ALL INDIA INSTITUTE OF MEDICAL SCIENCES

NEW DELHI

 

ETHICS COMMITTEE

 

Responsibility, Composition and Procedures

 

Responsibility:

To ensure that the research projects that are carried out in AIIMS Hospital

 

  • Are sound in design, have statistical validity and are conducted according to the ICMR and ICH/GCP guidelines
  • Do not compromise safety of the patients or volunteers
  • Are conducted under the supervision of trained medical / bio medical persons with the required expertise
  • Include, solely, patients who have given voluntary and informed consent

 

The committee expects from the investigators:

  • A progress report on six monthly basis or more frequently as the committee feels it.
  • A report of each serious event when observed during the conduct of the study
  • To keep informed of amendments to any study related documents
  • To keep informed of study discontinuation with reasons.

 

Composition:

The ethics committee consists of 10 members

  • 5 members are from inside AIIMS
  • 5 members are from outside AIIMS
  • 2 members are ladies,

 

These members are as follows:

a)      Outside AIIMS

i)                    Prof. J.P. Wali, Former Professor of Medicine, AIIMS

ii)                  Justice S.R. Singh (Retd. Justice, High Court)

iii)                Dr. Ganga Prasad Vimal, Former Chairperson and Prof. Centre of Indian Languages, JLN University and Ex-Director, Central Hindi Dte., Govt. of India.

iv)                Dr. Vijay Kumar Dy. DG, ICMR, Ansari Nagar, New Delhi

v)                  Prof. Anand Kumar, Coordinator Global Studies Program, Centre for Study on Social Systems, JLN University, New Delhi

b)     Inside AIIMS

i)                    Prof. R.C. Deka, Dean

ii)                  Prof. Sunita Mittal, HOD, Dept. of Obst. & Gynae

iii)                Prof. Y.K. Gupta, HOD, Dept. of Pharmacology

iv)                Editor, National Medical Journal of India

v)                  Dr. Renu Saxena, Professor & Head, Dpet. Of Hematology

 

If a member is unable to attend a meeting his/her opinion on the project on the agenda may be submitted in writing to the chairperson of the committee before the date of the meeting or decision.  The decision of the committee is taken by majority vote. If Chairman is absent he can nominate a person from the Ethics Committee to chair.  Professor in charge, Research, Chairman and Member Secretary Ethics Sub Committee may be special invitee to maintain continuity.

 

Procedures:

 

A quorum is required for all meetings (5 members out of 10 make a quorum).  But approval of a project requires voting by a show hand by members present at the meeting. 

 

The notice of each meeting with the agenda is sent out to the members at least one week before the meeting.

 

The chairman appoints a member to write the minutes of the meetings:  It is the member secretary who writes the minutes.

 

Minutes are circulated to the chairman and after his approval the comment letters to applicants may be dispatched after the signature of Member Secretary of the Ethics Committee.  The minutes will be placed for information of other members of Ethics Committee in the next Ethics Committee meeting.

 

In order to streamline the work of Ethics Committee, M.Sc./MD/MS/DM/M.Ch./Ph.D Sub Committee has been formed to assist in evaluation of ethical angles of the DM, MD, Ph.D thesis.  The report of this committee will be submitted in the meeting of Ethics Committee for approval.

 

The applicant of a proposal is required to submit 10 copies of his / her application letter and copies of the following documents.

1)      Research Protocol

2)      Investigator’s Brochure

3)      Informed consent form and information sheet in English and translated language any other project – specific document.

4)      Updated brief CV of Principle Investigator

 

The schedules of submitting the proposal is as follows:

Submissions will be received on all days.  Proposals received till 15th of any month will be processed in the coming ethics committee meeting and those received after 15th  will be processed in the next ethics committee meeting.  All meetings of ethics committee will be held on first Monday of Jan, Feb, March, April, August, September, October, November and those of ethics Sub Committee on the immediately preceding Friday of the above dates.


 

 

 

Date of meeting of ethics Sub-Committee

 

Date of meeting of ethics committee

 

2nd August 2008

4th August 2008

29th August 2008

1st September 2008

3rd October 2008

6th October 2008

31st October,  2008

3rd November 2008

28th November, 2008

1st December, 2008

Break

Break

2nd January 2009

5th January 2009

30th January 2009

2nd February 2009

27th February 2009

2nd March 2009

 3rd  April 2009

 6th April 2009

1st May, 2009

4th May, 2009

Break

Break

 

 

The committee will give its opinion on the project in writing in one of the following ways:

 

Approval

Disapproval

Modification before approval

Discontinuation of previously approved project

 

The chairman / member secretary of the committee may provisionally approve without calling a full meeting in case where only administrative amendment has been made.  This decision will be ratified at the next full committee meeting and minuted.  All documents pertaining to the ethics committee will be held in the office of the Member Secretary of Ethics Committee.

 

 

 

(Dr. Renu Saxena)
Member Secretary

Ethics Committee