INSTITUTIONAL ETHICS COMMITTEE (IEC)

MAHARAJA SRIRAM CHANDRA BHANJA DEO UNIVERSITY

ETHICAL REVIEW PROCEDURES: AS PER THE ICMR GUIDELINES]

INTRODUCTION

Institutional Ethics Committee (IEC), also referred to as, Institutional Review Board (IRB), Ethics
Review Board (ERB) and Research Ethics Board (REB) in many countries and situations, serves
as an independent representative and competent body to review, evaluate and decide on the
scientific and ethical merits of research proposals. The primary purpose of this committee is to
protect the rights, safety and well being of human subjects who participate in a research project.
The Ethics Committees are entrusted with the initial review of the proposed research protocols
prior to initiation of the projects and also have a continuing responsibility of regular monitoring of
the approved programmes till the same are completed. Such an ongoing review is in accordance
with the Declaration of Helsinki and all the international guidelines for biomedical research. The
need for evaluation of research proposals has been emphasized under the Statement of General
Principles at item no. 5 (http://icmr.nic.in/human_ethics.htm#Guidelines) pertaining to precaution
and riskminimization.

BASIC RESPONSIBILITIES

The basic responsibility of an Institutional Ethics Committee (IEC) is to ensure a competent

review of all ethical aspects of the project proposals received by it in an objective manner. IECs
should provide advice to the researchers on all aspects of the welfare and safety of the research
participants after ensuring the scientific soundness of the proposed research through appropriate
Scientific Review Committee. In institutions where this is lacking, the IEC may take up the dual
responsibility of review of both, the scientific content and ethical aspects of the proposal. It is
advisable to have separate Committees for each, taking care that the scientific review precedes the
scrutiny for ethical issues. The scientific evaluation should ensure technical appropriateness of the
proposed study. The IECs should specify in writing the authority under which the Committee is
established.

Small institutions could form alliance with other IECs or approach registered IEC. Large
institutions/Universities with large number of proposals can have more than one suitably
constituted IECs for different research areas for which large number of research proposals are
submitted. However, the institutional policy should be same for all these IECs to safeguard the
research participant's rights.

The main IEC may review proposals submitted by undergraduate or post-graduate students or if
necessary, a committee may be separately constituted for the purpose, which will review

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proposals in the same manner as described above. The responsibilities of an IEC can be defined
as follows:-

• To protect the dignity, rights and well being of the potential researchparticipants.
• To ensure that universal ethical values and international scientific standards are expressed
in terms of local community values andcustoms.
• To assist in the development and the education of a research community responsive to
local health carerequirements.

COMPOSITION

The IECs should be multidisciplinary and multisectorial in composition. Independence and

competence are the two hallmarks of an IEC. The number of persons in an ethics committee
should be kept fairly small (8 - 12 members). It is generally accepted that a minimum of five
persons is required to form the quorum without which a decision regarding the research should
not be taken. The members should be a mix of medical/ non-medical, scientific and non-
scientific persons including lay persons to represent the differed points of view.

The composition may be as follows:-

1. Chairperson
2. One - two persons from basic medical sciencearea
3. One - two clinicians from variousInstitutes
4. One legal expert or retiredjudge
5. One social scientist / representative of non-governmental voluntaryagency
6. One philosopher / ethicist /theologian
7. One lay person from thecommunity
8. MemberSecretary

As per revised Schedule Y of Drugs & Cosmetics Act, 1940, amended in 2005, the ethics
committee approving drug trials should have in the quorum at least one representative from the
following groups:

1. One basic medical scientist (preferably onepharmacologist).

2. Oneclinician
3. One legal expert or retiredjudge
4. One social scientist/ representative of non-governmental organization / philosopher /
ethicist / theologian or a similarperson
5. One lay person from thecommunity.

The Ethics Committee (EC) can have as its members, individuals from other institutions or
communities with adequate representation of age and gender to safeguard the interests and
welfare of all sections of the community/society. If required, subject experts could be invited to
offer their views, for instance, a pediatrician for pediatric conditions, a cardiologist for cardiac
disorders etc. Similarly, based on the requirement of research area, for example HIV, genetic
disorders etc. it is desirable to include a member from specific patient groups in the Committee.
Members should be aware of local, social and cultural norms. Only those Ethics Committee
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members who are independent of the sponsor and clinical trial should vote/provide opinion in
matters related to the study.

TERMS OF REFERENCE

The Terms of References should include Terms of Appointment with reference to the duration of
the term, the policy for removal, replacement, resignation procedure, frequency of meetings, and
payment of processing fee to the IEC for review, honorarium / consultancy to the members/
invited experts etc. and these should be specified in the SOP which should be made available to
each member. Every IEC should have its own written SOPs according to which the Committee
should function.

The SOPs should be updated periodically based on the changing requirements. The term of
appointment of members could be extended for another term and a defined percentage of
members could be changed on regular basis. It would be preferable to appoint persons trained in
bioethics or persons conversant with ethical guidelines and laws of the country. Substitute
member may be nominated if meetings have been continuously missed by a member due to
illness or other unforeseen circumstances. For this the criteria for number of missed meetings
may be defined in the SOP.

TRAINING

The EC members should be encouraged to keep abreast of all national and international
developments in ethics through orientation courses on related topics by its own members or
regular training organized by constituted body(ies), so that they become aware of their role and
responsibilities. For drug trial review it is preferable to train the IEC members in Good Clinical
Practice. Any change in the regulatory requirements should be brought to their attention and they
should be aware of local, social and cultural norms, as this is the most important social control
mechanism.

REGULATION

Once the legislation of guidelines occurs which is currently under active consideration by the
Ministry of Health, Government of India, a Biomedical Research Authority will be set up under
the proposed Bill on Biomedical Research on Human Participants(Promotion and Regulation)
which would require that all IECs register with this Authority. It will also evaluate and monitor
functioning of the IECs, and develop mechanisms for enforcing accountability and transparency
by the institutions.

REVIEW PROCEDURES

The IEC should review every research proposal on human participants before the research is
initiated. It should ensure that a scientific evaluation has been completed before ethical review is
takenup.TheCommitteeshouldevaluatethepossibleriskstotheparticipantswithproper

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justification, the expected benefits and adequacy of documentation for ensuring privacy,
confidentiality and the justice issues.

