Standard Operating Procedures for the Office of Research Version 3.0 (April 2025) - Christian Medical College Vellore, Tamil Nadu, India
This comprehensive document outlines the official policies and standard operating procedures governing all human subject research conducted at Christian Medical College. It incorporates the latest ICMR 2023 guidelines, international ethical standards, and institutional best practices to ensure rigorous scientific integrity and subject protection.
Authorized by the Senatus and the Vice Principal for Research, these procedures are mandatory for all researchers, faculty, students, and staff engaged in clinical and non-clinical investigations.
Policies and Procedures of the Office of Research & IRB, CMC Vellore, Revised Version 3.0, 1st April 2025.
General Information
The policies and standard operating procedures of the Institutional Review Board (IRB) of the Christian Medical College (CMC) Vellore were comprehensively revised in April 2016 (Version 2.0) and further updated on April 1st, 2025 (Version 3.0) to incorporate the latest Indian Council of Medical Research (ICMR) guidelines. This document ensures CMC's IRB compliance with current Indian regulatory requirements while upholding the institution's ethical principles and Christian values. The foundational framework was established in October 2007 (Version 1.0) and received formal approval from the Senatus of CMC in 2010.
Section 1
Provides a detailed overview of the historical and contemporary ethical principles and regulatory frameworks governing biomedical research in India, including ICMR guidelines, Schedule Y regulations, and international standards like the Declaration of Helsinki and the Nuremberg Code.
Section 2
Comprehensively outlines the constitution, scope, authority, and operational procedures of the three Institutional Review Boards at CMC Vellore: Research and Ethics Committee, Institutional Ethics Committee, and Animal Ethics Committee, including submission requirements and review processes.
Section 3
Articulates specific policies for vulnerable populations, clinical trials, genetic research, stem cell research, and biobanking based on the updated ICMR Ethical Guidelines (2017, 2023) and the amended Drugs and Cosmetics Act regulations as of 2025, with particular emphasis on informed consent processes.
Section 4
Delineates the organizational structure of the Office of Research, detailing the composition, responsibilities, and interdependencies of committees including the Research Committee, Data Safety Monitoring Board, Scientific Review Board, and their reporting relationships to institutional leadership.
This comprehensive document is accessible as a downloadable PDF from the CMC intranet portal. Additional resources including application forms, consent templates, ICMR guidelines, and relevant regulatory documents are available on the CMC Research Website (research.cmcvellore.ac.in). Regular training workshops on these guidelines are conducted quarterly for researchers.
Principles And Regulations Governing Contemporary Biomedical Research In India
The ethical framework for biomedical research in India has evolved through international declarations and national adaptations of these principles. These guidelines form the foundation of CMC Vellore's research ethics policies.
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1947 - Nuremberg Code
Formulated in response to the Nazi medical experiments during World War II, establishing 10 key principles including voluntary consent, avoidance of unnecessary suffering, and freedom to withdraw. These principles were later incorporated into Indian research guidelines and remain fundamental to CMC Vellore's ethical review process.
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1948 - Universal Declaration of Human Rights
Adopted by the UN General Assembly, affirming the dignity and rights of all humans. Article 27 specifically addresses scientific advancement rights. This declaration influenced the development of India's post-independence biomedical research frameworks and continues to guide CMC's approach to participant rights protection.
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1964 - Declaration of Helsinki
The World Medical Association established this pivotal document distinguishing between therapeutic and non-therapeutic research. It introduced risk-benefit analysis and emphasized special protection for vulnerable populations. India's regulatory bodies, including ICMR, have incorporated these principles, which CMC Vellore strictly follows in its clinical research protocols.
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1978 - The Belmont Report
Identified three fundamental ethical principles: respect for persons, beneficence, and justice. These principles shaped India's bioethics framework and were adopted by ICMR in its initial 1980 guidelines. CMC Vellore's IRB evaluates all research proposals against these core principles to ensure ethical compliance.
These international guidelines have been systematically incorporated into Indian regulatory frameworks by the Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), forming the ethical foundation that guides CMC Vellore's research practices.
