The purpose of this procedure is to elaborate administrative process and provide instructions for preparation, review, approval, and distribution of meeting agenda, minutes, and notification letters of IRB, CIHSR meetings.
6.2 General meeting of IRB
The day, time, and venue of IRB meetings are specified as follows:
SC-IRB meets at 2.00 PM on a Friday of every 4-5 months
EC-IRB meets at 9.00 AM on a Saturday of every 4-5 months
The date will be decided by the Secretariat depending on the number of proposals per IRB meeting
Maximum interval between 2 regular meetings will be not more than 4-5 months.
Venue: Board Room, Administrative office,
CIHSR, 4th Mile, Dimapur, Nagaland-797115
This SOP applies to administrative processes concerning the conduct of the meeting.
It is the responsibility of the research coordinator and IRB secretariat to prepare for the respective IRB meeting.
6.5. Detailed instructions
6.5.1 Before IRB meeting
- Prepare the agenda of the IRB meetin
- Schedule protocols on the agenda on a first come first serve basis
- Only a maximum of 6 proposals will be processed per meeting
- The remaining proposals (if any) will be carried forward to the next meeting.
- The travel remuneration for the members outside CIHSR will have to be processed ahead in the Accounts department.
6.5.2 Distribution of Protocol/Documents Packages to the IRB Members
- Distribute copies of the protocols to the IRB members by e-mail (in case of electronic submission of protocols)
- Verify (verbally, by e-mail) with the members whether the protocol packages are
- It is the responsibility of the IRB member to verify items of the parcel on receipt and in the event of any missing items, intimate the IRB office immediately so that the relevant documents could be made available to the members before the meeting.
6.5.3 Preparation for the meeting
- Reserve the IRB meeting room on the scheduled meeting date and The meeting will be held in the Board room, unless otherwise specified.
- Ensure that the room, equipment (projectors, recorder, etc) and facilities are available in good housekeeping conditions on the day of the meeting.
- On the previous day of the meeting, keep all original files of protocols on the agenda in the meeting room for ready reference during the meeting.
6.5.4 Conduct of meeting
- The members should gather in IRB meeting room on scheduled
- The chairperson should determine that the quorum requirements are
- The chairperson should ask for declaration of conflict of interest either verbally or written on any protocol for discussion.
- If an IRB member has conflict of interest involving a project then he / she should declare the same, before the meeting commences and leave the meeting room before the discussion on the This should be recorded in the minutes.
- The member secretary should table the minutes of the previous meeting and present the agenda for
- The IRB may invite investigators to attend the IRB meeting related to their studies, and clarify doubts, if
- The meeting proceeds in the sequential order of the agenda; however, the chairperson may change the order, if the situation so demands
- The member secretary will request the lead discussant to discuss the research protocol.
- Amendment will be reviewed by previously assigned lead scientific
- In case the lead discussant cannot attend the meeting, member secretary or any other IRB member may brief the IRB about the research protocol and also discuss the written comments/duly filled study assessment form, if provided by the lead discussant.
- The member secretary/ research coordinator, records the proceedings of the IRB meeting
6.5.5 Decision Making Process
IRB provide complete and adequate review of the research proposals submitted to them. The committees will review new project proposals, amendments, annual progress of ongoing projects, SAE reports, and assess final reports of all research activities through a scheduled agenda.
- An IRB member will withdraw from the meeting for the decision procedure concerning an application where a conflict of interest exis
- If IRB member has her/his own proposal for IRB review he/she will not participate in the IRB discussion on that particular
- 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, representatives of the sponsor, independent consultants) from the meeting, with the exception of IRB
- Decisions will only be made at meetings where a quorum is
- The documents required for a full review of the application should be complete and the relevant elements considered before a decision is
- Only IRB members who attend the meeting will participate in the decisi
- Decisions will be arrived at through When a consensus is not possible, the IRB will vote.
