Process of Submission

This section describes the procedures of submission of an application for initial review to the UP Manila Research Ethics Board (UPMREB) and the common issues in accomplishing the registration forms.

I. Initial review via iREB

1. Register study with RGAO (Research Grants Administration Office) at http://rgao.upm.edu.ph/registration.
You will receive the registration certificate via email within 1-2 working days. Input the RGAO reference number in the registration and application form (UPMREB Form 2B, item 1.1)
You may reach RGAO at rgao.upm@up.edu.ph for inquiries on ethics fees, clinical trial agreements, and opportunities for funding (as applicable).

2. Request for an iREB account at https://ireb.upm.edu.ph/account/request and use your UP ADS account, while waiting for the RGAO reference code. Your account details will be sent to your registered email address within 1 to 2 working days.
If no UP ADS account yet, please wait for the IMS to notify you regarding the creation of ADS credential. To request for ADS password reset, please email ads-admins@post.upm.edu.ph with the subject "Request for ADS Password Reset".

3. Log in to iREB at https://ireb.upm.edu.ph/login, complete the online forms and upload all the required documents in PDF format.

Correctly upload documents in their respective fields as incorrect uploading may create delay in your application. Merge all CVs in one pdf file, and all GCPs in another pdf file. Upload a signed UPMREB Form 2B (e.g. signature fields on item 28, Section II, Section III, Section IV as applicable, and Section V), in the "Others" field.

You may refer to our website at http://reb.upm.edu.ph/ for detailed information on the submission process, cut-off dates, review status, etc. Updated versions of UPMREB forms are downloadable at http://reb.upm.edu.ph/sops-and-forms (see SOP II).

4. Wait for UPMREB's email notification regarding acceptance of iREB application

UPMREB Secretariat screens the correctness and completeness of your submission and you will receive an email regarding receipt of documents or screening issues that need to be addressed. Please take note that iREB sends you an email using a 'no-reply' email address. For any concerns, you can reach us at upmreb@post.upm.edu.ph.

5. Due to the pandemic, we have temporarily lifted the requirement to submit hard copies until further notice. Once possible, UPMREB will issue a memo regarding the need to submit four (4) complete sets of printed copies of the required forms and basic documents to UPMREB at Room 126, NIH Bldg., UP Manila.

II. General Instructions for Other Type of Submissions

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. Due to the pandemic, we have temporarily lifted the requirement to submit hard copies until further notice. Once possible, UPMREB will issue a memo regarding the need to submit four (4) complete sets of printed copies of the required forms and basic documents to UPMREB at Room 126, NIH Bldg., UP Manila.

III. Initial Review – Detailed instructions regarding the registration and application form
1. 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 an official decision letter.

2. Study Category
a. Research involving human participants - Research 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)

3. 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.), socio-behavioral, 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)

4. 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.

5. Purpose of the study
*Multi-center: see IX. Study site
*Collaborative study – attach terms of collaboration

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

7. 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.

8. 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).

9. 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. 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.

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.

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

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

12. 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).

13. 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.

14. 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.
15. 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).

IV. Resubmission
1. Summarize the revisions vis-a-vis the panel recommendations in a cover letter addressed to the Panel Chair indicating in which page of the revised study protocol the respective revision may be found;

2. Integrate the requested revisions into a revised STUDY PROTOCOL/PACKAGE and UPMREB FORM2(B)2012 APPLICATION FORM, with the revisions underlined and bold-faced;

3. Write the panel recommendations in the first column of the UPMREB FORM 2(H)2012: REVIEW OF
RESUBMITTED REVIEW FORM, and the second column only with a number outline corresponding the
recommendations (e.g. 1.1, 1.2, 1.3, ..). This column will be filled out by the reviewer.

4. Ensure that the version number and date are indicated in the revised protocol and other revised protocol-related files.

5. Submit the resubmission package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Resubmission_Dela Cruz_UPMREB 2020-001-01_Panel 1)

6. Please note that resubmissions can only be accepted within 90 days from the date of the decision letter. Failure to respond within 90 days from the date of the letter will inactivate the application and study protocol will be archived. Subsequent submissions will be processed as an initial review.

V. Study Protocol Amendment
1. Accomplish UPMREB Form 3(A)2012: Study Protocol Amendment Submission Form completely and accurately (e.g. Study Protocol Title, Study Protocol Approval Date)
2. Specify the type of amendment, section in the protocol, and justification for the change/s.
3. If there are changes in the approved protocol and documents, ensure to update version number and date
4. Submit a signed Form 3A, and a version in word form (to be accomplished by the reviewers)
5. Submit the amendment package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Amendment_Dela Cruz_UPMREB 2020-001-01_Panel 2)
6. Ensure that the study has a valid ethical clearance prior to submission of any subsequent applications.

VI. Continuing Review Application
1. Accomplish UPMREB Form 3(B)2012: Continuing Review Application Form completely and accurately (e.g. Study Protocol Title, Study Protocol Approval Date)
2. List only reports (e.g. amendments, deviations) that were processed and approved prior to submission of the continuing review application
3. Attach the protocol synopsis and copy of the latest approved ICF (as applicable)
4. Submit a signed Form 3B, and a version in word form (to be accomplished by the reviewers)
5. Submit the package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: CRA_Dela Cruz_UPMREB 2020-001-01_Panel 3)
6. We advise to submit the continuing review application form at least 30 days prior to expiry date of the ethical clearance.

VII. Final Report Form
1. Accomplish UPMREB Form 3(C)2012: Final Report Form completely and accurately (e.g. Study Protocol Title, Study Protocol Approval Date, period of data collection)
2. Attach the final report and the copy of the latest approved ICF (as applicable). Also submit turn-it-in results as appropriate.
3. Submit a signed Form 3C, and a version in word form (to be accomplished by the reviewers)
4. Submit the package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Final Report_Dela Cruz_UPMREB 2020-001-01_Panel 3)

VIII. Deviation / Early Termination / Notification / SAE
1. Accomplish the appropriate UPMREB Forms completely and accurately:
a. UPMREB FORM 3(D)2012 Study NonCompliance Report
b. UPMREB FORM 3(E)2012 Early Study Termination Report Form
c. UPMREB FORM 3(G)2012 Suspected Unexpected Serious Adverse Events Report
d. UPMREB FORM 3(I)2012 Queries Notification and Complaints
2. Submit a signed Form, and a version in word form (to be accomplished by the reviewers). Attach applicable documents as necessary.
3. Submit the package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Deviation / Early Termination / Notification / SAE_Dela Cruz_UPMREB 2020-001-01_Panel 3)