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CITI Informed Consent SBE Answers.

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CITI Informed Consent SBE Answers




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.




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 NOT be 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.

, 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.




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.




As part of the consent process, the federal regulations require researchers to:

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