Citi Group 2 + responsible conduct of research
A waiver of the requirement for documentation of informed consent may be granted when:
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
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 wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:
Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.
The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?
"Tastes, Ties, and Time (T3)" study
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
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 example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
Which of the following is true regarding authors who seek to publish the same content in multiple papers?
If the same content is used in multiple papers, it is essential that this information be properly disclosed to journal editors and other relevant entities.
A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?
Justice
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.
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
Must occur within 12 months of the approval date.
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
Reviewers have a responsibility to promote ethical peer review by:
Preserving the confidentiality of the submission.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
Prisoners
A medical record is an example of:
Private information
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
There was neither a violation of privacy nor a breach of confidentiality.
Which of the following most accurately describes the main purpose of the Super Circular also known as the Uniform Guidance?
They outline the rules for the financial management of sponsored projects.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
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
An example of an individual financial COI is:
A researcher's spouse 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.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
Identify the example of when situation and time are key to assessing risk of harm in a research study:
A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers in the United States
Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:
All of the above
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
A reviewer's main responsibility is to:
Behave professionally.
A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that:
Confidentiality of the prisoners' health status is maintained.
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 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.
Which of the following is true regarding data acquisition?
Data acquisition should follow a detailed collection plan that is set in advance.
To minimize potential risks of harm, a researcher conducting an on-line survey can:
Design the survey so that no direct or indirect identifiers are collected.
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?
Designing the survey so that subjects are not forced to answer one question before going to the next.
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
Determined by the institution in its written policies and procedures
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
Experience emotional or psychological distress.
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
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 is true of inducements in research?
Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
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
Researchers must report potential unanticipated problems that involve risks to others directly to the:
Institutional Review Board (IRB)
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
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 with respect to collaborative research?
It helps collaborative 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 a single or program-specific audit (in other words, a 2 CFR 200.501, Subpart F 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 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.
According to federal regulations, the expedited review process may be used when the study procedures pose:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB?
No, this does not need to be reported because it is unrelated to participation in the study.
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.
You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated. However, the study was not approved by the IRB in accordance with the requirements for research involving prisoners under Subpart C. What is the best course of action?
Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?
Promptly
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
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 census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:
Public information
Additional safeguards that may be included in a social and behavioral study may include:
Remove all direct identifiers from the data as soon as possible.
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
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.
The Belmont principle of beneficence requires that:
Risks to subjects are reasonable in relation to anticipated benefits.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
Securing a Certificate of Confidentiality
Authors who reuse portions of text that have appeared in one of their earlier published papers run the risk of being accused of:
Self-plagiarism
Which of the following is most directly related to successful mentoring?
Someone who is committed to the professional development of the trainee.
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 a key reason why international collaborations can be challenging?
The collaborators may have different disciplinary and cultural backgrounds and practices.
Which author is normally responsible for sharing reprints of a publication with readers?
The corresponding author.
What is needed to make a normally unreasonable cost an allowable expense in a grant?
The cost needs to be in furtherance of the goals of the grant.
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 true regarding academic-industry collaborations?
The industry sponsor typically owns the data from research that it funds.
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 therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
According to the federal regulations, research is eligible for exemption, if:
The research falls into one of eight categories of research activity described in the regulations.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group.
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 scenario best describes a researcher making thoughtful considerations in the design of their informed consent process on an online study?
The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, "If you agree to be in this study click below to begin."
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.
In any collaboration, data ownership is typically determined by:
The type and source of funds used to support the project.
What is the primary responsibility of oversight bodies (such as an IRB or IACUC)?
To determine compliance with regulatory requirements, including those relating to protecting research subjects.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk
Revelations about the Facebook Emotional Contagion study highlights what key ethical consideration to conducting research using social media?
Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites' terms of use.
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Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
If there is sufficient evidence to proceed, what is the next main phase that takes place after the inquiry in response to a research misconduct allegation?
An investigation
According to the U.S. Federal Research Misconduct Policy, falsification involves:
Manipulating research materials, equipment, or processes, or changing or omitting data.
Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
Respect for persons
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.
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
Justice
A general requirement for 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?
Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
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.
According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:
Obtains, uses, studies, analyzes, or generates identifiable private information.
The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:
Cognitive or communicative vulnerability
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval.