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STANDARD OPERATING PROCEDURES
SINHGAD DENTAL COLLEGE AND HOSPITAL
The Standard Operating Procedures mentioned herewith should be followed
Aim:
The aim of the IEC will be to follow systematic review procedures, to ensure quality and
consistency of the various research proposals involving human subjects, to foster
advancement of dental and other biomedical research undertaken in this institute.
Objectives
1. To provide independent guidance advice and decision (in the form of
approval/recommendations/stipulation/disapproval) on health research or other
specific research protocols involving human subjects under taken by various
researchers in this institution.
2. To ensure the protection of rights, safety and wellbeing of the human subjects
involved in a research project.
3. To take care of all the cardinal principles of research ethics viz, Autonomy,
Beneficence, Non-malfeasance, justice, confidentiality and veracity.
4. To look into informed consent process, risk benefit ratio, distribution of burden and
benefit and provisions for appropriate compensations wherever required.
5. To review proposals before the start of the study as well as to monitor it throughout
the study until and after the completion by examining biannually and the final reports.
6. To ensure that all the regulatory laws are complied, in accordance with the local, state
and national court of law.
7. To educate the professional, administrative and support staff about the ethical issues.
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Authority under which IEC is constituted:
The Principal, SDC&H will constitute the IEC.
Composition and details of Membership of IEC
IEC, will be multidisciplinary and multi-sectorial in composition.
The IEC will preferably consist of 10-12 members including one member secretary.
The IEC of the institution will be constituted keeping in mind the following points:

There shall be adequate representation by age.

There shall be adequate representation by gender.

There shall be adequate representation of members with various clinical and academic
expertise in the Committee to safeguard the interests and welfare of all sections of the
community / society.

If required specialist members from relevant field or specific patient groups will be
invited in special studies (like patient groups in HIV, experts in cases of stem cells
etc)

