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Information collected by the play ground designer does not involve any information about human subjects even though it does involve interaction between the designer and school staff. An analysis of aggregate data doesn't involve interactions with...
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CITI Training for Human Subjects Research
Show or Reveal the Answer Answer: The research falls into one of six categories of research activity described in the regulations. A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB.
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What action can he expect by the IRB? A: The IRB will review this study because it includes human subjects and is considered research. B: The IRB will not review this study because it does not involve an investigational new device. C: The IRB will not review this study because it is not research as defined by the federal regulations. D: The IRB will not review this study because it does not include human subjects as defined by the federal regulations. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A: A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine.
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B: A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches. C: A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. D: Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques. Show or Reveal the Answer Answer: A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. A: A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the U.
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Conducting a linguistic analysis of comments posted on a public blog involves neither interaction with individuals nor collecting private identified information and thus does not meet the definition of research with human subjects. The study proposed by the developmental psychologist does meet the definition of research with human subjects. It involves interactions with living individuals and is designed to contribute to a field of knowledge. A: A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department. B: An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. C: A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.
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D: An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership. Show or Reveal the Answer Answer: B: An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. An in-house study conducted with the intention of improving a department's mentoring programs is not research with human subjects, but rather program improvement.
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Receiving data with no identifiers is not research with human subjects because there is no interaction or intervention with a living human being and no collection of private identifiable data. In addition, creating a report for a membership organization does not involve a research question, as defined by the federal regulations, so it too is not research with human subjects. Census data the final report as published by the Census Bureau is an example of: A: Private behavior.
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Two factors that must be considered in relation to each other when assessing risk Probability and magnitude of harm AS well as population context 3. Why is independent assessment of risk is critical? How can researchers safeguard data from unauthorized access? The two parts to informed consent 1 The process of providing information to prospective subjects. Exception to informed consent In some cases, an oral consent process without documentation may be approved by an Institutional Review Board IRB. Documentation also may be by audio or video recording as approved by an IRB.
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Informed Consent includes 1 Providing specific information about the study to subjects in a way that is understandable to them. The agreement is only to enter the study, as subjects may withdraw at any time, decline to answer specific questions, or complete specific tasks at any time during the research. Potentially vulnerable subjects include children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons Safeguards employed for vulnerable subjects include: 1 assessing the decision-making capacity of potential subjects, 2 requiring parental permission from both parents rather than just one parent for some studies with children, and 3 ensuring that incentives are not coercive.
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Privacy Can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself physically, behaviorally, or intellectually with others. Confidentiality Privacy Can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself physically, behaviorally, or intellectually with others. Confidentiality Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others, in ways that are inconsistent with the understanding of the original disclosure without permission. Our Team is always ready to provide free answers for your Questions Answerout.
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RCR consists of a basic course, additional content that can be incorporated based on organizational and learner needs, and a refresher course, which reemphasizes and expands on key concepts. It is suitable for any person involved in research ranging from upper-level undergraduates to established faculty. Particular emphasis is given to the educational needs of graduate students and postdoctoral researchers. RCR can provide students or other researchers with a conceptual foundation that can enhance the quality of in-person training. These courses were written and peer-reviewed by experts. Federal Research Misconduct Policy, fabrication involves: Making up data or results and recording or reporting them. Which of the following is most likely to be considered plagiarism? Using materials from a source without proper citation.
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Which of the following is the most effective strategy for preventing research misconduct? Good mentoring Which of the following is true regarding the U. Federal Research Misconduct Policy? To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly. Which type of research misconduct most likely occurred if someone intentionally removes data points on a graph in order to generate a deceptive conclusion?
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Falsification According to U. Federal Research Misconduct Policy, which of the following is considered to be research misconduct? Plagiarism 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 According to the U. Federal Research Misconduct Policy, falsification involves: Manipulating research materials, equipment, or processes, or changing or omitting data.
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To detect compliance with regulatory requirements, including those relating to protecting research subjects. What are the three main goals of data lifecycle management? Confidentiality, availability, and integrity In the research context, the term validity most commonly refers to: Whether operationalized concepts actually measure what they purport to measure. 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 of following is most likely to own the data resulting from a research project? The institution where a federally-funded project takes place. Which of the following is true regarding data sharing and stewardship? Agencies that fund research may include data sharing requirements in their funding contracts. Which of the following most accurately describes the practice of ghost authorship?
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It is a situation where the individual who wrote the manuscript is not listed as an author. Which of the following is a responsibility of each author? Confirming that data have been accurately presented. Which of the following is an example of plagiarism? Which of the following is true regarding an acknowledgments section? The contributions of students and technicians are often listed in the acknowledgments section if they do not meet all of the criteria for authorship.
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Which of the following is true regarding publishing the same content in multiple papers? Using the same content in multiple papers is deceptive if it is not properly disclosed. Which author is normally responsible for sharing reprints of a publication with readers? The corresponding author. 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 the primary criterion for authorship? Having made a significant intellectual contribution to the work. Which of the following statements is true regarding authorship practices?
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Different disciplines have different practices about who should be included as an author. 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. The two main criteria that the National Science Foundation NSF uses to evaluate grant proposals are: Intellectual merits and broader impacts. Which of the following statements is true regarding the responsibilities of a reviewer? Which of the following is most directly related to successful mentoring? Someone who is committed to the professional development of the trainee. What is the most appropriate course of action for a trainee who has a problem with a mentor?
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After first attempting to communicate directly with the mentor, the trainee should seek the counsel of a trusted senior person in the department or organization. Which of the following is to be avoided when seeking an effective mentor? Trainees should assume that whoever is assigned to them as the thesis or research adviser will be their best choice for a mentor. 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. 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. Which of the following statements best exemplifies the importance of mentoring? A mechanism to transmit values and standards of professional conduct. The defining characteristic of a mentor is someone who: Takes a sincere interest in the growth and development of a trainee.
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Which of the following is most likely to create a poor relationship between mentor and trainee? 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 rather than completely eliminating them. 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 most accurately describes a conflict of commitment? A researcher becomes overly attached to a specific research outcome. Which of the following most accurately describes an institutional conflict of interest?
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Which of following is true about conflicts of interest? They increase the likelihood of bias. Data ownership is typically determined by: The type and source of funds used to support the project. 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 is true regarding academic-industry collaborations? The industry sponsor typically owns the data from research that it funds.
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What is the most appropriate process for determining which journal a collaborative research team should submit their work to? It should be discussed early on in the collaboration by the members of the research team. Which of the following is true regarding industry-sponsored research? Industry sponsors of research may place restrictions on the disclosure of research results. What is the main function of the Bayh-Dole Act of as it relates academic institutions?
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It allows institutions to have control over the intellectual property from federally-funded research. What is the main function of a Technology Transfer Office? It helps researchers to commercialize their work. A research collaboration can be enhanced by: Discussing intellectual property issues while the collaboration is forming. Which of the following is true regarding the use of animals in research? The attending veterinarian must be allowed to have access to all research animals at all times. Which of the following is the main reason why proper training in euthanasia techniques is important? Improper techniques can cause unnecessary pain and distress in animals. Which of the following is empowered by the U. Which of the following most accurately describes the process that must occur when working with research animals covered by U. The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.
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Which entity is responsible for monitoring institutional compliance with PHS Policy? To decrease the use of animals in research and to minimize pain and distress caused by animal experiments. Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals? Any procedure that causes pain or distress in human beings may cause pain or distress in other animals. Which justification would an IACUC most likely accept if a research team plans to withhold pain relief analgesia from animals during a project? Which of the following best describes when a protocol may be eligible for expedited review by the IRB: The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government.
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