CITI COI, CITI RCR, CITI social and behavioral research, clinical ethics exam 1
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
Which statement best describes information that must be included in a consent form?
A description of the research's potential benefits and risks
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.
Severely compromised quality of life
A form of life where a person's overall physical condition has seriously and irreversibly deteriorated, range of function is limited, ability to communicate is minimal, suffering discomfort and pain. Patient has essentially lost the ability to communicate any evaluation, this life to an observer is undesirable
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.
Permanent Vegetative State
A neurologic prognosis defined as "a sustained, complete loss of self-aware cognition with wake/sleep cycles and other autonomic functions remaining relatively intact. The condition can either follow acute, severe bilateral cerebral damage or develop gradually as the end stage of a progressive dementia"
If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as:
A personal conflict of interest.
POLST (Physician's Order for Life-Sustaining Care)
A physician order to ensure those who have serious advance illness will not receive certain treatments they do not want.
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
Abandonment
A physician without giving timely notice, ceases to provide care for a patient who is still in need of medical attention or when the physician is dilatory and careless. Not obliged to arrange further care, but there is a legal obligation to provide full medical records to the new attending physician. Can d/c if pt is in danger or endangering others.
According to the U.S. Public Health Service regulations, investigators are required to disclose travel sponsored or reimbursed by:
A publicly traded company.
Which of the following statements most accurately describes a mitigation report?
A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest.
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?
A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond
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.
ethics
A set of principles of right and wrong. A theory or system of moral values regarding what is right and what is wrong, which guides behavior in relationships among people in accordance with certain social roles
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.
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.
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
All research funded by HHS
Parental notification, in lieu of active parental permission, is allowed when:
An IRB has approved a waiver of the requirement for parental permission.
According to the U.S. Public Health Service, which of the following would be considered a significant financial interest?
An equity interest valued at $5,000 owned by the investigator's spouse in a company that produces products related to the investigator's institutional responsibilities
Physiological futility
An ethical justification for the physician to recommend withdrawing all interventions, with the exception of those that will provide comfort
According to the federal regulations, which of the following studies meets the definition of research with human subjects? 1
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
Autonomy
An individual's right of self-government, without infringing upon the rights of others (14th amendment of the constitution)
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
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
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.
Which of the following is true regarding the U.S. Public Health Service and its approach to the disclosure of significant financial interests?
Any equity interest in a non-publicly traded company must be disclosed.
Contextual Features
Any issues the pt cant control (i.e: Finances, insurance, hospital resources, etc...)
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 FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
Identify the example of when situation and time are key to assessing risk of harm in a research study:
Asking women if they have had an abortion
Which of the following is the least important activity when protecting human subjects in international research?
Assessing transportation conditions
Unless the subject matter is considered common knowledge, citations are necessary when writing about:
Ideas, methodologies, or data from other authors and also your own previously published ideas, methodologies or data.
Overall goal of the Belmont Report
Identify ethical principles surrounding human research, risk benefit ratio, informed consent/ethical selection of participants
A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?
If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
Which of the following is true regarding authors who seek to publish the same content in multiple papers?
If the same content s used in multiple papers, it is essential that this information be properly disclosed to journal editors and other relevant entities.
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.
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.
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
According to the U.S. Public Health Service, the definition of the term "investigator":
Includes anyone involved in the conduct or reporting of research
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is:
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
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)
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
Which of the following statements is true regarding the reporting of outside interests and the management of conflicts?
Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.
Uniform Definition of Death Act (UDDA)
Irreversible cessation of circulatory or resp. function. Irreversible cessation of all functions of the entire brain, including brain stem, is dead
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because:
Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
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.
Natural Death Act
Can state if incapacitated or lethal illness occurs and they are permanently unconscious, they do not wish to be kept alive by artificial means.
Which of the following is true regarding the reporting of research results?
Clear specification of the methods and procedures used is essential.
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 examples of using the internet to conduct research meets the federal definition of research with human subjects?
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
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.
Which of the following is true about conflicts of interest?
Conflicts of interest increase the likelihood of bias.
The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because:
Control the quality of published papers.
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 one of the following is most likely to constitute an act of plagiarism?
Copying someone else's text word-for-word without using quotation marks and adding a citation at the end of the material.
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
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 of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?
Directory information.
The U.S. Public Health Service (PHS) requires institutions to:
Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them.
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
Disclose their potential COI and may answer questions, but recuse themselves from voting
Definitions and Standards of Disclosure
Disclosure by the physician of the nature of the intervention, its risks and benefits, and also its alternatives with their risks and benefits
A research collaboration can be enhanced by:
Discussing intellectual property issues while the collaboration is forming.
