CITI Training
Which of the following statements best exemplifies the importance of mentoring?
A mechanism to transmit values and standards of professional conduct.
Award documentation is typically required to be prepared and submitted within how long after the end of a project period:
90 days
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:
A breach of confidentiality.
If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:
A conflict of conscience
The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is:
A conflict of interest committee
Which of the following is most likely to create a poor relationship between a mentor and a trainee?
A mentor who searches out 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.
An example of an individual financial COI is:
A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
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.
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:
A study on the genetic links between DNA samples found at a prehistoric central Asian archeological site and west coast Native American Indian tribes.
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.
Information security's goals are sometimes described by the letters "CIA." Which of the following is correct definition of C, I, or A?
All of the above
Which of the following are important for protecting computing devices and systems?
All of the above
Which of the following is a good practice if one wishes to avoid "social engineering" attacks?
All of the above
Which of the following practices can be effective in minimizing group harms?
All of the above
The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) is intended to:
Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
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?
An investigation
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 officer ("Privacy Officer"), or privacy official ("Privacy Official"), 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:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
What are the main elements necessary for ensuring that costs are appropriately charged?
Applying allocable, allowable, consistent, and reasonable costing policies and procedures.
Under HIPAA, an organization is required to do which of the following?
Appoint a Privacy Officer to administer HIPAA rules.
A reviewer's main responsibility is to:
Be professional and prompt.
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 participants
Which of these is not a good security practice for web browsing?
Browsing to sites using links sent in emails without taking steps to assure the destination is safe.
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.
Under the federal HIPAA regulations, state health privacy laws:
Can remain in force if "more stringent" than HIPAA, complementing HIPAA's foundation of protections, provided there is no direct conflict in requirements.
Which of the following is true regarding the reporting of research results?
Clear specification of the methods and procedures used is essential.
Which of the following most accurately describes what effort reporting is supposed to capture?
Compensated activities
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?
Confidentiality of the individual subject's responses
What are the three main goals of data lifecycle management (DLM)?
Confidentiality, availability, and integrity
Which of the following is a responsibility of each author?
Confirming that data have been accurately presented.
Which of the following is true about conflicts of interest?
Conflicts of interest increase the likelihood of bias.
The main reason that the Royal Society of London developed the modern form of peer review was to:
Control the quality of published papers.
Which one of the following situations is most likely to constitute an act of plagiarism?
Copying someone else's text word-for-word without using quotation marks and adding a citation at the end of the material.
What is the term for when a sponsor requests that the organization contribute financial support to a project?
Cost Sharing
Which of the following is true regarding data acquisition?
Data acquisition should follow a detailed collection plan that is set in advance.
Which of the following is true regarding data analysis?
Data analysis methods should be specified in advance before a study begins.
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.
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:
De-Identified
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
HIPAA includes in its definition of "research," activities related to ...
Development of generalizable knowledge.
HIPAA includes in its definition of "research," activities related to:
Development of generalizable knowledge.
Which of the following statements is true regarding authorship practices?
Different disciplines have different practices about who should be included as an author.
Which of these is not a good security practice for portable devices?
Disabling any remote-locate, remote-shutdown, and remote-erase capabilities because these can accidentally erase data.
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
A research collaboration can be enhanced by:
Discussing intellectual property issues while the collaboration is forming.
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
Which of the following most accurately describes good mentoring practice?
Encouraging trainees to receive mentoring from a collection of individuals.
The National Research Act of 1974
Established the National Commission.
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.
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?
Falsification
In the U.S., privacy protections for health information come from:
Federal, state, local, and private certification organizations' requirements
The main focus of NIH's conflict of interest policy is:
Financial conflicts of interest
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 of the following statements most accurately describes the review process for grant proposals?
Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal.
Fines and jail time (occasionally) for information security failures are:
Generally, only applied for serious, deliberate misuse, where someone intentionally accesses data in order to do harm or for personal gain.
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.
Which of the following is the most effective strategy for preventing research misconduct?
Good mentoring
Which of the following is the primary criterion for authorship?
Having made a significant intellectual contribution to the work.
HIPAA privacy protections cover identifiable personal information about the "past, present or future physical or mental health condition." What does that include?
Health information in any form or medium, as long as it is identified (or identifiable) as a particular person's information.
