INSTITUTIONAL ETHICS COMMITTEE-BIOMEDICAL RESEARCH (IEC-BMR) - Standard Operating Procedure - Version AH-02 - 2022

Sep 12, 2026

Institutional Ethics Committee-Biomedical Research (IEC-BMR) Standard Operating Procedure defines governance for biomedical research conducted with human subjects at Apollo Hospitals. The SOP establishes document management, committee formation and membership terms, chairperson nomination, expert invitation, and structured submission and checklists for new studies. It also specifies review and decision-making procedures, informed consent requirements, additional safeguards for vulnerable subjects, SAE/unanticipated problems handling, continuing review and monitoring, and related administrative and record-keeping workflows.

LanguageEnglish

CategoryForms

FormatPDF

Pages196

Reading Time1 h 9 min

AccessFree to download

Index

Preamble

SOP-1 Document Management for Standard Operating Procedure

SOP-2 Formation of the IEC and Terms of Reference for Membership

SOP-3 Nomination of the Chairperson of Institutional Ethics Committee

SOP-4 Changes in Membership of Institutional Ethics Committee

SOP-5 Inviting a Subject Expert

SOP-6 Submission of Documents for Review of New study

SOP-7 Review and Decision-Making Procedures

SOP-8 Continuing Review & Monitoring of Ongoing Studies

SOP-9 Expedited Review Procedure

SOP-10 Informed Consent

SOP-11 Review of Research Involving Vulnerable Subjects

SOP-12 Review of Serious Adverse Events (SAE)/Unanticipated problems

SOP-13 Change of Principal Investigator

SOP-14 Payment to Research Subjects

SOP-15 General Administration

| | | | | --- | --- | --- | | INSTITUTIONAL ETHICS COMMITTEE-BIOMEDICAL RESEARCH
(IEC-BMR)
STANDARD OPERATING PROCEDURE
(Version No.: AH-02, Dated-------2022)
ADDRESS: | | | INDEX | SOP No | Standard Operating Procedure | Page No. | Addendum \# | Name | | --- | --- | --- | --- | --- | | | | | Effective from | Sign /date | | | Preamble | 6 | | | | SOP-1 | Document Management for Standard Operating Procedure | 13 | | | | | | | | | | Att. 1.3.1 | Template for Standard Operating Procedure | 16 | | | | Att. 1.3.2 | SOP Review and Revision Tracker | 18 | | | | Att. 1.3.3 | Template for Summary of Changes (Addendums) | 20 | | | | SOP –2 | Formation of the IEC and Terms of Reference for Membership | 22 | | | | | | | | | | Att. 2.3.1 | List of Institutional Ethics Committee Clinical Studies Members | 30 | | | | Att. 2.3.2 | Honorarium Structure | 32 | | | | Att. 2.3.3 | Confidentiality and Conflict of Interest Undertaking ( Ethics Committee member) | 34 | | | | Att. 2.3.3.a | Confidentiality and Conflict of Interest Undertaking(Guest/Observer) | 37 | | | | Att. 2.3.4 | Delegation Log for Institutional Ethics Committee Secretariat personnel | 40 | | | | SOP–3 | Nomination of the Chairperson of Institutional Ethics Committee | 43 | | | | | | | | | | SOP–4 | Changes in Membership of Institutional Ethics Committee | 45 | | | | | | | | | | Att. 4.3.1 | List of Institutional Ethics Committee Members ( Revised) | 48 | | | | SOP –5 | Inviting a Subject Expert | 50 | | | | | | | | | | Att. 5.3.1 | Confidentiality and Conflict of Interest | | | | | | Undertaking (Subject Expert) | 53 | | | | --- | --- | --- | --- | --- | | Att. 5.3.2 | Honorarium structure for Subject Expert | 56 | | | | SOP –6 | Submission of Documents for Review of New study | 58 | | | | | | | | | | Att. 6.3.1.a | Documents Checklist for Clinical Studies | 62 | | | | Att. 6.3.1.b | Study Documents Checklist for DNB& Academic Proposals | 65 | | | | Att. 6.3.1.c | Study Documents Checklist for Biological Materials and Bio Banking | 67 | | | | Att. 6.3.1.d | Study Documents Checklist for Stem Cell Research | 69 | | | | Att. 6.3.2 | Institutional Ethics Committee Fees Structure | 71 | | | | Att. 6.3.3 | Checklist for Types of Review | 73 | | | | SOP – 7 | Review and Decision-Making Procedures | 75 | | | | | | | | | | Att. 7.3.1 | Primary Review Form | 83 | | | | Att. 7.3.2 | Format for Conditional Approval Letter | 89 | | | | Att. 7.3.3 | Format for Final Approval Letter | 92 | | | | Att. 7.3.4 | Format for the Approval letter for DNB projects | 95 | | | | Att.7.3.5 | Format for Approval for Publication | 97 | | | | Att.7.3.6 | Template for Agenda/Minutes of Meeting | 100 | | | | Att.7.3.7 | Checklist for Clinical Trial Agreement review | 106 | | | | Att.7.3.8 | Format for Attendance and COI log | 109 | | | | SOP –8 | Continuing Review & Monitoring of Ongoing Studies. | 111 | | | INDEX | | | | | | | --- | --- | --- | --- | --- | | Att. 8.3.1 | Template for PI’s report on changes in the Amended Documents | 116 | | | | Att. 8.3.2 | Study Documents Amendments Tracking Log | 118 | | | | Att. 8.3.3 | Format for Study Completion/Close-out Report | 120 | | | | Att.8.3.4 | Format for Study Status/Progress Report | 123 | | | | Att. 8.3.5 | List of documents for re-approval | 125 | | | | Att.8.3.6 | Format for Re-Approval Letter | 127 | | | | Att.8.3.7 | Subject feedback and Redressal Form(Paper/ Electronic version) | 130 | | | | SOP –9 | Expedited Review Procedure | 133 | | | | | | | | | | Att. 9.3.1 | Template for Expedited Approval Letter | 136 | | | | SOP –10 | Informed Consent | 139 | | | | | | | | | | Att. 10.3.1 | Sample Consent Document in English | 145 | | | | Att.10.3.2 | ICD Review Form | 153 | | | | SOP –11 | Review of Research Involving Vulnerable Subjects | 156 | | | | | | | | | | Att. 11.3.1 | List

FAQs

What is the purpose of the IEC-BMR Standard Operating Procedure at Apollo Hospitals?

It defines how the Institutional Ethics Committee for Biomedical Research conducts and oversees biomedical research involving human subjects, ensuring due care and caution across all stages.

Which process does SOP-6 cover for starting a new study?

SOP-6 covers submission of documents for review of a new study, including document checklist requirements and study document tracking for different study types.

How does the SOP handle ongoing studies and serious adverse events?

SOP-8 provides continuing review and monitoring for ongoing studies, while SOP-12 sets procedures for review of serious adverse events (SAE) and unanticipated problems, supported by reporting templates and related regulations.

Sep 12, 2026

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