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1

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 only participate in no more than minimal risk research.

B) Persons involved in research cannot financially benefit.

C) Persons with diminished autonomy should be excluded from research.

D) Persons with diminished autonomy are entitled to protection.

Answer: D

2

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

A) Informed Consent, Institutional Assurance, Research Responsibility

B) Privacy, Confidentiality, Equitable Selection of Subjects

C) IRB Review, Federal Regulations, Declaration of Helsinki

D) Respect for Persons, Beneficence, Justice

Answer: D

3

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

A) Ensuring that persons with diminished autonomy are protected.

B) Ensuring that the selection of subjects includes people from all the segments of the population.

C) Providing detailed information about the study and obtaining the subject's consent to participate.

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

Answer: D

4

The Belmont principle of beneficence requires that:

A) Subjects derive individual benefit from study participation.

B) Potential benefits justify the risks of harm.

C) Risks are managed so that they are no more than minimal.

D) The study makes a significant contribution to generalizable knowledge.

Answer: B

5

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

A) Providing detailed information about the study to potential subjects

B) Ensuring that subjects understand that participation is voluntary

C) Ensuring that the selection of subjects is fair

D) Ensuring that the risks are reasonable in relationship to anticipated benefits

Answer: D

6

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

A) Milgram's "Obedience to Authority" study

B) Zimbardo's "Stanford Prison Experiment"

C) "Tastes, Ties, and Time (T3)" study (2006-2009)

D) The Tuskegee study

Answer: C

7

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

A) Justice

B) Respect for Persons

C) Beneficence

Answer: A

8

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

Answer: C

9

A student is conducting a research project that involves using a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?

A) Not Human Subjects

B) Expedited Review

C) Exempt Review

D) Full Board Review

Answer: C

10

Per federal regulations, which of the following elements must be included in an informed consent document?

A) A listing of the principal investigator's past research.

B) The location where the research activities will occur.

C) Compensation for research activities.

D) All foreseeable risks and discomforts.

Answer: D

11

A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plan to collect data about the personal experiences the principals have had with disruptive students, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?

A) Expedited Review

B) Exempt Review

C) Not Human Subjects

D) Full Board Review

Answer: D

12

How can faculty researchers avoid undue influence of student subjects?

A) Conduct research for less than 10 minutes during class so as to not take up much class time

B) Provide extra credit to those who participate

C) Offer more monetary compensation

D) Avoid using their own students in their research

Answer: D

13

Which type of IRB review does not require IRB approval but does require a determination by the IRB or an IRB designee?

A) Full/Convened Board

B) Exempt

C) Expedited

Answer: B

14

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) Observes public behavior.

B) Obtains, uses, studies, analyzes, or generates identifiable private information.

C) Obtains, uses, studies, analyzes, or generates identifiable public information.

D) Obtains, uses, studies, analyzes, or generates de-identified private information.

Answer: B

15

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) 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.

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 a report for its membership.

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.

Answer: A

16

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.

Answer: A

17

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 developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

C) 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.

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.

Answer: B

18

A medical record is an example of:

A) Public behavior

B) Private behavior

C) Public information

D) Private information

Answer: D

19

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

A) Department chairs can overturn an IRB disapproval.

B) Officials of the institution may overturn an IRB disapproval.

C) Officials of the institution may overrule an IRB approval.

D) Institutional priorities take precedence over all IRB determinations.

Answer: C

20

According to federal regulations, the expedited review process may be used when the study procedures pose:

A) Any level of risk, but all the subjects are adults.

B) A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.

C) More than minimal risk. but the study replicates previously approved research.

D) No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

Answer: D

21

According to the federal regulations, research is eligible for exemption, if:

A) Participation in the research will involve ten minutes or less of the subjects' time.

B) All the subjects are adults and the risk is minimal.

C) The research is experienced in the field of inquiry.

D) The research falls into one of eight categories of research activity describe in the regulations.

Answer: D

22

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) Prisoners

B) College students

C) The elderly

D)) Adults with decisional impairments

Answer: A

23

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 not required unless additional risks have been identified.

C) Is limited to review of unanticipated problems.

D) Must occur within 12 months of the approval date.

Answer: D

24

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

A) Risks are specific to time, situation, and culture.

B) If a study offers potential benefits, it is not necessary to minimize risks.

C) There are never any risks.

D) Anonymizing data effectively manages the risk of creating emotional distress.

Answer: A

25

The primary purpose of a Certificate of Confidentiality is to:

A) Protect identifiable research information from compelled disclosure.

B) Allow law enforcement to investigate abuse cases.

C) Protect researchers from disclosing conflicts of interest.

D) Prevent subjects from knowing the purpose of a study.

Answer: A

26

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 Certificate of Confidentiality.

B) Obtain a waiver of documentation of informed consent.

C) Code the subjects' responses.

D) Have the subject sign the consent form under an assumed name.

Answer: B

27

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) Feel that their privacy has been invaded.

B) Lose their legal status.

C) Experience emotional or psychological distress.

D) Lose their employment.

Answer: C

28

Additional safeguards that may be included in a social and behavioral study may include:

A) Requiring pregnancy tests before administration of the study drug.

B) Frequent monitoring of the subject's heart through ECG after administration of the study drug.

C) Remove all direct identifiers from the data as soon as possible.

D) Requiring a legally authorized representative to provide signed consent for an incapacitated subject.

Answer: C

29

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 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.

B) 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.

C) The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes.

D) If it is the best interests of the community that the children participate in the study, parental permission is optional.

Answer: B

30

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.

C) 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.

D) 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.

Answer: A

31

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.

Answer: C

32

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.

Answer: C

33

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) Describe penalties that may be imposed for non-participation.

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

D)Recommend that potential subjects discuss their decision to participate with family members.

Answer: C

34

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 asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.

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, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.

Answer: A

35

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) Confidentiality of the data has been breached.

B) There was both a violation of privacy and a breach of confidentiality.

C) The subjects’ privacy has been violated.

D) There was neither a violation of privacy nor a breach of confidentiality.

Answer: D

36

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) The researcher cannot control what participants repeat about others outside the group.

C) If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.

D) If group members know each other confidentiality is not an issue.

Answer: B

37

Data are made anonymous by

A) Keeping the key linking names to responses in a secure location.

B) Reporting data in aggregate form in publications resulting from the research.

C) Destroying all identifiers connected to the data.

D) Requiring all members of the research team to sign confidentiality agreements.

Answer: C

38

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) Securing a Certificate of Confidentiality

B) Waiving documentation of consent

C) Using pseudonyms in research reports

D) Using data encryption for stored files

Answer: A