Institutional Ethics Committee
Institutional Ethics Committee
Institutional Ethics Committee
Terms of Reference of the Committee
Terms of Reference of the Committee
Terms of Reference of the Committee
The Institutional Ethics Committee (IEC) will review and approve all research protocols involving human participants, with a primary focus on safeguarding the dignity, rights, safety, and wellbeing of all actual and potential participants. Regardless of the significance of the research objectives, these goals must never take precedence over the health and welfare of research participants. The IEC will ensure that the fundamental principles of research ethics, Autonomy, Beneficence, Non-malfeasance, and Justice, are rigorously upheld in the design, conduct, and reporting of all proposed studies. The IEC promotes good clinical practices (GCP) in all the studies approved by the committee.
In research involving AI tools, algorithms, or data-driven methodologies, the IEC will additionally evaluate ethical safeguards specific to AI, including transparency, data privacy, algorithmic fairness, explainability, and mitigation of potential biases or harms. The committee will carefully review the informed consent process, risk–benefit assessments, equitable distribution of burdens and benefits, and provisions for appropriate compensation where required.
Any protocol submitted to the IEC should have undergone review by the Scientific Advisory Board to ensure that the proposed work is scientifically robust, clinically relevant, and strategically aligned with TANUH objectives and public health needs. The IEC will conduct oversight from the initial proposal stage through the entire lifecycle of the study, including post-completion monitoring, using well-documented procedures such as annual and final reports, and site visits. Compliance with all regulatory requirements, applicable guidelines, and relevant laws, including those pertaining to AI research, will be examined. The IEC’s mandate encompasses the review of all research projects involving human subjects, including studies using human biological materials and data, conducted at the Institute, irrespective of the source of funding.
The Institutional Ethics Committee (IEC) will review and approve all research protocols involving human participants, with a primary focus on safeguarding the dignity, rights, safety, and wellbeing of all actual and potential participants. Regardless of the significance of the research objectives, these goals must never take precedence over the health and welfare of research participants. The IEC will ensure that the fundamental principles of research ethics, Autonomy, Beneficence, Non-malfeasance, and Justice, are rigorously upheld in the design, conduct, and reporting of all proposed studies. The IEC promotes good clinical practices (GCP) in all the studies approved by the committee.
In research involving AI tools, algorithms, or data-driven methodologies, the IEC will additionally evaluate ethical safeguards specific to AI, including transparency, data privacy, algorithmic fairness, explainability, and mitigation of potential biases or harms. The committee will carefully review the informed consent process, risk–benefit assessments, equitable distribution of burdens and benefits, and provisions for appropriate compensation where required.
Any protocol submitted to the IEC should have undergone review by the Scientific Advisory Board to ensure that the proposed work is scientifically robust, clinically relevant, and strategically aligned with TANUH objectives and public health needs. The IEC will conduct oversight from the initial proposal stage through the entire lifecycle of the study, including post-completion monitoring, using well-documented procedures such as annual and final reports, and site visits. Compliance with all regulatory requirements, applicable guidelines, and relevant laws, including those pertaining to AI research, will be examined. The IEC’s mandate encompasses the review of all research projects involving human subjects, including studies using human biological materials and data, conducted at the Institute, irrespective of the source of funding.
The Institutional Ethics Committee (IEC) will review and approve all research protocols involving human participants, with a primary focus on safeguarding the dignity, rights, safety, and wellbeing of all actual and potential participants. Regardless of the significance of the research objectives, these goals must never take precedence over the health and welfare of research participants. The IEC will ensure that the fundamental principles of research ethics, Autonomy, Beneficence, Non-malfeasance, and Justice, are rigorously upheld in the design, conduct, and reporting of all proposed studies. The IEC promotes good clinical practices (GCP) in all the studies approved by the committee.
In research involving AI tools, algorithms, or data-driven methodologies, the IEC will additionally evaluate ethical safeguards specific to AI, including transparency, data privacy, algorithmic fairness, explainability, and mitigation of potential biases or harms. The committee will carefully review the informed consent process, risk–benefit assessments, equitable distribution of burdens and benefits, and provisions for appropriate compensation where required.