The IEC’s member-secretary or secretariat shall screen the proposals for their completeness and
depending on the risk involved categorize them into three types, namely, exemption from review,
expedited review and full review (see below for explanation). Minimal risk would be defined as
one which may be anticipated as harm or discomfort not greater than that encountered in routine
daily life activities of general population or during the performance of routine physical or
psychological examinations or tests. However, in some cases like surgery, chemotherapy or
radiation therapy, great risk would be inherent in the treatment itself, but this may be within the
range of minimal risk for the research participant undergoing these interventions since it would
be undertaken as part of current everyday life. An investigator cannot decide that her/his protocol
falls in the exempted category without approval from the IEC. All proposals will be scrutinized
to decide under which of the following three categories it will beconsidered:

1. Exemption from review

Proposals which present less than minimal risk fall under this category as may be seen in
following situations:

i. Research on educational practices such as instructional strategies or effectiveness of or the

comparison among instructional techniques, curricula, or classroom management methods.

Exceptions:
i. When research on use of educational tests, survey or interview procedures, or observation of
public behavior can identify the human participant directly or through identifiers, and the
disclosure of information outside research could subject the participant to the risk of civil or
criminal or financial liability or psychosocialharm.

ii. When interviews involve direct approach or access to privatepapers.

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 Subcommittee of the IEC may do expedited review only if the protocols
involve-
1. Minor deviations from originally approved research during the period of approval(usually
of one yearduration).

2. Revised proposal previously approved through full review by the IEC or continuingreview
of approved proposals where there is no additional risk or activity is limited to dataanalysis.

3. Research activities that involve only procedures listed in one or more of the following
categories:
a. Clinical studies of drugs and medical devices only when-
i. research is on already approved drugs except when studying drug interaction or
conducting trial on vulnerable populationor

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 ii. Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor
nature isreported.
4. Research involving clinical materials (data, documents, records, or specimens) that have
been collected for non-research (clinical)purposes.

5. 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 pilotstudy.

a. 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 suchinstance
of medical care could be allowed in patients -

i. 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 availablelater;

ii. When the intervention has undergone testing for safety prior to its use in emergency
situations and sponsor has obtained prior approval of the Drug Controller General of
India(DCGI);

iii. Only if the local IEC reviews the protocol since institutional responsibility is of
paramount importance in suchinstances.

iv. If Data Safety Monitoring Board (DSMB) is constituted to review thedata;

b. 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 suchresearch:

i. Research planned to be conducted after a disaster should be essential culturally

sensitive and specific in nature with possible application in future disaster
situations.

ii. Disaster-affected community participation before and during the research is

essential and its representative or advocate must beidentified.

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 iii. Extra care must be taken to protect the privacy and confidentialityof
participants andcommunities.

iv. Protection must be ensured so that only minimal additional risk isimposed.

v. 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 theresearcher.

vi. All international collaborative research in the disaster-affected area should be

done with a local partner on equal partnershipbasis.

vii. Transfer of biological material, if any, should be as per Government rules

taking care of intellectual property rightsissues.

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.

While reviewing the proposals, the following situations may be carefully assessed against the
existing facilities at the research site for risk/benefit analysis:

a. Collection of blood samples by finger prick, heel prick, ear prick, orvenipuncture:
i. from healthy adults and non-pregnant women who weigh normal for their age and not
more than 500 ml blood is drawn in an 8 week period and frequency of collection is not
more than 2 times perweek;

ii. from other adults and children, where the age, weight, and health of the participants, the
collection procedure, the amount of blood to be collected, and the frequency with which it
will be collected has been considered and not more than 50 ml or 3 ml per kg, whichever is
lesser is drawn in an 8 week period and not more than 2 times perweek;

iii. from neonates depending on the haemodynamics, body weight of the baby and other
purposes not more than 10% of blood is drawn within 48 – 72 hours. If more than this
amount is to be drawn it becomes a risky condition requiring infusion/bloodtransfusion;

iv. prospective collection of biological specimens for research purposes by noninvasive

means. Forinstance:

1. skin appendages like hair and nail clippings in a non-disfiguringmanner;

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 2. dental procedures - deciduous teeth at time of exfoliation or if routine patient
care indicates a need for extraction of permanent teeth; supra and subgingival
dental plaque and calculus, provided the collection procedure is not more invasive
than routine prophylactic scaling of theteeth;
3. excreta and external secretions (includingsweat);
4. uncannulated saliva collected either in an unstimulated fashion or stimulated by
chewing gum or by applying a dilute citric solution to thetongue;
5. placenta removed atdelivery;
6. amniotic fluid obtained at the time of rupture of the membrane prior to or
duringlabor;
7. mucosal and skin cells collected by buccal scraping or swab, skin swab, or
mouthwashings;
8. sputum collected after saline mist nebulization and bronchiallavages.

b. Collection of data through noninvasive procedures routinely employed in clinical

practice. Where medical devices are employed, they must be cleared/ approved for
marketing, for instance-
i. physical sensors that are applied either to the surface of the body or at a
distance and do not involve input of significant amounts of energy into the
participant or an invasion of the participant'sprivacy;
ii. weighing or testing sensoryacuity;
iii. magnetic resonanceimaging;
iv. electrocardiography,echocardiography; electroencephalography, thermography,
detection of naturally occurring radioactivity, electroretinography, ultrasound,
diagnostic infrared imaging, Doppler bloodflow,
v. moderate exercise, muscular strength testing, body composition assessment,
and flexibility testing where appropriate given the age, weight, and health of the
individual.

c. Research involving clinical materials (data, documents, records, or specimens) that will
be collected solely for non-research (clinical)purposes.

d. Collection of data from voice, video, digital, or image recordings made for research
purposes.

e. Research on individual or group characteristics or behavior not limited to research on

perception, cognition, motivation, identity, language, communication, cultural beliefs or
practices, and social behavior or research employing survey, interview, oral history, focus
group, program evaluation, human factors evaluation, or quality assurancemethodologies.

SUBMISSION OF APPLICATION

The researcher should submit an application in a prescribed format along with the study protocol
as prescribed in SOP of IEC concerned. The protocol should include the following: -

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 1. The title with signature of Principal Investigator (PI) and Co-investigators as attestation for
conducting thestudy.

2. Clear research objectives and rationale for undertaking the investigation in human
participants in the light of existingknowledge.

3. Recent curriculum vitae of the Investigators indicating qualification andexperience.

4. Participant recruitment procedures and brochures, ifany.

5. Inclusion and exclusion criteria for entry ofparticipants.

6. 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 ifany.

7. Plan to withdraw or withhold standard therapies in the course ofresearch.

8. Plan for statistical analysis of thestudy.

9. Procedure for seeking and obtaining informed consent with sample of patient information
sheet and informed consent forms in English and locallanguages.

10. Safety of proposed intervention and any drug or vaccine to be tested, including results of
relevant laboratory, animal and humanresearch.

11. For research involving more than minimal risk, an account of management of such risk or
injury.

12. Proposed compensation and reimbursement of incidental expenses and management of

research related and unrelated injury/ illness during and after researchperiod.

