UNPICKING THE ACTION

INFORMED CONSENT FORM FOR SUBJECTS

TITLE OF RESEARCH: ASSESSMENT OF STROKE RISK BY DETERMINING CEREBRAL BLOOD FLOW VELOCITIES AND OTHER SELECTED FACTORS IN CHILDREN WITH SICKLE CELL ANAEMIA IN LAGOS.

NAME AND AFFILIATION OF THE RESEARCHER: This study is being conducted by Dr Ebere Agwu, a postgraduate student of the Department of Paediatrics, Lagos University Teaching Hospital [LUTH], Lagos State.

INTRODUCTION: you must have heard of stroke before now but you may surprise that it occurs in children especially those with sickle cell anaemia. Stroke can make you not to walk, see or write.

It can even kill. For those that survive, the treatment of stroke is expensive and will reduce the quality of life for the child. The good news is that, this may be detected early before it happens It is better to prevent than to cure. Transcranial Doppler [TCD] is a scan that will show the speed of blood flow. Knowledge of this speed can help detect those who are likely to have stroke in future.

This scan is cheap, non-invasive and can be repeated as the need arises.

PURPOSES OF THE RESEARCH: the study is to determine the speed of blood flow in the brain using transcranial Doppler in children with sickle cell anemia. It will also determine the proportion of those children who are likely to have stroke in future.

PROCEDURE OF THE RESEARCH: Some questions will be asked about your child. He/ She will then be examined, after which a blood sample [2mls] will be taken for tests and a scan done to check the speed of blood flow in the brain.

POTENTIAL BENEFITS: The good things that can happen with this research is that it will create awareness that stroke happen in children and it will help the training centre form a guideline to prevent and treat stroke and assist the government in policy making and providing more scans for the brain in Nigeria. The results will be published in a journal so that others who support sickle cell can be aware.

POTENTIAL RISKS:Your child will experience slight pain when blood is taken this will be minimized by putting. Emlair patch or cream 30 minutes before blood collection. Oral paracetamol will also be given afterwards. However the scan is not invasive, not painful and there is no known harm.

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CONFIDENTIALITY: All information that will be obtained from this study will be given code numbers and no name will be recorded. This cannot be linked to you in any way and your child’s name will not be used in any publication or reports from this study.

WILLINGNESS TO PARTICIPATE: Your participation in this research is entirely voluntary and if you choose not to participate, it will not affect the services your child is to receive from the hospital. You can choose to withdraw from the research at any time.

WHAT HAPPENS TO RESEARCH PARTICIPANTS WHEN THE RESEARCH IS OVER?

The results of the scans and blood test will be communicated back to you and if need be, you will be referred to haematology clinic for further counseling and follow up. There is no conflict of interest whatsoever on the part of the researcher.

STATEMENT OF PERSON OBTAINING INFORMED CONSENY:I have fully explained this research to the respondent and given sufficient information, including the risks and benefits, to make an informed decision.

Date:………..

Signature: ………

STATEMENT OF PERSON GIVING CONSENT:I have read the description of the research. I understand that my participation is voluntary. I have known enough about the purpose, methods, risks and benefits of the research study to judge that I want my child to take part in it. I understand that my child may freely stop being part of this study at any time. I have received a copy of this consent to keep for myself.

Date: ……….

Signature: ………

For further enquiry, please:

Research’s contact Dr Agwu, Ebere Lilian

Mobile contact: 08037066641

Email address: [email protected]

LUTH Health Research Ethics Committee’s contact

Room 107, Administrative block, Lagos University Teaching Hospital [LUTH]Idi-Araba, Lagos.

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APPENDIX III B

INFORMED CONSENT FORM FOR CONTROLS

TITLE OF RESEARCH: ASSESSMENT OF STROKE RISK BY DETERMINING CEREBRAL BLOOD FLOW VELOCITIES AND OTHER SELECTED FACTORS IN CHILDREN WITH SICKLE CELL ANAEMIA IN LAGOS.

NAME AND AFFILIATION OF THE RESEARCHER: This study is being conducted by Dr Agwu Ebere, a postgraduate student of the Department of Paediatrics, Lagos University Teaching Hospital [LUTH], Lagos State.

INTRODUCTION: You must have heard of stroke before now but you may surprise that it occurs in children especially those with sickle cell anaemia. Stroke can make you not to walk, see or write.

It can even kill. For those that survive, the treatment of stroke is expensive and will reduce the quality of life for the child. The good news is that, this may be detected early before it happens. It is better to prevent than to cure. Transcranial Doppler [TCD] is a scan that will show the speed of blood flow. Knowledge of this speed can help detect those who are likely to have stroke in future.

This scan is cheap, non-invasive and can be repeated as the need arises.

PURPOSES OF THE RESEARCH: The study is to determine the speed of blood flow in the brain using transcranial Doppler in your child whose genotype is AA. If your child becomes part of this study, he or she will be one of the several children doing so. This result will be compared to those of children with sickle cell anaemia.

PROCEDURE OF THE RESEARCH: Some questions will be asked about your child. He/ She will then be examined, after which a blood sample [2mls] will be taken for tests and a scan done to check the speed of blood flow in the brain.

POTENTIAL BENEFITS: The good things that can happen with this research is that it will create awareness that stroke happen in children and assist the government in policy making and providing more scans for the brain in Nigeria. The results will be published in a journal so that others who support sickle cell can be aware.

POTENTIAL RISKS:Your child will experience slight pain when blood is taken. Emlair patch or cream 30 minutes before blood collection. Oral paracetamol will also be given afterwards.

However the scan is not invasive, not painful and there is no known harm.

122

CONFIDENTIALITY: All information that will be obtained from this study will be given code numbers and no name will be recorded. This cannot be linked to you in any way and your child’s name will not be used in any publication or reports from this study.

WILLINGNESS TO PARTICIPATE: Your participation in this research is entirely voluntary and if you choose not to participate, it will not affect the services your child is to receive from the hospital. You can choose to withdraw from the research at any time.

WHAT HAPPENS TO RESEARCH PARTICIPANTS WHEN THE RESEARCH IS OVER?

The results of the scans and blood test will be communicated back to you. It is expected to be normal but if abnormal, you will be referred to appropriate clinic for further management. There is no conflict of interest whatsoever on the part of the researcher.

STATEMENT OF PERSON OBTAINING INFORMED CONSENT: I have fully explained this research to the respondent and given sufficient information, including the risks and benefits, to make an informed decision.

Date:………..

Signature: ………

STATEMENT OF PERSON GIVING CONSENT:

I have read the description of the research. I understand that my participation is voluntary. I have known enough about the purpose, methods, risks and benefits of the research study to judge that I want my child to take part in it. I understand that my child may freely stop being part of this study at any time. I have received a copy of this consent to keep for myself.

Date: ……….

Signature: ………

For further enquiry, please:

Research’s contact Dr Agwu, Ebere Lilian

Mobile contact: 08037066641

Email address: [email protected]

LUTH Health Research Ethics Committee’s contact

Room 107, Administrative block, Lagos University Teaching Hospital [LUTH]

Idi-Araba, Lagos.

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