Professional Documents
Culture Documents
To be filled by Proponent
Indicate if the Page and
Essential Elements REVIEWER
ICF contains the Paragraph
(as applicable to the study) specified element where element COMMENTS
YES N/A is found
1. Statement that the study involves Page 1
/
research
2. Statement describing the purpose Page 1
/
of the study
3. Study-related treatments and Page 37-38
/
probability for random assignment
4. Study procedures including all
invasive procedures
5. Responsibilities of the participant Page 39,
/ Paragraph
3
6. Expected duration of participation Page 1,
/
in the study no.5
7. Approximate number of Page 37-
participants in the study 38,
/
Paragraph
1
8. Study aspects that are
/
experimental
9. Foreseeable risks to
participant/embryo/fetus/ nursing
infant; including pain, discomfort,
/
or inconvenience associated with
participation including risks to
spouse or partner
10. Risks from allowable use of placebo
/
(as applicable)
11. Reasonably expected benefits or Page
absence of direct benefit to / 1,no.6
participant, as applicable
12. Expected benefits to the Page 31-33
community or to society; or
/
contributions to scientific
knowledge
13. Description of post-study access to
the study product or intervention
/
that have been proven safe and
effective
14. Alternative procedures or treatment Page 37-38
/
available to participant
15. Compensation or insurance or
treatment entitlements of the
/
participant in case of study-related
injury
16. Anticipated payment, if any, to the /
participant in the course of the
study; whether money or other
forms of material goods, and if so,
Saint Louis College Reference Code
City of San Fernando (La Union) FM-RSMO-056
Revision No. 0
Research Management Office
Effectivity Oct. 1, 2022
Tel (072) 242-5535 loc 151
participant to continue to
participate
27. Statement describing access of Page 41,
participant to the result of the / Paragraph
study 2
28. Statement describing extent of Page 56,
participant’s right to access their Paragraph
records (or lack thereof) vis a vis / 6
pending request for approval of non
or partial disclosure
29. Perceivable circumstances and Page 56,
reasons under which participation / Paragraph
to the study may be terminated 7
30. Sponsor, institutional affiliation of
the researchers and nature and /
sources of funds
31. Statement whether the researcher
is serving only as an investigator or
/
as both investigator and the
participant’s healthcare provider
32. Person(s) to contact in the study Page 56
team for further information
regarding the study and whom to /
contact in the event of study-
related injury
33. Statement that the RERB has Page 56
approved the study and may be
reached through the following
contact for information regarding
the rights of the study participants,
including grievances and
complaints /
Date_______________