Certification For Irb Professionals (Cip) Exam Complete Questions & Answers

A waiver of the requirement for documentation of informed consent may be granted when: {Ans: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.}longitudinal study {Ans: a study that observes the same participants on many occasions over a long period of time}Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections: {Ans: Subpart B: Pregnant women, human fetuses and neonates; Subpart C: Prisoners; and Subpart D: Children}How long is an investigator required to keep consent documents, IRB correspondence, and research records? {Ans: For a minimum of three years after completion of the study}In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? {Ans: Securing a Certificate of Confidentiality}A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears