Embed Size (px)
Citation preview
~
~
Narayana HrudayalayaMedical Ethics Committee
NarayanaHrudayalayaHospitals
Caring with Compassion
CHAIRMAN &LEGAL EXPERT
Dr. S.Y. Joga Rao
To,Dr Sanjay Mehrotra,Sr.Consultant cardiologist,Narayana Hrudayalaya Hospitals,No. 258/ A, Bommasandra Industrial Area, Anekal Taluk,Bangalore-560 099, India
Dr. Lloyd Vincent(Academician)
Ref: "UMPIRE - Use of a Multidrug fill !n Reducingcard iovascu lar~ vents".Protocol Number: 241849. EudraCT Number: 2009-016278-34.Product: Red Heart Pill. Sponsor: Imperial College London.
Dr. George Cherian(Academician)
Dr. P.S. Jairaj(Academician)
Dr. Ashley D'cruz(Pediatric Surgeon)
Dr. K.V. Nataraj(Basic Medical Scientist
Pharmacologist)
Sub: Ethics Committee approval for the conduct to clinical trial"UMPIRE - 1!se of a Multidrug fill !n Reducing cardiovascular~vents". Protocol Number: 241849.
Rev. K. Vasudevan(Theologian)
Dr. Muralidhar K.(Academician)
With reference to your submission letter dated "4 oct 2010 "wewish to inform you that the "Narayana Hrudayalaya MedicalEthics committee" reviewed and discussed your application toconduct the clinical trial entitled "UMPIRE - 1!se of a Multidrugfill!n Reducing cardiovascular ~vents" on "3 Nov 2010"
Dr. Srikrishna(Academician)
Dr. Murali Mohan(Academician)
Dr. Anuradha B.S.(Women & Child care)
Mr. Anil Shankar(General Public)
Mrs. Geeta MK(Medical Social Worker)
l.UMPIRE Study ProtocolVersion 2, dated 21 April 20102.Summary of changes to UMPIRE study protocolVersion 1.1 dated 28 Jan 2010 to Version 2 dated 21 April20103.Participant information sheet with informed consentForm: Version 2, dated 11 May 2010 (English, Hindi and
Kannada)4.Summary of changes to participant information sheetwith informed consent form version 1 dated 10 Dee 2009to Version 2 dated 11 May 2010S.Translation certificateDated 20 May 20106.DCGI approval for the conduct of UMPIRE studyDated 03 May 20107.Product liability Insurance
# 258/A, Bommasandra Industrial Area, Anekal (Taluk), Bangalore - 560 099.Tel.: 080-27835000 to 18 (Extn.: 2124) Fax: 080-27832648 Mob: +91-95350 12356
Narayana HrudayalayaMedical Ethics Committee
NarayanaHrudayalayaHospitals
Caring with Compassion
CHAIRMAN &LEGAL EXPERT
Dr. S.Y. Joga Rao
The following members of the ethics committee were present at themeeting held on "3 Nay 2010 at 1:30pm Narayana HrudayalayaHospital".
Sr. Name and Qualification, Department! Role!AffiliationNo. Gender Designation Institute
Advocates,1 Dr. Joga Rao, M.L, M. Phill, PhD Solicitors and Chairman &
Gender: Male LEGALEXCEL Healthcare Legal expert!Consultants Not Affiliated
2 Dr.L1oyd MD.,DM(Neph)MSc, Sr.Consultant MemberVincent MHSc,CHE Nephrologist SecretaryGender: MaleDr. George MD, DM, (Card) Sr. Consultant- Academician
3 Cherian FRCP, FAMS, CardiologyFACC
Dr.Muralidhar Director -K, M.D (Anae) Academic Academician
4 Gender: Male NHH5 Dr. K,V. Professor of
Nataraj Ph.D (Phar) Pharmacology, Basic MedicalGender: Male Bangalore Scientist! Not
Medical College Affiliated6 Senior
Dr. P.S. Jairaj MS, FRACS (CT Consultant,Cardio AcademicianGender: Male Surgery) Thoracic Surgery
7 Dr. Ashley MS, M.Ch (Ped. Pediatric SurgeonD'cruz Surgery) MemberGender: Male
8 Dr Murali Professor, Basic MedicalMohanGender: MBBS,MD, MRCP General Medicine ScientistMale
9 Rev. Theologian,Bethal ReligiousK,Vasudevan Bachelor of Fellowship, RepresentativeGender: Male Theology Mathikere, Theologian!
Bangalore Not Affiliated
10 Dr. Anuradha MBBS, MD, DNB, ConsultantBS FN B(Reproductive GynaecologistGender: Medicine) NHH Basic ScientistFemale
11 Mrs. Geeta B.A, MSW Social Worker Medical SocialM.K Gender: NHH WorkerFemale
12 Mr. Anil Travel DeskShankar B. Sc: Manager NHI-I General Public
Dr. Lloyd Vincent(Academician)
Dr. George Cherian(Academician)
Dr. P.S. Jairaj(Academician)
Dr. Ashley D'cruz(Pediatric Surgeon)
Dr. K.V. Nataraj(Basic Medical Scientist
Pharmacologist)
Rev. K. Vasudevan(Theologian)
Dr. Muralidhar K.(Academician)
Dr. Srikrishna(Academician)
Dr. MuraU Mohan(Academician)
Dr. Anuradha B.S.(Women & Child care)
Mr. Anil Shankar(General PUblic)
Mrs. Geeta M.K.(Medical Social Worker)
# 258/A, Bommasandra Industrial Area, Anekal (Taluk), Bangalore - 560 099.Tel.: 080-27835000 to 18 (Extn.: 2124) Fax: 080-27832648 Mob.: +91-95350 12356
~
\!YNarayana Hrudayalaya
Medical Ethics Committee
III Narayana=¥= HrudayalayaIII HospitalsCaring with Compassion
CHAIRMAN &LEGAL EXPERT
Dr. S.v. Joga Rao
We approve the trial to be conducted"Narayana Hrudayalaya Hospital"
The Institutional Reveiw Board / Independent Ethics Committeeexpects to be informed about the progress of the study, any SAEoccurring in the course of the study, any changes in the protocol andpatient information / informed consent and asks to be provided a copyof the final report.
Dr. Lloyd Vincent(Academician)
The EC is organized & operates according to the requirements of ICH-GCr, Indian Council of Medical Research guidelines & Schedule Y.
Dr. George Cherian(Academician)
Dr. P.S. Jairaj(Academician)
Dr. Ashley D'cruz(Pediatric Surgeon)
Dr. K.V. Nataraj(Basic Medical Scientist
Pharmacologist)
Rev. K. Vasudevan(Theologian)
Dr. LLOYD VINCENTMember Secretary
Narayana Hrudayalaya MedicalEthics Committee
Dr. Muralidhar K.(Academician)
Dr. Srikrishna(Academician)
Dr. Murali Mohan(Academician)
Dr. Anuradha B.S.(Women & Child care)
Mr. Anil Shankar(General Public)
Mrs. Geeta M.K.(Medical Social Worker)
# 258/A, Bommasandra Industrial Area, Anekal (Taluk), Bangalore - 560 099.Tel.: 080-27835000 to 18 (Extn.: 2124) Fax: 080-27832648 Mob.: +91-95350 12356
![Untitled-2 [medicare.lk] · gem hospital institute of gastroenterology & laparoscopy vamsam fertility research centre narayana hrudayalaya limited parampara fertility and gynaec centre](https://img.pdfslide.us/doc/110x75/5ec5b02076c4b41a435bf125/untitled-2-gem-hospital-institute-of-gastroenterology-laparoscopy-vamsam.jpg)
