ERC PROTOCOL ASSESSMENT FORM
(Please check the appropriate column)
[Legend: Y-yes/ N-no / NA-not applicable]
Y
N
NA Comments
1.
1.1.
1.2.
FAIR SUBJECT SELECTION
Are the study site(s) appropriate for the study
Are the vulnerable populations (women,
infants, pregnant women, children until 18,
students, military personnel, mentally
challenged, prisoners or institutionalized
people) the subject of the study?
1.3. Is the use of vulnerable population in this
study justifiable?
1.4. Are the proposed study participants
appropriate for the study?
1.5. Are the inclusion and exclusion criteria clearly
defined as to risks?
2.
MINIMIZE HARM/ MAXIMIZE BENEFITS
2.1. Does the research provide adequate measures
to minimize harm or risks to research
participants?
2.2. Will there be appropriate benefits to
participants and/or communities where the
research will be conducted?
2.3. Will there be treatment of adverse events?
3.
INFORMED CONSENT
3.1. Will the consent be obtained from appropriate
and eligible decision makers?
3.2. Are the participants provided with
appropriate study information?
3.3. Is the consent form going to be obtained on a
voluntary manner?
3.4. Are the personal data protected? Is
confidentiality assured?
3.5. Are the people who have access to the data
clearly indicated?
3.6. Is the purpose of the research indicated?
3.7. Is the expectation for the research participant
clearly indicated?
3.8. Is the language clear and understandable to
the participant?
3.9. Is the monetary benefit indicated or clearly
communicated (if no monetary benefit)?
3.10. Are the risks to participants clearly described
as well as the alternative treatments?
3.11. Is the compensation to injury indicated?
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3.12. Is there clear statement that the research
participant can withdraw anytime without loss
of benefits?
3.13. Is the number of participants indicated in the
participant information as well as the duration
of participation?
3.14 Is the name of the contact person and contact
numbers, office address, etc. indicated in the
informed consent?
DECISION: (PLEASE CHECK ONE)
1.
2.
3.
4.
APPROVED AS WRITTEN ____
APPROVAL WITHHELD WITH MINOR REVISION ____
APPROVAL WITHHELD WITH MAJOR REVISION ____
DISAPPROVED ___x (it should be pointed out that the purpose of review is
not to put down the researcher but rather to guide the researcher to
achieve his goals without compromising respect for the participants’
rights. In studies where the flaw is in an integral to the study such that a
separate study design should be
Name of Reviewer
Date of Review: dd/month/yyyy
Signature of reviewer
SUGGESTED REVISIONS/ COMMENTS:
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