveillance
f. Others - Studies that are not cited above (select this only as your last option upon considering the selection above)

IV. Category of Investigator
MD-PHD students are under UPM Graduate student
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.

V. Purpose of the study
If multi-site/center, verify if needing SJREB review. Studies involving 3 sites with at least 1 DOH hospital requires to undergo SJREB review. Nationwide/Community studies can also be reviewed by SJREB. Please indicate upon initial submission whether your study will undergo SJREB review to avoid duplication of review. If PI later on decides to submit to SJREB, UPMREB approval may not be applicable and another set of review may be required.

VI. Study Title
There are no issues noted in this section.

VII. Study Protocol Synopsis
Answers in this section must also be in the protocol. Ethical consideration should be discussed and not just placed 'N/A'.

VIII. Study Duration
There are no issues noted in this section.

IX. Use of special populations or vulnerable groups
Correctly identify whether your study will involve special populations or vulnerable groups (e.g. children, indigenous populations, etc) and ensure to discuss in the protocol measures to minimize and address vulnerability.

X. Endorsing/College/Unit/Institution
As much as possible, we encourage one endorsing institution. The institution cited will be the one who will sign the 'UPMREB Form 2B Section III. Institution Endorsement'. As per UPMREB Memo dated 4 Aug 2020, applications will be received upon receipt of complete and signed endorsements (Sections II and III in the Registration and Application Form).

XI. Study site
If multi-site/center, verify if needing SJREB review. Studies involving 3 sites with at least 1 DOH hospital requires to undergo SJREB review. For Non-UPM site, accomplish and submit a signed Section IV of the UPMREB Form 2B Registration and Application Form. For electronic surveys or studies involving online recruitment, there is no need to accomplish Section IV.

XII. Funding Agency
Indicate the name of the funding agency (i.e. name of PI if the study is self-funded/ PI funded.)

XIII. Study Budget
Submit the final study budget to RGAO.

XIV. Previous ethical approval or clearance issued by other sites
Indicate details of the institution that issued ethical approval of the study, if any. For studies done in a foreign institution or sites with IRB/ERC, ethical approval must also be sought from these institutions. These can be submitted while review is ongoing. However, if the site is in UP Manila / PGH and the PI is affiliated with a foreign / non-UPM institution, their approval must precede UPMREB approval (as the site).

XV. Other ongoing studies
Declare studies that are ongoing.

XVI. Declaration of Conflict of Interest of PI
Ensure to accomplish and sign Section V of the UPMREB Form 2B Registration and Application Form. If a conflict of interest is declared, submit a disclosure form detailing the conflicts of interest.

XVII. Other investigators with corresponding task description
List the roles of the investigators using appropriate terms for reference of the panel. For studies that are done as an academic / training requirement, ensure to indicate the roles of adviser. Please refer to the 2017 National Ethical Guidelines on Health and Health Related Research (NEGHHR) page 47-50 for the roles of research adviser and investigators.

XVIII. Technical Review
Indicate details of the committee/office that reviewed the scientific soundness of the study and issued the appropriate approval. The committee cited will be the one who will sign the 'UPMREB Form 2B Section II. Scientific/Technical Review Approval Endorsement'. As per UPMREB Memo dated 4 Aug 2020, applications will be received upon receipt of complete and signed endorsements (Sections II and III in the Registration and Application Form).

Further instructions regarding UPMREB submission is posted in the Frequently Asked Questions (FAQs) tab.