CITI

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

When researchers plan to involve a prisoner population, which answer best describes the type of federally supported research that may be conducted?

Research that is relevant to prisoners and their conditions or situations

Which of the following is included in the Nuremberg Code:

Voluntary consent

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.

Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (HHS) regulations to ensure additional protections when this population is being considered for research.

prisioners

Which of the following studies has the LEAST potential to create group harm?

A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.

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

The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms by stigmatizing members of the group (even for individuals who do not participate in the research) is:

A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state.

Which of the following practices can be effective in minimizing group harms?

All of the above

An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study?

Assent of the child and permission of both parents are required.

The purpose of a federally supported research study is to examine the effect of scheduled cell searches on gang violence among men confined to drug treatment facilities under court order. Which of the following best describes the IRB's duties when reviewing this research?

Because this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met

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)

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

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

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

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.

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?

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

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

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

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.

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

US Public Health Service Policy

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?

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

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

Which of the following brought increased public attention to the problems with the IRB system?

Death of Research Subject (Jesse Gelsinger)

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

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

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

A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?

Honor the child's decision.

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.

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

Interviews

A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves:

No more than minimal risk to the child.

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

Occur at least annually.

When reviewing federally supported research involving prisoners, an IRB must have which of the following, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented:

One member who is a prisoner or prisoner representative

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

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

Pregnant women, prisoners, children

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

What is the Belmont Report?

The Belmont Report, released in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, provides the ethical framework for the federal regulations designed to protect human research subjects.

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.