Submission Guidelines

Submitting an Application


The Provincial Department of Health Services, Central Province, now offers an online system for obtaining administrative permission to conduct Health & Health-related Research in Healthcare Institutions, other Institutions, and Community Settings within the province. This process follows the guidelines issued by the Ministry of Health under Health Ministry General Circular No. 01-30/2020. (Download Circular: Sinhala / English. )

Please follow the steps below to submit your application.



Documents to Submit


The following documents are required to complete the application.
(* - Mandatory, # - Applicable only in specific cases) - click to expand each document.

1. Request Letter *

Addressed to the Provincial Director of Health Services, Central Province.

2. Ethics Review Committee Certificate *

As per the Health Ministry General Circular No. 01-30/2020, all health and health-related research must have ethical clearance.

For clinical trials or interventional studies, including field trials involving medicines that require National Medicines Regulatory Authority (NMRA) approval, ethics clearance must be obtained from an ERC recognized by NMRA.

The recognized ERCs are:

  • Ethics Review Committee, Sri Lanka Medical Association
  • Ethics Review Committee, Faculty of Medicine, University of Colombo
  • Ethics Review Committee, Faculty of Medicine, University of Peradeniya
  • Ethics Review Committee, Faculty of Medicine, University of Ruhuna
  • Ethics Review Committee, Faculty of Medicine, University of Kelaniya
  • Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura
  • Ethics Review Committee, Faculty of Medicine, University of Jaffna
  • Ethics Review Committee, Medical Research Institute, Ministry of Health
  • Ethics Review Committee, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka

If the research involves foreign collaborations or is conducted under a foreign university, ethical approval must also be obtained from a recognized local Ethics Review Committee.

3. Research Proposal *

A summary of the research protocol, including data collection instruments.

4. Research Proposal Approval Letter #

Issued by the relevant university/institution (Applicable only if required by the relevant institution).

5. Ministry of Health Approval Letter #

Approval from the Education & Training Unit, Ministry of Health is required for:

  • Research involving foreign collaborations, transfer of biospecimens or protected health information, or funding from an international body.
  • Cohort studies or patient registries.
  • Island-wide studies or those involving multiple provinces.
6. Approval Certificate of the NMRA #

For clinical trials involving unregistered medicines and registered medicines where the proposed clinical trial is outside the conditions of such registration. These may include changes to:

  • Indications and clinical use.
  • Target patient population.
  • Routes of administration and dosage regimens.


Review Process & Decisions




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