International Ethical Guidelines
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1982 - WHO and CIOMS
The World Health Organization and Council for International Organizations of Medical Sciences issued the 'Proposed International Guidelines for Biomedical Research involving Human Subjects.' These guidelines established fundamental principles for international research ethics, emphasizing protections for vulnerable populations and addressing ethical challenges in developing countries.
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1991 - Epidemiological Guidelines
CIOMS brought out the 'International Guidelines for Ethical Review in Epidemiological studies' which addressed the unique ethical considerations in population-based research. These guidelines established standards for community consultation, privacy protections in data collection, and ethical oversight of public health surveillance activities.
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1993 - Biomedical Research Guidelines
CIOMS published comprehensive 'International Ethical Guidelines for Biomedical Research involving Human Subjects' which expanded previous frameworks. These guidelines introduced 15 specific principles addressing informed consent processes, research in developing countries, standards for ethics committees, and compensation for research-related injuries.
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UNESCO Declarations
"The Universal Declaration on Human Genome and Human Rights" (1997) protected human dignity in genetic research, "The International Declaration on Human Gene Data" (2003) established standards for collecting and processing genetic information, and "Universal Declaration on Bioethics and Human Rights"(2005) created a comprehensive framework addressing social responsibility, cultural diversity, and equitable access to healthcare advances.
Ethical Guidelines And Regulatory Procedures In India
1980 - Initial Policy Statement
ICMR brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects'
2000 - First Revision
Revised guidelines as the 'Ethical guidelines for Biomedical Research on Human Subjects'
2006 - Major Update
ICMR issued its revised guidelines taking into account rapid developments in science and technology, globalization, and revised CIOMS guidelines
The revised guidelines take into account the challenges faced by Indian researchers in applying universal ethical principles to biomedical research in a multicultural Indian society with a multiplicity of health-care systems of variable standards.
Cardinal Ethical Principles in Research
Respect for Autonomy
Requires researchers to obtain proper informed consent as per ICMR guidelines, with special provisions for vulnerable populations in India such as tribal communities, children, and mentally challenged individuals. Participants must have the freedom to withdraw at any stage without penalty.
Beneficence
Researchers must demonstrate potential benefits to participants and society in Ethics Committee applications. For clinical trials in India, post-trial access to beneficial treatments must be considered, and community benefits must be explicitly defined in community-based research.
Non-maleficence
Ethics Committees in India must evaluate protocols for potential harms, especially in genetics research and vaccine trials. Compensation mechanisms for research-related injuries must be established before study initiation as mandated by the Drugs and Cosmetics Act amendments of 2013.
Justice
Ensures equitable participant selection across India's diverse socioeconomic and cultural groups. Mandates fair distribution of research benefits, addressing concerns of exploitation in international collaborative research, and providing special protection for marginalized communities as highlighted in the 2006 ICMR guidelines.
These principles form the ethical foundation for the regulatory framework governing biomedical research in India, with specific adaptations to address unique challenges in the Indian context including cultural diversity, literacy levels, and healthcare access disparities.
Informed Consent Elements
Information
Disclosure of research purpose, duration, procedures, risks, benefits, alternatives, confidentiality measures, compensation, and contact information for questions
Comprehension
Researchers must ensure participants understand the information through clear language, appropriate literacy levels, and opportunity for questions before making decisions
Voluntariness
Participants must be free from coercion, undue influence, or exploitation, with explicit right to withdraw at any time without negative consequences
Informed consent contains three essential elements: information, comprehension (and competence), and voluntariness. The "reasonable volunteer" standard for information disclosure requires that sufficient information be provided that would allow persons to decide whether they wish to participate in the research. This includes clear explanations of risks in language appropriate to the participant's understanding, avoiding technical jargon, and accommodating cultural and linguistic differences. Researchers must document this process while respecting participant autonomy in accordance with the cardinal ethical principle of respect for persons.
The Statement of General Principles for Research of the ICMR
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Principles of essentiality
Research entailing the use of human participants is considered absolutely essential only after due consideration of all alternatives including in vitro studies, computer simulations, and animal experimentation. Researchers must provide strong scientific justification for involving human subjects in their protocols.
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Principles of voluntariness, informed consent and community agreement
Research participants are fully apprised of the research objectives, methods, potential risks, benefits, and alternatives before participation. They retain the right to abstain from further participation without penalty or loss of benefits. For community-based studies, proper consultation and approval from community representatives must be obtained.
