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INSTITUTIONAL REVIEW BOARD (IRB)CHRISTIAN MEDICAL COLLEGE

VELLORE 632 002, INDIA

Dr. George Thomas, D OrthEditor, Indian Journal of Medical Ethics

Chairperson, Ethics Committee

Dr. L. Jeyaseelan, MSc, PhD

Secretary, Research Committee, IRB

November 9, 2011

Dr. Phijam DhaneshworPG RegistrarDepartment of Obstetrics and GynecologyChristian Medical CollegeVellore 632 004

Dr. Alfred Job Daniel, MS OrthoChairperson, Research Committee &Principal

Dr. Gagandeep Kang, MD, PhD, FRCPathDeputy ChairpersonSecretary, Ethics Committee, IRBAdditional Vice Principal(Research)

Sub: FLUID Research grant project NEW PROPOSAL:Gestational diabetes well controlled on medical nutritional therapy: a randomized trial

of active induction of labour compared with expectant managementDr. Phijam Dhaneshwor, Post graduate registrar, Obstetrics and Gynecology,Dr. Annie Regi, Dr. Ruby Jose, Dr. Jiji Matthews, Obstetrics and Gynecology.

Ref: IRB Min. No. 7643 dated 25.10.2011

Dear Dr. Dhaneshwor,

The Institutional Review Board (Silver, Research and Ethics Committee) of the Christian

Medical College, Vellore, reviewed and discussed your project titled "Gestational diabetes wellcontrolled on medical nutritional therapy: a randomized trial of active induction of labour

compared with expectant management" on October 25, 2011.

The Committees reviewed the following documents:

1. Format for application to IRB submission2. Patient Information Sheet and Informed Consent Form (English and Tamil)

3. Cvs ofDrs Phijam Dhaneshwor, Annie Regi, Jiji Mathews, Ruby Jose, ElsyThomas

4.' A CD containing document 1 - 3

The following Institutional Review Board (Ethics Committee) members were present at

the meeting held on October 25,2011 in the CREST/SACN Conference Room, ChristianMedical College, Bagayam, Vellore 632002.

TEL:0416-2284294,2284202 FAX:0416-2262788, 2284481 E-mail: [email protected]









Name

Dr. George Thomas

Mrs. Mary Johnson

(on behalf of Mrs.Dr.Jayarani Premkum

Mrs. Shirley David (0behalf of Mrs. Rosali

Jayaka~an) _Rev. Malhia Joshua

Mr. Harikrishnan

Mr. Samuel Abraham

Mrs. S. Pattabiraman

Dr. P. Zachariah

Dr. Gagandeep Kang

--Qualification Designation Oth

MBBS, D.Ortho

Chairperson (IRB) & Non

Orthopaedic Surgeon, St. Isabel Hospital, Chennai &--

Editor, Indian Journal of Medical Ethics-M.Sc. (Nursing) Nursing Superintendent, CMC.

---~

I M.Sc. (Nursing), R Dean, College of Nursing, CMC.RM

- ~------------ --_._-_ .._--~--_.._---

~._-~

MA, MEd, MTh, Chaplain, CMCPhD

- ..--- ~----+-_.--- --.----- --------

BL. Lawyer Non

---~--_ .. -. ---------._-

MA,PGDBA, Legal Advisor, CMC.PGDPM, M.Phil, B

------

BSc, OSSA Social Worker, Vellore Non

-

Retired Professor, Vellore--------

MBBS, PhDNon

-

------ +-

MD, PhD, FRCPat Secretary IRB (EC)& Dy. Chairperson (IRI

Professor of Microbiology& Add!. Vice Principal (Research), CMC.----

-CMC

.-

-CMC

-CMC

We approve the project to be conducted as presented.

The Institutional Ethics Committee expects to be informed about the progress of the

project, any serious adverse events occurring in the course of the project, any changes in

the protocol and the patient information/informed consent and requires a copy of the finalreport.

TEL : 0416 - 2284294, 2284202 FAX: 0416 - 2262788, 2284481 E-mail: [email protected]









A sum of ~ 40,000/- (Rupees Forty thousand only) is sanctioned for 1 year.

Yours sincerely,

TEL:0416-2284294,2284202 FAX: 0416 -2262788, 2284481 E-mail: [email protected]

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