Submission Procedure

We accept applications for reviewing human and animal ethical aspect of the research proposals. The investigators are requested to submit their proposals along with all listed documents below (see the checklist).

An application for the review of the ethics of proposed biomedical research should be submitted by a qualified researcher responsible for the ethical and scientific conduct of the research.

Application submission is open between 1st to 10th of every month.

Incomplete applications will be returned to the investigator within 7 days from the date of submission closure (10th of every month).

Once returned, the applications need to be submitted again as fresh proposals for the next month. Therefore, please follow the guidelines and the checklist carefully before submission.

The document should be error free. If there are more than 10 typo + grammar errors it will be rejected without further review.

Sticking to these deadlines will avoid unnecessary delays.

Document Checklist

Prepare two sets of documents including a blinded copy as given below to support review process.

Prepare them as two (2) zipped folders (one as full application and the other as blinded copy of application) and submit them to erc@wyb.ac.lk

Full Application Blinded Copy of Application
Application form (fully completed, signed and dated) Blinded – Application form (fully completed, signed and dated) (remove applicant identification wherever possible)

The protocol of the proposed research (clearly identified and dated), together with supporting documents and annexures

a description (usually included in the protocol) of the ethical considerations involved in the research

The protocol of the proposed research (clearly identified and dated), together with supporting documents and annexures

a description (usually included in the protocol) of the ethical considerations involved in the research (Blind them at where necessary)

A summary (as far as possible in non-technical language), synopsis, or diagrammatic presentation (‘flowchart’) of the protocol A summary (as far as possible in non-technical language), synopsis, or diagrammatic presentation (‘flowchart’) of the protocol
Case report forms, diary cards, and other questionnaires intended for research participants (If apply) Case report forms, diary cards, and other questionnaires intended for research participants (If apply)
Participant information sheets and consent forms, including translations in other two languages (If apply) Blinded copies of participant information sheets and consent forms, including translations in other two languages (If apply)
When the research involves a study product (such as a new food or pharmaceutical or device under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the study product together with a summary of clinical experience with the study product to date (e.g., recent investigator’s brochure, published data, a summary of the product’s characteristics) When the research involves a study product (such as a new food or pharmaceutical or device under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the study product together with a summary of clinical experience with the study product to date (e.g., recent investigator’s brochure, published data, a summary of the product’s characteristics)
Material to be used (including advertisements) for the recruitment of potential research participants Material to be used (including advertisements) for the recruitment of potential research participants
All investigator (s)’s curriculum vitae (updated, signed, and dated)  

Review Process

Accepting Applications

Application submission is open between 1st to 10th of every month.

Incomplete applications will be returned to the investigator within 7 days from the date of submission closure (10th of every month).

 

Reviewing Applications

ERC usually meet in the first week of every month, processing the applications received in preceding month.

the decision on the submitted proposal applications will be sent to the investigator within 10 days after the meeting.

The regular review process will take 60-75 days, during which the decision will be conveyed to the applicant.

Failure to comply with these instructions would result in the application being returned, and/or delay in obtaining ethical clearance.