Clinical Research & Institutional Ethics Committee

Overview

clinical-research
Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. In clinical practice one uses established treatments, while in clinical research evidence is collected to establish a treatment.The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond.

Post Graduate & Doctoral students need to carry out clinical research for their projects which strictly needs to follow the universal ethics guide lines. For monitoring proper following of these guide lines a Parul University – Institutional Ethics Committee For Human Research has been formed which is registered & recognized by Government of India. The members of this Ethics committee are as per the guidelines of the government and well acquainted with the updated guidelines & norms of government regarding Clinical Research.

Students at Parul University Carry out Clinical Research with accordance to the Standard Operating Procedures of PU-ICHER. Parul University also welcomes external research projects as a collaborative part of Industry Academia Research Programme, a well defined structure for associating the sponsor, principal investigator and patients. The committee supports the sponsor for the PI identification, patient recruitment and retention, and also for the documentation and processing of ethical application, ICF, CRF, Undertaking, SAE reporting, & Trial Audit for clinical study.

There is huge scope of clinical research at Parul University owing to following reasons:

  • Faculties of Various Medicinal Systems under one roof like Modern Medicine, Ayurved, Homoepathy, Physiotherapy, Nursing, and Pharmacy.
  • Total number of postgraduate students in above medicinal fields, who select clinical research as main curriculum under guidance of renowned and expert faculties exceeds 510.
  • Parul Sevashram Hospital with capacity of 300 beds and   advanced medical facilities of specialized care under numerous departments. It runs with large variety of patients every day taken care of by GCP trained staff and doctors.
  •  Parul Ayurveda Hospital with 200 beds capacity offers excellent Ayurveda medical treatment facilities.
  • Dedicated research team and experienced GCP trained staff with well-equipped drug testing laboratories in the campus is an additional attraction.
  • Central Institutional ethics committee registered with Government of India to approve and monitor every clinical research activity at Parul University.
How to Apply?

Application should be made in prescribed format duly attested with departmental approval and fees. Guidelines given in SOP should be followed for necessary supporting documents.

Application Fees Detail

Fees will be charged by the PU-IECHR for Protocol review, which will be received together with the documents as mentioned in section 4. 1. of SOP. Fees will also be charged for review or amendments to the Protocol. This fee is to cover administrative expenses. An EC fee is to be paid by cheque in favor of “PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH”. Such fees will be used by the office to have regular EC meetings, to maintain an office, secretarial staff, computer and internet connection, printer, fax and phone line, travel allowance and also to obtain storage for archiving the office documents. The PU-IECHR reserves rights to modify the fee structure or waiver in any way under special circumstances, as understood by the university management. The fees will be charged as follows:

Proposal Type
Nature of Applicant
1st Application
For Every Revision
Academic
Student
Rs.1000/-
Rs.500/-
Faculty Member
Rs.1000/-
Rs.1000/-
PhD Scholar
Rs.2000/-
Rs.1000/-
Govt. Sponsored
Student/ Faculty (Work-Budget less than 1 lakh)
Rs.5000/-
Rs.1500/-
Student/ Faculty (Work- Budget more than 1 lakh)
Rs.1000/-
Rs.1500/-
PhD Scholar
Rs.1000/-
Rs.3000/-
Industry/CRO Sponsored
Student/ Faculty
Rs.15000/-
Rs.1500/-
PhD Scholar
Rs.20000/-
Rs.3000/-
Ethics Committee

Introduction

Parul University Institutional Ethics Committee for Human Research (PU-IECHR) is the central ethical committee of Parul University to monitor and supervise clinical research activity in Parul University Campus. Committee is registered under authority of Drug Controller General of India, Ministry of Health and Family Welfare, Government of India (Reg. No. ECR/702/Inst/GJ/2015)

Current Composition of Committee

S.No
Designation in PU-IECHR
Name
Professional Designation
01
Chairman & Clinician
Dr. Sandeep Shah
Professor& Head, Dept. of Psychiatry,
GMERS Medical College, Vadodara
02
Basic Medical Scientist
Dr. Tejas Patel
Assistant Professor, Dept. of Pharmacology, GMERS Medical College, Vadodara
03
Member Secretary
Dr. Avnish Dave
Professor& Head, Dept. of Physiology, Parul Institute Of Medical Sciences & Research,
Parul University
04
Para-Clinician
Dr. Geetika Madan Patel
MBBS, MD
Medical Director, Parul University
05
Advisor
Dr. Komal Patel, MD
Managing Trustee, Parul University
06
Clinician
Dr. B.D. Parmar
Professor& Head, Dept. of Medicine,
Parul Institute of Medical Sciences & Research, Parul University
07
Clinician
Dr. K.D Chavda

Professor &Head,Surgery,Parul Institute of Medical Sciences & Research, Parul University

08
Basic Medical Scientist
Dr. D.C.Sharma

Professor, Dept. of Pharmacology,
Parul Institute of Medical Sciences & Research, Parul University

09
Legal Expert
Prof. FomiDwivedi

Professor, Parul Institute Of Management,,Parul University

10
Social Scientist
Mrs. Dipti Joshi
Clinical Psychologist,
Brij Psychiatry Clinic, Vadodara
11
Pharmacology Expert
Dr. Nehal Shah
Assistant Professor, Dept. of Pharmacology, Parul Institute of Medical Sciences & Research, Parul University
12

Lay Person

Mr. Kaushik Solanki
Peon, Parul Institute of Medical Sciences & Research, Parul University