Certification for IRB Professionals (CIP) Exam

Certification for IRB Professionals (CIP) Exam According to the Belmont Report, respect for persons usually demands that subjects... - ANS enter into research voluntarily & with adequate information According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - ANS Justice A poorly designed protocol is considered unethical because... - ANS research subjects may be put at risk or inconvenienced for insufficient reason When should an IRB suspend or terminate approval of research? - ANS When it is not being conducted in accordance with the IRB's requirements A quorum for a convened IRB meeting requires the presence of... - ANS a nonscientific member What is required in research involving no more than minimal risk with children? - ANS 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... - ANS 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? - ANS Respect for Persons, Justice, & Beneficence An example of how the Principle of Beneficence can be applied to a study employing human subjects? - ANS 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? - ANS Harvard "Tastes, Ties, and Time (T3)" study ()" What is an example of how the principle of beneficence is applied to a study involving human subjects? - ANS 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: - ANS 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? - ANS "The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male" The Belmont Principle of beneficence requires that... - ANS 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? - ANS 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? - ANS 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? - ANS The study involves no more than minimal risk and meets one of the