ERB Self Management Program
ERB Self Management Program
To the principal investigator/research proponent: Kindly arrange the required (with bullets)
and other documents in your protocol package according to the following order. Write NA if
the document is not applicable.
Please coordinate with the ERB Secretariat should you need clarification regarding your
protocol package’s review track.
FOR ERB:
_______________________________________________________Date______________
ERB Reviewer/Representative’s Name and Signature
_______________________________________________________Date:______________
ERB Reviewer/Representative’s Name and Signature
_______________________________________________________Date______________
ERB Reviewer/Representative’s Name and Signature
_______________________________________________________Date______________
ERB Reviewer/Representative’s Name and Signature
_______________________________________________________Date______________
ERB Reviewer/Representative’s Name and Signature
Republic of the Philippines
CAVITE STATE UNIVERSITY
Don Severino de las Alas Campus
Indang, Cavite
' (046) 862-1654
www.cvsu.edu.ph
May I request for the registration, review and approval of protocol entitled:
And the other documents checked in the accompanying CvSU ERB Form 01
For the items below, kindly MARK ALL which apply and provide details where applicable.
1. Details regarding the study: To reduce the level of psychache of the participants and their
non- suicidal self- injury and to enhance their self- management behaviors.
(√ ) Social Science Research ( ) Health Science Research
( ) multi-center ( ) multi-national (√ ) Philippines ONLY
(√ ) undergraduate research (√) university research
( ) Graduate thesis/dissertation (√ ) Student’s Requirement
( ) Clinical Trial Phase _____ Involving ( ) Drug ( ) Device ( ) Other _______________
Sponsor/Funding Agency:
Contract Research
Organization:
Are you the author of this ( ) N, I am only implementing this protocol
protocol? (√) Y, this is a self-initiated protocol
2. In connection with this submission I disclose the following:
(√) I have no conflict of interest in any form (financial, proprietary, professional) with
sponsor, the study, co-investigators, nor site
( ) I have personal/family Financial interest in the results of study
Explanation:
( ) I have proprietary interest in the research (patent, trademark, copyright, licensing)
(Indicate nature)
( ) I am connected with the sponsoring agency in my capacity as:______________
3. I am currently involved (as PI) in (Number) studies being conducted at the following sites:
Protocol Title & Sponsor Site Inclusive Dates
N/A N/A N/A
4. I have completed the following research ethics or GCP trainings*:
Training Title Offered by Date
N/A N/A N/A
* Provide proof of attendance
5. I attest to the truthfulness of the entries made in this form.
6. I am submitting 7 copies of the protocol package, along with a protocol summary
containing study diagram & flowchart, and statistical & analysis plan.
Principals Signature Date
Dago-oc, Maricah Jomela 03/10/20
Gener, Bianca L.
Sales, Zandrine Nicole V. 03/10/20
Principal Investigator/Proponents:
MARIA ANGELA L. DIOPOL, RPSY, LPT Guidance Coordinator, CvSU- Imus 03-10-2020
_________________________________________________________________________
Signature over Printed Name / Designation/ Institution Date
_________________________________________________________________________
Signature over Printed Name / Designation/ Institution Date
Funding N/A
Agency:
Budget: N/A
Study Site: Cavite State University- Imus Campus
Duration: August 29 - May 2020
[ ] IT
No. and Date of ERB Meeting when protocol was initially reviewed/ reported for initial review
(for expedited track): _____________________________________
Chair, ERB:
________________________
Signature over Printed Name Date
Republic of the Philippines
CAVITE STATE UNIVERSITY
Don Severino de las Alas Campus
Indang, Cavite
' (046) 862-1654
www.cvsu.edu.ph
Participants: The research participants for this study are the students of Cavite State
University – Imus Campus who have a high level of psychache.
Risks and discomforts: They are free to choose if they can or cannot participate. If they
choose to participate, but became hesitant due to some unexpected conditions that may
arise, they can withdraw at any time without consequences of any kind.
Potential benefits: The benefit in every participant is the prevention of their non-
suicidal self- injury behaviors and the decrease their psychological pain. The
information also will benefit the university to increase awareness about the issue.
I have read this consent form and have been given the opportunity to ask questions.
Approved:
Name: __________________________
Ethics Review Board Chair
Contact number: __________
Republic of the Philippines
CAVITE STATE UNIVERSITY
Don Severino de las Alas Campus
Indang, Cavite
' (046) 862-1654
www.cvsu.edu.ph
This checklist has been prepared to ensure that the protocol submission complies with GCP
standards.
