OVERVIEW

The Medical Research Department at Bhaktivedanta Hospital & Research Institute undertakes and promotes Scientific as well as Ethical research studies dedicated towards new outcomes for better patient treatment and care. The department is centralized and co-ordinates with all the clinical departments of the Hospital to facilitate Investigator Initiated and Sponsored Clinical Trial research projects. The Medical Research Department enhances the strength of the Hospital with distinguished competent clinicians and clinical researchers. The Hospital supports the effective functioning of the Medical Research Department through a variety of patients, state-of-the-art diagnostic and therapeutic technologies and an excellent medical record system.


KEY FEATURES





  • Established SOPs in compliance with GCP guidelines, Schedule Y, QCI and other international requirements




  • Experienced and GCP trained Investigators and Clinical Research Co-ordinators




  • Established SOPs for Audio-Video Consent process




  • Separate drug and blood sample storage refrigerators for research




  • Dedicated working area, for storage, archival and Sponsor/Regulatory Audit




  • Assistance for Preparation for Research protocol, Publication or any other Medical Writing




  • Training Internship for Clinical Research Professionals




 


CONTACT US


For more information and further assistance please contact:





  • Dr. Komal Dalal Advisor - Clinical Research





E-mail: drkomal.bhaktivedantamrd@gmail.com





  • Dr. Parag Sarve Asst. Manager- Clinical Research





E-mail: drparag@bhaktivedantahospital.com


 


Medical Research Department


5th and 6th Floor,


Bhaktivedanta Hospital & Research Institute


Mira Road East, Thane - 401107


Phone: 022-2945 2532/2469/2603


HOSPITAL RESEARCH COMMITTEE

Bhaktivedanta Hospital Research Committee is constituted under Dr. Ajay Sankhe – Director, Bhaktivedanta Hospital & Research Institute to supervise the activities of the Medical Research Department. The committee provides administrative approval prior to commencement of a study and oversees administrative aspects including legal agreements, collaborations as well as infrastructure requirements for conduct of a study. Research study is initiated only after approval of both Bhaktivedanta Hospital Research Committee and Ethics Committee of the Hospital.

HOSPITAL ETHICS COMMITTEE

Bhaktivedanta Hospital Ethics Committee reviews the Scientific and Ethical aspects of each research project to safeguard the dignity, rights, safety and wellbeing of all potential research participants. Bhaktivedanta Hospital Ethics Committee (Bhaktivedanta HEC) is registered as Institutional Ethics Committee under Central Drug Standard Control Organization (CDSCO) working under Union Health Ministry (Reg. No.: ECR/396/Inst/MH/2013/RR-16). Bhaktivedanta HEC monitors each ongoing study at intervals, appropriate to the degree of risk to human subjects.


For more details, please contact on 022-29452532 or send an e-mail to bhaktivedantahec@gmail.com


To download Ethics Committee SOP please click the link below


bhaktivedanta-hec_sops_version_05_21_08_17-min.pdf


Rights & Responsibilities of Research Participants


For English: Research Patients Rights Responsibility


For Hindi: Research Patients Rights Responsibility


 