13. An account of storage and maintenance of all data collected during thetrial.

14. Plans for publication of results - positive or negative - while maintaining the privacy and
confidentiality of the studyparticipants.

15. A statement on probable ethical issues and steps taken to tackle the same likejustification
for washout of standard drug, or the use of placebocontrol.

16. All other relevant documents related to the study protocol like investigator's brochure for
trial on drugs/devices /vaccines /herbal remedies and statement of relevant regulatoryclearances.

17. Agreement to comply with national and international Good Clinical Practices (GCP)
protocols for clinicaltrials.

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 18. Details of Funding agency/ Sponsors and fund allocation. (Format for MSCBD
University provided)

19. For international collaborative study details about foreign collaborators and documents for
review of Health Ministry's Screening Committee(HMSC) or appropriate Committees under
other agencies/authority like Drug Controller General of India(DCGI)

20. For exchange of biological material in international collaborative study a MoU/ Material
Transfer Agreement between the collaboratingpartners.

21. A statement on conflict-of-interest (COI), ifany.

DECISION MAKING PROCESS

The IEC should be able to provide complete and adequate review of the research proposals
submitted to them. It should meet periodically at frequent intervals to review new proposals,
evaluate annual progress of ongoing ones, review serious adverse event (SAE) reports and assess
final reports of all research activities involving human beings through a previously scheduled
agenda, amended wherever appropriate. The following points should be considered while doing
so:

1. The decision must be taken by a broad consensus after the quorum requirements are fulfilled
to recommend / reject / suggest modification for a repeat review or advice appropriate steps. The
Member Secretary should communicate the decision in writing to the Principal Investigator(PI).

2. If a member has conflict-of-interest (COI) involving a project then s/he should submit this in
writing to the chairperson before the review meeting, and it should also be recorded in the
minutes.,

3. If one of the members has her/his own proposal for review or has any COI then s/he should
withdraw from the IEC while the project is beingdiscussed.

4. A negative decision should always be supported by clearly definedreason.

5. An IEC may decide to reverse its positive decision on a study if it receives information that
may adversely affect the risk/ benefitratio.

6. The discontinuation of a trial should be ordered if the IEC finds that the goals of the trial have
already been achieved midway or unequivocal results areobtained.

7. In case of premature termination of study, notification should include the reasons for
termination along with the summary of results conducted tilldate.

8. The following circumstances require the matter to be brought to the attention ofIEC:

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 a. any amendment to the protocol from the originally approved protocol with proper
justification;

b. serious and unexpected adverse events and remedial steps taken to tacklethem;

c. any new information that may influence the conduct of thestudy.

9. If necessary, the applicant/investigator may be invited to present the protocol or offer

clarifications in the meeting. Representative of the patient groups or interest groups can be
invited during deliberations to offer theirviewpoint.

10. Subject experts may be invited to offer their views, but should not take part in the decision
making process. However, her / his opinion must berecorded.

11. Meetings are to be minuted which should be approved and signed by the Chairperson/
alternate Chairperson/ designated member of thecommittee.

REVIEW PROCESS

The method of review should be stated in the SOP whether the review should be done by all
reviewers or by primary reviewer(s) in which case a brief summary of the project with informed
consent and patient information sheet, advertisements or brochures, if any, should be circulated
to all the othermembers.

The ethical review should be done in formal meetings and IEC should not take decisions
through circulation of proposals.The committee should meet at regular intervals and should
not keep a decision pending for more than 3 - 6 months, which may be defined in theSOP.

PERIODIC REVIEW
The ongoing research may be reviewed at regular intervals of six months to one year as may be
specified in the SOP of the ethics committee.

CONTINUING REVIEW
The IEC has the responsibility to continue reviewing approved projects for continuation, new
information, adverse event monitoring, follow-up and later after completion if need be.

INTERIM REVIEW
Each IEC should decide the special circumstances and the mechanism when an interim review
can be resorted to by a sub-committee instead of waiting for the scheduled time of the meeting
like re-examination of a proposal already examined by the IEC or any other matter which should
be brought to the attention of the IEC. However, decisions taken should be brought to the notice
of the main committee.

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 MONITORING

Once IEC gives a certificate of approval it is the duty of the IEC to monitor the approved studies,
therefore an oversight mechanism should be in place. Actual site visits can be made especially in
the event of reporting of adverse events or violations of human rights. Additionally, periodic
status reports must be asked for at appropriate intervals based on the safety concerns and this
should be specified in the SOP of the IEC. SAE reports from the site as well as other sites are
reviewed by IEC and appropriate action taken when required. In case the IEC desires so, reports
of monitoring done by the sponsor and the recommendations of the DSMB may also be sought.

RECORD KEEPING

All documentation and communication of an IEC are to be dated, filed and preserved according
to written procedures. Strict confidentiality is to be maintained during access and retrieval
procedures. The following records should be maintained for the following:

i. the Constitution and composition of theIEC;

ii. signed and dated copies of the latest the curriculum vitae of all IEC members with records of
training ifany;

iii. standard operating procedures of theIEC;

iv. National and Internationalguidelines;

v. copies of protocols submitted forreview;

vi. all correspondence with IEC members and investigators regarding application, decision and
follow up;

vii. agenda of all IECmeetings;

viii. minutes of all IEC meetings with signature of theChairperson;

ix. copies of decisions communicated to theapplicants;

x. record of all notification issued for premature termination of a study with a summary of the
reasons;

xi. final report of the study including microfilms, CDs and Videorecordings.

It is recommended that all records must be safely maintained after the completion/termination of
the study for a period of 3 years if it is not possible to maintain the same for more than that due
to resource crunch and lack ofinfrastructure.

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 NB: This document has been adapted from ICMR Ethical Guidelines for Biomedical research
on Human Participants (2006), Institutional Ethics Review Board draft proposal of
Jawaharlal Nehru University, and Standard Operating Procedures of all India Institute Of
Medical Sciences, New Delhi Institute Ethics Committee.

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 STANDARD OPERATING PROCEDURES
OF
INSTITUTIONAL ETHICS COMMITTEE, MAHARAJA SRIRAM CHANDRA
BHANJA DEO UNIVERSITY

This Standard Operating Procedures (SOP) is to outline the development, approval, organization,
implementation and management of all Human Research protocols to be conducted in MSCBD
University. This SOP document is also meant to guide the researcher on how to apply for ethical
clearance, what all documents to submit and the points that s/he must observe while dealing with
human participants and / or materials. It is recommended that the following principles should
apply to all research carried out in the University as per national and international norms and
guidelines.

1. Informed consent and respect forconfidentiality

2. Enhanced ethical consideration in respect of those who may be vulnerable, which

includes tribal populations from backward regions, illiterates,, small children and people
with cognitive deficits / patients/ institutionalized persons/ homes for the aged/ who may
not be able to comprehend the purpose of study and yet may be obliged toparticipate

3. Consideration of risks, maximized benefit, minimized harm:, Research should balance

the anticipated benefits against potential harms to the biosphere including human or
animal subjects, and theenvironment.

