CITI Quiz

Data that does not cross state lines when disclosed by the covered entity

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

No later than the time of proposal submission

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.

A breach of confidentiality

An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:

Persons with diminished autonomy are entitled to protection

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:

Inherent controls

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

must be more detailed for disclosures that involve fewer than 50 subject records

When required, the information provided to the data subject in a HIPAA disclosure accounting...

A physician recruiting his patients to be subjects

Which is an example of a situation where deferential vulnerability might be a factor?

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

Physical control, coercion, undue influence, and manipulation

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?

The changed must be immediately implemented for the health and well-being of the subject

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:

An industry sponsor pays for the construction of a new research laboratory at the organization

An example of an institutional COI is:

For a minimum of three years after completion of the study

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

US Public Health Service Policy

Issued in 1974, 45 CFR 46 raised to regulatory status:

Effects of findings on other family members

When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity

Recruiting into research

De-identified

As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH-funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are:

Disclose their potential COI and may answer questions, but recuse themselves from voting

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

Occur at least annually

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:

An organizational IRB or Privacy Board ("Privacy Officer"), or security official ("Security Officer"), depending on the issue

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

The research could not practicably be carried out without the waiver of consent

In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which of the following:

Respect for Persons

Informed consent is considered an application of which Belmont principle

Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research

Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified?

Cognitive or communicative vulnerability

The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:

Established the National Commission

The National Research Act of 1974

There may be bias by the peer reviewer as to the area of research

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

Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Pregnant women, prisoners, children

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:

No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification

Investigator A has biological specimens that are coded and linked to identifiers of the source individuals. Investigator A provides the specimens to Investigator B but does not provide the individual identifiers. Investigator B agrees not to re-identify the source individuals. Is Investigator B's research using the biospecimens human subjects research according to the definition of human subjects research in the federal regulations?

To all human subjects research that uses PHI without an authorization from the data subject

The HIPAA "minimum necessary" standard applies...

Prisoners may not be used to conduct research that only benefits the larger society

The use of prisoners in research is a concern under the Belmont principle of Justice because:

Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.

Which is true of inducements in research?

Respect for Persons, Beneficence, Justice

Which of the following are the three principles discussed in the Belmont Report?

The researcher will not be interacting/intervening with subjects and the data has no identifiers

Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?

Determining that the study has a maximization of benefits and a minimization of risks

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

Understanding the purpose and context of a specific study is critical in determining the risk involved

Which of the following statements is accurate in determining subject risk involved in a genetic study:

Realization that ethical abuses are not limited to the Nazi regime

Which of the following was the result of the Beecher article?