IMPACTOS DE LA MIGRACION

Title of the Research: DOPPLER ECHOCARDIOGRAPHIC ASSESSMENT OF PULMONARY ARTERY PRESSURE IN CHILDREN WITH SICKLE CELL ANAEMIA IN STEADY STATE AT THE LAGOS STATE UNIVERSITY TEACHING HOSPITAL, IKEJA

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Name and affiliation of researcher of applicant: This is a study by Dr Lamina Moriam Omolola of the Lagos State University Teaching Hospital, LASUTH, Ikeja.

Sponsor of research: self-sponsored

Purpose of research: The purpose of this research is to determine the prevalence of pulmonary artery pressure among children with sickle cell anaemia at LASUTH.

Procedure of the research, what shall be required of each participant and approximate total number of participants that would be involved in the research: The researcher intends to perform an echocardiography and conduct some blood laboratory investigations on sickle cell anaemia patients at steady state as well as stable children with Hb genotype AA aged one to twelve years attending the sickle cell Out Patient clinic and General Out Patient clinics of LASUTH. A total of 240 patients would be involved in the study (120 sickle cell anaemia patients, 120 patients with Hb AA genotype). In total 240 patients will be recruited for this study. The investigations would be performed you at contact after a consent has been given by you. You may be required to be seen at the next follow up clinic day.

Expected duration of research and participant(s) involvement: You are expected to be involved in this study for not more than two clinic visits to the hospital.

Risk(s): There may be some slight pain at the site of blood prick while taking blood samples for investigations during this study but this will disappear away quickly.

Costs to the participants, if any, of joining the research: Your participation in this research will not cost you anything

Benefits: The goal of this research is to find ways of determining the complication of pulmonary artery hypertension in sickle cell anaemia patients and to ensure prompt treatment before complications set in.

Confidentiality: All information from this study will be kept confidential. No names shall be recorded or published

Voluntariness: Your participation in this research is entirely voluntary.

Alternatives to participation: If you choose not to participate in the study, this will not affect your treatment in the hospital in any way.

I have fully explained this research to ……….

And have given sufficient information, including about risks and benefits, to make an informed decision.

DATE: ………

SIGNATURE:………

NAME:……….

Statement of the person giving consent:

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I have read the description of the research or have had it translated into language I understand. I have also talked it over with the doctor to my satisfaction. I understand that my participation is voluntary. I know enough about the purpose, methods, risks and benefits of the research study to judge that I want to take part in it. I understand that my participation is voluntary. I know enough about the purpose, methods, risks and benefits of the research study to judge that I want to take part in it. I understand that I may freely stop being part of this study at any time. I have received a copy of this consent form and additional information sheer to keep for myself.

DATE: ………

SIGNATURE: ……….

NAME: ………..

WITNESS SIGNATURE (If applicable): ……….

WITNESS NAME (If applicable): ………..

Contact information of researcher, Institutional HREC and Head of Institution: If you have any question about your participation in this research, you can contact the principal investigator Dr Lamina Moriam Omolola at the Department of Paediatrics, Lagos State University Teaching Hospital, LASUTH, Ikeja. Telephone number 08024585163.

Ethics committee assigned approval number: ………

Ethics committee approval date: ……….

Duration of ethics committee approval: ……….

Due inducements: The cost of all investigations will be borne by the researcher.

Consequences of participant’s decision to withdraw from research and procedures for orderly termination of participation: You can choose to withdraw from the research at any time. Please note that some of the information that has been obtained about you before you choose to withdraw may have been modified or used in reports and publications. This cannot be withdrawn anymore. However the researcher promises to make good faith effort to comply with your wishes as much as is practicable.

Modality of providing treatments and action(s) to be taken in case of injury or adverse event(s): If you suffer any injury which is very unlikely during the course of this study, you will be treated at the Lagos State University Teaching Hospital and all costs of treatment will be borne by the researcher.

What happens to research participants when the research is over: Patients found to have developed a raised pulmonary artery hypertension during the study will be referred to the paediatric respiratory unit and recommended for prompt treatment.

Any apparent or potential conflict of interest: None Statement of person obtaining informed consent:

NAME………

SIGNATURE………..

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APPENDIX 2