STANDARD OPERATING PROCEDURES

For Institutional Ethics Committee on Human participants MSCBD University

1. OBJECTIVES
The IEC is responsible for reviewing research involving human participants at this institution, to
ensure that subjects' safety, rights, and welfare are protected in conformity with applicable
regulations and guidelines issued by the ICMR, UNESCO, WHO, Indian state and local laws and
regulations where such laws or regulations provide protection for human subjects that exceed the
protection afforded under national law. A number of studies pursued in MSCBD University
include biological sample (blood / tissue/ stored sample) collected from diseased and normal
subjects for research purposes; and non-invasive studies on speech and language deficit in cases
of neurological damage, aphasia studies, dyslexia and developmental disorders of language etc.
Non invasive studies also include socio-psychological, socio-cultural studies involving human
participants. All such studies on biological samples, stored samples, behavioural data samples
and socio-cultural-psychological data samples involving human participants need ethical
clearance by Institutional Ethics Committee (IEC). Clinical trial of new drugs developed from

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natural/syntheticsourcesincludingnewdrugformulationsarecarriedoutonhumansubjects

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after ascertaining their safety and efficacy through pre-clinical trial. New formulations developed
from already approved drugs are subjected to clinical trial involving human volunteers.
Pathological investigation & biochemical parameter observation of healthy human participants as
well as patients suffering from a particular disease, bioavailability & bioequivalence studies of
drugs / drug formulations and patient counseling also need ethical clearance by Institutional
Ethics Committee (IEC). All such studies require IEC clearance before the commencement of the
study.

This Standard Operating Procedures (SOP) is to outline the development, approval, organization,
implementation and management of all Human Research protocols to be conducted in MSCBD
University. The Committe is entrusted not only with the initial review of the proposed research
protocols prior to the initiation of the project; in case of adverse effects reported by the Principal
Investigator (PI) /participants, the Committe is also mandated to review and fix
compensations/reimbursement. All adverse effects/ injury /damage/ loss /death must be reported
immediately to the IEC, death to be reported within 24 hours, as per Government of India (GOI)/
Central Drugs Standard Control Organization (CDSCO) norms.

In case of modifications in research tools & procedures during the course of the study, reported
by the PI/ participants, the Committee is also mandated to review and accept/reject the
modifications proposed as the case may be.

2. ROLE AND RESPONSIBILITIES OF THE REVIEWCOMMITTE

The basic responsibility of IEC is to ensure a competent review of all ethical aspects of the
project proposals received by it in an objective manner. IEC shall provide advice to the
researchers on all aspects of the welfare and safety of the research participants after ensuring the
scientific soundness of the proposed research through appropriate Scientific Review Committee.
The mandate of the committee will be to review all research projects involving human
subjects/materials to be conducted in different Departments, affiliated colleges/ research
institutes, centers of MSCBD University. The Committee will review all research proposals
involving human subjects, submitted by faculty members and research students/Research
Fellow/Postdoctoral Fellow (through their respective Supervisors/Mentors). Each investigator
shall be responsible, for proving the benefit of placing human subjects at risk, and assure the
review committee about appropriate Informed Consent Process and Subject Confidentiality. All
studies need to be approved before the study procedures begin provide details of primary
data/secondary data/stored samples/cell lines/ Buying data to the review committee in her/his
presentation; also assure the review committee about appropriate IC process &subject
confidentiality before the commencement of the study. No completed studies or those already
being pursued will be reviewed by the Board.

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3. OPERATING PROCEDURES

CONSTITUTION OFIEC.
As per ICMR guidelines, the IEC should be multidisciplinary and multisectorial in composition.
Independence and competence are the two hallmarks of an Institutional Ethics Review
Board/Committee. The members should be a mix of medical/ non-medical professionals, legal
experts, experts from sciences and social sciences and humanities, philosophers and activists,
internal and external; also including lay persons from NGO's to represent the civil society. (See
appendix B for relevant sections of ICMR guidelines) A panel of names in each one of the
categories specified below, approved by the Syndicate, will serve as the Institutional Ethics
Committee- MSCBD University.
.
Constitution of Institutional Ethics Committee (IEC)

1. Chairperson(External)
2. Scientist from Medical Practice(External)
3. Scientist from Basic Sciences(External)
4. Scientist from Basic Sciences (MSCBDUniversity)
5. Social Scientist / Philosopher / Social Activist(External)
6. Social Scientist / Philosopher / Activist (MSCBDUniversity)
7. Member of another IEC (RMRC (ICMR) / AIIMS / anyother)
8. Legal Advisor(External)
9. Legal Advisor(Internal)
10. Lay Persons (NGOs representatives of Civil Society/laypersons).
11. Member Secretary (MSCBDUniversity)

As per revised Schedule Y of Drugs & Cosmetics Act, 1940, amended in 2005, the ethics
committee approving drug trials should have in the quorum at least one representative from the
following groups:
1. One basic medical scientist (preferably onepharmacologist).
2. Oneclinician
3. One legal expert or retiredjudge
4. One social scientist/ representative of non-governmental organization / philosopher/
ethicist / theologian or a similarperson
5. One lay person from thecommunity

COMPOSITION OF A REVIEWCOMMITTEE.
The number of persons in an ethics committee should be 8 to 12, drawn from the panel of names
approved by the Syndicate, as specified above. The Chairperson, IEC will approve the names of
the members of a review committee, at least one from each category, depending on the nature of
the research proposal to be reviewed. (Appendix A for the current Panel of Experts in the IEC-
MSCBD University).

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 APPOINTMENT, RESIGNATION ANDRECONSTITUTION

For appointment to the committee, a candidate should have had at least 10 years of work
experience at positions of significant responsibility. Professional integrity and commitment to
human welfare would be important criteria for inclusion as members. After the initial
constitution, subsequent appointment to the committee shall be guided by the quorum
requirements and activity of the members involved. As per ICMR guidelines, the appointee will
be informed of the rights and duties of the committee, and that the external members will receive
honorarium for every consultative meeting held on the campus.

All Committee members shall sign a confidentiality agreement at the time of appointment, the
terms of which shall be binding on them even after the term expires. Co-opted members are also
expected to sign confidentiality agreement. All members, except the Chairperson and Member
Secretary, shall serve a maximum of a three-year term on the committee, after which a fresh
panel of three names in the same category will be submitted to the Syndicate, MSCBD
University so that one out of the three may be appointed in place of the retiring person. For the
sake of continuity, the Chairperson and the Member-Secretary will have a term of five years.
Extension of membership may be considered due to non-availability of members of similar
stature, qualification and intent to contribute to ethical humantesting.

