CITI Modules
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A) A researcher conducts a linguistic study of comments posted on a local public blog. B) A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the U.S. between 1820-1845 to track the numbers of immigrants from certain ethnic groups. C) A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. D) A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.
A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention
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) In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees. C) A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. 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.
Which is an example of a situation where deferential vulnerability might be a factor? A) An employer recruiting among persons who directly report to them B) A physician recruiting patients to be subjects C) A college professor recruiting among their students D) An army medical officer recruiting subjects among lower ranks
A physician recruiting patients to be subjects
An example of an individual financial COI is: A) A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. B) A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza. C) 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. D) A researcher's spouse works at the same university as the researcher.
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 in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. B) 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. C) 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. D) 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.
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.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A) The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided. B) 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. C) An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information. D) A feasibility study for implementing a year-round school program, focusing on economic issues such as facilities utilization and transportation costs.
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.
Identify the example of when situation and time are key to assessing risk of harm in a research study: A) A study asking women if they have completed an advanced degree and what city they were born in B) A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers (who are underage to purchase tobacco) in the United States C) Research on the prevalence of retired individuals who have been harassed in different academic disciplines D) A survey with educators on their experience about implementation of a novel preschool program
A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers (who are underage to purchase tobacco) in the United States
Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include: 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. E) All of the above
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 HHS B) All research that is more than minimal risk C) All research involving children D) All research funded by any federal agency
All research funded by HHS
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A) An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. B) An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership. C) A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university. D) A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
An example of an institutional COI is: A) An industry sponsor pays for the construction of a new research laboratory at the organization B) The organization's president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the organization C) The organization gives scholarships to some post-doctoral researchers D) One of the organization's deans is the vice-chair of the organization's IRB
An industry sponsor pays for the construction of a new research laboratory at the organization
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 designs a computer program to extract work experience information from LinkedIn profiles. B) An investigator registers an account on Reddit to observe the way people interact with each other. C) An investigator analyzes user comments on articles posted on her university's website. D) An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals? A) Any procedure that would be painful to animals will likely not be painful in humans. B) Any procedure that would be painful for higher phylum species is likely to be less painful for lower phylum species. C) Any procedure that causes pain or distress in human beings may cause pain or distress in other animals. D)Any procedure with an animal is expected to involve some degree of pain
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: A) sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies B) Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies C) Researchers to annually self-disclose financial COIs to the FDA D) Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: A) Physical vulnerability B) Institutional vulnerability C) Economic or social vulnerability D) Cognitive or communicative vulnerability
Cognitive or communicative vulnerability
Which of the following is the least important activity when protecting human subjects in international research? A )Consulting with members of the community from which subjects will be recruited B) Assessing transportation conditions C) Determining if the research might present unique risks to subjects given local socio-economic conditions D) considering local customs, norms, and laws
Assessing transportation conditions
Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects? A) 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. B) Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted. C) Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual's social network. D) Downloading a publicly available dataset that includes high school students' academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states.
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: A) Confidentiality of the prisoners' health status is maintained. B) A medical doctor serves as co-investigator. C) All prisoners receive HIV testing. D) The survey instrument is standardized.
Confidentiality of the prisoners' health status is maintained.
To minimize potential risks of harm, a researcher conducting an on-line survey can: A) Suggest that subjects print a copy of the informed consent form for their records. B) Comply with the survey software's Terms of Service agreement. C) Specify that all respondents must be legal adults. D) Design the survey so that no direct or indirect identifiers are collected.
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) Designing the survey so that subjects are not forced to answer one question before going to the next. B) Providing a thorough debriefing at the end of the study. C) Including the institution's privacy policy on the survey site. D )Giving examples in the consent process of the kinds of questions that will be asked.
Designing the survey so that subjects are not forced to answer one question before going to the next.
