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.
© Christian Medical College Vellore 2025 – CC BY-NC-SA 4.0
Policies and Procedures of the Office of Research & IRB, CMC Vellore, Revised Version 3.0, 1st April 2025.
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.
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.
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.
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.
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.
CDSCO - Ethics Committee Registration No: ECR/326/Inst/TN/2013/RR-24
DHR Registration No: EC/NEW/INST/2023/TN/0211
Valid until: March 31, 2028
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.
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.
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.
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.
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.
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.
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.
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.
"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.
ICMR brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects'
Revised guidelines as the 'Ethical guidelines for Biomedical Research on Human Subjects'
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.
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.
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.
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.
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.
Disclosure of research purpose, duration, procedures, risks, benefits, alternatives, confidentiality measures, compensation, and contact information for questions
Researchers must ensure participants understand the information through clear language, appropriate literacy levels, and opportunity for questions before making decisions
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.
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.
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.
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.
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.
Due care and caution at all stages to ensure minimum risk to research participants
Research conducted by competent and qualified persons with total integrity and impartiality
Research conducted in a fair, honest, impartial and transparent manner after full disclosure
Research conducted to benefit all human kind, especially the least advantaged
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.
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.
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.
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.
Research must not bestow upon participating employees or students any competitive academic or occupational advantage over others who do not volunteer.
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.
Women should not be deprived arbitrarily of the opportunity to benefit from investigations, drugs, vaccines or other agents that promise therapeutic or preventive benefits.
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.
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.
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.
"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".
The Council of CMC, which met on June 16, 1994, authorized the establishment of the Institutional Review Board (IRB)
The Principal of CMC constitutes the IRBs under the directive of the Christian Medical College Council
Any appeals regarding IRB decisions shall be directed to the Principal, who serves as the appellate authority
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.
Reviews all external research proposals, proposals from faculty and all interventional trials
Reviews applications for non-interventional studies from trainees (Medical, Nursing & Allied Health)
Protect the rights, dignity, welfare and privacy of human research participants
Contribute to the effective functioning of the IRBs
Ensure responsible and consistent ethical review mechanism for health and biomedical research
Comply with national guidelines from DHR, ICMR and regulations under the Drugs and Cosmetics Act
Require that all research conducted in the institution be presented to the IRBs for assessment in the prescribed format
Provide competent and timely review of all research proposals submitted to ensure scientific validity and ethical conduct
Evaluate the informed consent process and documentation; assess the risk-benefit ratio, distribution of burden and benefit
Provide ongoing monitoring of all research that it approves, including site visits and audits of procedures and documentation
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.
Persons of stature with scientific background and adequate familiarity with ethics principles, external to the institution
Representative of non-governmental organization, ethicist, theologian or similar person
Legal expert to interpret regulations and ensure compliance with applicable laws
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.
IRB members will be provided a training pack consisting of relevant guidelines regarding the science and ethics of biomedical research
All RC members must have attended basic training in research study design and ethics of human research participants' protection
IRB members will be offered ongoing opportunities for enhancing their capacity for ethical review, including participation at periodic Research Ethics and GCP workshops
A record will be maintained of the training obtained by IRB members and updated annually
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.
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.
Total grant amount for two years (limited to Rs. 1,50,000 per year)
PI and Guide must sign agreement within 30 days to initiate account opening
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.
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.
Should have at least one fluid research grant funding as a PI or external grant funding at least as a co-PI.
At least 1 research paper published in National/International Journals related to this field, preferably indexed.
The researcher can avail up to 50% of the total budget towards employing research staff.
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
Encourage basic, translational and clinical research among confirmed junior faculty
Acquire data/experience for facilitating external funding and publications in indexed journals
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.
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.
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.
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.
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.
Submit on prescribed forms according to study design
Completeness check and mandatory document review
Reviewers allotted with minimum seven calendar days for review
Concurrent scientific and ethical review by committees
Non-refundable processing fee for external research proposals funded by commercial organizations
Additional GST applicable as per Government norms
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.
