Researchers must report potential unanticipated problems that involve risks to others directly to:

Researchers must report potential unanticipated problems that involve risks to others directly to:

Institutional Risk Manager


American Psychological Association


HIPAA Compliance Officer


Institutional Review Board (IRB)


Answer: 

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?

Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm.


Yes, this must be reported because it involved a subject in a research study and it's up to the IRB to determine if it was related to participation.


No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.


No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study.


Answer: No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

Researchers must report potential unanticipated problems that involve risks to others directly to:

Researchers must report potential unanticipated problems that involve risks to others directly to:

Institutional Risk Manager


American Psychological Association


HIPAA Compliance Officer


Institutional Review Board (IRB)


Answer: Institutional Review Board (IRB)

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?

Promptly


Within 48 hours


Within 24 hours


Within two weeks


Answer: Promptly

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk


Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk


Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk


Expected, related or possible related to the research, suggests the research puts others at greater risk


Answer: Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk

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

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

All research involving children


All research that is more than minimal risk


All research funded by any federal agency


All research funded by HHS


Answer: All research funded by HHS

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Stated in the human subject protection regulations, but not in the drug or device regulations


Included in the consent process


Determined by research staff


Determined by the institution in its written policies and procedures


Answer: Determined by the institution in its written policies and procedures

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHS regulations, the researcher report this event to the IRB?

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHS regulations, the researcher report this event to the IRB?

No, this does not need to be reported since the subject had the heart attack when they were home, not at the focus group.


No, this does not need to be reported since it is unrelated to participation in the study.


No, this does not need to be reported because two weeks have passed.


No, this does not need to be reported since the subject recovered.


Answer: No, this does not need to be reported since it is unrelated to participation in the study.

According to federal regulations, "children" are defined as:

According to federal regulations, "children" are defined as:

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved.


Persons who are under 18 years of age.


Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.


Persons who are under 21 years of age.


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.

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 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?

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.


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


The new research would need full review by a convened IRB because children are a protected population.


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.


Answer: 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.

According to Subpart D, research with children may be eligible for exemption when:

According to Subpart D, research with children may be eligible for exemption when:

The children will be asked to complete a survey


The research involves the use of educational tests


The children will be interviewed by the researcher.


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


Answer: The research involves the use of educational tests

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:

Is wrong since the chair is the only person who can determine that a study is exempt from further review. It is not the researcher's call.


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


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


Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.


Answer: Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?

This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.


This research would require full committee review since it involves children.


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


This research would be eligible for expedited IRB review since the researcher is not interacting with the children and the playground is public.


Answer: This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.

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

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

Parents must approve written documentation.


Documentation is required unless waived by an IRB.


To protect minors documentation is always required.


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


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

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 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?

Parents must be notified that the study is taking place.


An independent consultant must approve the waiver.


The students must be offered an optional classroom activity.


The research must pose no more than minimal risk.


Answer: The research must pose no more than minimal risk.

The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:

The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:

Subpart B: Additional Protections for Children Involved as Subjects in Research


Subpart A: The Common Rule


Subpart D: Additional Protections for Children Involved as Subjects in Research


Subpart C: Protections for Children in Research


Answer: Subpart D: Additional Protections for Children Involved as Subjects in Research

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 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 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.


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


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


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


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

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 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:

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


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


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


Approve this project but submit it for federal review.


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

Which example of research with prisoners would be allowable under the regulations?

Which example of research with prisoners would be allowable under the regulations?

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


Examining the use of financial incentives to improve compliance with dentist appointments.


Investigating genetic biomarkers as predictors of intelligence.


Determining safety of a new formulation of deodorant.


Answer: 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 getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C since 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.


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


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.


Stop since this type of study is not permitted under CRS 42.44.101.


Answer: Do nothing in regards the Subpart C since 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.