Good Society for Ethical Research – An Independent Ethics Committee for Biomedical and Health Research.
GSER-IEC also constituted under rule 15 of NDCT Rules 2019 and National Ethical Guidelines for Biomedical and Health Research Involving Human Participants by ICMR
GSER-IEC is an independent body constituted of medical professionals and non-medical members, whose responsibility is to ensure the protection of the rights, safety and wellbeing of human subjects participate in Biomedical and Health Research (Research including studies on basic, applied and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioral); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation) and to provide assurance of their protection, by among other things, review and approve / providing favorable opinion on, the study protocol, the suitability of the investigator(s), facilities, and the methods and material to be used for documenting and obtaining informed consent from the trial subjects.
GSER-IEC also review and oversee the conduct of research as detailed in National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.
GSER-IEC is registered with the U.S. Department of Health and Human Services (DHHS # IRB00005032), accredited with National Accreditation Board for Hospitals & Healthcare Providers (NABH)(Certificate No – EC-CT-2019-0115) and applied with Department of Health Research (DHR) for registration of GSER-IEC for biomedical and health research involving human participants through NAITIK portal (Application No.- EC/NEW/IND/2019/358).
GSER-IEC have ‘quorum’ to provide collective expertise ensuring a comprehensive review of the Biomedical and Human Research submitted for ethical review. The composition is in compliance with ICH-GCP guidelines as well as ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017 which includes:
The composition is in compliance with ICH-GCP guidelines as well as New Drugs and Clinical trial Rules 2019 which includes
| Sr.No | Members of EC | Eligibility |
|---|---|---|
| 1 | Chairperson/ Vice Chairperson (optional) Non-affiliated | A well-respected person from any background with prior experience of having served/serving in an EC. |
| 2 | Member Secretary/ Alternate Member Secretary (optional) Affiliated | Should be a staff member of the institution Should have knowledge and experience in clinical research and ethics, be motivated and have good communication skills. Should be able to devote adequate time to this activity which should be protected by the institution. |
| 3 | Basic Medical Scientist(s) Affiliated/ non-affiliated | Non-medical or medical person with qualifications in basic medical sciences In case of EC reviewing clinical trials with drugs, the basic medical scientist should preferably be a pharmacologist |
| 4 | Clinician(s) Affiliated/non-affiliated | Should be individual/s with recognized medical qualification, expertise and training |
| 5 | Legal expert/s Affiliated/non-affiliated | Should have a basic degree in Law from a recognized university, with experience Desirable: Training in medical law. |
| 6 | Social scientist/ philosopher/ethicist/theologian Affiliated/ non-affiliated | Should be an individual with social/behavioural science/ philosophy/religious qualification and training and/or expertise and be sensitive to local cultural and moral values. Can be from an NGO involved in health-related activities |
| 7 | Lay person(s) Non-affiliated | Lay person(s) Non-affiliated Literate person who has not pursued a medical science/health related career in the last 5 years May be a representative of the community and aware of the local language, cultural and moral values of the community Desirable: involved in social and community welfare activities |
The Principal Investigator (PI) or PI representative can submit research proposal to the GSER office for ethical review and approval under any of the five sections mentioned below:
All proposals should be submitted in the prescribed application form, the details of which are as per GSER-IEC submission check list (available in download section). All relevant documents should be enclosed with letter to Chairman/ Member Secretary.
Total of 15 hard copies along with one soft copy of study documents will be submitted in case of off line submission, if investigator opt online submission only one hard copy will be submitted to GSER-IEC office along with GSER-IEC submission check list.
The meeting of the GSER-IEC should be scheduled on every 10th, 20th and 30th day of month (±2 days), if have any protocol/s for review and additional meetings may be held in case of any emergency for e.g. due to SAE reporting etc. Study proposals will be sent to members at least 10±3days in advance. Decisions will be taken by consensus after discussions, and whenever needed voting will be done.
GSER has been established by dedicated, experienced clinical research and quality professionals. We believe in working proactively with our customer to bring changes to develop an Ethical mindset. We have a standardized EC review process from submission approval and till study completion through online submission. We have well defined SOP driven process has been put in place for identification and analysis of study updates, AE & SAE reports, Protocol deviation/ violation and GCP non-compliance which in turn would help organizations that approach us for review and approval of their clinical studies.
We believe in working proactively with our customer to bring changes to develop an Ethical mindset on the followings.
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We offers established by dedicated, experienced clinical research and quality professionals
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Our Main Goal is to Create to provide excellent services
Dr. Vaidehi Garg is ICMR Research Associate working at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi. Her research forte includes development of nanotechnology based ocular drug delivery systems.
She did her PhD in Pharmaceutics in the year 2017 with Research fellowship from Indian Council of Medical Research, India. Dr. Garg provides consultancy to various companies in the field of clinical research and formulation development. She had published in high impact and reputed journals and involved in organizing various workshops/symposium.
Dr. Kanchan Kohli, M.Pharm, Ph.D (Pharmaceutics) is presently working as an Professor, Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India with an overall 35 years of experience.
She has more than 150 research and review articles to her credit in various national and international peer reviewed journals, 1 US Patent and 10 Indian patents. She received honor like FIP Congress Travel Grant of 2500 Euros by the Honorable Jury of 69th International Congress of FIP (International Pharmaceutical Federation), which was held at Istanbul, (Turkey), 2009.