Who Can Apply?

In order to accept an application for ethics review, at least one of the investigators must belong to one of the following institutions:

1. Sabaragamuwa University of Sri Lanka (SUSL)
   • permanent academic staff (including probationary staff) 
   • Undergraduate and postgraduate students
2. Teaching Hospital Ratnapura, affiliated hospitals of the Faculty of Medicine (FoM), SUSL Office of the Medical Officer of Health, Ratnapura and Healthcare institutions under the provincial healthcare services
   • Consultants, Medical Officers and Nurses, Professionals from professions supplementary to Medicine (PSM’s) and paramedical categories
3. Faculty of Graduate Studies (FGS), SUSL or the Post Graduate Institute of Medicine ( PGIM) , University of Colombo.
   • Trainers and trainees - All Trainers and Trainees of the FGS and PGIM must obtain approval from the FGS and the respective Boards of Study ( BoS)  of the PGIM respectively , before  submitting an application.
4. Any other researcher who wishes to obtain ethical clearance from the ERC-FOM-SUSL.

Please read this carefully to ensure that your application is properly filled, the relevant documents are correctly prepared as this would minimize delays in evaluating your application.

GENERAL INSTRUCTIONS 

• All research proposals involving human subjects should conform to the principles of Good Clinical Practice: scientifically sound; able to generate credible data; conform to ethical principles. 
• Applications related to clinical trials are not accepted
• Although the CONSORT Guidelines have been formulated for reporting a clinical trial, they are very useful when writing the project proposal as well. Similarly, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies are useful when writing proposals for   Cohort/ Case-control/ Cross sectional studies and the Guidelines for Reporting Reliability and Agreement Studies (GRRAS) are useful when writing proposals measuring reliability and agreement]. Other research proposals too should conform to the accepted formats of such proposals ( eg. Exploratory/ Qualitative Studies, Registry Based Studies, Validation of a Screening/ Diagnostic Test, Translation and Validation of a Questionnaire etc)  
• Researchers are also advised to ensure that the research proposal conforms to the accepted norms of “Scientific Writing” [clarity, brevity, uniformity, simplicity and reproducibility of method], as well as the use of correct grammar, punctuation, spelling and syntax. 
• Badly planned and poorly designed research that cause inconvenience to participants with possible risks will not produce useful or valid results and is considered to be unethical. It is the responsibility of the researcher to ensure that his / her research is of good scientific quality before making an application for ethics review.
• The ERC may return the application if it is flawed in research methodology, fails to demonstrate adequate scientific rigor, or is badly written. 

