CITI

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.

a. persons with diminished autonomy are entitled to protection

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

a. Privacy, Confidentiality, Equitable Selection of Subjects

b. Informed Consent, Institutional Assurance, Researcher Responsibility

c. Respect for Persons, Beneficence, Justice

d. IRB Review, Federal Regulations, Declaration of Helsinki

c. Respect for Persons, Beneficence, Justice

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 persons with diminished autonomy are protected.

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

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

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

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

A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?

a. Not Human Subjects

b. Determination for Exemption

c. Expedited Review

d. Convened Review

b. Determination for Exemption

Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with?

Select all that apply.

a. Reviewing manuscripts prior to submission for publication.

b. Protecting the rights and welfare of human subjects.

c. Reviewing subject recruitment materials and strategies.

d. Conducting inquiries into scientific misconduct.

e. Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.

b. Protecting the rights and welfare of human subjects.

c. Reviewing subject recruitment materials and strategies.

e. Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.

Identify one way faculty researchers can possibly avoid undue influence of student subjects?

a. Provide extra credit to those who participate

b. Offer more monetary compensation to those who participate

c. Conduct research for less than ten minutes during class

d. Avoid recruiting their own students in the research

d. Avoid recruiting their own students in the research

In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.

a. Declaration of Helsinki

*b. Belmont Report*

c. Nuremberg Code

d. Common Rule

d. Common Rule

Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)?

a. Expedited

b. Convened/Full Board

c. Exempt

c. Exempt

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply.

a. IRB Office

b. The Student Union

c. Export ControlOffice

d. Faculty Advisor/Research Mentor

a. IRB Office

d. Faculty Advisor/Research Mentor

Your informed consent form must describe _______.

a. All foreseeable risks and discomforts.

b. The names of all IRB members who reviewed the study.

c. The total budget for the research project.

d. The principal investigator's past research.

a. All foreseeable risks and discomforts.

Which of the following studies would need IRB approval?

a. Studies that use data collected for internal department use only and the aim of the study is quality improvement for the department only.

b. Studies that use publicly available census data from the years 1890-1910.

c. Studies collecting identifiable information about living individuals.

d. Studies that involve cadavers.

c. Studies collecting identifiable information about living individuals.

A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals’ careers. The student will collect identifiers. This study would be subject to which type of review?

a. Not Human Subjects

b. Convened Review

c. Determination for Exemption

d. Expedited Review

b. Convened Review

The researcher’s failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?

a. Milgram’s “Obedience to Authority” study

b. PHS Tuskegee study

c. "Tastes, Ties, and Time (T3)" study

d. Zimbardo’s “Stanford Prison Experiment”

c. "Tastes, Ties, and Time (T3)" study

The Belmont principle of beneficence requires that:

a. Subjects derive individual benefit from study participation.

b. The study makes a significant contribution to generalizable knowledge.

c. Risks to subjects are reasonable in relation to anticipated benefits.

d. Risks are managed so that they are no more than minimal.

c. Risks to subjects are reasonable in relation to anticipated benefits.

According to the *Belmont Report*, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:

a. Beneficence

b. Justice

c. Respect for persons

b. Justice

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. Providing detailed information about the study to potential subjects

c. Ensuring that risks are reasonable in relationship to anticipated benefits

d. Ensuring that the selection of subjects is fair

c. Ensuring that risks are reasonable in relationship to anticipated benefits

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. Respect for persons

c. Beneficence

b. Respect for persons

An example cited in the *Belmont Report* (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?

a. Beneficence

b. Justice

c. Respect for persons

b. Justice

A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the *Belmont Report*?

a. Beneficence

b. Justice

c. Respect for persons

b. Justice

A study was submitted to the IRB designed to evaluate the effect of background noise on an individual’s ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:

a. Beneficence

b. Respect for persons

c. Justice

b. Respect for persons

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. PHS Tuskegee Study

b. Stanford Prison Experiment (Zimbardo)

c. Tearoom Trade Study (Humphreys)

d. All of the above

e. None of the above

a. PHS Tuskegee Study

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:

a. Public information

b. Private behavior

c. Private information

d. Public behavior

a. Public information

A medical record is an example of:

a. Public information

b. Public behavior

c. Private information

d. Private behavior

c. Private information

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. Private information

b. Public information

c. Public behavior

d. Private behavior

c. Public behavior

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.

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 private information.

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

c. Observes public behavior.

d. Obtains, uses, studies, analyzes, or generates identifiable public information.

a. Obtains, uses, studies, analyzes, or generates identifiable private information.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

a. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine.

b. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.

c. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

d. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.

c. 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 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.

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 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.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

a. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

b. A feasibility study for implementing a year-round school program, focusing on economic issues such as facilities utilization and transportation costs.

c. 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.

d. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.

a. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

a. 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.

b. 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.

c. A researcher conducts a linguistic study of comments posted on a local public blog.

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

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

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. Institutional priorities take precedence over all IRB determinations.

d. Officials of the institution may overrule an IRB approval.

d. Officials of the institution may overrule an IRB approval.

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. Is not required unless additional risks have been identified.

d. Must occur within 12 months of the approval date.

d. Must occur within 12 months of the approval date.

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. The researcher is experienced in the field of inquiry.

c. All the subjects are adults and the risk is minimal.

d. The research falls into one of eight categories of research activity described in the regulations.

d. The research falls into one of eight categories of research activity described in the regulations.

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. College students

b. The elderly

c. Prisoners

d. Adults with decisional impairments

c. Prisoners

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

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

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

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

The primary purpose of a Certificate of Confidentiality is to:

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

b. Protect researchers from disclosing conflicts of interest.

c. Protect identifiable research information from compelled disclosure.

d. Allow law enforcement to investigate abuse cases.

c. Protect identifiable research information from compelled disclosure.

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

c. Obtain a Certificate of Confidentiality.

d. Code the subjects' responses.

a. Obtain a waiver of documentation of informed consent.

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. Research on the prevalence of retired individuals who have been harassed in different academic disciplines

c. A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers in the United States

d. A survey with educators on their experience about implementation of a novel preschool program

c. A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers in the United States

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

a. Frequent monitoring of the subject’s heart through ECG after administration of the study drug.

b. Requiring pregnancy tests before 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.

c. Remove all direct identifiers from the data as soon as possible.

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. Neither the magnitude or probability of harm.

b. Both the magnitude (or severity) and the probability (or likelihood) of harm.

c. Solely by the probability of expected harm.

d. Solely by the magnitude or severity of expected harm.

b. Both the magnitude (or severity) and the probability (or likelihood) of harm.

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. Experience emotional or psychological distress.

c. Feel that their privacy has been invaded.

d. Lose their employment.

b. Experience emotional or psychological distress.

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 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.

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

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

d. 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.

a. 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 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. In the event of any distress you may have related to this research, you will be given access to appropriate resources.

b. 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.

c. 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.

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.

c. 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 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 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.

b. 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.

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.

b. 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.

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. 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. 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.

As part of the consent process, the federal regulations require researchers to:

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

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

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

d. Provide a list of the IRB members who reviewed the protocol.

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

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

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

d. 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.

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

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:

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

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

c. Reporting data in aggregate form in publications resulting from the research.

d. Destroying all identifiers connected to the data.

e. All of the above

e. All of the above

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

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

c. Using pseudonyms in reports removes the concern about any confidences shared in the group.

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.

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 neither a violation of privacy nor a breach of confidentiality.

c. The subjects’ privacy has been violated.

d. There was both a violation of privacy and a breach of confidentiality.

b. There was neither a violation of privacy nor a breach of confidentiality.

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. Using data encryption for stored files

c. Waiving documentation of consent

d. Using pseudonyms in research reports

a. Securing a Certificate of Confidentiality

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 correct if the IRB chair is also the prisoner representative for the IRB.

b. Is correct because the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners.

c. 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.

d. Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.

d. Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.

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. Stop all research activities with the subject immediately.

b Notify OHRP and request an exception.

c. Withdraw the subject from the study and delete the collected data.

d. Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.

d. Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.

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. Investigating genetic biomarkers as predictors of intelligence.

d. Examining age at first arrest as a predictor of adult criminal history.

d. Examining age at first arrest as a predictor of adult criminal history.

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. 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.

b. Have made initial contact with potential subjects while they were in prison.

c. 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.

d. Stop because this type of study is not permitted under federal regulations.

c. 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.

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. Age appropriate.

b. Not an excessive incentive.

c. Educational.

d. Of high quality.

b. Not an excessive incentive.

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. All prisoners receive HIV testing.

c. A medical doctor serves as co-investigator.

d. The survey instrument is standardized.

a. Confidentiality of the prisoners' health status is maintained.

Which of the following statements about prison research is true?

a. It is permissible for risks to be higher than those that would be accepted by non-prisoners.

b. Participation in research can be considered during parole hearings.

c. Researchers may study the effects of privilege upgrades awarded by the prison.

d. The regulations prohibit compensating prisoners.

c. Researchers may study the effects of privilege upgrades awarded by the prison.

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. Not approve this project because the prisoners are merely a population of convenience for the student.

b. Approve this project but submit it for federal review.

c. Approve this project because the superintendent is the ultimate authority on what happens in his facility.

d. Approve this project since the risk appears to be no more than minimal.

a. Not approve this project because the prisoners are merely a population of convenience for the student.

