CITI TRAINING QUESTIONS WITH ANSWERS 2022

CITI TRAINING QUESTIONS WITH ANSWERS 2022 Three principles of Belmont Report - ANS Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - ANS MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - ANS TRUE The Belmont Report Respect for Person - ANS Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent) The Belmont Report defines and delineates... - ANS "Practice" and "Research" The Belmont Report The Principle of Justice - ANS Research benefit and burden distribution and that selection of subjects is fair. T/F The Belmont report describes the necessity to effectively manage conflicts of interest - ANS FALSE Students in Research The history of ethical regulations in human subjects research began with the - ANS Nuremberg Code Nuremberg Code - ANS Human subjects research guidelines and regulations Year of the Nuremberg Code - ANS 1949 Additional resources regarding IRB approval process - ANS Faculty advisor/Research Mentor IRB office Human subjects research websites What element must be included in an informed consent? - ANS All foreseeable risks and discomforts Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB? - ANS If the study qualifies for EXEMPTION Another name for the "Exempt" status - ANS the Common Rule stated in Title 45 Part 46 Subpart A How can faculty researchers avoid coercion of student subjects? - ANS Avoid using their own students in their research Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information. - ANS Exempt Review category 2 Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects. - ANS Full Board Review Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal - ANS Expedited review Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a business - ANS Not Human Subjects Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components) - ANS " through intervention or interaction with the individual 2. identifiable private information" Name the 3 responsibilities the IRB is charged with - ANS 1. Protecting the rights and welfare of human subjects 2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed 3. Reviewing subject recruitment materials and strategies T/F IRB's investigate scientific misconduct - ANS False T/F IRB's do not review manuscripts prior to submission for publication - ANS True DHHS FDA - ANS Depts. IRB's review for current policies -Department of Health and Human Services -Food and Drug Administration Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately 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 Tuskegee Study relates to which Belmont principle? - ANS The principle of beneficence: Potential benefits justify the risks of harm 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 Belmont Report 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 How is the principle of beneficence applied to a study involving human subjects? - ANS Ensuring that risks are reasonable in relationship to anticipated benefits. Human subject study or not? Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression - ANS Yes Human subject study or not? The study of a list with deceased passengers - ANS No:Human subject is a living individual Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases? - ANS No: 'what' question rather than 'who' question Human subject study or not? Conducting linguistic analysis of comments posted on a public blog - ANS Not: involves neither interaction with individuals nor collecting private identified info Human subject study or not? A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledge - ANS Yes: humans Human subject study? A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors - ANS Yes: Interacting w/ living individuals. Human subject study or not? Questioning a superintendent of schools to acquire data about the ethnic composition of a school - ANS No: it is an "about what" question rather than "about whom" question Human subject study or not? Study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over 3-month period - ANS Yes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation Human subject study or not? Info collected by play ground designer - ANS No: does not involve info about human subjects even though there is interactions between designer and school staff. Human subject study or not? An analysis of aggregate data - ANS No: doesn't involve interactions w/ living individuals nor collection of private identifiable data Human subject study or not? An economic feasibility study - ANS No: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer "about what" ? rather than "about whom" ? According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or: - ANS identifiable PRIVATE information (Public info does not meet criteria) Subpart of DHHS regulations provides additional protections for which vulnerable populations? - ANS 1. Pregnant women 2. Fetuses 3. Neonates 4. Prisoners Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations? - ANS 1. elderly 2. students 3. for persons whose decision-making capabilities are impaired The expedited review process may be used when the study procedures pose: - ANS No more than minimal risk and the research activities fall within regulatory categories identified as eligible The expedited review process may NOT be used when the study procedures pose: - ANS -more than minimal risk, even if the subjects are adults, -the sponsor is in a hurry -the study replicates previously approved research Continuing review of an approved and ongoing protocol...? - ANS Must occur within 12 months of the approval date (even if no additional risks have been identified) Continuing review process must include: - ANS -unanticipated problems -number of subjects accrued -recent relevant literature -copy of current consent form T/F Officials of the institution may overrule an IRB approval - ANS True, however no one may overrule if an IRB disapproved a protocol An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate meausre will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: - ANS Experience emotional or psychological distress If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful? - ANS Obtain a waiver of documentation of informed consent The primary purpose of a Certificate of Confidentiality is to: - ANS Protect identifiable research info from compelled disclosure Certificates of Confidentiality protect sensitive info provided by research subjects from: - ANS civil, criminal, or administrative subpoena T/F Risk should be evaluated solely by the magnitude or severity of expected harm, not probability - ANS False: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered. Risks are specific to: - ANS Time, situation, and culture A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will: - ANS Not affect future care T/F The fact that a therapist has access to her clients' records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assent - ANS False: S/he needs both parental permission & child assent T/F School authority's permission to conduct research replaces the need for permission and assent - ANS False T/F Children's right to choose cannot be overridden in the pursuit of an indeterminate community interest - ANS True, it cannot be overridden Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the study - ANS informing participants they were assigned to a study based on undesirable or unflattering physical characteristics for example, or anything that may be judged negative or distressing would be considered appropriate criterion