BORANG PERMOHONAN KELULUSAN ETIKA
PELAJAR PASCA IJAZAH (M.Med, M.Sc & Ph.D) PUSAT PENGAJIAN SAINS PERUBATAN (PPSP)
ETHICAL APPROVAL APPLICATION FORM for POSTGRADUATE STUDENT (M.Med, M.Sc & Ph.D) PPSP
Nota:(Notes):1. Borang permohonan terdiri daripada 8 mukasurat.
(Application form consists of 8 pages).
2. Contoh Carta Aliran Projek dan Carta Gantt sila rujuk mukasurat 9 - 11.
(Example of ‘Project Flow Chart ’and ‘Gantt Chart’ refer page 9 - 11).
3. Senarai kumpulan FOR rujuk mukasurat 12 - 14 dan kumpulan SEO dimukasurat 15 untuk rujukan
sahaja [tidak perlu dicetak].
(List of FOR group refer page 12 – 14 and SEO group refer page 15).For reference only [no need to
print].
4. Permohonan hendaklah dimajukan ke Pejabat Bhg. Siswazah, PPSP untuk diperakukan oleh Dekan
dan Timbalan Dekan (Pengajian Siswazah & Latihan Iktisas), PPSP.
Please send the form to the Postgraduate Office, School of Medical Sciences for endorsement by the
Dean and Deputy Dean (Postgraduate and Professional Training), School of Medical Sciences.
5. Selepas mendapat perakuan Dekan dan Timbalan Dekan (Pengajian Siswazah & Latihan Ikhtisas),
PPSP, serahkan 3 salinan borang ini (termasuk salinan asal) ke Pejabat Pelantar Penyelidikan Sains
Klinikal, USM untuk tindakan lanjut.
(Following the approval from the Dean and Deputy Dean (Postgraduate and Professional Training),
School of Medical Sciences, please make 3 copies (including original copy) and send to Clinical
Science Research Platform Office, USM for further action).
FOR POSTGRADUATE OFFICE’S USE ONLY
Stamp Date received (From PG Student):
Received by:
Signature:
Stamp Date received (From Dean’s Office):
Received by:
Signature:
Stamp Date received (Research Platform Office):
Received by:
Signature:
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
1
CHECKLIST FOR ETHICAL APPROVAL
(To be submitted together with the Application Form) ; Postgraduate Office, PPSP
Note:
1.
2.
3.
PI or Co-researchers has to defend their research proposal.
Student dissertation is required in the research proposal.
Supervisor or Co-supervisor must be present during student’s presentation of research proposal.
No.
Project Title
1.
Name of Postgraduate Student
2.
Specialty / Area
3.
Name of Main Supervisor
4.
Name of Co-supervisors / Co-researchers
5.
Location of Research
6.
Duration of this research
Please Answer the Following Questions
7.
Has similar study been done before? (If yes, when?)
8.
Research Problem / Rationale / Justification of the study given.
9.
Objectives
10.
Hypothesis
11.
Study design
12.
Sample size calculation
13.
Detailed methodology
14.
References
15.
Flow Chart of research
16.
Gantt Chart of research activities
17.
Expected results
18.
Benefit of the study
19.
Budget
20.
Pages are numbered
21.
Informed consent / subject information
M.Med Dissertation / M.Sc / Ph.D
i)
ii)
iii)
Yes / No / Not Applicable
a. Ethical issues (Animal / Human)
(if yes, please specify either Animal or Human or Both)
22.
b. Approval from Health Ministry or other Ministries required?
(If yes, please specify)
23.
Discussion at Department:
(Attach a copy of the Attendance Sheet signed by Head of Dept)
Verification and Comment by Student’s Supervisor
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
2
ATTENDANCE SHEET
(To be filled up at department level)
Date: __________________
Nama
Name
No.
1.
Tandatangan
Signature
Ketua Jabatan:
Head Department:
2.
3.
4.
5.
6.
7.
8.
9.
10.
Endorsed by:
………………………….
(Head of Department)
Stamp:
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
3
BORANG ETIKA - 01
JAWATANKUASA ETIKA PENYELIDIKAN (MANUSIA) - JEPeM
RESEARCH ETHICS COMMITTEE (HUMA N)
PERMOHONAN KELULUSAN ETIKA
(ETHICAL APPROVAL APPLICATION)
(Sila sampaikan 3 salinan kertas kerja ini (termasuk salinan asal) kepada Pejabat Pelantar Penyelidikan Sains
Klinikal, Kampus Kesihatan USM melalui Dekan / Pengarah / Ketua Jabatan di Pusat Pengajian masing-masing)
(Please submit 3 copies (including original sopy) of your research proposal to Clinical Research Platform Office, USM
Health Campus through your respected Deans / Head Department)
Tajuk penyelidikan yang dicadangkan:
Title of proposed research
A.
