Form 1: REVIEWER’S ASSESSMENT FORM
(Adapted with Permission from the UP-NIH Ethics Review Board)
UNIVERSITY OF SANTO TOMAS
Graduate School
Ethics Review Committee
PROJECT TITLE/RESEARCH STUDY: ____________________________________________________________________
PROPONENT: _________________________________________________
INSTITUTION/AFFILIATION:_____________________________________
CONTACT NUMBER OF PRIMARY INVESTIGATOR:_______________________________________
ADVISER:_______________________________________________________
Research Classification
 Undergraduate
 Masteral
Supervisor’s Name:
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Doctoral
Independent
For the Principal Investigator
Reviewer’s Assessment Form
(kindly check the items that apply to your protocol)
A. The protocol/research study contains the following:
1. Background of Study
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Significance of Study
Rationale of Study
Literature Review
a. Results of animal/human studies
b. Known risks of procedures
c. Known benefits of procedure
d. Known adverse effects of drugs/procedures
5. Objectives of Study
a. Primary objective
b. Secondary objectives.
6. Statement of Risks of the Project
a. To study participants
b. To community
7. Possible adverse events (AE)
8. Statement of benefits of the project
a. To study participants
b. To community
9. Recruitment of participants
a. Recruitment procedures
b. Inclusion/exclusion criteria
10. Methods
a. Type of study design
b. Setting for project
c. Duration of project
d. Procedures to be done
11. Informed consent/Elements of Informed Consent
a. Participation information
b. Informed Consent of Participant/s
c. Voluntarism of Participants
d. Consent of legal guardian/s (if needed)
e. Two witnesses (if needed)
12. Conflict of interest
a. Full disclosure of potential sources of conflict of
interest involving any of the authors or the granting
agency
b. Anonymity, privacy and confidentiality of health
information
c. Full disclosure of publication rights
d. Amount and method of reimbursement of trialrelated expenses of the study participants
13.Vulnerable subjects involved in the study
a. A description of who may solicit consent, how, and
when it will be done
b. A description of who may give consent (involving
minors and not legally competent to give consent)
For the Reviewer/s
(kindly include your review comments)
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c.
Involvement of sensitive topics (sexual activity,
illegal or political behaviour, mental health, gender
or ethnic status, drug use).
14. Risks
a. Provisions for management of adverse
Reactions
b. Interim analysis and provisional or mandatory
cessation guidelines in case harmful effect are
demonstrated during the study
c. Non-material compensation to participant/s
such as health education or other creative
benefits, where no clear, direct benefit
from the project will be received by the said
participant/s
d. Guarantee of medical care/indemnification of
study participant/s in case of trial-related
injuries, which shall not be subject to previous
Waiver
e. Involving the collection, use and storage of human
tissues/specimens and genetic information (blood,
urine, saliva, DNA, etc.)
f. Level of risks
1) Low
2) Medium
3) High
15. Curriculum vitae of investigators
a. Complete name, titles, institutional affiliations
of principal investigator
b. Name of co-workers
c. Job description of co-workers
d. Responsibilities of each co-worker
e. Contract with sponsor
16. Project sponsor/s
a. Complete name
b. Address
c. Name of contact person/s
d. Telephone number of contact person/s
e. Statement of sponsor’s interest/co-authorship
17. List of references
18. Budget
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B. COMMENTS
 Approval/Favorable opinion
 Modifications required prior to approval
 Disapproval/Negative opinion
Reason/s for disapproval:
(Chairman, UST GS Ethical Review Committee)
Signature over Printed Name
Date: ____________________
C. FINAL ACTION
 APPROVED
 DISAPPROVED
___________________________
Signature over Printed Name
Date:_____________________
Form 2: Self-assessment Checklist for Informed Consent Form
(Adapted with Permission from the UP-NIH Ethics Review Board)
UNIVERSITY OF SANTO TOMAS
Graduate School
Ethics Review Committee
PROJECT TITLE: ____________________________________________________________________________
PROPONENT: ____________________________________________________________
ADVISER: _________________________________________________________________
For the Principal Investigator
Self-Assessment Checklist for Informed Consent
(kindly check the items that apply to your informed consent form)
A. ASSESSMENT FOR INFORMED CONSENT
1. Informed consent form (in English and Filipino or in a language understandable to the study
participants)
2. Contains the following elements of an informed consent:
2.1. The study’s investigative nature
2.2. The number of the study participants in the trial
2.3. The purpose/objective of the study
2.4. The trial treatments and probability for random assignment to each treatment
2.5. The trial procedures to be done, including all invasive procedures
2.6. The expected duration of a subject’s involvement and number of follow-up visits
2.7. Potential or direct benefits (if any) from participation
2.8. Alternative procedure(s) or course(s) of treatment that may be available
2.9. The risks, discomforts and inconveniences associated with the study, or when
applicable to an embryo, fetus or nursing infant
2.10. The provision for management of adverse reaction
2.11. The study participant’s responsibilities
2.12. A statement that participation is voluntary
2.13. A statement giving study participants the option to withdraw
2.14. That a study participant shall be given information that may be relevant to
his/her willingness to continue participation
2.15. A statement guaranteeing confidentiality
2.16. Circumstances/reasons under which the subject’s participation may be
Terminated
2.17. A statement on reimbursement of trial-related expenses of participants (if
applicable)
2.18. A statement guaranteeing medical care/indemnification for adverse events not
subject to previous waiver
2.19. Whom to contact in case of questions on adverse event (telephone number of
contacts included)
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B . COMMENTS:
 Approval/favourable opinion
 Modifications required prior to approval
 Disapproval/Negative opinion
______________________________
Signature over Printed Name
Date:____________________
B. FINAL ACTION:
 APPROVED
 DISAPPROVED
_____________________________
Signature over Printed Name
Date:____________________