Members may voluntarily resign from the Committee at a month's notice citing appropriate
reasons, and in case of internal members, their membership would be considered withdrawn, if
they resign from the University. A member who has direct involvement or self affirmed conflict
of interest with a proposal being considered shall not form a part of the quorum.
If a member is found to have a conflict of interest with the results of decision and fails to declare
the same, or is found to have drawn direct benefit arising out of the results of the research, or has
involved self-interest with the sponsor(s) or investigators, his/her membership shall be
terminated with provision of appropriate legal proceedings. In case a member breaches the
confidentiality, his/her membership shall be terminated and the institution may initiate
appropriate legalproceedings.

HONORARIUM
External members of the IEC, and experts invited (if any) shall receive honourarium/seating fee
as per rules of the University.

PROCEDURE FOR SUBMISSION ANDREVIEW

The IEC will ordinarily meet once in two to three months or more if required, to review all the
applications, including proposals for MA, M.Sc, M. Pharm, M.Tech, M.Phil, Ph.D; also
including research proposals submitted by the faculty involving human subjects materials for any
kindofdata.AllproposalsshallbereviewedaspertheapplicableguidelinesgiveninAppendix
C. (see Research and Protocol Organization Guidelines in Appendix C.) Exact meeting date shall
be notified ordinarily 7 days in advance so that all members can make themselves available for
the purpose. However, in case of pressing need, this can be convened with a short notice. The
Chairperson/Member-Secretaryshallbetheconvenerwithresponsibilityoflayingoutthe

5|Page
agenda for the meeting. All material relevant to the agenda shall be made available to IEC in
advance. Before they are circulated to the external members the Member Secretary of the
committee together with one or two internal members, will screen the proposals, to see if it needs
(i) exemption from review, or (ii) expedited review or (iii) full review, see appendix B, for
relevant excerpts from ICMR guidelines (pp 26 to 28).

All protocols should be submitted in the format prescribed in Appendix C. The proposals shall be
addressed and submitted to the office of the Member Secretary, Institutional Ethics
Committee, Department of ----, MSCBD University, Takatpur, Mayurbhanj - 757003. Eight
copies each of the documents should be submitted (see 3.5 for list of documents). An application
should be submitted at least two weeks prior to the next review meeting. A unique submission
number shall be assigned to proposals submitted forreview.

To Review MA/ M.Sc/ M.Pharm/ M.Tech/ M.Philproposals:

The constitution of the committee to review students' proposals will be as under:
1. Chairperson or hisnominee
2. Two externalmembers
3. At least one legal expertmember
4. Two or three internalmembers
5. Member -Secretary

Further the committee will review MA/ MSc./ M.Pharm/ M. Tech./ M. Phil proposals in a time
bound manner. This committee will take full responsibility of all the decisions. Ph. D proposals
will be reviewed in the main committee along with the faculty research proposals.

Recommendation of theCommittee:
After discussion, the committee may make one of the following recommendations:

• Approval - indicating that the proposal is approved assubmitted;

• Approval after clarifications - indicating that the proposal is approved if the
clarification(s) requested are provided to the satisfaction of designated committee
members;
• Approval after amendment(s) - indicating that the proposal is approved subject to the
incorporation of the specified amendment(s) verified by designated committeemembers;
• Deferment - indicating that the proposal is not approved as submitted but it can be
reassessed after revision to address the specified reason(s) fordeferment;
• Disapproval - indicating that the proposal is not approved for the reasonsspecified.
Format for the Ethical clearance certificate will be as given in the Appendix C.

Authority under which IEC isconstituted:

The Institutional Ethics Committee (IEC) will be constituted by the Vice Chancellor for a
period of two years. However, the Committee will continue until the formation of a
subsequent Committee.

6|Page
 Membershiprequirements:
a. The duration of appointment is initially for a period of 2years
b. At the end of 2 years, as the case may be, the committee is reconstituted, and 50% of the
members will be replaced by a definedprocedure.
c. A member can 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.
d. A member can tender resignation from the committee with proper reasons to doso.
e. All members should maintain absolute confidentiality of all discussions during the meeting
and sign a confidentialityform.
f. Conflict of interest should be declared by members of theIEC

Quorumrequirements:
The minimum of 5 members are required to compose a quorum. All decisions should
be ordinarily taken in meetings after going through proposals.

Offices
The Chairperson will conduct all meetings of the IEC. If for reasons beyond control, the
Chairperson is not available, the Deputy Chairperson or 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 appropriateauthority.

Independentconsultants
IEC may call upon subject experts as independent consultants who may provide special review
of selected research protocols, if need be. These experts may be specialists in ethical or legal
aspects, specific diseases or methodologies, or represent specific communities, patient groups or
special interest groups e.g. Cancer patients, HIV/AIDS positive persons or ethnic minorities.
They are required to give their specialized views but do not take part in the decision making
process which will be made by the members of the IEC.

ApplicationProcedures:
a. All proposals should be submitted in the prescribed application form, the details
of which are given underDocumentation
b. All relevant documents should be enclosed with application forms. Required number of copies
of the proposal along with the application and documents in prescribed format duly signed by the
Principal Investigator (PI) and Co-investigators / Collaborators should be forwarded by the Head
of the Departments / Institution to the Institutional EthicsCommittee.
c. The date of meeting will be intimated to the researcher, to be present, ifnecessary
7|Page
to offer clarifications.
d. The decision will be communicated in writing. If revision is to be made, the revised document
in required number of copies should be submitted within a stipulated period of time as specified
in the communication or before the nextmeeting.
e. Prescribed fee if any, to be decided by the university should be remitted along with the
application.

DOCUMENTS FOR SUBMISSION OF THEPROPOSAL:

1. Protocol of the proposed research in the prescribed format whichincludes:

Rationale / Backgroundinformation
A description of the ethical considerations involved in theresearch
Case report forms, diary cards, and other questionnaires intended for researchparticipants
Summary of safety, pharmacological, pharmaceutical, and toxicological data available on the
study product, whereverapplicable
Statement of agreement to comply with ethicalprinciples
Statement of conflict ofinterest
Name and address of the Sponsor/Fundingagency
Insurance Statement (Whereverrequired)

2. Investigator's Brochure Including Report of PriorInvestigations

3. Investigator(s)'s curriculumvitae
4. InformedConsent
5. In case of students' proposals, synopsis of the MPhil/Ph.D research as approved bythe
Department/College/Centre.

Regarding Informed Consent, a template is given in the Appendix-E which may be modified
depending on the nature of participation expected from the studyparticipants.

