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INSTITUTION ETHICS COMMITTEE (IEC)(AN INSTITUTIONAL ETHICAL ISSUES REVIEW BOARD)
Dr. B.R.Ambedkar Medical College & HospitalK.G. Halli, Bangalore -560 045. Off. : 080-25476498, Fax: 080-25471784
CHAIRPERSON
Dr. RADHAS. MURTHY,MBBS., MIFA., MIGS.,
Managing TrusteeNightingale's Medical Trust,Ravindranath Tagore Nagar,Bangalore - 560 032.Mob. : 9844037381
MEMBERS:
BASIC SCIENTISTS:·Dr. B.R. Ramesh., M.S.,9448889607Dr. R. Hemalatha, M.D.9845019684
CLINICAL PHARMACOLOGIST:Dr. L. Padma, M.D,944824882
PHYSICIAN:Dr. N. Bhakthavatchalam, M.D,9845015873
SURGEONDr. Stanley John M.S.9845176912
REPRESENTATIVE OF NGO·Mr. Prem Kumar Raja9243100560
LEGAL EXPERT:Mr. B.C. Thiruvengadam, LL.B.,9844092926
PHILOSOPHER:Dr. M. Sreenivas, M.Phil., PhD9886676720
COMMUNITY LEADER:Mr. Lakshmi Narayan9945689830
.==-====.MEMBER SECRETARY
Dr. B.M. NAGARAJ,MD.,Dip. Medical Law & Ethics (NLSIU)
Professor and Head,Dept. of Forensic Medicine
Dr. B.R. Arnbedkar Medical College,Kad ugondanahalli, Bangalore.
Mob. :9844141088
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Date: 25.08.2012ToDr. Prashanth C.NDr. B.R Ambedkar Medical College,Bangalore.
From,The Chairperson,Institutional Ethics Committee,Dr. B.R Ambedkar Medical College,Bangalore.
Protocol No: CD-12-340
Subject: Approval for the study and the Study submissions.
Study Title: "A multi center, open label, randomized, parallel,single dose to compare the Pharmacokinetics of marketedproduct LotemaxTM (Loteprednol Etabonate OphthalmicSuspension 0.5%; Bausch & Lomb, Inc.) to an investigationalLoteprednol Etabonate Ophthalmic Suspension, 0.5% (Hi-TechPharmacal Co., Inc.] in Aqueous Humor in patients undergoingindicated cataract surgery".
Dear Dr. Prashanth C.N,
With reference to the above mentioned study, the followingdocuments were received from you and the same has beenreviewed by us.
"
Sl. NAMEno
VERSION & DATE
1 Study Protocol Version 1 .23-May-2012
Date of preparation 12 Jan2009
2 Product Monograph
INSTITUTION ETHICS COMMITTEE (lEC)(AN INSTITUTIONAL ETHICAL ISSUES REVIEW BOARD)
Dr. H.R.Ambedkar Medical College & HospitalK.G. Halli, Bangalore -560 045. Off. : 080-25476498, Fax: 080-25471784
CHAIRPERSONDr. RADHA8. MURTHY,
MBBS., MIFA., MIGS.,Managing TrusteeNightingale's Medical Trust,Ravindranath Tagore Nagar,Bangalore - 560 032.Mob. : 9844037381
MEMBER SECRETARYDr. B.M. NAGARAJ, MD.,
Dip. Medical Law & Ethics (NLSIU)Professor and Head,
Dept. of Forensic MedicineDr. B.R. Ambedkar Medical College,
Kadugondanahalli, Bangalore.Mob. :9844141088
MEMBERS:
BASIC SCIENTISTS:Dr. B.R. Ramesh., M.S.,9448889607Dr. R. Hernalatha, M.D.9845019684
CLINICALPHARMACOLOGIST:Dr. L. Padma, M.D,944824882
PHYSICIAN:Dr. N. Bhakthavatchalam, M.D,9845015873
SURGEONDr. Stanley John M.S.9845176912
REPRESENTATIVE OF NGOMr. Prem Kumar Raja9243100560
LEGALEXPERT:Mr. B.C. Thiruvengadam, LL.B.,9844092926
PHILOSOPHER:Dr. M. Sreenivas, M.Phil., PhD9886676720
COMMUNITYLEADER:Mr. Lakshmi Narayan9945689830
3 lCD-English Version 1 .23-May-2012
4 lCD-Hindi Version 1 .23-May-2012
5 ICD-Marathi Version 1 .23-May-2012
6 lCD-Tamil Version 1 .23-May-2012
7 ICD-Telugu Version 1 .23-May-2012
8 ICD-Kannada Version 1 .23-May-2012
9 ICD-Malayalam Version 1 .23-May-2012
10 lCD-Urdu Version 1 .23-May-2012
11 Investigators undertaking Dated 16 June 2012
12 CV&MRC Dated 08 June 2012
The following members of the Ethics Committee were presentduring the meeting held at Dr.B.RAmbedkar Medical College &Hospital on 1st August 2012 at 12.00 AM and have decided toapprove the above mentioned documents for use in referencedstudy.
