Application Form for Initial Review (Human Ethical Committee)
Chhatrapati Shahu Ji Maharaj University, Kanpur
EC Ref. No. (for office use):
General Instructions: a) Tick one or more as applicable. Mark NA if not applicable
b) Attach additional sheets, if required
SECTION A - BASIC INFORMATION
1. ADMINISTRATIVE DETAILS
(a) Date of Submission: ……………………………………………
(b) Title of the study: ………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………
(c) Version number:
(d) Details of Investigators:
Name Designation and Department and Address for communication with Mobile number
Qualification Institution and mail ID
Principal Investigator/Guide
Co-investigator/student/fellow
(e) Duration of the study: …………………………………………………………..
2. FUNDING DETAILS AND BUDGET
(a) Total estimated budget for site:
(b) Self-funding Institutional funding Funding agency
(Specify)
3. OVERVIEW OF RESEARCH
(a) Lay Summary of study (within 300 words)
Attach a separate sheet (A1)
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(b) Type of study:
Basic Sciences Clinical Cross Sectional
Retrospective Epidemiological/Public Health Case Control
Prospective Socio-behavioral Cohort
Qualitative Systematic
Review
Quantitative Biological samples/Data
Mixed Method Any others (Specify)
Specify Sample and study type: Invasive/Non-Invasive; Brief details: ……………………………………………………….
……………………………………………………………………………………………………………………………………………………………
4. METHODOLOGY
(a) Sample size/ No. of Participants (as applicable)
………………………………………………………………………………………………………………………………………………………………
Control Group: ……………………………………… Study Group: ……………………………………………………….
Justification for the sample size chosen; In case of qualitative study, mention the criteria used for
saturation ………………………………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………
(b) Is there an external laboratory/outsourcing involved for investigations? Yes No NA
(c) How was the scientific quality of the study assessed?
Independent external review Review by Sponsor/Funder Review within PI’s institution
Review within multi-center No Review
research group
Comments of Scientific Committee, if any………………………………………………………………………………………….
……………………………………………………………………………………………………………………………………………………………..
SECTION B - PARTICIPANT RELATED INFORMATION
5. RECRUITMENT AND RESEARCH PARTICIPANTS
(a) Type of participants in the study:
Healthy Patient Vulnerable person/ Others
volunteer Special groups (Specify)
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(b) i. Will there be vulnerable person/special groups involved? Yes No NA
ii. If yes, type of vulnerable person /special groups
Children under 18 yrs Pregnant or lactating women
Differently abled (Mental/Physical) Employees/Students/Nurses/
Staff
Elderly Institutionalized
Economically and socially disadvantaged Refugees/Migrants/Homeless
Terminally Ill (stigmatized or rare
diseases)
Any other (Specify):
iii. Provide justification for inclusion/exclusion…………………………………………………………………
……………………………………………………………………………………………………………………………………..
(c) Are there any incentives to the participant? Yes No
If yes, Monetary Non-monetary Provide details…………………………………………………………….
6. BENEFITS AND RISKS
(a) i. Are there any anticipated physical/social/psychological discomforts/ risk to participants?
Yes No
If yes, categorize the level of risk:
Less than Minimal risk Minimal risk
Minor increase over minimal risk or More than Minimal Risk or High Risk
Low Risk
ii. Describe the risk management strategy:
……………………………………………………………………………………………………………………………………..
(b) What are the potential benefits from the study? Yes No If yes, Direct Indirect
For the participant
For the society/community
For improvement in science
Please describe how the benefits justify the risks
……………………………………………………………………………………………………………………………………………………….
(c) Are Adverse Events expected in the study? Yes No NA
If Yes, justify……………………………………………………………………………………………………………………………………….
…………………………………………….…………………………………………….…………………………………………….
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7. INFORMED CONSENT
(a) Number of Participant Information Sheet (PIS):
(b) Type of consent planned for:
Signed consent Verbal/ oral Witnessed Audio-Video
consent consent (A/V) consent
Consent from LAR For children<7 yrs Verbal assent Written Assent
(If so, specify from parental/LAR from minor (7- from Minor (13-
whom) consent 12 yrs) along 18 yrs) along with
with parental parental consent
consent
Other (specify)
(d) Who will obtain the informed consent?
PI/Co-I Nurse/Counselor Research Staff Other(Specify)
Any tools to be used ………………………………………………….
(e) Participant Information Sheet(PIS) and Informed Consent Form (ICF)
English Local language other (specify)
List the languages in which translations were done
(f) Provide details of Consent requirement for previously stored samples if used in the study:
………………………………………………….………………………………………………….………………………………………………….
8. STORAGE AND CONFIDENTIALITY
(a) Who will be maintaining the data pertaining to the study?
(b) For how long will the data be stored?
(e) Do you propose to use stored samples/data in future studies? Yes No Maybe
If yes, explain how you might use stored material/data in the future?
…………………………………………….…………………………………………….…………………………………………….
9. PUBLICATION, BENEFIT SHARING AND IPR ISSUES
(a) Will the results of the study be reported and published? Yes No NA
(b) Will you inform participants about the results of the study? Yes No NA
(d) Is there any plan for post research benefit sharing with participants? If yes, specify
Yes No NA
(e) Is there is any commercial value or a plan to patent/IPR issues. If yes, Please provide details
Yes No NA
(f) Do you have any additional information to add in support of the application, which is not included
elsewhere in the form? If yes, provide the details. Yes No
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DECLARATION AND CHECKLIST
11. DECLARATION (Please tick or cross as applicable)
I/We certify that the information provided in this application is complete and correct.
I/We confirm that all investigators have approved the submitted version of proposal/related
documents.
I/We confirm that this study will be conducted in accordance with the latest ICMR National
Ethical Guidelines for Biomedical and Health Research involving Human Participants and other
applicable regulations and guidelines including responsible.
I/We confirm that this study will be conducted in accordance with the Drugs and Cosmetics Act
1940 and its Rules 1945 as amended from time to time, GCP guidelines and other applicable
regulations and guidelines.
I/We will comply with all policies and guidelines of the institute and affiliated/collaborating
institutions where this study will be conducted.
I/We will ensure that personnel performing this study are qualified, appropriately trained and
will adhere to the provisions of the EC approved protocol.
I/We declare that the expenditure in case of injury related to the study will be taken care of.
If applicable, I/We confirm that an undertaking of what will be done with the leftover samples
is provided, if applicable.
I/We confirm that we shall submit any protocol amendments, adverse events report, significant
deviations from protocols, progress reports (if required) and a final report and also participate
in any audit of the study if needed.
I/We confirm that we will maintain accurate and complete records of all aspects of the study.
I/We will protect the privacy of participants and assure safety and confidentiality of study data
and biological samples.
I/We hereby declare that I/any of the investigators, researchers and/or close relative(s), have
no conflict of interest (Financial/Non-Financial) with the sponsor(s) and outcome of study.
I/We have mentioned the conflict of interest (PI/Co-PI), if any, in a separate sheet.
I/We declare/confirm that all necessary government approvals will be obtained as per
requirements wherever applicable.
Name of Applicant: Signature:
Name of Guide: Signature:
Name of Co-PI: Signature:
Name of HOD: Signature:
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