Skip navigation

After receiving the committee’s decision

(Click on each tab for further elaboration)

If your study is rejected

  • You may make a new ethics application if you still want to carry out your research. However, you should carefully consider why the ethics committee has rejected your application in the first place.
  • If you are unhappy with how the ethics committee has processed your application, you should check with the ethics committee or your institution about any appeal or grievance procedures.

If your approval is pending further modifications

  • You should make any revisions and submit any extra documents that are requested by the ethics committee promptly.
  • Correct revisions can usually be approved through expedited review.

If your study is approved

  • You may still need to receive approval from other agencies before you can carry out your research. For example:

    • All studies should receive permission from the local study site in which they will be carried out (e.g. approval from hospital Director or Head of Department).
    • Research using existing data or stored biological samples should receive approval from the database or biobank custodian.
    • Clinical drug trials should have approval from the National Pharmaceutical Regulatory Agency (NPRA). (11)
    • Clinical research utilising unregistered medical devices should have approval from the Medical Device Authority (MDA). (12,13)

  • You should make sure that everyone in your research team is well-trained to follow the research protocol and any SOPs that are in place.
  • You may begin your study.

National Pharmaceutical Regulatory Agency. Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption Edition 6.4 [Internet]. Ministry of Health Malaysia; 2017. Available from: http://www.npra.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/CTILCTXGuidelineEdn64updated07082017cleanTSC.pdf

Medical Device Authority (MDA). MDA/GD/0006 Definition of medical device (First edition) [Internet]. Ministry of Health Malaysia; 2014. Available from: https://portal.mda.gov.my/documents/guidance-documents/803-6-def-of-md/file.html

Medical Device Authority (MDA). MDA/GD/0016 Notification of exemption from registration of medical devices for the purpose of clinical research or performance evaluation (First edition) [Internet]. Ministry of Health Malaysia; 2017. Available from: https://portal.mda.gov.my/documents/guidance-documents/807-16-notification-for-clinical-research-or-performance-evaluation/file.html










2. Protocol amendments