CITI Training

Privacy, in the health information context, refers to:

In the U.S., privacy protections for health information come from:

With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category do discussions with family members go?

Under HIPAA, an organization is required to do which of the following?

When patients receive a copy of an organization's privacy notice, why are they asked to sign an acknowledgment?

Which of these is not a right under HIPAA?

HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum necessary standard. What is excused?

When a privacy problem is discovered, which of the following is true?

What kinds of persons and organizations are affected by HIPAA's requirements?

With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category does information related to research, marketing, and fundraising go?

With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category does information related to "treatment, payment and health care operations" go?

HIPAA privacy protections cover identifiable personal information about the "past, present or future physical or mental health condition." What does that include?

Under the federal HIPAA regulations, state health privacy laws:

What does HIPAA's "minimum necessary" and related standards require of healthcare workers?

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

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

Recruiting into research ...

Under HIPAA, a "disclosure accounting" is required:

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

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

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

The HIPAA "minimum necessary" standard applies...

A HIPAA authorization has which of the following characteristics:

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:

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:

Which of these is not generally a good practice for fax machine use?

Which of these is not a good practice for physical security?

Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities?

Which of the following is a correct statement about the balance among prevention, detection, and response (PDR)?

Which of these is not generally a good practice for telephone use?

Fines and jail time (occasionally) for information security failures are:

Information security's goals are sometimes described by the letters "CIA." Which of the following is correct definition of C, I, or A?

Security measures are sometimes described as a combination of physical, technical, and administrative (PTA) safeguards. Which of these would be considered a technical safeguard?

Which of the following is a good practice if one wishes to avoid "social engineering" attacks?

Which of these is not a good practice for protecting computing devices?

Which of these is not a good security practice for email?

Which of these is not a good security practice for web browsing?

Which of these is not a good security practice for portable devices?

Which of the following are important for protecting computing devices and systems?

Which of the following is generally allowed in most organizations?

Which of these is not a good practice for controlling computer access?

Unless the subject matter is considered common knowledge, citations are necessary when writing about:

Which one of the following situations is most likely to constitute an act of plagiarism?

According to federal research misconduct policies, what is the maximum number of consecutive words that one can use before it is classified as an instance of plagiarism?

Ethical writing and scholarship is based on an implicit contract between the author and readers, whereby readers assume that what they read is accurate, has been written by the author, and has:

The reuse of one's previously published material in a new journal article is most appropriate if:

When authors summarize the work of others, they typically should:

Authors who reuse portions of text that have appeared in one of their earlier published papers run the risk of being accused by journal editors of:

Proper paraphrasing of a sentence written by someone else may be accomplished by:

The primary way to determine whether an idea constitutes "common knowledge" is:

The proper use of citations involves:

Paraphrasing another author's paragraph by substituting one or two words in each sentence and then adding one citation to the author at the end of the paragraph:

An idea is most likely to represent "common knowledge" if:

Which one of the following statements most accurately describes how plagiarism has been defined in this module?

Which of the following situations is most likely to constitute an instance of plagiarism?

Which of the following is the primary criterion for authorship?

Which of the following is an example of plagiarism?

Which of the following statements is true regarding authorship practices?

Which of the following most accurately describes the practice of ghost authorship?

Which of the following is true regarding an acknowledgments section?

Which of the following is a responsibility of each author?

Which author is normally responsible for sharing reprints of a publication with readers?

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

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

What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions?

Which of the following statements is true regarding international research and U.S. regulations?

Which of the following is true regarding academic-industry collaborations?

Which of the following is a key reason why international collaborations can be challenging?

What is the main function of a Technology Transfer Office?

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

Data ownership is typically determined by:

A research collaboration can be enhanced by:

What is the most appropriate process for determining which journal a collaborative research team should submit their work to?

The most important factor determining whether a research collaboration will be successful is:

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

Which of the following is true regarding data analysis?

Which of the following is true regarding data acquisition?

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

Which of the following is true regarding the reporting of research results?

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

Which of the following statements is true concerning data selection?

What is the primary responsibility of oversight bodies (such as an IRB or IACUC)?

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

What are the three main goals of data lifecycle management (DLM)?

Which of the following is true regarding data analysis?

What are the main elements necessary for ensuring that costs are appropriately charged?

What is the term for when a sponsor requests that the organization contribute financial support to a project?

Which of the following most accurately describes what effort reporting is supposed to capture?

Which of the following most accurately describes an 2 CFR Part 200.425(2) audit?

Which of the following most accurately describes the main purpose of the OMB Circulars?

Crystal clear theory refers to the notion that:

Which of the following most accurately describes allocability?

Award documentation is typically required to be prepared and submitted within how long after the end of a project period:

Which of the following most accurately describes voluntary committed cost sharing?

Closeout instructions on a sponsored project are most directly determined by:

Which of the following statements most accurately describes the mentoring relationship?

Which of the following statements about mentoring is true?

The defining characteristic of a mentor is someone who:

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?

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

Which of the following is most directly related to successful mentoring?

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

Which of the following most accurately describes good mentoring practice?

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

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

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:

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

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

Which of the following is true regarding the traditional peer review process:

Reviewers have a responsibility to promote ethical peer review by:

Which of the following statements most accurately describes the review process for grant proposals?

Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly?

A reviewer's main responsibility is to:

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

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

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

In response to a research misconduct allegation, what is the next main phase that takes place after the inquiry if there is sufficient evidence to proceed?

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?

Which of the following is most likely to be considered plagiarism?

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

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

The typical first main phase in response to a research misconduct allegation is called:

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?

Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion?

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

The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is:

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

The main focus of NIH's conflict of interest policy is:

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

Which of the following is true about conflicts of interest?

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

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

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 is:

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

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

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.

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.

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.

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.

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.

An example of an individual financial COI is:

The COI management plan aims to:

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

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.

An example of an institutional COI is:

The FDA regulations governing disclosure of individual COIs require:

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

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

The National Research Act of 1974

Which of the following is included in the Nuremberg Code:

Which of the following concerns is related to the Belmont Principle of Justice:

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

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

Issued in 1974, 45 CFR 46 raised which of the following to regulatory status?

Informed consent is considered an application of which Belmont principle?

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?

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

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

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

IRB continuing review of an approved protocol must:

The purpose of informed consent is:

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?

An elderly gentleman, whose wife is his legally authorized representative 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.

A general requirement for the 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?

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 legal representative 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:

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 volunteers 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?

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?

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

Which of the following is not considered an SBR data collections method?

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?

As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?

An investigator obtains consent 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 patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:

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?

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:

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

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

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?

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

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

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?

Which choice best describes the purpose of most pharmacogenomic research?

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?

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?

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?

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

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:

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

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

Recruiting into research ...

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

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:

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

Under HIPAA, a "disclosure accounting" is required:

The HIPAA "minimum necessary" standard applies...

HIPAA protects a category of information known as protected health information (PHI). PHI includes: