Research Method and Design Quiz 2

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.

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.

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

Which of the following is most likely to create a poor relationship between a mentor and a trainee?

A mentor who recruits trainees merely for the mentor's own career advancement.

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.

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.Comment

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.

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

What are the main elements necessary for ensuring that costs are appropriately charged?

Applying allocable, allowable, consistent, and reasonable costing policies and procedures.

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

Both the magnitude (or severity) and the probability (or likelihood) of harm.

In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.

Common Rule

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 of the following most accurately describes good mentoring practice?

Encouraging trainees to receive mentoring from a collection of individuals.

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

Ensuring that risks are reasonable in relationship to anticipated benefits

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

The main focus of NIH's conflict of interest policy is:

Financial conflicts of interest

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.

An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?

Justice

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.

In the research context, the term validity most commonly refers to:

In the research context, the term validity most commonly refers to:

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.

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:

Intellectual merit and broader impact.

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.

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 data lifecycle management (DLM)?

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

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

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.

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.

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 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 graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?

Not Human Subjects

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.

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

Obtain a waiver of documentation of informed consent.

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 of the following represents 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.

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

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

The three ethical principles discussed in the Belmont Report are:

Respect for Persons, Beneficence, Justice

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:

Respect for persons

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

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.

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

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.

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.

Closeout instructions on a sponsored project are most directly determined by:

The terms and conditions in the agreement with the sponsor.

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​.

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 Super Circular also known as the Uniform Guidance?

They outline the rules for the financial management of sponsored projects.

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.

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.

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 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 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.

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?

PHS Tuskegee Study

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?

PHS Tuskegee study

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 with diminished autonomy are entitled to protection.

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

Plagiarism

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 statement best describes what an IRB is responsible for reviewing?

Research involving a human subject

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 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.

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.

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.

Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply.

- Protecting the rights and welfare of human subjects.- Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.- Reviewing subject recruitment materials and strategies.

Award documentation is typically required to be prepared and submitted within how long after the end of a project period:

90 days

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

A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review?

Convened Review

Which of the following is true regarding data analysis?

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

Data are made anonymous by

Destroying all identifiers connected to the data.

A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review?

Determination for Exemption

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?

Determining that the study has a maximization of benefits and a minimization of risks.

Which of the following statements most clearly illustrates the principle of beneficence?

Determining whether the benefits of a study outweigh the risks.

Which justification would an IACUC most likely accept if a research team plans to withhold pain relief (analgesia) from animals during a project?

Documented evidence that the analgesic agent will interfere with the aims of the project.

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.

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. What action can he expect by the IRB?

The IRB will not review this study because it is not research as defined by the federal regulations.

Which entity is responsible for monitoring institutional compliance with PHS Policy?

The Office of Laboratory Animal Welfare (OLAW)

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

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 author is normally responsible for sharing reprints of a publication with readers?

The corresponding author.

Which of the following is true regarding academic-industry collaborations?

The industry sponsor typically owns the data from research that it funds.

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 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.