citi training and belmont report|2023 LATEST UPDATE|GUARANTEED SUCCESS

Three principles of Belmont Report Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest TRUE The Belmont Report Respect for Person 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... "Practice" and "Research" The Belmont Report The Principle of Justice 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 FALSE Students in Research The history of ethical regulations in human subjects research began with the Nuremberg Code Nuremberg Code Human subjects research guidelines and regulations Year of the Nuremberg Code 1949 Additional resources regarding IRB approval process Faculty advisor/Research Mentor IRB office Human subjects research websites What element must be included in an informed consent? All foreseeable risks and discomforts Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB? If the study qualifies for EXEMPTION Another name for the "Exempt" status the Common Rule stated in Title 45 Part 46 Subpart A How can faculty researchers avoid coercion of student subjects? 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. 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. 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 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 Not Human Subjects Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components) " through intervention or interaction with the individual 2. identifiable private information" Name the 3 responsibilities the IRB is charged with 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 False T/F IRB's do not review manuscripts prior to submission for publication True DHHS FDA 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 The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male The Tuskegee Study relates to which Belmont principle? 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: 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: Justice How is the principle of beneficence applied to a study involving human subjects? 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 Yes Human subject study or not? The study of a list with deceased passengers 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? No: 'what' question rather than 'who' question Human subject study or not? Conducting linguistic analysis of comments posted on a public blog 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 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 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 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 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 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 No: doesn't involve interactions w/ living individuals nor collection of private identifiable data Human subject study or not? An economic feasibility study 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: identifiable PRIVATE information (Public info does not meet criteria) Subpart of DHHS regulations provides additional protections for which vulnerable populations? 1. Pregnant women 2. Fetuses 3. Neonates 4. Prisoners Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations? 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: 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: -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...? Must occur within 12 months of the approval date (even if no additional risks have been identified) Continuing review process must include: -unanticipated problems -number of subjects accrued -recent relevant literature -copy of current consent form