Social & Behavioral Research - Basic/Refresher
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.
A. Officials of the institution may overrule an IRB approval.
The age of majority in international research is determined by the A. Laws, customs, and norms in the area in which the research will be conducted. B. Laws in the state where the researchers' institution resides. C. The research sponsor. D. Legal drinking age where the research will take place.
A. Laws, customs, and norms in the area in which the research will be conducted.
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.
A. Must occur within 12 months of the approval date.
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
If research in a private school is directly funded by the Department of Education, then: A. PPRA only applies if the research is no more than minimal risk. B. PPRA applies. C. PPRA does not apply. D. PPRA only applies if the research is more than minimal risk.
B. PPRA applies.
The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? A. "Tastes, Ties, and Time (T3)" study (2006-2009) B. The Tuskegee study C. Milgram's "Obedience to Authority" study D. Zimbardo's "Stanford Prison Experiment"
A. "Tastes, Ties and Time (T3)" study (2006-2009)
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
D. Prisoners
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
A.Medical vulnerability
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
B. Economic Vulnerability
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. Have the subject sign the consent form under an assumed name. B. Obtain a waiver of documentation of informed consent. C. Code the subjects' responses. D. Obtain a Certificate of Confidentiality.
B. Obtain a waiver of documentation of informed consent.
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, related or possibly related to the research, suggests the research puts subjects or others at greater risk C. Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts 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
B. Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk
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
C. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
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
C. Justice
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
C. Public Information
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 ensure that the research complies with ethical principles (such as, the World Medical Association's Declaration of Helsinki). C. Procedures in place to outline how unanticipated problems will be reported to the local IRB. D. 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 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.
A medical record is an example of: A. Private information B. Private behavior C. Public information D. Public behavior
A. Private information
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.
A. There was neither a violation of privacy nor a breach of confidentiality.
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
A. Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk
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
B. All research funded by HHS
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.
B. The IRB will not review this study because it is not research as defined by the federal regulations.
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.
B. The only record linking the subject and the research is the consent document and the principal risk is 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.
C. 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 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.
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.
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.
D. The researcher cannot control what participants repeat about others outside the group.
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. 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. A physician recruiting patients to be subjects B. An army medical officer recruiting subjects among lower ranks C. An employer recruiting among persons who directly report to them D. A college professor recruiting among their students
A. A physician recruiting patients to be subjects
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? A. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. B. A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings. C. A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time. D. A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her.
A. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
An example of an institutional COI is: A. An industry sponsor pays for the construction of a new research laboratory at the organization B. One of the organization's deans is the vice-chair of the organization's IRB C. 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 D. The organization gives scholarships to some post-doctoral researchers
A. 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 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.
A. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
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
A. Cognitive or communicative vulnerability
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. The survey instrument is standardized. C. A medical doctor serves as co-investigator. D. All prisoners receive HIV testing.
A. Confidentiality of the prisoners' health status is maintained.
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.
A. Design the survey so that no direct or indirect identifiers are collected.
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
A. Determined by the institution in its written policies and procedures
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. Directory information. B. Citizenship. C. Religious affiliation. D. SAT scores.
A. Directory information.
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
A. FERPA, PPRA, and Subpart D of the federal regulations
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.
A. In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
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.
A. No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
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
A. Pregnant women, prisoners, children
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.
A. Provide potential subjects with information at the appropriate reading comprehension level.
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
A. 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
A. 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
A. 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
A. Respect for persons
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
A. 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. 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.
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.
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.
A. The research falls into one of 8 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.
A. 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.
A. The research must pose no more than minimal risk.
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: A. There may be bias by the peer reviewer as to the area of research. B. Their connections to the journal may yield some concern C. They are not informed of the area of work D. The project has a limited scope
A. There may be bias by the peer reviewer as to the area of research.
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?
A. Will the researchers have collaborators at the research site abroad?
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. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs. D. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.
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.
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.
B. An IRB has approved a waiver of the requirement for parental permission.
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.
B. Both the magnitude (or severity) and the probability (or likelihood) of harm.
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.
B. Determining that the study has a maximization of benefits and a minimization of risks.
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
B. Ensuring that risks are reasonable in relationship to anticipated benefits
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.
B. Examining age at first arrest as a predictor of adult criminal history.
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.
B. Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
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
B. Institutional Review Board (IRB)
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: A. Are there adequate resources to conduct the study? B. Is there a power differential between researchers and subjects? C. Has the researcher completed required training? D. Are the research procedures greater than minimal risk of harm?
B. Is there a power differential between researchers and subjects?
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.
B. Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.
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
B. No later than the time of proposal submission
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 two weeks have passed. B. No, this does not need to be reported because it is unrelated to participation in the study. C. No, this does not need to be reported because the subject had the heart attack when they were home, not at the focus group. D. No, this does not need to be reported because the subject recovered.
B. 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 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.
B. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
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.
B. Potential benefits justify the risks of harm.
Which of the following statements about prison research is true? A. Participation in research can be considered during parole hearings. B. Researchers may study the effects of privilege upgrades awarded by the prison. C. The regulations prohibit compensating prisoners. D. It is permissible for risks to be higher than those that would be accepted by non-prisoners.
B. Researchers may study the effects of privilege upgrades awarded by the prison.
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.
B. The researcher should contact prison authorities about the medical issue , and report the events to the IRB of record.
According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? A. Physical control, coercion, undue influence, and neglect B. Coercion, undue influence, neglect, and disrespect C. Physical control, coercion, undue influence, and manipulation D. Prejudice, physical control, manipulation, and coercion
C. Physical control, coercion, undue influence, and manipulation
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. 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. B. A researcher conducts a linguistic study of comments posted on a local public blog. 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 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.
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.
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.
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. Design the survey so that no direct or indirect identifiers are collected. D. Specify that all respondents must be legal adults.
C. 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.
C. 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.
C. Destroying all identifiers connected to the data.
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.
C. 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 at the U.S. site by the institution's IRB. 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. D. 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.
C. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should: A. Approve this project since the risk appears to be no more than minimal. B. Approve this project but submit it for federal review. C. Not approve this project because the prisoners are merely a population of convenience for the student. D. Approve this project because the superintendent is the ultimate authority on what happens in his facility.
C. Not approve this project because the prisoners are merely a population of convenience for the student.
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.
C. Obtaining informed consent and conducting research interviews.
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.
C. Persons with diminished autonomy are entitled to protection.
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
C. Promptly
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.
C. Provide parents certain rights over their children's educational records.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? A. Subpart D of 45 CFR 46. B. The No Child Left Behind Act. C. The Family Educational Rights and Privacy Act. D. The Protection of Pupil Rights Amendment.
C. The Family Educational Rights and Privacy Act.
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.
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.
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.
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.
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? A. A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings. B. A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time. C. A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her. D. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
D. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
An example of an individual financial COI is: A. 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.
D. A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. 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. B. 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. C. 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. D. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
D. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
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
D. Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
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
D. Disclose their potential COI and may answer questions, but recuse themselves from voting
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: A.Lose their legal status. B. Lose their employment. C. Feel that their privacy has been invaded. D. Experience emotional or psychological distress.
D. Experience emotional or psychological distress.
Which is true of inducements in research? A. Like coercion, undue inducement is easy for IRBs to determine. B. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. C. Offering $10 for an hour long research study constitutes undue inducement. D. 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.
D. 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.
What is the term for management controls that are built in to a research study (for example, independent data analysis)? A. Mandated controls B. Required controls C. Objective controls D. Inherent controls
D. Inherent controls
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
D. Invasion of privacy, breach of confidentiality, and study procedures
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: A. The organization can have policies that affect the research B. The members of the advisory board know each other C. The research result could be flawed from missing data D. It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
D. It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
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. Deferential vulnerability B. Therapeutic misconception C. Economic vulnerability D. Medical vulnerability
D. Medical vulnerability
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.
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.
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 identifiable public information. B. Obtains, uses, studies, analyzes, or generates de-identified private information. C. Observes public behavior. D. Obtains, uses, studies, analyzes, or generates identifiable private information.
D. Obtains, uses, studies, analyzes, or generates identifiable private information.
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
D. Participation in third-party survey research or exposure to instructional materials developed by researchers
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
D. Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
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.
D. Risks are specific to time, situation, and culture.
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
D. Securing a Certificate of Confidentiality
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
D. The Public Health Service Study of Untreated Syphilis
