Research 1 Midterm CITI

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. -Report the adverse drug experience to the IRB only if there are several other occurrences. -Do not report the adverse drug experience to the IRB since it is a common adverse experience. -Report the adverse drug experience as part of the continuing review report.

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

What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to? -Submit the work to several journals that represent the interests of all the authors. -Obtain advice from the Technology Transfer Office. -It is appropriate to submit the work to any peer reviewed journal. -The research team should discuss the issue early on and while the project is ongoing.

the research team should discuss the issue early on and while the project is ongoing

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 -The study is required for a student research project -The study does not require informed consent or survey instruments. -The study includes only research subjects that are healthy volunteers.

the study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Issued in 1974, 45 CFR 46 raised to regulatory status: -The Nuremberg Code -The 1974 National Research Act -Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act -US Public Health Service Policy

US public health service policy

The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is: -The researcher -The university president -A conflict of interest committee -The faculty senate

a conflict of interest committee

Which of the following is most likely to create a poor relationship between a mentor and a trainee? -The mentor has experience and interest in the trainee's field of study. -The relationship includes clear discussions about each person's expectations. -The trainee has an interest in learning more about the mentor's field of study. -A mentor who recruits trainees merely for the mentor's own career advancement.

a mentor who recruits trainees merely for the metor's own career advancement

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. -Correcting grammatical mistakes in the manuscript. -Having read a draft of the manuscript before it is published. -Obtaining financial support for the work.

having made a significant intellectual contribution to the work

Which of the following studies has the LEAST potential to create group harm? -An anonymous survey of state high school teachers, athletic directors, and administrators that, among other things, asks for perceptions about the sexual preferences of their high school coaches. -A study that surveys the perceptions of nurses and other health care workers about illegal drug use among cardiovascular surgeons in New York City. -A genetic study to identify ancestral relationships between DNA obtained from a Cherokee Indian burial site and members of a Central Asian community. -A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.

a phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer

What are the three main goals of data lifecycle management (DLM)? -technology, sharing, disposal -ownership, propriety, control -confidentiality, availability, integrity -secrecy, privacy, disposal

confidentiality, availability, integrity

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines? -The first author is the only person that is held publicly responsible for the contents of the paper. -Conducting the technical aspects of the research is sufficient to warrant authorship. -Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section. -Acquiring funding for a research project is sufficient to warrant authorship

individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgements section

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship? -A trainee is too junior to have any responsibilities in the mentoring relationship. -The trainee must take the lead in all aspects of the relationship. -The trainee must take an active role in the relationship and clearly communicate needs and expectations. -The trainee's primary role is to avoid seeking the mentor's advice in order to grow as a researcher.

the trainee must take an active role in the relationship and clearly communicate needs and expectations

The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because: -Having a conflict of interest means an individual does not have the time to perform the review. -Having a conflict of interest means an individual does not have the relevant expertise to perform the review. -The author of the proposal may learn about the situation. -Their removal lessens the chance that bias will affect the review process​.

their removal lessens the chance that bias will affect the review process

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

using materials from a source without proper citation

In the research context, the term validity most commonly refers to_____ -whether operationalized terms actually measure what they purport to measure -whether funding has been obtained for the project -whether a project is worth pursuing -whether a project has been approved by an oversight board

whether operationalized terms actually measure what they purport to measure

The most important factor in determining whether a research collaboration will be successful is: -Whether the research team has access an effective Technology Transfer Office. -Whether each research team member was trained in the same research methods. -Whether there is ongoing communication among the team members about their goals and responsibilities. -Whether each research team member has an equal share of resources.

whether there is ongoing communication among the team members about their goals and responsibilities

Which of the following most accurately describes good mentoring practice? -Encouraging trainees to receive mentoring from a collection of individuals. -Informing trainees that they must rely on their adviser for all mentoring. -Informing trainees that faculty are the only individuals who have enough experience to serve as mentors. -Avoiding being a mentor unless one works in the same research field as a trainee.

