• IEC SOP must be written in Times New Roman font with font size 12. If the Appendices have smaller in font size it is to adjust as per the page requirement or size. The SOP will be distributed in controlled form to all the members and other stakeholders. The SOP will be updated within every 3years; if the requirements change it must be updated intermittently. The SOP version or SOP date will be changed in case of the SOP is updated. The intermittently modified or changed appendices SOP will not to be updated. The new appendices may be enclosed along with the SOP to address change or modification in the enclosed appendices.
• The chairperson will conduct all meetings of the IEC. If for any reasons beyond control, the chairperson is not available, 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 Chairperson before communicating to the researchers. Ethics Committee will meet as and when required.
• Applicant must submit the proposal two weeks in advance of the scheduled IEC meetings along with the supporting documents in hard copy and soft copy as well.
• The IEC member (or Designee) will acknowledge the receipt of the package by signing and dating the acknowledgment copy of the application letter. If available, the member (or designee) will stamp the letter with IEC stamp. In case of soft copy circulations, embers can acknowledge the same by email.
• On receipt of proposal, the documents will be circulated to all the IEC members well in advance of the meeting, for detailed review. While reviewing the proposal following criteria should be considered:
  
  Minimize risk to the participants
  Risks must be reasonable in relation to the anticipated benefits
  Participants are selected equitably
  Informed consent is adequate, easy to understand and properly documented
  The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants, where appropriate
  There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data where appropriate
  Appropriate safeguards are included to protect vulnerable participants
  
• During each meeting limited number of protocols will be discussed (i.e., as decided and communicated by Ethics Committee) keeping in view that all parameters required for competent review are discussed and consensus drawn.
• Quorum of 5 members, as given in the SOP, is required to conduct the IEC meeting. If a member is unable to attend a meeting, his/her opinion on the project MUST be submitted in writing to the Chairperson of the committee, before the date of the meeting for a decision. The members, who are unable to attend a meeting, will not be allowed to vote. But their feedback or suggestions on the proposal may be discussed during the meeting to maintain the multi-sectorial and competent review of the proposal.
• For expedited review the IEC will meet earlier as is required. Requirement of quorum is similar to that explained above
• For expedited review the IEC will meet earlier as is required. Requirement of quorum is similar to that explained above
Approval
Disapproval
Modification before Approval
Discontinuation of previously approved project

• The IEC decisions will be communicated in writing under the signature of the IEC member secretary
• In case of a positive decision a statement of the responsibilities of the applicant will be communicated. The IEC expects that, the researchers keep the committee informed of, but not limiting to the following:
All cases of protocol amendments should be submitted for IEC review and approval before implementation
All cases of amendments to the Informed Consent Form and Patient Information Sheet must be submitted to IEC for review and approval before implementation.
All cases of amendments to recruitment material
Serious and unexpected adverse events related to the conduct of the study
Protocol deviation, if any should be informed with adequate justification
Any new information that may affect the risk/benefit ratio of the study
Half yearly progress report (the clock for the same starts from the date of receipt of IEC approval for the study)
Final report to be submitted at the end of the study
Premature termination of the study should be notified with reasons along with summary of the data obtained so far
Site close out to be notified along with the final status report including the details of subjects, IP and documentation
All administrative changes, which has study implications must be notified to IEC

• In case of a conditional decision i.e., where ethics clearance is subject to condition i.e., Modification of study documents or requirement of additional documents, the IEC will communicate to the researcher or Investigator the stipulated requirement, including suggestions for revision and the procedure for re-reviewing the application. Any time limit imposed for reply will also be stated.
• In case of negative decision, a clear statement of the reason(s) for the negative decision will be communicated to the researcher or Investigator including whether it may be submitted as new proposal with appropriate changes. The right to appeal and procedure for re-review (if any) will also be communicated.
• With regard to approval of amendments: should an amendment to a study-related document be administrative in nature and does not involve any change which may jeopardize the subject or the study, then it may be approved by EC in an expedited manner or as an amendment. But the decision to consider the amendment as minor or major lies fully with the IEC. If an amendment is considered major it will be approved during a full meeting involving the full quorum as stated in the New Drug CT rule_2019.
• Reported SAEs will be discussed during the IEC meetings to decide on the quantum of compensation and causality of the event.
• An IEC may decide to reverse its positive decision on a study if it receives information that may adversely affect the risk/benefit ration
• The discontinuation of a trial may be ordered if the IEC finds that the goals of the trial have already been achieved midway or unequivocal results are obtained.
• IEC allows investigators to present and defend the proposals during the IEC meetings. The Investigator may also be called to present if a clarification is sought on certain issues in the applications
• IEC may seek help from the outside experts (from within or outside RIO, KOLKATA), if required. 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 members of the IEC.
• Minutes of meetings will be documented and maintained for every meeting conducted by IEC.
• IEC decision will be communicated within 6 weeks of the submission for protocols requiring review by the IEC members
• IEC decision to be completed within 45 days from submission for expedited protocols or amendments
• All proposals are to be submitted with the covering letter mentioning all the listed documents need to be review and approved.
• Seven hard copies of the proposal along with a soft copy need to be submitted to IEC for competent review
• The date of IEC meetings will be communicated to researchers or investigators. If there is any change in the schedule it will be communicated well in advance.
• Study Status report should be intimated by the respective Principal Investigator on half yearly basis.