Advantages And Disadvantages Of Individual Informed Consent

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4.3 Individual informed consent
For all biomedical research involving humans the investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the permission of a legally authorized representative in accordance with applicable law (CIOMS, 1992). Generally, the Informed consent is in two parts - the Participant Information Sheet (PIS) and the Informed Consent Form (ICF). The PIS & ICF provides the following information to the participant:
• A brief description of the study objectives in simple language (verbal & written)
• Purpose of the study
• Identity of the researchers & Institutional affiliations
• Study Procedures
• Risk & Benefit of study, including the discomfort it may entail.
• Compensation
• Confidentiality
• Rights of participants
• Advantages and disadvantages of the research
• Sources of funding
• Any possible conflicts of interest
• Future use of information
Once the participant has understood the information, the Informed Consent should be obtained in writing.
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While 60% were unwilling to sign the consent form, 70% had difficulty in understanding an elaborate consent form. These issues are discussed in details in a later segment.

Further, 80 % worried of social stigma in case confidentiality of the participant was compromised. The social intricacies led to 40% of parents/ guardians being in a state of denial / difficulty in acceptance of a special child. They believed, that they would keep the child in a special education centre for a few months and soon integrate him/ her in a normal school as ‘the problem was a temporary one.’

20% reported past negative research experience where they faced difficulties including researchers leaving without intimation, not sharing research data after completion of research work, using photographs of their child without

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