University of Cebu Academe
Research Ethics Committee
Informed Consent Evaluation Form
Form 2.4
Part 1. to be filled by the PI
PROTOCOL TITLE:
PROTOCOL NO. :
Type of Review:
PRINCIPAL INVESTIGATOR:
CONTACT DETAILS: (email add & mobile number)
ADVISER:
CONTACT DETAILS: (email add & mobile number)
INSTITUTION:
Status:
NEW
Re-submission
REVIEWER:
Part 2. to be filled by the ICF Reviewer
GUIDE FOR REVIEWING THE INFORM CONSENT PROCESS & FORM
1. Is it necessary to seek the Informed Consent of the participants?
Unable to Assess
YES
NO
IF NO, please explain
IF YES, are the participants provided with sufficient information about the following
items?
YES
o
o
o
o
o
o
o
o
Purpose of the study?
Expected duration of participation?
Procedure to be carried out?
Discomforts and inconvenience?
Risks (including possible discrimination)?
Benefits to the participants?
Compensation and/or medical treatment in case of injury?
Who to contact for pertinent questions and/or for assistance
in research-related concerns or injury?
o Extent of confidentiality?
NO
2. Is the inform consent written or presented in non-technical language that participants can
understand?
Unable to Assess
YES
NO
3. Does the protocol include an adequate process for ensuring that the consent is voluntary?
Unable to Assess
YES
NO
4. Are the different types of consent forms (assent, patient representative) appropriate for the
types of study participants?
Unable to Assess
YES
NO
5. Are the names and contact numbers from the research team and REC in the informed
consent?
Unable to Assess
YES
NO
6. Is the Informed Consent translated into the local language/dialect? (if applicable)
Unable to Assess
YES
7. Do you have any other concerns?
RECOMMENDATION:
APPROVED
Minor Revisions Required
Major Revisions Required
DISAPPROVED
Signature over Printed Name of Reviewer
Review Date
NO