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:
Health insurance and employment discrimination
What kinds of persons and organizations are affected by HIPAA's requirements?
Healthcare providers, health plans, and health information clearinghouses, as well as their business associates and by extension the workers for those organizations.
When a privacy problem is discovered, which of the following is true?
Healthcare workers and patients are protected from intimidation or retaliation for reporting.
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?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
Unless the subject matter is considered common knowledge, citations are necessary when writing about:
Ideas, methodologies, or data from other authors and also your own previously published ideas, methodologies, or data.
HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:
Identifiable health information that is created or held by covered entities and their business associates.
HIPAA protects a category of information known as protected health information (PHI). PHI includes:
Identifiable health information that is created or held by covered entities and their business associates.
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.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:
Intellectual merit and broader impact.
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.
What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions?
It allows institutions to have control over the intellectual property from federally-funded research.
An idea is most likely to represent "common knowledge" if:
It can be safely assumed that the readers and the author are both thoroughly familiar with the idea and its source.
What is the main function of a Technology Transfer Office?
It helps researchers to commercialize their work.
Which of the following most accurately describes the practice of ghost authorship?
It is a situation where the individual who wrote the manuscript is not listed as an author.
Which of the following most accurately describes an 2 CFR Part 200.425(2) audit?
It is an annual audit of an organization that receives over a certain threshold of federal funds each year.
Which of the following most accurately describes voluntary committed cost sharing?
It means that the cost share is quantified in the proposal but not required by the sponsor.
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.
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 allocability?
It refers to how direct expenses are calculated based on the benefit to the project.
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.
When patients receive a copy of an organization's privacy notice, why are they asked to sign an acknowledgment?
It shows they received it.
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 a key reason why international collaborations can be challenging?
Language barriers and cultural differences among collaborators can complicate communication.
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable and less treatable than physical harms
Which of these is not a good practice for controlling computer access?
Logging into systems with a shared user-ID or password.
Which of these is not a good practice for protecting computing devices?
Login and screen-saver passwords, or token or biometric mechanisms, are disabled to make it easier to use the device quickly.
Which of following is true about the management of conflicts of interest?
Management plans are often created to reduce the impact of conflicts of interest.
According to the U.S. Federal Research Misconduct Policy, falsification involves:
Manipulating research materials, equipment, or processes, or changing or omitting data.
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:
May constitute plagiarism because the original material has not been sufficiently modified to constitute a proper paraphrase.
Security measures are sometimes described as a combination of physical, technical, and administrative (PTA) safeguards. Which of these would be considered a technical safeguard?
Measures including device data encryption, anti-malware software, and communications encryption.
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.
Which of the following statements most accurately describes the mentoring relationship?
Mentors teach trainees about aspects of academic life that are not covered in textbooks.
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.
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.
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:
Not been disseminated before unless noted otherwise.
IRB continuing review of an approved protocol must:
Occur at least annually.
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
Which of the following was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
Which of the following studies has the LEAST potential to create group harm?
Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.
The proper use of citations involves:
Placing citations in ways that are consistent with practices seen in well-written articles.
According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?
Plagiarism
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
Which one of the following statements most accurately describes how plagiarism has been defined in this module?
Plagiarism applies not only to ideas that are found in print but also those that are communicated verbally.
Which of the following is an example of plagiarism?
Presenting someone else's ideas or words and claiming them as one's own.
Reviewers have a responsibility to promote ethical peer review by:
Preserving the confidentiality of the submission.
Which of the following concerns is related to the Belmont Principle of Justice:
Prisoners participating in research that only benefits the larger society
When authors summarize the work of others, they typically should:
Provide a condensed (shorter) version of the original material.
The COI management plan aims to:
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
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.
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.
Informed consent is considered an application of which Belmont principle?
Respect for Persons
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.
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:
Self-plagiarism
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.
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.
Which of these is not a good security practice for email?
Sending sensitive information in email messages or in attachments to such messages, as long as a legally-binding confidentiality notice is included.
Which of these is not generally a good practice for fax machine use?
Sensitive faxes -- inbound or outbound -- are left sitting in or around the machine.
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
Which of the following is generally allowed in most organizations?
Social networking if done for approved business-related purposes.
Which of the following is most directly related to successful mentoring?
Someone who is committed to the professional development of the trainee.
