The objective of this Standard Operating Procedures of the Institutional Ethics Committee (IEC) of ESIC Medical College & Hospital, KK Nagar, Chennai is to maintain effective functioning of the IEC and to ensure quality and technical excellence and consistent ethical review of all the submitted health and biomedical research proposals and ongoing approved research studies involving human participants in accordance with the ICMR ethical guidelines for biomedical research on human subjects 2017.

Constitution and Composition of the IEC of ESIC Medical College & Hospital, Chennai

The Dean, ESIC Medical College & Hospital will appoint the Chairperson of the IEC and all the committee members based on their competence, experience and integrity by sending an official request letter. The members will give their acceptance letter to the Dean. The Chairperson will be from outside ESIC Medical College & Hospital, KK Nagar, Chennai. The members of the ESIC MC & Hospital, Chennai will include:

Chairperson (from outside ESIC MC & Hospital, Chennai)
One - two persons from basic medical science area
One - two clinicians from various departments
One legal expert or retired judge
One social scientist/ representative of non-governmental voluntary agency
One philosopher/ ethicist/ theologian
One lay person from the community
Member Secretary (from inside ESIC MC & Hospital, Chennai)

The chairperson of the IEC will be from outside the Institution to maintain the independence of the Committee. The Member Secretary will belong to the same Institution and will conduct the business of the Committee. Other members will be a mix of medical / non-medical, legal, scientific and non-scientific persons and may also include members of public to reflect the differed points of view.

There will be representation of age and gender in the Committee to safeguard the interest and welfare of all sections of the society. Member should be aware of local, social and cultural norms, as this is an important social control mechanism. The IEC may invite subject experts to take their views, whenever it is needed.

All members of the IEC will serve for a period of 5 years on a renewable basis. New members will be included in the IEC in a phased manner such that there will be presence of new and old members in the IEC at any given point of time. The Dean in consultation with the Chairperson may disqualify any member of the IEC during the term, if their contribution is not adequate or if they are non-available for a long period of time for review and meetings. A member may resign their post in the IEC after providing a month’s advance notice in writing to the Dean through the Chairperson.

All members must have undergone training on Research Ethics and this should be documented in the IEC secretariat in the form of training certificates. All members should also sign a confidentiality agreement and this should be documented.

Roles and Responsibilities of Members

The members of the IEC have the responsibility to ensure that all research conducted at ESIC MC & Hospital, Chennai

Are sound in design, have statistical validity and are conducted according to the Indian Council of Medical Research and International Conference on Harmonization/Good Clinical Practice guidelines
Do not compromise right, safety and benefits of the patients or volunteers/ study participants.
No undue exploitation of the research participants takes place
The goals of research, however important, should never be permitted to override the health and wellbeing of the research subjects.
Are conducted under the supervision of trained medical / bio-medical persons with the required expertise
Properly documented informed consent is always obtained from the participants
Include, solely, patients or participant who have given voluntary and informed consent
It may be ensured that no research project shall be / can be started unless Ethics Clearance / Approval is obtained
No retrospective / post facto Ethics Clearance/ Approval can be provided to research projects which were neither submitted nor wetted by the IEC.
Serious adverse event reports submitted to the IEC are reviewed in a timely manner and adjudicated

During a full board IEC Meeting the following will be the roles of the members:

The Member Secretary will present the minutes of the previous meeting
Decisions made through Expedited review process will be presented by the Member Secretary for approval by the IEC
The full board meeting will be closed meeting with only the IEC members and special invitees in attendance. The PI of the research studies may be invited into the meeting if necessary, for providing clarifications.
The Chairperson will call the meeting to a start
Each technical member of the IEC will review and present the research studies allotted to them and highlight ethical issues and concerns
The members of the IEC will discuss each project
If required, the Principal Investigator will be called into the meeting for clarifications
Decisions on approval of research proposals will be made by consensus among IEC members
The decision of the Chairperson will be final
The Member Secretary will prepare a brief minutes of the meeting with the important decisions on the proposals and this will be signed by all members of the ethics committee and filed.
The Member Secretary will take detailed notes of the minutes of the meeting and submit the minutes to the IEC members for approval, which will be archived for storage.
The Member Secretary will communicate the decision of the IEC on various research studies to the respective PIs through email.