Nama:
Name
No. Kad Pengenalan:
Identity Card No.
Pusat Tanggungjawab [PTJ]:
School / Department / Unit
No. Matrik:
Matric Number
No. Telefon Pejabat:
Office Telephone No.
Alamat E-mel:
E-mail Address
Jawatan:
Position
Tahun
Pengajian:
Year
Tarikh mula berkhidmat dengan Universiti ini:
Date of first Appointment to the University
Jika kontrak, nyatakan tarikh tamat:
If on contract, state expiry date
Pelantar Penyelidikan dipilih ( √ ):
Selected Research Platform
Clinical Research
Engineering & Technology
Fundamental Sciences
Biomedical & Health Sciences
Social Transformation
Life Sciences
Information & Comm. Technology
B (i).
Kumpulan FOR (Field of Research Group)
*(Sila rujuk Panduan / Please refer to
" Malaysian (R&D) Classification System”)
Kumpulan SEO (Socio-Economic Objective Group)
*(Sila rujuk Panduan / Please refer to
"Malaysian (R&D) Classification System")
Kod FOR:
Kod SEO:
Tempat penyelidikan dijalankan:
Location of research
Tempoh projek (tidak melebihi 24 bulan):
Duration of project (not more than 24 months)
*Terdapat di Pusat Pengajian masing-masing atau layari http://www.research.kk.usm.my/borang/MRDCS_5th_Edition.pdf
*Available at your School or go to http://www.research.kk.usm.my/borang/MRDCS_5th_Edition.pdf
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
4
B (ii).
Ringkasan Penyelidikan
Summary of Research Proposal
* [Perlu meliputi latar belakang dan penyataan masalah, tujuan penyelidikan, kaedah penyelidikan
(sertakan carta alir dan carta gantt), hasil yang dijangkakan dan senaraikan penerbitan yang berkaitan
(jika ada).]
*[Must include the background and problem statement, objectives, research methodology (please include flow
chart), expected outcome and list of related publications]
(a)
Tujuan (Objectives)
(b)
Latarbelakang (Background)
(c)
Kaedah (Methodology) - Sila sertakan carta alir dan carta Gantt
(Please provide a flowchart and Gantt chart)
(d)
Hasil (Expected Outcome)
(e)
Penerbitan Berkaitan (Related publication)
* Jika terdapat maklumat tambahan, sila sertakan.
* Please attach additional information if necessary
B (iii).
B (iv).
Kepentingan dan faedah Penyelidikan
The importance and the benefits of the research
Alat - alat dan bahan yang terdapat di Universiti untuk kegunaan penyelidikan ini.
Equipment and materials available in the University to be used for this research.
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
5
C (i).
Jika penyelidikan ini dijalankan bersama dengan penyelidik lain, nyatakan peranan mereka:
If this research is conducted together with other researchers, please state their role:
Nama dan No. Kad Pengenalan
Name and Identity Card No.
D.
Pusat Pengajian/Jabatan/Unit
School/Department/Unit
Tandatangan
Signature
Sumbangan/ Peranan
dalam kajian
Role in this research
Pengakuan
Declaration
Saya mengaku bahawa semua maklumat yang diberi adalah benar dan cadangan penyelidikan ini tidak
dipohon untuk geran lain.
I hereby declare that all information provided are accurate and that this proposal has not been submitted to any
other grant.
Tarikh: …………………….
Date
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
Tandatangan Pemohon: …………………….
Applicant’s Signature
6
E.
Komen Ketua Jabatan:
Head Department’s Comments
i. Relevance
- Have similar studies been done before? Yes/No. If Yes, where and how will this research add value?
- How will this research contribute to the schools/university/society’s aspirations?
ii. Approach
- Is this research practical and deliverable?
- Does the proposed methodology have sufficient scientific and research merit in its knowledge domain?
- Does the proposal methodology have any ethical issue. Please elaborate.
..................................................
Tandatangan Ketua Jabatan
Head Department’s Signature
...............................
Tarikh
Date
Cop Rasmi:
Official Stamp
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
7
F.
Komen Timbalan Dekan (Pengajian Siswazah & Latihan Ikhtisas):
Deputy Dean’s (Postgraduate & Professional Training) Comments
.......................................................................
Tandatangan Timbalan Dekan (Pengajian Siswazah & Latihan Ikhtisas)
Deputy Dean’s (Postgraduate & Professional Training) Signature
...............................
Tarikh
Date
Cop Rasmi:
Official Stamp
G.
Komen Dekan:
Dean’s Comments
............................................
Tandatangan Dekan
Dean’s Signature
...............................
