CITI Training

Which of the following is true regarding an acknowledgments section?

The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship.

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

A conflict of conscience

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

Which of the following is most likely to create a poor relationship between a mentor and a trainee?

A mentor who recruits trainees merely for the mentor's own career advancement.

If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as:

A personal conflict of interest.

Which of the following statements is true regarding the responsibilities of a reviewer?

A reviewer's conflict of interest should be disclosed to the journal editor or grant agency.

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.

If a researcher creates the idea for a project and is not listed in the preferred author order position on resulting publications, is this considered to be research misconduct under federal policy?

No; instead it is a type of authorship dispute.

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

Which type of inappropriate practice most likely occurred if a researcher takes credit for someone else's idea and does not acknowledge the original source?

Plagiarism

In the research context, the term validity most commonly refers to:

Whether operationalized terms actually measure what they purport to measure.

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

An example of an institutional COI is:

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

What is the most appropriate course of action for a trainee who has a problem with a mentor?

After trying to communicate directly with the mentor, the trainee should seek advice from a senior person that the trainee trusts.

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:

All of the above

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

All of the above

The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:

Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.

The FDA regulations governing disclosure of individual COIs require:

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

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.

A reviewer's main responsibility is to:

Behave professionally.

Which of the following statements is true regarding authorship practices?

Both within and between disciplines, practices differ with regard to who should be included as an author, and in what order they should be listed.

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)

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

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 a responsibility of each author?

Confirming that data have been accurately presented in the paper.

The main reason that the Royal Society of London developed the modern form of peer review was to:

Control the quality of published papers.

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.

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

Death of Research Subject (Jesse Gelsinger)

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

Development of generalizable knowledge.

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

Which of the following most accurately describes good mentoring practice?

Encouraging trainees to receive mentoring from a collection of individuals.

Which of the following statements is true concerning data selection?

Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.

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.

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.

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.

What is the main function of a Technology Transfer Office with respect to collaborative research?

It helps collaborative researchers to commercialize their work.

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

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution's financial or non-financial interests could interfere with its research activities.

Question Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one's primary employer.

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

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

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

Researcher

Which of the following is true regarding data sharing and stewardship?

Researchers who receive federal funding may have to adhere to a data sharing requirement.

Which of the following statements is true regarding the responsibilities of reviewers?

Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed.

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

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.

What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to?

The research team should discuss the issue early on and while the project is ongoing.

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

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.

Which of the following is included in the Nuremberg Code:

Voluntary consent

In any collaboration, data ownership is typically determined by:

The type and source of funds used to support the project.

The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because:

Their removal lessens the chance that bias will affect the review process​.

Which of the following is the most effective strategy for preventing research misconduct?

Good mentoring

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.

Which of the following is true regarding authors who seek to publish the same content in multiple papers?

If the same content s used in multiple papers, it is essential that this information be properly disclosed to journal editors and other relevant entities.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines?

Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section.

Which of the following is true regarding industry-sponsored research?

Industry sponsors of research may seek to place restrictions on the disclosure of research results.

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

Interviews

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?

Which of the following most accurately describes data lifecycle management (DLM)?

It refers to the tools and processes for handling data during a research study and after it concludes.

According to the U.S. Federal Research Misconduct Policy, fabrication involves:

Making up data or results and recording or reporting them.

Which of the following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest.

Which of the following statements about mentoring is true?

Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of 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

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.

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.

A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?

Significant risk device

An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action?

Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

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 academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow:

The medical center to replace the use of paper records with electronic records for its research.

Which of the following is most likely to own the data resulting from a research project?

The organization that receives federal funding for a project.

A research project is designed to evaluate a new experimental type of fetal surgery to correct diaphragmatic hernia in the fetus (a potentially life-threatening condition for the baby) prior to delivery. This research is directed toward the fetus as subject to meet the health needs of the fetus. The pregnant woman is otherwise healthy. The investigator must obtain consent from whom?

The pregnant woman and the father of the fetus.

Investigators wish to evaluate a new treatment for eclampsia (a life-threatening condition in pregnant women) in women 30 - 50 years of age. The research is intended to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator must obtain consent from whom?

The pregnant woman only.

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.

According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research?

There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.

Which of the following is true regarding the U.S. Federal Research Misconduct Policy?

To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.

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.

An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action?

Treat the patient with the drug based on physician's best medical judgment

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.

True

Which of the following statements is true regarding the regulations that govern research?

U.S. funded research collaborations are often governed by U.S. regulations no matter where the research takes place.

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

US Public Health Service Policy

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

Workers