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Principles of non-exploitation
Research participants are remunerated fairly for their time, inconvenience, and expenses incurred during participation. They are kept fully apprised of all potential dangers through comprehensive risk disclosure. Special protections are implemented for vulnerable populations including children, pregnant women, economically disadvantaged persons, and those with diminished autonomy.
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Principles of privacy and confidentiality
The identity and records of human participants are kept confidential through coding systems, secure data storage, and limited access protocols. All personal identifiers are removed from published data, and researchers are required to implement safeguards against unauthorized access. Participants have the right to control how their personal information is shared with third parties.
Additional ICMR Principles
Precaution and risk minimisation
Due care and caution at all stages to ensure minimum risk to research participants
Professional competence
Research conducted by competent and qualified persons with total integrity and impartiality
Accountability and transparency
Research conducted in a fair, honest, impartial and transparent manner after full disclosure
Maximisation of public interest
Research conducted to benefit all human kind, especially the least advantaged
Research Combined with Clinical Care
Therapeutic Misconception
Arises when patients recruited as research participants are unable to comprehend the differences between participating in a study and receiving treatment in the clinical setting. Rather than understanding these differences, study participants tend to believe that therapy and research were governed by the same primary goal, to advance the individual patient's best interests.
Declaration of Helsinki Guidelines
The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value
The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current methods
Every patient entered into the study should be assured of access to the best proven methods identified by the study
The physician should fully inform the patient which aspects of the care are related to the research
Research on Vulnerable Participants
Vulnerable research participants are individuals whose willingness to volunteer in research may be unduly influenced by the expectation of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate, or those whose consent may not be valid due to a variety of reasons.
Children and Adolescents
The purpose of including children in research is to gain knowledge relevant to the health needs of children. Children will not be involved in research that could be carried out equally well with adults.
Economically Disadvantaged
Persons who are economically or socially disadvantaged should not be used to benefit those who are better off than them. Special care must be taken in the informed consent process.
Students and Employees
Research must not bestow upon participating employees or students any competitive academic or occupational advantage over others who do not volunteer.
Research on Pregnant or Nursing Women
General Principle
Pregnant or nursing women should in no circumstances be the subject of any research unless the research carries no more than minimal risk to the foetus or nursing infant and the object of the research is to obtain new knowledge about the foetus, pregnancy and lactation.
Therapeutic Research
Women should not be deprived arbitrarily of the opportunity to benefit from investigations, drugs, vaccines or other agents that promise therapeutic or preventive benefits.
Special Considerations
Research related to termination of pregnancy and pre-natal diagnostic techniques must comply with specific Indian legislation including The Medical Termination of Pregnancy Act and the Prenatal Diagnostic Techniques Act.
Research at CMC Vellore
The Christian Medical College, Vellore (CMC) is an institution owned and administered by The Christian Medical College Vellore Association, a society registered under the Societies Registration Act, 1860 having its Registered Office at Ida Scudder Road, Vellore 632 004, Tamil Nadu, India.
Mission Statement
CMC, Vellore is an unaided, non-capitation, Christian minority educational institution affiliated with the Tamil Nadu Dr M.G.R. Medical University, set up with the mission to develop through education, research and training of, compassionate, professionally excellent, ethically sound individuals who will go out as servant-leaders of health teams and healing communities.
Institutional Motto
"NOT TO BE MINISTERED UNTO, BUT TO MINISTER"
The aim is "the establishment, maintenance and development of a Christian Medical College and hospitals in India, where women and men shall receive an education of highest grade in the art and science of medicine, nursing, or in related professions, to equip them in the Spirit of Christ for service in the relief of suffering and the promotion of health".
Institutional Authority
Council Authorization
The Council of CMC, which met on June 16, 1994, authorized the establishment of the Institutional Review Board (IRB)
Principal's Role
The Principal of CMC constitutes the IRBs under the directive of the Christian Medical College Council
Appeals Process
Any appeals regarding IRB decisions shall be directed to the Principal, who serves as the appellate authority
The Institutional Review Board (IRB)
CMC utilizes a centralized program to review all research. Until 2010, CMC operated one Institutional Review Board, but because of the increased workload, and in order to conform to national and international requirements of research oversight, from 2011 CMC has operated two Institutional Review Boards (IRB) [Silver, Blue] that each comprise of a Research Committee (RC) charged with reviewing the scientific validity of research proposals and an Ethics Committee (EC) that specifically addresses ethical concerns.