LIST OF BHAKTIVEDANTA HOSPITAL ETHICS COMMITTEE MEMBERS


































































































Name of Members Position on Ethics Committee Designation & Affiliation Qualification
Dr. Raakhi Tripathi Chairperson, External Associate Professor, (Pharmacology) GSMC & KEMH MBBS, MD
Dr. Suraj Bhagde Member Secretary, Clinician, Internal Consultant Ophthalmologist, Bhaktivedanta Hospital & Research Institute MBBS, MS, DNB
Dr. Swapnil Gautam Member, Clinician, Internal Consultant Physician and Intensivist Bhaktivedanta Hospital & Research Institute MBBS, MD, DNB (General Medicine) MRCP
Dr. Ameya Joshi Member, Clinician, Internal Consultant Endocrinologist Bhaktivedanta Hospital & Research Institute MBBS MD (Internal Medicine) DM (Endocrinology)
Dr. Komal Dalal Member, Internal Consultant Accupuncturist, Advisor - Clinical Research Bhaktivedanta Hospital & Research Institute MBBS, PGDCRM
Dr. Vijaykumar Gawali Member, External Senior Manager - Clinical Research Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Andheri West, Mumbai MBBS
Dr. Sunil Kuyare Member, Basic Medical Scientist, External Assistant Professor, Department of Microbiology H.B.T Medical College and Dr. R. N. Cooper Hospital, Mumbai MBBS, MD, DHA, FME Post Graduate Diploma in Bioethics (PGDBE)
Dr. Anita Ramchandran Member, Basic Medical Scientist, External Assistant Professor, Microbiology LTMMC & GH, Sion, Mumbai MBBS, MD, FME, FAIMER
Mrs. Noopur Desai Member, Representative of NGO, External Social Worker for KATALYST and ISKCON Food Relief Foundation BSc Life Sciences
Mrs. Hetal Varma Member, Social Scientist, Internal Medical Social Worker, Bhaktivedanta Hospital and Research Institute Masters of Social Work
Mr. Anant Singh Member, Legal Expert, External Practicing Advocate at Mumbai Court; Lawyer - Regrace Group of Companies, Mumbai LLM, LLB, Masters of Public Administration
Mrs. Devyani Maheshwari Member, Legal Expert, External - BA, LLB
Mrs. Sarita Gadhari Member, Lay person, External - BA, BEd
Mrs. Meera Singh Member, Lay person, External - BCom

HOSPITAL INITIATED & ACADEMIC RESEARCH

The Medical Research Department conducts multi-speciality Investigator Initiated (Hospital funded) and Academic studies. We provide assistance in study related Documents Preparation, Data Analysis (Statistical work), Project Management, Manuscript Writing and Publications. We are conducting Hospital Initiated & Academic Research studies in the following domains:





  • Spiritual Care




  • Community




  • Ayurveda




  • Nutraceuticals




  • Nursing




  • Medicine




  • Integrated Medicine




CLINICAL TRIALS

We are conducting Clinical Trials in collaboration with more than 25 National/Global Sponsors as well as Clinical Research Organisations in various Multispecialty Clinical Research Projects since 2013. The Medical Research Department is well equipped with all essential facilities which are necessary to conduct clinical trials of drugs, medical devices and surgical trials. We have successfully completed CRO and Sponsor Quality Analysis audits without any significant findings. Dedicated team of experienced, GCP trained Investigators, Co-ordinators and QA Manager work together to ensure study Protocol compliance. We are conducting Clinical Trials in the following therapeutics areas:





  • Cardiology




  • Dermatology




  • ENT




  • Endocrinology




  • Gynecology




  • Hematology




  • Medicine




  • Neurology




  • Pulmonary Medicine




  • Urology




  • Rheumatology




  • Oncology




  • Ophthalmology




  • Orthopedics




PUBLICATIONS

 


ORIGINAL ARTICLES


(To read an Original Article, please click on its title.)






























































Sr. No. Title Authors Name of Journal
1 Spiritual Care Therapy on Quality of Life in Cancer Patients and Their Caregivers: A Prospective Non-randomized Single-Cohort Study Dr. Ajay Sankhe, Dr. Komal Dalal, Dr. Vishnu Agarwal, Dr. Parag Sarve Journal of Religion and Health (Springer, Pubmed Index)
2 Evaluation of the effect of Spiritual care on patients with generalized anxiety and depression: a randomized controlled study Dr. Ajay Sankhe, Dr. Komal Dalal, Dr. Devendra Save, Dr. Parag Sarve Psychology, Health and Medicine Journal(PubMed Indexed, Peer review)
3 Evaluation of performance of the Medical Research Department in 'Research naive' non-academic hospital: An audit Mrs. Mukta Kuyare, Dr. Parag Sarve, Dr. Komal Dalal, Dr. Raakhi Tripathi Perspective in Clinical Research (PubMed Index, Peer review)
4 A Comparative Assessment of Hydroxyl and Calcium Ion Diffusion from Calcium Hydroxide Based Intracanal Medicaments in Primary Teeth - An In Vitro Study Dr. Sneha Sreedhar, Dr. Rashmi Nayak BAOJ Dentistry
5 Vitamin D – Is it a neglected analgesic for non-specific musculoskeletal pain? Dr. Pramodini S., Dr Parag Sarve European Journal of Biomedical and Pharmaceutical Sciences (Peer review)
6 Integrated approach in the management of bronchial asthma: A retrospective analysis Dr. Memane, Dr. Sankhe International journal of Ayurveda and Pharmaceutical Research (Peer review)
7 Establishing Institutional Ethics Committees: Challenges and Solutions- a review of the Literature Mrs. Mukta Kuyare, Dr. Santosh Taur, Dr. Urmila Thatte Indian Journal of Medical Ethics (PubMed Index, Peer review)
8 Perceptions and Experiences of Community Members Serving on Institutional Review Boards: A Questionnaire Based Study Mrs. Mukta Kuyare, Dr Marathe, Dr. Urmila Thatte, Dr. Sunil Kuyare (KEM Hospital) HEC Forum International Journal (PubMed Index, Peer review)


