Informed Consent

2ND

MEDETHICS Subject CONSDENT FORM Topic DR. MARIANO Lecturer SHIFTING/ AUG 22,2008 Shifting /Date OC-OC Group Trans group

CONSENT FORM DEFINITION OF CONSENT FORM & INFORMED CONSENT I am being asked to participate and to allow my child to participate in a clinical research study. Clinical research is the study of human diseases in an a attempt to improve diagnosis and treatment of certain conditions. In order to decide, whether or not I should agree for me and my child to be part of this research study, I should understand enough about its risks and benefits to make a judgement. This process is called informed consent. This consent gives information about the research study, which will be discussed with me. Once I understand this study, I will be asked to sign this form if I wish for my child and me to participate. I will have a copy for my own and my child’s record. PURPOSE OF THE STUDY I understand that Dr.________of the Dept. of _______Section____of the College of Medicine of PLM is doing a study on the use of a drug called recombinant human granulocyte colony stimulating factor(rh-GCSF). I undrrstand that this new________may decrease the incidence of sepsis and thereby decrease the chances of death from sepsis. For this to be studied, Dr.___needs to test this drug on a number of premature infants weighing less than 1550grams. I understand that since my baby is premature and weight less than 1500gm, we are being asked to take part in this study, because this study is meant to benefit premature babies, I understand that this study cannot be done on any other population. DESCRIPTION OF THE REASEARCH PROCEDURE If my baby and I take part in this study, my baby will receive either rh-GCSF or a placebo aside from receiving standard medications and treatment needed in the treatment of my baby’s condition. The occurrence of sepsis other infections and death among all babies who received rh-GCSF will be compared with those who did not receive rh-GCSF. I understand that the rh-GCSF medications will be provided at no cost to me. POSSIBLE RISKS I understand that my baby will be exposed to the risks and receiving rh-GCSF. This includes anemia and thrombocytopenia (low platelets) I understand that babies are monitored daily and if my baby should develop low platelet, proper treatment which includes platelet transfusions will be given to my baby. RIGHT TO REFUSE AND WITHDRAW I understand that I may refuse to participate in this study or withdrawn my baby from the study without any change in the care given to my baby by the doctors. PRIVACY AND CONFIDENTIALITY OF RECORDS I understand that information learned from this study will be kept confidential to the extent permitted by law, except as explained in this paragraph. Information obtained from this study may be published or given to other people doing research, but neither my name nor my child’s name will be mentioned. I understand that in the event or injury resulting from participation in this study, no compensation and no free medical treatment nor imbursement is offered by PLM or any other parity involved in this study. Any questions I have asked about this study have been answered to my satisfaction. If I have any questions later on, nor if I believe my child has suffered injury as a result of participating in this study, I may call_____ who is a member of the ethics review of the hospital. By signing this document, I am saying that o have read it, understand it and that I agree that my child and I will participate in this study.

DATE:______________________ PARENT____________________

SIGNATURE

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WITNESS:___________________ PHYSICIAN__________________

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MARY YVETTE ALLAIN TINA RALPH SHERYL BART HEINRICH PIPOY KC JAM CECILLE DENESSE VINCE HOOPS CES XTIAN LAINEY RIZ KIX EZRA GOLDIE BUFF MONA AM MAAN ADI KC PENG KARLA ALPHE AARON KYTH ANNE EISA KRING CANDY ISAY MARCO JOSHUA FARS RAIN JASSIE MIKA SHAR ERIKA MACKY VIKI JOAN PREI KATE BAM AMS HANNAH MEMAY PAU RACHE ESTHER JOEL GLENN TONI

Subject: Topic: Page 2 of 2 QUESTIONS: (1/2 crosswise yellow paper) 1) What are the provisions lacking in the IC form? 2) Who is responsible for making sure this IC form is prepared adequately? 3) How can these provisions be improved?

4)

Does the subject participant have a choice not to join in this study after reading this protocol? Why or why not?