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. Acceptable only when the researcher’s IRB grants a special waiver.

b. 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.

c. Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

d. A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher.

c. Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

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. Only subpart C applies because of the need for assent forms, as a result of *in loco parentis* status for juveniles

b. Subpart C still applies, as the potential subjects are juveniles

c. Both subparts apply, as these individuals are under the legal age of consent and are incarcerated

d. The need for the signatures of both parents outweighs the two subparts

c. Both subparts apply, as these individuals are under the legal age of consent and are incarcerated

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 not interacting with the children and the playground is public.

b. This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.

c. This research would require full committee review because it involves children.

d. This research would be eligible for expedited IRB review because the researcher is participating in the activities observed.

b. This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.

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. Parents must be notified that the study is taking place.

c. An independent consultant must approve the waiver.

d. The students must be offered an optional classroom activity.

a. The research must pose no more than minimal risk.

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 will be conducted.

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 was approved.

d. Persons who are under 21 years of age.

a. 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 provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

a. All research that is more than minimal risk

b. All research funded by HHS

c. All research involving children

d. All research funded by any federal agency

b. All research funded by HHS

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

a. True

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 research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.

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. 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. 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 statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

a. To protect minors documentation is always required.

b. Parents must approve written documentation.

c. Federal regulations do not require the documentation of minors' assent.

d. Documentation is required unless waived by an IRB.

c. Federal regulations do not require the documentation of minors' assent.

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 asked to complete a survey

c. The children will be interviewed by the researcher.

d. The research with children will involve participant observation with researcher interaction.

a. The research involves the use of educational tests

Parental notification, in lieu of active parental permission, is allowed when:

a. The researcher has conducted a similar study at another institution.

b. The superintendent of schools and the principals have approved the study.

c. An IRB has approved a waiver of the requirement for parental permission.

d. The researcher anticipates a low response rate.

c. An IRB has approved a waiver of the requirement for parental permission.

PPRA gives parents some level of control over their child’s:

a. Medical records

b. Participation in third-party survey research or exposure to instructional materials developed by researchers

c. Educational records

d. Ability to opt out of health education (specifically, sexual health education)

b. Participation in third-party survey research or exposure to instructional materials developed by researchers

If research in a private school is directly funded by the Department of Education, then:

a. PPRA only applies if the research is more than minimal risk.

b. PPRA does not apply.

c. PPRA only applies if the research is no more than minimal risk.

d. PPRA applies.

d. PPRA applies.

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 Protection of Pupil Rights Amendment.

c. The No Child Left Behind Act.

d. The Family Educational Rights and Privacy Act.

d. The Family Educational Rights and Privacy Act.

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. Interviews

b. Observation of public behavior when the researcher participates in the activities being observed

c. Research about aptitude testing

d. Survey procedures

c. Research about aptitude testing

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

a. Allow school counselors to access students' grades.

b. 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.

d. Give school principals the right to discuss students' behavioral problems with their parents.

c. Provide parents certain rights over their children's educational records.

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 they are interacting with potential research subjects and informing them about the study.

b. No, they are not engaged because the research is not taking place at their clinic.

c. 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. Yes, they are engaged because the research is taking place at the clinic and they work there.

c. No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.

A researcher 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 require review at the foreign site where it will be conducted.

b. If a proposed study qualifies for exemption, federal regulations do not 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, but still require review by the institutional official at the local site.

b. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

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. Does the professor speak Spanish fluently?

c. Is the survey more than minimal risk?

d. Does the potential subject population include children?

a. Will the researchers have collaborators at the research site abroad?

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 subjects' permission for researchers to contact them.

d. Obtaining informed consent and conducting research interviews.

d. Obtaining informed consent and conducting research interviews.

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. Ensuring that the consent process does not slow down the recruitment.

c. Maintaining confidentiality of responses to survey questions.

d. Including a witness signature line on the consent form.

a. In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

Which of the following is the least important activity when protecting human subjects in international research?

a. Determining if the research might present unique risks to subjects given local socio-economic conditions

b.Consulting with members of the community from which subjects will be recruited

c. Assessing transportation conditions

d. Considering local customs, norms, and laws

c. Assessing transportation conditions

What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?

a. 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.

b. Procedures in place to outline how unanticipated problems will be reported to the local IRB.

c. Procedures in place to ensure that the research complies with ethical principles (such as, the World Medical Association’s Declaration of Helsinki).

d. Procedures in place to outline how subjects will be randomized.

a. 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.

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 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.

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 linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings.

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.

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. Design the survey so that no direct or indirect identifiers are collected.

c. Comply with the survey software’s Terms of Service agreement.

d. Specify that all respondents must be legal adults.

b. Design the survey so that no direct or indirect identifiers are collected.