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: A) Stated in the human subject protection regulations, but not in the drug or device regulations B) Determined by the institution in its written policies and procedures C) Included in the consent process D) Determined by research staff
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? A) Ensuring that the selection of subjects includes people from all segments of the population. B) Providing detailed information about the study and obtaining the subject's consent to participate. C) Ensuring that persons with diminished autonomy are protected. D) Determining that the study has a maximization of benefits and a minimization of risks.
Determining that the study has a maximization of benefits and a minimization of risks.
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: A) Disclose their potential COI, but not answer any questions about the study B) Disclose their potential COI and not participate in any action C) Disclose their potential COI and may answer questions, but recuse themselves from voting D) Leave the meeting immediately
Disclose their potential COI and may answer questions, but recuse themselves from voting
Which justification would an IACUC most likely accept if a research team plans to withhold pain relief (analgesia) from animals during a project? A) An explanation from the research team that the pain caused will be significant but temporary. B)That providing analgesia will add expense to the project. C)That it is inconvenient for the research team to provide analgesia. D) Documented evidence that the analgesic agent will interfere with the aims of the project.
Documented evidence that the analgesic agent will interfere with the aims of the project.
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 the selection of subjects is fair C) Providing detailed information about the study to potential subjects D) Ensuring that risks are reasonable in relationship to anticipated benefits
Ensuring that risks are reasonable in relationship to anticipated benefits
Which example of research with prisoners would be allowable under the regulations? A) Determining safety of a new formulation of deodorant. B) Examining the use of financial incentives to improve compliance with dentist appointments. C) Examining age at first arrest as a predictor of adult criminal history. D) Investigating genetic biomarkers as predictors of intelligence.
Examining age at first arrest as a predictor of adult criminal history.
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 )FERPA and Subpart D of the federal regulations D) PPRA and Subpart D of the federal regulations
FERPA, PPRA, and Subpart D of the federal regulations
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) to protect minors documentation is always required. C) Federal regulations do not require the documentation of minors' assent. D) Parents must approve written documentation.
Federal regulations do not require the documentation of minors' assent.
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? A) If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted, but still require review by the institutional official at the local site. B) If a proposed study qualifies for exemption, federal regulations do require review at the foreign site where it will be conducted. C) If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted but still require review at the U.S. site by the institution's IRB. D) If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted but still require review at the U.S. site by the institution's IRB.
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?
Which is true of inducements in research? A) Like coercion, undue inducement is easy for IRBs to determine. B) 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. C) Offering $10 for an hour long research study constitutes undue inducement. D) Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons.
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.
Researchers must report potential unanticipated problems that involve risks to others directly to the: A) HIPAA Compliance Officer B) Institutional Review Board (IRB) C) American Psychological Association D) Institutional Risk Manager
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
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? A) An investigation B) Mediation C) Arbitration D) The resolution
Investigation
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: A) Is wrong because the chair is the only person who can determine that a study is exempt from further review. It is not the researcher's call B) Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners. C) is correct because the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners. D) 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 requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: A) Justice B) Beneficence C) Respect for persons
Justice
The age of majority in international research is determined by the A) Legal drinking age where the research will take place. B) Laws in the state where the researchers' institution resides. C) Laws, customs, and norms in the area in which the research will be conducted. D) The research sponsor.
Laws, customs, and norms in the area in which the research will be conducted.
According to the U.S. Federal Research Misconduct Policy, fabrication involves: A) Making up data or results and recording or reporting them. B) Using another person's ideas or words without giving appropriate credit. C) Mismanaging research funds. D) Failing to list a collaborator as an author.
Making up data or results and recording or reporting them.
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: A) Must be conducted by a convened IRB. B) Is limited to review of unanticipated problems. C) Must occur within 12 months of the approval date. D) Is not required unless additional risks have been identified.
Must occur within 12 months of the approval date.
According to federal regulations, the expedited review process may be used when the study procedures pose: A) More than minimal risk, but the study replicates previously approved research. 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) No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
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? A) No, this does not need to be reported because the subject recovered. B) No, this does not need to be reported because the subject had the heart attack when they were home, not at the focus group. C) No, this does not need to be reported because it is unrelated to participation in the study. D) No, this does not need to be reported because two weeks have passed.
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? A) 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. B) 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. C) No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study. D) No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
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: A) Educational B) Not an excessive incentive. C) Of high quality D)Age appropriate.
Not an excessive incentive.
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? A) Notify OHRP and request an exception. B) Withdraw the subject from the study and delete the collected data. C) Stop all research activities with the subject immediately. D )Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: A) Obtain a waiver of documentation of informed consent. B) Obtain a Certificate of Confidentiality. C) Code the subjects' responses. D) Have the subject sign the consent form under an assumed name.
Obtain a waiver of documentation of informed consent.
Which of the following activities constitutes engagement in research? A) Informing prospective subjects about the availability of research. B) Obtaining informed consent and conducting research interviews. C) Providing potential subjects with written information about a study. D) Obtaining subjects' permission for researchers to contact them.
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: A) Obtains, uses, studies, analyzes, or generates de-identified private information. B) Obtains, uses, studies, analyzes, or generates identifiable public information. C) Observes public behavior. D) Obtains, uses, studies, analyzes, or generates identifiable private information.
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? A) Officials of the institution may overrule an IRB approval. B) Institutional priorities take precedence over all IRB determinations. C) Officials of the institution may overturn an IRB disapproval. D) Department chairs can overturn an IRB disapproval.
Officials of the institution may overrule an IRB approval.
Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection? A) Tearoom Trade Study (Humphreys) B) PHS Tuskegee Study C) Stanford Prison Experiment (Zimbardo) D)All of the above E) None of the above
PHS Tuskegee Study
If research in a private school is directly funded by the Department of Education, then: A) PPRA does not apply. B) PPRA only applies if the research is no more than minimal risk. C) PPRA applies. D) PPRA only applies if the research is more than minimal risk.
PPRA applies.
According to federal regulations, "children" are defined as: A) Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved. B) Persons who are under 18 years of age. C)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. D) Persons who are under 21 years of age.
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 are entitled to protection. B) Persons with diminished autonomy should be excluded from research. C) Persons with diminished autonomy should only participate in no more than minimal risk research. D) Persons involved in research cannot financially benefit.
Persons with diminished autonomy are entitled to protection.
According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct? A) Conflict of interest B) Gift authorship C) Harassing a co-worker D) Plagiarism
Plagiarism
Which type of inappropriate practice most likely occurred if a researcher takes credit for someone else's idea and does not acknowledge the original source? A) Fabrication B) Plagiarism C) Conflict of interest D) Falsification
Plagiarism
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, and mentally disabled B) Pregnant women, prisoners, children C) Children, prisoners, and terminally ill D) Prisoners, children, and elderly
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 )Adults with decisional impairments B) The elderly C) College students D) Prisoners
Prisoners
What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency? A) Procedures in place to outline how subjects will be randomized. B) Procedures in place to outline how unanticipated problems will be reported to the local IRB. C) 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. D) Procedures in place to ensure that the research complies with ethical principles (such as, the World Medical Association's Declaration of Helsinki).
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 primary purpose of a Certificate of Confidentiality is to: A) Protect researchers from disclosing conflicts of interest. B) Protect identifiable research information from compelled disclosure. C) Allow law enforcement to investigate abuse cases. D) Prevent subjects from knowing the purpose of a study.
Protect identifiable research information from compelled disclosure.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: A) Ensure that surveys do not ask school children to provide sensitive information about their parents. B) Provide parents certain rights over their children's educational records. C) Give school principals the right to discuss students' behavioral problems with their parents. D) Allow school counselors to access students' grades.
Provide parents certain rights over their children's educational records.
As part of the consent process, the federal regulations require researchers to: A) Provide a list of the IRB members who reviewed the protocol. B) Recommend that potential subjects discuss their decision to participate with family members. C) Describe penalties that may be imposed for non-participation. D) Provide potential subjects with information at the appropriate reading comprehension level.
Provide potential subjects with information at the appropriate reading comprehension level.
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: A) Public information B) Public behavior C) Private information D) Private behavior
Public behavior
Researchers designing online studies should consider the following with respect to participant protections. A ) There is no one, right way to secure informed consent online. B) Re-identification methods are unique to internet-based research. C) Online sites and services (such as social media platforms) require users to agree to their individual terms of use. D) The prevalence of artificial intelligence (e.g., avatars and bots) make it hard to determine which online users are living humans.
Re-identification methods are unique to internet-based research.
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) Survey procedures B) Research about aptitude testing C) Observation of public behavior when the researcher participates in the activities being observed D) Interviews
Research about aptitude testing
Which of the following statements about prison research is true? A) Participation in research can be considered during parole hearings. B) The regulations prohibit compensating prisoners C) It is permissible for risks to be higher than those that would be accepted by non-prisoners. D) Researchers may study the effects of privilege upgrades awarded by the prison.
Researchers may study the effects of privilege upgrades awarded by the prison.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Person, 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) Justice B) Beneficence C) Respect for persons
Respect for persons
What statement about risks in social and behavioral sciences research is most accurate: A) Anonymizing data effectively manages the risk of creating emotional distress. B) If a study offers potential benefits, it is not necessary to minimize risks. C) Risks are specific to time, situation, and culture. D) There are never any risks.
Risks are specific to time, situation, and culture.
The Belmont principle of beneficence requires that: A) The study makes a significant contribution to generalizable knowledge. B) Risks to subjects are reasonable in relation to anticipated benefits. C) subjects derive individual benefit from study participation. D) Risks are managed so that they are no more than minimal.
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? A) Waiving documentation of consent B) Using data encryption for stored files C) Using pseudonyms in research reports 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) Economic vulnerability B) Capacity-related cognitive vulnerability C) Situational cognitive vulnerability D) Communicative vulnerability
Situational cognitive vulnerability
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) 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. B) Your participation in this research is voluntary. 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. C) In the event of any distress you may have related to this research, you will be given access to appropriate resources. D) 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.
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 is not research as defined by the federal regulations. B) The IRB will not review this study because it does not include human subjects 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 involve an investigational new device.
The IRB will not review this study because it is not research as defined by the federal regulations.
Which entity is responsible for monitoring institutional compliance with PHS Policy? A) The Centers for Disease Control and Prevention (CDC) B) The Fish and Wildlife Service C) The Environmental Protection Agency D) The Office of Laboratory Animal Welfare (OLAW)
The Office of Laboratory Animal Welfare (OLAW)
Which of the following is true regarding the use of animals in research? A) The attending veterinarian must be allowed to have access to all research animals at all times. B) U.S. regulations require veterinary review of protocols involving primates but not other types of animal species. C) IACUC review is required for animal research funded by the USDA but not for animal research funded by other branches of the federal government. D) The meetings where an IACUC reviews animal research protocols must be open to anyone who wants to attend.
The attending veterinarian must be allowed to have access to all research animals at all times.
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 a research assistant will download all the research data to a password-protected computer located in a research team member's office. The data will then be uploaded to a secure cloud-based server. B) 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. C) The investigator uses the informed consent process to explain her institution's method for guaranteeing absolute confidentiality of research data. D) Respondents are informed that investigators will try to keep their participation confidential; however, confidentiality cannot be assured.
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 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) If it is the best interests of the community that the children participate in the study, parental permission is optional. B)The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes. C) 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. D) 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.
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 researcher is experienced in the field of inquiry. B) Participation in the research will involve ten minutes or less of the subjects' time. C) The research falls into one of eight categories of research activity described in the regulations. 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 children will be interviewed by the researcher. B) The research with children will involve participant observation with researcher interaction. C) The research involves the use of educational tests D) The children will be asked to complete a survey
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 students must be offered an optional classroom activity. B) Parents must be notified that the study is taking place. C) The research must pose no more than minimal risk. D) An independent consultant must approve the waiver.