Encouraging trainees to receive mentoring from a collection of individuals

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 by stigmatizing members of the group (even for individuals who do not participate in the research) is: -A study of sleeping patterns and productivity in college students. -A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state. -A study of the efficacy of a new glucose monitoring device in middle-aged women. -A study on the effects of an innovative literacy program on absenteeism in elementary schools.

a study of the types and prevalence of STIs in small rural towns in a midwestern state

Which of the following practices can be effective in minimizing group harms? -Collaborative IRB review -Ongoing consultation -Community consultation -Planning disclosure of research results -All of the above

all of the above

A reviewer's main responsibility is to: -Be friendly. -Behave professionally. -Contact the authors when the review is completed. -Avoid criticizing the work of other researchers.

behave professionally

Which of the following is true regarding data analysis? -Data analysis methods can typically be specified at the close of a study after it is clear what kind of data has been collected. -Data analysis methods should usually be specified in advance before a study begins. -Disciplines and professions do not provide guidance on data analysis. -Data analysis methods are generally uniform across disciplines.

data analysis methods should usually be specified in advance before a study begins

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? -Ensuring that the selection of subjects includes people from all segments of the population. -Providing detailed information about the study and obtaining the subject's consent to participate. -Ensuring that persons with diminished autonomy are protected. -Determining that the study has a maximization of benefits and a minimization of risks.

determining that the study has a maximization of benefits and a minimization of risks

Which of the following statements is true regarding authorship practices? -Different disciplines have different practices about who should be included as an author. -In scientific fields, authors have to be listed in order of seniority. -In scientific fields, authors have to be listed in alphabetical order. -Journals do not permit a graduate student to be listed as the first author.

different disciplines have different practices about who should be included as an author

The National Research Act of 1974 -Required that all federal agencies have the same regulations governing human subjects research. -Identified guidelines to ensure the ethical conduct of research. -Established the National Commission. -Identified the basic ethical principles of human subjects research.

established the national commission

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

falsification

The main focus of NIH's conflict of interest policy is: -Conflicts of conscience -Financial conflicts of interest -Personal conflicts of interest -Academic conflicts of interest

financial conflicts of interest

How long is an investigator required to keep consent documents, IRB correspondence, and research records? -Until data analysis is complete -For a minimum of three years after completion of the study -As long as the investigator is at that institution -Until the study is closed

for a minimum of 3 years after completion of the study

Which of the following is true regarding industry-sponsored research? -Industry sponsors must give ownership of the data to the research team. -The research must take place within the industry's facilities and not at a university. -Industry sponsors of research may seek to place restrictions on the disclosure of research results. -Industry sponsors are not permitted to review data from academic projects that they sponsor.

industry sponsors of research may seek to place restrictions on the disclosure of research results

The typical 1st main phase in response to a research misconduct allegation is called _________

inquiry

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are: -Intellectual merit and broader impact. -Ethical integrity and legal compliance. -Quality and quantity. -Sustainability and innovation.

intellectual merit and broader impact

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?

investigation

What is the main function of a Technology Transfer Office with respect to collaborative research? -It arranges the purchase and delivery of new computer hardware for research teams. -It arranges movers to pack and ship equipment to a researcher's new facilities. -It helps collaborative researchers to commercialize their work. -It sets up new e-mail accounts.

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 a high profile researcher is added as an author to improve the chance of publishing a manuscript. -It is a situation where the individual who wrote the manuscript is not listed as an author. -It is a situation where someone provides constructive comments on a manuscript before it is submitted. -It is a situation where someone does not include all of the data that have been collected.

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 institutional conflict of interest? -It occurs when two or more departments within a college are competing for the same research funding. -It occurs when an institution's financial or non-financial interests could interfere with its research activities. -It occurs when two or more institutions are competing for the same research funding. -It occurs when two or more researchers within a department are competing for the same research funding.

