Appendix 1 - Informed Consent

Management of Type 1 Diabetes in a Limited Resource Context: A Study of the DREAM Trust, Nagpur, Central India

N.B. This consent document will be translated into Hindi. For those potential participants who cannot read, the individual obtaining consent will read the document aloud to them.

We would like to invite you/your child to participate in a study that will help us to find out more about the way DREAM Trust treats patients with type 1 diabetes. We are doing this study in association with a group of doctors in Ottawa, Canada at the Children’s Hospital of Eastern Ontario (CHEO)

Purpose of the Study

This study will evaluate how well patients at DREAM Trust are being treated for type 1 diabetes. If we find that DREAM Trust has a good way of treating type 1 diabetes, this model of care may be able to be used in other diabetes clinics in India and around the world.

Study Procedure

All of DREAM Trust’s patients will be asked if they would like to participate in this study if they have been followed at DREAM Trust for type 1 diabetes care since childhood. You are being asked to participate because you/your child is a patient at DREAM Trust.

If you choose to participate, we will review your chart and ask you some questions. This will take about 20 minutes.

Participation in this study is entirely voluntary: you are free to choose to participate or not. If you choose to participate, you only have to answer the questions that you are comfortable answering. Your care at DREAM Trust will not be affected in any way if you decide not to participate.

Confidentiality

When we collect information, you/your child will be identified by a number only. Your/your child’s name will not be linked directly to your/your child’s answers or the information from your/your child’s chart. This information, identified by number only, will be sent to Canada for review and statistical analysis. Your/your child’s personal information will be kept confidential. Only those people involved in the study and the Research Ethics Board at the hospital in Canada (a group of people who monitor human research) will have access to your/your child’s information.

Your/ your child’s individual information will be combined statistically with the information of other participants. It will therefore be impossible to identify you/your child individually when the results of this study are presented or published.

Risks

There are no risks to participating in this study.

Benefits

There are no direct benefits to you/your child from participating in this study. Your answers will help us to better understand DREAM Trust’s patient population and the diabetes care that DREAM Trust provides. This may help us to improve the care provided to others with type 1 diabetes in India and around the world.

Other Information

This study is being conducted by Dr. Pendsey, Dr. Sharma and Seema Chalkhore, in association with Dr. Zuijdwijk, Dr. Ahmet, Dr. Ron and Dr. MacKenzie at CHEO in Ottawa, Canada. If you have any questions, please to do hesitate to contact:

Dr. Pendsey at DREAM Trust

Shreeniwas, Opp.Dhantoli Park, Nagpur 440 012 (M.S.), INDIA

Email:

Phone: +91 712 243-1523 or +91 712 242-1898

At the end of the research study, you will be able to learn of the results through Dr. Pendsey or other DREAM Trust staff.

This study has been reviewed and approved by the CHEO Research Ethics Board in Ottawa, Canada. The CHEO Research Ethics Board is a committee of the hospital that includes people from different backgrounds. The Board reviews all human research that takes place at the hospital. Its goal is to ensure the protection of the rights and welfare of people participating in research. The Board’s work is not intended to replace a parent or child’s judgment about what decisions and choices are best for them.

You will be provided a copy of the signed consent form for you to keep.

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Management of Type 1 Diabetes in a Limited Resource Context: A Study of the DREAM Trust, Nagpur, Central India

The above study has been explained to me and the research assistant has answered all of my questions. I give permission to allow myself/my child to be enrolled in this study

Note: If the patient is under 18 years of age, the signature or thumbprint of a parent/ guardian is also required. The patient, if they are old enough to understand the study, is also asked to sign or mark their thumbprint to indicate assent.

 Written consent obtained

Name of patient / Signature of patient / Date
Name of parent/guardian / Signature of parent/guardian / Date

OR

 Verbal consent obtained

Thumbprint:

Patient / Parent/guardian
Name of witness / Signature of witness / Date

For all patients:

I have explained this study to the person authorized to sign above and I am satisfied that it is understood.

 I have provided a copy of this consent form to the patient or patient’s parent/guardian.

Name of research assistant / Signature of research assistant / Date

1

Consent Form Version: Version #2, June 13, 2011
Protocol Version: Amendment #1, June 13, 2011
CHEO Protocol Number: #11/14E
Investigator/Coordinator Initials: Dr. Caroline Zuijdwijk/ SC