Ethics Committee
Government Dental College&
Hospital Raipur, Chhattisgarh-492001
Standard Operating Procedure
(SOP)
Address for Correspondence
Member Secretary, Ethics Committee
Government Dental College, Raipur, Chhattisgarh-492001
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Standard Operating Procedure
CONTENTS
1. Introduction
2. Formation & Composition
3. Role
4. Quorum requirements
5. Offices
6. Independent consultants
7. Application Procedures
8. Documentation
9. Review procedures
10. Expedited review
11. Decision-making
12. Communicating the decision
13. Appeal
14. Fees
15. Record keeping
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1. Introduction
All research in human subject is now guided by the principles given in the
Declaration of Helsinki. This is also the basis of good clinical research practices (GCP)
adopted by the international conference on harmonization (ICH).The Indian Council of
Medical Research (ICMR) has also issued ethical guidelines for research on human
subjects. They also form a part of the GCP guidelines issued by the Central Drugs
Standard Control Organization (CDSCO) of the Ministry of Health, Government of India.
Putting into practice these principles, a Standard Operating Procedure is formulated for
the functioning of the Ethics Committee (EC). The objective of this SOP is to ascertain a
quality and consistent ethical review mechanism for health and biomedical research on
human subjects.
2. Formation & Composition
The EC shall be constituted by the Dean/Principal, Government Dental College,
Raipur as per the ICMR guidelines for Human research. The tenure of the EC shall be for
a period of 3 years. At the end of 3 years the committee shall be reconstituted.
However, Principal, Government Dental College, Raipur will have the power to
reconstitute the EC before the completion of scheduled tenure. A member may be
replaced in the event of death or long-term non-availability or for any action not
commensurate with the responsibilities laid down in the guidelines deemed unfit for a
member. A member may tender resignation from the committee with proper reasons to
do so. All members shall maintain absolute confidentiality of all discussions during the
Meeting. Conflict of interest is to be declared by members of the EC.
3. Role
EC will review and approve all types of research proposals involving human
participants with a view to safeguard the dignity, rights, safety and well being of all
actual and potential research participants. The EC will review research proposals
submitted by personnel affiliated to Government Dental College, Raipur. The goals of
research, however important, shall never be permitted to override the health and well
being of the research subjects. The EC will take care that all the cardinal principles of
research ethics viz. Autonomy, Beneficence, Non -malfeasance and Justice are taken
care of in planning, conduct and reporting of the proposed research. For this purpose, it
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will look into the aspects of informed consent process, risk benefit ratio, distribution of
burden and benefit and provisions for appropriate compensations wherever required. It
will review the proposals before start of the study as well as monitor the research
throughout the study until and after completion of the study through appropriate well
documented procedures for example annual reports, final reports and site visits etc. The
committee will also examine compliance with all regulatory requirements, applicable
guidelines and laws. The mandate of the ECs will be to review all research projects
involving human subjects to be conducted at the Institute, irrespective of the funding
agency. The role of EC can be modified according to the requirement of each Institute
4. Quorum requirements
The minimum of 5 members are required to compose a quorum. All decisions will
be taken in meetings and not by circulation of project proposals.
5. Offices
The meeting of the EC will be held on the third week of every month. The
member secretary can also convene a meeting (apart from the scheduled meeting) after
consultation with the chairperson. The Chairperson will conduct all meetings of the EC.
If for reasons beyond control, the Chairperson is not available, an alternate Chairperson
will be elected from the members by the members present, who will conduct the
meeting. The Member Secretary is responsible for organizing the meetings, maintaining
the records and communicating with all concerned. He/she will prepare the minutes of
the meetings and get it approved by the Chairman before communicating to the
researchers with the approval of the appropriate authority.
6. Independent consultants
EC may call upon subject experts as independent consultants who may provide
special review of selected research protocols, if need be.
7. Application Procedures
All proposals should be submitted along with the relevant documents. A cover
letter duly signed by the Principal Investigator (PI) and forwarded by the Head of the
Departments should be submitted to the EC. 10 copies of the proposal along with the
documents should be enclosed with application. The date of meeting will be intimated
to the researcher, to be present, if necessary to offer clarifications. The decision will be
communicated in writing. If revision is to be made, the revised document in required
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number of copies should be submitted within a stipulated period of time as specified in
the communication or before the next meeting.
8. Documentation
For a thorough and complete review, all research proposals should be submitted
with the following documents:
1. Name of the applicant with designation
2. Name of the Department/ Field area where research will be conducted.
3. Approval of the Head of the Department
4. Protocol of the proposed research
5. Ethical issues in the study and plans to address these issues.
6. Proposal should be submitted with all relevant enclosures like proforma, case report
forms, questionnaires, follow - up cards, etc.
7. Informed consent process, including patient information sheet and informed
consent form in local language(s).
