SOP Ethics Committee IHBAS

Institutional Biomedical Research Ethics Committee
IHBAS
Standard Operating Procedures
SOP Title: Standard Operating Procedures: Institutional Biomedical

Research Ethics Committee, IHBAS
♦ SOP Author(s). IHBAS, Ethics Committee Members
♦ SOP Status: Current
♦ Version: February 5, 2008
• Pages 23 pages
Approval 1: Ethics Committee
Approval 2: The Director
Developed by: Dr. Sangeeta Sharma

Member Secretary
IHBAS Ethics Committee
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SOPs Ethics Committee, IHBAS. Status Current Version 1 dated February 5, 2008 1
Prepared and issued by: Ethics Committee, IHBAS Approved by Director, IHBAS
CONTENTS
1.0 OBJECTIVE
_____________________________________________________________
2.0 PROCESS FLOW
3.1 Application Procedure
3.2 Pre Meeting Procedure
3.3. Meeting Procedure
3.4. Post Meeting Procedure
_____________________________________________________________
3.0 SOP - APPLICABLE TO
3.1 All Members of Ethics Committee
3.2 All personnel of the Ethics Office
3.3 All personnel submitting an application
_____________________________________________________________
4.0 DEFINITIONS
_____________________________________________________________
5.0 PROCEDURES
5.1 Composition of Committee
5.2 Term of appointment
5.3 Conditions of appointment
5.4 Functions of Committee
5.5 Responsibilities of Committee
5.6 Meeting Procedures
5.7 Application procedure
5.8 Committee Review Procedure
5.9 Decision making
5.10 Communicating a decision
5.11 Record keeping
_____________________________________________________________
6.0 INVESTIGATORS RESPONSIBILITIES
6.1 Notification of Amendments
6.2 Notification of Adverse Events
6.3 Annual Review and Renewal
6.4 Patient Information Leaflet
6.5 Patient Consent
6.6 Final Report
_____________________________________________________________
7.0 Appellate Authority
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1.0 OBJECTIVE
To ensure effective functioning of the Ethics Committee so that a quality and

consistent ethical review takes place as prescribed by the Ethical
Guidelines for Biomedical Research on Human Participants, ICMR,
2006 and that the content of the clinical trial documentation is relevant and
accurate, the submissions are prepared and progressed in a consistent
manner.
2.0 PROCESS FLOW
2.1 APPLICATION PROCEDURE
Inquiry to Ethics Office for submission procedures.
Ethics office to forward Submission must be

1. Application Form. received by Ethics Office
2. SOP at least 1 month prior to
Available in both next review meeting.
Hard copy or disc
All details of
1. Application form
2. Summary of the proposal & Justification for study, drug developmental history in case of drug
trials
3. Permission of the HOD & Head of the Institute
4. Protocol
5. Questionnaires
6. Informed consent form (Hindi and English)
7. Patient Information Leaflets (Hindi and English)
8. Investigator’s Brochure, in case of clinical
Post Meetin trial
9. Approval of DCGI in case of clinical trial
10. Agreement/ Undertaking by the Principal Investigator
11. Signed Indemnity bond
12. Insurance
13. Financial disclosure: Details of Funding agency/sponsors and fund allocation for the proposed
work.
14. Curriculum vitae of all the investigators
15. Any other voluntary disclosure
All documents must be bound & sent to Ethics Committee office for processing.
When all the above requirements are processed.

1. Log Proposal on Database.
2. Include on Agenda for next Committee Meeting.
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2.2 PRE MEETING PROCEDURE
Confirm date, time and agenda with the

Chairperson & book the meeting room
Notify all committee

members of next meeting Ensure that the meeting will
date. be properly constituted –at
least quorum of 5.
Each member is circulated with

Each protocol is allocated to all Agenda, Previous Meeting Minutes
committee member for detailed and a copy of all proposals,
review. protocols, Investigators Brochure
and appendices for review.
Inform each
Chief Investigator required to
Log all amendments, adverse attend the meeting at a appointed
events and notifications for time for presentation or
review at next meeting clarification, if any for their
proposal presentation.
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2.3 COMMITTEE MEETING PROCEDURE
A quorum of at least 5 members must be present.