Quorum for a Full Board Meeting of the IEC

Quorum for a full board IEC meeting is said to be present if the following conditions are met:

At least one basic medical scientist
At least one clinical scientist
One legal expert
One social scientist / NGO representative / philosopher / ethicist / theologian
Chairperson / Alternate Chairperson
Member Secretary / Alternate Member Secretary
At least one member from outside the institution, one non scientific member, and one member from opposite gender should be present

Application procedure

The dates of the IEC meeting will be publicized in advance through the institution website and through official announcement
The last date for submission of proposals is two weeks ahead of the planned SRC meeting and at least four weeks ahead of the planned IEC meeting
The format of the IEC application is enclosed in the Annexure
All relevant document along with the application form including:
- Synopsis of Proposal
- Full proposal
- Questionnaire, data collection proforma
- Informed consent form
- Translated documents in local language if applicable
- Copies of other material to be used including educational material
- Comments by the Scientific Review Committee (SRC), responses of the PI to the SRC comments and highlights of the revisions incorporated after SRC review.

Should be submitted as email attachment to the Secretariat of the IEC addressed to the Chairperson through the Member Secretary.

All applications not on the recommended application format and all incomplete applications will be rejected.

Review Procedure

All research proposals will be reviewed by the Scientific Review Committee (SRC), ESIC MC and Hospital, Chennai. The SRC review will focus on the scientific and technical aspects of the research. External experts in the field will be invited for the SRC meeting and their comments will be documented and shared with the researchers. This thorough SRC review will ensure that only ethical issues are discussed during the IEC meeting.
The meeting of the ESIC MC & Hospital, Chennai IEC will be held twice every year, once in April-May and once in Oct-Nov. Additional meetings can be held as required, based on the number of proposals submitted and special requirements.
The Member Secretary will initially review the submitted proposals, for completeness, adherence to the application guidelines and revert to the PI within 1 week of submission. At this point the Member Secretary will communicate to the PI whether the application is complete, and in case it is incomplete, the Member Secretary will request the PI to submit a revised application with a last date for submission. All incomplete submissions as on the last date for submission of revised applications, will be rejected and not taken up for the IEC meeting.
The Member Secretary will perform an initial review and classify the proposals into the following three categories:
- Exemption from review: Proposals which present less than minimal risk fall under this category as may be seen in following situations: Research on educational practices such as instructional strategies or effectiveness of or the comparison among instructional techniques, curricula, or class room management methods.
- Expedited review: The proposals presenting no more than minimal risk to research participants may be subjected to expedited review. The Member- Secretary and the Chairperson of the IEC or designated member of the Committee or may do expedited review under the following conditions –
  - Minor deviations from originally approved research during the period of approval (usually of one-year duration).
  - Revised proposal previously approved through full review by the IEC or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis.
  - Research activities that involve only procedures listed in one or more of the following categories: Clinical studies of drugs and medical devices only when –
    - Research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or
    - Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is reported.
  - Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical) purposes, when the participants’ personal identity is not collected or used for analysis
  - Research by students involving questionnaire-based surveys, record reviews, non-invasive tests, which comprise of less than minimal risk to the research participants, such that it does not ask sensitive questions, does not deal with a stigmatizing illness, does not involve vulnerable participants.
  - When in emergency situations like serious outbreaks or disasters a full review of the research is not possible, prior written permission of IEC may be taken before use of the test intervention. Such research can only be approved for pilot study or preliminary work to study the safety and efficacy of the intervention and the same participants should not be included in the clinical trial that may be initiated later based on the findings of the pilot study.