Silver IRB
Reviews all external research proposals, proposals from faculty and all interventional trials
Blue IRB
Reviews applications for non-interventional studies from trainees (Medical, Nursing & Allied Health)
Purpose of the Policies and Standard Operating Procedures
Protect Rights
Protect the rights, dignity, welfare and privacy of human research participants
Effective Functioning
Contribute to the effective functioning of the IRBs
Consistent Review
Ensure responsible and consistent ethical review mechanism for health and biomedical research
Compliance
Comply with national guidelines from DHR, ICMR and regulations under the Drugs and Cosmetics Act
Mandate of the IRBs
Review Requirement
Require that all research conducted in the institution be presented to the IRBs for assessment in the prescribed format
Timely Review
Provide competent and timely review of all research proposals submitted to ensure scientific validity and ethical conduct
Informed Consent
Evaluate the informed consent process and documentation; assess the risk-benefit ratio, distribution of burden and benefit
Ongoing Monitoring
Provide ongoing monitoring of all research that it approves, including site visits and audits of procedures and documentation
Composition of Research Committee (Silver)
Leadership Structure
Chairperson (a member of the Senatus nominated by the Principal)
Member Secretary (ex officio the Head of the Department of Biostatistics)
Senior faculty members of CMC nominated by the Principal to represent a mix of specialities and research expertise
Research Committee (Blue)
The Research Committee of the Blue IRB follows the same structure as the Silver IRB, with a Chairperson (a member of the Senatus nominated by the Principal), a Member Secretary (ex officio the Head of the Department of Biostatistics), and senior faculty members representing various specialities and research expertise.
Ethics Committee Composition
Chairperson & Deputy
Persons of stature with scientific background and adequate familiarity with ethics principles, external to the institution
Social Scientist
Representative of non-governmental organization, ethicist, theologian or similar person
Legal Expert
Legal expert to interpret regulations and ensure compliance with applicable laws
Community Representative
Layperson from the community to represent participant perspectives
The composition shall include a basic medical scientist (preferably a pharmacologist) and a clinician. Preferably 50% of the members should be non-affiliated or from outside the institution.
Education of IRB Members
Training Pack
IRB members will be provided a training pack consisting of relevant guidelines regarding the science and ethics of biomedical research
Basic Training
All RC members must have attended basic training in research study design and ethics of human research participants' protection
Ongoing Education
IRB members will be offered ongoing opportunities for enhancing their capacity for ethical review, including participation at periodic Research Ethics and GCP workshops
Record Keeping
A record will be maintained of the training obtained by IRB members and updated annually
Responsibilities of IRB Members
Chairperson of EC Responsibilities
Conduct EC meetings according to established SOPs and be accountable for ensuring the independent, competent and efficient functioning of the committee in accordance with GCP guidelines
Facilitate active participation of all members in discussions by allocating sufficient time for each agenda item and encouraging diverse viewpoints on ethical considerations
Review and ratify minutes of the previous meetings within 7 days of receipt to ensure accuracy of recorded decisions and action items
Collect written Conflict of Interest declarations from all members at the beginning of each meeting and ensure a minimum quorum of 5 members including at least one non-scientific member for valid decision-making
Establish formal procedures to handle complaints against researchers or EC members, including a dedicated sub-committee to investigate conflict of interest issues within 14 days of reporting
Member Secretary Responsibilities
Implement standardized procedures for receiving, preparing, and circulating research proposals at least 7 days before scheduled review meetings to allow adequate preparation by members
Schedule EC meetings at least once monthly, prepare comprehensive agenda with time allocations, and draft detailed minutes capturing key discussions and rationale for decisions
Maintain complete documentation including proposal submissions, review reports, communications with investigators, and archive records securely for a minimum of 5 years after study completion
Coordinate mandatory initial training for new EC members within 30 days of appointment and annual refresher training on GCP, ethical guidelines, and regulatory updates
Lead the review and update of Standard Operating Procedures every 2 years or whenever regulatory changes occur, ensuring compliance with current international and national regulations
Basic Medical Scientist Responsibilities
Conduct rigorous scientific and ethical review with special emphasis on evaluating intervention methodology, providing quantitative benefit-risk analysis using standardized assessment tools
Critically assess research design elements including sample size calculations, randomization procedures, blinding methods, and statistical analysis plans to ensure scientific validity
For clinical trials, the pharmacologist member must thoroughly review drug safety profiles, pharmacokinetics, dosage rationale, and potential drug interactions in accordance with ICH-GCP guidelines
Perform systematic ongoing review of protocol implementation by evaluating Serious Adverse Event reports within 48 hours, analyzing protocol deviations, reviewing quarterly progress reports, and assessing final completion reports
Purpose of the Research Committees
The Research Committees will discuss and review the design, scientific content, statistical methods and the appropriateness of the study in the setting of CMC, compliance with regulations, and the budgets. The Research Committee will make recommendations on any request for intramural research funding.