1. The application form and check list can be downloaded from the website of FOM-SUSL. (https://www.sab.ac.lk/med/ethics-review-committee)
2. Applicants must prepare the information sheets and consent forms to include all relevant information. See annexure
3. Please ensure that all documents have a file name with a brief title and initials of the principle investigator and that each   document has a brief running title (without initials of the principle investigator) / version number/date and a page number in the footer/header.
4. Please note that all communications by the ERC, FOM- SUSL will be exclusively with the Principal Investigator.
5. Please allow a minimum of two months for processing.
6. The principal Investigator/applicant must email a complete set of all documents, type written on A4 size pages as (.docx) files to the Secretary ERC (erc@med.sab.ac.lk) 
7. Ethical approval will be granted only for one year and the principal investigator (PI) should submit the final report of the study before the completion of one year 
8. Ethical approval submissions from those who fails to submit a final report of a study at the end of one year will not be considered
9. If PI wishes to continue the study for another one year, he/she should submit an extension application giving reason for the extension with a progress report.
10. Any document that is not relevant to the study should be mentioned as “Not applicable (N/A)” in respective space of the check list.    
11. Filling an application form
    1. All research proposals must be submitted on the prescribed application form.
    2. The application form must be typed with word processing software such as MS Word. The cages are expandable as you type.
    3. The application form should be completely filled, giving pertinent information according to instructions given.
    4. Ensure that contact details of applicant, co-investigators and supervisors are current and accurate to avoid delays.
    5. Please do not leave any sections blank and indicate as 'not applicable' any questions that are not relevant.
    6. The relevant section/s and page numbers on the proposal must be clearly indicated in the application form as required.
    7. Applications and all other relevant documents including translations must be typed and hand-written applications/forms will not be accepted.
    8. Once filled, the applicant and all other co-investigators must place their scanned signatures in the application form.
12. Documents to be submitted as a zipped folder 
    1. Duly filled checklist and all relevant documents as mentioned below.
    2. One (1) copy of each of the following
       1. Covering letter signed by the applicant (Principal Investigator)
       2. .Letter from supervisor (if relevant)
       3. Copy of approval letter from FGS or BoS of PGIM (for postgraduate students only)
       4. Brief and relevant Curriculum Vitae of Principal Investigator (For external applicants only)
       5. The application form duly filled and signed
       6. The proposal ( Postgraduate students must submit a copy identical to that approved by the FGS or BoS of PGIM 
       7. The project summary
       8. Study instruments in English and Sinhala and Tamil translations where relevant e.g. questionnaires, focus group guides etc.
       9. Information sheets in English and Sinhala and Tamil translations where relevant
       10. Consent forms in English and Sinhala and Tamil translations where relevant
       11. Assent forms in English and Sinhala and Tamil translations where relevant
       12. Advertisements for recruitment and Sinhala and Tamil translations where relevant.
13. Submission dead line and meeting dates
    1. The ERC, FOM – SUSL meets every first Thursday of the month.
    2. Duly completed applications submitted before the next scheduled meeting will be taken up for review at the next meeting.
14. Submission process fees – A nonrefundable processing fee will be charged from each new applicant with effect from April 2022

Research Projects without external funding

1. All students & academic staff members of FoM, SUSL  - free of charge
2. All postgraduates from FGS-SUSL and PGIM Colombo - Rs 2000/=              
3. All consultants, medical officers and nurses, professionals of professions supplementary to medicine (PSM’s) and paramedical categories in Teaching Hospital Ratnapura, affiliated hospitals of the FoM, office of the medical officer of health, Ratnapura and healthcare institutions under the provincial healthcare services - Rs  2500/=
4. A researcher who is not included in the above  categories - Rs 3000/=

Research Projects with external funding 

1. Grants of < Rs 100,000 same as in a) to d) above( i.e no additional fee although funded)
2. For researchers belonging to categories b) to d), where the  research is funded by funding agencies such as National Science Foundation, University Grants Commission and  Sabaragamuwa University of Sri Lanka      - Rs 5000/-
3. For researchers belonging to categories b) to d), where the  research is funded by  other funding agencies, the fees shall be as mentioned below.
4. Grants of  Rs 100,000  to Rs 500,000                                  - Rs 5000
5. Grants  of > Rs 500,000  up to  Rs 1,000,000                      - Rs 7500
6. Grants  of  > Rs 1,000,000                                                  -Rs10 000

The Principal Investigator/Applicant should make the payments in favour of ERC-FOM-SUSL to the

• A/C No: 017100126353140
• Bank Name: Pepoles Bank - Balangoda 
• Account Name: Sabaragamuwa University of Sri Lanka

The paying in slip should be attached to the application at the time of submission.

Annexure; Informed Consent forms

Instructions

Informed consent form should have two parts; Part 1: information sheet Part 11: certificate of consent

Please use the templates below to assist you in preparing the information sheet and consent form. Do not duplicate the sample information sheet. Some paragraphs may not be relevant to your study. Please select those which are applicable to your study. Use the template as a guide to prepare the Information Sheet to be used in your study, paying particular attention to the wording when the information is directed at parents and guardians of minors less than 18 years of age, who will constitute the study population. 

