Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
Date:
Annexure I: PROFORMA TO BE SUBMITTED TO THE INSTITUTIONAL
ETHICS COMMITTEE (HUMAN STUDIES)
Kindly submit 12 copies of proforma and consent forms in 2 parts (in English and Marathi) to
the Member Secretary, Institutional Ethics Committee (Human Studies) of SMBT Institute of
Medical Sciences & Research Centre Dhamangaon Ghoti, Nashik
1. Title of the project:
2. Name of the investigators/co-investigators with designation & department:
3. Number of projects already with the investigators/co-investigators:
4. Sources of funding:
1
Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
5. Objectives of the study:
6. Justification for the conduct of the study:
7. Methodology: It should provide details of number of patients, inclusion
criteria, exclusion criteria, control(s), study design, dosages of drug, duration
of treatment, investigations to be done etc.:
2
Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
8. Permission from Drug Controller General of India (DCGI) if applicable
9. Costs involved (Appx. in Rs.):
10. Investigations (if any)
11. Disposables (if any)
12. Implants (if any)
13. Drugs/Contrast Media (if any)
14. Who will bear the costs of the requirements?
a. Patient
b. Project
c.
Exempt
d. Other Agencies (Name)
3
Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
15. Ethical issues involved in the study: less than minimal risk / minimal risk / more
than minimal risk to the study subjects [Along with the level of risk, the risks
should be discussed in detail]
16. Do you need exemption from obtaining Informed Consent from study
subjects? if so give justifications.
17. Whether Consent forms in English and in local language are enclosed? (if the
consent form in local language is not applicable, appropriate explanations must be
provided)
4
Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
18. Documents attached (tick the appropriate one)
a. Brief CV of investigators (including no. of projects with him/her)
b. Investigator’s Brochure
c. Others
19. Conflict of interest for any other investigator(s)? (if yes, please explain in brief)
20. Whether soft copy of the Proforma (CD) has been attached?
We, the undersigned, have read and understood this protocol and hereby agree to conduct
the study in accordance with this protocol and to comply with all requirements of the
guidelines.
Signature of the Investigators:
Date:
Signature of the Head of the Department
Date:
5
Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
Date:
Annexure II: INFORMATION FOR PARTICIPANTS OF THE
STUDY
1. Title of the project:
2. Name of the investigator/guide:
3. Purpose of this project/study:
4. Procedure/methods of the study:
5. Expected duration of the subject participation:
6. The benefits to be expected from the research to the participant or to others and the post trial
responsibilities of the investigator:
7. Any risks expected from the study to the participant:
8. Maintenance of confidentiality of records:
9. Provision of free treatment for research related injury:
10. Compensation of the participants not only for disability or death resulting from such injury but also
for unforeseeable risks:
11. Freedom to withdraw from the study at any time during the study period without the loss of benefits
that the participant would otherwise be entitled:
12. Possible current and future uses of the biological material and of the data to be generated from the
research and if the material is likely to be used for secondary purposes or would be shared with
others, this should be mentioned:
13. Address and telephone number of the investigator and co-investigator/guide:
14. The patient information sheet must be duly signed by the investigator:
6
Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
Date:
Annexure III: PARTICIPANT CONSENT FORM
Participant’s name:
Address:
Title of the project:
The details of the study have been provided to me in writing and explained to me in my own
language. I confirm that I have understood the above study and had the opportunity to ask questions. I
understand that my participation in the study is voluntary and that I am free to withdraw at any time,
without giving any reason, without the medical care that will normally be provided by the hospital being
affected. I agree not to restrict the use of any data or results that arise from this study provided such a use
is only for scientific purpose(s). I have been given an information sheet giving details of the study. I fully
consent to participate in the above study.
Signature of the participant:
Date:
Signature of the witness:
Date:
Signature of the investigator:
Date:
7
Institutional Ethics Committee
SMBT INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
Nandi-hills, Dhamangaon, Tal.Igatpuri, Dist. Nashik
Date:
Annexure IV: CONSENT FORM (FOR PARTICIPANTS LESS
THAN 18 YEARS OF AGE)
Participant’s name:
Address:
Parent/LAR’ s name:
Title of the project:
The details of the study have been provided to me in writing and explained to me in my own
language. I confirm that I have understood the above study and had the opportunity to ask questions. I
understand that my child/ward’s participation in the study is voluntary and that I am free to withdraw my
child/ward at any time, without giving any reason, without the medical care that will normally be
provided by the hospital being affected. I agree not to restrict the use of any data or results that arise from
this study provided such a use is only for scientific purpose(s). I have been given an information sheet
giving details of the study. I fully consent for the participation of my child/ward in the above study.
Assent of child/ward obtained (for participants 7 to 18 years of age)
Signature of the parent/ LAR:
Date:
Signature of the witness:
Date:
Signature of the investigator:
Date:
8