Application for approval of Research Proposal involving Human Participants
Ethics Committee,
Government Medical College, Bhavnagar
Application type: New Revised Date: __/__/____
For office use only:
Received date:
Purpose: Dissertation Academic Research
EC No.:
Department No.:
EC meeting no. and date:
Any amendment after approval: Yes No
Amendment approval date:
Study title and details of PI:
Study Title:
Details of PI:
Sr Contact number &
Name Qualifications & Designation
No. Email id
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Details of Co-investigator/ Academic guide/ Mentor:
Sr Contact number &
Name Qualifications & Designation
No. Email id
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2
Study details:
Observational Interventional Other (Specify)
If interventional, provide details mentioned below:
Type of study:
a) Type of intervention:
b) Details of intervention:
Are you aware if this study/ Yes No
similar study is being done • If yes, attach details with application.
elsewhere?
Sample size:
(Total and per group)
Study duration: (Total)
Study participants:
No Pregnant lady Elderly
Children Handicapped Terminally ill
Vulnerable
Socially and economically
population: Mentally challenged Illiterate
backwards
Other (Specify):
Special No Students Nursing / Dependent staff
groups: Employees Armed forces Other (Specify):
Ethical consideration:
Yes No
Will written informed consent be
• If no, provide reason:
obtained? (Provide participant
information sheet and informed • Do you seek consent
consent document for review) waiver from EC? Yes No
How will you ensure data
confidentiality?
Is there physical / social /
Yes No
psychological risk /discomfort?
Is the risk reasonable compared to
the anticipated benefits to Yes No NA
participants/ community?
Is there compensation for
Yes No
participation?
Is there a plan for interim analysis of
Yes No
data?
Will any advertising be done for Yes No
recruitment of participants? • If yes, attach copy of advertisement to be done.
Yes No
Do you have conflict of interest?
If yes, specify:
Are you planning to publish your Yes No
data? If no, provide reason:
Who will do archival of all the study
documents for at least 3 years (5
years in case of regulatory trial) after
completion of study? (Provide name
and contact details)
Attached following documents for review along with application:
Sr. No. Documents Attached
Study proposal in prescribed format (For dissertation/
1 Yes No NA
academic research)
2 Case Record Form / Study questionnaire Yes No NA
Patient Information Sheet & Informed Consent Documents
3 Yes No NA
(English & Gujarati)
4 Minimum 2 relevant full text reference articles Yes No NA
5 Any other document (Specify) Yes No NA
Investigator's declaration
Department of _______________
Government Medical College &
Sir Takhatsinhji General Hospital Bhavnagar-364001
Study title:
1. The study will be initiated only after review and approval by EC, Govt. Medical
College, Bhavnagar.
2. We will obtain approval from the EC, Govt. Medical College, Bhavnagar, before
making any significant changes/ amendments in the study proposal.
3. We will do our study according to National Ethical Guidelines for Biomedical and
Health Research Involving Human Participants Statement (2017)/ ICH-GCP
guidelines and maintain all the study related records. Whenever asked, we are bound
to produce to EC, Govt. Medical College, Bhavnagar.
We herewith declare that information provided herewith is correct and if there will be any change
or deviation from provided details, we are bound to inform that to EC and take permission for the
same.
Sr. No. Name PI/ Co-I Sign & Date
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