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.
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 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
Institutional policies on tenure and promotion can contribute to reproducibility problems by:
Encouraging researchers to publish a high number of low quality articles.
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 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.
Institutions are required by the U.S. Public Health Service to do which of the following:
Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest.
Quality of Life
Evaluates the overall before and after treatment outcomes
At a minimum, how often are investigators funded by the U.S. National Institutes of Health required to receive conflict of interest training?
Every 4 years
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
According to the U.S. Public Health Service, a "significant financial interest" includes royalty income paid to an investigator and its disclosure is required:
Except if that income is from the institution that currently employs the investigator.
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.
In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:
FERPA, PPRA, and Subpart D of the federal regulations
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
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
Which of the following is true regarding research misconduct?
Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?
Federal regulations do not require the documentation of minors' assent.
The main focus of NIH's conflict of interest policy is:
Financial conflicts of interest
DNR portability
For EMTs to see with a wearable bracelet to indicate not to do CPR
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.
Which of the following is the most effective strategy for preventing research misconduct?
Good mentoring
Benefit-Risk Ratio
Guide physician to determine how much risk is justified by the intended benefit
Within the context of RCR, integrity primarily refers to:
Having a sincere commitment to upholding one's word and adhering to ethical and professional standards
Which of the following is the primary criterion for authorship?
Having made a significant intellectual contribution to the work.
Vitalism
Holds that organic life must be preserved when all other human functions are lost (secular)
A researcher's study uses an identifiable dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision:
Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.
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.
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
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.
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.
Which of the following is true about hypothesis-free research?
It should normally be disclosed because the practice can introduce bias into a study.
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 Belmont Report
July 12, 1974 Nat'l Research Act signed into law. Thus creating: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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 Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
Justice
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
Contextual Features considers
Justice
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
Locked in state
Lesions in the midbrain paralyze efferent pathways governing movement and communication, but leave consciousness intact (cant speak or move but is conscious and aware)
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.
According to the U.S. Federal Research Misconduct Policy, falsification involves:
Manipulating research materials, equipment, or processes, or changing or omitting data.
Paraphrasing another author's paragraph by substituting one or two words in each sentence and then adding one citation to the author at the end of the paragraph:
May constitute plagiarism because the original material has not been sufficiently modified to constitute a proper paraphrase.
The 4 Topic Method
Medical Indications, Patient Preferences, Quality of Life, Contextual Features
Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:
Medical vulnerability
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.
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.
requirements of autonomy
Must be 18 yo and competent (mentally and socially).
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.
Vegetative state
Neurological condition following severe head trauma or anoxic insult, must associate with 'persistent' or 'permanent'
Which of following most accurately describes when investigators pursuing U.S. Public Health Service funding are required to disclose their significant financial interests to their institution?
No later than the time of applying for funding.
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 proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?
No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.
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.
A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
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.
Prior to implementing any significant change in the use of animals, what is the most important thing that the research team must do?
Obtain IACUC approval for the change.
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
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.
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 is true regarding data sharing and stewardship?
Researchers who receive federal funding may have to adhere to a data sharing requirement.
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
Patient Preferences
Respect for the patient's autonomy
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.
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.
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.
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
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
Situational cognitive vulnerability
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.
states which permit physician-assisted dying
Oregon, Washington, and Vermont. Montana and New Mexico rely on judicial rulings
Initiation and Continuation of Care
PAs are morally bound to provide care in emergency situations and, when necessary, to arrange proper follow-up
Which of the following is most directly related to successful mentoring?
Someone who is committed to the professional development of the trainee.
Beneficence
Something done to benefit others
Nondiscrimination of Patients and Family
PAs should not discriminate against classes or categories of patients in the delivery of needed healthcare. Gender, color, creed, race, religion, age
Confidentiality
PAs should use and advocate for methods of storage and transmission of patient information that minimize the likelihood of data becoming available to unauthorized persons or organizations.
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
If research in a private school is directly funded by the Department of Education, then:
PPRA applies.
PPRA gives parents some level of control over their child's:
Participation in third-party survey research or exposure to instructional materials developed by researchers
Advanced Directive
Person's right to make decisions regarding terminal care, and provide directions about how that right can be affected after loss of capacity
According to federal regulations, "children" are defined as:
Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.
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 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
According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?
Plagiarism
Living Will
Statement detailing a person's desires regarding their medical treatment in circumstances in which they are no longer able to express informed consent
Which of the following situations is most likely to constitute an instance of plagiarism?
