Citi Program

Citi Program

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	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?
Your answer	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.
Result	Correct
Comment	When a care provider becomes a researcher, both the child clients and their parents may not feel free to choose not to participate in the provider's study. A researcher who is also a care provider needs to be very clear that a decision not to participate in a study, or to allow records to be used, will not affect the care provided in the future. The fact that the therapist has access to her clients' records as a clinician does not entitle her to use information in the records for research purposes without parental permission and child assent. A school authority's permission to conduct the research does not replace the need for permission or assent. Finally, the children's right to choose cannot be overridden in the pursuit of an indeterminate community interest.

Question 2

Question	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?
Your answer	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.
Result	Correct
Comment	A statement in a consent form that says that subjects who agree to take part in the research waive their legal rights constitutes exculpatory language. Statements about the voluntary nature of consent, about the possible need to remove subjects from a study in order to protect their welfare, and statements about providing referrals do not waive subjects' rights.

Question 3

Question	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:
Your answer	A study in which subjects were assigned to study activities based on an undesirable or unflattering personal physical characteristic as assessed by members of the research team.
Result	Correct
Comment	If subjects were to learn that the research team assigned them to study conditions based on a perceived undesirable or unflattering personal physical characteristic, the knowledge that their appearance was judged negatively by the research team could be very distressing and, therefore, it would not be appropriate to inform subjects after the study about how they were assigned. In the other studies, informing subjects about the actual research procedures after the completion of the study would be unlikely to cause harm and would be appropriate.

Question 4

Question	A waiver of the requirement for documentation of informed consent may be granted when:
Your answer	The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
Result	Correct
Comment	The requirement to document informed consent can be waived if the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The requirement may also be waived if the study poses no more than minimal risk to subjects and involves no procedures for which written consent is normally required outside of the research context. With regard to non-English speakers, if documentation is required, investigators must provide informed consent materials in the subjects' language. If a researcher anticipates that subjects might be embarrassed by questions, this concern should be addressed in the consent process. Finally, identifying secure storage space for consent forms is an investigator's responsibility.

Question 5

Question	As part of the consent process, the federal regulations require researchers to:
Your answer	Provide potential subjects with information at the appropriate reading comprehension level.
Result	Correct
Comment	Researchers must provide information to subjects in a manner that facilitates comprehension. Therefore, the material must be written at the appropriate reading comprehension level. Researchers may not impose penalties for non-participation because to do so would violate the ethical principle of respect for persons. In some circumstances it may be appropriate to ask subjects to discuss the research with their families before making a decision about whether to participate, but it is not a regulatory requirement. Finally, researchers are not required to provide a list of the IRB members who reviewed the research.

Quiz Results

You correctly answered 4 of 5 quiz questions.

Question 1

Question	When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
Your answer	The researcher cannot control what participants repeat about others outside the group.
Result	Correct
Comment	It is not possible for a researcher to promise confidentiality in a focus group setting. Participants may choose to repeat sensitive information outside the group setting even if they have signed confidentiality agreements. This is true even if the participants know each other. Using pseudonyms in the report does not remove concerns about what group members might say outside the group.

Question 2

Question	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)?
Your answer	A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
Result	Incorrect
Correct Answer	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.
Comment	No agreements were made regarding confidentiality with the subjects who were unknowingly audio-taped; whose interactions were recorded, or whose cocaine use was revealed by another. Therefore, there was no breach of an agreement about confidentiality, but the subjects’ right to decide who can access their personal information was violated. If a researcher told subjects that only he or she would have access to identifiable data and then gives identifiable data to others that action constitutes a breach of confidentiality and a violation of privacy – the subjects’ right to control who has access to personal information.

Question 3

Question	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?
Your answer	Securing a Certificate of Confidentiality
Result	Correct
Comment	Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.

Question 4

Question	Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:
Your answer	All of the above
Result	Correct
Comment	Reporting data in aggregate form can help protect the identity of subjects (but does not make the data anonymous). Keeping keys in secure locations and requiring members of the research team to sign confidentiality agreements are methods for protecting identifiable information. Researchers can also remove all identifying information from the data and completely disconnect any links between the subjects and data about the subjects.

