Biomedical Responsible Conduct of Research
If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:
A conflict of conscience * A conflict of conscience occurs when personal beliefs could influence objectivity.
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 * Academic institutions typically have a conflict of interest committee that determines whether a researcher's conflicts of interest are manageable.
If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as:
A personal conflict of interest. * Personal conflicts of interest can include situations where a friendship with an applicant or other individual could interfere with a hiring decision.
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. * Reviewers should disclose their conflicts of interest. They should be experts in the field and should be able to review the manuscript objectively. Professors should not transfer their review responsibilities to a student without first obtaining permission from the journal editor.
Which of following protocols is the one that is most likely to require IRB review?
A study to evaluate a newly designed wheelchair by asking elderly individuals to use it. * The wheelchair study can require IRB review because it can pose risks to the individuals involved (such as, if the wheelchair collapses). IRBs only examine research involving humans so the study involving the chimpanzee needs to be reviewed by another group (IACUC). Therefore, IRB approval is not needed (unless human beings are going to be enrolled).
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. * The U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training state that "Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals."
A reviewer's main responsibility is to:
Behave professionally. * A reviewer's main responsibility is to behave professionally. A reviewer should avoid personal attacks but does not necessarily have to be friendly or avoid criticizing the content of the manuscript.
A literature review by Freedman, Cockburn, and Simcoe in 2015 estimates that in the U.S., the failure of research to replicate is associated with a cost of:
Billions of dollars per year * The cost estimate provided by Freedman, Cockburn, and Simcoe is based on the assumption that half of the research conducted in the U.S. does not replicate, which comes out to approximately $28.2 billion per year.
Which of the following statements is true regarding authorship practices?
Both within and between disciplines, practices differ with regard to who should be included as an author, and in what order they should be listed. * Trainees should understand the variety of authorship policies that are common to their own field and sub-fields. It is best to have these policies explained and understood when a trainee first begins a project.
Which of the following is a responsibility of each author?
Confirming that data have been accurately presented in the paper. * Along with other responsibilities, each author should confirm that data have been accurately presented.
Which of the following is true about conflicts of interest?
Conflicts of interest increase the likelihood of bias. * Conflicts of interest do not guarantee that wrongdoing will occur but they do 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. * The Royal Society of London developed the modern form of peer review in order to control the quality of published papers.
Which of the following statements most clearly illustrates the principle of beneficence?
Determining whether the benefits of a study outweigh the risks. * According to the Belmont Report, a determination that a study has a favorable risk to benefit ratio is an example of the principle of beneficence.
A research collaboration can be enhanced by:
Discussing intellectual property issues while the collaboration is forming. * Discussing intellectual property before a collaboration starts can enhance its effectiveness.
Conducting numerous, separate statistical analyses increases the chance that one or more of the results appear to be statistically significant, but are actually attributable to random variation or measurement error. The problem is referred to as:
Family-wise inflation of error rate * Family-wise inflation of error rate refers to the problem of not accounting for repeated testing that can cause the results to reach statistical significance, but they are actually attributable to random variation or measurement error. Testing a large number of variables increases the likelihood of finding one or more that has a p value less than 0.05 by chance alone.
The main focus of NIH's conflict of interest policy is:
Financial conflicts of interest * The main focus of federal COI policies, including from the NIH, is the management and disclosure of financial conflicts of interest.
Which of the following is the primary criterion for authorship?
Having made a significant intellectual contribution to the work. * Although authorship practices and norms do vary, the primary criterion for authorship is whether the person made a significant intellectual contribution to the work.
Michael McFarland argues that proximity is one reason why researchers have an obligation to help the public. Which of following most accurately describes what McFarland means by proximity?
Having the specialized expertise to reduce technical risks. * According to McFarland, proximity refers to having expertise that the public lacks. Such expertise results in an obligation to help the public.
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. * Authors are obliged to disclose to journal editors and others when they plan to use the same or similar content multiple times.
The U.S. National Institutes of Health (NIH) is seeking to increase research reproducibility by:
Implementing a grant review process that evaluates various factors such as the rigor of the research premise and study design. * The NIH is seeking to increase research reproducibility by implementing a grant review process that evaluates the rigor of the research premise and study design. Focusing on the quality of the research design and the scientific importance of the research question increases the likelihood that the experimental results will be replicable.
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. * Appropriate training is important because improper techniques can cause unnecessary pain and distress in animals.