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) The researcher cannot control what participants repeat about others outside the group. B) If group members know each other confidentiality is not an issue. C) Using pseudonyms in reports removes the concern about any confidences shared in the group. D) If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
The researcher cannot control what participants repeat about others outside the group.
Which scenario best describes a researcher making thoughtful considerations in the design of their informed consent process on an online study? A) The researcher will ask for a waiver of informed consent because the prevalence of bots completing online studies means there is no certain way to secure informed consent form actual research participants. B) The researcher will ask for a waiver to document informed consent because participation in the study is limited to non-playable characters (NPCs) or avatars designed and controlled by artificial intelligence. C) The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, "If you agree to be in this study click below to begin." D) The researcher will ask for a waiver of informed consent because prospective participants are individuals registered in an on-line panels, thus they have already given their consent to be a research participant.
The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, "If you agree to be in this study click below to begin."
Which of the following most clearly illustrates Russell and Burch's Replacement concept? A) The use of a new analgesic that provides better postoperative pain relief. B) The use of computer modeling software instead of using animals in an experiment. C) The use of a smaller number of animals than was originally planned. D) The use of newer surgical techniques that result in less tissue trauma.
The use of computer modeling software instead of using animals in an experiment.
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 be eligible for expedited IRB review because the researcher is participating in the activities observed. B) This research would require full committee review because it involves children C) .This research would be eligible for expedited IRB review because the researcher is not interacting with the children and the playground is public. D) This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
Which of the following is true regarding the U.S. Federal Research Misconduct Policy? A) The standard of innocent until proven guilty does not apply in misconduct cases. B) To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly. C) The Policy covers conflicts of interest and the misuse of grant funding. D) Misconduct must be proven beyond a reasonable doubt.
To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? A) SAT scores B) Religious affiliation C) Citizenship D) Directory information.
directory information
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: A) Expected, related or possibly related to the research, suggests the research puts others at greater risk B)Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk C) Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk D) Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or 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) 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. B) The new research would need full review by a convened IRB because children are a protected population. C) 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. D) the research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.
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.
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: A) Stop because this type of study is not permitted under federal regulations. B) 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. C) Have made initial contact with potential subjects while they were in prison. D) Obtain the permission of the Parole Board to ensure that no negative consequences will happen to those who decline to take part, and who return to prison.
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.
What is the term for management controls that are built in to a research study (for example, independent data analysis)? A) Required controls B) Inherent controls C) Mandated controls D) Objective controls
inherent controls
A medical record is an example of: A) Public behavior B) Public information C) Private behavior D) Private information
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 24 hours B) Promptly C) Within two weeks D) Within 48 hours
promptly
The COI management plan aims to: A) provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed B) Address disclosure of COIs in multi-center research when a COI is disclosed C) Eliminate all COIs in research when a COI is disclosed D) Reduce IRB review burden when a COI is disclosed
provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
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
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? A)Sponsor B) Organization C) Applicants submitting marketing applications for drugs, biologics, or devices D) Researcher E) IRB Member
researcher
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? A) the Protection of Pupil Rights Amendment B) the Family Educational Rights and Privacy Act. C) The No Child Left Behind Act D) Subpart D of 45 CFR 46.
the Family Educational Rights and Privacy Act.
A waiver of the requirement for documentation of informed consent may be granted when: A) The subjects are literate in their own language; however, they do not read, write, or speak English. B) Potential subjects might find some of the research questions embarrassing, personal, or intrusive. C) the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. D) The investigator has no convenient place to store signed consent forms separate from the research data.
the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
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. A) True B) False
true
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: A) A valid use of a statistical technique referred to "snowball sampling" wherein the inclusion of the first subject leads to the recruitment of another one subject. B) Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners. C) Acceptable only when the researcher's IRB grants a special waiver. D) A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher.
wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
