Common Issues in Registration and Application Form

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.
b. Research involving non-human living vertebrates - Researches involving non-human materials.
c. Others - any other research not cited above.

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.

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

V. Purpose of the study
There are no issues noted in this section.

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
There are no issues noted in this section.

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'.

XI. Study site
There are no issues noted in this section.

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
There are no issues noted in this section.

XIV. Previous ethical approval or clearance issued by other sites
Indicate details of the institution that issued ethical approval of the study, if any.

XV. Other ongoing studies
There are no issues noted in this section.

XVI. Declaration of Conflict of Interest of PI
There are no issues noted in this section.

XVII. Other investigators with corresponding task description
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'.

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