    - Research on interventions in emergency situation When proven prophylactic, diagnostic, and therapeutic methods do not exist or have been ineffective, physicians may use new intervention as investigational drug (IND) / devices/ vaccine to provide emergency medical care to their patients in life threatening conditions. Research in such instance of medical care could be allowed in patients
      - when consent of person/ patient/ responsible relative or custodian/ team of designated doctors for such an event is not possible. However, information about the intervention should be given to the relative/ legal guardian when available later;
      - When the intervention has undergone testing for safety prior to its use in emergency situations and sponsor has obtained prior approval of DCGI;
      - Only if the local IEC reviews the protocol since institutional responsibility is of paramount importance in such instances.
      - If Data Safety Monitoring Board (DSMB) is constituted to review the data;
    - Research on disaster management : A disaster is the sudden occurrence of a calamitous event at any time resulting in substantial material damage, affecting persons, society, community or state(s). It may be periodic, caused by both nature and humans and creates an imbalance between the capacity and resources of the society and the needs of the survivors or the people whose lives are threatened, over a given period of time. It may also be unethical sometimes not to do research in such circumstances. Disasters create vulnerable persons and groups in society, particularly so in disadvantaged communities, and therefore, the following points need to be considered when reviewing such research:
      - Research planned to be conducted after a disaster should be essential culturally sensitive and specific in nature with possible application in future disaster situations.
      - Disaster-affected community participation before and during the research is essential and its representative or advocate must be identified.
      - Extra care must be taken to protect the privacy and confidentiality of participants and communities.
      - Protection must be ensured so that only minimal additional risk is imposed.
      - The research undertaken should provide direct or indirect benefits to the participants, the disaster-affected community or future disaster- affected population and a priori agreement should be reached on this, whenever possible, between the community and the researcher.
      - All international collaborative research in the disaster-affected area should be done with a local partner on equal partnership basis.
      - Transfer of biological material, if any, should be as per Government rules taking care of intellectual property rights issues.
- Full Review: All research presenting with more than minimal risk, proposals/ protocols which do not qualify for exempted or expedited review and projects that involve vulnerable population and special groups shall be subjected to full review by all the members. This involves studies which include collection of blood, body fluid, urine, stool, hair, nail, mucosal samples from participants. It also involves questionnaire-based studies which involve more than minimal risk, asks questions on sensitive topics, stigmatizing conditions, and involves vulnerable participants.
The studies identified for exemption from review will be documented by the Member Secretary and the Member Secretary will provide a letter exempting the study from review. This will be presented in the full board IEC meeting.
The studies identified for expedited review will be circulated to the Chairperson and, the Member Secretary and the Chairperson in consultation will review these and make a decision. The decision will be communicated to the PI by the Member Secretary and this decision will be presented in the full board IEC meeting.
Copies of the studies identified for full review will be circulated to all IEC members. Each member will be identified as the lead reviewer of a certain number of proposals. These members will have to read, review and present a summary of these projects on the day of the IEC meeting. Following this, the IEC will discuss and come to a decision on the proposals. The Chairperson and Member Secretary will not be responsible for review of proposals. Their primary role will be to facilitate, conduct, and document the IEC meeting.
While reviewing the proposals the reviewers may consider the following ethical issues:
- Whether comments of scientific review committee have been addressed and whether the study is based on sound science
- Risks and benefit analysis
- Procedure for selection of study participants – inclusion, exclusion criteria
- Research related injuries and compensation
- Post study access to treatment, intervention
- How the findings of the research will be disseminated, how will it be used
- Information sheet – easy to understand, clear
- Informed consent form
- Measures to protect privacy and confidentiality of participants
- Community engagement measures
- Justice and non-discrimination of study participants

Decision after IEC Review

After a detailed review, the IEC may arrive at one of the following four decisions:

- Approval
- Rejection
- Expedited Review after revision – expedited review will be performed after the PI submits the revised proposal
- Full Review after revision – The proposal has to be reviewed by the full board after incorporating the revisions.
Decision of the meeting on the proposals will be communicated by the Member Secretary in writing to the PI / Research Scholar within 10 working days after the meeting at which the decision was taken
The letter of decision from the IEC will contain the following:
- Name and address of IEC.
- The date, place and time of decision.
- The name and designation of the applicant.
- Title of the research proposal reviewed.
- The clear identification of protocol no., version no., date, amendment no., date.
- Along with protocol, other documents reviewed- Clear description of these documents along with Version No. and Date.
- Type of review – exemption, expedited, full board review
- List of IEC members who attended the meeting- clear description of their role, affiliation and gender.
- A clear statement of decision reached.
- Any advice by the IEC to the applicant including the schedule / plan of ongoing review by the IEC
- In case of conditional decision, any requirement by IEC, including suggestions for revision, and the procedure for having the application re-reviewed.
- In case of rejection of the proposal, reason(s) for the rejection will be clearly stated.
- Signature of the member secretary with date.

Follow up procedures after approval by IEC

IEC will review the progress of all the studies for which a positive decision has been reached from the time of decision till the termination of the research.
Periodic status reports of the approved research should be submitted to the IEC – quarterly for studies which are of less than 2 years duration and half yearly for longer studies
Final report of the study along with an abstract should be submitted at the completion of the study
Following instances and events will require the follow-up review/ Renewed Approval:
- Any protocol amendment likely to affect rights, safety or well-being of research subject of conduct of study.
- Serious or unexpected ADR related to study or product, action taken by Investigator, Sponsor and Regulatory Authority.
- Any event or information that may affect the benefit/risk ratio of the study
Protocol deviation, if any, should be informed with adequate justifications.
Any new information related to the study should be communicated.
Premature termination of study shall be notified with reasons along with summary of the data obtained so far.
Change of investigators/sites must be informed to the office of IEC
Monitoring: Oversight mechanism will be in place to monitor the approved studies. Actual site visits can be made especially in the event of reporting of adverse events or violations of human rights and appropriate action will be taken when required and communicated to the applicant indicating modification/suspension/termination /continuation of the project. In case the IEC desires so, reports of monitoring done by the sponsor and the recommendations of the DSMB may also be sought.
Applicant must inform the time of completion of study and must send the result summary to IEC. IEC must receive a copy of final summary of study completed from the applicant

Record keeping and archiving by the IEC

All documents will be dated, filed and archived in the IEC in electronic, digital form.
The electronic digital database will be password protected and will be accessible only to the member secretary and office staff of the IEC
All the documents related to research proposals will be archived for a minimum period of 3 years in the Institute, following the completion /termination of the study.
The IEC members will not retain or have access to any of the research related documents after the IEC meeting. They will delete all the documents in their email and computers
The following administrative files will be filed in the IEC office
- Constitution and Composition of the ESIC MC and Hospital,
  KK Nagar, Ethical Review Committee
- Curriculum Vitae of all IEC members
- Certificates of training in research ethics of all IEC members
- Standard Operating Procedure of Ethical Review Committee of ESIC MC and Hospital, KK Nagar
- Minutes of meeting
- Annual Reports
- A record of all income and expenses of the EC, including allowances and reimbursements made to the secretariat and EC members
- Copy of all study protocols with enclosed documents, progress reports, and SAEs
- Agendas and Minutes of all IEC meetings duly signed by the Chairperson / Member secretary.
- Copy of ICMR Ethical Guidelines for Medical Research on Human Participants 2017
- Copy of all correspondence with members, Principal Investigators and other regulatory bodies
- Copy of all final reports of studies reviewed by the IEC

Annexure 1: Ethical Review Committee Appointment Order

Dr/ Mr. / Mrs.: _________________________________Date: _________________

I am pleased to appoint you as __________________________ of the Ethical Review Committee (IEC) at ESIC Medical College & Hospital, KK Nagar, Chennai w.e.f.___________ for a term of ________ year / months provided following conditions of appointment are met.

1. You should be willing to publicize your full name, profession & affiliation.

2. You are willing to record all reimbursement for work & expenses, if any, within or related to an IEC & make it available to the public upon request.

3. You consent to sign confidentiality agreement between you & the IEC regarding meeting deliberations, applications, information on research participants, & related matters.

