CITI Quiz
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.
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 regarding data analysis?
Data analysis methods should usually be specified in advance before a study begins.
To minimize potential risks of harm, a researcher conducting an on-line survey can: A. Design the survey so that no direct or indirect identifiers are collected. B. Specify that all respondents must be legal adults. C. Comply with the survey software's Terms of Service agreement. D. Suggest that subjects print a copy of the informed consent form for their records.
Design the survey so that no direct or indirect identifiers are collected.
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? A. Giving examples in the consent process of the kinds of questions that will be asked. B. Including the institution's privacy policy on the survey site. C. Designing the survey so that subjects are not forced to answer one question before going to the next. D. Providing a thorough debriefing at the end of the study.
Designing the survey so that subjects are not forced to answer one question before going to the next.
Data are made anonymous by A. Requiring all members of the research team to sign confidentiality agreements. B. Reporting data in aggregate form in publications resulting from the research. C. Destroying all identifiers connected to the data. D. Keeping the key linking names to responses in a secure location.
Destroying all identifiers connected to the data.
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: A. Determined by the institution in its written policies and procedures B. Stated in the human subject protection regulations, but not in the drug or device regulations C. Included in the consent process D. Determined by research staff
Determined by the institution in its written policies and procedures
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: A. FERPA, PPRA, and Subpart D of the federal regulations B. FERPA, PPRA, and No Child Left Behind Act C. PPRA and Subpart D of the federal regulations D. FERPA and Subpart D of the federal regulations
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
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? A. Documentation is required unless waived by an IRB B. Parents must approve written documentation. C. Federal regulations do not require the documentation of minors' assent. D. To protect minors documentation is always required.
Federal regulations do not require the documentation of minors' assent.
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: A.Medical vulnerability B. Deferential vulnerability C. Therapeutic misconception D. Economic vulnerability
Medical vulnerability
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: A. Must occur within 12 months of the approval date. B. Is limited to review of unanticipated problems. C. Is not required unless additional risks have been identified. D. Must be conducted by a convened IRB.
Must occur within 12 months of the approval date.
Within how many days of acquiring or discovering a significant financial interest is the investigator required to submit an updated disclosure to the institution? A. 90 days. B. 7 days. C. 30 days. D. 365 days.
30 days
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. 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. B. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. C. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees. D. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study
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.
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. A report from an institution telling the U.S. Public Health Service how bias will be minimized before a research project begins. B. 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. C. A report from the U.S. Public Health Service to an institution of what must be done to deal with financial conflicts of interest of its PHS-funded researchers. D. An annual report to the U.S. Public Health Service of all the significant financial interests of the institution's PHS-funded researchers.
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.
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: A. Cognitive or communicative vulnerability B. Institutional vulnerability C. Physical vulnerability D. Economic or social vulnerability
Cognitive or communicative vulnerability
An example of an individual financial COI is: A. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza. B. A researcher's 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher's ongoing projects. C. A researcher's spouse works at the same university as the researcher. D. A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
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. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects. B. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material. C. 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. D. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
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 studies meets the definition of research with human subjects? A. 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 over a three-month period. B. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs. C. analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information. D. psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. E. psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods manage aggression. F. experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
All of the above
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: A. All research funded by any federal agency B. All research funded by HHS C. All research involving children D. All research that is more than minimal risk
All research funded by HHS
Parental notification, in lieu of active parental permission, is allowed when: A. The researcher has conducted a similar study at another institution. B. An IRB has approved a waiver of the requirement for parental permission. C. The superintendent of schools and the principals have approved the study. D. The researcher anticipates a low response rate.
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? A. Income from the university where the investigator is currently employed. B. An equity interest valued at $10,000 or more that is not related to the investigator's institutional responsibilities. C. Travel expenses reimbursed by a U.S. institution of higher education. D. 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.
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.
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? A. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. B. An investigator analyzes user comments on articles posted on her university's website. C. An investigator designs a computer program to extract work experience information from LinkedIn profiles. D. An investigator registers an account on SecondLife to observe the way people interact with each other.
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
The FDA regulations governing disclosure of individual COIs require: A. Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application B. Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies C. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies D. Researchers to annually self-disclose financial COIs to the FDA
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
Which of the following is the least important activity when protecting human subjects in international research?
Assessing transportation conditions
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: A. The need for the signatures of both parents outweighs the two subparts B. Subpart C still applies, as the potential subjects are juveniles C. Only subpart C applies because of the need for assent forms, as a result of in loco parentis status for juveniles D. Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
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: A. Solely by the magnitude or severity of expected harm. B. Both the magnitude (or severity) and the probability (or likelihood) of harm. C. Neither the magnitude or probability of harm. D. Solely by the probability of expected harm.