The members of IEC preferably will be appointed from these fields:
 Specialist Medical and dental practitioners / academicians, epidemiologist,
Sociologist,
Lawyer/legal
expert,
Statistician,
Clinicians,
Clinical
Pharmacologist and lay person.
 They will be appointed by the Head of the Institution based on their
competencies and integrity, and could be drawn from any public or private
Institute in the country.
The composition will preferably be as follows:1. One Chairman – from outside the institution.
2. One Member-Secretary (from the same institution).
3. 1-2 basic medical scientist
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4. 1-2 clinicians from various institutions
5. One legal expert
6. One social scientist
7. One lay person.
Total : 10-12 members depending upon availability at that point of time.
MEMBERSHIP DETAILS:
Appointment
a) The duration of appointment of the IEC members will be for a period of 2 years.
b) At the end of 2 years from the date of appointment, the committee will be
reconstituted and preferably 50% of the members shall be replaced / or if required the
entire IEC shall be re-constituted.
c) In case of untoward event (death) or long-term non-availability (absence for more
than 3 consecutive meetings held by IEC in succession) the member shall be
terminated from the IEC.
d) Any member not willing to follow the guidelines of IEC will be deemed unfit to
continue the membership.
Resignation and the Replacement procedure
a) A member can tender resignation from the committee with proper reasons to do so.
b) IEC members who decide to resign must provide written intimation - to the head of
the institution , chairman IEC and member secretary 1 month prior to the next
scheduled meeting of the IEC.
c) The members who have resigned may be replaced at the discretion of the head of the
institution.
Quorum requirements:
1. A minimum of 5 members are required to compose a quorum and the meeting to
proceed.
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2. In case if less than 50% members are present then the meeting shall be considered as
cancelled and next date will be fixed as per convenience.
3. In case of conflict of opinion between the members, the chairman’s decision will be
deemed as final and binding.
4. All decisions should be taken in meetings and not by circulation of project proposals.
Offices
5. The Chairman will conduct all meetings of the IEC. If for reasons beyond control, the
Chairman is not available, an alternate Chairman will be elected from the members by
the members present, who will conduct the meeting.
6. All members will maintain absolute confidentiality of all the discussions during the
meeting and sign a confidentiality form post meeting. (Annexure -A)
7. The Member Secretary is responsible for organizing these 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 (head of institution).
GUIDELINES FOR SUBMITTING THE RESEARCH PROPOSALS TO IEC:
The research proposals submitted to IRB and those requiring review by the IEC shall be
submitted in the format attached as per (Annexure –B).
1. No research proposals will be entertained until and unless approved by the
Institutional Research Board (IRB).
2. The IEC should ensure that the IRB forwards the research proposals requiring IEC
clearance by intimating the concerned Principal Investigator (PI), who in-turn will
make 15 copies of the research proposals that require IEC Clearance and submit the
same to the IEC.
3. The IEC will make sure that the research proposals submitted by the Investigators are
duly signed by the Principal investigator, the guide, co-guide and H.O.D in case of
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students (UG & PG) and the principal investigator and the H.O.D. in case of any
research project undertaken by the staff.
4. The Principal investigators shall submit the synopsis/research proposals as per the
IRB requirements. They are advised to refer to institutional website for details
(www.sdchpune.org/Constitution_IRB.html)
Documentation:
For a thorough and complete review, all research proposals shall be submitted with
the following documents:
1. Name of the applicant with designation.
2. Name of the Institute/Hospital/Field area with complete postal address/email/contact
number (mobile/office phone) where research will be conducted.
3. Approval of the Head of the Department / Institution. (Sinhgad Dental College and
Hospital , Vadgaon (Bk), Pune-411041.
4. Protocol of the proposed research as per the Institutional Research Board (IRB)
guidelines. (Annexure –B)
5. Ethical issues in the study and plans to address these issues.
6. Proposal should be submitted with all relevant enclosures like proformae, case report
forms, questionnaires, follow - up cards, etc.
7. Informed consent process, including patient information sheet and informed consent
form in local language(s) to be framed as per the study undertaken by the principal
researcher.
8. For any drug / device trial, all relevant pre-clinical animal data and clinical trial data
from other centers within the country / countries, if available. Approval from CTRI
will have to be taken in advance before the study is under taken.
9. Curriculum vitae of all the investigators (may not be possible in case of PG students)
