INDIAN COUNCIL OF MEDICAL RESEARCH V. Ramalingaswami Bhawan, Ansari Nagar, Post Box No. 4911, New Delhi 110029 DO. No. 4717/2005-BMS ',- Dr. Vasantha Muthuswamy Senior Deputy Director General Date :-3-t:'5:2Q06 gl:1- \00 Subject: Project entitled "Ongoing /CECHR No. 3/2002 : Multicentric Task Force based '~'Management of new born infants" submitted by Dr. Malabika Roy, Divn. of RHN, ICi\1R, ,New Delhi Dear Dr. Roy, The above-mentioned proposal was considered in the meeting of the Central Ethics Committee on Human Research, which was held on 8th May, 2006 at ICMR Headquarters Office, New Delhi. While approving the proposal, the following recommendations were made by the committee with regard to your proposal: 1. The minor corrections on Page 6 as discussed may be carried out and the modified latest version of informed consent in English translated in regional languages should be submitted. 2. It has to be kept in mind that the method used in this project can be only a temporary method and should not be taken as a permanent solution for management of newborn infants. With kind regards, Yours Sincerely, (Vasantha Musthuswamy) Dr. Malabika Roy DOG and Co-ordinator (RHN) Divisi0!1 of RHN ICMR .Telefax (Direct) : 26589791 PABX : 26588980/26589794 Extn. 216 Email:[email protected]
Transcript
INDIAN COUNCIL OF MEDICAL RESEARCHV. Ramalingaswami Bhawan, Ansari Nagar,
Post Box No. 4911, New Delhi 110029
DO. No. 4717/2005-BMS
',-
Dr. Vasantha MuthuswamySenior Deputy Director General
Date :-3-t:'5:2Q06gl:1- \00Subject: Project entitled "Ongoing /CECHR No. 3/2002 : Multicentric Task Force based
'~'Management of new born infants" submitted by Dr. Malabika Roy, Divn. of RHN,ICi\1R, ,New Delhi
Dear Dr. Roy,
The above-mentioned proposal was considered in the meeting of the Central EthicsCommittee on Human Research, which was held on 8th May, 2006 at ICMR HeadquartersOffice, New Delhi. While approving the proposal, the following recommendations weremade by the committee with regard to your proposal:
1. The minor corrections on Page 6 as discussed may be carried out and the modifiedlatest version of informed consent in English translated in regional languages should besubmitted.
2. It has to be kept in mind that the method used in this project can be only a temporarymethod and should not be taken as a permanent solution for management of newborninfants.
With kind regards,
Yours Sincerely,
(Vasantha Musthuswamy)Dr. Malabika RoyDOG and Co-ordinator (RHN)
~Lv....;/ /yI Relevant portion of the the Div. Of RHN from the Minutes of the meeting of Central
Ethical Committee held on 4.7.2002 at ICMR at 2.30 r.M at Headquarters office,New Delhi
Item" No.2 lVlulticentric Task Force based management of new born infantssubmitted by Division of RHN, ICMR HQRS., N Delhi.
Dr. A.K. Paul from AIIMS, member project implementing comminee gave briefaccount of the study. Overall the study was found to be feasible, good serviceoriented and may result in the reduction in maternal mortalilty, perinatal mortalityand neonatal mortality which is major national problem.
In the proposal, it is proposed to compare a village-based system of neonatal caresupported by referral system as it is now delivered through Anganwadi workers and aneonatal local village based worker with the current system. It is proposed to providetraining to thes,~ two cadres in home based neonatal care, assessment of sick neonatesand administration of oral plus irijectible antibiotics (1M) to those considered to have
probable sepsis. ~,,_
(
The study in\·olves extensive training component to be provided to the ShishuRakshaks / A WWS to enable them to carry out new born care intervention. imparthealth education etc. for good supervision is available with the PI's. they arecommitted and have been working in the area for quite some years which has resultedin fruitful outcome.
The Committee made following recommendations :-
ICMR may seek legal opinion from Ministry of Health regarding use of gentamycininjection by shishurakshas informing them that this study is important as the infantmortality is high in the country and stagnating at the current level since not sufficientmedical staff is available for taking care of the problem specially in the rural areas. It
is highly essential to have para medical staff trained in this direction .. Previousexperience by SEARCH at Gadchiroli has been encouraging.Initially this study couldbe tried at one of the Govt. Institutions and the results should be sent to the Ethics
Committee for consideration of extension of the study to other centres. ~lassessment of cases, administration of oral antibiotics and of 1M injection at :3 to -+
VITlages under supervision of a physician and observations, based on an objectivisedprotorma 5eSU15ffiitted to the data safety committee to be set up. These workers mustdeal wIth about 10 ·cases each.
Patient information sheet should be separate informing the parents/guardians theexact problems faced and causes of neonatal sepsis and benefit of the treatmentproposed and also details about the treatment regarding care at birth, identification ofinfections in infants, treatment of babies with sepsis etc. Essentiality of village basedhealth worker to treat the sick babies, as families do not seek care of hospitals till it is
too late. \Vhen the disease is diagnosed families will be requested to send the baby tohospital for treatment. Only when they refuse the SRs will give the treatment a...'1dparents will be infom1ed about the same and written consent obtained. The consentform needs to be modified. The sentence as qouted in Annexure III as " I take allresponsibility of whatever happens to my child," needs to be removed.
A data safety monitoring committee, with representatives from the ethics committeeto monitor the study to be constituted.
The formative phase of the study with limited intervention as pilot study at one centre ,.was recommended.
