Policies and
Operations guidelines
for Biomedical
Research
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TABLE OF CONTENTS
Sr.no
1.
2.
3.
4.
5.
Contents
Abbreviations Used
Introduction
Schedule for Submitting Proposal to
Institutional Ethics Committee
The Institutional Ethics Committee
Schedule for Submission of synopsis to
the University (thesis only)
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3
3
3
4
5
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1. Abbreviations
MPDC = Manubhai Patel Dental College
IEC= Institutional Ethics Committee
ICMR= Indian Council of Medical Research
GCP = Good Clinical Practices
PI= Principal Investigator
PICF =Participant Informed Consent Form
PIS =Participant Information Sheet
2. Introduction
The aim of these guidelines is to provide the Principal Investigator (PI) who may be a
faculty, PG student or a UG student understand the basic protocol for any research
work that may be carried out at the college. All research work must follow the ICMR
Ethical guidelines for Biomedical Research.
Any person wishing to suggest a new or revised policy, procedure or form is invited
to submit the suggestion in writing to the Dean, along with a description of the
rationale for the change.
3. Schedule for Submitting Proposal to
Ethics Committee (IES)
Submission of the proposal shall be received on all working days (in the format
provided to all departments) by the Post Graduate Director. For thesis topics
submission the deadline for submission is provided by the office of the dean as per
the Dental Council of India guidelines.
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The applicant shall submit the proposal (2 Copies) and the following documents (2
copies).
(a) A letter of application to the IES by the applicant.
(b) Participant Informed Consent form (PICF) in English and Gujarati, with signature,
name, and address of a witness.
(c) Participant Information sheet in English and Gujarati.
(d) A letter from Investigator certifying that no work has started before approval.
(e) A letter from the Investigator that work will be done as per ICMR/GCP guidelines.
(f) Permission to use copyrighted questionnaire or Performa, if necessary.
4. Institutional Ethics Committee (IES)
The Institutional Ethics Committee is composed of 8-12 members who are from
multidisciplinary backgrounds. The basic responsibility of the Institutional Ethics
Committee (IEC) will be to ensure a competent review of all ethical aspects of the
project proposals received by it in an objective manner. IECs will provide advice to the
researchers on all aspects of the welfare and safety of the research participants and
also ensure the scientific soundness of the proposed research.
Procedure
The following procedure will be followed by the Institutional Ethics Committee.
1. The Post Graduate director shall then forward the synopsis to the Secretary of the
Ethics Committee. The Secretary shall do a preliminary assessment of each
proposal. The Secretary shall then inform the applicant if the submitted
documents confine to the criteria or return the documents for changes if
necessary.
2. The Ethics Committee shall meet once in every two months and on special
deadlines to review the material of the study to be conducted by the PI.
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3. The Applicants shall be notified 10 days prior to the meeting of the Ethical
Committee and must be present at the time of meeting in case any clarifications
are required.
4. T he decision taken by the IES shall be conveyed to the applicant in the form of
letter/certificate signed by the Member Secretary and Chairman.
5. Schedule for Submission of synopsis to
the University (thesis applicants only)
The applicant shall submit the letter of application, the proposal synopsis and the
certificate of clearance of the Institutional Ethical Committee to the Administrative
office of the College for further instructions. The deadline of the application to the
University shall be notified by the Dean Office.
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