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Institutional Review Board and Ethics Committee

The Institutional review board and Ethics Committee are installed in order to promote and safeguard the dignity, rights and well-being of the patients and Staff of the hospital by providing ethical guidelines, education in ethical treatment and documentation guidelines.The resolution of ethical problems requires an Ethics Committee. This is multidisciplinary and multicultural in composition, includes relevant scientific and legal expertise, with balanced age, gender and ethnic distribution, as well as lay persons representing the concerns of the wider community. This committee will lay down appropriate guidelines based on established ethical principles, and in accordance with the values of the community that the hospital serves.

Ethics Committee Objectives

  • Formulate and publish Ethical Guidelines for the hospital,
  • Ensure these guidelines are understood and accepted by the hospital staff and the wider community.
  • Provide a mechanism for arranging consultation on urgent ethical problems.
  • Periodic review of ethical decisions taken to ensure that they fall within the guidelines provided.
  • Ethical review of research protocols and the conduct of research at the hospital accordingly.

As different aspects of child hood diseases are analysed, the newer generation of vaccines and their potential are identified. Hence the physicians want to look into the details of administration of vaccines and newer generation of drugs. In this matter, the Govt. of India and ICMR has brought forward certain guidelines for vaccine trials. These guidelines must be adhered to strictly by drug companies as well as the institutions carrying out the trials and a clearance must be obtained from the Drug Controller General of India – New Delhi. When an institution applies for this clearance, the necessity of an Ethical Clearance from the Ethics Committee of the institution is mandatory. Hence in 2005 Jan, an Ethics Committee (otherwise known as Institutional Review Board) was formed by the management as per the protocol of the ICMR.

The informed consent form was formulated by the CTMRF and today regular Ethics Committee meetings are conducted once in six months, both for initial clearance and final validation of the outcome. The hospital (KKCTH) adopts the decisions on all these matters, as the Ethics Committee of the hospital is governed by the Medical Research Foundation.

Ethics Committee of the Childs Trust Hospital Affiliated to the C.T.M.R.F. Ethics committee was started in KKCTH as per ICMR guide lines and is functioning actively. The aims and objectives are clearly elucidated as follows. It was started in 2005 since the government has made it mandatory to have an internal review board and Ethics committee in every institution that conducts clinical research.

Drug controller General of India has given permission to CHILDS Trust Medical Research Foundation to conduct research activities (including vaccine and drug trials on 21.04. 2014).

Responsibilities, Composition and Procedures.

Responsibility (Scientific and Ethical)

To ensure that the research protocols that are carried out in the Kanchi Kamakoti CHILDS Trust Hospital & Child Trust Medical Research Foundation:

  •  Are sound in design, have statistical validity and are conducted according to the parameters of ICH / GCP. (Scientific soundness)
  • Do not compromise safety of patients
  • Are conducted under the supervision of medical persons with the required expertise Include solely patients who have given voluntary and informed consent.

The committee will review research projects on a bi-monthly basis. The committee will maintain a list of projects submitted, approved/disapproved and their outcome. All approved projects will be reviewed six monthly for the way it is conducted and progress. Appropriate changes if any in the study protocol/design as deemed necessary can then be permitted. (Justification necessary)

Composition

The ethics committee will not have more than 12 elected members including director of research & additional director of research. Amongst these there would be one representative public, one legal expert and 2 – 3 non-institutional members.

Additionally following will be ex-officio members

  • DPS s
  • Secretary to the Board of Management
  • Director Audit and quality control

In case, the Research Director is the chairman of the committee, then he will carry out the functions of the secretary as well. Members will be appointed for a 3 year period wherein it is mandatory that they attend 75% of the meetings held in one year, If a member is unable to attend a meeting, his / her opinion on the project on the agenda must be submitted in writing to the Chairperson of the committee, before the date of the meeting for a decision for scientific assessment, final approval of the project will be taken only by members present. The names of the members who attended a meeting, at which a project was approved, will be noted / provided.

Procedures

A quorum is required for all meetings (either 1/3rd or two, whichever is least). But approval of a project will be voting by a show of hands by members present at a meeting and a written opinion on the project from those who are absent. The committee will meet as and when necessary approximately six times in a year.

