IHEC – MGMCRI SOPs SOP Code: SOP 08/V2

Agenda Preparation, Meeting Procedures and Effective from 21/10/2019

Recording of Minutes

Title: Agenda Preparation, Meeting Procedures and Recording of Minutes

SOP Code: SOP 08/V2

Effective Date: 21-10-2019

SOP Constitution and Approval:

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to describe the administrative process and
provide instructions for preparation, review, approval and distribution of meeting agenda, and
minutes of IHEC.

2. Scope
This SOP applies to processes concerning preparation of agenda and recording minutes of all
IHEC meetings.

3. Responsibility
 It is the responsibility of the Member Secretary/Additional Member Secretary assisted by
Secretariat to prepare agenda for IHEC meeting.
 The Chairperson will review and approve the agenda.
 It is the responsibility of Member Secretary/Additional Member Secretary to ensure proper
recording and dissemination of minutes after the meeting is over.
 It is the responsibility of all members to read and approve the minutes sent to them.
 The Chairperson will review and finally approve the minutes.

4. Detailed instructions
4.1 Before each Board meeting
IHEC full Board meeting will be regularly scheduled once in two months and the dates will be
decided by the Member Secretary/Additional Member Secretary with the help of the secretariat at
the beginning of the year. After discussing in the IHEC meeting the approved dates will be given
for MGMCRI research calendar and the meetings will be held on those days.

4.2 Preparation of meeting agenda

The Member Secretary/Additional Member Secretary assisted by the Secretariat will prepare the
meeting agenda, according to the format in AX 01/SOP 08/V2 annexure of this document. This
should include:

a. Apologies
b. Ensure quorum by Chairperson
c. Reading and approving minutes of the previous meeting.

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

d. Enquiry about CoI by Chairperson

e. Conformation regards the waiver of consent in a new protocol
f. All projects for Initial Review
g. All resubmitted protocols for full board review.
h. Review of Amended protocols or protocol-related documents for Full Board review.
i. Issues for consideration.
 Continuing review of study protocols.
 Review of Study Completion Reports.
 Review of premature study termination.
 Review of Site Monitoring Visit Reports.
 SAE reports
 Minutes of SAE Subcommittee
j. Issues to be discussed including emergency concerns/ IHEC policies/ training of Members/
revising SOPs/ any other issues raised by member(s).
k. Any other matter referred for IHEC opinion or issues to be informed to the members.
l. Report of any other subcommittee or group appointed/ designated by Chairperson for any
specific or general purpose.
m. Any other matter

The Secretariat will collect and verify all forms/documents submitted to IHEC for completeness
and keep it ready for the meeting.
 The Secretariat will schedule protocols in the agenda as per date of receipt.
 Answers to the IHEC queries and amended study related documents (Protocol, ICD, CRF
and IB) from the investigators received 30 days before and other types of documents
received 10 days prior to the date of full board IHEC meeting will be included in the
agenda after primary review.
 The agenda for the IHEC meeting is prepared 3 days in advance before the date of
meeting.
 Any study-related document (except if related to safety of a participant including SAE
report) received within 3 days preceding the date of meeting will not be considered for the

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

meeting. It will be deferred to the next month’s meeting for discussion except in some
cases when the matter is urgent and important (having direct bearing on the safety of the
research participants such as SAE report or major protocol violation) in the opinion of the
IHEC Secretary or Chairperson.
 In case a meeting is to be rescheduled due to unavoidable circumstances, the date and time
will be informed to the IHEC members via e-mail.

 The Secretariat will send via e-mail to members the agenda of the meeting at least 1 day in
advance of the scheduled meeting.

 The Secretariat will make sure that the meeting venue, equipment and facilities are
available for the meeting day.

4.3 During the meeting

 The committee will endeavor to hold regular meeting at least once in 2 months gap
between any two meetings will not exceed 60 days.
 Even if there are no research proposals for review, the gap between two meetings will not
exceed 12 weeks.
 Meeting will be held as scheduled provided there is quorum.
 For IHEC meeting, besides the Member Secretary /Additional Member Secretary and the
Chairperson the quorum will consist of:
o One basic medical scientist (preferably a pharmacologist),
o One social worker (or a social scientist, theologian, ethicist, Philosopher, member
or representative of a non-governmental voluntary agency or a similar person),
o A clinician,
o A lay person from the community and
o A legal expert
 At the discretion of the Chairman, guests may be allowed to observe the Board meeting
(See SOP 05/V2). These guests may include a student, inspectors, auditors, members of
other Ethics Committees, surveyors, regulators, members of regulatory agencies,
representatives of patient groups, representatives of special interest groups, representatives
of accrediting organizations, members of general public etc. All guests are required to
sign a confidentiality agreement prior to attending the meeting (SOP 05/V2).