8. For any drug / device trial, all relevant pre-clinical animal data and clinical
trial data from other centres within the country / countries, if available.
9. Curriculum vitae of Principal Investigator (PI).
10. Any regulatory clearances required.
11. Source of funding and financial requirements for the project.
12. Other financial issues including those related to insurance
13. An agreement to report only Serious Adverse Events (SAE) to EC.
14. Statement of conflicts of interest, if any.
15. Agreement to comply with the relevant national and applicable international
guidelines.
16. A statement describing any compensation for study participation (including
expenses and access to medical care) to be given to research participants; a
description of the arrangements for indemnity, if applicable (in study-related
injuries); a description of the arrangements for insurance coverage for
research participants, if applicable; all significant previous decisions(e.g.,
those leading to a negative decision or modified protocol) by other ECs or
regulatory authorities for the proposed study (whether in the same location or
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elsewhere) and an indication of the modification(s) to the protocol made on
that account. The reasons for negative decisions should be provided.
17. Plans for publication of results – positive or negative- while maintaining the
privacy and confidentiality of the study participants.
18. Any other information relevant to the study
9. Review procedures
The meeting of the EC shall be held on scheduled intervals as prescribed and
additional meetings may be held as and when the proposals are received for review. The
proposals will be sent to members at least 2 weeks in advance. Decisions will be taken
by consensus after discussions, and whenever needed voting will be done. Researchers
will be invited to offer clarifications if need be. Independent consultants/Experts may be
invited to offer their opinion on specific research proposals if needed. The decisions will
be minuted and Chairperson’s approval taken in writing.
10. Expedited review
All revised proposals, unless specifically required to go to the main committee,
will be examined in a meeting of identified members convened by the Chairman to
expedite decision making. Expedited review may also be taken up in cases of nationally
relevant proposals requiring urgent review. The nature of the applications,
amendments, and other considerations that will be eligible for expedited review should
be specified.
11. Decision-making
Members will discuss the various issues before arriving at a consensus decision. A
member will withdraw from the meeting during the decision procedure concerning an
application where a conflict of interest arises and this will be indicated to the
chairperson prior to the review of the application and recorded in the minutes.
Decisions will be made only in meetings where quorum is complete. Only members can
make the decision. The expert consultants will only offer their opinions. Decision may be
to approve, reject or revise the proposals. Specific suggestions for modifications and
reasons for rejection will be given. In cases of conditional decisions, clear suggestions
for revision and the procedure for having the application re-reviewed will be specified.
Modified proposals may be reviewed by an expedited review through identified
members.
12. Communicating the decision
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Decision will be communicated by the Member Secretary in writing. Suggestions
for modifications, if any, will be sent by EC. Reasons for rejection will be informed to the
researchers.
13. Appeal
If a proposal is rejected by the committee, the Principal Investigator may appeal
within 3 months for a fresh review after providing necessary justification for such
consideration
14. Fees
No fees will be charged by the EC for review of protocols.
15. Record keeping
The following documents will be kept for this purpose:
a. Copy of all study protocols with enclosed documents, progress reports, and SAEs.
b. Minutes of all meetings duly signed by the Member Secretary.
c. Copy of all existing relevant national and international guidelines on research ethics
and laws along with amendments.
d. Copy of all correspondence with members, researchers and other regulatory bodies.
e. Final report of the approved projects.
Member Secretary
Ethics Committee
Principal
Government Dental College
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Ethics Committee Members
1.
2.
3.
4.
5.
6.
7.
8.
Padmashree (Dr.) A.T. Dabke Prof. (Dr.) R.K. Dubey
Prof. (Dr.)Bhagwant Singh
Dr. Rajesh Hrishikar
Dr. Satendra Singh
Dr. Virendra Vadher
Sri Ashok Sahu
Sri Kishore Jadwani
-
Chairperson
Member Secretary
Member
Member
Member
Member
Member
Member
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Government Dental College& Hospital
Raipur, Chhattisgarh-492001
PROFORMA FOR INSTITUTIONAL ETHICS COMMITTEE
CLEARANCE OF STUDY/RESEARCH PROJECTS
Note :
1. All columns should be clearly filled up. Use additional sheets, if necessary.
2. Send five copies of the proforma duly signed by the applicant.
1.
Full title of the study/ Research
Project
2
In case of MDS thesis/Ph.D
Pattern of tooth loss, Prosthodontics
status and treatment needs among the
diabetic and non-diabetic patients
2.1 Name & signatures of the
candidate
2.2 Department
2.3 Batch of admission to course
2.4 Month & year of submission of
thesis
3.
Name of the Principal
Dr. Rajendra Kumar Dubey
Investigator/Supervisor,
Designation, address and
Professor
Department of Prosthodontics
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4.
5.
6.
signature
Government Dental College,
Raipur (C.G.)