DOCUMENTATION ANDRECORDS
The proceedings of all meetings shall be documented and shall be kept in confidence. The
release of the detailed documentation to non-committee members can only be made in case of
exceptional circumstances, which shall be verified either by court orders or by affirmative
opinions by the Chairperson and the Member Secretary. Minutes of the meeting shall be
circulated by Member Secretary for verification by the Chairperson and members present during
the discussion. After verification, the Member Secretary shall communicate final decisions
regarding protocols to the investigator(s). All documentation sample for different kinds of
studies and must be retained ordinarily for five years after the completion ofthe/study

The following records should be maintained by the IEC office:

I. The Constitution and composition of theIEC
II. SignedanddatedcopiesofthecurriculumvitaeofallIEC members with records of
training ifany

8|Page
 III. Standard Operating Procedures of the IEC and modifications approved form time to
time.
IV. National and Internationalguidelines
V. Copies of protocols submitted forreview
VI. All correspondence with the members of the Board, and investigators regarding
application, decision and followup;
VII. Notice and agenda of all IECmeetings;
VIII. Minutes of all IEC meetings with signatures of the Member Secretary and the
Chairperson.
IX. Copies of decisions communicated to theapplicants;
X. Record of all notifications issued for premature termination of a study with a summary
of thereasons;
XI. Final report of the study including microfilms, CDs and Video recordings/samples for
different kinds of studies. PI may be asked to report completion of thestudy.

NOTIFICATION OFAMENDMENTS
Any revision to an approved research protocol or written consent form if proposed, must be
brought to the attention of the committee for approval. Amendments to approved protocols and
other study related documents should not be initiated until the committee approval has been
obtained. All deviations from the study protocol should be documented in the original records
along with the reasons for doing so. In case of any adverse event the same along with the
remedial measures taken must be reported by the investigator(s) immediately to the Chairperson
and the Member Secretary besides making a note of it in the study documentation.

3.7 ANNUAL REVIEW AND FINAL REPORTING

The Committee should be updated regarding the progress of the study on an annual basis. The
Committee must be notified of the trials completed or terminated (wherever applicable). A copy
of the final report should be submitted as soon as it is available. Statement of PI regarding
conclusion/ completion/ termination/ abandonment of the study must be submitted as soon as the
study is terminated

3.8. RECONSTITUTION OF COMMITTEE

The Committee shall be considered non-functional and reconstitution considered in the following
instances:

No meeting is convened for a continuous period of 6 months

3.9 AMENDING THIS DOCUMENT

Any amendments to this document shall be approved under the same procedure as for other
proposals under the preview of IEC.

4. Appendices
Appendix A: List of Members of IEC
Appendix B: Relevant sections of the ICMR guidelines

9|Page
 Appendix C: Research Protocol Organization guidelines
Institutional Ethics Committee for Research involving Human Participants
Appendix D: Institutional Ethics Committee, MSCBD University
Appendix E: Informed consent Form (ICF)
Appendix F: Declaration by the Participant

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 APPENDIX A

The panel of names in each category as approved by the Syndicate, MSCBD University (one
member from eachcategory).

1. Chairperson(External)
Director, Regional Medical Research Centre (ICMR), Mayurbhanj

2. Scientist from Medical Practice(External)

i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………
iii.Mr/Mrs/Dr/Prof…………………………………..
iv.Mr/Mrs/Dr/Prof……………………………..

3. Basic Sciences / Researchers(External)

i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………
iii.Mr/Mrs/Dr/Prof…………………………………..
iv. Mr/Mrs/Dr/Prof……………………………..

4. Basic Sciences / Researchers (MSCBDUniversity)

i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………
iii.Mr/Mrs/Dr/Prof…………………………………..
iv. Mr/Mrs/Dr/Prof……………………………..

5. Social Scientist /Philosopher Social / Activist(External)

i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………
iii.Mr/Mrs/Dr/Prof…………………………………..
iv. Mr/Mrs/Dr/Prof……………………………..

6. Social Scientist /Philosopher Social / Activist (MSCBDUniversity)

i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………
iii.Mr/Mrs/Dr/Prof…………………………………..
iv. Mr/Mrs/Dr/Prof……………………………..

7. Advisor from another IEC/IERB (ICMR(RMRC)/ ILS/anyother)

i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………
iii.Mr/Mrs/Dr/Prof…………………………………..
iv. Mr/Mrs/Dr/Prof……………………………..

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 8. Legal Advisor(external)
i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………
iii.Mr/Mrs/Dr/Prof…………………………………..
iv. Mr/Mrs/Dr/Prof……………………………..

9. Legal Advisor (MSCBDUniversity)

i. Mr/Mrs/Dr/Prof.…………………………………..
ii. Mr/Mrs/Dr/Prof.……………………………………

10. Laypersons:
i. Mr/Mrs/.…………………………………..
ii. Mr/Mrs/.……………………………………
iii.Mr/Mrs/ …………………………………..
iv. Mr/Mrs/ ……………………………..

11. Member Secretary (MSCBD University, one senior professor from the Department of
Anthropology/Biotechnology/Botany/Chemistry/ Zoology and/or AlliedSciences)

Prof/Dr.. …………………………..

*Duration: The Committee is constituted ordinarily for two years.

**The purview of Institutional Ethics Committee (IEC) of MSCBD University will generally cover
research projects/proposals that involve human subjects, such as Anthropology/Biotechnology/ Botany/
Chemistry/ Zoology and/or Allied Sciences.

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 APPENDIX B

Excerpts from ICMR Guidelines (page 12-15)

The IEC's Member-Secretary or secretariat shall screen the proposals for their completeness and
depending on the risk involved categorize them into three types, namely, exemption from
review, expedited review and full review (see below for explanation). Minimal risk would be
defined as one which may be anticipated as harm or discomfort not greater than that encountered
in routine daily life activities of general population or during the performance of routine physical
or psychological examinations or tests. However, in some cases like surgery, chemotherapy or
radiation therapy, great risk would be inherent in the treatment itself, but this may be within the
range of minimal risk for the research participant undergoing these interventions since it would
be undertaken as part of current everyday life. An investigator cannot decide that her/his protocol
falls in the exempted category without approval from the IEC. All proposals will be scrutinized
to decide under which of the following three categories it will beconsidered:

1. Exemption from review

Proposals which present less than minimal risk fall under this category as may be seen in
following situations:
i. Research on educational practices such as instructional strategies or effectiveness of or the
comparison among instructional techniques, curricula, or classroom managementmethods.
ii. Exceptions: When research on use of educational tests, survey or interview procedures, or
observation of public behavior can identify the human participant directly or through identifiers,
and the disclosure of information outside research could subject the participant to the risk of civil
or criminal or financial liability or psychosocialharm.
iii. When interviews involve direct approach or access to privatepapers.
a. 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 of the IEC may do expedited review only if the protocols involve-
1. Minor deviations from originally approved research during the period of approval (usually of
one yearduration).
2. 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 dataanalysis.
3. Research activities that involve only procedures listed in one or more of the following
categories:
a. Clinical studies of drugs and medical devices only when –
i. research is on already approved drugs except when studying drug interaction or conducting
trial on vulnerable populationor
ii. Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature isreported.
4. Research involving clinical materials (data, documents, records, or specimens) that have been
collected for non- research (clinical)purposes.
5. 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