Terms of Appointment
The Principal of CMC nominates members of the faculty to serve on the Research Committee
The duration of appointment for members is for a period of three years
The appointment may be renewed at the discretion of the Principal for additional terms
For the ex-officio members, membership is for the duration of their tenure in the administrative office
Replacement Criteria
A member can be replaced in the event of resignation or non-attendance for three consecutive Research Committee meetings (unless this was intimated in advance to the member secretary on sufficient grounds), or for any action not commensurate with the responsibilities laid down in the guidelines.
Research Grant Funding
Rs. 3L
Standard Grant
Total grant amount for two years (limited to Rs. 1,50,000 per year)
30 days
Agreement Timeline
PI and Guide must sign agreement within 30 days to initiate account opening
7 days
Processing Time
Account opening completed within 7 working days upon receipt of signed agreement
If the PI requests a fluid research grant in the IRB application, an itemized budget is to be provided. If the budget is approved, an agreement form is sent along with the IRB approval letter.
Major Research Grant Eligibility
Faculty Level
Confirmed Medical faculty– Assistant Professor Grade I & II; Associate Professor Grade I & II. Confirmed Non-medical Post Docs Up to Associate Professor Grade I equivalent.
Funding History
Should have at least one fluid research grant funding as a PI or external grant funding at least as a co-PI.
Publication Record
At least 1 research paper published in National/International Journals related to this field, preferably indexed.
Research Staff
The researcher can avail up to 50% of the total budget towards employing research staff.
Special Grants - CMC Vellore & Mission Network Collaborative Research Grant
Broad Aims
Capacity building among CMC Vellore Mission Network Hospitals for field, epidemiological, clinical and translational research
Create Data Sub-hubs among CMC Vellore Mission Network Hospitals to leverage systematic and centralized data management for research
Funding Details
Amount: Ten lakh INR per grant for a total duration of 2 years
Annual Allocation: A maximum of 4 grants will be awarded annually
Eligibility: PI must be a confirmed medical faculty in CMC Vellore with at least one Co-PI/Co-I from Mission Network Hospitals
VELLORE CMC FOUNDATION (VCMCF) Research Grant
Primary Aim
Encourage basic, translational and clinical research among confirmed junior faculty
Data Acquisition
Acquire data/experience for facilitating external funding and publications in indexed journals
Funding Amount
Rs. 10,00,000 per grant with maximum of 2 grants awarded annually
This grant supports confirmed junior faculty in pursuing high-quality research with significant funding allocation for comprehensive research projects.
Purpose of the Ethics Committee
The Institutional Review Board (IRB) Ethics Committees of CMC Vellore provide comprehensive ethical oversight for all research conducted within the institution. These committees meticulously evaluate research proposals for social acceptability, cultural sensitivity, legal compliance, and ethical soundness. They specifically focus on scrutinizing informed consent documents, ensuring participant autonomy, and implementing robust safeguards against research-related harms through standardized risk assessment protocols.
Terms of Appointment
The Principal of CMC Vellore extends invitations to distinguished professionals with relevant expertise from both within the institution and the broader community. Selection criteria include demonstrated expertise in research ethics, relevant clinical experience, and commitment to ethical principles. Appointments are formalized for a defined period of three years, with possibility of one term renewal based on performance evaluation.
