Ethics Review Committee

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The Ethics Review Committee (ERC) of the Faculty of Medicine and Allied Sciences (FMAS), Rajarata University of Sri Lanka (RUSL) was established with full documentation in 2012 (earlier it has been part of the Higher degrees committee of the FMAS). It has lay members and members from clinical staff of the Anuradhapura Teaching Hospital. It functions independently under the faculty board of the FMAS, RUSL. It considers research projects submitted for ethical approval in the prescribed application form.

The ERC committee considers ethical applications from any individual doing research on human subjects and also considers ethical review applications about animal research. We also provide clinical ethics consultation. Bad science is bad ethics and we believe ethics is a friend of research.

The ERC is a member of the Forum for Ethics Review Committees (FERCSL) and applied for registration at the Ministry of Health at the Cosmetics, Devices & Drugs Regulatory Authority. Next year (2014) we will be applying for The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) recognition.

 
How to Apply

 

INFORMATION FOR APPLICANTS WHO ARE APPLYING FOR ETHICAL CLEARENCE FOR RESEARCH PROJECTS

 

1.How to apply

1.1.Application for Ethics Review

Application for Ethics Review (latest version November 2013) can be downloaded from the application menu under ethics review committee (ERC) of the faculty web site. Samples of patient information leaflet, consent form, also can be downloaded. A separate application for ethics review is available for students’ research projects.

The applicants are advised to read the instructions on how to fill the Application for Ethics Review which is provided with the application prior to completing.

1.2.Application check list

Application must be submitted in the application form given by the ERC and should include the following documents:

 

1. Covering letter

2. A receipt obtained certifying the payment for primary review.

3. Twenty three copies of project summaries which include title, PIs name and affiliation, unstructured summary of their proposed work with the word count.

4. Three copies of application enclosing the following documents

   a. The complete research proposal

   b. Information sheets  and consent forms and other relevant documents - in English as well as in Sinhala and Tamil where appropriate

   c. Curriculum vitae of the principal investigator and the other relevant investigators

   d. Any document from prior scientific/ethical review.

 All the documents mentioned above should be included in the application. One copy of the application (labelled master copy) should contain a covering letter. Project summaries should be included in a separate file with principal investigators name and the project title on the top.

 

1.3.Handing over

Applications should be submitted to Department of Medicine, 2nd Floor, Professorial Unit, Teaching Hospital, Anuradhapura. The applicants are instructed to handover applications to Mr.Piyumal Dharmasena (Technical Officer), Mrs.Sumithra Ranatunga (Computer application assistant) or to a demonstrator assigned to the ERC. Application also can be handed over to Ms RangaEdirisinghe, department of Biochemistry, Faculty of Medicine & Allied Sciences at Saliyapura.

Submission can be done between 9 am to 4 pm from Monday to Friday except on public and mercantile holidays.

1.4. Payments

All the students from Rajarata University of Sri Lanka are not required to pay any fee for the processing of their ethical review application forms. The charges for the applicants of other categories are listed below.

Academic staff members of the Rajarata University of Sri Lanka   Rs. 1000
Clinical staff members of the Teaching Hospital Anuradhapura 
Rs. 1000
All other health professionals     
Rs. 2000
Students from other Universities Rs. 2000
Research projects supported by other organisations and industries Rs 10000

 

Research projects supported by the Pharmaceutical industries; fee will be decided on case by case basis. Please contact before applying. Payments can be done at Department of Medicine, 2nd Floor, Professorial Unit, Teaching Hospital, Anuradhapura and a receipt confirming the payment will be issued (please make sure to obtain the receipt once payments are done). Amendments of the approved research projects should be accompanied by required fees according to the section 1.4(see above)

2.Approval

2.1. Ethics Review Committee (ERC) meetings

ERC meetings are held every first Wednesday of the month, unless postponed due to some extraneous reasons. Therefore 12 ERC meetings will be held per year. The applicants must submit applications before 20th (or the next working day) of each calendar month for the application to be considered for the next month.

2.2. Time Frame for ERC approval

All duly filled applications are sent to two referees (can be external or internal) and the review reports are expected to be submitted before the next ERC meeting. ERC approval could be delayed due to incomplete applications or deferred referee reports.

2.3. Ethical approval certificate

Ethical Approval certificate can be collected within seven working days from the Department of Medicine, 2nd Floor, Professorial Unit, Teaching Hospital Anuradhapura. There will be additional letter explaining the conditions of the ERC approval and the duration, the frequency of progress report and date of submission of final report will also will be noted in that letter.

2.4. Minor corrections

If the application is approved with minor corrections the applicant may submit these corrections to the Department of Medicine, 2ndFloor, Professorial Unit, Teaching Hospital Anuradhapura and collect the certificate within seven working days after submitting the corrections.

2.5 Resubmissions

If the application is subjected to resubmission, the applicant needs to resubmit the applicationbefore 20th of each month to be considered at the next ERC meeting.

A resubmitted application is considered as a new submission and a new ERC number will be issued for it.

The resubmitted package should contain:

a. Covering letter addressing the corrections recommended by the primary reviewers

b. Completed ethical application form (in three copies)

c. Corrected version of the research proposal (in three copies)

d. Corrected version of other relevant documents such as informed consent forms, information sheet, questionnaires.

e. A copy of receipt of payment for the resubmitting document

f. 23 copies of the project summery.

 

2.6. Rejections

If the application is rejected, the applicant will be provided the reasons for rejection and could resubmit it with changes for approval again as a new submission. They need major modifications in the protocol.

 

 
Committee

 

ERC

Chair:

Prof. Sisira Siribaddana

 

Secretary:

 

Mrs E.A.R.I.E. Siriwardane

E This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

Ethical Review Committee, Department of Biochemistry, Faculty of Medicine & Allied Sciences,Rajarata University, Saliyapura,

Sri Lanka AD 50008

T +94 (0)25 2234461

 

 

Other members:

 

Ven .Chandrakeerthi Thera

Dr. N.J. Dahanayaka

Dr. F.M.M.T. Marikar

Dr. (Ms) R.M.U. Ratnayake

Dr. S.P.B. Thalgaspitiya

Dr. S.B. Agampodi

Dr. (Mrs) G.G.G.T. Amarakoon

Dr. W.A.J.C. Chandrakumara

Dr. P.H.G.J. Pushpakumara

Dr. S.D. Pilapitiya

Dr. N.K.A. Silva

Dr. K.G.A.D. Weerakoon

Mr. H.M. Abeykoon

Dr. R. Dissanayaka

Dr. Y.V.N.D. Sirisena

Dr. D. L. Waidyarathne

Dr (Mrs) T.C. Agampodi

Dr (Mrs)S.V. Rajasinghe

Mr MCM Zakeel

 

 
Applications

word Application for ethics review FMAS, RUSL

word Applications for ethics review student projects

word Sample consent form

word Sample participant information leaflet

word Progress report

 

 
Clinical Ethics

 

 
SOP & TOR

word Annex 1- letter of appointment

word Annex 2 -confidentiality agreement

word Annex 3-  ERC application form

wordAnnex 4 Sample participant information leaflet

word Annex 5 Sample consent form

word Annex 6 - proposal evaluation form

word Annex 7- letter for notification of ERC decision

word Annex 8 - ethical clearance certificate

word Annex 9 - ethical approval letter

word Annex 10- approval letter for amendment and extension

word Annex 11 - letter for clarification for further information

word Annex 12 - report of adverse effects

word Annex 13 - format for progress report

word SOP

word TOR

 

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