Any protocol submitted to the IEC should have undergone review by the Scientific Advisory Board to ensure that the proposed work is scientifically robust, clinically relevant, and strategically aligned with TANUH objectives and public health needs. The IEC will conduct oversight from the initial proposal stage through the entire lifecycle of the study, including post-completion monitoring, using well-documented procedures such as annual and final reports, and site visits. Compliance with all regulatory requirements, applicable guidelines, and relevant laws, including those pertaining to AI research, will be examined. The IEC’s mandate encompasses the review of all research projects involving human subjects, including studies using human biological materials and data, conducted at the Institute, irrespective of the source of funding.
Scientific Review Board
Scientific Review Board
Scientific Review Board
The Scientific Review Board (SRB) shall consist of domain experts with experience in the scientific, technical, and methodological evaluation of the proposals. The SRB ensures that all projects meet standards of scientific validity and methodological soundness before submission to the IEC.
The Scientific Review Board (SRB) shall consist of domain experts with experience in the scientific, technical, and methodological evaluation of the proposals. The SRB ensures that all projects meet standards of scientific validity and methodological soundness before submission to the IEC.
The Scientific Review Board (SRB) shall consist of domain experts with experience in the scientific, technical, and methodological evaluation of the proposals. The SRB ensures that all projects meet standards of scientific validity and methodological soundness before submission to the IEC.
Members
Members
Members
Chief Engineering Manager, TANUH
Chief Engineering Manager, TANUH
Chief Engineering Manager, TANUH
Program Manager, Breast Cancer, TANUH
Program Manager, Breast Cancer, TANUH
Program Manager, Breast Cancer, TANUH
Chief Project Manager, TANUH
Chief Project Manager, TANUH
Chief Project Manager, TANUH
Assistant Professor, Department of Computational and Data Sciences, IISc
Assistant Professor, Department of Computational and Data Sciences, IISc
Assistant Professor, Department of Computational and Data Sciences, IISc
CTO, Women’s Health & X-Ray and VP, Engineering at GE HealthCare Technology Centre India
CTO, Women’s Health & X-Ray and VP, Engineering at GE HealthCare Technology Centre India
Data Protection Compliance Committee
Data Protection Compliance Committee
Data Protection Compliance Committee
To ensure the highest standards of privacy and ethical integrity in AI healthcare research, the Data Protection Compliance Committee (DPCC) serves as the primary oversight body for the TANUH: AI Centre of Excellence in Healthcare.
The DPCC ensures that every project involving sensitive health information remains compliant with the Digital Personal Data Protection (DPDP) Act and National Ethical Guidelines.
To ensure the highest standards of privacy and ethical integrity in AI healthcare research, the Data Protection Compliance Committee (DPCC) serves as the primary oversight body for the TANUH: AI Centre of Excellence in Healthcare.
The DPCC ensures that every project involving sensitive health information remains compliant with the Digital Personal Data Protection (DPDP) Act and National Ethical Guidelines.
To ensure the highest standards of privacy and ethical integrity in AI healthcare research, the Data Protection Compliance Committee (DPCC) serves as the primary oversight body for the TANUH: AI Centre of Excellence in Healthcare.
The DPCC ensures that every project involving sensitive health information remains compliant with the Digital Personal Data Protection (DPDP) Act and National Ethical Guidelines.
Core Mandate & Responsibilities
Core Mandate & Responsibilities
Core Mandate & Responsibilities
Protocol Oversight: Reviewing and approving all data collection and curation of protocols for TANUH projects to ensure scientific and ethical rigor.
Regulatory Compliance: Guaranteeing that all data handling, storage, and sharing practices strictly adhere to the DPDP Act and prevailing healthcare privacy norms.
Technical Advisory: Acting as a specialized consultant to the IEC on complex technical matters, including data pseudonymization, de-identification, and cybersecurity.
Lifecycle Monitoring: Continuously auditing data integrity and safety throughout the entire research and development lifecycle, from initial acquisition to final model deployment/continuous fine tuning.
Protocol Oversight: Reviewing and approving all data collection and curation of protocols for TANUH projects to ensure scientific and ethical rigor.
Regulatory Compliance: Guaranteeing that all data handling, storage, and sharing practices strictly adhere to the DPDP Act and prevailing healthcare privacy norms.
Technical Advisory: Acting as a specialized consultant to the IEC on complex technical matters, including data pseudonymization, de-identification, and cybersecurity.
Lifecycle Monitoring: Continuously auditing data integrity and safety throughout the entire research and development lifecycle, from initial acquisition to final model deployment/continuous fine tuning.
