SJGH Ethical Review Committee

Introduction

This is an institutional body comprising of Medical and Non Medical individuals, responsible for ensuring that the medical experimentation and human participant research are carried out in an ethical manner, in accordance with Institutional, National and International law. ERC/ SJGH is recognized by the Ministry of Health Sri Lanka as a standard Ethics Review Committee, with twelve affiliated and non affiliated members appointed as per Ministry guidelines.

Information for Researchers Seeking Approval from ERC/SJGH

• ERC/SJGH will accept ethics review applications on research proposals, to be conducted in Sri Jayewardenepura General Hospital, for the purpose of determining whether the proposed study is designed in accordance with country and international rules, regulations and research ethics, respecting the rights of research participants, regardless of them being patients or staff members of the hospital.
• ERC/ SJGH does not accept research proposals concerning animals.
• ERC/ SJGH will have concerns on rejecting poorly designed research proposals which may cause risks, hazards, inconvenience and discomfort to the research participants mentally, physically, socially or financially, breaching research ethics. It will consider the risks and potential benefits of the proposed research in granting approval.
• ERC/SJGH may evaluate the study design to ensure the proposed study to be of good scientific quality with a satisfactory research methodology.
• ERC/SJGH will have further concerns on source of funding for the research, incentives provided for the researchers and participants, if any and the conflict of interest of the researchers in granting approval.

How to Apply for Ethical Approval from ERC/SJGH

• ERC/ SJGH will accept applications for ethics review, only if the principal investigator of the proposed study is included in one of the following categories
  • A member of permanent Medical/ Nursing/ Allied Health or Other Staff category in Sri Jayewardenepura General Hospital or any other government hospital in Sri Lanka.
  • A member of permanent academic staff in a recognized University in Sri Lanka
  • Undergraduate student of Faculty of Medicine, Dentistry, Allied Health or Nursing in a recognized University in Sri Lanka
  • Trainers and Trainees in Post Graduate Institute of Medicine, Sri Lanka
  • A researcher who is conducting research projects on behalf of the Ministry of Health.
• Application procedure is clearly mentioned in ERC/SJGH website sjgh.health.gov.lk
• All research proposals for ethical approval must be submitted along with the duly filled application forms which are available in our website.
• Downloaded application forms have to be filled completely without leaving any blank spaces (please mention “not applicable” if the question is not relevant) and should be submitted with two copies
• All hard copies of the study proposal have to be single spaced and double sided
• Study proposal along with the documents mentioned in the following checklist have to be submitted to ERC office at second floor, Cardiac Building, Sri Jayewardenepura General Hospital, in person after the endorsement of the Director/SJGH, on the covering letter signed by the applicant.
  Document check list :
  • Covering Letter requesting permission to conduct the study in Sri Jayewardenepura General Hospital, from Director/SJGH signed by the applicant (Should be endorsed by the Director/SJGH prior to submission)
  • Three copies of duly filled application
  • Three copies of complete study proposal
  • Three copies of consent forms/study instruments in English, Sinhala and Tamil versions
  • Three copies of participant information sheet in all three languages where relevant (participant information sheet must carry the statement "this study has been granted ethical approval by Ethics Review Committee of Sri Jayewardenepura General Hospital. If you have any related queries or complaints against the conduct of the study, feel free to contact ERC Coordinator/SJGH on 0112778610 (Ext: 3502)"
  • Three copies of proof for funding source (if applicable)
  • A copy of ERC approval letter if ethical approval is already granted for the study from another institute in multicentre studies
  • Short Curriculum Vitae of all investigators
  • Letter from supervisor (if applicable)
• Opening hours for submission: Monday to Friday 9.00 a.m to 3.00 p.m. Contact person: Ms.Hemali Wickramarachchi, Transplant & ERC Coordinator (+94112778610 Ext: 3502)
• The proposed study would be duly registered and a reference number would be issued to the applicant following registration
• The soft copy of the full document in PDF form has to be emailed to ercsjgh@gmail.com within two days following the submission and registration.
• Every research applicant should get ethics approval from ERC/SJGH prior to the initiation of the study at Sri Jayewardenepura General Hospital and the date of the initiation of the study has to be clearly mentioned in the application.
• Applications for ERC approval for the studies that are already initiated or concluded at Sri Jayewardenepura General Hospital will not be accepted under any circumstance unless previously approved by an ethics committee of another recognized institute.
• The monthly review meeting of ERC/SJGH is held on every last Tuesday of the Month. Study proposals to be considered in each month have to be submitted on the last working date of the previous month.
• Applicant should credit a processing fee to the hospital to cover the expenses incurred by the hospital for ethics review process and the resources used in conducting the research studies in the hospital.
  The processing fees are as follows;
  • Self Funded Researches LKR 3,000/=
  • For Local Researches Funded by Funding Agencies LKR 5,000/=
  • For Local Clinical Trials LKR 25,000/=
  • For International Researches/ Clinical Trials USD 1,000/=
• The processing fee needs to be paid to the cashier counter at the general office of the hospital and the payment slip needs to be provided with the other documents at registration process of the study.