Page/Paragraph
No.
and
PI’s/Proponents
remarks
1. Were potential conflicts of interest between
the Principal Investigator (PI) /Proponents
and the participant disclosed and √
addressed?
2. Has a scientific/technical review been done
by a research advisory committee?
√
3. Has the protocol been submitted
to/approved by an ERB elsewhere?
a. If yes, please submit the result of N/A
the ERB review elsewhere with the
documents for your present
application.
4. Is there a section on ethical concerns in
the protocol?
√
a. Are possible ethical issues
identified? [gender, culture, equity
(fairness in treating people without √
prejudice)]
b. Is the informed consent process
clearly described?
5. Is the investigator/proponent qualified to
undertake the study?
a. Please submit updated CV of Page 129
investigator (s) and research staff
b. If applicable, please submit certified N/A
true copy of GCP training
certificate.
c. If the study involves patients,
procedures outside the expertise
and/or experience of the
investigator, does the study include
a consultant with the necessary √
qualifications?
6. If the research is collaborative in nature,
are there statements that ensure protection
of: √
a. intellectual property rights
b. publication rights
Is a MOA available/or being executed?
√
7. For studies using a questionnaire or
interview guide,
Evaluator Only:
Signature: ____________________________
Name of Reviewer: ____________________
Date submitted to ERB Secretariat: ________________________________
This protocol was taken up at the (no. of meeting of the ERB on)
NOTE:
A study presents minimal risk if "the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests."
A study has more than minimal risk (moderate to severe) if as a result of research
participation, the subjects would be exposed to more than a remote possibility of "substantial
or prolonged pain, discomfort, or distress" or "clinically significant deterioration of a medical
condition”
(http://bioethics.georgetown.edu/nbac/capacity/Assessment.htm#Para5, accessed 30 June
2009)
A study with severe risk to participants is disapproved unless there is a strong justification
for the study to be conducted, in which case additional safeguards are recommended.
0- less than 7 yrs. Oral assent only meaning the parents are largely
responsible for the child’s response to the procedures to be
done. However, any sign of dissent on the part of the child
(e.g. refusal of a procedure) must be respected.
7 to less than 18 yrs. Oral or Written assent, depending on risk of study. The
study is explained to the child in an appropriate language
taking into consideration the child’s capability to understand
the procedures. Oral assent means that the child does not
sign on the document. Written assent means the participant
signs on the document. Either way, there must be a
statement in the protocol on how the oral or written assent
is to be obtained and documented.
Republic of the Philippines
CAVITE STATE UNIVERSITY
Don Severino de las Alas Campus
Indang, Cavite
(046) 862-1654
cvsu.edu.ph
Research Paradigm:
Methodology:
Ethical Consideration:
The researchers will ensure that every procedure
that will obtain the needed data is done accordingly
to the code of ethics followed by psychology
professionals, and practitioners. These ethical
considerations helped not only researchers, but the
respondents as well for this gave them an idea
regarding the nature of their participation and rights
as a respondent.
Instrument/s:
The Psychache Scale (Holden et al., 2001)
is a 13-item self-report questionnaire designed to
assess Shneidman's conceptualization of
psychache or psychological pain. Items were
rationally constructed to focus directly on the
definition of psychache and were written to be
responded to on 5-point scales ranging from either
never to always or from strongly disagree to
strongly agree and explicitly avoid any reference to
suicidality. The Psychache Scale has high reliability
and validity in samples of students and offenders.
The α reliability coefficients of this scale were
generally exceeding 0.90 (Holden et al., 2001; Mills
et al., 2005). Moreover, the Psychache Scale can
successfully tell apart between suicide attempters
and non-attempters (Holden et al., 2001).
Student Researcher/s
GENER, BIANCA L.
Screened by:
Participants: The research participants for this study are the students of Cavite State
University – Imus Campus who have a high level of psychache.
Risks and discomforts: They are free to choose if they can or cannot participate. If they
choose to participate, but became hesitant due to some unexpected conditions that may
arise, they can withdraw at any time without consequences of any kind.
Potential benefits: The benefit in every participant is the prevention of their non-
suicidal self- injury behaviors and the decrease their psychological pain. The
information also will benefit the university to increase awareness about the issue.
I have read this consent form and have been given the opportunity to ask questions.
Approved:
Name: __________________________
Ethics Review Board Chair
Contact number: __________