Continuity Provision
To maintain institutional memory and procedural consistency, member rotation follows a staggered schedule. When existing members complete their terms, new appointments are made strategically to ensure at least 50% of committee composition remains unchanged. This balanced approach preserves experiential knowledge while introducing fresh perspectives for comprehensive ethical review.
Compensation Structure
External members receive comprehensive support for their contributions, including arranged transportation to EC meetings or reimbursement for travel expenses at standard institutional rates. Additionally, they receive an honorarium of Rs. 5,000 per meeting for their expert participation and review activities. Internal members serve as part of their institutional responsibilities without additional compensation.
Research Proposal Submission Process
Application
Submit on prescribed forms according to study design
Document Verification
Completeness check and mandatory document review
Review Chart Preparation
Reviewers allotted with minimum seven calendar days for review
IRB Meeting
Concurrent scientific and ethical review by committees
Processing Fee for IRB Clearance
Rs. 75K
Standard Fee
Non-refundable processing fee for external research proposals funded by commercial organizations
18%
GST
Additional GST applicable as per Government norms
0
Non-Commercial
No fee applicable to proposals funded by non-commercial sponsors
This fee is levied on all external research proposals that are funded by agencies or organizations with a commercial orientation (pharmaceutical companies, contract research organizations, etc) for IRB approval.
Mandatory Documents for IRB Submission
Completed IRB Application
Form with responses for each question or "not applicable" for those that do not call for a response
Required Approvals
Signatures of Principal Investigator, Co-Investigators, Guide (for student research), and Head of Department
CVs of Investigators
Curriculum vitae highlighting expertise of investigators in conducting the proposed research
Consent Documents
Patient Information Sheet/Informed Consent Forms with translations and any recruitment advertisements
Review Procedure Categories
Exemption from Review
Proposals which present less than minimal risk, such as research on educational practices
Expedited Review
Research activities that present no more than minimal risk and involve only specific listed procedures
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Full Review
All research presenting more than minimal risk, involving vulnerable populations and special groups
Final Reports
All final reports reviewed by assigned Research Committee member
Expedited Review Categories
Clinical Studies
Studies of drugs and medical devices only when research is on already approved drugs
Blood Collection
Collection by finger prick, heel prick, ear prick, or venepuncture with specific volume limits
Biological Specimens
Prospective collection by non-invasive means including hair, nail clippings, saliva, placenta
Non-invasive Procedures
Data collection through procedures routinely employed in clinical practice
Ethical Issues Related to Reviewing a Protocol
Social Values Assessment
The basic requirement for health research to be ethically permissible is that it must have anticipated social value. The outcome should be relevant to the health problems of society.
Scientific Design Evaluation
Valid scientific methods are essential to make research ethically viable as poor science can expose research participants to risks without any possibility of benefit.
Benefit-Risk Analysis
The benefits accruing from the planned research must justify the risks inherent in the research. Risks may be physical, psychological, economic, social or legal.
IRB Meeting Procedures
Meeting Schedule
The IRB Silver meets every month (except May) for detailed review of all proposals
The IRB Blue meets every month (except May) on the 1st Wednesday
All decisions taken at convened meetings, not solely by circulation
Time and venue communicated to investigators 5-6 days prior to meeting
Quorum Requirements
RC Review: 4 members
EC Review: 5 members including:
One basic medical scientist (preferably pharmacologist)
One clinician
One legal expert or retired judge
One social scientist/NGO representative/philosopher/ethicist/theologian
One layperson from the community
Elements of Review
Research Committee Review
Reviews rationale and need for study, appropriateness of study design, statistical methodology, risk-benefit justification, and adequacy of investigative team and facilities
Care and Protection
Evaluates investigator qualifications, medical care provisions, withdrawal procedures, compensation arrangements, and insurance coverage
Confidentiality Protection
Reviews access to personal data, measures for confidentiality and security of personal information concerning research participants
Informed Consent Process
Evaluates process for obtaining consent, adequacy of information provided, and provisions for vulnerable populations
Informed Consent in Emergency Protocols
Emergency Criteria
When participants are in life-threatening situations, available treatments are unproven, and intervention must be administered before consent is feasible
Direct Benefit Requirement
Participation must hold prospect of direct benefit because participants face life-threatening situation that necessitates intervention
Therapeutic Window
Protocol must define length of potential therapeutic window and investigator must attempt to contact legally authorized representative within that window
Information Provision
Procedures must be in place to inform participant or representative at earliest feasible opportunity about inclusion in research and right to discontinue
Decision Making Process
Conflict Management
Member withdraws during decision procedure concerning application where there is conflict of interest
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Quorum Maintenance
Decisions only made when sufficient time allowed for review and quorum present for each proposal
Consensus Building
Decisions arrived at through consensus where possible; when consensus not possible, IRB will vote
Documentation
Record of discussion serves as minutes, approved and signed by Chairperson with clear reasons for any negative decisions
Communicating IRB Decisions
Initial Communication
Decision communicated in writing to applicant within two weeks of the meeting. Queries emailed to PI within 4-5 business days after IRB meeting.
