Welcome to University of Santo Tomas Hospital - Research Ethics Committee!
Welcome to University of Santo Tomas Hospital - Research Ethics Committee!
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For the initial submission of a New Protocol Application for ethics review, please prepare and submit the following documents using the file names written in BOLD letters:
01 Request Letter
- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.
02 Endorsement Letter
- certification issued / signed by your Dept. Research Committee stating technical review, approval, and endorsement addressed to REC Head Dr. JM Lumitao. For USTH Trainees, letter must be noted by DMER.
03 F06 Requirements Checklist Form
- properly accomplished REC F06 Form.
04 F07 Application Form
- Properly accomplished signed and dated REC F07 Form, completed with the details of all study team members.
05 F08 Assessment Form (FOR OTHER RESEARCH TYPE ONLY *e.g., Experimental, Observational, Surveys, etc.)
- properly accomplished signed and dated REC F08 Form, To be submitted in word format.
05. F33 Case Report Checklist Form ( FOR CASE REPORT ONLY )
- properly accomplished signed and dated REC F33 Form. To be submitted in word format.
06 F22 Compliance Form
- must be signed by all members of the study team.
07 Research Protocol v1
- Manuscript with a footer version date & no. (e.g. Protocol Version 1 dated DD_MM_YYYY) & pagination.
08 Informed Consent Forms English/Filipino v1
- must consist of 2 parts. (Information Sheet & Certificate of Consent) - e.g. ICF English/Filipino Version 1 dated DD_MM_YYYY.
09 CV - First Name Surname
- Updated short CVs of all authors, co-authors, and the research adviser.
10 GCP - First Name Surname
- Valid GCP training certificate (3-year validity), issued by a local accredited provider, for all authors, co-authors, and the research adviser
11 F34 AI Declaration Form
- properly accomplished signed and dated REC F34 Form.
12 Certificate of Plagiarism ( Except Case Report )
- A certificate or report confirming that the manuscript/document has a similarity index of 20% or lower. You may use either Turnitin or Grammarly for the plagiarism check. The complete/full version of the plagiarism report or results must be submitted, not just the summary or certificate page.
13 Review Fee - Charge Slip/Official Receipt.
- scanned copy of charge slip and official receipt
14 Others
- F27 rev6 Protocol Submission Tracking Form, Data Collection Forms, Questionnaires, Recruitment Materials, Permission Letters, etc.
For initial submission of new protocol for ethics review, please prepare / submit the following documents using the "file names" indicated in this guideline (e.g. 01 Request Letter).
FOR ONLINE SUBMISSION: Submit the complete requirements in pdf format except REC F08,F33 & F27 (must be in docx/word. format).
FOR PRINTED COPY SUBMISSION : Provide 1 printed copy (complete set).
Formatting Requirements:
*Incomplete submission will not be accepted/processed.
For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com
The REC Forms may be downloaded here:
For the submission of a Resubmitted/Revised Protocol for review and approval, please prepare and submit your documents using the file names written in BOLD letters:
1. Request Letter
- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.
2. F11 Resubmission Form
- Properly completed REC Form signed by all authors, To be submitted in word format.
3. Amended Protocol / Informed Consent Forms
- Include a footer version number and date (Version No. _ dated day_month_year).
4. Certificate of Plagiarism ( Except Case Report )
- A certificate or report confirming that the manuscript/document has a similarity index of 20% or lower. You may use either Turnitin or Grammarly for the plagiarism check. The complete/full version of the plagiarism report or results must be submitted, not just the summary or certificate page.
5. F34 AI Declaration Form
- properly accomplished signed and dated REC F34 Form.
6. Other Documents Needing Revision
- Includes ICFs, Data Collection Forms, GANTT Chart, etc.
For Resubmission of Revised Protocols:
For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com
The REC Forms may be downloaded here:
For the submission of a Protocol Amendment for review and approval, please prepare and submit your documents using the file names written in BOLD letters:
1. Request Letter
- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.
2. F14 Amendment Form
- Properly accomplished, signed and dated REC F14 Form signed by all authors, To be submitted in word format.
3. Amended Protocol / Informed Consent Forms
- Include a footer version number and date (Amended Protocol Version No. _ dated day_month_year).
4. Certificate of Plagiarism
- A certificate or report confirming that the manuscript/document has a similarity index of 20% or lower. You may use either Turnitin or Grammarly for the plagiarism check. The complete/full version of the plagiarism report or results must be submitted, not just the summary or certificate page.
