DDOSC-REC Form 2.

4
Informed Consent/Assent Evaluation Form
Republic of the Philippines April 12, 2018
Davao de Oro State College
RESEARCH ETHICS COMMITTEE

INFORMED CONSENT/ASSENT EVALUATION FORM

Note: Kindly fill all the items with a red asterisk (*)
REC Code Click here to enter text.

*Study Protocol Title Click here to enter text.

*Researcher/s Click here to enter text.
*Submission Date

INSTRUCTIONS
*To the Researcher/s:
To the Primary Reviewer/s:
Please indicate in the space provided below whether or not the
specified element is addressed by the Informed Consent/Assent Form
(ICF). To facilitate the evaluation of the assessment point, indicate the
page and paragraph where this information can be found. Further,
those items with RED asterisks shall be incorporated in your ICF and
that be marked as YES.
Please evaluate how the elements outlined below have been
appropriately addressed by the Informed Consent/Assent Form (ICF),
as applicable, and by confirming the submitted information and putting
your comments in the space provided under “REVIEWER
COMMENTS.” In your comments, ensure that vulnerability,
recruitment process, and process of obtaining informed consent
are always assessed in the context of the study protocol and the
participant. Finalize your review by indicating your conclusions under
“RECOMMENDED ACTION” and signing in space provided for the
primary reviewer.

To be filled out by the

Investigator/Researcher
ESSENTIAL ELEMENTS Indicate if the Page and REVIEWER COMMENTS
(as applicable to the study) ICF has the paragraph
specified where the
element element is
found
YES N/A
1. Statement that the study involves Click here to Click here to enter text.
research* enter text.
2. Statement describing the Click here to Click here to enter text.
purpose of the study* enter text.
1. Study-related treatments and Click here to Click here to enter text.
probability for random enter text.
assignment
3. Study procedures including all Click here to Click here to enter text.
invasive procedures* enter text.
4. Responsibilities of the Click here to Click here to enter text.
participant* enter text.
5. Expected duration of participation Click here to Click here to enter text.
in the study* enter text.
6. Approximate number of Click here to Click here to enter text.
participants in the study* enter text.
7. Study aspects that are Click here to Click here to enter text.
experimental enter text.
8. Foreseeable risks to participant Click here to Click here to enter text.
nursing infant; including pain, enter text.
discomfort, or inconvenience
associated with participation
including risks to spouse or
partner; and integrating risks as

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 DDOSC-REC Form 2.4
Informed Consent/Assent Evaluation Form
Republic of the Philippines April 12, 2018
Davao de Oro State College
RESEARCH ETHICS COMMITTEE

detailed in the investigator’s

brochure*
9. Reasonably expected benefits; or Click here to Click here to enter text.
absence of direct benefit to enter text.
participants, as applicable*
2. Expected benefits to the Click here to Click here to enter text.
community or to society, or enter text.
contributions to scientific
knowledge*
10. Description of post-study access Click here to Click here to enter text.
to the study product or enter text.
intervention that have been
proven safe and effective*
11. Alternative procedures or Click here to Click here to enter text.
treatment available to participant enter text.
12. Compensation or insurance or Click here to Click here to enter text.
treatment entitlements of the enter text.
participant in case of study-
related injury
13. Anticipated payment, if any, to Click here to Click here to enter text.
the participant in the course of enter text.
the study; whether money or
other forms of material goods,
and if so, the kind and amount
14. Compensation (or no plans of Click here to Click here to enter text.
compensation) for the participant enter text.
or the participant’s family or
dependents in case of disability
or death resulting from study-
related injuries
3. Anticipated expenses, if any, to Click here to Click here to enter text.
the participant in the course of enter text.
the study
15. Statement that participation is Click here to Click here to enter text.
voluntary, and that participant enter text.
may withdraw anytime without
penalty or loss of benefit to which
the participant is entitled*
16. Statement that the records Click here to Click here to enter text.
identifying the participant will be enter text.
kept confidential and will not be
made publicly available, to the
extent permitted by law; and that
the identity of the participant will
remain confidential in the event
the study results are published;
including limitations to the
investigator’s ability to guarantee
confidentiality*
17. Statement that the participant or Click here to Click here to enter text.
participant’s legally acceptable enter text.
representative will be informed in
a timely manner if information
becomes available that may be
relevant to willingness of the
participant to continue to
participation
18. Statement describing access of Click here to Click here to enter text.
participant to the result of the enter text.
study*
4. Statement describing extent of Click here to Click here to enter text.
participant’s right to access enter text.
his/her records (or lack thereof
vis à vis pending request for

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 DDOSC-REC Form 2.4
Informed Consent/Assent Evaluation Form
Republic of the Philippines April 12, 2018
Davao de Oro State College
RESEARCH ETHICS COMMITTEE

approval of non or partial

disclosure)*
19. Foreseeable circumstances and Click here to Click here to enter text.
reasons under which enter text.
participation in the study may be
terminated*
5. Sponsor, institutional affiliation of Click here to Click here to enter text.
the investigators, and nature and enter text.
sources of funds
20. Person(s) to contact in the study Click here to Click here to enter text.
team for further information enter text.
regarding the study and whom to
contact in the event of study-
related injury*
21. Statement that the DDOSC-REC ✘ Click here to
(specify) has approved the study,
enter text. Click here to enter text.
and may be reached through the
following contact for information
regarding rights of study
participants, including grievances
and complaints:*
Name of DDOSC-REC Chair
Address: Purok 10 Poblacion,
Compostela, Davao de
Oro, Philippines 8803
Email: rec@ddosc.edu.ph
Mobile: 0998-571-7507

22. Comprehensibility of language Click here to enter text.

used
23. Other comments not addressed Click here to enter text.
by items 1-27
RECOMMENDED ACTION:
APPROVE
MINOR MODIFICATIONS
MAJOR MODIFICATIONS
DISAPPROVE

JUSTIFICATION FOR RECOMMENDED ACTION

Click here to enter text.

Prepared by:

Click here to enter text.

_________________________________________
Researcher/s (Signature over Printed Name)

Note by:

Click here to enter text.

_______________________________________
Research Adviser (Signature over Printed Name)

Reviewed by:

Click here to enter text.

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 DDOSC-REC Form 2.4
Informed Consent/Assent Evaluation Form
Republic of the Philippines April 12, 2018
Davao de Oro State College
RESEARCH ETHICS COMMITTEE

________________________________________
Reviewer (Signature over printed name)

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