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

 The Secretariat will obtain signatures on the Confidentiality Guests/ observers/

Independent Consultants prior to the start of the meeting (SOP 05/V2)
 The Secretariat will obtain the signatures of all the IHEC members on the attendance
register.
 The Chairperson will initiate the meeting after ensuring that the quorum has been met. The
Chairperson at his/ her discretion will delegate the responsibility of conducting the
meeting as per agenda to the Member-Secretary.
 The Chairperson will ask the members whether anyone has any conflict(s) of interest in
the projects to be discussed and if so, to declare the conflict.
 The Secretariat will obtain signatures on the Conflict of Interest Agreement Form from
members who declare a conflict (e.g. members who are PIs or Co-Is) prior to the start of
the meeting (SOP 05/V2).
 If a conflict of interest has been declared by a member, the Chairperson will ask the
concerned member to leave the meeting room when the concerned issue is being
discussed.
 The Member Secretary/Additional Member Secretary will ask the members whether any
points need to be discussed regarding minutes of the previous meeting. If no points are
raised, the minutes will be considered as confirmed.
 The Member Secretary/Additional Member Secretary will present the agenda of the day’s
meeting for discussion.
 The meeting shall generally proceed in the order organized in the agenda. However, the
Chairperson may allow adjustments in the order of issues to be discussed depending on the
situation.
 In case of projects submitted for initial review; the detailed instructions given in SOP
07/V2.
 The primary reviewer presents the overview of the protocol
 Investigators who have been asked by IHEC secretariat to provide additional information
or clarifications related to their project may do so by attending IHEC meeting. The
discussion amongst IHEC members will not be done while the investigator is in the

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

meeting room.
 For other points on the agenda, the member secretary/Additional Member Secretary will
present the gist of the matter/ read the relevant letters from the investigator (if deemed
necessary) and request the members to give their comments. The Member-Secretary
assisted by the secretarial staff will also record a gist of discussions and decisions arrived
on other issues discussed at the meeting.
4.4 Decision making

 The final decision on each proposal/ issue discussed in the meeting shall be by voting. A
majority vote is defined as 2/3rd of the members (who have reviewed the project), present
at the meeting and by voting/shall be by consensus.
 Decisions will include approval, disapproval-with reasons, request for modifications of a
study, Deferment – pending further reference by the IHEC members, suspension or
termination of an ongoing study
 The following will not vote at the meeting:
o Member(s) of the committee who is/are listed as investigator(s) on a research
proposal
o An investigator or study team member invited for the meeting
o An independent consultant invited for the meeting to provide opinion
o Specific patient groups invited for the meeting, if any
 The schedule of the next meeting will be discussed and finalized by the members.
4.5 After the Board meeting

 The Secretariat will compose the summary of each meeting discussion and decision in a
concise and easy-to-read style in the minutes within 14working days of the meeting day.

 The Secretariat will make sure to cover all contents in each particular category to include
the following:

o Name of person preparing the minutes

o Location where the meeting was held (city, state)
o Meeting number, date/duration of the meeting (time of commencement and end)
o Names of the IHEC members and guests attending the meeting

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

o Name of the individual serving as Chairperson of the meeting

o Determination of a duly constituted quorum by Chairperson to proceed with
meeting
 Requirements for each study or activity requesting approval:
o Sponsor’s name, if applicable
o Protocol number/date/version of protocol, when available
o Investigator’s name
o Names of the Primary Reviewers who presented their findings
o Discussion as deemed appropriate by the Chairperson
o Follow-up action decided upon
o Reference to the investigator approval letter that lists all changes requested by the
board
o Determination of the next requested continuing review.
 Requirements for each study or activity requesting expedited review:
o Sponsor’s name; if applicable
o Protocol number, if applicable
o Investigator’s name
o Lists of expedited approval requests and outcomes.

 Requirements for each Continuing Review Report:

o Sponsor’s name; if applicable
o Protocol number, if applicable
o Investigator’s name
o Indication of the Board’s determination to continue, terminate, or amend the study
o Lists of recommendations or actions to be taken up with the investigator, if
applicable.

 Requirements for each Adverse Event notification and Final Report:

o Sponsor’s name; if applicable
o Protocol number, if applicable
o Investigator’s name
o Report or summary of report provided by the SAE sub-committee
o Actions deemed appropriate by the Board’s review

 Requirements for Termination of Approval:

o Name of the Sponsor, if applicable
o Protocol number, if applicable
o Investigator’s name; reason for termination

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

4.6 Approval of the minutes

 The Secretariat will check the correctness and completeness of the minutes and present the
minutes to the Chairperson for review and approval within 7 working days of the meeting
day.
 The Secretariat will email the minutes of the meeting to the IHEC members.
 The Chairperson indicates approval by signing and dating the minutes (after approval in
the next meeting).