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. * Authors must make significant intellectual contributions to the research. In general, contributors who do not meet the criteria for authorship should usually be 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. * Industry sponsors of research may place restrictions on the disclosure of results. The details of this arrangement with the industry sponsor are normally described in a non-disclosure agreement.
The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:
Intellectual merit and broader impact. * The two main criteria used by NSF to evaluate a grant proposal are the intellectual merit and broader impacts of the proposal.
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. * The Bayh-Dole Act permits academic institutions and research organizations to retain the commercial and patent rights to intellectual property developed with federal funds.
What is the main function of a Technology Transfer Office with respect to collaborative research?
It helps collaborative researchers to commercialize their work. * Technology Transfer Offices at universities helps collaborative researchers to commercialize their work.
Which of the following most accurately describes the Green Revolution?
It involved mobilizing a technological system to improve food production. * The Green Revolution mobilized a technological system to increase food production. It involved the integration of ideas, technologies, people, and institutions.
Which of the following most accurately describes the "reproducibility crisis?"
It is a problem that can potentially affect any research field. * Recent attention in the mainstream media has been largely focused on the biomedical sciences, but the lack of reproducibility is a problem that can potentially affect any research field.
Which of the following most accurately describes technological momentum?
It is a system's inertia or resistance to change. * Technological momentum is a system's inertia or resistance to change.
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. * An institutional conflict of interest can occur 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. * Conflicts of commitment occur when outside activities could interfere with obligations to one's primary employer.
Which of the following is true about hypothesis-free research?
It should normally be disclosed because the practice can introduce bias into a study. * Hypothesis-free research is a practice that should be disclosed as such because it can introduce bias into a study and lead to inflation of error rate. At times, it can border on research misconduct if it contributes to a researcher intentionally distorting how data are interpreted.
Which statement most accurately describes the process leading to the development of the Nuremberg Code:
It was created in response to the harms caused by Nazi researchers around the time of the Second World War. * The Nuremberg Code was developed in response to the harms caused by Nazi researchers. The researchers subjected human beings to various types of cruel and painful experiments.
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. * Organizations often create management plans to reduce the impact of conflicts of interest rather than completely eliminating them. However, in some cases, it will be necessary to eliminate a conflict of interest.
Which of the following is most likely to help the journal publication process mitigate reproducibility problems?
Moving away from a review process that favors the publication of positive results. * The journal publication process could help mitigate reproducibility problems by moving away from a review process that favors the publication of positive results. If this occurs, researchers might not face as much pressure to produce and disseminate results that appear to be statistically significant.
Which of the following represents plagiarism?
Presenting someone else's ideas or words and claiming them as one's own. * Plagiarism involves 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. * Authors of a paper or a grant proposal expect that their valued original information is respected and confidentiality preserved in order to attain the credit for their hard work.
The main way in which the organization Doctors Without Borders acts on social responsibilities is by:
Providing medical care in emergency situations. * The main way in which the organization Doctors Without Borders acts on social responsibilities is by providing medical care in emergency situations.
The authors Martin and Schinzinger claim that researchers have special obligations to society primarily because:
Research and innovation can be considered potentially risky experiments that involve society. * In Ethics in Engineering, authors Mike Martin and Roland Schinzinger propose that engineering researchers and others should think of their work as experiments on society that may cause risks. When viewed in this manner, they argue that researchers have special obligations to society.
Which statement best describes what an IRB is responsible for reviewing?
Research involving a human subject
Social responsibility is usually expressed in professional codes of ethics by stating that:
Researchers have an obligation to the public. * Social responsibility is usually expressed in professional codes of ethics by stating that researchers have an obligation to the public.
A Type I error, or a false positive, refers to a situation when:
Results are found to be statistically significant, but they are actually due to chance. * Type I error, which is also called a false positive, occurs when results are found to be statistically significant (for example, the p value falls below the 0.05 level), but they are actually due to chance.
A Type II error, or a false negative, refers to a situation when:
Results are not found to be statistically significant, but a significant effect is actually present. * Type II error, which is also called a false negative, occurs when results are not found to be statistically significant, but a significant effect is actually present. Low study power is often responsible as small effects are difficult to detect with low sample sizes.
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. * Reviewers should be fair and objective and only agree to review manuscripts that they are qualified to evaluate. The information gained through the review is confidential and should not be used for any purpose unrelated to the review process.
Which of the following most accurately describes U.S. federal policy related to RCR instruction?
Some federal agencies have RCR policies but they differ in terms of the particular format of training that is required. * The U.S. federal agencies that have developed RCR policies include the National Institutes of Health (NIH), the National Science Foundation (NSF), and the U.S. Department of Agriculture (USDA), National Institute of Food and Agriculture (NIFA). The format and duration of such training and who must complete it varies by funding agency.