Vice chairman. may act as Chairman in his/her absence
Each submission is discussed in

Previous Minutes and
detail and a list of queries is
Matters arising are discussed.
compiled
Each Investigator in turn answers any queries the

committee may have.
Decision mostly by consensus recorded in the minutes of the

meeting. If no consensus could be reached, dissent with reasons to
be recorded.
If any of the members are participating in a study that is under
review by the Committee, he/she must not participate in the
discussion on that submission and must absent him/herself from the
decision making.
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2.4. POST MEETING PROCEDURE
Recorded minutes are

maintained.
All Investigators of Investigators who submitted

protocols submitted for Amendments or Adverse
review are informed of the events for review will be
committee’s decision in notified of the committee’s
writing including any decision in writing.
modifications or conditions
within 2 weeks.
All correspondence must be

signed by the Member Secretary
All Ethically Approved Studies/Trials Must Include:

1. Application form
2. Summary of the proposal & Justification for study, drug
developmental history in case of drug trials
4. Protocol
5. Questionnaires
8. Investigator’s Brochure, in case of clinical trial
9. Approval of DCGI in case of clinical trial*
10. Agreement/ Undertaking by the Principal Investigator*
11. Signed Indemnity bond*
12. Insurance*
13. Financial disclosure: Details of Funding agency/sponsors and fund
allocation for the proposed work.
* Where Applicable
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3.0 SOP APPLICABLE TO
3.1 All members of the Ethics Committee

3.2 All personnel of the Ethics Office
3.3 All investigators submitting an application
4.0 DEFINITIONS
EC, IHBAS: Ethics Committee, IHBAS

ICH GCP: International Conference on Harmonisation of Good
Clinical Practice. (Harmonized Tripartite Guidelines for
Good Clinical Practice.)
Sch Y: Schedule Y, Regulatory Requirements for Clinical Trials in
India
DCGI Drugs Controller General of India
5.0 PROCEDURES
5.1 Composition of Committee.
The Institutional Biomedical Research Ethics Committee, IHBAS is

constituted by the Executive Council of the Institute. The EC, IHBAS
was established in 1996. A panel of members will be proposed by the
Director in consultation with the Chairperson and Vice Chairperson,
Ethics Committee and Heads of the departments for selection by the
Executive Council of IHBAS. The Ethics Committee will comprise of a
minimum 11 members and up to 15 members. Appellate authority will
be the Director. Majority of the members should be external. A
quorum of at least five members must be present at each
meeting. See Appendix A for current list of Members and their
qualifications. All members of the Committee, including ex-officio
members, are voting members.
5.2 Term of Appointment
The term of office of each member is three years (renewable for one
term). Any change to membership of the Ethics Committee must be
done by the Director from a panel of approved members. The Ethics
Committee can have as its members, individuals from other
institutions or committees, if required. If required, experts could be
invited to offer their views. The members be preferably trained in
bioethics or person should be conversant with ethical guidelines and
laws of the country.
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Replacement procedure
The members may be replaced at the discretion of the appointing

authority for the same.
Removal procedure
A member may be relieved of his/her membership in case of a conduct

unbecoming for a member of the Ethics Committee or inability to
participate in the three consecutive meetings on any grounds.
5.3 CONDITIONS OF APPOINTMENT
Name, age, gender, profession, and affiliation will be publicized

whenever the committee is reconstituted or there is a change in the
membership.
Conflict of interest to be disclosed if any exists.
Members must apprise themselves of the relevant documents, codes,