81 Name of the EC Role Designation & GenderNo Member Qualification1 Dr.Radha.S.Murthy CHAIR MBBS, Female
PERSON MIFA,MIGS2 Dr.B.M Nagaraj Member MD, Dip Male
Secretary medical law ðics (NLSIU)
3 Dr.B.RRamesh Basic M.S Malescientist
4 Dr.RHemalatha Basic M.D Femalescientist
INSTITUTION ETHICS COMMITTEE (IEC)(AN INSTITUTIONAL ETHICAL ISSUES REVIEW BOARD)
Dr. H.R.Ambedkar Medical College & HospitalK.G. Haiti, Bangalore - 560 045. Off. : 080-25476498, Fax: 080-25471784
CHAIRPERSONDr. RADHA S. MURTHY,
MBBS., MIFA., MIGS.,Managing TrusteeNightingale's Medical Trust,Ravindranath Tagore Nagar,Bangalore - 560032.Mob. : 9844037381
MEMBER SECRETARYDr. B.M. NAGARAJ, MD.,
Dip. Medical Law & Ethics (NLSIU)Professor and Head,
Dept. of Forensic MedicineDr. B.R. Ambedkar Medical College,
Kadugondanahalli, Bangalore.Mob. :9844141088
MEMBERS:
BASIC SCIENTISTS:Dr. B.R. Ramesh., M.S.,9448889607Dr. R. Hemalatha, M.D.9845019684
CLINICAL PHARMACOLOGIST:Dr. L. Padma, M.D,944824882
PHYSICIAN:Dr. N. Bhakthavatchalam, M.D,9845015873
SURGEONDr. Stanley John M.S.9845176912
REPRESENTATIVE OF NGOMr. Prem Kumar Raja9243100560
LEGAL EXPERT:Mr. B.C. Thiruvengadam, LL.B.,9844092926
PHILOSOPHER:Dr. M. Sreenivas, M.Phil., PhD9886676720
COMMUNITY LEADER:Mr. Lakshmi Narayan9945689830
5 Dr.L.Padma Clinical MD FemalePharmacologist
6 Dr.Bhakthavatchala Physician MD Malem
7 Dr.Stanley John Surgeon M.S Male :Mr.Prem kumar Social . MaleRaja scientist / Re
p ofNGO9 Mr.B.C.Thiruvengad Legal Expert L.L.B Male
am10 Dr.M.Srinivas Philosopher M.Phil,Phd Male11 Mr.Lakshmi Community Male
Narayan leader
We confirm that neither you nor your study team membersparticipated in the deliberations of the Ethics Committee & did notvote on the proposal for this study.
Thanking you,
~L--a-'~'
Dr .Radha.S.Murthy(Chairperson)
Dr. RADHA .S. MURTHYMaas, "'FA MIGS.
Chair PersonEthical Committe.
Dr. I.R. Ambedklr Medicll Collegeaangalore-S80045.