The notice of each meeting with agenda will be sent out to the members at least two weeks before the meeting.

  • Minutes of the meeting will be duly recorded.
  • Minutes will be circulated to the members within two weeks of the meeting.
  • The applicant of a proposal is required to submit, one copy of his / her application letter and 5 copies of the following documents as applicable.

a) Drug Trials

  •  Protocol
  • Investigator brochure
  • Informed consent form and information sheet in English and local languages
  • Any other project – specific documents

b) Other Projects

  • Study Protocol
  • A review of information available on the subject will be submitted
  • Past experience if any guidelines of the committee
  • Any other relevant information

c) Sponsored Projects / Drug Trials

Step should be taken to ensure that the sponsors do not seek to drive undue commercial benefit from their association with HNH in this regard. The committee’s opinion on the project will be given in one of the following ways:

  •  Approval
  • Disapproval
  • Modification before approval
  • Discontinuation of a previously approved project

Should an amendment to a study -related document be administrative in nature and not involving any safety criteria, it may be provisionally be approved in writing, by the chairman of the committee without calling a full meeting. The chairman will inform other members of the committee of the amendment and his decision. The decision will be ratified at the next full meeting and this will be minuted.

All documents pertaining to the Research & Ethics Committee will be held in the office of the Director of Research, Dr. K. Mathangi Ramakrishnan, ( Director, Research & Ethics Committee), Kanchi Kamakoti CHILDS Trust Hospital & Childs Trust Medical Research Foundation. No 12-A Nageswara Road, Nungambakkam, Chennai: 600 034.

Informed Consent Form for Clinical research and Drug / Vaccine Trials on Human Subjects ( Kanchi Kamakoti CHILDS Trust Hospital & Childs Trust Medical Research Foundation)

Protocol No – To be created

Study Title: Randomized, Double-blinded, Placebo-Controlled, Fixed Dose -Ranging Study to assess the safety, tolerability and efficacy of the drug, open label study, phase I, II, III or IV study in cases of certain drug trials & vaccine trials.

Read this information carefully

You are being asked to give permission for your child to volunteer to take part in a drug / vaccine research study. Before you give consent / permission for your child to be part of this study, please read the following. Ask as many questions as you need to be sure that you understand what taking part will involve.

What is the purpose of the study (To be explained by the physician- investigator) 1. Explain the purpose in terms of evaluation of the safety and efficacy of the drug / vaccine in controlling the diseases, or to make preventive precautionary measure to avoid the diseases onset or to make a controlled efficacy or safety data on children (age wise) so that this study will provide scientific information that could help doctors in the future who treat the diseases under consideration

How many parts or steps are (Physician- investigator to explain) there for this research – specify one, two, three or four. The duration of each part must be specified and understood. After consent, you and your childs doctor agree your child will enter the part of the study. Here there will be diet restrictions and blood may have to be withdrawn for study. The childs urine may have to be collected, in which case, a bag may be kept in the diaper for collection Physical examination will be conducted at each visit, and necessary data recorded, depending upon the study.

Each time you come for review you may be given a questionnaire which needs to be filled by the parent and returned to the doctor who is conducting the research.

Common phase of study

First phase in every study is the screening phase. This phase will last upto 3 days, is to determine if the child qualifies for the study.

This phase will include Full medical check up, as well as special tests for the research that is being conducted. Then, the subsequent phases of study are the double blind phase, open label phase, controlled study procedures and other special studies which the particular research demands.

Study Medication / Vaccine

Appraisal on this part will be given to the parents in great detail and proper underrating of this is necessary.

You must not give your child’s study drug to anyone else :

The physician will tell you not to give any medications from super market etc, without consent of the doctor, for other minor ailments.

What are the risks and inconveniences of being with this study. For each study the physician conducting the study will explain the specific risks carefully. What happens if my child has an injury related to the study ? If your child suffers side effects, injuries, or illness relating to the study, contact your child’s doctor. The doctor will ensure medical care and advice during and after the study. Treatment for injuries from the research may include any serious physical or mental injury. The Sponsor’s insurance covers your child for medical costs due to injuries related to the study. The above statement does not limit your child’s rights.

