RxDx Healthcare is committed to research that advances knowledge in the field of healthcare and delivers better health outcomes to people everywhere. As we pursue, participate in, or support a wide range of research projects, we strive to protect the rights, dignity, safety and wellbeing of all human subjects who may participate in the research. To make sure of this, our Institutional Ethics Committee was established in January 2021 under the New Drugs and Clinical Trials Rules, 2019, with registration number ECR/1494/Inst/KA/2021.
WHAT DOES THE INSTITUTIONAL ETHICS COMMITTEE DO?
The IEC safeguards and protects the rights, dignity, safety and wellbeing of all actual and potential research project participants.
- It ensures that sources of funding and research goals, however vital, never override the health and wellbeing of the participants.
- It provides independent, competent and timely ethical reviews of every research proposal before a study can commence; carefully monitors ongoing studies; and monitors participants’ wellbeing after study completion.
- It ensures that the cardinal principles of research ethics – autonomy, beneficence, non-malfeasance and justice – imbue every stage of planning, conducting and reporting all our research studies.
- It scrutinizes and oversees informed consent, risk/benefit ratios, burden/benefit distribution, and appropriate compensation issues.
- It ensures that all our research studies comply with all regulatory requirements, guidelines and best practices.
VISION, MISSION & GOALS
Vision
To protect the human rights and wellbeing of human research subjects while supporting the research goals of RxDx Healthcare.
Mission
To support and encourage researchers to design, undertake and report research studies ethically and provide guidance through the process to benefit both the researches and society at large.
Goals
- To support and encourage ethical research practices
- To protect the human rights and wellbeing of human research participants
- To identify the value and necessity of proposed research studies for improving and growing the healthcare system
- To assess the risks and benefits of research proposals, and ensure that risks posed to human subjects are kept to the absolute minimum and justified by the potential benefits of the research
- To ensure that Informed Consent or Health Information Use and Disclosure Authorization is obtained from each research subject wherever appropriate
- To ensure that all clinical studies comply with the New Drugs and Clinical Trials Rules, 2019, and the ICMR Guidelines for Biomedical Research on Human Subjects
APPROVED RESEARCH PROPOSALS
Here are a few research projects we are working on, carefully monitored by the IEC:
G7 Synergon
A prospective, randomized, double-blind, multiple-dose, parallel, placebo-controlled clinical intervention study to evaluate the efficacy and safety of an immunostimulant supplement on the immunity of healthy human subjects
MA-ECM
A prospective, multi-center, single-arm, open-label Phase IV clinical study to evaluate safety and efficacy of minimally manipulated extracellular matrix (MA-ECM) biopatch prepared using Alkem’s DRRIM (3D bio-printer) in diabetic foot ulcer patients
Foot Secure
A Prospective, Open-Level, Multi-centered, Non-Randomized, Non-Comparative Active Post-Marketing Surveillance to test the safety and efficacy of Diperoxochloric Acid [DPOCL] topical solution in Subjects with diabetic neuropathic ulcers of skin and subcutaneous tissue
Waist Study
Correlation Between Reduction of Glycated Haemoglobin (HbA1c) to Waist Circumference in People Living with Type 2 Diabetes Using Sugarfit’s Diabetes Reversal Program: A Retrospective Analysis
Hip Ratio Study
Effective Multi-Interventional Approach Focused on Customized Nutrition, Progressive Fitness, and Lifestyle Modification Reduced the HbA1c and Fasting Blood Sugar in Type 2 Diabetes: A Retrospective Study
MIS-C Study
Multisystem Inflammatory Syndrome in Children – A Paediatric Cardiologist’s Perspective
Chikki Study
Impact Assessment on ‘Svasti – Nutrition for Women and Children’ Program in Kolar and Tumkur Districts, Karnataka
HAVE A RESEARCH IDEA?
If you are interested in or preparing a new submission, please take a moment to review the checklist of documents to ensure your application is review-ready by the IEC and facilitate a shorter turnaround time.
- Current curriculum vitae of the principal investigator
- Study protocols and any amendments
- Investigator brochure
- Proposed informed consent document in English and Hindi
- Subject advertisement and recruitment procedure
- DCGI submission and approval letter
- Data collection form / case report form
- Insurance policy / proposed compensation plan for participation and serious adverse events occurring during study participation (as applicable)
- Investigator’s agreement(s) with the sponsor
- Investigator’s undertaking
- Previous review by any other IEC
- CTRI registration letter
- Any other information relevant to the study
- Any other documents required as per the NDCT Rules, 2019