Revelations about the Facebook Emotional Contagion study highlights what key ethical consideration to conducting research using social media?

a. Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites’ terms of use.

b. Research using social media does not consider the ethical principal of justice.

c. Publicly available information on social media sites are not covered in the federal regulations.

d. Participants who use social media have expectations of privacy that may be at odds with the reality that their data is available publicly.

a. Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites’ terms of use.

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. Giving examples in the consent process of the kinds of questions that will be asked.

c. Including the institution's privacy policy on the survey site.

d. Providing a thorough debriefing at the end of the study.

a. Designing the survey so that subjects are not forced to answer one question before going to the next.

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 registers an account on Reddit to observe the way people interact with each other.

b. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

c. An investigator designs a computer program to extract work experience information from LinkedIn profiles.

d. An investigator analyzes user comments on articles posted on her university’s website.

b. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

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. Respondents are informed that investigators will try to keep their participation confidential; however, confidentiality cannot be assured.

d. The investigator uses the informed consent process to explain her institution’s method for guaranteeing absolute confidentiality of research data.

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.

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. People assume pseudonymous on-line identities, such as an avatar in an MMORPG.

b. Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.

c. Online studies do not require the documentation of informed consent.

d. 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.

What consideration should researchers take into account when designing an online study that presents participants with misleading information?

a. Researchers cannot guarantee that participants reached the end of the study, and read and understood the debrief.

b. Adding attention or logic checks can affect the way participants understand misleading information.

c. The prevalence of bots completing online studies makes it difficult for researchers to gather reliable data, thus unable to determine whether the manipulation was effective.

d. Participants can use a search engine to figure out the deception and effectively undo the manipulation.

a. Researchers cannot guarantee that participants reached the end of the study, and read and understood the debrief.

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

a. Data that does not cross state lines when disclosed by the covered entity.

b. Activities preparatory to research, with certain representations by the researcher.

c. Limited data set with an approved data use agreement.

d. Use of decedents’ information, with certain representations by the researcher.

a. Data that does not cross state lines when disclosed by the covered entity.

HIPAA includes in its definition of “research,” activities related to:

a. Development of generalizable knowledge.

b. Quality assessment and improvement.

c. Population health.

d. Anything a researcher does in a federally-supported laboratory.

a. Development of generalizable knowledge.

A HIPAA authorization has which of the following characteristics:

a. Cannot be combined with any other document related to the research.

b. Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

c. Is provided at the investigator’s discretion.

d. Cannot be revoked by the data subject.

b. Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

When required, the information provided to the data subject in a HIPAA disclosure accounting …

a. is always the same, regardless of the number of records involved.

b. is at the discretion of the organization, given its accounting policies.

c. is limited to the information elements the data subject specifically requests.

d. must be more detailed for disclosures that involve fewer than 50 subject records.

d. must be more detailed for disclosures that involve fewer than 50 subject records.

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally …

a. Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

b. Must meet HIPAA requirements only if the data collection is in a different jurisdiction (state) than the researcher accessing it.

c. Does not meet the definition of research, and so requires no HIPAA authorization or meeting one of the criteria for waiving authorization.

d. Is covered by Common Rule/FDA requirements, but not HIPAA’s.

a. Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

a. A designated security official (a.k.a., "Security Officer").

b. An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.

c. A designated privacy official (a.k.a., "Privacy Officer").

d. An organizational IRB or Privacy Board.

b. An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:

a. Identifiable health information that is created or held by covered entities and their business associates.

b. Identifiable health information that is created or held by covered entities and their business associates that operate across state lines.

c. Identifiable health information that is created or held by covered entities and their business associates, provided the data subject is a US citizen.

d. Any identifiable health information.

a. Identifiable health information that is created or held by covered entities and their business associates.

HIPAA’s protections for health information used for research purposes…

a. Supplement those of the Common Rule and FDA.

b. Replace those of the Common Rule and FDA for human subjects protection.

c. May be used at the institution’s discretion instead of the Common Rule and FDA protections.

d. Only apply to research conducted inside covered entities.

a. Supplement those of the Common Rule and FDA.

The HIPAA "minimum necessary" standard applies…

a. To all research where the data crosses state lines.

b. To all human subjects research.

c. To all human subjects research that uses PHI.

d. To all human subjects research that uses PHI without an authorization from the data subject.

d. To all human subjects research that uses PHI without an authorization from the data subject.

Recruiting into research …

a. Can qualify as an activity “preparatory to research,” at least for the initial contact, but data should not leave the covered entity.

b. Always requires a written authorization for ANY contact with the patient.

c. Never requires a written authorization.

d. Is entirely at the investigator’s discretion.

a. Can qualify as an activity “preparatory to research,” at least for the initial contact, but data should not leave the covered entity.