CITI Trainings & Plaigerism
According to the federal regulations, which of the following studies meets the definition of research with human subjects? (a) A professor at Little City University is writing a biography about Ruth Bader Ginsberg and conducting oral histories with all of Ruth Bader Ginsberg's friends, family members, and colleagues. (b) A faculty member is conducting a survey of mentoring practices within the department to identify strategies to improve the mentoring program within their department (c) A professor is conducting interviews with parents of toddlers with developmental disabilities to identify how family perception of family burden relates to how often parents are implementing intervention strategies at home (d) A researcher gets deidentified data from a large healthcare system to identify frequency of emergency room visits for Long COVID-19 patients
(c) A professor is conducting interviews with parents of toddlers with developmental disabilities to identify how family perception of family burden relates to how often parents are implementing intervention strategies at home
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.
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.
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.
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.
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
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
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
Public Information
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.
What is the common rule?
every institution that is conducting research with federal support must enter into an agreement called an "assurance," an assurance identifies the regulations for protecting research subjects that the institution must abide by.
Which of the following studies meet the definition of research with human subjects but are exempt from the provisions of the Common rule? (a) Public Observation of Trader Joe's Shoppers Pumpkin Spice Item Selection Frequency (b) Secondary data analysis of identifiable data (c) Research with only interview or survey procedures (d) Health intervention study measuring body composition (e) All of the above (f) A, B, and C only
f. A, B and C only