The renewal of your appointment will be by consensus & 1 month notice on either side will be necessary prior to resignation/ termination of appointment. Terms & Conditions regarding the resignation procedure, disqualification procedures, replacement procedures etc. may be found in the Standard Operating Procedures (SOPs) of IEC, ESIC MC and Hospital, KK Nagar, Chennai.

You will be paid a sum of Rs______________ per sitting as Honorarium for your services rendered.

We sincerely hope your association with IEC, ESIC MC and Hospital, KK Nagar, Chennai will be fruitful to the Institute & the Community we serve.

Chairperson Signature of Appointee IEC, ESIC MC and Hospital KK Nagar, Chennai

Annexure 2: Confidentiality Agreement to be signed by all IEC Members

Confidentiality Agreement Form for IEC Members

In recognition of the fact, that I _________________________________________________

(Member’s name, and his/her affiliation) herein referred to as the “undersigned”, have been appointed as a member of the IEC, have been asked to assess research studies involving research participants in order to ensure that they are conducted in a humane and ethical manner, adhering to the highest standards of care as per the national, and local regulations and institutional policies and guidelines and international and national guidelines; Whereas, the appointment of the undersigned as a member of the IEC is based on individual merits and not as an advocate or representative of a home province, territory or community nor as a delegate of any organization or private interest;

Whereas, the fundamental duty of an IEC member is to independently review both scientific and ethical aspects of research protocols involving human subjects and make a determination and the best possible objective recommendations, based on the merits of the submissions under review;

Whereas, the IEC must meet the highest ethical standards in order to merit the trust and confidence of the communities in the protection of the rights and well-being of research participants;

The undersigned, as a member of the IEC, is expected to meet the same high standards of ethical behavior to carry out its mandate. This Agreement thus encompasses any information deemed Confidential or Proprietary provided to the Undersigned in conjunction with the duties as a member of the IEC.

Any written information provided to the undersigned that is of a Confidential, Proprietary, or Privileged nature shall be identified accordingly. As such, the undersigned agrees to hold all Confidential or Proprietary trade secrets (“information”) in trust or confidence and agrees that it shall be used only for contemplated purposes and shall not be used for any other purpose or disclosed to any third party.

Written Confidential information provided for review shall not be copied or retained. All Confidential information (and any copies and notes thereof) shall remain the sole property of the IEC. The Undersigned agrees not to disclose or utilize, directly or indirectly, any Confidential or Proprietary information belonging to a third party in fulfilling this agreement. Furthermore, the Undersigned confirms that his/her performance of this agreement is consistent with the institute’s policies and any contractual obligations they may have to third parties.

In the course of my activities as a member of the IEC, I may be provided with confidential information and documentation (which we will refer to as the Confidential Information; subject to applicable legislation, including the Access to "Confidential Information"). I agree to take reasonable measures to protect the Information Act, not to disclose the Confidential Information to any person; not to use the Confidential Information for any purpose outside the Committee's mandate, and in particular, in a manner which would result in a benefit to myself or any third party; and to destroy all Confidential Information (including any minutes or notes I have made as part of my duties) to the Chairperson upon termination of my functions as a Committee member.

I, ________________________________________________ (name of the member) have read and accept the aforementioned terms and conditions as explained in this Agreement.

__________________________ __________________

Signature Date

Annexure 3: Application form of Ethical Review Committee

Application form of Institutional Ethics Committee, ESIC MC & Hospital, Chennai

PART A: Summary

Title of the research

Principal investigator, contact details

Name

Position

Department

Work address

Telephone number

Email ID

Purpose of the research: (Tick as appropriate)

Student Research

Dissertation

Educational Research

Medical Audit or Health Service Evaluation

Other _________________________________________________

Select from the list below to describe your research: (You may select more than one)

Research on or with human participants

Research working with data of human participants

New data collected by qualitative methods

New data collected by quantitative methods

New data collected from observing individuals or populations

Routinely collected data or secondary data

Research working with aggregated or population data

Research using already published data or data in the public domain

Research working with human tissue samples

Will the participants be from any of the following groups? (Tick as appropriate)

Children under 16 Specify age group: ___________________________________

Adults with disabilities

Adults with other forms of mental incapacity or mental illness

Adults in emergency situations or critically ill adults

Prisoners or young offenders

Those who could be considered to have a particularly dependent relationship with the investigator, eg members of staff, students

Other vulnerable groups

No participants from any of the above groups

Please justify the inclusion of the above groups, explaining why the research cannot be conducted on non-vulnerable groups.