with relevant publications in last five years.
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10. Any regulatory clearances required (from IRB, CTRI etc)
11. Source of funding and financial requirements for the project.
12. An agreement to report Serious Adverse Events (SAE) to IEC.
13. Statement of conflicts of interest, if any.
14. Agreement to comply with the relevant national and applicable international
guidelines to conduct research work.
15. Plans for publication of results – positive or negative- while maintaining the privacy
and confidentiality of the study participants.
16. Any other information relevant to the study.
17. The member secretary will maintain all the records of the meeting and neatly file
them by maintaining proper registers and files for future reference and records.
18. Appropriate forms will be given to the members to record their decisions on the day
of presentations and these decision letters will be forwarded to the members by the
member secretary. (Attached as Annexure-C)
Review procedures:
1. The meeting of the IEC will be held biannually (in the months of August and
December, usually in the 2nd week) and additional meetings may be held as and when
the proposals are received for review as per convenience.
2. The date of meeting will be intimated to the researchers and the members, 1month in
advance.
3. The Member- Secretary IEC shall ensure that the research proposals cleared by the
Institutional Research Board (IRB) and those requiring ethical clearance by IEC,
reach the IEC by 1st week of the above said months. This will ensure that the research
proposals reach the chairman and other members of IEC in time and they have at least
7 days to review them for the upcoming meeting to be held in the 2nd or 3rd week.
4. The proposals will be sent to members at least 7 days in advance.
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5. If required the proposals can be presented over a period of two days.
6. The principal investigators shall make a formal power-point presentation in front of
IEC members, for about 8-10 minutes.
7. The head of institution will be required to attend all the meetings of the IEC to ensure
smooth functioning of the meetings.
8. Decision making by the IEC members
a. The IEC members will review the proposals in light of following points before
arriving at a decision. Points attached as (Annexure-D)
b. The IEC members will make the decision in the format attached as (Annexure- C)
and will submit the same to the Member secretary IEC at the end of the day. They
will also make sure that the principle investigator has signed the confidentiality
agreement. Attached as (Annexure –E)
c. The decisions may be in the form of voice votes, show of hands, or if required by
a secret ballot or as decided by the chairman, after discussion.
d. All members will be entitled to cast one vote.
e. In case of a tie the chairman will give the casting vote.
f. Opinions of the absent members shall be considered by mail, telephone or fax by
the members present but shall not be counted as votes for formally convened full
board meetings.
g. Experts called on special occasion will not have voting rights.
h. The decision of the IEC will be communicated in writing by the member secretary
of the IEC to the researcher. If revision is to be made, as specified in the
communication, the revised document should be submitted by the researcher to the
member secretary of the IEC within 5 working days.
i. Following which the Member secretary will inform the chairman and send the
revised research proposal back to the chair man for his comments. The comments
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will be conveyed back to the principal investigator in writing as soon as possible.
9. The minutes of the entire meeting will be maintained and Chairman’s approval will be
taken in writing by the Member-Secretary.
10. Annual activity report of the IEC will be submitted to the chairman and the head of
the institution at the end of the year.
Follow up procedures
1. The research protocols after getting clearance from the IEC will have to be
monitored every 6 months.
2. The researchers are advised to fill up the adverse effects form, if at any given point
of time any adverse affects are witnessed by the investigators after the start of the
study.
Record Keeping and Archiving
1. All documents related to the IEC will be maintained properly by the member
secretary of the IEC.
2. He/she will keep the following registers/files updated at any given point of time
a. Inward/outward register
b. Copy of research proposals sent by the investigators
c. Decision letters of the members
d. Decision letters of the IEC members
e. Curriculum vitae of the members
f. IEC registration register
g. CTRI registration documents
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(Annexure -A)
Confidentiality Agreement
Title of Research Project:
Principal Investigator:
As a member of this research team/researcher, I understand that I may have access to
confidential information about study sites and participants. By signing this statement, I am
indicating my understanding of my responsibilities to maintain confidentiality and agree to
the following:

I understand that names and any other identifying information about study sites and
participants are completely confidential.

I agree not to divulge, publish, or otherwise make known to unauthorized persons or
to the public any information obtained in the course of this research project that could
identify the persons who participated in the study.

I understand that all information about study sites or participants obtained or accessed
by me in the course of my work is confidential. I agree not to divulge or otherwise
make known to unauthorized persons any of this information, unless specifically
authorized to do so by approved protocol or by the local principal investigator acting
in response to applicable law or court order, or public health or clinical need.

I understand that I am not to read information about study sites or participants, or any
other confidential documents, nor ask questions of study participants for my own
personal information but only to the extent and for the purpose of performing my
assigned duties on this research project.

I agree to notify the local principal investigator immediately should I become aware
of an actual breach of confidentiality or a situation which could potentially result in a
breach, whether this is on my part or on the part of another person.
______________________________
Signature
________________ _____________________
Date
Printed name
______________________________ ________________ _____________________
Signature of local principal investigator
Date
Printed name
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(Annexure- B)
FORMAT FOR PROPOSED RESEARCH PROJECT FOR
STAFF/STUDENTS/OTHERS
Instructions:




Follow Times new roman font for entire document.
Font size for Main title: 16 with bold font style and underlined
Subtitles: 14 with bold font style and underlined
Rest of the text: 14 font size with regular style
1. Title of research project
(Dissertation)
2. Principal Investigator
(Name and
Department)
3. Co-investigators
(Name, Department and
institution)
4. Subject
5. Introduction and need for the study: (Mention the background of the study, identify lacunae
in current knowledge, and provide justifications/rationale for conducting the study and any
anticipated implications of the study. Word count should not be more than 500 words. You
may add 2-3 references from literature.)
6. Review of Literature: (Give a brief review identifying 3-6 research articles relevant to the
proposed study. Word count not more than 1500 words)
7. Aims and Objectives: (Mention the aims and objectives for your study. Each Aim/objective
should be numbered /separated with a bullet; 2-4 Aims/objectives are desirable)
8. Materials and Methods:
9a.
Duration of project:
9b.
Period for collection of data:
9c.
Deadline for collection of data:
9d.
Period that may be required for analyzing the data:
9e.
Place of study:
9f.
Sample size:
9g.
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Methodology in brief: Study design, Source of data/study population, Selection
Criteria(Inclusion & Exclusion criteria),Sampling procedure, Sample size, Data collection
procedure(Procedures, Instruments and methods of measurement), Method of data analysis
List of references: (Mention references in Vancouver style, in the order of appearance in the
text. Number each reference and provide it as a superscript in the text. Consult ICMJE
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Guidelines for further clarifications)
12.
12.a.
Ethical Issues
Does the study involve human participants?
Yes
No
If yes, mention the details : How the participants will be recruited? Provide a copy of
informed consent form, participant information sheet, details of procedure to be performed if
12.b.
any, anticipated complications / Risks involved to participants, benefits of participation/
compensations if any in english and vernacular language.
Does the project involve any drug trial on human beings?
Yes
No
12.c.
If so, clarify.
Does the project involve any drug trial on animals? If so, does the
12.d.
facility for animal house exist in or around the unit?
12.e.
12.f.
12.g.
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13.a.
Are the human subjects available in or near the unit?
Have you obtained clearance from the Institutional Ethical
Committee?
Do you consider the proposed number of subjects will be available
within the proposed period of study and will be adequate to make the
study result oriented?
Administrative Issues
Does the study involve external funding?
Yes
No
If yes, mention the details (Name and details of the funding agency, approximate amount
13.b. granted, conflicts of interest if any)
Is the infrastructure facility required for the conduct of the dissertation
13.c.
available in the Institution and affiliated hospital?
Is the necessary support from various other specialties required for the
13.d.
dissertation available?
Have you discussed the matter with concerned administrative
13.e.
authorities?
14. Name & Signature of Principal Investigator:
15. Name & Signature of Co-investigator:
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Each annexure should be duly numbered in Roman letters. You may provide
the following (wherever applicable):
16. Appendix:
• Consent form (In English as well as Marathi. Also, any other language
wherever required)
• Participant Information sheet (Explain the study in brief in patient’s language
explaining the purpose, anticipated risks and benefits to the participant)
• Data collection form (case record form/ data record form)
• Questionnaire
• Sample contact letters
• Permission letters from other institutions
• Letter of support from other experts
• Conflict of interest form (for funded projects) and Disclosure of source of
funding.
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(Annexure- C)
SDCH/IEC/Out/2013-14/
Date:-
Institutional Ethics Committee (IEC)
Decision Letter
To,
______________________
Reference: Your research proposed titled
___________________________________________________________________________
___________________________________________________
This is to inform you that in the IEC meeting held on ________the following decision has
been taken regarding the aforementioned project submitted by you for ethical clearance
 Approved and permitted to conduct the project as per protocol.
 The following modification/s required prior to its approval within 15 days
(failing which the project will have to be submitted as a fresh proposal
as per enclosure).
 Disapproval and unfavorable opinion.
 Termination /suspension of the previously approved project.
Best Wishes
Dr. R.N. Deshpande
Chairman (IEC)
Dr. Sangeeta Muglikar
Dr. Dhaware
Dr. Sarita Mulkalwar
Dr. Shrikant Diwanay
Mr. Amar Pol
Dr. Sheetal Potnis
Mrs. Ashwini Shete
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Dr. Dheeraj Kalra
Dr. Amit Mhapuskar
(Annexure - D)
POINTS FOR THE IEC MEMBERS TO CONSIDER
DATE:
Name of IEC member _________________________ Designation ______________
Research title: _____________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
Principal Investigator_______________________________________
PG student
Staff
(If PG student then name of guide and co guide)
Guide
______________________________________________
Co Guide
______________________________________________
Co-investigators ______________________________________________
S.NO
POINTS TO CONSIDER
DECISION
COMMENTS AND
SUGGESTIONS IF ANY
1.
Scientific Design and
conduct of Study
a) Requires no Change
b) Requires minor changes
c) Requires major changes
2.
Examination of potential
risks/harms
a) Requires no Change
b) Requires minor changes
c) Requires major changes
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(Annexure -E)
Confidentiality Agreement
Title of Research Project:
As a member/chairman of the IEC, I understand that I may have access to confidential
information about study sites and participants. By signing this statement, I am indicating my
understanding of my responsibilities to maintain confidentiality and agree to the following:

I understand that names and any other identifying information about study sites and
participants will be kept completely confidential.

I understand that all information about study sites or participants obtained or accessed
by me in the course of the research by the investigators will be kept confidential. I
agree not to divulge or otherwise make known to unauthorized persons any of this
information, unless specifically authorized to do so by approved protocol or by the
local principal investigator acting in response to applicable law or court order, or
public health or clinical need.

I agree to notify the local principal investigator immediately should I become aware
of an actual breach of confidentiality or a situation which could potentially result in a
breach, whether this is on my part or on the part of another person.
______________________________
Signature
________________ _____________________
Date
Printed name
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