Form with responses for each question or "not applicable" for those that do not call for a response
Signatures of Principal Investigator, Co-Investigators, Guide (for student research), and Head of Department
Curriculum vitae highlighting expertise of investigators in conducting the proposed research
Patient Information Sheet/Informed Consent Forms with translations and any recruitment advertisements
Proposals which present less than minimal risk, such as research on educational practices
Research activities that present no more than minimal risk and involve only specific listed procedures
All research presenting more than minimal risk, involving vulnerable populations and special groups
All final reports reviewed by assigned Research Committee member
Studies of drugs and medical devices only when research is on already approved drugs
Collection by finger prick, heel prick, ear prick, or venepuncture with specific volume limits
Prospective collection by non-invasive means including hair, nail clippings, saliva, placenta
Data collection through procedures routinely employed in clinical practice
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.
Valid scientific methods are essential to make research ethically viable as poor science can expose research participants to risks without any possibility of benefit.
The benefits accruing from the planned research must justify the risks inherent in the research. Risks may be physical, psychological, economic, social or legal.
RC Review: 4 members
EC Review: 5 members including:
Reviews rationale and need for study, appropriateness of study design, statistical methodology, risk-benefit justification, and adequacy of investigative team and facilities
Evaluates investigator qualifications, medical care provisions, withdrawal procedures, compensation arrangements, and insurance coverage
Reviews access to personal data, measures for confidentiality and security of personal information concerning research participants
Evaluates process for obtaining consent, adequacy of information provided, and provisions for vulnerable populations
When participants are in life-threatening situations, available treatments are unproven, and intervention must be administered before consent is feasible
Participation must hold prospect of direct benefit because participants face life-threatening situation that necessitates intervention
Protocol must define length of potential therapeutic window and investigator must attempt to contact legally authorized representative within that window
Procedures must be in place to inform participant or representative at earliest feasible opportunity about inclusion in research and right to discontinue
Member withdraws during decision procedure concerning application where there is conflict of interest
Decisions only made when sufficient time allowed for review and quorum present for each proposal
Decisions arrived at through consensus where possible; when consensus not possible, IRB will vote
Record of discussion serves as minutes, approved and signed by Chairperson with clear reasons for any negative decisions
Decision communicated in writing to applicant within two weeks of the meeting. Queries emailed to PI within 4-5 business days after IRB meeting.
Investigators provide responses to queries via email within 3 months from receipt, along with filled revision checklist.
Final IRB approval letter issued after receiving approval from Primary & Secondary reviewers via email.
All communication shared as PDFs with electronic signatures by Class III Adobe Acrobat Sign.
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.
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:
The IRB may nominate a subcommittee to monitor conduct of clinical trials, operating under the CMC Clinical Trial Monitoring Committee (CTMC)
Follow-up review intervals determined by nature and events of research projects, with each protocol undergoing review at least once annually
All SAEs and interventions undertaken should be intimated to the IRB in prescribed format with copy to study sponsor
Final report should be submitted at end of study including externally funded studies
All amendments must be submitted within study duration and reviewed before implementation
Amendments forwarded to original reviewers; minor changes may be administratively approved
Serious adverse events reported to CMC IRB Safety Monitor within 24 hours of awareness
No study procedure deviation permitted until written IRB approval received
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.
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.
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 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.
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.
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
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".
Informed consent is a process, not merely a signature on consent form
Verbal description and discussion of study details including randomization, components, and other pertinent aspects
Written information sheet in participant's vernacular and separate ICF used to document consent
Statement that study involves research and explanation of research purpose
Expected duration of participant's participation
Description of procedures to be followed, including all invasive procedures
Description of reasonably foreseeable risks or discomforts and any benefits reasonably expected
Statement that participation is voluntary, participant can withdraw at any time without penalty
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:
Fresh consent or re-consent must be obtained and documented in the following circumstances:
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:
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.
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:
CHRISTIAN MEDICAL COLLEGE