Both the magnitude (or severity) and the probability (or likelihood) of harm.
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.
Which of the following is true regarding the reporting of research results?
Clear specification of the methods and procedures used is essential.
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? A. Ensuring that the selection of subjects includes people from all segments of the population. B. Determining that the study has a maximization of benefits and a minimization of risks. C. Ensuring that persons with diminished autonomy are protected. D. Providing detailed information about the study and obtaining the subject's consent to participate.
Determining that the study has a maximization of benefits and a minimization of risks.
The U.S. Public Health Service (PHS) requires institutions to: A. Collect information about the significant financial interests of all faculty and staff. B. Post the significant financial interests of all researchers to a publicly available website. C. Block faculty from owning any equity interest in a company that sponsors research. D. Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them.
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: A. Leave the meeting immediately B. Disclose their potential COI and not participate in any action C. Disclose their potential COI, but not answer any questions about the study D. Disclose their potential COI and may answer questions, but recuse themselves from voting
Disclose their potential COI and may answer questions, but recuse themselves from voting
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: A. Institutional vulnerability B. Economic vulnerability C. Social vulnerability D. Communicative vulnerability
Economic vulnerability
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? A. Ensuring that subjects understand that participation is voluntary B. Ensuring that risks are reasonable in relationship to anticipated benefits C. Providing detailed information about the study to potential subjects D. Ensuring that the selection of subjects is fair
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: A. Update their financial conflict of interest policy every four years. B. Eliminate any and all conflicts of interest. C. Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest. D. Apply the same financial conflict of interest policy to all researchers regardless of their funding source.
Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest.
Which example of research with prisoners would be allowable under the regulations? A. Examining age at first arrest as a predictor of adult criminal history. B. Examining the use of financial incentives to improve compliance with dentist appointments. C. Investigating genetic biomarkers as predictors of intelligence. D. Determining safety of a new formulation of deodorant.
Examining age at first arrest as a predictor of adult criminal history.
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? A. In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? B. Including a witness signature line on the consent form. C. Maintaining confidentiality of responses to survey questions. D. Ensuring that the consent process does not slow down the recruitment.
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: A. Recruiting, consenting and debriefing subjects takes place on-line, and may require little to no interaction with the subjects. B. Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. C. People assume pseudonymous on-line identities, such as an avatar in an MMORPG. D. Online studies do not require the documentation of informed consent.
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.
Researchers must report potential unanticipated problems that involve risks to others directly to the: A. Institutional Risk Manager B. Institutional Review Board (IRB) C. HIPAA Compliance Officer D. American Psychological Association
Institutional Review Board (IRB)
Risk of harm in social and behavioral sciences generally fall in three categories, which are: A. Breach of confidentiality, loss of autonomy, and study procedures B. Study procedures, breach of confidentiality, and loss of employment C. Invasion of privacy, adverse reaction to study drug, and discrimination D. Invasion of privacy, breach of confidentiality, and study procedures
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? A. Investigators are responsible for developing their own management plans for significant financial interests. B. Investigators must disclose all of their financial interests regardless of whether they are related to a research project. C. The institution must report identified financial conflicts of interest to the U.S. Office of Research Integrity. D. Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.
Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.
A researcher's study uses a 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: A. Is correct because the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners. B. Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners. C. Is wrong because the chair is the only person who can determine that a study is exempt from further review. D. It is not the researcher's call.Is correct if the IRB chair is also the prisoner representative for the IRB.
Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: A. Respect for persons B. Beneficence C. Justice
Justice
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. A. Researchers must only submit COI disclosures if they have a significant financial interest related to the research B. No later than the time of proposal submission C. Not until a notice of award is received D. Never -- the PHS regulation does not require researchers to submit COI disclosures
No later than the time of proposal submission
According to federal regulations, the expedited review process may be used when the study procedures pose: A. No more than minimal risk and the research activities fall within regulatory categories identified as eligible. B. Any level of risk, but all the subjects are adults. C. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting. D. More than minimal risk, but the study replicates previously approved research.
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? A. Yes, they are engaged because the research is taking place at the clinic and they work there. B. Yes, they are engaged because they are interacting with potential research subjects and informing them about the study. C. No, they are not engaged because the research is not taking place at their clinic. D. 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.
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 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? A. Yes, this must be reported because it involved a subject in a research study and it is up to the IRB to determine if it was related to participation. B. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. C. No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study. D. Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm.
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
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.
Which of the following activities constitutes engagement in research? A. Providing potential subjects with written information about a study. B. Informing prospective subjects about the availability of research. C. Obtaining informed consent and conducting research interviews. D. Obtaining subjects' permission for researchers to contact them.