GCP, ICH guidelines and the ICMR code.
An investigator can be a member of the EC; however, the investigator-

as-member cannot participate in the review and approval process for
any project in which he or she has a present or potential conflict of
interest.
5.4 Functions
5.4.1. To review and approve research protocols, including surveys and other
data collecting instruments, if human subjects are involved or must
verify that the research needs criteria for exemption. To consider the
justification for conducting the proposed trial/study and the
circumstances under which proposed trial/study is to be conducted
and, where the committee considers that the proposed trial is justified
and it is satisfied with those circumstances, it shall give its approval to
the conducting of the proposed study and the person who is arranging
for the conducting of the proposed study in compliance with ICMR
guidelines 2006 and Drugs & Cosmetics Rules, 1945, amended 2005,
Schedule Y, Regulatory Requirements for Clinical Trials in India,
Central Drugs Standard Control Organization, DGHS, Ministry of Health
& Family Welfare, Government of India.
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5.4.2. The committee will not consider the proposed clinical trial/study ethical
unless it is satisfied that there is little risk of injury to participants and
that what risk their may be is justifiable. Risks incurred by
participants are few and justified by virtue of the potential benefits to
the individual participant and or future recipients of the trial/study
drug.
5.5 Committee Responsibilities
5.5.1. To safeguard the rights, safety and well being of all trial/study
subjects.
5.5.2. Obtain the following documents:
For thorough and complete review, all research proposals should be

submitted with the following documents:
i. Name of the applicant with designation

ii. Name of the Institute/Hospital/Field area where research will be
conducted
iii. Approval of the Head of the Department and institution.
iv. Protocol of the proposed research
v. A brief statement of the objectives and rationale for undertaking
the study in his/her own words along with the existing knowledge
on the subject. The statement must briefly outline the study
design and methodology; subject recruitment procedures; inclusion
and exclusion criteria and safety or risk factors associated with the
study.
If the study/clinical trial is a continuation of the previously
approved proposal summary of the results of the proposal along
with its status should be submitted with the new proposal.
vi. Ethical issues in the study and plans to address these issues.
vii. Proposal should be submitted with all relevant enclosures like
proformae, case report forms, questionnaires, follow up cards etc.
viii. Informed Consent process, including patient information sheet and
informed consent form in local language(s).
ix. For any drug/device trial, all relevant pre-clinical animal data and
clinical trial data and available Safety reports from other centres
within the country/countries, if available.
x. Curriculum vitae of all the investigators with relevant publications
in last five years (Signed and dated)
xi. Copy of signed Indemnity Form, approval of the DCGI, insurance
etc, where applicable.
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xii. Proposed compensation and reimbursement of incidental expenses.

xiii. Details of Funding agency/sponsors and fund allocation for the
proposed work.
5.5.3. To review proposed study with regard to the following:
i. The objectives and element of public good

ii. Scientific design and conduct of the study
iii. The sample size calculation
iv. The subject inclusion and exclusion criteria
v. The exposure of participants to risk
vi. Justification for the use of control arm
vii. The extent of medical and laboratory examination proposed
viii. The storage of data and laboratory samples
ix. The proposed analysis of data
x. The procedures proposed to achieve informed consent
xi. The proposed mechanisms to ensure confidentiality
xii. Informed Consent form
xiii. A statement on the proposed method for recruitment of study
subjects including all advertisements, probable ethical issues and
steps taken to tackle the same
xiv. The qualification and competence of the investigators
xv. The adequacy of provisions made for monitoring and auditing the
conduct of the research including the constitution of a Data Safety
Monitoring Board in case of clinical trials.
xvi. The adequacy of the site, including the supporting staff, available
facilities and emergency procedures.
xvii. The manner in which the results of the research will be reported
and published
xviii. Proposed compensation and reimbursement of incidental expenses.
xix. Details of Funding agency/sponsors and fund allocation for the
proposed work along with allocation for institutional overhead
charges for different types of funding agencies – Government
agencies (e.g., ICMR, DBT), Not for profit organizations and
pharmaceutical companies. While for government agencies it could
be as per policy of the government but for pharmaceutical
companies it should be at least 15% and for Not-for-profit
organization could be at least 5%.
xx. All other relevant documents relating to the study protocol
including regulatory clearance, Agreement between PI & sponsor,
Insurance, Indemnity Bond, Agreement to comply with national and
international GCP protocols for clinical trial
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In addition, EC has responsibility within the Institution for the following

