1. Initial ethics application

Documentary requirements

The ethics committee needs to know how you will conduct your study from start to finish. They also need to be able to picture how research subjects will be treated throughout the process. Essentially:

‘If a participant will read / hear / view it, 

the ethics committee needs to read / hear / view it.’

(Adapted from: TCPS2: CORE, Module 8: REB review) ⁽¹⁾

For this purpose, you should submit, where applicable:^a

Full research protocol Written participant information sheet and consent form Subject recruitment advertisements Data collection tools (e.g. questionnaires, interview guide, etc.) Available safety information for research interventions (e.g. Investigator’s Brochure) Information about payment and compensation to subjects Curriculum vitae for all researchers Good Clinical Practice (GCP) certificates for all researchersb Exemption letters from regulatory authorities (e.g. NPRAc and MDAd) allowing the use of unregistered products for clinical research purposes All additional documents in the checklist for research on stem cells and cell-based therapiese Any other plans / SOPs / materials that will help the ethics committee understand more about your study

Note: 
a. Any documents that you submit should bear a version number and date. This is to avoid confusion if future changes are made to these documents. 

b. GCP certificate is required for clinical trials only.

c. Letter from the National Pharmaceutical Regulatory Agency (NPRA) is required for clinical trials testing unregistered drugs or testing registered drugs for off-label indications or methods of administration. For more guidance, refer to the Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption (Edition 6.4) (NPRA, 2017), visit the NPRA website or contact the Centre of Investigational New Product.

d. Letter from the Medical Device Authority (MDA) is required for clinical trials testing unregistered medical devices. For more guidance, refer to the guideline on Notification of exemption from registration of medical devices for the purpose of clinical research or performance evaluation (Edition 1) (MDA, 2017), visit the MDA website or contact ci@mda.gov.my.

e. This applies to all research involving the use of stem cells or cell-based therapies (including all types of stem cells, biologics, cell-based immunotherapy and gene products). The ethics committee will forward all documents in this checklist to the National Cells Research and Therapy Ethics Subcommittee (NCERT) for its recommendation prior to issuing an approval. 

For further information, refer to Module 2: Research protocol and protocol-related documents.

Evaluation criteria of the ethics committee →