Proposal Sample with Gantt Chart by pyd30058

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									                                       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.           PI or Co-researchers has to defend their research proposal.
            2.           Student dissertation is required in the research proposal.
            3.           Supervisor or Co-supervisor must be present during student’s presentation of research proposal.



 No.     Project Title



 1.      Name of Postgraduate Student
                                                                                     M.Med Dissertation / M.Sc / Ph.D

 2.      Specialty / Area

 3.      Name of Main Supervisor
                                                                                     i)
 4.      Name of Co-supervisors / Co-researchers                                     ii)
                                                                                     iii)
 5.      Location of Research

 6.      Duration of this research

                    Please Answer the Following Questions                                                 Yes / No / Not Applicable

 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
         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)
         Discussion at Department:
 23.
         (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                                   Tandatangan
       No.
                                                          Name                                     Signature


        1.       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



             Nama:                                                                          No. Kad Pengenalan:
             Name                                                                           Identity Card No.

             Pusat Tanggungjawab [PTJ]:                                                     No. Matrik:
             School / Department / Unit                                                     Matric Number

    A.
             No. Telefon Pejabat:                                                           Alamat E-mel:
             Office Telephone No.                                                           E-mail Address

                                                                                            Tahun
             Jawatan:
                                                                                            Pengajian:
             Position
                                                                                            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)                      Kumpulan SEO (Socio-Economic Objective Group)
             *(Sila rujuk Panduan / Please refer to                      *(Sila rujuk Panduan / Please refer to
             " Malaysian (R&D) Classification System”)                    "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
               Ringkasan Penyelidikan
   B (ii).
               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


                Kepentingan dan faedah Penyelidikan
    B (iii).
                The importance and the benefits of the research




                Alat - alat dan bahan yang terdapat di Universiti untuk kegunaan penyelidikan ini.
  B (iv).
                Equipment and materials available in the University to be used for this research.




JEPeM/EthicalForm01/Ver.3 - 2010   Updated: 15/12/2010                                                                  5
               Jika penyelidikan ini dijalankan bersama dengan penyelidik lain, nyatakan peranan mereka:
    C (i).
               If this research is conducted together with other researchers, please state their role:

                                                                                                      Sumbangan/ Peranan
       Nama dan No. Kad Pengenalan                       Pusat Pengajian/Jabatan/Unit   Tandatangan
                                                                                                          dalam kajian
         Name and Identity Card No.                         School/Department/Unit        Signature
                                                                                                       Role in this research




     D.      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: …………………….                                                    Tandatangan Pemohon: …………………….
             Date                                                                 Applicant’s Signature




JEPeM/EthicalForm01/Ver.3 - 2010   Updated: 15/12/2010                                                                         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                                               Tarikh
                                     Head Department’s Signature                                              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)                      Tarikh
             Deputy Dean’s (Postgraduate & Professional Training) Signature                          Date


             Cop Rasmi:
             Official Stamp



     G.      Komen Dekan:
             Dean’s Comments




                                    ............................................       ...............................
                                        Tandatangan Dekan                                          Tarikh
                                           Dean’s Signature                                         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                                                          Random Selection
                    of 50 Samples                                                             of 50 Samples



                                                                RT-PCR Test
                                                                For HGV-RNA




           Agroser Gel Electrophoresis                                                   PCR-ELISA for Confirmation

                                                                 Statistical




(B)         <TITLE OF THE STUDY>

              Haemodialysis                        Multiply Transf.            Intravenous          Chronic & Acute
                Subjects                              Subjects                 Drug Users            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                                                                Mukims



       GFS          OHT             DC           OTHER                            GFS         OHT    DC     OTHER
       n=45         n=45           n=45          n=45                             n=45        n=45   n=45    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                          2009                               2010                                             2011                                2012



 Research Activities                  S      O     N     D   J   F   M   A   M   J   J   A   S   O   N   D   J   F   M   A   M    J   J   A   S   O   N   D   J   F   M   A   M   J


 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.    End of March 2010 : Completion of Phase 1 Data Collection
      2.    Sept. 2010 : Completion of Phase 2 Data Collection
      3.    End of Sept. 2010 : Data Analysis
      4.    April 2011 : Preparation of Research Presentation
      5.    Oct. 2011 : Report submission




JEPeM/EthicalForm01/Ver.3 - 2010   Updated: 15/12/2010                                                                       11
                                                                                              LAMPIRAN A (ATTACHMENT A)
                                                         LIST FIELD OF RESEARCH (FOR)


Category           F1100000                    Medical and Health Sciences

                    F1100100                   Immunology
                                               F1100101           Allergy
                                               F1100102           Cellular immunology
                                               F1100103           Humeral immunology
                                               F1100104           Immunochemistry
                                               F1100105           Immunogenetics
                                               F1100107           Transplantation immunology
                                               F1100108           Tumor immunology
                                               F1100199           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           Clinical pharmacology
                                               F1100402           Medical pharmacology
                                                                  Pharmaceutical field
                                                                  Pharmaceutical research
                                                                  Pharmaceutical technology
                                                                  Pharmacy
                                               F1100404           Radiopharmacology
                                                                  Radiotoxicology
                                               F1100405           Therapeutics
                                               F1100407           Traditional medicine and natural product
                                               F1100499           Other pharmacology

                    F1100500                   Physiology
                                               F1100501           Cell physiology
                                               F1100502           Comparative physiology
                                               F1100503           Exercise/physical fitness
                                               F1100504           Human biophysics
                                               F1100506           Stress physiology
                                               F1100507           Systems physiology
                                               F1100599           Other physiology

                    F1100600                   Neurosciences
                                               F1100601           Autonomic nervous system
                                               F1100602           Cell receptors
                                               F1100603           Cellular nervous system
                                               F1100604           Central nervous system
                                               F1100605           Mechanism of tissue damage
                                               F1100606           Molecular characterization
                                               F1100607           Peripheral nervous system
                                               F1100608           Sensory systems
                                               F1100599           Other neurosciences




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
                                                                  Dental health
                                               S3010203           Disease distribution & transmission
                                               S3010206           Environmental health
                                               S3010211           Food safety (public health)
                                               S3010212           Health & women
                                               S3010213           Health & behavior
                                               S3010214           Health & children
                                               S3010215           Health & indigenous people
                                               S3010216           Health & social structure
                                               S3010217           Health & the ageing
                                               S3010218           Health (public) indicators
                                               S3010220           Malignancies
                                                                  Maternal & child health
                                               S3010221           Mental health
                                               S3010222           Occupational health
                                               S3010224           Preventive medicine
                                               S3010226           Substance abuse (health)
                                               S3010227           Urban health
                                               S3010299           Other public health


                    S3010300                   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


                    S30199                         Other health not elsewhere classified




JEPeM/EthicalForm01/Ver.3 - 2010   Updated: 15/12/2010                                                               15

								
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