objectives:
a. Education of professional, administrative and support staff about

ethical issues
b. Continuing education and training programmes that assure that EC
members are qualified to perform their specific duties within the
Ethics Committee.
5.6 MEETING PROCEDURES
The Chairperson will conduct all meeting of the EC. If for reasons
beyond control, the Chairperson is not available, the Vice-Chairperson
nominated by the Executive Council will conduct the meeting.
Professor Kusum Saigal is nominated as Vice Chairperson. 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.
5.6.1
i. A minimum of four meetings to be held per annum. The
Committee will meet once in three months and additional meetings
may be held as and when the proposals are received at the
discretion of the Chairman. Project applications must be submitted
at least one month prior to each meeting.
ii. All members to be notified of meetings
iii. Agenda, previous minutes and application forms to be circulated to
the committee two weeks prior to the meeting
iv. Minutes of the meeting to be recorded
v. All meetings must consist of at least a quorum i.e., five.
vi. All proposals received on or before the cut-off date will be put up
by the Member Secretary for review at any one meeting. If a large
volume of applications is received for a meeting, the applications
may not all be dealt with and some may have to be postponed to a
subsequent meeting. The applications will be taken on a first
come, first served basis or at the discretion of the Chairman.
vii. As part of the review process, an individual on the committee may
be assigned the task of acting as the primary reviewer.
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5.7 Application Procedures
i. All proposals should be submitted in the prescribed application

form, the details of which are given under Documentation. Only
complete proposals to be put up for review by the Committee.
Incomplete proposals to be returned by the Member-Secretary.
ii. All relevant documents should be enclosed with application form.
iii. All necessary documents showing that the appropriate regulatory
clearances have been taken must be enclosed. In case of drug
trials recruitment of subjects will be initiated only after clearance
form the Drugs Controller General of India (DCGI).
iv. Investigator initiated proposals to be reviewed by Internal Review
Committee before submission to the Ethics Committee.
v. 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 department(s)/Institution
to the Ethics Committee.
vi. The date of meeting will be intimated to the investigator, to be
present, if necessary to offer clarifications.
vii. 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 one month before the next meeting.
5.8 COMMITTEE REVIEW PROCEDURE
5.8.1 When protocols involve more than minimal risk to human subjects,
meaning a greater risk than that found in ordinary daily life, they must
be reviewed by the Ethics Committee. A review of the Ethics
Committee is defined as a regular meeting of a quorum (5 or more) of
the committee members.
5.8.2. TYPES OF REVIEW BY EC
Full Board review: Review of proposed research at a convened

meeting at which a valid quorum of EC members is present. For the
research to be approved, it must receive the approval by consensus.
All clinical trials should undergo full board review.
Expedited review: Review of proposed research by the EC Chair or a

designated voting member or group of voting members or by one or
more experienced reviewers designated by the chairperson from
among members of the EC rather than by the entire EC.
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Expedited review may be taken up depending on the discretion of the

Chairperson for certain kinds of research involving no more than
minimal risk and for minor changes in approved research. Expedited
review may also be taken up in cases of nationally relevant proposals
or post-graduate teaching programme (thesis/dissertation) requiring
urgent review.
Proposals for expedited review to be submitted on separate application
form clearly mentioning the reasons for expedited review. A brief
summary and review decision of the protocol will be placed before the
EC members in the next meeting.
The expedited review procedure may not be used where identification

of the subjects and/or their responses would reasonably place them at
risk of criminal or civil liability or be damaging to the subjects' financial
standing, employability, insurability, reputation, or be stigmatizing,
unless reasonable and appropriate protections will be implemented so
that risks related to invasion of privacy and breach of confidentiality
are no greater than minimal.
The standard requirements for informed consent (or its waiver,

alteration, or exception) apply regardless of the type of review,
expedited or convened.
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 or the comparison among
instructional techniques, curricula, or classroom
management methods.
ii. Research involving the collection or study of existing data,
documents, records, specimens, that have been collected or will be
collected solely for non-research purposes (such as medical
treatment or diagnosis) and if these sources are publicly available
or if the information is recorded by the investigator in such a
manner that subjects cannot be identified, directly or through
identifiers linked to the subjects.
Exceptions:
a. recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects; and
b. any disclosure of the human subjects' responses outside the
research could reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial standing,
employability, or reputation.
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5.8.3 An investigator cannot decide that her/his protocol falls in the