 


CASE REPORTS


(To read a Case Study, please click on its title.)






















































































Sr. No. Title Authors Name of Journal
1 Strawberry skull in Edwards syndrome Dr. Umesh Shriniwas Mudaliyar, Dr. Sneha Umesh Mudaliyar The British Institute of Radiology Journal (PubMed Indexed)
2 Chaos syndrome Dr. Umesh Mudaliyar, Dr. Sneha Sreedhar The British Institute of Radiology Journal (PubMed Indexed)
3 A case of intrauterine contraceptive device in peritoneal cavity invading sigmoid colon – A rare entity Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
4 Giant Fibro epithelial Polyp of Vulva – A rarest of its occurrencel Dr. B. C. Shah, Dr. Sarang Degloorkar Mumbai Journal of Case Reports
5 Hyperphosphatemic Tumoral Calcinosis Dr. Umesh Mudaliyar Journal of Case Reports
6 A rare case of left sided acute appendicitis in a patient with mid gut malrotation Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
7 Largest Chondroid Syringoma of the skin: A case report Dr. Vishnu Agarwal Indian Journal of Medical Case Reports
8 Obturator Hernia Causing Intestinal Obstruction Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
9 Volvulus Of Meckels Divetticulum – A Rare Cause Of Intestinal Obstruction In Children Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
10 Leiomyoma Of Testis Dr B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports
11 Rare Occurrence Of Enterocutaneous Fistulae Following Onlay Mesh Repair For Incisional Hernia: A Case Series Dr. B. C. Shah, Dr. Sarang Degloorkar South American Journal of Surgery
12 Gall stones presenting as left lumbar pain: A rare occurrence Dr. B. C. Shah, Dr. Sarang Degloorkar Journal of Case Reports


 


RESEARCH PAPER/POSTER PRESENTATION AT CONFERENCES
































Sr. No. Title Authors Name of Journal
1 Spirituality and Medicine: An integrated approach to cope up with anxiety and depression among patients and caregivers Dr. Ashok Shetty DERMACON - National Conference of Indian Association of Dermatologist, 2015
2 Reviewing use of deception as Intervention in Clinical Research Mrs. Mukta Kuyare


  • American College of Clinical Pharmacology (ACCPSF2015), San Francisco, USA

  • The Forum for Ethical Review Committees in the Asian and Western Pacific FERCAP - 2015 International Conference at Nagasaki, Japan



3 Community Member Perspective in Institutional Review Board Mrs. Mukta Kuyare The Forum for Ethical Review Committees in the Asian and Western Pacific FERCAP -2015 International Conference at Nagasaki, Japan

NEWS & ACHIEVEMENTS




  • Successful Registration renewal of BhaktiVedanta Hospital Ethics Committee (Institutional Ethics Committee) under Central Drug standard control organization (CDSCO) working under Union Health Ministry, New Delhi (Reg. No.: ECR/396/Inst/MH/2013RR-16, Period: June 2016 to June 2019)


    http://www.cdsco.nic.in/writereaddata/mhBHAKTI-804%20RC.pdf




  • Bhaktivedanta Hospital & Research Institute is the recipient of the prestigious ‘Worldwide Achiever Award 2015 - Best Multispecialty Hospital for Innovation and Research’




  • Hospital is registered under USFDA for conducting Global Clinical Trials – (GUDFA FEI number- 3010542690) in May 2015