Question 5

Question	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?
Your answer	There was neither a violation of privacy nor a breach of confidentiality.
Result	Correct
Comment	The subjects’ privacy has not been violated because the identity of subjects was not included in the file. The confidentiality of the data has not been breached because the data could not be linked to identifiers. Therefore, the correct answer is that there was neither a violation of privacy nor a breach of confidentiality. The release of aggregate data with no identifiers does not constitute a violation of privacy or a breach of confidentiality.

Quiz Results

You correctly answered 3 of 5 quiz questions.

Question 1

Question	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:
Your answer	Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
Result	Correct
Comment	Because prisoners are vulnerable by their incarceration, it is necessary that research with prisoners does not impose further constraints on voluntariness of their decisions. Researchers must enhance the voluntariness of a prisoner’s consent by minimizing the influence of other people, especially staff or prisoners who may exercise arbitrary authority over these potential subjects. Subject selection needs to be fair within the population that potentially meets the study criteria. Using staff or prisoners to help select subjects leads to undue influence and coercion. This methodology is not “snowball sampling.” There is no waiver for this type of recruitment.

Question 2

Question	Which example of research with prisoners would be allowable under the regulations?
Your answer	Examining the use of financial incentives to improve compliance with dentist appointments.
Result	Incorrect
Correct Answer	Examining age at first arrest as a predictor of adult criminal history.
Comment	Examining age at first arrest is the correct answer. This reason for conducting research falls under the first category, “Study of the possible causes, effects, and processes of incarceration, and of criminal behavior.” Working with de-identified data, this study would be minimal risk – there is no intervention and the confidentiality risk is low. None of the other answers fall within one of the categories of allowable research. While these other studies have possible merit, there is no acceptable rationale for including prisoners. There is no benefit to the prisoners as individuals or as a group.

Question 3

Question	A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by an interview. The IRB must ensure that:
Your answer	Confidentiality of the prisoners' health status is maintained.
Result	Correct
Comment	By participating in the research, it is possible that subjects will become publicly identified as HIV-positive. This breach of confidentiality could lead to negative consequences for the prisoner. One method for the investigator to preserve this confidentiality is to interview a larger sample of offenders, some of whom are HIV-positive and some who are not. While the survey should be validated and reliable, it does not have to be standardized. Because the research is behavioral only, there is no need for a medical doctor. The prison's HIV testing procedures are not part of the study.

Question 4

Question	Which of the following statements about prison research is true?
Your answer	The regulations prohibit compensating prisoners.
Result	Incorrect
Correct Answer	Researchers may study the effects of privilege upgrades awarded by the prison.
Comment	Because studies of the effects of processes of incarceration are allowed under the regulations, researchers may study the effects of privilege upgrades awarded by the prison. The regulations do not prohibit payment of prisoners for their participation. However, the amount of compensation cannot constitute undue influence to participate. Many correctional institutions may prohibit payment. The decision to participate in research may not be considered during parole hearings, as this practice would clearly constitute undue influence to participate. The regulations require that IRBs determine that risks involved in research with prisoners are commensurate with risks that would be accepted by non-prison volunteers.

Question 5

Question	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:
Your answer	Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
Result	Correct
Comment	This population is considered doubly vulnerable due to their age and status as prisoners. Both subparts need to be carefully considered. There is no in loco parentis status for prisoners. Having a warden give consent would violate the basic tenets of informed consent. The regulations also prohibit the involvement of staff in prisoner selection for research. Parental signatures are not required.

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	Which example of research with prisoners would be allowable under the regulations?
Your answer	Examining age at first arrest as a predictor of adult criminal history.
Result	Correct
Comment	Examining age at first arrest is the correct answer. This reason for conducting research falls under the first category, “Study of the possible causes, effects, and processes of incarceration, and of criminal behavior.” Working with de-identified data, this study would be minimal risk – there is no intervention and the confidentiality risk is low. None of the other answers fall within one of the categories of allowable research. While these other studies have possible merit, there is no acceptable rationale for including prisoners. There is no benefit to the prisoners as individuals or as a group.

