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75 APPENDIX I INFORMED CONSENT
TITLE:
CD4+ T-LYMPHOCYTE, GAMMA-INTERFERON AND INTERLEUKIN-4 AND ULTRASONOGRAPHIC SPLENIC SIZE IN HOMOZYGOUS SICKLE CELL ANAEMIA PATIENTS
NAME OF APPLICANT:
This study is being conducted by Dr Omotola T Ojo Department of Haematology, University College Hospital, Ibadan.
SPONSOR OF RESEARCH: Self.
PURPOSE OF RESEARCH:
T o assess cellular immunity using CD4 T lymphocyte count, serum IFN-γ and IL-4 levels in patients with sickle cell anaemia. These levels will be correlated with spleen sizes.
PROCEDURE OF THE RESEARCH: A total of 90 consenting people, comprising of 45 patients with sickle cell anaemia (cases) who present at haematology clinic and 45 people whose haemoglobin electrophoresis is A(control) would be selected by consecutive sampling method respectively. The participants’ will be the researching physician using an interviewer administered questionnaire. The physical examinations, and systemic examinations, will be carried out by the physician. Voluntary pre-testing counseling will be done for HIV screening before the blood sample will be obtained for CD4, interferon gamma and interleukin-4 analysis; this is to prevent bias on the results. Abdominal ultrasound will be done thereafter.
EXPECTED DURATION OF RESEARCH AND OF PARTICIPANTS’
INVOLVEMENT: The study is expected to be over a period of three months, however you will only be interviewed and examined once during this period. The questionnaire is expected to be completed in 10-15 minutes and you will be examined for about 10 minutes.
RISK(S): You will not be at any risk by participating in this study. The routine examination will be carried out by a female physician with a male chaperon as need arise and your blood sample will be collected after which abdominal ultrasound will be done
COST(S) TO THE PARTICIPANTS, IF ANY, OF JOINING THE RESEARCH: Your participation in this research will not cost you anything.
BENEFIT(S): The goal of this study is to assess an aspect of immune function in patients with sickle cell anaemia; the result might be useful in the course of the disease for effective management of patient with sickle cell anaemia.
CONFIDENTIALITY: All the information collected from this study will be coded and you are not required to write your names. This cannot be linked to you in any way and your name or identifier will not be in any publication or reports from this study.
VOLUNTARINESS: Your participation on this study is entirely voluntary.
ALTERNATIVES TO PARTICIPATION: If you choose not to participate, this will not affect your treatment in this hospital in any way.
DUE INDUCEMENT(S): You will not be paid any fees for participating in this research.
You will be adequately informed of any abnormality detected and measures will be taken to ensure that appropriate management is instituted.
CONSEQUENCES OF PARTICIPANTS’ DECISION TO WITHDRAW FROM RESEARCH AND PROCEDURE FOR ORDERLY TERMINATION OF PARTICIPATION: You can also choose to withdraw from the research at anytime. WHAT HAPPENS TO RESEARCH PARTICIPANTS AND THE COMMUNITIES WHEN
76
THE RESEARCH IS OVER: You will be informed on the outcome of the research through a subsequent follow-up clinic visits. During the course of this research, you will be informed about any information that may affect your health.
STATEMENT OF PERSON OBTAINING INFORMED CONSENT: I have fully explained this research to ______________________________________________ and have given sufficient information, including about risk and benefits, to make an informed decision.
DATE:__________________________ SIGNATURE:______________________________
NAME:___________________ ___________
STATEMENT OF PERSON GIVING CONSENT: I have read the description of the research or have had it translated into the 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, method, 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 to keep for myself.
DATE______________SIGNATURE/THUMBPRINT______________________________
NAME_________________________________
WITNESS’ SIGNATURE (if applicable)____________________________________
WITNESS’ NAME (if applicable)______________________________________
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APPENDIX II
PARTICIPANT QUESTIONNAIRE