Which entity is responsible for monitoring institutional compliance with PHS Policy?
The Office of Laboratory Animal Welfare (OLAW) * The Office of Laboratory Animal Welfare (OLAW) is responsible for monitoring institutional compliance with PHS Policy.
Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report?
The Tuskegee Study * The Tuskegee Study triggered congressional action and the creation of the National Research Act and the Belmont Report.
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. * A key reason why international collaborations can be challenging is that the collaborators may have different disciplinary and cultural backgrounds and practices.
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. * Sponsors and others who were involved with a project but who do not meet all of the requirements of an author are usually recognized in the acknowledgments section in the article.
Which author is normally responsible for sharing reprints of a publication with readers?
The corresponding author. * It is the corresponding author is normally responsible for sharing reprints of a publication with readers.
Which of the following is true regarding academic-industry collaborations?
The industry sponsor typically owns the data from research that it funds. * It is common for an industry sponsor to own the data from research that it funds.
Within the context of RCR, compliance primarily refers to:
The obligation to follow specific directives, such as laws and regulations, that govern a research activity. * In the context of RCR, compliance primarily refers to the overarching obligation to follow specific directives, including those contained within the organizational policies, put forward by research funding agencies, and more broadly, any applicable law or regulation governing a research activity.
Within the context of RCR, stewardship primarily refers to:
The obligation to use resources available for research ethically in order to conduct the best research possible. * In the context of RCR, stewardship primarily refers to the ethical obligation of every researcher and research community to use resources available to conduct the best research possible.
The view that there is a social contract between researchers and the public is most accurately described by stating that:
The public supports research in various ways and researchers have a corresponding obligation to avoid abusing the public's trust. * Some argue that a social contract exists between research communities and the public. The public supports research in various ways, including by providing funding for it, and researchers have a corresponding obligation to avoid abusing the public's trust.
What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to?
The research team should discuss the issue early on and while the project is ongoing. * The most effective way to identify a suitable journal is for the research team to discuss the issue both before the work begins and throughout the project.
As a first step, what must be done before enrolling a young child in a research protocol?
The risks and benefits must be explained to the child's parents or legally authorized representative. * The risks and benefits must be explained to the child's parents or legally authorized representative before enrolling the child. If the child is old enough to understand the research, it may be appropriate to explain the research to the child as well. Of course, there are other relevant steps before proceeding with the research (such as, approval must have been granted by the IRB).
In any collaboration, data ownership is typically determined by:
The type and source of funds used to support the project. * The type and source of funds used to support the project typically determines who owns the data from a collaborative project.
Which of the following most clearly illustrates Russell and Burch's Replacement concept?
The use of computer modeling software instead of using animals in an experiment. * The use of computer modeling software to substitute for animal experiments is an example of Replacement. The use of a new analgesic that provides better postoperative pain relief and the use of newer surgical techniques that result in less tissue trauma are examples of Refinement.
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. * A conflict of interest may bias the review process. It could cause a reviewer to reject or endorse a grant proposal in an unfair manner.
What is the primary purpose of the "3Rs" concept from Russell and Burch?
To decrease the use of animals in research and to minimize pain and distress caused by animal experiments. * The primary purpose of the "3Rs" concept of Russell and Burch was to urge researchers to decrease the use of animals in research and to minimize pain and distress caused by experiments.
Which of the following most accurately describes the main goal of RCR education and training?
To promote greater awareness of proper research practice and research ethics. * The focus of RCR education and training is to promote greater awareness of norms, guidelines, policies, regulations, and laws that inform proper research practice.
Which of the following statements is true regarding the regulations that govern research?
U.S. funded research collaborations are often governed by U.S. regulations no matter where the research takes place. * U.S. funded research is often governed by U.S. regulations no matter where the research takes place.
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. * For either type of review, authors are not directly informed of the identities of the reviewers. In single-blind review, the identity of the author is revealed to the reviewer.
The most important factor in determining whether a research collaboration will be successful is:
Whether there is ongoing communication among the team members about their goals and responsibilities. * The most important factor in determining whether a research collaboration will be successful is whether there is ongoing communication among the team members about their goals and responsibilities.
Which statement best describes the role of an IRB:
a committee that reviews different types of human subjects research. * An IRB is responsible for reviewing human subjects research to assure the rights and welfare of subjects are protected. It is not responsible for reviewing other forms of research (such as, a protocol with animals).
