CITI

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

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:

Persons with diminished autonomy are entitled to protection.

Which of the following is included in the Nuremberg Code:

Voluntary consent

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

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

An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk.

This is an unanticipated problem requiring notification to the IRB and FDA.

Which choice best describes the purpose of most pharmacogenomic research?

To evaluate how the genomes of infectious agents impact the efficacy of certain antibiotics

Which choice best describes the purpose of most pharmacogenomic research?

To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs

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:

A breach of confidentiality

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

Occur at least annually.

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?

Physical control, coercion, undue influence, and manipulation

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

Researcher

A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research?

Breach of confidentiality from the focus group subjects (therapists)

HIPAA includes in its definition of "research," activities related to:

Development of generalizable knowledge.

Which is true of inducements in research?

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.

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

Inherent controls

Which of the following is considered a SBR data collection method?

Interviews

Which of the following most accurately describes the risks associated with SBR?

Less predictable, more variable, and less treatable than physical harms

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

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

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:

The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.

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

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

An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk.

There was no need to inform the IRB because this was a screening procedure.

Housekeeping employees of the medical center were recruited for a federally funded study of blood pressure, blood count levels, infectious disease history, and job stress. The interviews and blood tests were conducted in a private location not affiliated with the study center. Follow-up interviews were conducted in the same location. The study coordinator stopped at the cafeteria on her way back to the study office after the second study visit for the last three study subjects and lost the three file folders. Records of one subject indicated he had a history of a sexually transmitted disease and another had recently been treated for tuberculosis. The subjects were notified of the loss. Following this event, the IRB approved a protocol change requiring that all records be transmitted electronically to the study office using the medical center's secure network.

This is an unanticipated problem and not an adverse event.

The HIPAA "minimum necessary" standard applies...

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

An example of an institutional COI is:

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

Recruiting into research ...

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

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:

Cognitive or communicative vulnerability

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

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

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:

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

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of

Economic vulnerability

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?

Effects of findings on other family members

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?

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

A general requirement for the informed consent form is that it may not 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?

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

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

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?

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

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 may answer questions, but recuse themselves from voting

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

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

A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?

Confidentiality of the individual subject's responses

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

For a minimum of three years after completion of the study

Under HIPAA, a "disclosure accounting" is required:

For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.

Which choice is the best definition of "genetic determinism?"

Genes are primarily responsible for human traits, including health, behavior, and disease

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:

Health insurance and employment discrimination

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

Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects?

Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:

Medical vulnerability

Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens?

Original signed consent documents include provisions for recontacting subjects

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

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

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

Realization that ethical abuses are not limited to the Nazi regime

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?

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.

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

Respect for Persons, Beneficence, Justice

An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip.

Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Situational cognitive vulnerability

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

Supplement those of the Common Rule and FDA.

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

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

A HIPAA authorization has which of the following characteristics:

Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

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

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

A study requires that each subject be given two study drugs. The first study drug is given on Day 1. A second study drug is given on Day 7 to counteract the toxicity of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone.

This is an unanticipated problem that does not include an adverse event.

A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs.

This is an unanticipated problem, which resulted in an adverse event.

A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. This event required revision of the informed consent form to disclose the higher rate. A change in the eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be reconsented.

This is an unanticipated problem.

The purpose of informed consent is:

To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.

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?

Yes, because Investigator A retains the identifiers and therefore the specimens are identifiable.