- If the full board approves a research proposal in principle subject to minor modifications, the revised project proposal submitted by the PI will be reviewed and approved by the member secretary or in some cases by the primary reviewer on behalf of the full Such revised proposals will not be taken up for the full board review. However, in case of major changes, the revised documents will be discussed in full board meeting.
- An IRB may decide to reverse its positive decision on a study if it receives information that may adversely affect the risk/ benefit
- In cases of conditional decisions, clear suggestions for revision and the procedure for having the application re-reviewed will be spe
- A negative decision on an application will be supported by clearly stated If the investigator wishes to appeal to the decision, he/she may do so by contacting the IRB Secretariat.
- The discontinuation of a study will be recommended if the IRB finds that the goals of the study have already been achieved midway or unequivocal results are obtained.
- If necessary, the investigator may be invited to present the protocol or offer clarifications in the Representative of the patient groups or community can be invited during deliberations to offer their viewpoint.
- Subject expert/s may be invited to offer their views, but expert/s should not participate in the decision making process. However, his / her opinion must be recorded.
- The proceedings of the IRB meetings will be documented and signed by the member secretary.
6.5.6 After the IRB meeting
6.5.6.a Preparing the minutes and the decision letters
- The member secretary will compile the proceedings of IRB meeting in a concise and easy-to-read style and will check spelling, grammar and context of the written
- The minutes of the meeting will be compiled within a week.
6.5.6.b Approval of the minutes and the decision
- The minutes of the IRB meeting will be signed by member secretary
- The minutes of the IRB meeting will be ratified in the subsequent IRB
- The IRB decisions will be communicated to the PIs in a standard format via email.
6.5.6.c Filing of the minutes of the meeting
- Place the original version of the minutes in the minute’s file and copy of the minutes are filed in the corresponding research protocol file.
6.5.7 Communicating Decision
- The decision will be communicated in writing to the PI, preferably within a period of 14 days of the IRB meeting at which the decision was
- The communication of the decision will include, but is not limited to, the following,
- CIHSR Proposal and title of the research proposal reviewed
- The clear identification of the protocol of the proposed research or amendment, date and version number (if applicable).
- The names and specific identification number, version numbers, dates of the documents reviewed, including the potential research participant information sheet/material and informed consent
- The name and title of the Principal Investigator
- The name of the site(s)
- The date and place of the decision
- A clear statement of the decision reached
- Validity of approval usually will be yearly for multiyear projects, however may change on case to case ba
- Any suggestions by the
- A conditional decision (i.e. approval with recommendations or modifications, suggestions for revision and the procedure, any other requirements by the IRB), will be valid only for three months from the date of issue of If the PI does not comply with the IRB suggestions during these three months, a reminder will be issued. The modifications will be re-reviewed by member secretary of primary reviewer/s and /or may be referred for IRB review.
- The final hard copy of the completed IRB form with suggested changes and supporting documents and signatures.
- In the case of a positive decision, the PI is notified of the following requirements through an approval letter:
- A statement of the responsibilities of the PI; for example, confirmation of the acceptance of any requirements recommended by the IRB
- Submission of progress report(s) decided on case to case basis, usually yearly.
- The need to notify the IRB in cases of protocol amendments (other than amendments involving only logistical or administrative aspects of the study)
- The need to notify the IRB in the case of amendments to the recruitment material like 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 significant decisions by other IRBs
- The information the IRB expects to receive in order to perform ongoing review
- The final summary or final report
- In the case of a negative decision, the reasons should be clearly stated in the communication to the PI
- The PI will also be notified of the duration of the approval, which will not exceed one
- All decision and approval letters will be signed by the member secretary and the
- Every page of consent forms (English, Hindi, and Nagamese) of investigator initiated study and first page of ICFs of sponsored study (English, Hindi, Nagamese) will be signed and dated by member secretary, These approved ICFs will be sent to the PI along with the approval letter.
- The chairperson and member secretary will sign and date the approval letter and approval certificate in the original research proto