Question 2

Question	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:
Your answer	Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
Result	Correct
Comment	This population is considered doubly vulnerable due to their age and status as prisoners. Both subparts need to be carefully considered. There is no in loco parentis status for prisoners. Having a warden give consent would violate the basic tenets of informed consent. The regulations also prohibit the involvement of staff in prisoner selection for research. Parental signatures are not required.

Question 3

Question	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, which the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
Your answer	Not an excessive incentive.
Result	Correct
Comment	Mothers who may have recently separated from their children may find the prospect of doing something special for their children more important than making a considered decision about becoming a research subject. Thus the toys may be an undue influence to participate. The issue of the toys being educational, of high quality, and age appropriate are not the focus of the study. The IRB focus needs to be on any undue influence on the women.

Question 4

Question	A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by an interview. The IRB must ensure that:
Your answer	Confidentiality of the prisoners' health status is maintained.
Result	Correct
Comment	By participating in the research, it is possible that subjects will become publicly identified as HIV-positive. This breach of confidentiality could lead to negative consequences for the prisoner. One method for the investigator to preserve this confidentiality is to interview a larger sample of offenders, some of whom are HIV-positive and some who are not. While the survey should be validated and reliable, it does not have to be standardized. Because the research is behavioral only, there is no need for a medical doctor. The prison's HIV testing procedures are not part of the study.

Question 5

Question	Which of the following statements about prison research is true?
Your answer	Researchers may study the effects of privilege upgrades awarded by the prison.
Result	Correct
Comment	Because studies of the effects of processes of incarceration are allowed under the regulations, researchers may study the effects of privilege upgrades awarded by the prison. The regulations do not prohibit payment of prisoners for their participation. However, the amount of compensation cannot constitute undue influence to participate. Many correctional institutions may prohibit payment. The decision to participate in research may not be considered during parole hearings, as this practice would clearly constitute undue influence to participate. The regulations require that IRBs determine that risks involved in research with prisoners are commensurate with risks that would be accepted by non-prison volunteers.

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
Your answer	All research funded by HHS
Result	Correct
Comment	The provisions of Subpart D must be applied to all research funded by the HHS (which includes NIH). However, not all federal agencies that have adopted the Common Rule have also adopted Subpart D. In addition to HHS, only the U.S. Food and Drug Administration and the Department of Education have adopted it. Institutions may elect to apply the subpart to all research, regardless of the source of funding.

Question 2

Question	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.
Your answer	True
Result	Correct
Comment	The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children.

Question 3

Question	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?
Your answer	The research must pose no more than minimal risk.
Result	Correct
Comment	One of the four criteria for waiving parental permission is that the research must pose no more than minimal risk. Although it may be appropriate to notify parents that the study is taking place, and many researchers do so, it is not required by the regulations when a waiver of parental permission has been approved. While children must provide assent to participate, depending upon the age of the children there are multiple strategies for accommodating children who do not want to participate other than alternate classroom activities. It is not required that an independent consultant approve waivers of parental permission.

Question 4

Question	According to Subpart D, research with children may be eligible for exemption under Category 2 when:
Your answer	The research involves the use of educational tests
Result	Correct
Comment	Subpart D restricts the use of exemptions when children are research subjects. Research that involves interviews, surveys, or participant observation when the researcher interacts with the children is not eligible for exemption under Category 2.

Question 5

Question	According to federal regulations, “children” are defined as:
Your answer	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.
Result	Correct
Comment	According to the federal regulations, children are 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. Generally, though not always, the age of consent is the age at which minors reach the age of majority and are considered adults. In the United States, state law dictates the age of majority. In most states, the age of majority is 18. This means that a 17-year-old may be considered a child when applying the federal regulations for protecting research subjects.

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