4.7 Filing the minutes

 The Secretariat will place the original version of the minutes in the minutes file.
 The Secretariat will file the IHEC Decision Forms in the project files and place all
correspondence in the appropriate files.
 The Secretariat will send a list of the studies approved and rejected by the IHEC at the
monthly meetings (title of the study with name of the Principal Investigator) to the Head of
the Institute every month within 21 days of the IHEC meeting.
4.8 Calling an Emergency Meeting of IHEC

 The Member Secretary/Additional Member Secretary in consultation with Chairperson

may decide to call an emergency meeting for any one or more of the following reasons.
o Urgent issues (which, if not decided upon early could adversely affect or have
adverse impact on patient safety, public safety or national economy etc.)
o Occurrence of unexpected serious adverse event(s).
o Other reasons, as deemed appropriate by the Member Secretary/Additional
Member Secretary /Chairperson.
 The Secretariat will endeavor to contact each and every IHEC member and inform about
the date, time and venue of the meeting as well as the reason for calling for the meeting.
 The administrative officer will prepare packets for distribution to the members containing
the information and documents about the matter(s) for which emergency meeting is
scheduled or send the relevant details via email.
 During the meeting, the Chairperson/Secretary will determine if there is a quorum.
 If a quorum is not met, the meeting will be postponed for 15 minutes. However, if there is
no quorum at the end of 15 minutes; the meeting would be held without a quorum provided
at least four members (at least one scientific and one nonscientific member) are present,

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

given the urgency of the matter under consideration. The IHEC members will act
according to the relevant IHEC SOPs (Expedited Review, SAE review, Review of Protocol
deviations/violations etc.) for discussion and decision-making on the matter under
consideration. The minutes of the emergency meeting would be prepared, distributed,
approved and filed as described in the steps above for regular full board meeting.

5. References to other applicable SOPs

SOP 05/V2: Procedures for allowing Guest/ Observer to visit Institutional Human Ethics
Committee or attend IHEC meeting.
SOP 06/V2: Management of Research Study Protocol and Study Related Documents Submitted
for Ethics Review
SOP 07/V2: Categorization of Submitted Protocols for Ethics Review

6. Glossary
Quorum Number of IHEC members required to act on any motion presented
to the Board for action.

Majority vote A motion is carried out if one half plus one member of the required
quorum votes in its favor.

7. Annexures
Annexure 1: AX01/SOP 08/V2- Agenda format
Annexure2: AX02/SOP08/V2- Conflict of Interest form to be signed by IHEC member before
Board meeting

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

Annexure 1: AX 01/SOP 08/V2

Agenda Format

Agenda of the IHEC Meeting

Meeting No IHEC meeting nn/yyyy
Location of the meeting
Meeting Date & Meeting time
The Board meeting will proceed in the following sequences:
Period 1: Discussion of the points arising from the minutes of the previous meeting and
presentation of agenda of the day’s meeting and Declaration of Conflict.
Period 2: A] New Protocol Presentation, Review, Discussion and reaching
decision by voting to approve/raise queries
B] Review responses forwarded by the principal investigator to the query letter/
resubmitted protocols
C] Approve protocol amendment and related documents.
D] To review the continuing review report/ completion report/ final clinical trial report/
Annual report / Termination reports.
E] To review Protocol Deviations / Violations
F] To review other Letters related to projects
G] To review Monitoring reports
H] To inform about the IHEC meeting and to review the policy decisions
I] To inform about the SAE Subcommittee meetings and to review SAE/Safety reports.
J] Other points for discussion
Period 3: Issues reviewed and approved by the IHEC member Secretary/Additional Member
Secretary and Chairperson which are to be reported for consideration
Period 4: Issues to be informed to the members at Full Board which are approved by the IHEC
member Secretary/Additional Member Secretary and Chairperson and letters already sent to the
principal investigator.
Period 5: Other issues of interest to the members.

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

Annexure 2: AX02/SOP08/V2
Conflict of Interest form to be signed by IHEC member before board meeting

Date:
To
The Chairperson,
IHEC,
MGMCRI,
Puducherry.

I hereby declare the conflict of interest for the project no. EC/ /
entitled,____________________________________________________________________
as :

1. I am the investigator / co-investigator/Author/study team

2. I have Financial interest
3. _________________________
4. ___________________________
5. ______________________________
6. _____________________________
in the project which will be discussed in today’s meeting on .XX day of XX month XX year.

Dr. ________________________
Member, IHEC

_________________
Chairperson, IHEC

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IHEC – MGMCRI SOPs SOP Code: SOP 08/V2
Agenda Preparation, Meeting Procedures and Effective from 21/10/2019
Recording of Minutes

8. Flow Chart

Preparation of meeting agenda prior to a board meeting

IHEC Secretariat

During the Meeting

IHEC Secretariat, Members and Chairperson

After Board Meeting and Preparing the minutes

IHEC Secretariat/ Member Secretary/Additional Member Secretary

Approval of minutes
IHEC members / Chairperson

Filing the minutes

IHEC Secretariat

Calling an emergency meeting

Member Secretary in consultation with Chairperson

9. References
 Forum for Ethics review Committees in India (FERCI). Standard Operating Procedures of
Institutional Ethics Committee (cited 5th October 2019). Available from:
http://www.ferci.org/sops/
 Indian Council of Medical Research (ICMR). National Ethical guidelines for biomedical
and health research involving human participants, October 2017 (cited 6th October 2019)
available from: http://www.icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf

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