La escuela como agente integrador de las familias ecuatorianas

154

155 PURPOSE OF RESEARCH:

You are being invited to participate in this research which will entail performing some examinations on you to find out if the diabetes that you have been suffering from has had any effect on the functions of your nerves

DURATION OF THE STUDY:

If you agree to participate, then you have to keep your clinic appointments without miss for the next 6months which will not be more than 4 visits over this period.

PROCEDURE:

You will be required to answer some questions about yourself which will not take more than 10 minutes to complete.

Just like any other clinic visit you will be required to come early before 8.30am each day fasting to enable a fasting sugar sample to be taken and result ready before you are seen later in the day.

On the last day of your participation, you will be examined to assess your nerve functions, apart from the physical examination, an instrument which tests the ability of your nerves to detect vibrations on your big toe. This instrument is very safe and does not cause any harm or shock.

On the same last visit for the research, in addition to the blood usually collected for the usual sugar test, about 5mls extra will be collected for one other test at no extra cost to you.

This test known as test for glycated hemoglobin gives an indication of how good your sugar has been controlled.

POSSIBLE RISKS, DISCOMFORT AND INCONVENIENCES:

If you agree to participate in the study, then you will need to keep all you appointments regularly throughout the duration of your participation. The process of collecting blood sample will be the same as you normally do on your routine clinic visit. You are not likely to suffer any extra discomfort. You will still feel the pain that you normally experience as the needle is being inserted to collect blood.

156

The neurothesiometer reading process is quite safe and you will experience some vibration impulses. There is no associated electrical shock.

COST TO PARTICIPANTS AND BENEFITS:

Participation in the research will not entail any extra cost to you in terms of money, but as explained earlier, it will require a more dedicated attendance to your clinic appointments.

There is however no guarantee or promise that you will receive any benefit from the research, and you will not be paid to take part in this study.

CONDITIONS OF PARTICIPATION:

Your participation in this study is entirely voluntary. Your decision either to participate or not will not in any way prejudice you or your medical care. You will be free to change your mind to withdraw from this study at any point if you so desire without affecting your ability to continue to receive medical care for your medical condition. However, any information that would have been obtained prior to your withdrawal may have been modified or used and cannot be retracted.

Every information that will be generated will be coded and treated with utmost confidentiality, and is not to be linked in any way to you. However, the results generated are likely to be used for scientific presentations and publications without disclosing your identity.

If for any reason you may not be able to keep your appointment, it will be good to inform us ahead of time and reschedule the appointment at the nearest possible time.

In the unlikely event of your developing any medical complications as a result of participating in this study, the researcher will help you in obtaining the appropriate medical treatment. If you develop any illness that is directly caused by your participation in this study, reimbursement for all related costs of management will be pursued with your insurer, managed care plan or any other benefit programme. You will bear the responsibility of any associated co-payments or deductibles as required by your insurance.

APPARENT OR POTENTIAL CONFLICT OF INTEREST:

There is no identified apparent or potential conflict of interest in this research.

157

STATEMENT OF RESEARCHER OBTAINING INFORMED CONSENT

I have fully to the best of my ability explained the import of this study to

--- and have given sufficient information including the risks and benefits involved, to make an informed consideration and decision

DATE……….. SIGNATURE………

NAME……….

STATEMENT OF THE PERSON GIVING CONSENT

I have read the description of this study OR have had the it explained to me in a language I understand. I have talked it over with the doctor to my satisfaction. I fully understand that my participation is voluntary. I know about the purpose, methods, risks and benefits of the research study to decide that I want to be part of it. I understand that I may freely opt out of the study at any point in time. I have received a copy of this consent form and additional information sheet to keep for myself.

DATE……….. SIGNATURE………..

NAME……….

158