CITI Certification Answered with complete solution (latest updated version)

A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of: - ANSWER Public information A researcher is interest ...

A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of: - ANSWER Public 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: - ANSWER Public behavior A medical record is an example of: - ANSWER private information According to the federal regulations, which of the following studies meets the definition of research with human subjects? - ANSWER A study of twenty 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 a three-month period. 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: - ANSWER Obtains, uses, studies, analyzes, or generates identifiable private information. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? - ANSWER prisoners According to the federal regulations, research is eligible for exemption, if: - ANSWER The research falls into one of eight categories of research activity described in the regulations. Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? - ANSWER Officials of the institution may overrule an IRB approval. Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: - ANSWER Must occur within 12 months of the approval date. According to federal regulations, the expedited review process may be used when the study procedures pose: - ANSWER No more than minimal risk and the research activities fall within regulatory categories identified as eligible. 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: - ANSWER Experience emotional or psychological distress. Identify the example of when situation and time are key to assessing risk of harm in a research study: - ANSWER Asking women if they have had an abortion The primary purpose of a Certificate of Confidentiality is to: - ANSWER Protect identifiable research information from compelled disclosure. A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: - ANSWER Both the magnitude (or severity) and the probability (or likelihood) of harm. 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: - ANSWER Obtain a waiver of documentation of informed consent. 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? - ANSWER 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? - ANSWER 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.