Name of the Co- Investigators /Cosupervisors, designation, address
and
1.Dr. D. K. Gupta
signature
Department of Prosthodontics
Government Dental College,
Raipur (C.G.)
Name of the department(s) where
research is proposed to be carried
out
Department of Prosthodontics
Name of the department(s) that
None
Lecturer
Government Dental College,
Raipur (C.G.)
would collaborate in the project.
7.
Name of outside institution(s) that
would collaborate in the study.
None
8.
In case the study is multi-centric
give details of all other centers,
investigators etc.
Not applicable
9.
Name and address of agency
proposed to fund the project/
study and whether any such grant
No
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is already available.
Duration of the proposed
study/project with phasing and
limitations, if any.
10.
3months
11. Brief description of work to be undertaken, material methods etc. :
1. Objectives of the study/research project
2. Brief justification about need of study/research project
3. Methodology
A. Number of Patients:
B. Inclusion criteria
a)______________________________________________
b)______________________________________________
c)______________________________________________
d)______________________________________________
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C. Exclusion criteria
a)______________________________________________
b)______________________________________________
c)______________________________________________
d)______________________________________________
D. Control(s)
E. Study design
F. Dosages of drug
G. Duration of treatment
H. Investigation specifically related to projects
I. Permission to use copyrighted Questionnaire/proforma
J. Others
12.
Permission from Drug Controller
General of India (DCGI)
1. Required
required
2. Not
3. Received
when:
4. Applied
Anticipated risks involved in the
implementation of the project and
remedies suggested (This needs to be
given in full details)
13.
RISKS




Procedural
Adverse drug reaction due to
investigational drug treatment
Invasive investigation
Any other risk
Explain measure to counter/compensate
the above risk factors
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14.
Are the necessary facilities available in the
department where the research/study is
proposed to be carried out? If so, give
details thereof. Will patient/subject be
sent to other places? Give reasons
thereof. (letter of permission/willingness
to cooperate from other
department(s)/institution(s).
15.
Details of facilities which are not available
in the department and are proposed to be
sought from other Department. (letter of
permission/ willingness to cooperate from
other department(s).
16.
Details of facilities which are not available
in Govt. Dental Dollege, Raipur, are to be
availed of from other institution(s) (letter
of permission/ willingness to cooperate
from other institution(s).
17.
A.Details of Costs Involved (Appx. in Rs.)
Yes
B. Who will bear the costs of the
requirements?
1. Patient
Exempted
2. Project
3.
4. Other Agencies
(Name)_______________________
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A) Consent is necessary from the
participating subject. A copy of proposed
Consent Form in English and Hindi must be
enclosed.
18.
Consent form












Does it have the name of the institution at
the top
Does it also have the name, address and
telephone No. of the candidate and
Guide/Investigators etc
B) Patient Information Sheet informing
patient about
Freedom of individual to withdraw from
research.
Publication, if any including photograph
and pedigree chart
Duration of participation in study
Benefit that may be expected as an
outcome of research to the subject
Alternative procedure or treatment if
available.
His right to prevent use of his/her
biological sample(s) at any time during the
conduct of research
Foreseeable discomfort or risk to the
subject
Extent to which confidentiality of record
could be maintained
Responsibility of investigator
Provision of compensation of risk
C) Case Record Form
19.
Whether clearance has been obtained
from any other agency related to the
proposed study/ project, if so details
thereof.
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20.
Whether clearance is necessary from any
other agency? If so, details thereof
21.
Is there any provision to compensate the
investigators/victims in case of mishaps?
If so, details thereof.
22.
In case the project is sponsored by a
private agency, particularly a multinational
agency having business interest in India,
whether prior approval of the competent
authority has been obtained?
23.
Full justification of Project keeping in view
the policies and programmes of the
Government including details of current
knowledge on the subject and therein.
24.
Has the project been sent to any other
Institution/Body for Ethical Clearance? If
.
yes, give details.
25.
Any other information which may be
useful for consideration of the project by
the IEC
26.
Attached documents;
A. Covering letter, through proper
channel.
B. Copy of the detailed protocol is
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mandatory
C. Undertaking that the study shall be
done in accordance with ICMR and GCP
guidelines
D. In case of multicentric study, IEC
clearance of other centers must be
provided
E. Definite undertaking as to who will bear
the
expenditure of injury related to the
project
F. In case an insurance cover is intended,
Insurance certificate must be provided (as
per ICMR guidelines)
G. Permission to use copyrighted
Questionnaire/proforma
H. In case of Clinical trials, proof of
registration of Clinical trial with ICMR
needs to be submitted
I. Investigator should provide undertaking
what they will do with the leftover sample
tissue.
G. Others: Permission letters and other
necessary documents as per above
mentioned Performa
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