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 an individual allows personal beliefs to interfere with objectivity. -It occurs when outside activities interfere with obligations to one's primary employer. -It occurs when researchers have a financial interest related to their research. -It occurs when a researcher is not sure whether to renew a contract with an employer.

it occurs when outside activities interfere with obligations to one's primary employer

Which of the following most accurately describes data lifecycle management (DLM)? -It refers to the data collection requirements of a particular organization. -It refers to the obligation to uphold data confidentiality imposed by federal law. -It refers to the tools and processes for handling data during a research study and after it concludes. -It refers to the obligation to share data imposed by professional journals.

it refers to the tools and processes for handling data during a research study and after it concludes

Which of the following is true about the management of conflicts of interest? -Organizations do not require that conflicts of interest are managed as long as researchers disclose them. -Researchers are typically permitted to judge for themselves whether a conflict of interest needs to be managed. -Management plans are often created to reduce the impact of conflicts of interest. -Researchers are required to eliminate all conflicts of interest that they have.

management plans are often created to reduce the impact of conflicts of interest

Which of the following statements most accurately describes the mentoring relationship? -Mentoring relationships happen naturally and do not require work. -Mentors teach trainees about aspects of academic life that are not covered in textbooks. -A mentoring relationship must not turn into a friendship or else it is a failure. -Graduate students, but not mentors, gain from the mentoring relationship.

mentors teach trainees about aspects of academic life that are not covered in textbooks

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: -Occur at least annually. -Occur only when the level of risk changes. -Be conducted by an expedited review. -Include copies of all signed consent forms.

occur at least annually

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: -Persons involved in research cannot financially benefit. -Persons with diminished autonomy should only participate in no more than minimal risk research. -Persons with diminished autonomy should be excluded from research. -Persons with diminished autonomy are entitled to protection.

persons with diminished autonomy are entitled to protection

Reviewers have a responsibility to promote ethical peer review by: -Using the information contained in a reviewed manuscript to further their own research. -Revealing their identity to the authors of the manuscript or grant proposal. -Seeking the help of others in the research team to perform the review. -Preserving the confidentiality of the submission.

preserving the confidentiality of the submission

The use of prisoners in research is a concern under the Belmont principle of Justice because: -Prisoners are not a representative sample of the general population -Prisoners may be used to conduct research that only benefits the larger society -Prisoners are not free to say no -Prisoners are less educated that the general population and have difficulty understanding research

prisoners may be used to conduct research that only benefits the larger society

Informed consent is considered an application of which Belmont principle? -Non-maleficence -Respect for Persons -Beneficence -Justice

respect for persons

Which of the following are the three principles discussed in the Belmont Report? -IRB Review, Federal Regulations, Declaration of Helsinki -Respect for Persons, Beneficence, Justice -Privacy, Confidentiality, Equitable Selection of Subjects -Informed Consent, Institutional Assurance, Researcher Responsibility

respect for persons, beneficence, justice

Which of the following statements is true regarding the responsibilities of reviewers? -Reviewers should be an advocate for the author and to help convince the editor to publish the manuscript. -Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed. -Reviewers are not supposed to turn down opportunities to review manuscripts even if they lack the relevant expertise. -Reviewers can make use of the information in a manuscript before it is published, giving them an advantage over competitors.

reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed

The defining characteristic of a mentor is someone who: -Takes a sincere interest in the growth and development of a trainee. -Advises a trainee on how to complete paperwork for graduation. -Pays for a trainee's research projects. -Advises a trainee on which academic courses to take.

takes a sincere interest in the growth and development of a trainee

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: -They are eligible for review using expedited procedures. -The changes must be immediately implemented for the health and well-being of the subject. -They only involve changes to the consent form. -The investigator keeps careful records of all changes and includes them in the final report.

the changes must be immediately implemented for the health and well-being of the subject

Which author is normally responsible for sharing reprints of a publication with readers? -The first author. -The author who has made the most significant contribution. -The last author. -The corresponding author.

the corresponding author

Which of the following is true regarding academic-industry collaborations? -Conflicts of interest are not common in these collaborations. -Federal law does not permit an academic institution to own anything that is produced from the collaboration. -They cannot happen because of the Bayh-Dole Act of 1980. -The industry sponsor typically owns the data from research that it funds.

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? -A faculty member working on a federally-funded project. -The organization that receives federal funding for a project. -a technician who collected the data -a graduate student working under the direction of a faculty member

the organization that receives federal funding for a project.