IRB
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.
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:
Both the magnitude (or severity) and the probability (or likelihood) of harm.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
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.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
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.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
Disclose their potential COI and not participate in any action
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.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
No later than the time of proposal submission
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
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
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
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.
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.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
Data are made anonymous by
Destroying all identifiers connected to the data.
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
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.
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.
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.
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
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.
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.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
Census data (the final report as published by the Census Bureau) is an example of:
Public information
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 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.
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.
