IRB Law Questions with Answers
2. How long is an investigator required to keep consent documents, IRB correspondence, and research records?3. According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations4. Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:The changes must be immediately implemented for the health and well being of the subject.5. IRB continuing review of an approved protocol must:Occur at least annually.1. A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.2. 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 to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.3. A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOTbe appropriate to provide subjects with information about missing elements of consent:A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.4. A waiver of the requirement for documentation of informed consent may be granted when:The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality
5. As part of the consent process, the federal regulations require researchers to:Provide potential subjects with information at the appropriate reading comprehension leve
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