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APPENDIX C-Protocol Format

This document appears to be a research protocol format for projects reviewed by the CLHRDC Ethics Review Committee in the Department of Science and Technology Region III in the Philippines. The format includes sections for the title of the study, investigators, significance, literature review, objectives, methodology, study population, inclusion/exclusion criteria, ethical considerations, risks/benefits, data protection, vulnerable populations, informed consent, compensation, data analysis, safety information, and emergency contacts. It also includes spaces for the principal investigator's signature, institution, and address, as well as areas for the reviewer's comments and overall evaluation on whether the protocol is approved, needs revision, or requires inviting the principal investigator for deliberation.

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Ryan John de Lara
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46 views4 pages

APPENDIX C-Protocol Format

This document appears to be a research protocol format for projects reviewed by the CLHRDC Ethics Review Committee in the Department of Science and Technology Region III in the Philippines. The format includes sections for the title of the study, investigators, significance, literature review, objectives, methodology, study population, inclusion/exclusion criteria, ethical considerations, risks/benefits, data protection, vulnerable populations, informed consent, compensation, data analysis, safety information, and emergency contacts. It also includes spaces for the principal investigator's signature, institution, and address, as well as areas for the reviewer's comments and overall evaluation on whether the protocol is approved, needs revision, or requires inviting the principal investigator for deliberation.

Uploaded by

Ryan John de Lara
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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APPENDIX C

DEPARTMENT OF SCIENCE AND TECHNOLOGY REGION III (Base Secretariat)


Dios a o Maca!a"a# Go$er%&e%t Ce%ter' Mai&!is' Cit( o) Sa% Fer%a% o' Pa&!a%"a

Te#e)a* No+, (-./) .//0-1-- 2 (-./).//0340.1

CLHRDC ETHICS REVIEW COMMITTEE RESEARCH PROTOCOL FORMAT


To be filled up by the CLHRDC Ethics Review Committee Secretariat

CLHRDC ETHICS REVIEW COMMITTEE Address: Department of Science and Technology Region III DM Government Center, Maimpis, City of San Fernando, ampanga

R!F!R!"C! "#:

R#T#C#$ "#: R#T#C#$ TIT$!:

DAT! R#T#C#$ R!C!I%!D &' T(! !RC:


To be filled up by the Principal Investi ator

rincipal Investigator)s Signat*re over rinted "ame: +++++++++++++++++++++++++++++++++++++++++++++++++ I"STIT,TI#": ++++++++++++++++++++++++++++++++++++++++++++++++++ ADDR!SS: +++++++++++++++++++++++++++++++++++++++++++++++++

S #"S#R:

CLHRDC-EC Rev 1 05/04/12

RESEARCH PROTOCOL REQUIREMENTS


!to be filled up by the primary investi ator"

REVIEWERS COMMENTS

-. Title of the st*dy /. Investigators0researchers 1. Significance of the st*dy 2. $iterat*re revie3


!may use separate sheet for literature review"

4. #56ectives of the st*dy 7. Methodology and proced*res 8. Description of the st*dy pop*lation 9. !:cl*sion0Incl*sion Criteria ;. !thical Considerations that sho*ld state 3hat relevant international and national g*idelines 3ill 5e *sed as reference in the st*dy and incl*de ethical iss*es a. Anticipated ris<s =ho3 these 3ill 5e minimi>ed? and 3hy they are o*t3eighed 5y potential 5enefit 5. rotection of confidentiality of data and privacy of the
CLHRDC-EC Rev 1 05/04/12

research participants c. %*lnera5ility of the research participants d. Management of adverse effects =for clinical trials? e. (o3 informed consent 3ill 5e o5tained

f. #ther potential conflicts of interest -@. Information regarding compensation for the st*dy participants0 s*56ects
--. Data Analysis

-/. Safety Information a. Safety reca*tion

5. Contact person and telephone n*m5er in case of emergency sit*ation O5ERALL E5AL6ATION OF THE PROTOCOL,

CERTIFICATION, This is to certify that the above research protocol as revie e! by 3 """"""""""""""""""""""""""""""""""""""""" ERC #e$ber %i&'at(re over )ri'te! *a$e Date+"""""""""""""

CLHRDC-EC Rev 1 05/04/12

,pprove! *ee!s Revisio' *ee! to i'vite pri'cipal i'vesti&ator !(ri'& !eliberatio' Details+ """"""""""""""""""""""""""""""""""" """""""""""""""""""""""""""""""""""

CLHRDC-EC Rev 1 05/04/12

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