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 efficacyoftheinterventionandthesameparticipantsshouldnotbeincludedintheclinical

14 | P a g e
 trial that may Institutional Ethics Review Board for Research involving Human Participants
Institutional Ethics Review Board for Research involving Human Participants be initiated later
based on the findings of the pilot study.
a. 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–

i. 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 availablelater;
ii. When the intervention has undergone testing for safety prior to its use in emergency situations
and sponsor has obtained prior approval ofDCGI;
iii. Only if the local IEC reviews the protocol since institutional responsibility is of paramount
importance in suchinstances.
iv. If Data Safety Monitoring Board (DSMB) is constituted to review thedata;
b. 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 suchresearch:
i. Research planned to be conducted after a disaster should be essential culturally sensitive and
specific in nature with possible application in future disastersituations.
ii. Disaster-affected community participation before and during the research is essential and its
representative or advocate must beidentified.
iii. Extra care must be taken to protect the privacy and confidentiality of participants and
communities.
iv. Protection must be ensured so that only minimal additional risk isimposed.
v. 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 theresearcher.
vi. All international collaborative research in the disaster-affected area should be done with a
local partner on equal partnershipbasis.
vii. Transfer of biological material, if any, should be as per Government rules taking care of
intellectual property rightsissues.

c. 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. While reviewing the proposals, the

15 | P a g e
 following situations may be carefully assessed against the existing facilities at the research site
for risk/benefit analysis:

1. Collection of blood samples by finger prick, heel prick, ear prick, or vein puncture, from
adults and children, where the age, weight, and health of the participants, the collection
procedure, the amount of blood to be collected, and the frequency with which it will be collected
is strictly as per WHOnorms.
2. Prospective collection of biological specimens for research purposes by noninvasive means,
forinstance:
d. Skin appendages like hair and nail clippings in a non-disfiguringmanner;
e. Dental procedures – deciduous teeth at time of exfoliation or if routine patient care indicates a
need for extraction of permanent teeth; supra and sub gingival dental plaque and calculus,
provided the collection procedure is not more invasive than routine prophylactic scaling of the
teeth;
f. Excreta and external secretions (includingsweat);
g. Unanimated saliva collected either in an unstimulated fashion or stimulated by chewing gum
or by applying a dilute citric solution to thetongue;
h. placenta removed atdelivery;
i. amniotic fluid obtained at the time of rupture of the membrane prior to or duringlabor;
j. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouthwashings;
k. sputum collected after saline mist nebulization and bronchiallavages.
l. Collection of data through noninvasive procedures routinely employed in clinical practice.
Where medical devices are employed, they must be cleared/ approved for marketing, for
instance:
m. physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the participant or an invasion of the
participant's privacy; weighing or testing sensoryacuity;
n. magnetic resonanceimaging;
o. electrocardiography, echocardiography; electroencephalography, thermography, detection of
naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging,
Doppler bloodflow,
p. moderate exercise, muscular strength testing, body composition assessment, and flexibility
testing where appropriate given the age, weight, and health of theindividual.
q. Research involving clinical materials (data, documents, records, or specimens) that will be
collected solely for non-research (clinical)purposes.
r. Collection of data from voice, video, digital, or image recordings made for researchpurposes.
s. Research on individual or group characteristics or behavior not limited to research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or
practices, and social behavior or research employing survey, interview, oral history, focus group,
program evaluation, human factors evaluation, or quality assurancemethodologies.

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 APPENDIX C

Research Protocol Organization guidelines

1. Protocol
Following are the section headings and brief guidelines on the protocol contents. Though the
arrangement below is not binding, conformance to these will enable speedy review

1. Title ofProject
2. PrincipalInvestigator
3. Co-Investigator and other investigative team member list with identified delegation of
responsibility
4. Rationale & background information: The Rationale specifies the reasons for conducting the
research in light of current knowledge. It should include a well documented statement of the
need/problem that is the basis of the project, the cause of this problem and its possible solutions.
It is equivalent to the introduction in a research paper and it puts the proposal in context. It
should answer the question of why and what: why the research needs to be done and what will be
itsrelevance.
5. Objectives: Specific objectives are statements of the research question(s). Objectives should
be simple, specific and stated in advance. After statement of the primary objective, secondary
objectives may bementioned.
6. Study Design: The scientific integrity of the study and the credibility of the study data depend
substantially on the study design and methodology. The design of the study should include
information on the type of study, the research population or the samplingframe.
7. Participant Selection Criteria: Patients who can take part in the study (e.g. inclusion and
exclusion criteria, withdrawal criteria etc.), and the expected duration of the study with follow up
periods.
8. Methodology: It should include detailed information on the procedures to be used,
measurements to be taken, observations to be made, laboratory investigations to be done etc.
along with a tabular form study schedule of procedures, for both Qualitative and quantitative-
studies
9. Evaluation of Safety: The adverse event & serious adverse event criteria and the process to
record and report to the IRB and any applicable regulatoryagency.
10. Research Questionnaire: The protocol should provide research questionnaire containing all
parameters understudy and also provide information on how the data will be collected including
data handling and coding for computer analysis, monitoring andverification.

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 11. Statistical Analysis: The statistical methods proposed to be used for the analysis of data
should be clearly outlined, including reasons for the sample size selected, power of the study,
level of significance to be used, in quantitative study. For Qualitative studies as in psychology&
cognitive science, the tools and instruments may be clearlyexplained
12. Informed Consent Forms: A description of the informed consent process is required
accompanied by copies of informed consent forms, both in English and the local language in
which they are going to be administered as per ICMR/WHO requirement. (DCGI/CDSCO
requirement for Drugtrials)
13. Budget: The budget section should contain a detailed item-wise breakdown of the funds
requested for, along with a justification for each item asapplicable.
14. Other support for the Project: This section should provide information about the funding
received or anticipated for this project from other fundingorganizations.
15. Collaboration with other scientists or research institutions, if any. A copy of ethical clearance
obtained from the other institution already, must besubmitted.
16. References: Brief description of the most relevant studies published, a minimum of 11 on the
subject also belisted.
17. Publication policy: Publication policy should be clearly discussed regarding the authorships
who will take the lead in publication and who will be acknowledged in publications. Guidelines
for the publication prescribed in AppendixD.
18. Statement of agreement to comply with ethicalprinciples.
19. Signature of PI and Supervisor or Research, Scholar, Co investigators, Chairperson/Dean of
theCentre/School.