Response Timeline
Investigators provide responses to queries via email within 3 months from receipt, along with filled revision checklist.
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Final Approval
Final IRB approval letter issued after receiving approval from Primary & Secondary reviewers via email.
Electronic Documentation
All communication shared as PDFs with electronic signatures by Class III Adobe Acrobat Sign.
Prospective Registration of Clinical Trials
Registration Requirements
The ICMR and WHO require prospective registration of all clinical trials before enrolment of the first participant in a Primary Register of the WHO International Clinical Trials Registry Platform. Prior registration is now a condition of publishing clinical trials for many journals.
All interventional clinical trials conducted in India involving Indian participants need registration
Registration mandatory by CDSCO on 15 June 2009 for trials under Drugs and Cosmetics Act
Registration voluntary for other biomedical and health research
CTRI Registration Process
The Clinical Trials Registry–India (CTRI) was launched on 20 July 2007 by ICMR as a free online public record system. Trial registration involves providing information regarding:
Study details and investigators
Sites and sponsor information
Ethics committees and regulatory clearances
Disease/condition and study methodologies
Outcomes and other relevant details
Follow-up and Monitoring
Monitoring Committee
The IRB may nominate a subcommittee to monitor conduct of clinical trials, operating under the CMC Clinical Trial Monitoring Committee (CTMC)
Review Intervals
Follow-up review intervals determined by nature and events of research projects, with each protocol undergoing review at least once annually
SAE Reporting
All SAEs and interventions undertaken should be intimated to the IRB in prescribed format with copy to study sponsor
Final Reports
Final report should be submitted at end of study including externally funded studies
Continuing Review and Amendments
Amendment Submission
All amendments must be submitted within study duration and reviewed before implementation
Review Process
Amendments forwarded to original reviewers; minor changes may be administratively approved
SAE Reporting
Serious adverse events reported to CMC IRB Safety Monitor within 24 hours of awareness
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Written Approval
No study procedure deviation permitted until written IRB approval received
Record Keeping and Archiving
File Preparation
Files must be prepared for archival within 30 days of final report submission. Each file receives a unique alphanumeric identifier (format: IRB-YYYY-###-PT) with standardized index sheet listing all contents. Electronic copies must be converted to PDF/A format for long-term preservation.
Retention Periods
Fluid Grant studies: minimum 3 years post-completion. Externally funded studies: minimum 5 years. Clinical trials: minimum 5 years after last participant contact or 2 years post-publication, whichever is longer. Studies involving minors: until 2 years after subjects reach age of majority.
Security Measures
Physical files stored in fire-resistant, locked file room with limited-access key cards. Electronic copies stored on encrypted servers with AES-256 encryption and multi-factor authentication. Access logs maintained for 7 years. Quarterly security audits conducted by Information Security Officer.
Retrieval Process
Retrieval requests must be submitted via official IRB.Retrieval@cmc.edu email with Form R-42 attached. Only authorized personnel may access archived materials. Chain-of-custody log requires signature, date, time, and purpose for each access event. Materials must be returned within 14 business days.