exempted category without approval from the Ethics Committee. All
proposals to be scrutinized by the Member Secretary to decide under
which of category it will be considered.
5.8.4 The Investigator/ Co-investigator to attend the meeting to make a
presentation and answer any queries, if any on the protocol. The
committee then discusses the protocol until a consensus is reached.
Following each Ethics committee meeting the investigator will be
informed of the protocol status in writing.
5.9 Decision Making
Decision may only be taken when sufficient time has been allowed for
review and discussion of an application in the absence of non-
members (e.g. the investigator or representative of the sponsor,
independent consultant) from the meeting, with the exception of EC
staff.
i. Decision will only be made at meetings where a quorum is present.

No proposal will be approved by circulation of study proposals.
ii. The documents required for a full review of the document should be
complete and the relevant elements considered before a decision is
made.
iii. Members of the Committee must be sensitive to the potential for
real or perceived conflict of interest and advise the rest of the
Committee whenever there is potential for either (e.g. as in the
case of current or past research collaborations). In addition,
members must not participate during the portion of a meeting that
involves ethics review decisions of projects on which they are listed
as principal investigators or co-investigators, or of projects of
students they supervise. Any conflict of interest will be recorded in
the meeting minutes.
iv. Only members without any direct or potential conflict of interest,
who participate in the review, will participate in the decision. The
experts will only offer their opinions.
v. The Committee strives to reach decisions concerning ethics review
and clearance of applications by sufficient discussion to reach a
consensus. In cases, however, when a consensus is not possible or
a vote is required, a simple majority of the quorum of those
present is required. The vote and dissent recorded if required.
vi. Detailed proceedings and minutes of the Committee's deliberations
and decisions will be securely maintained by the Office Ethics
Committee and will be considered strictly confidential.
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vii. In cases of conditional decisions, clear suggestions for revisions and

the procedure for having the application re-reviewed will be
specified.
viii. A negative decision on an application will be supported by clearly
stated reasons.
ix. Member Secretary will communicate the decision in writing.
5.9.1 Approval
If full ethical approval is granted, the investigator may only begin the
research proposed in the protocol when it has been outlined in a letter.
5.9.2 Conditional Approval:
Conditional approval of a protocol may be granted, requiring

modifications in the protocol and/or patient information sheet and/or
patient consent form before initiation or responses to specific inquiries
by the Ethics Committee. In this case, the investigator should submit
a cover letter along with a modified submission form, protocol, consent
form or supplemental information as requested with the changes
highlighted.
No research may be started until all conditions have been met and full
approval has been obtained.
Where conditional approval is granted the Chairman and Member

Secretary may review the modified submissions and grant approval
subject to the affirmation of the committee at its following meeting.
5.9.3 Deferral
A deferred protocol must be revised and resubmitted to the Ethics

committee within 2 months. If not resubmitted within stipulated time,
the proposal will be considered as withdrawn.
5.9.4 Rejection
Protocols may be rejected by the Ethics Committee. This may occur if

a protocol has been deferred three times and the Ethics Committee
feels that the proposed research is not justified and/or poses severe or
unnecessary risk to the subjects. The Ethics Committee will not accept
any further revisions to a rejected protocol.
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5.9.5 Amendments
All amendments to approved protocols to be submitted to the Ethics

Committee for review.
Amendments to approved protocols may not be initiated until Ethics

Committee approval has been obtained.
Amendments to approved study will be reviewed by the Chairman and