Obtaining informed consent and conducting research interviews.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? A. Officials of the institution may overrule an IRB approval. B. Officials of the institution may overturn an IRB disapproval. C. Department chairs can overturn an IRB disapproval. D. Institutional priorities take precedence over all IRB determinations.
Officials of the institution may overrule an IRB approval.
PPRA gives parents some level of control over their child's: A. Educational records B. Medical records C. Ability to opt out of health education (specifically, sexual health education) D. Participation in third-party survey research or exposure to instructional materials developed by researchers
Participation in third-party survey research or exposure to instructional materials developed by researchers
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: A. Persons with diminished autonomy should be excluded from research. B. Persons with diminished autonomy should only participate in no more than minimal risk research. C. Persons with diminished autonomy are entitled to protection. D. Persons involved in research cannot financially benefit.
Persons with diminished autonomy are entitled to protection.
The Belmont principle of beneficence requires that: A. Subjects derive individual benefit from study participation. B. Potential benefits justify the risks of harm. C. The study makes a significant contribution to generalizable knowledge. D. Risks are managed so that they are no more than minimal.
Potential benefits justify the risks of harm.
Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: A. Pregnant women, prisoners, children B. Prisoners, children, and elderly C. Pregnant women, prisoners, and mentally disabled D. Children, prisoners, and terminally ill
Pregnant women, prisoners, children
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? A.The elderly B. Adults with decisional impairments C. College students D. Prisoners
Prisoners
A medical record is an example of: A. Private information B. Private behavior C. Public information D. Public behavior
Private information
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? A. Within 48 hours B. Within 24 hours C. Promptly D. Within two weeks
Promptly
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: A. Give school principals the right to discuss students' behavioral problems with their parents. B. Allow school counselors to access students' grades. C. Provide parents certain rights over their children's educational records. D. Ensure that surveys do not ask school children to provide sensitive information about their parents.
Provide parents certain rights over their children's educational records.
As part of the consent process, the federal regulations require researchers to: A. Provide potential subjects with information at the appropriate reading comprehension level. B. Provide a list of the IRB members who reviewed the protocol. C. Describe penalties that may be imposed for non-participation. D. Recommend that potential subjects discuss their decision to participate with family members.
Provide potential subjects with information at the appropriate reading comprehension level.
The COI management plan aims to: A. Eliminate all COIs in research when a COI is disclosed B. Reduce IRB review burden when a COI is disclosed C. Address disclosure of COIs in multi-center research when a COI is disclosed D. Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
Census data (the final report as published by the Census Bureau) is an example of: A. Public Behavior B. Private Behavior C. Public Information D. Private Information
Public information
Additional safeguards that may be included in a social and behavioral study may include: A. Remove all direct identifiers from the data as soon as possible. B. Requiring a legally authorized representative to provide signed consent for an incapacitated subject. C. Frequent monitoring of the subject's heart through ECG after administration of the study drug. D. Requiring pregnancy tests before administration of the study drug
Remove all direct identifiers from the data as soon as possible.
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)? A. Research about aptitude testing B. Survey procedures C. Observation of public behavior when the researcher participates in the activities being observed D. Interviews
Research about aptitude testing
Which of the following are the three principles discussed in the Belmont Report? A. Respect for Persons, Beneficence, Justice B. Informed Consent, Institutional Assurance, Researcher Responsibility C. Privacy, Confidentiality, Equitable Selection of Subjects D. IRB Review, Federal Regulations, Declaration of Helsinki
Respect for Persons, Beneficence, Justice
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: A. Respect for persons B. Beneficence C. Justice
Respect for persons
What statement about risks in social and behavioral sciences research is most accurate: A. There are never any risks. B. If a study offers potential benefits, it is not necessary to minimize risks. C. Anonymizing data effectively manages the risk of creating emotional distress. D. Risks are specific to time, situation, and culture.
Risks are specific to time, situation, and culture.
Which author is normally responsible for sharing reprints of a publication with readers?
The corresponding author.
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? A. Using pseudonyms in research reports B. Using data encryption for stored files C. Waiving documentation of consent D. Securing a Certificate of Confidentiality
Securing a Certificate of Confidentiality
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: A. Situational cognitive vulnerability B. Capacity-related cognitive vulnerability C. Economic vulnerability D.Communicative vulnerability
Situational cognitive vulnerability
The specific Department of Health and Human Services (HHS) regulations that apply to research with children are known as: Subpart A: The Common Rule Subpart D: Additional Protections for Children Involved as Subjects in Research Subpart B: Additional Protections for Children Involved as Subjects in Research Subpart C: Protections for Children in Research
Subpart D: Additional Protections for Children Involved as Subjects in Research
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? A. 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. B. In the event of any distress you may have related to this research, you will be given access to appropriate resources.Your participation in this research is voluntary. C. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. D. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
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? A. The IRB will not review this study because it does not involve an investigational new device. B. The IRB will not review this study because it is not research as defined by the federal regulations. C. The IRB will review this study because it includes human subjects and is considered research. D. The IRB will not review this study because it does not include human subjects as defined by the federal regulations.
