ETHICS COMVITTEE GOVERNMENT MEDICAL COLLEGE Di to 28.

04
2023)
(Re registration no. ECR/SSTInst GJ2014/RR-20 effective from 29.042020
BHAVNAGAR Plhone: (0278) 2511S11. Fax: (0278) 242201. Email: ib enncb&valo co
Date:02/1 2/202.3

To,
Dr. Swati Choudhary.
Ist year resident. Department of Ophthalmology.
Governnment MedicalCollege,
Bhavnagar- 364001. (Gujarat), India.
ECApproval No. 1213/2022
Department No. 60/2022
Project title "A comparison of endothelial cell injury in Small Incision Cataract Surgey
versus Phacoemulsification-Anobservational study'
(Dissertation Work)
Approval Date 13/12/2022
EC Decision Approved
Trial duration 15 Months
and Sample size
Dear Dr. Swati Choudhary,
The Ethics Committee.Government Medical College, Bhavnagar has reviewed and
approved your proposal in 57" ECmeeting held on Tuesday, 13" December - 2022.
Following documents were reviewed in the meeting.
1. EC form.
2. Study Proposal.
3.Participants Information Sheet and lnformed Consent Formin Gujarati and English.
4.Case Record Form

Your proposalis approved considering that foiiowing conditions of approval meet:

1. Sudv (Interventional trial) should be started only after getting CTRI registration number and submit
the same to EC.
2. Conduct the study strictly in accordance with the proposal submitted and granted ethics approval.
inchuding anyamerndments made to the proposal required by the EC.
3. Notify immediately toEC if any serious ADR occurs or other issues or any complaints in relation to
the project which may warrant review of the ethical approval of the project.
4. Plalso advised to report to EC if any new information arising from study that can increase risk to
participant or other participants in the study.
5. Make submission for approval of amendments to the approved project before implementing such
changes.
6. Provide a 'progress report' at every six months and final report when the study is completed.
7. Provide study records whenever asked byy EC.
8. Notify to ECin writing if the project has been discontinued.
9. Complete CTRI registration process and submit final registration certificate. Ethical
10. Please note that failure to comply with the conditions of approval and the National (2017) may
Guidelines for Biomedical and Health Research Involving Human Participants Statenmçnt
result in withdrawal of approval for the study.
Yours Simeerely
Member Seeretary, Ethics Committee,
Gov. MMedical C
MemberSecretary,
Governiment MedcaiCollege,
Bhvnagar-364001(Gujarat)