Certification for IRB Professionals (CIP) Exam Questions and Answers (100% Correct Answers)

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According to the Belmont Report, respect for persons usually demands that subjects... enter into research voluntarily & with adequate information According to the Belmont Report, the moral requi... rement that there be fair outcomes in the selection of research subjects, expresses the principle of: Justice A poorly designed protocol is considered unethical because... research subjects may be put at risk or inconvenienced for insufficient reason When should an IRB suspend or terminate approval of research? When it is not being conducted in accordance with the IRB's requirements A quorum for a convened IRB meeting requires the presence of... a nonscientific member What is required in research involving no more than minimal risk with children? Adequate provisions are made for assent of the child and permission of parent or guardian Federal regulations require each IRB to have written procedures for... initial & continuing review of research and for reporting its findings and actions to the investigator and the institution What are the 3 ethical principles discussed in the Belmont Report? Respect for Persons, Justice, & Beneficence An example of how the Principle of Beneficence can be applied to a study employing human subjects? Determining that the study has a maximization of benefits & a minimization of risks. The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation of which study? Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" What is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that risks are reasonable in relationship to anticipated benefits Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: Respect for Persons Which study is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? "The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male" The Belmont Principle of beneficence requires that... potential benefits justify the risks of harm A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. How long is an investigator required to keep consent documents, IRB correspondence, and research records? For a minimum of three years after completion of the study According to federal regulations, when can the IRB use expedited review on a new, proposed study? The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations 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. 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 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 we choose you as a participant, you waive the right to legal redress for any research-related injuries" 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 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: Provide potential subjects with information at the appropriate reading comprehension level. Data are made anonymous by... Destroying all identifiers connected to the data. A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? There was neither a violation of privacy nor a breach of confidentiality. Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. The Right of Subject Privacy The right of the individuals to be protected against intrusion into their personal lives or affairs The Right of Subject Confidentiality Refers to a condition in which the researcher knows the identity of a research subject, but takes steps to protect that identity from being discovered by others. 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? Securing a Certificate of Confidentiality [Show More]

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