Summarizing a published article in 2-3 distinct paragraphs and including this in a paper.
Which one of the following statements most accurately describes how plagiarism has been defined in this module?
Plagiarism applies not only to ideas that are found in print but also those that are communicated verbally.
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
Vulnerable people
Pregnant women, prisoners, children, mentally ill
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.
Patient Preferences considers
Principle of Autonomy
Justice
Principle of fairness. Benefits and burdens should be distributed fairly when interests compete or conflict
3 Fundamental Principles of Professionalism
Principle of patient welfare, Principle of patient autonomy, Principle of social justice
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
What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?
Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
The defining characteristic of a mentor is someone who:
Takes a sincere interest in the growth and development of a trainee.
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.
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 most appropriate step to take if authors believe that their manuscript was reviewed unfairly?
The author can contact the editor with their concerns.
The reuse of one's previously published material in a new journal article is most appropriate if:
The author informs all the relevant parties and obtains permission to do so.
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 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.
Which author is normally responsible for sharing reprints of a publication with readers?
The corresponding author.
Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request?
The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service.
Which of the following is true regarding academic-industry collaborations?
The industry sponsor typically owns the data from research that it funds.
The typical first main phase in response to a research misconduct allegation is called:
The inquiry
Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?
The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.
Within the context of RCR, social responsibility primarily refers to:
The obligation to design technology or acquire information in ways that take into account what effects those actions may have on society.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 is true regarding the U.S. Federal Research Misconduct Policy?
To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly
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.
PA Role and Responsibilities
To respect the health, safety, welfare, and dignity of all human beings. This concept is the foundation of the patient-PA relationship.
The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research.
True
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.
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.
In the research context, the term validity most commonly refers to:
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 there is ongoing communication among the team members about their goals and responsibilities.
A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB?
Will the researchers have collaborators at the research site abroad?
Treatment decisions should be based on
medical need and patient preferences.
Quality of Life is gauged by
mobility, performance of activities of daily living, absence or presence of pain, social interaction, mental acuity.
Profoundly diminished quality of life
objective where patient suffers extreme physical debilitation together with completely and irreversible loss of sensory and intellectual activity. Communicative abilities and neurological capacities to process sensory input and mental activities are lost. Observer notices as patient evaluation cannot be determined as the patient lacks the ability to perceive, understand and evaluate on state
The clinical signs of vegetative state
open eyes, limb movement, yawning, and sleep-wake cycles. Can lead observers, particularly family, to interpret these noncognitive behaviors as signs of consciousness.
Voluntary euthanasia
patient was consciously requesting death, death request
Involuntary euthanasia
patients killed against their wishes
Nonvoluntary
patients without decisional capacity, no death request expressed
physicians not required to treat people who
persist in actions that run directly counter to the goals of treatment
Continued or chronic vegetative state
persists for several months
Triage
practice of classifying the sick, injured, or wounded in order to most efficiently employ medical resources in a crisis. Prioritize in view of serious need. Can cause competition between rival claimants to medical attention
Social worth is not relevant to diagnose and treat patients, physicians must
provide medical treatment to all people regardless of their social standing
Ethical obligations of physicians are
the wishes of the patient and the goals of medicine. If illegal or against the goals of medicine, physician has no obligation to treat
Best-interest Standard
when the patient's preferences are not known, the surrogate's judgement must promote the best interests of the patient (68% accuracy)
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 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
Euthanasia
"good death", doctor assures patient has died peacefully and comfortable as medicine provided (later called "mercy killing")
Implications of Forgoing Life-Sustaining Tx
1) It is virtually certain that further medical intervention will not attain any of the goals of medicine other than sustaining organic life; 2) the preferences of the patient are not known and cannot be determined; 3) quality of life clearly falls below minimal; 4) family are in accord.
Potential Bias that may Prejudice the Provider's Evaluation of Pt's Quality of Life
1. Racial bias; 2. bias against elderly and disabilities; 3. Lifestyle bias
Within how many days of acquiring or discovering a significant financial interest is the investigator required to submit an updated disclosure to the institution?
30 days.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? 2
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.
Which statement best describes the role of an IRB:
A committee that reviews different types of human subjects research
According to the federal regulations, which of the following studies meets the definition of research with human subjects? 3
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.
Determination of Death
Absence of resp., no pulse, fixed pupils. Cardiorespiratory criterion of death
The Common Rule (1981):
Baseline standard of ethics by which any government-funded research in the U.S. is held
A reviewer's main responsibility is to:
Behave professionally.
