CITI questions correctly answered latest update 2023

CITI questions correctly answered latest update 2023Which of the following studies would need IRB approval? Studies collecting identifiable information about living individuals. Identify one way faculty researchers can possibly avoid undue influence of student subjects? Avoid recruiting their own students in the research Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. - Protecting the rights and welfare of human subjects.- Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.- Reviewing subject recruitment materials and strategies. Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. - Faculty Advisor/Research Mentor - IRB Office In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________. Common Rule Which of the following is 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 and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? Respect for Persons, Beneficence, Justice The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: Persons with diminished autonomy are entitled to protection. Your informed consent form must describe _______. All foreseeable risks and discomforts. A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review? Convened Review The Belmont principle of beneficence requires that: Risks to subjects are reasonable in relation to anticipated benefits. An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle? Justice According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: Justice A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of: Respect for persons 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 A medical record is an example of: Private information A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of: Public behavior According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or: Obtains, uses, studies, analyzes, or generates identifiable private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. According to the federal regulations, which of the following studies meets the definition of research with human subjects? An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Officials of the institution may overrule an IRB approval. According to the federal regulations, research is eligible for exemption, if: The research falls into one of eight categories of research activity described in the regulations. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? Prisoners According to federal regulations, 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. Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Must occur within 12 months of the approval date. What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture. A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: 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 of the following would be most helpful: Obtain a waiver of documentation of informed consent. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure Identify the example of when situation and time are key to assessing risk of harm in a research study: Asking women if they have had an abortion 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 if you choose to take part, 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. 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. When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? The researcher cannot control what participants repeat about others outside the group. Data are made anonymous by Destroying all identifiers connected to the data. 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. 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 Which of the following statements about prison research is true? Researchers may study the effects of privile