1 · Prepare the dossier
Protocol, investigator brochure, participant information sheet and informed-consent forms in English and the local language, plus the investigator's CV and site details.
Ethics & Regulatory Oversight
Institutional Ethics Committee
Every study conducted at Meera Hospitals is reviewed and monitored by an independent Institutional Ethics Committee, registered with the Central Drugs Standard Control Organisation under the New Drugs and Clinical Trials Rules, 2019. Its single purpose is to protect the rights, safety and wellbeing of every research participant.
Registration
Registered with CDSCO.
The committee is re-registered with the Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare, Government of India.
CDSCO Central Drugs Standard Control Organisation
GCP ICH-GCP & Indian GCP Guidelines
NDCT New Drugs & Clinical Trials Rules, 2019
Our Mandate
Independent review, before anything begins.
No study may start at Meera Hospitals until the Ethics Committee has reviewed it and given written approval.
The committee examines the science, the risks and benefits, the suitability of the investigator and the site, the way consent will be taken, and the compensation available if a participant is harmed. Its authority does not end at approval: it continues to monitor each study, reviews serious adverse events, and may suspend or stop a trial at any stage if participants' rights, safety or wellbeing are at risk.
What We Review
- ✓The protocol and its science
Whether the study is well designed and the question worth asking.
- ✓Risk against benefit
Whether foreseeable risks are reasonable in relation to the expected benefit.
- ✓Informed consent
That information is given in a language the participant genuinely understands.
- ✓Investigator and site suitability
That the team and the facilities can run the study safely.
- ✓Compensation for injury
Provisions for care and compensation if a participant is harmed.
- ✓Ongoing conduct
Continuing review, serious adverse event reports, and the power to halt a study.
Composition
Eleven members. A majority independent.
The rules require a minimum of seven members, at least half unaffiliated with the institution, and a Chairperson from outside it. Our committee brings together clinicians, a pharmacologist, legal experts, social scientists and lay members who speak for the participant.
Meera Institutional Ethics Committee
As recorded in the annexure to the CDSCO registration certificate.
| Member | Qualification | Role |
|---|---|---|
| Dr. Kiran P. Patil | B.D.S. | Chairperson |
| Dr. Ashraf A. Memon | B.H.M.S., P.G.D.M.S. | Member Secretary |
| Dr. Dipika G. Ganvir Malhotra | M.B.B.S., Diploma in Psychiatry | Clinician |
| Dr. Nishikant A. Sharma | M.B.B.S., M.D. (Medicine) | Clinician |
| Dr. Abhishek R. Mane | M.B.B.S., M.D. (Pharmacology) | Medical Scientist |
| Ms. Sushma S. Patel | B.Sc., L.L.B. | Legal Expert |
| Ms. Vimmi I. Sachdev | L.L.B., B.Com. | Legal Expert |
| Mr. Shreyash L. Agrawal | M.B.S., M.B.A. (NGO Representative) | Social Scientist |
| Mr. Arif Memon | B.Com. | Social Scientist |
| Ms. Rehmat A. Memon | B.Com. | Lay Person |
| Ms. Poonam S. Thombe | B.A. | Lay Person |
A quorum of at least five members — including a medical scientist, a clinician, a legal expert, an independent social scientist or ethicist, and a lay person — must be present before any protocol can be reviewed.
Documents
The certificate itself.
The full CDSCO re-registration certificate, including all conditions of registration and the committee annexure, is reproduced below and available to download.
Ethics Committee Re-Registration Certificate
ECR/1005/Inst/MH/2017/RR-26 · Form CT-02 · 4 pages · 296 KB
Further documents — the committee's standard operating procedures, submission checklist, meeting calendar and application forms — will be published here as they are released by the hospital.
For Investigators & Sponsors
Submitting a study for review.
2 · Submit to the Member Secretary
Send the complete set to meeraresearch1@gmail.com. The Member Secretary confirms receipt and tells you the submission deadline for the next meeting.
3 · Review and decision
The committee meets with a full quorum, may call the investigator to present, and issues a written decision — approval, modification, or rejection — with reasons recorded.
4 · Continuing oversight
Approved studies report progress and any serious adverse events to the committee, which retains the power to suspend or terminate the trial.
Questions
Ethics, answered.
The Institutional Ethics Committee reviews every research protocol before it can begin at Meera Hospitals. It independently assesses the scientific merit, the risks and benefits to participants, the informed-consent process and the compensation provisions — and can approve, ask for changes, reject, suspend or stop a study at any stage.
Yes. Under the New Drugs and Clinical Trials Rules, 2019, at least half of the members must not be affiliated with the institution, and the Chairperson must be an unaffiliated member. Our Chairperson and a majority of members meet this requirement.
Investigators and sponsors should write to meeraresearch1@gmail.com with the protocol, investigator brochure, participant information sheet and informed-consent documents in English and the local language. The Member Secretary will confirm the submission deadline and the next meeting date.
Any trial participant may contact the Member Secretary directly. Concerns about your rights, safety or wellbeing can be raised at any time, and you may withdraw from a study at any stage without affecting your routine medical care.
Contact
Reach the committee.
Member Secretary
Dr. Ashraf A. Memon
All protocol submissions, correspondence and participant concerns are routed through the Member Secretary.
meeraresearch1@gmail.com
Chairperson
Dr. Kiran P. Patil
The Chairperson presides over committee meetings and is independent of the institution.
Via the Member Secretary
Registered Address
Meera Multispeciality Hospital
Devi Bhavan, Bail Bazar, Behind Zojwalla Petrol Pump, Kalyan West, Thane, Maharashtra — 421301.
96193 89849Considering a study at Meera?
Sponsors, CROs and investigators are welcome to contact the committee about submission timelines and requirements.