What are the benefits of being in the study?

Taking part in this study may improve your child’s condition, although this cannot be guaranteed. While your child is in this study, the doctor will closely follow your child’s condition. Your child’s participation may help patients in the future.

What happens to the information collected about my child?

Regulatory authorities, members of the independent Ethics Committees/ Institutional Review Boards study site personnel and representatives of the Sponsor may review your child’s medical records. Your child’s records will not be made publicly available, to the extent permitted by law. By signing this form, you are permitting direct access to your child’s medical records.

The information about your child collected for the sponsor will be stored both on paper and computer records, without identifying you or your child by name. These records will be handled by either sponsor personnel or a third party. They may be used for registration of the drug in different countries. Your child’s records will be kept by the sponsor for as long as necessary. During that time they will be kept confidential to the extent permitted by law. If the results of the study are published, your child will not be personally identified. You have the right to ask to see your child’s personal data and, if needed, to ask that it be corrected. By signing this form, you are permitting the use of your child’s information.

By signing the informed consent form the parent ( or their acceptable representative ) of the child is authorizing such access, and agrees to be re-contacted after study completion by those listed above for the purpose of obtaining consent safety evaluation if needed.

What if I change my mind ?

Your child’s participation in this study is voluntary. You don’t have to give permission for your child to be in this research study. You can agree for your child’s participation in the study now and change your mind later. Your decision will not affect your child’s regular care or the benefits to which he or she is otherwise entitled.’

Your child may be taken out of the study, even without your agreement if

  •  It is not in your child’s best medical interests to continue
  •  He or she needs treatment not allowed in this study
  •  You fail to follow instructions, or
  •  The study is cancelled.

If you stop your child’s participation in this study early, you will be asked to return to the doctor to
have final tests done on your child.

If you decide that your child should no longer take part in the study, you agree not to restrict the
use of the study data.

Who do I contact for information?

If you have any questions about the study, please contact Dr.

__________________________________________________________________

Physician / investigator

In case of any injury related to the study, please contact Dr. _________________________

Co investigator

If you have any questions about your child’s rights as a research subject, please contact:

Medical Director, Kanchi Kamakoti Childs Trust Hospital 12A, Nageshwara Road, Nungambakkam Chennai 600034, Phone: 044-4200 1800.

 

Agreement to Take Part In The Study

This consent form contains important information, to help you decide if you wish give your permission for your child to take part in this study. If you still have questions, please ask the doctor or a member of his or her staff, before signing this form.

You will receive a copy of this signed informed consent form, in English or the language you wish. Please initial box ( Subject)

  •  I confirm that I have read and understood the information sheet dated ………[ ] for the above study and have had the opportunity to ask questions.
  •  I understand that participation of my child in the study is voluntary and [ ] that I am free to withdraw my child at any time, without giving any reason, without my child’s medical care or legs  rights being affected.
  •  I understand that the Sponsor of the clinical trial, others working on the [ ] Sponsor’s behalf, th Ethics Committee and the regulatory authorities will not need my permission to look at my child’ health records both in respect of the current study and any further research that may be conducted in relation to it, even if I withdraw from the trial. I agree to this access. However, I understand that my child’s identify will not be revealed in any information released the third parties or published.
  •  I agree not to restrict the use of any data or results that arise from this [ ] study provided such a use is only for scientific purpose(s)
  • I agree to the participation of my child in the above study. [ [

_________________________________________________________________ Printed Name of

Subject, in full

_________________________________________________________________

Printed Name of Obtaining Consent

_________________________________________________________________ ______ Signature

of Person Obtaining Consent Date

_________________________________________________________________

Printed Name of Parent

_________________________________________________________________ ______

Signature of Parent Date

_________________________________________________________________

Printed Name of Legally Acceptable Representative

_________________________________________________________________ ______

Signature of Legally Acceptable Representative Date

Relationship of Legally Acceptable Representative to the subject

_________________________________________________________________

Printed Name of Impartial Witness

_________________________________________________________________ ______

Signature of Impartial Witness Date