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and platelet is a common feature of the disease. There is no direct financial or other benefit for the participant of the study. However, all the investigations will be done free of cost to the patients and; the drugs (A) or (B) will be provided free. Treatment of any side effect will also be provided free of cost. Sponsor of the study will bear the cost of drugs, investigations and treatment of side effects related to the study drugs. Right of refusal to participate and withdrawal You are free to choose to participate in the study. You may refuse to participate without any loss of benefit which you are otherwise entitled to. You child will receive the same standard care and treatment which is considered best for him irrespective of your decision to participate in the study. You may also withdraw any time from the study without any adverse effect on management of your child or any loss of benefit which you are otherwise entitled to. You may also refuse to answer some or all the questions if you don’t feel comfortable with those questions. Confidentiality The information provided by you will remain confidential. Nobody except principal investigator will have an access to it. Your name and identity will also not be disclosed at any time. However the data may be seen by Ethical review committee and may be published in journal and elsewhere without giving your name or disclosing youridentity. Available Sources of Information If you have any further questions you may contact Principal Investigator (Dr. SAK), department of pediatrics at Aga Khan University on following phone number 486xxxx AUTHORIZATION I have read and understand this consent form, and I volunteer to participate in this research study. I understand that I will receive a copy of this form. I voluntarily choose to participate, but I understand that my consent does not take away any legal rights in the case of negligence or other legal fault of anyone who is involved in this study. I further understand that nothing in this consent form is intended to replace any applicable Federal, state, or local laws. Participant’s Name (Printed orTyped): Date: Participant’s Signature or thumb impression: Date: Principal Investigator’s Signature: Date: Signature of Person Obtaining Consent: Date: FIG. 1.2 Sample Informed Consent for a Clinical Trial of a Drug. From Sample Informed Consent for a Randomized Clinical Trial of a Drug. (n.d.) Aga Khan University. Retrieved from http://www.a sampleconsentforms.aspx 5 BOX 1.2 Informed Consent Checklist: Basic Items H2: Beneficence ELO: Define beneficence and how it is determined in drug research. Beneficence is the duty to protect research subjects from harm. It involves assessing potential risks and possible benefits and ensuring the benefits are greater than therisk. The risk-benefit ratio is one of the most complex problems faced by the researcher. All possible consequences of a clinical study must be analyzed and balanced against the inherent risks and the anticipated benefits. Physical, psychological, and social risks must be identified and weighed against the benefits. A requirement of the Department of Health and Human Services (DHHS) is that institutional review boards (IRBs) determine that risks to subjects be reasonable in relation to the anticipated benefits, if any, for subjects. No matter how noble the intentions, the calculation of risks and benefits by the researcher cannot be totally accurate or comprehensive. H2: Justice ELO: Describe what justice means in using human subjects in drug research. Justice requires that the selection of research subjects be fair. Research must be conducted so that the distribution of benefits and burdens is equitable (i.e., research subjects reflect all social classes and racial and ethnicgroups). H1: OBJECTIVES AND PHASES OF PHARMACEUTICAL RESEARCH TLO: Describe the objectives of each phase of human clinical experimentation. The FDA requires clinical research to follow the Good Clinical Practice (GCP) Consolidated Guideline, an international ethical and scientific quality standard for designing, conducting, monitoring, auditing, recording, analyzing, and reporting clinical
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