Member Secretary if amendments do not affect study protocol and
patient information sheet involving only or are related to logistical or
administrative aspects of the study and approval issued as appropriate
subject to affirmation by the committee at its following meeting.
5.10 COMMUNICATING A DECISION
A decision will be communicated in writing to the applicant, preferably

within two weeks’ time of the meeting at which the decision was made.
The communication of the decision will include, but is not limited to,
the following:
i. the exact title of the research proposal reviewed;
ii. the clear identification of the protocol of the proposed research or
amendment, date and version number (if applicable).
iii. the names and specific identification number version
numbers/dates of the documents reviewed, including the potential
research participant information sheet/material and informed
consent form;
iv. the name and title of the applicant;
v. the name of the site(s);
vi. the date and place of the decision;
vii. a clear statement of the decision reached;
viii. any advice by the EC;
ix. in case of a conditional decision, any requirements by the EC,
including suggestions for revision and the procedure for having the
application re-reviewed;
x. in the case of a positive decision, a statement of the responsibilities
of the applicant; for example, confirmation of the acceptance of any
requirements imposed by the EC; submission of progress report(s);
the need to notify the EC in cases of protocol amendments; the
need to notify the EC in the case of amendments to the recruitment
material, the potential research participant information, or the
informed consent form; the need to report serious and unexpected
adverse events related to the conduct of the study; the need to
report unforeseen circumstances, the termination of the study, or
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significant decisions by other EC; the information the HEC expects

to receive in order to perform ongoing review; the final summary or
final report;
xi. In the case of a negative decision, clearly stated reason(s) for the
negative decision;
xii. Signature (dated) of the Member Secretary of the EC.
5.11 RECORD KEEPING
i. Written Procedures
ii. Membership List
iii. List of membership qualifications & their CVs
iv. Agendas and Minutes of meetings
v. All Correspondence
vi. All reports/summaries
vii. All submitted documentation must be retained for at least ten years
after completion of trial
viii. Archival of documents – is the responsibility of the office.
6.0 INVESTIGATORS RESPONSIBILITIES
The Investigator of the study must attend the Ethics Committee

Review.
It is the responsibility of the Investigator to provide the Ethics

Committee with the appropriate information on the research protocol
including initial information, notification of subsequent modifications,
terminations and adverse reactions.
It is the responsibility of the Investigator to ensure that all equipment

used in trials has the appropriate certification of compliance for the
Year.
6.1 Notification of amendments
When any revision to an approved research protocol or written consent

form is proposed the amendment must be brought to the attention of
the ethics committee for approval.
Amendments to approved protocols may not be initiated until Ethics

Committee approval has been obtained.
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6.2 Notification of Adverse Events
All adverse events which may be related to the trial drug must be
brought to the attention of the sponsor within 24 hours and to the
ethics committee attention within 7 days.
All adverse events must be accompanied by an explanatory letter from

the Company or Principal Investigator involved.
6.2.1. SERIOUS ADVERSE EVENT (SAE) REPORTING
When a subject who is participating in a research study experiences an

unexpected or serious adverse event, the PI must promptly report the
incident to the sponsor’s Data and Safety Monitoring Committee and the
EC. A summary of the adverse event must be submitted along with
whether such events have been observed at our site. For adverse events
or reactions that occur at IHBAS the following apply:
i. Death and hospitalization for any reason must be reported

immediately to EC
ii. If the adverse event or reaction was anticipated in the protocol and
the subject was informed about the possibility of the event in the
consent form, there is no need to inform the EC unless the adverse
event was unexpectedly serious, life threatening, or fatal.
iii. If the adverse event or reaction was unanticipated, unexpectedly
serious, life-threatening or fatal, the adverse event must be
reported to the Sponsor within 24 hours and should be sent within
7 days to the Secretary Ethics Committee.
iv. If the research study is being supported by an industry sponsor,
the PI is also responsible for notifying the sponsor. The sponsor
must then notify the regulatory authorities within 7 days.
v. If the PI holds the Investigational New Drug (IND) or
Investigational New Device Exemption (IDE) in his/her name,
he/she is required to notify the regulatory authorities of the
adverse event or reaction within 24 hours, in addition to notifying
the EC.
vi. Within 15 working days, the PI must submit a written confirmatory
report of the adverse event or reaction to the EC.
vii. For industry sponsored research trials of drugs or devices, sponsors
are required to inform investigators of adverse events or reactions
that occur at other sites. When PIs are informed of the adverse
events in sponsor safety memos and other correspondence, the PI
must review the adverse event report and then notify the EC. This
should be done within 2 weeks of receipt of the report from the
sponsor.
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viii. PI in consultation with the Head of the Department and Institute &
the Member-Secretary may take the initiative to temporarily stop
the project in view of the life threatening SAEs reported even if
from sites other than IHBAS, whenever required.
6.3 ANNUAL REVIEW AND RENEWAL
i. Updated reports of all trials/studies must be forwarded to the ethics

