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AIIMS, Bibinagar is one of the apex healthcare institutes established in 2019 by the Ministry of Health & Family Welfare, Government of India under the PMSSY with a mission to establish a Centre of excellence in medical education and training and to provide a high-quality community and patient-focused health care that is readily accessible, cost effective and meets the needs of the communities and offer scientific research opportunities.
Bio medical research/Clinical trials involves a number of ethical issues that need to be addressed. The Institutional Human Ethics Committee (IHEC)/IEC plays an important role in guiding researchers in the ethical aspects associated with the biomedical research. Apart from ethical issues, IEC will also review the research proposals for the scientific relevance and risk involved in research. IEC functions as per the ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participant-2017 (ICMR National Ethical Guidelines) and New Drugs and Clinical Trials Rules 2019.
Composition
- AIIMS BBN - Institutional Ethics Committee (IEC) Reconstitution Office Order
- Constitution of PG Thesis Subcommittee under Institutional Ethics Committee
- Constitution of SAE Subcommittee under Institutional Ethics Committee
Institutional Ethics Committee (IEC)
Register Details
Forms
- Assent Form
- Appointment Order
- Application for Initial review
- Continuing Review / Annual report format
- Application/Notification form for Amendments
- Protocol Violation/Deviation Reporting Form (Reporting by case)
- Serious Adverse Event Reporting Format (Biomedical Health Research)
- Premature Termination/Suspension/ Discontinuation Report Format
- Application Form for Clinical Trials
- Serious Adverse Event Reporting Format (Clinical trials)
- Study completion/Final report format
- Participant information sheet
- Informed consent form
- Undertaking by the Investigator
Guidelines
- ICMR_Ethical_Guidelines_2017
- New Drugs and Clinical Trials Rules 2019
- National Guidelines for Ethics Committees Reviewing Biomedical & Health Research During COVID-19 Pandemic
- National Ethical Guidelines for Bio-Medical Research Involving Children
- Draft on ICMR Guidelines for common Ethics Review of Multicentre Research 2019
- Indian GCP
- ICH – efficacy guidelines - GCP
- ICH – GCP guidelines
Circulars
- 26th IEC Meeting Circular
- 25th IEC Meeting Circular
- 24th IEC Meeting Circular
- 23nd IEC Meeting Circular
- 22nd IEC Meeting Circular
- 21st IEC Meeting Circular
- 20th IEC Meeting Circular
- 19th IEC Meeting Circular
- 18th IEC Meeting Circular
- 17th IEC Meeting Circular
- 16th IEC Meeting Circular
- 15th IEC Meeting Circular
- Workshop on ETHICS AND CLINICAL TRIALS.
- 14th IEC Meeting Circular
- 13th IEC Meeting Circular
- 12th IEC Meeting Circular
- IEC Eleventh Meeting circular
- IEC Tenth Meeting circular
- IEC Ninth Meeting circular
- IEC Eighth Meeting circular
- IEC Sixth meeting circular
- IEC Fifth meeting circular
- IEC Fourth meeting circular
- IEC Third meeting circular
- Second meeting circular - Date extension
- Second IEC meeting circular
- Corrigendum - IEC first meeting
- IEC Meeting 16 Feb 2021 circular
Gallery
