purpose

The Ethics Review Committee (ERC), General (Teaching) Hospital-Peradeniya is established in order to provide independent advice and monitoring on health research and other specific research protocols involving human participants.

The main purpose of the ERC is to safeguard the dignity, rights, safety and wellbeing of all research participants to encourage and support researchers. The ERC should ensure the full review and evaluation of all ethical aspects of the research proposals it receives before they are carried out within a reasonable time period to make sure they follow ethical principles as stated in the Declaration of Helsinki (Annexure1).

composition of the ERC

  1. Should have a minimum of 8 members (8-10 members) including the chairperson and the secretary. The suggested composition with minimum requirements will be as follows: (the first two members of this composition list are relevant only for ERCs’ of provincial level health care institutions)
  2. The chairperson should be a qualified medical administrator. (a Person with a M.D. qualification in Medical Administration should be appointed.)
  3. Four Specialist Medical Officers: This is the minimum requirement and depending on the availability of medical specialists, the head of institution can appoint any even number of members. These persons will give guidance to the scientific, technical and methodological validity of the submitted research.
  4. An independent member who has expertise in legal matters and/ or ethics (Attorney at Law); and
  5. An independent member representing the community from the catchment area whose primary role is to share their insights about the communities from which the participants are likely to be drawn. This person should preferably be a scientific expert who has an expertise in behavioral or social sciences.
  6. The majority of the members should be doctors of TH-Peradeniya employed by the Ministry of Health.
  7. A development officer/health management assistant shall be designated to accept protocols and to convey decisions to applicants and to perform other secretarial work.

independent external reviewers

Whenever required, the ERC may obtain the services of appropriate experts approved by the ERC committee to assist with the review of a proposal as an external reviewer. The ERC must be satisfied that such experts have no conflicts of interest in relation to the project under consideration arising from any personal or immediate family involvement or participation in the project, or any financial interest in the outcome or any involvement in competing research. Such person(s) shall be required to provide an undertaking of confidentiality and shall not be entitled to vote on any matter.

exemption from review

Ethics review is not required for studies that amount to quality control, method validation, or medical audit provided that the results are not made available in a form that identifies the participants from whom the information was obtained.

Use of personal medical records without approaching or involving the patients concerned is, in principle, ethically acceptable provided confidentiality and anonymity are preserved. Such studies are entitled for waiver of the requirement for obtaining informed consent, but ethics review is essential.

Submission Flow Chart

step 1
step 1

Ethical clearance application, research protocol (proposal & related documents) received by the Development Officer (DO)/Health Management Assistant (HMA) of the ERC as electronic and paper copies.
step 2
step 2

Verification done as per document checklist by the DO/HMA and if incomplete return to principal investigator
step 2
step 2

Verification done as per document checklist by the DO/HMA and if incomplete return to principal investigator
step 3
step 3

Date stamp all documents in the protocol
step 4
step 4

Issue Document Receipt Form and register in the ERC with a registration number. Inform Secretary ERC or designated member
step 5
step 5

Secretary ERC or designated member checks for completeness; and if incomplete, inform principal investigator (PI) to complete documentation. Complete applications are to be handed over to the chairperson.
step 6
step 6

For review the chairperson ERC appoints a primary reviewer and reviewer/s
step 7
step 7

Applications not requiring ERC review will be issued an exemption letter signed by the Chairperson and Secretary of the ERC.
step 8
step 8

All complete applications with relevant documents, and all correspondence received by the Secretary ERC will be included on the agenda for ERC consideration at its next meeting.
step 9
step 9

All proposals shall be circulated to all members of the ERC for review prior to the meeting.
  • Submission shall be a Microsoft Word compatible soft copy and a hard copy. No handwritten applications are accepted.
  • A short resume (CV) of the principal investigator and the supervisor also should be included in the application.
  • Where research involves the recruitment of persons unfamiliar with the English language, the ERC shall ensure that the participant information sheet and informed consent form translated into the participants’ language are accurate and consistent with the English version.