committee on an annual basis and interim reports on biannual
basis. The committee must be notified when trials are completed
or terminated. The committee will prepare an annual report of
activity.
ii. EC will follow-up progress of all studies for which a positive decision
has been reached, from the time the decision was taken until the
termination/completion of the research.
iii. The follow-up review intervals will be determined by the nature and
the events of research projects, though each protocol will undergo
a follow-up review at least once a year.
iv. A decision of a follow-up review will be issued and communicated to
the applicant, indicating a modification, suspension, or termination
of the EC’s original decision or confirmation that the decision is still
valid.
v. In the case of the premature suspension/termination of a study,
the applicant must notify the EC of the reasons for
suspension/termination.
vi. A summary of results obtained in a study prematurely
suspended/terminated should be communicated to the EC.
vii. EC should receive notification from the applicant at the time of the
completion of a study
viii. EC should receive a copy of the final summary or final report of a
study.
6.4 PATIENT INFORMATION LEAFLET
Patient information leaflet should be in English and in the language

understandable by the patient. Patient information leaflet must
include the following elements:
i. A statement that the protocol involves research, an explanation of

the purposes of the research and the expected duration of the
subject’s participation, a description of the procedures to be
followed and identification of any procedures, drugs or devices,
which are experimental.
ii. Description of any reasonably foreseeable risks or discomforts to
the subject.
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iii. Description of any benefits to the subject or to others that may

reasonably be expected from the research, including payment or
free treatment.
iv. A disclosure of appropriate alternative procedures or courses of
treatment, if applicable, that might be advantageous to the subject.
v. A statement describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained.
vi. Have the title of the project/trial and the names of the investigators
clearly printed on the top of the form.
vii. Have space for signature/name/date of both the patient and
witness/guardian and the investigator (or investigator’s nominee).
viii. Include the statement “I’ve read over, explained and understand
the attached patient information leaflet.”
6.5 INFORMED CONSENT
Informed consent should be in English and in the language

understandable by the patient. The following points must be included
in the written patient informed consent:
• That the trial involved research

• The purpose of the trial
• The trial treatment (s) and the probability for random assignment
to each treatment
• The trial procedures to be followed including all invasive procedures
• The subject’s responsibilities
• The reasonably foreseeable risks
• The reasonably expected benefits
• The alternative procedures / treatments available
• That subject’s participation is voluntary and may withdraw at any
time
• That the records identifying the subject will be kept confidential
• The expected duration of the subject’s participation in the trial
• Compensation/ treatment available in event of trial related injury.
Page 21 of 23
6.6 FINAL REPORT
A copy of the final report should be sent to the Committee as soon as it is

available.
7. Appellate Authority
In case there are any disputes regarding decision of the Ethics Committee ,
the appellate authority will be the Head of the Institution. In case the
project belongs to the Head of the Institution, Chairperson IHBAS will be the
appellate authority.
Page 22 of 23
Appendix A
Good Clinical Practices for Clinical Research in India, ICMR 2006
The Ethics Committee is constituted and operates to the standards laid down
in the ICMR guidelines published in 2006.
COMPOSITION
S.No. Name & designation Address