Give a short summary of the research (500 words)

This section must be completed in language comprehensible to the lay person. Do not simply reproduce or refer to the protocol, although the protocol can also be submitted to provide any technical information that you think the ethics committee may require. This section should cover the main parts of the proposal.

What are the main ethical issues with the research and how will these be addressed?

Indicate any issues on which you would welcome advice from the ethics committee. Specifically focus on issues of autonomy, risks, benefits, privacy, confidentiality, justice.

PART B: About the research team
If this is a MD/MS dissertation, what degree and what subject? If MBBS research project, just mention MBBS
Supervisor’s name
Department
Supervisor’s telephone number
Supervisor’s email address
Other co-investigators names with affiliation and details
Part C: The research
What are the aims of the study? (Must be in language comprehensible to a lay person.)
How will this study add value to the society? How will it add value to scientific knowledge? (explain in simple words why this study is important and what social and scientific value it will add)
Describe the design of the research. Qualitative methods as well as quantitative methods should be included. (Must be in language comprehensible to a lay person.) It is important that the study can provide information about the aims that it intends to address. If a study cannot answer the questions/ add to the knowledge base that it intends to, due to the way that it is designed, then wasting participants’ time could be an ethical issue.
What will participants be asked to do in the study? (e.g. number of visits, time, travel required, interviews)
Proposed study dates and duration Research start date (DD/MM/YY): _________________ Research end date (DD/MM/YY): _________________ Fieldwork start date (DD/MM/YY): _________________ Fieldwork end date (DD/MM/YY): _________________
Where will the research be undertaken? (i.e, in the village, in the city, in the hospital, in the college etc.)

RECRUITMENT & CONSENT PROCESSES

How will potential participants in the study be identified, approached and recruited?

How will you ensure an appropriately convened sample group in order to meet the aims of the research? Give details for subgroups separately, if appropriate. How will any potential pitfalls, for example dual roles or potential for conflicts of interest, be addressed?

Will you be excluding any groups of people, and if so what is the rationale for that?

Excluding certain groups of people, intentionally or unintentionally may be unethical in some circumstances. It may be wholly appropriate to exclude groups of people in other cases

How many participants will be recruited and how was the number decided upon?

It is important to ensure that enough participants are recruited to be able to answer the aims of the research.

If you have a formal sample size calculation please replicate it here.

Will informed consent be obtained from the research participants?

Yes No

If yes, give details of how it will be done. Give details of any particular steps to provide information (in addition to a written information sheet) e.g. videos, interactive material. If you are not going to be obtaining informed consent you will need to justify this.

Will individual or group interviews/ questionnaires discuss any topics or issues that might be sensitive, embarrassing or upsetting, or is it possible that criminal or other disclosures requiring action could take place during the study (e.g. during interviews or group discussions)? The information sheet should explain under what circumstances action may be taken.

Yes No If yes, give details of procedures in place to deal with these issues.

Will individual research participants receive any payments, fees, reimbursement of expenses or any other incentives or benefits for taking part in this research?34

Yes No

If Yes, please describe the amount, number and size of incentives and on what basis this was decided.

RISKS OF THE STUDY

What are the potential benefits and/ or risks for research participants in both the short and medium-term? (list the benefits and risks in detail)

C.18 Does the research involve any risks to the researchers themselves, or people not directly involved in the research? Eg lone working

Yes No

RESEARCH DATA

Explain what measures will be put in place to protect personal data. E.g. anonymisation procedures, secure storage and coding of data. Any potential for re-identification should be made clear to participants in advance.