The Consent Form template may be used in its entirety for most studies needing consent from adults. However, in the case of proxy consent, the sentences will need to be suitably re-worded. An extra statement is needed if tissue samples are to be stored It is a good idea if provision is made for sufficiently mature children to give their assent, in addition to t e parental consent. In this case, there needs to be a separate form for the child’s assent in addition to the form for parental proxy consent with a suitable heading.

You should make the forms available in English, Sinhala and Tamil. However, you may limit to English and one of the other languages, or English alone, if you can justify the exclusion of any language/s on the basis of the language competence of the study population.

All forms – as well as all other documents submitted for review –should contain page numbers as well as the version number and  date in the page header.

Part 1: Information Sheet

Introduction

I……………. (Name of the PI) attached to…………..(state Institute) as…….. (designation) would like to invite you to take part in the….(title of the research) conducted by ……. (names of  investigator/s) at (site of study) 

1. Purpose of study; Explain the purpose of study (in simple / lay terms)
2. Type of research intervention; Explain what type of intervention that will be undertaken
3. Participation selection; State why this participant has been chosen for this research
4. Voluntary participation; Clearly indicate that each individual can choose to participate or not to participate
5. Procedure and protocol; Describe or explain the procedure that will be followed on a step by step. Explain what you expected them to do. Write “we would like to ask you to …….”. Explain what is routine and what is experimental
6. If it is a clinical trial - provide information on the trial drug (name). Which phase of the trial. Why you compare or test this new drug. Explain known information /experience of the trial drug
7. If any samples (blood/sputum/biopsy ….) taken Explain when/how many times/any preparations needed/what will be done with them/how long they will be stored/ how these are discarded/do they be sent abroad.
8. Duration; Indicate a statement about the time commitment (research duration and follow up)
9. Risks; Explain any possible /anticipated risks. If any problem occurs what will be the action
10.  Benefits; Mention actual benefits. (not what they are entitled due to participate in the research)

Mention is it individual or community benefit

1. Reimbursement; State clearly what you will provide for their participation. Ex travel cost/money for wages lost
2. Confidentiality; Explain how the research team will maintain the confidentiality of data
3. Sharing of results; Mention plan of sharing results
4.  Right to refuse or withdraw; Mention that participation is voluntary and has right to withdraw/refuse at any stage without explaining why? It will not affect the individual’s right to get proper / routine / treatment / care
5. Whom to contact; Contact numbers of PI and other investigators. Mention who gave approval for this and the contact number of that ERC

Part 11: Consent Form

To be completed:

1. By the participant; The participant should complete the whole of this sheet himself/herself. 
   1. Have you read the information sheet? (Please keep a copy for yourself) YES/NO
   2. Have you had an opportunity to discuss this study and ask any questions? YES/NO
   3. Have you had satisfactory answers to all your questions? YES/NO
   4. Have you received enough information about the study? YES/NO
   5. Who explained the study to you? …………………………………………………………
   6. Do you understand that you are free to withdraw from the study at any time, without having to give a reason and without affecting your future medical care? YES/NO
   7. Sections of your medical notes, including those held by the investigators relating to your participation in this study may be examined by other research assistants. All personal details will be treated as TRICTLY CONFIDENTIAL. Do you give your permission for these individuals to have access to your records? YES/NO
   8. Have you had sufficient time to come to your decision? YES/NO
   9. Do you agree to take part in this study? YES/NO

< If tissue samples are to be stored for later studies, insert an additional section here as no.

Asking for agreement 

1. to store tissue; 
2. to use stored material for future research
3. into the same condition as present research, 
4. research into any condition. >

Participant’s signature…………………………..…………Date…………………….

Name (BLOCK CAPITALS)…………………………………………………………

By the investigator

I have explained the study to the above participant and he/she has indicated willingness to take part.

Signature of investigator……………………....…………..Date……………………….

Name (BLOCK CAPITALS)…………………………………………………………

Reference: FERCSL 2018 51; Annex D