The IRB will not review this study because it is not research as defined by the federal regulations.
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? A. Stanford Prison Experiment (Zimbardo) B. Tearoom Trade Study (Humphreys) C. The T3 study D. The Public Health Service Study of Untreated Syphilis
The Public Health Service Study of Untreated Syphilis
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? A. The investigator does not havesignificant financial interest related to the grant because the consulting income is less than $5,000 B. The value of stock is not calculated when determining significant financial interests. C. The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest.D. The investigator does not have a significant financial interest related to the grant because the stock's value is less than $5,000.
The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest.
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? A. The financial interests of all faculty at an academic center. B. The conflicts of commitment of researchers funded by the U.S. Public Health Service. C. The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service. D. The financial interests of all research administrators at an academic center.
The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service.
The typical first main phase in response to a research misconduct allegation is called: A. Remediation B. The inquiry C. The adjudication D. The audit
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? A. Respondents are informed that investigators will try to keep their participation confidential; however, confidentiality cannot be assured. B. Respondents are informed that a research assistant will transfer all the research data to a password-protected computer that is not connected to the internet, via a USB flashdrive. The computer is located in a research team member's office. C. The investigator uses the informed consent process to explain her institution's method for guaranteeing absolute confidentiality of research data. D. 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.
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.
A waiver of the requirement for documentation of informed consent may be granted when: A. Potential subjects might find some of the research questions embarrassing, personal, or intrusive. B. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. C. The investigator has no convenient place to store signed consent forms separate from the research data. D. The subjects are literate in their own language; however, they do not read, write, or speak English.
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? A. A technician who collected the data. B. The organization that receives federal funding for a project. C. A faculty member working on a federally-funded project. D. A graduate student working under the direction of a faculty member.
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? A. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes. B. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission. C. 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. D. If it is the best interests of the community that the children participate in the study, parental permission is optional.
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: A. The research falls into one of eight categories of research activity described in the regulations. B. Participation in the research will involve ten minutes or less of the subjects' time. C. The researcher is experienced in the field of inquiry. D. All the subjects are adults and the risk is minimal.
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: A. The research involves the use of educational tests B. The children will be interviewed by the researcher. C. The children will be asked to complete a survey. D. The research with children will involve participant observation with researcher interaction.
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? A. The research must pose no more than minimal risk. B. The students must be offered an optional classroom activity. C. An independent consultant must approve the waiver. D. Parents must be notified that the study is taking place.
The research must pose no more than minimal risk.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? A. Using pseudonyms in reports removes the concern about any confidences shared in the group. B. If group members know each other confidentiality is not an issue. C. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality. D. The researcher cannot control what participants repeat about others outside the group.
The researcher cannot control what participants repeat about others outside the group.
One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should not be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher? A. Tell the subject to let prison authorities know that he is on an investigational medication that cannot be discontinued. B. The researcher should contact prison authorities about the medical issue , and report the events to the IRB of record. C. The researcher should remove the subject from the study because it was not approved for prison. D. The researcher should contact the judge in the case, asking that person to intervene.
The researcher should contact prison authorities about the medical issue , and report the events to the IRB of record.
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? A. There was neither a violation of privacy nor a breach of confidentiality. B. The subjects' privacy has been violated. C. Confidentiality of the data has been breached. D. There was both a violation of privacy and a breach of confidentiality.
There was neither a violation of privacy nor a breach of confidentiality.
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? A. This research would require full committee review because it involves children. B. This research would be eligible for expedited IRB review because the researcher is not interacting with the children and the playground is public. C. This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting. D. This research would be eligible for expedited IRB review because the researcher is participating in the activities observed
This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: A. Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk B. Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk C. Expected, related or possibly related to the research, suggests the research puts others at greater risk D. Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk
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? A. The new research would need full review by a convened IRB because children are a protected population. B. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors. C. 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. D. The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population.
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.
In the research context, the term validity most commonly refers to: A. Whether operationalized terms actually measure what they purport to measure. B. Whether funding has been obtained for the project. C. Whether a project is worth pursuing. D. Whether a project has been approved by an oversight board.
Whether operationalized terms actually measure what they purport to measure.
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? A. Will the researchers have collaborators at the research site abroad? B. Is the survey more than minimal risk? C. Does the professor speak Spanish fluently? D. Does the potential subject population include children?
Will the researchers have collaborators at the research site abroad?
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.
