Citi Training

What is the term for management controls that are built in to a research study (for example, independent data analysis)?

An example of an individual financial COI is:

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

The FDA regulations governing disclosure of individual COIs require:

The COI management plan aims to:

An example of an institutional COI is:

An example of an individual financial COI is:

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.

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

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:

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:

A medical record is an example of:

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

According to federal regulations, the expedited review process may be used when the study procedures pose:

According to the federal regulations, research is eligible for exemption, if

Continuing review of an approved and ongoing protocol

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

The primary purpose of a Certificate of Confidentiality is to:

Additional safeguards that may be included in a social and behavioral study may include:

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:

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Identify the example of when situation and time are key to assessing risk of harm in a research study:

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?

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?

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 waiver of the requirement for documentation of informed consent may be granted when:

As part of the consent process, the federal regulations require researchers to:

Privacy and Confidentiality - SBE Quiz

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?

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

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?

Data are made anonymous by

Research with Prisoners - SBE Quiz

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)?

One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should NOT be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?

A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:

Which of the following statements about prison research is true?

A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:

Research with Children - SBE Quiz

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

According to Subpart D, research with children may be eligible for exemption when:

The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:

Research in Public Elementary and Secondary Schools - SBE Quiz

According to federal regulations, "children" are defined as:

Parental notification, in lieu of active parental permission, is allowed when:

According to Subpart D, which of the following research activities with children would qualify for an exemption?

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

If research in a private school is directly funded by the Department of Education, then:

International Research - SBE Quiz

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee as well as the Big State University IRB?

PPRA gives parents some level of control over their child's:

The age of majority in international research is determined by the

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

What procedures must be described in an agreement called an "assurance of compliance" with OHRP?

Which of the following activities constitutes engagement in research?

International Studies Quiz

Which of the following is a commonly used resource for international ethical guidelines for human subjects research?

Researchers designing studies to be conducted in host countries outside the U.S. should:

Internet-Based Research - SBE Quiz

In most cases, a U.S. researcher affiliated with an academic institution, proposing to conducted funded research outside of the U.S., must have the approval of which of the following entities:

The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?

Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?

Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?

Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?

Research and HIPAA Privacy Protections Quiz

A HIPAA authorization has which of the following characteristics:

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

Vulnerable Subjects - Research Involving Workers/Employees Quiz

The HIPAA "minimum necessary" standard applies...

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, except:

HIPAA's protections for health information used for research purposes...

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:

When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.