Medical Indications considers
Beneficence & Non-maleficence
Quality of Life considers
Beneficence, non-maleficence & autonomy
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
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.
Vegetative State DOES NOT =
Brain Death
The publication of short methods sections:
Can contribute to reproducibility problems because important details about materials and procedures are likely to have been omitted.
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.
Durable Power of Attorney
Designated decision maker is given legal force in a durable power of attorney for healthcare. Agent to make all health care decisions after they have become incapacitated
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.
Data are made anonymous by
Destroying all identifiers connected to the data.
Which of the following is true regarding data acquisition?
Data acquisition should follow a detailed collection plan that is set in advance.
Which of the following is true regarding data analysis?
Data analysis methods should usually be specified in advance before a study begins.
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.
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 "reproducibility crisis?"
It is a problem that can potentially affect any research field.
If a researcher creates the idea for a project and is not listed in the preferred author order position on resulting publications, is this considered to be research misconduct under federal policy?
No; instead it is a type of authorship dispute.
A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
Not an excessive incentive.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
Not approve this project because the prisoners are merely a population of convenience for the student.
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
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.
When authors summarize the work of others, they typically should:
Provide a condensed (shorter) version of the original material.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children's educational records.
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
Substituted Judgment
Pt's preferences are known and surrogate states those preferences
A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:
Public behavior
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
Medical Indications
Questions regarding pt's physiologic + psychologic condition. Clinician considers which diagnostic/therapeutic interventions are appropriate
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.
Sanctity of life
Represents the highest value that must be strenuously protected and preserved (religious). Compatible with decisions to refrain from medical treatments that prolong life in certain circumstances
If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?
Research about aptitude testing
Which statement best describes what an IRB is responsible for reviewing?
Research involving a human subject
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?
The Family Educational Rights and Privacy Act.
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 of the following is empowered by the U.S. federal government to review and approve research activities involving vertebrate animals?
The Institutional Animal Care and Use Committee (IACUC)
Which entity is responsible for monitoring institutional compliance with PHS Policy?
The Office of Laboratory Animal Welfare (OLAW)
The PA and Diversity
The PA should respect the culture, values, beliefs, and expectations of the patient.
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
An investigator received $4,000 of consulting income from a publicly traded drug company over the past 12 months. The investigator also owns stock in that company valued at $2,000. The investigator is submitting a grant to the National Institutes of Health that involves evaluating the effectiveness of a drug produced by the same drug company. Which of the following is true?
The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest.
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.
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.
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?
The research must pose no more than minimal risk.
Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations?
The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.
Doctrine of the Double Effect
This doctrine says that if doing something morally good has a morally bad side-effect it is ethically OK to do it providing the bad side-effect was not intended. This is true even if you foresaw that the bad effect would probably happen.
A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true?
This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
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.
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
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?
Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
Which of the following is most likely to be considered plagiarism?
Using materials from a source without proper citation.
Events leading to Development of Medical Ethics
WWII human experimentation, Medical technology boom and lifesaving and life-prolonging interventions, Impersonal institutionalization of healthcare delivery systems, Tuskegee experiment Alabama: 1932
A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:
Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
Informed consent
a PA provides adequate information that is comprehendible to a patient or patient surrogate who has medical decision-making capacity
Ethical principle of proportionality
a medical treatment is ethically mandatory to the extent that it is likely to confer greater benefits than burdens upon the patient.
After initial consent to treatment occurs,
an ongoing dialogue between patient and physician concerning the patient's continuing medical needs reinforces the original consent. Can be more than a consent to a procedure, and more like a personal acceptance of changes in one's quality of life
4 Principle of Bioethics
autonomy, beneficence, nonmaleficence, justice
Minimal consciousness
intermittent evidence of self or environmental awareness, verbalization, or responses to commands or questions. Little is known about treating this
Physicians may prescribe dying medication,
but not administer it.
Subjective standard
conforms to the highest ethical goals of clinical care. Reasonable/prudent patient standard: meeting legal requirements
To consent to physician assisted euthanasia, Pt must have
decisional capacity
DNE
do not escalate, intervention should not be scaled up or down
exceptions for autonomous persons
emancipated minors, married minor, military service
Nonmaleficence
first, do no harm.
Contextual Features
identifies areas outside of the patient's direct control. Addresses justice and fairness, financial resources, legal issues, religion/culture, supply/demand, and third parties.
When can beneficence conflict with autonomy
if pt is unable to express preferences (unconscious)
