About IEC
The Institutional Ethics Committee of the Hamdard Institute of Medical Sciences & Research is an independent, multidisciplinary body committed to safeguarding the rights, dignity, safety, and well-being of participants involved in biomedical and health research.
IEC HIMSR is registered by the Central Licensing Agency (Central Drugs Standard Control Organisation), Directorate General of Health Services, Government of India, for reviewing protocols for clinical trials or Bioavailability or Bioequivalence studies, as per New Drugs and Clinical Trials Rules, 2019.
The Committee ensures that all research conducted under its oversight adheres to the highest ethical and scientific standards in accordance with the guidelines of the CDSCO and Indian Council of Medical Research, applicable national regulations, and internationally accepted ethical principles.
The IEC reviews research proposals involving human participants to ensure that the anticipated benefits justify the risks, participant rights are protected, informed consent is obtained appropriately, and confidentiality and privacy are maintained. In addition to the initial ethical review, the Committee oversees approved studies through continuing review, monitors protocol compliance, and evaluates protocol amendments, safety reports, and study completion reports.
The IEC also conducts training on Research Ethics and GCP for researchers, students and academicians.
The Composition of IEC:
Contact Details of IEC:
Member Secretary
Institutional Ethics Committee – HIMSR
IEC Secretariat
Ground Floor, HIMSR
The Terms of Reference of IEC:
The IEC shall review and oversee:
- Biomedical and health research involving human participants
- Clinical trials (drug, device, biologics)
- Public health, epidemiological, and social/behavioral research
- Student research projects and dissertations
- Research involving biological materials, data, devices and records
The IEC is authorized to:
- Approve, reject, or request modifications in research proposals
- Suspend or terminate studies in case of ethical violations
- Monitor ongoing studies through progress reports and site visits
- Ensure compliance with national regulatory requirements (ICMR, CDSCO, NDCT Rules, etc.)
Quorum:
A minimum of 5 members are required to constitute the quorum for the meeting of which at least one member must be from outside the institution, and atleast one member will be a non-scientific member & representing both genders.
For clinical trial, quorum will include at least one representative from all the following:
Minimum 5 members including:
- One basic medical scientist
- One clinician
- One legal expert
- Social Scientist / Ethicist
- One lay person
Frequency of Meeting:
The Committee shall meet atleast once in 2 months or more frequently as needed depending on the number of research protocols pending approval.
Tenure:
The IEC may be revised annually with replacement of one-third of members who complete three years of duration as members.
Roles and Responsibilities
Chairperson & Vice Chairperson
- Preside over meetings
- Conduct EC meetings and be accountable for independent and efficient functioning of the committee
- Ensure active participation of all members (particularly non-affiliated, non-medical/ non- technical) in all discussions and deliberations
- Ratify minutes of the previous meetings
- Seek COI declaration from members and ensure quorum and fair decision making.
- Handle complaints against researchers, EC members, conflict of interest issues and requests for use of EC data, etc.
Vice Chairperson
- In the absence of Chairperson discharge all the duties of the Chairperson
Member Secretary
- Schedule EC meetings, prepare the agenda and minutes
- Organize EC documentation, communication and archiving
- Ensure training of EC secretariat and EC members
- Ensure SOPs are updated as and when required
- Ensure adherence of EC functioning to the SOPs
- Prepare for and respond to audits and inspections
- Assess the need for expedited review/ exemption from review or full review.
Alternate Member Secretary
In the absence of Member Secretary discharges all the duties of the Member Secretary
Members
- Review proposals objectively and diligently
- Declare conflicts of interest
- Participate in discussions and decisions
- Attend atleast 75% of the meetings
All members of the IEC shall ensure adequate training as required and diligently uphold ethical discharge of their duties.
Functions of the IEC
The IEC shall:
- Review research protocols, informed consent documents, and investigator qualifications
- Assess risk-benefit ratio and participant protection measures
- Ensure equitable selection of participants
- Review provisions for privacy and confidentiality
- Evaluate compensation for injury and reimbursement
- Monitor adverse events and protocol deviations and report the same as required
- Conduct continuing review at defined intervals
Compliance and Guidelines
IEC shall function in accordance with:
- ICMR National Ethical Guidelines (latest edition)
- New Drugs and Clinical Trials Rules (NDCT), India
- CDSCO regulations
- ICH-GCP guidelines
Registration Certificate of IEC HIMSR
