How are the rights and welfare of the potential subjects preserved?
Rights and welfare of potential subjects are maintained by ensuring voluntary participation, obtaining informed consent, maintaining confidentiality of a person’s enrollment and data created, and informing subjects of the risks and benefits of study participation. This is addressed by: • The recruitment plan is approved by the IRB. • Screening and enrollment procedures adhere to IRB approved guidelines. • Subjects are not recruited from one study cohort to be in another concurrently. • If advertisement is used (poster, newspaper) to obtain potential subjects, it should adhere to the IRB guidelines, be IRB approved and contain the name & address of the PI, a summary of the purpose of the research, description of eligibility criteria, clear description of incentives to participate if any (eg. money, free treatment), location of the research and the name & telephone number of the person to contact for further information. • Voluntary participation- • Incentives do not influence an unwilli
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- How are the rights and welfare of the potential subjects preserved?