How will you make your research data available to others in line with: the University’s, funding bodies’ and publishers’ policies on making the results of publically funded research publically available. Explain the extent to which anonymity will be maintained. (max 200 words)

How do you intend to share the research data? (Indicate with an ‘X)

Submission of Dissertation / Project Report

Sharing data with other organisations

Publication of direct quotations from respondents

Publication of data that might allow identification of individuals to be identified

Submitting to a journal to support a publication

Depositing in a self-archiving system or an institutional repository

Dissemination via a project or institutional website

Informal peer-to-peer exchange

Depositing in a specialist data centre or archive

Other, please state: _____________________________________________.

No plans to report or disseminate the data

How do you intend to report and disseminate the results of the study? (Indicate with an ‘X)

Conference presentation

Peer reviewed journals

Publication as a dissertation

Publication on website

Other publication or report, please state: _______________________________

Submission to regulatory authorities

Other, please state: _______________________________________________.

No plans to report or disseminate the results

CONFLICTS OF INTEREST

Will any of the researchers or their institutions receive any other benefits or incentives for taking part in this research over and above normal salary or the costs of undertaking the research?39

Yes No

If yes, indicate how much and on what basis this has been decided

Is there scope for any other conflict of interest?

C.27 Does the research involve external funding? (Tick as appropriate)

Yes No If yes, what is the source of this funding? ___________________________________

C.27 Does the research involve external funding? (Tick as appropriate)

Yes No If yes, what is the source of this funding? ___________________________________

PART D: Declarations

Declaration by Principal Investigators

The information in this form is accurate to the best of my knowledge and belief and I take full responsibility for it.
I undertake to abide by the institution’s ethical and health & safety guidelines, and the ethical principles underlying good practice guidelines appropriate to my discipline.
If the research is approved I undertake to adhere to the study protocol, the terms of this application and any conditions set out by the Ethical Review Committee (IEC).
I undertake to seek an ethical opinion from the IEC before implementing substantial amendments to the protocol.
I undertake to submit progress reports if required.
I am aware of my responsibility to be up to date and comply with the requirements of the law and relevant guidelines relating to security and confidentiality of patient or other personal data,
I understand that research records/ data may be subject to inspection for audit purposes if required in future.
I understand that the IEC may choose to audit this project at any point after approval.

Principal Investigator:

Signature of Principal Investigator: ................................................................

(This needs to be an actual signature rather than just typed. Electronic signatures are acceptable)

Print name: ........................................................ Date: (dd/mm/yyyy): ....................................

Supervisor of student research:

I have read, edited and agree with the form above.

Supervisor’s signature: ................................................................

(This needs to be an actual signature rather than just typed. Electronic signatures are acceptable)

Print name: ........................................................ Date: (dd/mm/yyyy): .........................................

Annexure 4: Application Checklist

S.No	Item	Checklist
1	Application form completed
2	Declaration form signed by the PI
3	Covering letter from PI, forwarded by Guide and HoD
4	Full proposal Rationale for undertaking the investigations in human participants in the light of existing knowledge, inclusion and exclusion criteria for entry of participants. Precise description of methodology of the proposed research, including sample size (with justification), type of study design (observational, experimental, pilot, randomized, blinded etc.), intended intervention, dosages of drugs, route of administration, duration of treatment and details of invasive procedures if any, Plan to withdraw or withhold standard therapies in the course of research. Plan for statistical analysis of the study.
5	Proforma for data collection / questionnaire in English
6	Local language translation of proforma / questionnaire if applicable
7	Information sheet and informed consent form in English
8	Information sheet and informed consent form in local language if applicable
9	In case of drug trials, pre-clinical information
10	Scientific Review Committee Report, responses of PI and revisions
11	Financial information, funding information, grant details
12	Other relevant documents required – material transfer agreement, memoranda of understanding in case of collaborative research, copies of education material, advertisements and participant recruitment brochures

Annexure 5: Checklist for developing Informed Consent Form

Checklist of items to be present in the informed consent form

Information Sheet:

Title of study
Name of principal investigator
Designation and Institutional Affiliation
Background problem of the study explained
Objective of the study explained
What will be done during participation in the study – randomization, blinding, study procedures such as investigations, treatments
What are the anticipated risks of participating in the study – physical risks, mental and emotional risks, social risks
What are the anticipated benefits of participating in the study – will any compensation be provided, larger benefits to the society
A statement that the findings of the study may be analysed statistically and presented in conferences and workshops – may be published in research papers and journals
A statement that individual identifying information will be kept confidential.
A statement that the participation is voluntary, and the participant may withdraw at any time without giving reasons
A statement that refusal to participate in the study will not adversely affect their treatment
Contact details of investigator for further clarifications – mobile phone number

Consent sheet:

A statement that the participant has read and understood all the information / the information has been read out to them and they have understood
A statement that they are willing to participate voluntarily
A statement that they understand that they can withdraw at any time without giving reasons
A statement that they consent to the access and use of their research data by the researchers, and Institutional Ethics Committee for research presentation, writing and monitoring purposes
Signature of participant /legally acceptable representative
Witness signature in case of illiterate

Annexure 6: Communication of Decision of the IEC

Protocol title:

Principal Investigator:

Name & Address of Institution:

Type of Review: New Review / Revised Review / Expedited Review

Decision of the IEC/ IRB:

Recommended / Recommended with suggestions / Revision required /Rejected/Suggestions/ Reasons/ Remarks:

Recommended for a period of:

Please note * - Inform IEC immediately in case of any adverse events and serious adverse events. - Inform IEC in case of any change of study procedure, site and investigator - This permission is only for period mentioned above. Annual report to be submitted to IEC - Members of IEC have right to monitor the trial with prior intimation.

Signature of Member Secretary

IEC, ESIC MC & Hospital, KK Nagar, Chennai

Annexure 7: IEC Approval Letter Format

Protocol title:

Principal Investigator:

Name & Address of Institution:

Documents reviewed with version no. and date

List of IEC members present in the meeting

Decision of the IEC

Conditions of the approval

Recommended for a period of:

Signature of Member Secretary

IEC, ESIC MC & Hospital, KK Nagar, Chennai

INSTITUTIONAL ETHICS COMMITTEE (IEC)

S.No	Name of the Member	Speciality	Institutional Affiliation	Role
1	Dr. Srikumari Damodharam	Surgical Gastroenterology	Non Affiliated	Chairperson
2	Dr. Nataraj	Anaesthesiology	Affiliated	Clinician Member
3	Dr. M Ravish Kumar	Microbiology	Affiliated	Basic Medical Scientist
4	Dr. Priavadhana R	Pathology	Affiliated	Member Secretary, Basic Medical Scientist
5	Dr. Panduranga C	Pathology	Affiliated	Alternative Member Secretary, Basic Medical Scientist
6	Dr. Vignesh D	Community Medicine	Affiliated	Clinician/Statistician/ Ethicist
7	Dr. Saravanan	General Surgery	Non Affiliated	Clinician Member
8	Dr. Sudha	Pharmacology	Non Affiliated	Clinician Member
9	Dr. Baily Vincent	Social Work	Non Affiliated	Social Scientist
10	Dr. Arul Paul	Social Work	Non Affiliated	Social Scientist
11	Justice Kirubakaran	Law	Non Affiliated	Legal Expert
12	Ms. Jainy Joseph	Linguistics	Non Affiliated	Community Representative

Last updated / Reviewed : 2024-03-19

Medical Educational Institutions

Medical Educational Institutions

What's New

Ethnic-committee

Objectives

Quorum for a Full Board Meeting of the IEC

Application procedure

Review Procedure

Decision after IEC Review

Follow up procedures after approval by IEC

Record keeping and archiving by the IEC

Annexure 2: Confidentiality Agreement to be signed by all IEC Members

Annexure 3: Application form of Ethical Review Committee

Annexure 4: Application Checklist

Annexure 5: Checklist for developing Informed Consent Form

निर्देश

Instructions

You are being directed to CPGRAM website. You would be asked to Register with CPGRAM if not already registered. Registered users can login directly using their CPGRAM user ID and password.