Protocol Oversight: Reviewing and approving all data collection and curation of protocols for TANUH projects to ensure scientific and ethical rigor.
Regulatory Compliance: Guaranteeing that all data handling, storage, and sharing practices strictly adhere to the DPDP Act and prevailing healthcare privacy norms.
Technical Advisory: Acting as a specialized consultant to the IEC on complex technical matters, including data pseudonymization, de-identification, and cybersecurity.
Lifecycle Monitoring: Continuously auditing data integrity and safety throughout the entire research and development lifecycle, from initial acquisition to final model deployment/continuous fine tuning.
Detailed overview of DPCC responsibilities:
Detailed overview of DPCC responsibilities:
Detailed overview of DPCC responsibilities:
Reviewing study protocols from a data security and privacy perspective, including data collection, storage, access control, and processing workflows.
Being formally notified in the event of any personal data breach or data leak during the course of the study.
Overseeing compliance with the DPDP Act requirement that participants are notified within 72 hours of a confirmed data breach.
Leading and guiding the formulation of policies and standard operating procedures (SOPs) related to data breach management, escalation pathways, participant notification, and documentation.
Providing ongoing oversight and recommendations to strengthen data protection and risk mitigation throughout the study lifecycle.
Reviewing study protocols from a data security and privacy perspective, including data collection, storage, access control, and processing workflows.
Being formally notified in the event of any personal data breach or data leak during the course of the study.
Overseeing compliance with the DPDP Act requirement that participants are notified within 72 hours of a confirmed data breach.
Leading and guiding the formulation of policies and standard operating procedures (SOPs) related to data breach management, escalation pathways, participant notification, and documentation.
Providing ongoing oversight and recommendations to strengthen data protection and risk mitigation throughout the study lifecycle.
Reviewing study protocols from a data security and privacy perspective, including data collection, storage, access control, and processing workflows.
Being formally notified in the event of any personal data breach or data leak during the course of the study.
Overseeing compliance with the DPDP Act requirement that participants are notified within 72 hours of a confirmed data breach.
Leading and guiding the formulation of policies and standard operating procedures (SOPs) related to data breach management, escalation pathways, participant notification, and documentation.
Providing ongoing oversight and recommendations to strengthen data protection and risk mitigation throughout the study lifecycle.
Integration with IEC Approval
Integration with IEC Approval
Integration with IEC Approval
Mandatory Requirement: In line with our commitment to data security, DPCC clearance is a mandatory prerequisite. No project involving human subject data may receive final IEC approval without prior authorization from the DPCC.
Mandatory Requirement: In line with our commitment to data security, DPCC clearance is a mandatory prerequisite. No project involving human subject data may receive final IEC approval without prior authorization from the DPCC.
Mandatory Requirement: In line with our commitment to data security, DPCC clearance is a mandatory prerequisite. No project involving human subject data may receive final IEC approval without prior authorization from the DPCC.
Members
Members
Members
Chairman
Chairman
Chairman
Head of Data Science, Eka Care - External of TANUH
Head of Data Science, Eka Care - External of TANUH
Head of Data Science, Eka Care - External of TANUH
CPM
CPM
CPM
Chief Project Manager, TANUH
Chief Project Manager, TANUH
Chief Project Manager, TANUH
Technical/Imaging
Technical/Imaging
Technical/Imaging
Assistant Professor, Department of Computational and Data Sciences, IISc
Assistant Professor, Department of Computational and Data Sciences, IISc
Assistant Professor, Department of Computational and Data Sciences, IISc
Ethics/Regulatory
Ethics/Regulatory
Ethics/Regulatory
IEC Secretary. TANUH
IEC Secretary. TANUH
IEC Secretary. TANUH
Engineering/Implementation
Engineering/Implementation
Data Protection Officer/Lead Architect, TANUH
Data Protection Officer/Lead Architect, TANUH
Data Protection Officer/Lead Architect, TANUH
CTO, Women’s Health & X-Ray and VP, Engineering at GE HealthCare Technology Centre India
CTO, Women’s Health & X-Ray and VP, Engineering at GE HealthCare Technology Centre India
Standard Operating Procedure
Standard Operating Procedure
Standard Operating Procedure
The TANUH Ethics Committee follows the review lifecycle displayed below.
The TANUH Ethics Committee follows the review lifecycle displayed below.
The TANUH Ethics Committee follows the review lifecycle displayed below.
