University of the Philippines Manila Research Ethics Board (UPMREB)

PGH Review Panel

REQUIREMENTS FOR ETHICAL REVIEW

1.Review Checklist [UPMREB FORM 2(A)2012] - 2 copies

2.Printed Registration and Application Form [UPMREB FORM 2(B)2012] – 2 copies

3.Study Protocol Assessment Form [UPMREB FORM 2(C)2012] - 4 copies

4.Study protocol - 4 copies

5.Data collection forms (including CRFs) - 4 copies

6.Curriculum Vitae (with signature and date) of Principal Investigator (PI) and study team members - 1 original and 5 photocopies

**Preferably less than 5 pages per investigator. CVs w/o signatures will not be accepted.

7.1 page Abstract which includes title of the study, investigators, significance of the study, objectives and a brief discussion of the methodology - 10 copies

8.Permit to conduct research [EHRO FORM 3 November 2010] - 1 copy

**Required if study will be conducted in another department

9.Good Clinical Practice (GCP) Training Certificate of PI – 4 copies

10.Electronic/Soft copy of technically approved protocol & abstract - 1 CD copy

STUDY-SPECIFIC DOCUMENTS (submit as needed) – 4 copies

Investigator’s Brochure (for clinical trials phase I, II, III) or Basic Product Information Document (for clinical trials phase IV)

Informed Consent Assessment Form (for studies with human participants) [UPMREB FORM 2(D)2012]

Informed consent form in English (for studies with human participants)

**For studies requiring informed consent and/or assent, please use the EHRO Informed Consent & WHO Assent template which can be requested from the EHRO Secretary.

Informed consent form in local language (for studies with human participants)

Assent form in English (for studies involving minors and relevant populations deemed incompetent to sign an informed consent form )

Assent form in local language (for studies involving minors and relevant populations deemed incompetent to sign an informed consent form)

Recruitment advertisements (as needed by the study protocol)

Other information or documents for participants (such as diaries, etc.)

Material Transfer Agreement (for any research involving transfer of biological specimens)

Memorandum of Agreement (for collaborative studies)

Site Resources Checklist for Clinical Trial Outside UP-PGH By UPM Personnel [UPMREB FORM 2(E)2012]

Previous ethical review approvals/clearances (for students/personnel of foreign universities researching in the Philippines or those with prior ethical review)

National Commission for Indigenous People Clearance (for studies with indigenous populations; can be processed while UPMREB review is ongoing)

Instructions:

1.All 4 copies should be placed separately in an A4 L-type clear envelope bound with appropriate binder clip.

2.Strictly use A4 bond paper, font size = 12 or larger

3.Place all requirements in a long garterized expandable envelope, any color except black.

4.Other forms required will be determined during the conduct of research Applicable ONLY to previously ethically approved studies. Please inquire for full details

  • UPMREB FORM 3(A)2012: STUDY PROTOCOL AMENDMENT SUBMISSION FORM
  • UPMREB FORM 3(B)2012: CONTINUING REVIEW APPLICATION FORM
  • UPMREB FORM 3(C)2012: FINAL REPORT FORM
  • UPMREB FORM 3(D)2012: STUDY PROTOCOL DEVIATION/ NON-COMPLIANCE/VIOLATION RECORD
  • UPMREB FORM 3(E)2012: EARLY STUDY TERMINATION APPLICATION FORM
  • UPMREB FORM 3(G)2012: SERIOUS UNEXPECTED ADVERSE EVENT/S REPORT

5.Deadline of submission of protocols: two (2) weeks before each panel meeting.

6.Status of the protocol can be followed up one (1) week after each panel meeting.

Reminders:

  • Include in the protocol

1.Ethical considerations: (stated in paragraph form)

  • State that protocol will be submitted to University of the Philippines Manila Research Ethics Board (UPMRB) PGH Review Panel for ethics review and approval. Study will be conducted ONLY upon approval from the UPMREB PGH Review Panel. All patient information will be anonymized and kept confidential.
  • Declare source of funding
  • Disclose conflict of interest
  • For studies with informed consent:

Provide a description of who may solicit consent, how & when it will be done.

Provide a description of who may give consent (especially in studies involving minors & those who are not legally competent to give consent)

  • Address all other ethical issues.

2.Gantt chart/time table and budget proposal

  • At the upper right hand header of the protocol type
  • UPMREB Registration No. (year)- ___- PGH_ –(department code)–000_)

(e.g. UPMREB Registration No. 2012–___-PGH_-OVS-0001)

  • Version No. 1

3.At the lower right hand footer of the protocol type the page no.

Note: Please have one copy (forms & protocol) checked first by the EHRO Secretary before reproducing.

All of the forms can be requested from the EHRO Secretary. Please call or contact the Expanded Hospital Research Office (EHRO) 5548400 local 2065, Monday thru Friday, 8:00 AM – 4:00 PM or email us at Receiving of protocol-related submission is from Monday thru Thursday only. Thank you! :)