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
Which of the following situations is most likely to constitute an instance of plagiarism?
Summarizing a published article in 2-3 distinct paragraphs and including this in a paper.
HIPAA's protections for health information used for research purposes...
Supplement those of the Common Rule and FDA.
The defining characteristic of a mentor is someone who:
Takes a sincere interest in the growth and development of a trainee.
Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly?
The author can contact the editor with their concerns.
The reuse of one's previously published material in a new journal article is most appropriate if:
The author informs all the relevant parties and obtains permission to do so.
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.
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.
Which author is normally responsible for sharing reprints of a publication with readers?
The corresponding author.
Crystal clear theory refers to the notion that:
The financial details of a project should be explained plainly enough so that a non-expert would be able to understand them.
Which of the following is a correct statement about the balance among prevention, detection, and response (PDR)?
The greater the sensitivity and quantity of the data at issue, the more carefully the balance among these three must be evaluated.
Which of the following is true regarding academic-industry collaborations?
The industry sponsor typically owns the data from research that it funds.
The typical first main phase in response to a research misconduct allegation is called:
The inquiry
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:
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.
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 where a federally-funded project takes place.
What is the most appropriate process for determining which journal a collaborative research team 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.
Privacy, in the health information context, refers to:
The rules about who can access health information, and under what circumstances.
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
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?
The study is human subject research which is eligible for expedited review.
Closeout instructions on a sponsored project are most directly determined by:
The terms and conditions in the agreement with the sponsor.
Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?
The trainee must take an active role in the relationship and clearly communicate needs and expectations.
Data ownership is typically determined by:
The type and source of funds used to support the project.
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?
There is no official, federal standard for the number of consecutive words that can be used.
Which of the following most accurately describes the main purpose of the OMB Circulars?
They outline the rules for the financial management of sponsored projects.
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.
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.
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 HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
Which of these is not a right under HIPAA?
To control all disclosures of information in the health record.
What is the primary responsibility of oversight bodies (such as an IRB or IACUC)?
To detect compliance with regulatory requirements, including those relating to protecting research subjects.
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
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.
Which of these is not a good practice for physical security?
To preserve good customer relations, visitors are generally allowed access to all areas of a facility unless it appears they are doing something suspicious.
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
HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum necessary standard. What is excused?
Truly accidental "excess" uses and disclosures, where reasonable caution was otherwise used and there was no negligence.
Which of the following statements is true regarding international research and U.S. regulations?
U.S. funded research is often governed by U.S. regulations no matter where the research takes place.
Issued in 1974, 45 CFR 46 raised which of the following to regulatory status?
US Public Health Service Policy
Which of the following is true regarding the traditional peer review process:
Under single-blind review, the identity of the author is revealed to the reviewer.
Which of the following statements is accurate in determining subject risk involved in a genetic study:
Understanding the purpose and context of a specific study is critical in determining the risk involved
Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities?
Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification.
What does HIPAA's "minimum necessary" and related standards require of healthcare workers?
Use or disclose only the minimum necessary amount of health information to accomplish a task.
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.
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?
Uses or disclosures that can generally occur without any specific permission from the patient.
With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category do discussions with family members go?
Uses or disclosures that generally require oral agreement only.
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?
Uses or disclosures that generally require specific written authorization.
Which of the following is most likely to be considered plagiarism?
Using materials from a source without proper citation.
Which of the following is true regarding authors who seek to publish the same content in multiple papers?
Using the same content in multiple papers is deceptive if it is not properly disclosed to journal editors or other relevant entities.
Which of these is not generally a good practice for telephone use?
Using voicemail systems and answering machines that do not require a password or PIN for access.
Proper paraphrasing of a sentence written by someone else may be accomplished by:
Using your own words and writing voice to express the idea conveyed in the sentence.
Which of the following is included in the Nuremberg Code:
Voluntary consent
In the research context, the term validity most commonly refers to:
Whether operationalized terms actually measure what they purport to measure.
The primary way to determine whether an idea constitutes "common knowledge" is:
Whether there is an expectation that the readers and the author would be very familiar with the material.
The most important factor determining whether a research collaboration will be successful is:
Whether there is ongoing communication about goals and responsibilities.
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.
Which of the following is not considered an SBR data collections method?
hearing/audiological screenings
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.