Tarikh
Date
Cop Rasmi:
Official Stamp
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
8
CONTOH 1 (SAMPLE 1)
Flow Chart for Experimental Design
(A)
<TITLE OF THE STUDY>
5,000 Blood Donors
(HUSM & GHKB)
Routine
Screening
Anti-HCV
4,900 HCV-ve
100 HCV +ve
Random Selection
of 50 Samples
Random Selection
of 50 Samples
RT-PCR Test
For HGV-RNA
PCR-ELISA for Confirmation
Agroser Gel Electrophoresis
Statistical
(B)
<TITLE OF THE STUDY>
Haemodialysis
Subjects
Multiply Transf.
Subjects
Intravenous
Drug Users
Chronic & Acute
Viral Hepatitis
n=20
n=30
n=40
n=10
100 Serum
Samples
ELISA
HGV-RNA
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
9
CONTOH 2 (SAMPLE 2)
(C)
<TITLE OF THE STUDY>
This is a cross-sectional study in which a total of 360 household where selected from mukims in Pasir Puteh
and Tanah Merah by multistage random sampling. 45 samples will be collected from each type of water
supply system (gravity feed, overhead tank, direct connector and others). The household will be interview by
the researcher and research assistant/health inspector/public health assistant regarding the water quality and
water samples will be taken 2 times from each house.
KELANTAN
Multistage
6 DISTRICT (with all 4 types of water supplies available)
Random sampling
Pasir Puteh
Tanah Merah
Mukims
GFS
n=45
OHT
n=45
DC
n=45
Mukims
OTHER
n=45
GFS
n=45
OHT
n=45
DC
n=45
OTHER
n=45
This water samples will be taken to KMAM (Drinking Water Quality Control) unit laboratory in District Health
Office for analysis of physical, chemical and microbiological contamination.
The results will be compared with the standard value of drinking water from Ministry of Health to get the
percentage of contamination violation
Data entry, analysis, and interpretation by using the EPI INFO 6.04 and SPSS Software (version 9.0)
Report and paper preparation for presentation
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
10
CONTOH 3 (SAMPLE 3)
Gantt Chart of Research Activities: <Title of The Study>
PROJECT ACTIVITIES
Research Activities
2009
S
O
N
2010
D
J
F
M
A
M
J
J
2011
A
S
O
N
D
J
F
M
A
M
Patient / Subjects
Recruitment
Data Collection
Data Analysis /
Interpretation
Presentation &
Submission of Reports
Report Writing
Project Completed
Submission of
Research Papers
Milestone of Research Activities:
1.
2.
3.
4.
5.
End of March 2010 : Completion of Phase 1 Data Collection
Sept. 2010 : Completion of Phase 2 Data Collection
End of Sept. 2010 : Data Analysis
April 2011 : Preparation of Research Presentation
Oct. 2011 : Report submission
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
11
J
J
2012
A
S
O
N
D
J
F
M
A
M
J
LAMPIRAN A (ATTACHMENT A)
LIST FIELD OF RESEARCH (FOR)
Category
F1100000
Medical and Health Sciences
F1100100
Immunology
F1100101
F1100102
F1100103
F1100104
F1100105
F1100107
F1100108
F1100199
Allergy
Cellular immunology
Humeral immunology
Immunochemistry
Immunogenetics
Transplantation immunology
Tumor immunology
Other immunology
F1100200
Medical biochemistry and clinical chemistry
F1100201
Carbohydrates
F1100204
Lipids
F1100205
Nucleic acids
Peptides
F1100206
Proteins
F1100299
Other medical biochemistry and clinical chemistry
F1100300
Medical microbiology
F1100301
Bacteriology
F1100302
Mycology
F1100303
Parasitology
F1100304
Virology
F1100399
Other medical microbiology
F1100400
Pharmacology
F1100401
F1100402
F1100405
F1100407
F1100499
Clinical pharmacology
Medical pharmacology
Pharmaceutical field
Pharmaceutical research
Pharmaceutical technology
Pharmacy
Radiopharmacology
Radiotoxicology
Therapeutics
Traditional medicine and natural product
Other pharmacology
Physiology
F1100501
F1100502
F1100503
F1100504
F1100506
F1100507
F1100599
Cell physiology
Comparative physiology
Exercise/physical fitness
Human biophysics
Stress physiology
Systems physiology
Other physiology
Neurosciences
F1100601
F1100602
F1100603
F1100604
F1100605
F1100606
F1100607
F1100608
F1100599
Autonomic nervous system
Cell receptors
Cellular nervous system
Central nervous system
Mechanism of tissue damage
Molecular characterization
Peripheral nervous system
Sensory systems
Other neurosciences
F1100404
F1100500
F1100600
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
12
F1100700
Clinical sciences
F1100701
Allergies
F1100702
Anesthesia
Arthritis
F1100703
Carcinogenesis
F1100704
Cardiology
Child health
Dentistry
F1100706
Dermatology
F1100708
Endocrinology
Fetal development
Fetal medicine
F1100710
Gastroenterology
F1100711
Geriatrics
F1100712
Gynecology
Hearing therapy
F1100713
Hematology
F1100714
Infectious/communicable diseases
F1100715
Intensive care
F1100716
Medical genetics
F1100717
Neonatology
F1100718
Nephrology
F1100719
Neurology
F1100720
Neuromuscular diseases
F1100721
Nuclear medicine
F1100722
Obstetrics
F1100723
Occupational therapy
F1100724
Oncology
F1100725
Ophthalmology
Optometry
Oral surgery
Organ imaging
F1100726
Orthopedics
F1100727
Otolaryngology
F1100729
Pathology
F1100728
Paediatrics
Pharmaceuticals
Pharmacy
F1100730
Physical therapy
F1100731
Psychiatry
Psychology
F1100732
Radiology
F1100733
Radiotherapy
F1100734
Rehabilitation
F1100735
Reproduction
F1100736
Respiratory diseases
F1100737
Rheumatology
Speech therapy
F1100738
Surgery
Therapy
F1100740
Urology
F1100741
Venereology
F1100799
Other clinical sciences
F1100800
Public health, environmental & occupational health & safety research
F1100801
Air quality
F1100802
Drinking water quality
F1100803
Environmental protection & health impact
F1100804
Epidemiology
Food quality
F1100805
Health & safety (occupational)
F1100806
Health information systems
Infant Immunisation
F1100807
Injuries
F1100808
Mental health
F1100810
Preventive medicine
F1100811
Primary health care
F1100812
Radiation health & safety
Solid waste management
F1100813
Urban health
F1100815
Vector borne diseases
F1100816
Waste water collection & treatment
F1100899
Other public health, etc
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
13
F1100900
Nutrition (public health research)
F1100901
Clinical epidemiological
Laboratory
Toxicology
F1100999
Other nutrition (public health research)
F1101000
Health services research (including bioethics)
F1101001
Bioethics (human)
Education (health)
Health & community services
F1101002
Health care administration
F1101004
Health education & promotion
F1101005
Health systems management
Human bioethics
Mortality and morbidity studies
Nursing
F1101099
Other health services
F1101100
Health cares systems, industries and technologies
F1101101
Biomechanics
F1101104
Delivery systems
Emergency medicine
F1101108
Health legislation
F1101111
Health rehabilitation service
F1101114
Human resource development
F1101115
Innovative technology
F1101116
Medical biotechnology
Medical technology
Quality control of medical diagnostic instruments
Quality of life
F1101119
Other health care system, industries and technologies
F1101199
F1101200
Pharmaceutical industry
F1101201
Botanical pesticides
F1101205
Photochemical
F1101207
Purification technology
F1101208
Screening technology
F1101209
Synthesis technology
F1101299
Other pharmaceutical industry
F1109900
Other medical and health services not elsewhere classified
JEPeM/EthicalForm01/Ver.3 - 2010
Updated: 15/12/2010
14
SOCIO-ECONOMIC OBJECTIVE (SEO)
Category
S30100
Health
S3010100
Clinical (organs, diseases and conditions)
S3010101
Blood disorders
S3010102
Bone & Joint disorders
S3010103
Cancer
S3010104
Cardiovascular diseases
Chronic hepatitis
Digestive system
S3010107
Endocrine diseases
S3010109
Hearing, vision & speech
S3010111
Immune system & allergy
S3010112
Infectious diseases
S3010113
Inherited diseases
S3010114
Kidney diseases
S3010116
Neurological disorders
Orthodontics conditions
Reproductive medicine
S3010122
Respiratory diseases
S3010123
Sexuality transmitted disease and HIV infection
Skin & related conditions
S3010124
Surgical methods
Vaccines
Vector-borne diseases
S3010125
Other clinical health
S3010199
S3010200
Public health
S3010203
S3010206
S3010211
S3010212
S3010213
S3010214
S3010215
S3010216
S3010217
S3010218
S3010220
S3010221
S3010222
S3010224
S3010226
S3010227
S3010299
S3010300
S30199
JEPeM/EthicalForm01/Ver.3 - 2010
Dental health
Disease distribution & transmission
Environmental health
Food safety (public health)
Health & women
Health & behavior
Health & children
Health & indigenous people
Health & social structure
Health & the ageing
Health (public) indicators
Malignancies
Maternal & child health
Mental health
Occupational health
Preventive medicine
Substance abuse (health)
Urban health
Other public health
Health and support services
S3010304
Diagnostic methods/kids
S3010311
Health education & promotion
S3010312
Health policy economic outcomes
S3010313
Health policy evaluation
S3010316
Nursing care
S3010318
Occupation therapy
S3010320
Palliative care
S3010322
Physiotherapy
Speech therapy
S3010399
Other health and support services
Other health not elsewhere classified
Updated: 15/12/2010
15