Transparency Seal - fabella.doh.gov.ph

Details: Category: Transparency Seal; Published: 05 May 2021; Last Updated: 05 May 2021; Hits: 347

RESEARCH ETHICS COMMITTEE

An independent body constituted of medical, scientific and non-scientific members, whose responsibility is to ensure the projection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving and providing continuing review of trial protocol amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

FUNCTIONS

To monitor and regulate institutional research activities with respect to ethical standards.
To develop and implement ethical guidelines and policies in research involving human subjects.
To monitor institutional research activities with respect to ethical considerations.
To review research proposals dealing with human subjects done at the hospital to ensure that these follows.

Research Ethics Committee

Requirements for Initial Review

REQUIREMENTS FOR INITIAL REVIEW

Basic Documents (must submit)

1. Review Application Form (Form 2.1)

2. Review Summary Sheet (Form 2.2)

3. Protocol Evaluation Form (Form 2.3)

4. Informed Consent Assessment Form (Form 2.4) (not needed if retrospective)

5. Waiver for Informed Consent (Form 2.9) *submit if study is retrospective or does not need informed consent*

6. For retrospective study: Approved request letter from Data Privacy Officer indicating that you will retrieve data (medical records etc.) for the purpose of the study. Data Privacy Officer is Dr. Vicente Paulo M. Perez (under Dept. of Anesthesia)

7. Endorsement from the department/adviser/co-author *protocol should be signed by adviser*

8. Approval of Research Committee (Technical Review)

9. Endorsement/Approval from the thesis adviser/panel (non-DJFMH employees)

10. Research Protocol (include ethical considerations)

11. Informed Consent and assent documents (WHO format)

12. Curriculum vitae (CV) and Good Clinical Practice (GCP)/ Good Research Practice (GRP)

a. researcher/investigator

b. co-researcher/adviser

13. Study/protocol budget

14. Three (3) sets of REC requirements (including all forms, research paper, research tools, etc.) -(1) original and (2) photocopy

15. (2) long brown envelope/self-seal and (1) long orange expandable folder (sample photo attached)

16. Ethics Review Fee:

* (P500) for DJFMH residents/ fellows/ undergraduate (Order of payment will be given once requested)

*For review from outside institution, please call secretariat staff.

17. At the footer part of the protocol, please include this format: REC-____-_____1 ver. 1 dated January 1, 2020 (date of submission)

Study-specific Documents (submit as needed)

1. Study drug or medical device information (researcher brochures, published literature, etc.)

2. Statement of on presence or absence of COI of the researcher

3. Information regarding funding, sponsors, institutional affiliations, other potential COI

4. Contracts and approval of relevant offices (MOA if study is collaborative in nature; Material Transfer Agreement (MTA); Intellectual Property approval; Investigational Device Exemption (IDE), when relevant)

5. Study tools (questionnaires, case report form, posters, etc.)

Note:

1. All documents should be in A4 size.

2. Entry of details in forms must be typewritten.

3. "See attached" written in forms will not be accepted.

4. Email all the protocol package to be submitted for review.

Study-specific Documents (submit as needed)

1. Study drug or medical device information (researcher brochures, published literature, etc.)

2. Statement of on presence or absence of COI of the researcher

3. Information regarding funding, sponsors, institutional affiliations, other potential COI

5. Study tools (questionnaires, case report form, posters, etc.)

Note:

1. All documents should be in A4 size.

2. Entry of details in forms must be typewritten.

3. "See attached" written in forms will not be accepted.

4. Email all the protocol package to be submitted for review.

For Resubmission

INSTRUCTION FOR RESUBMISSION (protocols w/ minor or major modification as recommended action)

Form 2.8 (Resubmission Form)

1. Please put under "REC RECOMMENDATIONS" the comments of the reviewers.

2. On the "REVISIONS MADE BY THE PI" put your explanation and the page of the protocol where you made the revision.

Protocol

3. Please highlight the revised statements in the protocol by making it in bold form for it to be easier to see by the reviewer.

4. At the footer part of the protocol, please include this format: <REC protocol code><version no>< date of re-submission>

Example: REC-2020-001 ver. 2 dated January 1, 2020

Requirements for resubmission:

1. Protocol Resubmission Form (Form 2.8)

2. Waiver for Informed Consent (Form 2.9) (for retrospective study only)

3. For protocol with minor modification:

3 sets of the revised protocol package (protocols and all documents)

- (1) original and (2) photocopy; 3 pcs. long brown envelope

4. CV of your adviser/co-researcher (if not yet submitted)

5. Photocopy of Form 2.5 (REC Notice for Modification)

Flowchart

REC Fees

Review fee:

Protocol Review

-P500.00 for postgraduates/residents/fellows

-P3,000.00 for undergraduates

-P40,000.00 for Industry-Sponsored Researches

-P10,000.00 for Principal Investigator-Initiated with external funding

-P5,000.00 for Principal Investigator-Initiated without external funding

Institutional Fee:

-P100,000.00 or 10% of budget (whichever is higher) for Industry Sponsored Researches/Principal Investigator initiated with funding

-Principal Investigator initiated researches without external funding

P5,000.00 for Survey questionnaire and interview >50 participants
P3,000.00 for survey questionnaire and interview 25 to 50 participants.

REC Forms

Meeting Schedule

Submission of the research protocol

Details: Category: Transparency Seal; Published: 23 February 2021; Last Updated: 23 February 2021; Hits: 168

Hospital Memorandum No. 02 s. 2021

Deadline for the Submission of the Sworn Statements of Assets, Liabilities and Net Worth (SALN) and Disclosure of Business Interests and Financial Connections.