1. Prof. S.M. Channabasavanna 194, 10th Cross, Wilson Garden
Chairman Bangalore – 560 027
Tele: 080-22222726
Fax – 080 28432840
2 Prof. M. Gourie Devi Flat 9, Doctors’ Apartments
Member Vasundhara Enclave
Delhi – 110 096
3. Drugs Controller of Delhi or Delhi Sachivalaya
his nominee New Delhi
Member
4. Dr. R.K. Chadda, Prof. of Pocket E, Flat No. 581
Psychiatry, AIIMS Mayur Vihar Phase II, Delhi-91
Member
5. Prof. K.M. Prabhu
Dept. of Biochemistry, UCMS
Member
6. Mrs. Sona Khan, A/2 Oberoi Apartments
Lawyer, Supreme Court Shamnath Marg, Delhi-54
Member
7. Prof. Usha Gupta 1525, Park View Apartments,
Former, Head Dept. of Sector 29, NOIDA-201303
Pharmacology, MAMC,
Member
8. Prof. Kusum Saigal D-125, Sector 40
Member NOIDA – 201301
9. Prof. Nimesh G. Desai HOD (Psychiatry), IHBAS
Member
10. Dr. T.B. Singh HOD (Clinical Psychology),IHBAS
Member
11. Dr. Sangeeta Sharma HOD (Neuropsychopharmacology),
Member Secretary IHBAS
12. Office Assistant
Page 23 of 23
Check list for submission of the project to the Ethics Committee
1. Application form
2. Summary of the proposal & Justification for study, drug
developmental history in case of drug trials
4. Protocol
5. Questionnaires
8. Investigator’s Brochure
9. Approval of DCGI
10. Agreement/ Undertaking by the Principal Investigator
11. Signed Indemnity bond
12. Insurance
13. Financial disclosure: Details of Funding agency/sponsors and
fund allocation for the proposed work.

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Institutional Biomedical Research Ethics Committee

Standard Operating Procedures

SOP Title: Standard Operating Procedures: Institutional Biomedical

♦ SOP Author(s). IHBAS, Ethics Committee Members

♦ SOP Status: Current

♦ Version: February 5, 2008

Approval 1: Ethics Committee

Approval 2: The Director

Developed by: Dr. Sangeeta Sharma

To ensure effective functioning of the Ethics Committee so that a quality and

2.0 PROCESS FLOW

2.1 APPLICATION PROCEDURE

Inquiry to Ethics Office for submission procedures.

Ethics office to forward Submission must be

When all the above requirements are processed.

Confirm date, time and agenda with the

Notify all committee

Each member is circulated with

A quorum of at least 5 members must be present.

Each submission is discussed in

Each Investigator in turn answers any queries the

Decision mostly by consensus recorded in the minutes of the

Recorded minutes are

All Investigators of Investigators who submitted

All correspondence must be

All Ethically Approved Studies/Trials Must Include:

3.1 All members of the Ethics Committee

EC, IHBAS: Ethics Committee, IHBAS

5.1 Composition of Committee.

The Institutional Biomedical Research Ethics Committee, IHBAS is

5.2 Term of Appointment

The members may be replaced at the discretion of the appointing

A member may be relieved of his/her membership in case of a conduct

5.3 CONDITIONS OF APPOINTMENT

Name, age, gender, profession, and affiliation will be publicized

Conflict of interest to be disclosed if any exists.

Members must apprise themselves of the relevant documents, codes,

An investigator can be a member of the EC; however, the investigator-

5.5 Committee Responsibilities

5.5.2. Obtain the following documents:

For thorough and complete review, all research proposals should be

i. Name of the applicant with designation

xii. Proposed compensation and reimbursement of incidental expenses.

5.5.3. To review proposed study with regard to the following:

i. The objectives and element of public good

In addition, EC has responsibility within the Institution for the following

a. Education of professional, administrative and support staff about

5.6 MEETING PROCEDURES

i. All proposals should be submitted in the prescribed application

5.8 COMMITTEE REVIEW PROCEDURE

5.8.2. TYPES OF REVIEW BY EC

Full Board review: Review of proposed research at a convened

Expedited review: Review of proposed research by the EC Chair or a

Expedited review may be taken up depending on the discretion of the

The expedited review procedure may not be used where identification

The standard requirements for informed consent (or its waiver,

Exemption from Review

5.8.3 An investigator cannot decide that her/his protocol falls in the

5.9 Decision Making

i. Decision will only be made at meetings where a quorum is present.