Policy on Recruitment of Research Participants
General Recruitment Principles
The IRB evaluates all protocols for participant recruitment especially with respect to women with childbearing potential, minority groups and children. Exclusion of minorities, women or children will be recommended only when inclusion is inappropriate with respect to health or research purpose.
Patients identified through direct contact of PI with patients
Collaboration with physicians of other medical specialties
Posted written notices, flyers, or other IRB-approved methods
Specific Recruitment Guidelines
Inpatients: May be recruited only after consultation with patient's treating consultant/head of Unit
Outpatients: For minimal-risk research, recruitment possible without prior notification of personal physicians. For more than minimal risk research, participant's personal physician/consultant should be notified before enrollment
Minors/Incapacitated: Contact must be via parent or legal guardian
Policy and Procedures for Informed Consent
Informed consent is "consent given voluntarily by a competent individual who has received the necessary information, has adequately understood the information and after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation".
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Communication Process
Informed consent is a process, not merely a signature on consent form
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Information Provision
Verbal description and discussion of study details including randomization, components, and other pertinent aspects
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Documentation
Written information sheet in participant's vernacular and separate ICF used to document consent
Essential Elements of Informed Consent
Research Statement
Statement that study involves research and explanation of research purpose
Duration
Expected duration of participant's participation
Procedures
Description of procedures to be followed, including all invasive procedures
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Risks and Benefits
Description of reasonably foreseeable risks or discomforts and any benefits reasonably expected
Voluntary Participation
Statement that participation is voluntary, participant can withdraw at any time without penalty
Special Consent Situations
Waiver of Consent
Voluntary informed consent is normally required as outlined in previous sections, but can be waived by the Ethics Committee if research involves not more than minimal risk (defined as risk not greater than routine medical care) or when participant and researcher do not come into contact. Applicable for:
Research on publicly available information, documents, records, or pathological specimens
Research on anonymised biological samples from deceased individuals where no identifying information is recorded
Emergency situations when no surrogate consent can be taken and delay would threaten patient welfare (requires post-procedure consent when possible)
Retrospective studies on data where anonymity is assured and maintained
Re-consent Requirements
Fresh consent or re-consent must be obtained and documented in the following circumstances:
When participant crosses 18 years of age (legal age of consent), regardless of study duration
Availability of new information that substantially alters risks or benefits, necessitating protocol deviation
When research participant regains consciousness or becomes mentally competent after proxy consent
When long term follow-up or study extension is planned beyond the original consent timeline
Change in treatment modality, procedures, or investigational products
When new vulnerable populations are included after initial approval
Audio-visual Recording of Consent Process
Audio-visual recording of the informed consent process is mandatory for regulatory clinical trials as per DCGI office order dated 31st July 2015. Required for all clinical trials wherein new drug is being used or old drug for new clinical indication. The recording must:
Document the entire consent process, including explanation of study procedures
Capture clear confirmation of voluntary participation
Be stored securely for a minimum of five years after study completion
Include timestamp and clear identification of all parties present
Comply with privacy regulations and be accessible only to authorized personnel
Research Costs and Compensation Policy
Cost Considerations
If research participants may bear costs unnecessary if they declined participation, all potential participants must be fully informed of the nature and estimated extent of these costs when obtaining consent. These details must be explicitly outlined in the consent document.
Prolongation of treatment or hospitalization (typically ₹5,000-15,000 per additional day)
Extra diagnostic tests necessary for research (e.g., additional MRIs, CT scans, specialized blood work)
Extra clinical or laboratory assessments beyond standard care (may require 2-3 additional visits)
Research treatment more costly than standard treatment (participants should never bear differential costs)
Additional transportation expenses for extra study visits
Compensation Framework
Participants may be paid for inconvenience and time spent (₹500-2,000 per visit based on duration and procedures), and should be reimbursed for expenses incurred including travel (actual cost or standard rate of ₹300 per visit). However, payments should not be so large as to make prospective participants consent against their better judgment.
Injury Compensation: Research participants who suffer physical injury as result of participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. This includes:
Complete medical management of research-related injury (100% coverage)
Financial compensation as determined by the IEC based on the severity of injury
Compensation must be paid within 30 days of the EC determination
For serious adverse events, compensation follows DCGI guidelines (₹8 lakhs for death, scaled for other injuries)