IEC Approved Protocols
IEC Approved Protocols
IEC Approved Protocols
Protocol Title
Protocol Title
Protocol Title
Date of Approval
Date of Approval
Date of Approval
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age Related Macular Degeneration – Protocol 3 (TANUH Screening Site Host Contributor Model)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age Related Macular Degeneration – Protocol 3 (TANUH Screening Site Host Contributor Model)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age Related Macular Degeneration – Protocol 3 (TANUH Screening Site Host Contributor Model)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age Related Macular Degeneration – Protocol 2 (Prospective Clinical Contributor Study)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age Related Macular Degeneration – Protocol 2 (Prospective Clinical Contributor Study)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age Related Macular Degeneration – Protocol 2 (Prospective Clinical Contributor Study)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age-Related Macular Degeneration – Protocol 1 (Retrospective Study)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age-Related Macular Degeneration – Protocol 1 (Retrospective Study)
AI Enabled Retinal Fundus Based Screening Platform for Diabetic Retinopathy, Glaucoma, and Age-Related Macular Degeneration – Protocol 1 (Retrospective Study)
AI-Based Multimodal Estimation of eGFR Using Kidney Ultrasound and Clinical Parameters
AI-Based Multimodal Estimation of eGFR Using Kidney Ultrasound and Clinical Parameters
AI-Based Multimodal Estimation of eGFR Using Kidney Ultrasound and Clinical Parameters
Recalibration and Validation of the Kidney Failure Risk Equation in an Indian Chronic Kidney Disease Cohort
Recalibration and Validation of the Kidney Failure Risk Equation in an Indian Chronic Kidney Disease Cohort
Recalibration and Validation of the Kidney Failure Risk Equation in an Indian Chronic Kidney Disease Cohort
Community Baseline Coverage and Health System Preparedness Survey for Artificial Intelligence (AI) - Assisted Oral Cancer and Diabetes Mellitus Interventions
Community Baseline Coverage and Health System Preparedness Survey for Artificial Intelligence (AI) - Assisted Oral Cancer and Diabetes Mellitus Interventions
Community Baseline Coverage and Health System Preparedness Survey for Artificial Intelligence (AI) - Assisted Oral Cancer and Diabetes Mellitus Interventions
AI Solutions for Community Level Screening of Common Mental Health Disorders
AI Solutions for Community Level Screening of Common Mental Health Disorders
AI Solutions for Community Level Screening of Common Mental Health Disorders
AI Enabled Breast Cancer Screening Tool
AI Enabled Breast Cancer Screening Tool
AI Enabled Breast Cancer Screening Tool
Address of the TANUH IEC Office
Address of the TANUH IEC Office
Address of the TANUH IEC Office
Institutional Ethics Committee Office, TANUH (AI-CoE)
7th Floor, IDR building
IISc, Bangalore - 560012
Email ID: secretary.iec@tanuh.ai
Institutional Ethics Committee Office,
TANUH (AI-CoE)
7th Floor, IDR building
IISc, Bangalore - 560012
Email ID: secretary.iec@tanuh.ai
Institutional Ethics Committee Office, TANUH (AI-CoE)
7th Floor, IDR building
IISc, Bangalore - 560012
Email ID: secretary.iec@tanuh.ai
The AI Centre of Excellence in Healthcare
AI Centre of Excellence in Healthcare
Indian Institute of Science
Seventh Floor, TCS Smart-X Hub
Bengaluru, India - 560 012
Email: info@tanuh.ai
Telephone: (080) 2293 4106 | (080) 2293 4107
Solutions
Oral Cancer Screening
Renal Health
2026 by TANUH
The AI Centre of Excellence in Healthcare
AI Centre of Excellence in Healthcare
Indian Institute of Science
Seventh Floor, TCS Smart-X Hub
Bengaluru, India - 560 012
Email: info@tanuh.ai
Telephone: (080) 2293 4106 | (080) 2293 4107
Solutions
Oral Cancer Screening
Renal Health
2026 by TANUH
The AI Centre of Excellence in Healthcare
AI Centre of Excellence in Healthcare
Indian Institute of Science
Seventh Floor, TCS Smart-X Hub
Bengaluru, India - 560 012
Email: info@tanuh.ai
Telephone: (080) 2293 4106 | (080) 2293 4107
Solutions
Oral Cancer Screening
Renal Health
2026 by TANUH