5. F34 AI Declaration Form
- properly accomplished signed and dated REC F34 Form.
6. Other Documents As Needed
- ICFs, Data Collection Forms, GANTT Chart, Updated CV and/or GCP etc.
For Submission of Protocol Amendments:
FOR ONLINE SUBMISSION: Submit the above requirements in pdf format except REC F14 (must be in docx/word. format).
FOR PRINTED COPY : Please Provide 1 printed copy (complete set).
For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com
The REC Forms may be downloaded here:
For the submission of a Final Report for review and approval, please prepare and submit your documents using the file names written in BOLD letters:
1. Request Letter
- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.
2. F18 Final Report Form
- Properly accomplished, signed and dated REC F18 Form signed by all authors ,To be submitted in word format.
3. Final Report Protocol / Manuscript
- Include a footer version number and date (Final Report Protocol Version No. 1 dated day_month_year).
4. Certificate of Plagiarism ( Except Case Report )
- A certificate or report confirming that the manuscript/document has a similarity index of 20% or lower. You may use either Turnitin or Grammarly for the plagiarism check. The complete/full version of the plagiarism report or results must be submitted, not just the summary or certificate page.
5. F34 AI Declaration Form
- properly accomplished signed and dated REC F34 Form.
6. Other documents as needed
- Permission Letters secured from Medical Director, Data Privacy Officer and other department/units concerned.
For Submission of Final Report:
Submit the above requirements in pdf format except REC F18 (must be in docx/word. format).
For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com
The REC Forms may be downloaded here:
For For post approval revisions, you need to submit it as a Protocol Deviation Report
Please prepare & submit your documents using the following file names:
01. Request Letter
- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.
02 Properly accomplished REC Forms (in a word format) signed by all authors.
A. F16 Protocol Deviation and Violation Form
B. REC F11 Resubmission Form
C. REC F18 Final Report Form
For Submission of Protocol Amendments:
FOR ONLINE SUBMISSION: Submit the above requirements in pdf format except REC F16 & F11 (must be in docx/word. format).
FOR PRINTED COPY : Please Provide 1 printed copy (complete set).
For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com
The REC Forms may be downloaded here:
For application for Continuing Review and Progress please submit the following:
1. Letter of intent/request addressed to REC Head signed by the all authors
DR. JOSEPHINE M. LUMITAO
Head
Research Ethics Committee
University of Santo Tomas Hospital
2. Properly accomplished REC Forms (in a word format)
a. F19 Continuing Review and Progress Form
Submit the above requirements in pdf format except REC F19 (must be in docx/word. format).
For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com
The REC Forms may be downloaded here:
For application for Exemption from review please submit the following:
01. Letter of intent/request addressed to REC Head signed by the all authors
DR. JOSEPHINE M. LUMITAO
Head
Research Ethics Committee
University of Santo Tomas Hospital
02 Endorsement Letter
- certification issued / signed by your Dept. Research Committee stating technical review, approval, and endorsement addressed to REC Head Dr. JM Lumitao. For USTH Trainees, letter must be noted by DMER.
03. Properly accomplished REC Forms
a. F07 Application Form
b. F24 Exemption Review Form (to be submitted in word format)
c. F27 Protocol Tracking Form
d. F34 AI Declaration Form
04. Meta analysis protocol with a footer version no. & date
05. Updated short CV - signed & dated
06. Updated local GRP/GCP certificate
07. Plagiarism Certificate - A certificate or report confirming that the manuscript/document has a similarity index of 20% or lower. You may use either Turnitin or Grammarly for the plagiarism check. The complete/full version of the plagiarism report or results must be submitted, not just the summary or certificate page.
08.Proof of review fee payment (scanned copy of official receipt)
Submit the above requirements in pdf format except REC F24 & F27 (must be in docx/word. format).
For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com
The REC Forms may be downloaded here:
Researchers who intend to access and/or use hospital medical records for research purposes are required to secure clearance from the USTH Data Privacy Officer prior to data collection or record access.
Please note that Research Ethics Committee (REC) approval is a mandatory requirement in securing permission from the USTH DPO. Applicants must first obtain REC approval before submitting their request for DPO clearance.
Requirements and Procedure
1. Accomplish the official USTH DPO Clearance Form available at:
2. Submit the accomplished form together with all supporting documents, including a copy of the REC approval, through email to:dataprotection@usthospital.com.ph
3. Ensure that all submitted documents are complete and updated to avoid delays in processing.
For inquiries regarding data privacy clearance requirements, applicants may directly contact the USTH Data Protection Office through the email address above.