FLOW CHART OF APPLICATION FOR RESEARCH AND RESEARCH ETHICS by olliegoblue23

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									                         FLOW CHART OF APPLICATION FOR RESEARCH AND RESEARCH ETHICS APPROVAL
                                            UNIVERSITI KEBANGSAAN MALAYSIA

                                                                 Start



                                UKM Researcher                                                     Other than UKM Researcher
                                                                                                   Obtain Co-Researcher from UKM
                                                                                                   - Obtain Research & Ethics
                                                                                                     approval letter from researcher
          PPUKM                                              Other Faculty/Institute/Centre          own institution OR from MOH (if
                                                             - Undergo screening by                  MOH Hospital involved)
                                                               Faculty/Institute/Centre
                                                               Research Committee and
Special Study Module                      PPUKM                obtain a formal letter from
(SSM)/ Undergraduate,                  Lecturer/Staff          the committee
Masters, PhD
- Undergo presentation
  in the department
  level




              Clinical Trial          Animal                                             Other than Clinical Trial
                                      - Obtain approval from UKM committee of            - At least one of the researchers have
                                        Ethics in the Use of Animal in Research            “Good Clinical Practice” certificate


    Without                   With sponsorship from
sponsorship from       Pharmaceutical Company MUST pay
Pharmaceutical          RM1, 000.00 for administration fee
   Company


Principal Investigator MUST have “Good
      Clinical Practice” certificate



           Multicentre trial                                                     Not multicentre trial
           - Attach Research Agreement


1. Applicant completes:
    Research Application Form (fill up by Principal Investigator)
    Research Screening Form (fill up by Principal Investigator)
    Agreement Form Co-Researcher/Co-Supervisor (fill up by Co-Researcher)
2. Form must be endorsed by Head of Department after presentation in the department level. In case of the Head of
   Department is an applicant, endorsement must be made by Deputy Dean or Dean & Director of PPUKM.
3. Completed form, research proposal, related attachments; all 3 sets (1 original and 2 photocopies) must be sent to
   Medical Research & Industry Secretariat (MRIS)
4. PPUKM Medical Research Committee and UKM Research Ethics Committee will review applicant’s research proposal
5. Applicant will amend the research proposal based on the Committee recommendations (if required)
6. Amended proposal must be sent back to MRIS with amendments listed in a cover letter to the Committee Chairman
7. Approval letter will be issued by MRIS once approval by the Committee Chairman is obtained
8. Researcher can start the research




Clinical Trial                                                                Other than Clinical Trial
SAE/SUSAR report must be sent to UKM Research Ethics                          Progress Report every 6 months must be sent to
Committee and Research Secretariat in the respective faculty                  Research Secretariat in the respective faculty


                               Final Report must be sent to Research Secretariat in the respective faculty


                                                               END
                           CARTA ALIR PERMOHONAN KELULUSAN PENYELIDIKAN DAN ETIKA PENYELIDIKAN
                                            UNIVERSITI KEBANGSAAN MALAYSIA

                                                                 Mula



                                Penyelidik UKM                                                    Penyelidik luar UKM
                                                                                                  - Dapatkan Penyelidik Bersama
                                                                                                    daripada UKM
                                                                                                  - Dapatkan Kelulusan
             PPUKM                                             Fakulti/Institut/Pusat lain          Penyelidikan & Etika daripada
                                                               - Melalui saringan                   Institusi masing-masing ATAU
                                                                 Jawatankuasa Penyelidikan          daripada KKM (jika
                                                                 peringkat Fakulti/Institut/
   Pra-siswazah (Special           Pensyarah/Kakitan             Pusat dan dapatkan surat
   Study Module (SSM)/                gan PPUKM                  Jawatankuasa tersebut
   Sarjana Muda), Sarjana,
   PhD
   - Bentang di Jabatan
     masing-masing




                 Percubaan           Haiwan                                           Selain Percubaan Klinikal
                                     - Dapatkan kelulusan Jawatankuasa                - Sekurang-kurangnya seorang penyelidik
                                       Etika Penggunaan Haiwan Dalam                    mempunyai sijil “Good Clinical Practice”
                                       Penyelidikan UKM

    Tanpa tajaan                Ditaja oleh syarikat
       syarikat           farmaseutikal MESTI membayar
    farmaseutikal         yuran pentadbiran RM1, 000.00



    Penyelidik Utama MESTI mempunyai sijil
           “Good Clinical Practice”



              Percubaan pelbagai pusat “Multicentre trial”                    Bukan “Multicentre trial”
              - Lampirkan Perjanjian Penyelidikan


1. Pemohon melengkapkan:
    Borang Permohonan Penyelidikan (Diisi oleh Penyelia Utama)
    Borang Saringan (Diisi oleh Penyelia Utama)
    Borang Persetujuan Penyelidik Bersama / Penyelia Bersama (Diisi oleh Penyelia Bersama)
2. Borang mesti diperakukan oleh Ketua Jabatan masing-masing selepas pembentangan di jabatan masing-masing. Sekiranya
   pemohon adalah Ketua Jabatan, perakuan perlu dilakukan oleh Timbalan Dekan ataupun Dekan & Pengarah PPUKM
3. Borang yang telah lengkap diisi, proposal penyelidikan, lampiran berkaitan; kesemuanya 3 set (1 asal dan 2 salinan), dihantar ke
   Sekretariat Penyelidikan Perubatan & Industri (SPPI)
4. Jawatankuasa Penyelidikan Perubatan PPUKM dan Jawatankuasa Etika Penyelidikan UKM akan meneliti proposal penyelidikan
    pemohon
5. Pemohon membuat pembetulan (sekiranya ada) terhadap proposal penyelidikan berdasarkan cadangan Jawatankuasa
6. Proposal yang telah siap dibuat pembetulan dihantar ke SPPI semula dengan menyatakan senarai pembetulan dan muka surat
   dalam “cover letter” kepada Pengerusi Jawatankuasa
7. Surat kelulusan akan dikeluarkan oleh SPPI sekiranya mendapat kelulusan Pengerusi Jawatankuasa
8. Penyelidik mula menjalankan penyelidikan


    Percubaan Klinikal                                                       Selain Percubaan Klinikal
    Laporan SAE/SUSAR dihantar ke Jawatankuasa Etika                         Laporan Kemajuan setiap 6 bulan dihantar ke
    Penyelidikan UKM dan Sekretariat Penyelidikan di Fakulti                 Sekretariat Penyelidikan di Fakulti masing-masing


                             Laporan Akhir dihantar ke Sekretariat Penyelidikan di Fakulti masing-masing


                                                               TAMAT

								
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