2. Format for ethical clearancecertificate

3. Format for Participant Information Sheet (PIS)- Informed Consent Form(ICF)

Institutional Ethics Committee for Research involving Human Participants

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 APPENDIX-D

INSTITUTIONAL ETHICS COMMITTEE

MSCBD University
Takatpur, Mayurbhanj- 757003

Name of the Ethics Committee: IEC-MSCBD University Ref. No.....................................

Title of the Project Proposal:
Principal Investigator: Sponsor:
Fax:
Collaborators’ Name, Address, Tel. No. Fax &Email:

FOR OFFICIAL USE

The proposal was reviewed in a meeting held on (date) at (time). The following members
were present.
1. Chairperson
2. Member
3.
4.
5.
6.
7.
8. Member Secretary
The committee resolved to
[ ] Approve - indicating that the proposal is approved as submitted;
[ ] Approve- after clarifications - indicating that the proposal is approved if the clarifications
requested
are provided to the satisfaction of designated committee members;
[ ] Approve after amendment/s - indicating that the proposal is approved subject to the
incorporation of
the specified amendments verified by designated committee members;
[ ] Defer - indicating that the proposal is not approved as submitted but it can be re-assessed after
revision to address the specified reason/s for deferment;
[ ] Disapprove - indicating that the proposal is not approved for the reasons specified*.
Comments:
Date of Approval:
Member Secretary,
IEC, Ethics Committee
(To be filled in by PI and presented at the time of Review (Periodic, Continuing, and Interim)

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 Consent Form ( in English and in local language of the region)
Part I- PIS, Part II-ICF
Title of the Project:
Investigators:
Collaborators:
Potential Funding Agency:
PART -I Participant Information Sheet (PIS)
A brief description of the study objectives in simple language.............................................
.............................................................................................................................................
Section- A. The following have been explained to me,
1. Purpose of the Study [ ] Explained inDetail
.............................................
..............................................
2. Study Procedures []
.............................................
..............................................
3. Risk of the Study []
..............................................
..............................................
4. Benefits from the Study []
..............................................
5. Complications [ ] .............................................
..............................................
6. Compensations [ ] ...........................................
...........................................
7. Confidentiality [ ]

8. Rights of Participant [ ] ...........................................

...........................................
9. Alternatives to Participation in the Study [ ]

10.AnyOther ........................... [ ]

Name of the Subject/Participant:

Signature of Patient/Guardian:
Relationship to Subject:
Date:
Investigator’s Statement:
I, the undersigned have explained to the parent/guardian in a language she/he understands the
procedures to be followed in the study and risks and benefits.
Signature of the Investigator/ Date:
Name of the Investigator:
Signature of the Witness: Date:
Name of theWitness:

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 PART-II Informed ConsentForm(ICF) APPENDIX-E

The advantages and disadvantages of the research in which I am expected to participate, for
which I have to donate blood/ sputum/.hair sample/any other sample has been explained to me.
I willingly, under no pressure from the researcher agree to take part in this research, and agree to
participate in all investigations which will help acquire knowledge for the benefit of the mankind,
And I agree to donate my and my children's 5 ml blood/specify sample...)
My consent is explicitly not for disclosing any personal information. For disclosing any such
personal information obtained from the investigations conducted on my samples, further consent
should be obtained.

IhavebeeninformedthatMSCBDUniversityandtheresearchers(PI ....................................andher/his
colleagues) will take my prior consent before they draw benefits from research based on my
samples.

Signatures

................. ............................ ..............................

Subject/patient Witness Principle Investigator.

(Informed Consent Statement in Odia / Local Language/dialect)

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 SAMPLE II

Community Responses to Nutritional Rehabilitation in Odisha

INFORMED CONSENT OF RESPONDENTS IN IN-DEPTH INTERVIEWS AND FGD

Introduction: Mynameis ,Iamworkingfor

P.G.Departmentof ......................... ,MSCBDUniversity,Mayurbhanj.Weareinterviewingpeople
here (name of the city/ region/ site) in order to understand
your responses to the issues and the problems that you face on account of severely
undernourished children and your perceptions on availability and accessibility of services at the
nutritional rehabilitation centre. We are also trying to understand the reasons for the delay in
reaching the facilities. (Describe the purpose of the study). These issues are being studied in
another state aswell.
(Name of the otherstate

CONFIDENTIALITY AND CONSENT

The government has started nutritional rehabilitation centres in your state to take care of
malnourished children. In this context, it is important to understand the perceptions of mothers,
community leaders and the providers about the availability and access to these services. The goal
of this study is to understand the social dimensions, perceptions and likely determinants that
facilitate and act as barriers to home-based and institutional care of severe undernutrition.
It is with this main purpose that we wish to talk to you. Your honest answers to the questions will
help us understand all the involved issues better. We would highly appreciate your co-operation
to provide the information on the issues by your honest and frank responses to all the questions.
Your identity and information provided by you shall be completely confidential and the
information so gathered from different people shall be used only for research purposes. After
analysing the information we are gathering from you, we shall destroy the schedules. However,
if you feel strongly not to answer one or some of the question, you feel free not to answer such
questions. During the interview/Focus Group Discussion (FGD) process, if you feel not to go
ahead with the interview, you can withdraw from the interview at any time you want. You can
ask any question/clarify any doubt pertaining to the issues under study, its purpose or any other
related matter. The interview/FGD will take about half an hour-one hour to ask the questions. If
you are willing to participate, we can begin with the interview/FGD by yourconsent.

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 DECLARATION BYTHE PARTICIPANT APPENDIX-F

I have read/ I have been communicated the purpose and other details of the ICMR study
“Community Responses to Nutritional Rehabilitation in Odisha” and about my voluntary
participation in the study. I have been given an opportunity to ask questions and all of my
questions have been answered to my satisfaction. I have also been given the right not to answer
any question or withdraw from the study if I so desire.

BY SIGNING THIS FORM, I WILLINGLY AGREE TO PARTICIPATE IN THE RESEARCH

IT DESCRIBED.

Name and Signature of ParticipantDate

DECLARATION BY THE INVESTIGATOR

I have explained the research to the participant and answered all of his/her questions. I believe
that he/she understands the information described in this document and freely consent to
participate.

Name and Signature of the Investigator Date of the Interview

· Status of theinterview:

Completed Successfully 1
Respondent became uncomfortable and stopped answering 2
Some interruption due to which interview stopped 3
Did not agree to complete interview 4

References:
1. IEC guidelines ICMR
2. IEC guidelines Utkal University, Bhubaneswar

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