HTH 408 IRB APP EXAM QUESTIONS
AND ANSWERS
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?
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.
The therapist creates her clients' records; therefore, she does not need parents'
permission to use the information for research purposes.
If it is the best interests of the community that the children participate in the study,
parental permission is optional.
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. -
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.
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?
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.
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.
,In the event of any distress you may have related to this research, you will be given
access to appropriate resources.
The researcher may stop yo - 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.
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 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.
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.
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 study involving decision-making games in which s - Answer- 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:
The investigator has no convenient place to store signed consent forms separate from
the research data
The only record linking the subject and the research is the consent document and the
principal risk is a breach of confidentiality.
Potential subjects might find some of the research questions embarrassing, personal, or
intrusive
, The subjects are literate in their own language; however, they do not read, write, or
speak English - Answer- 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:
Provide potential subjects with information at the appropriate reading comprehension
level.
Recommend that potential subjects discuss their decision to participate with family
members.
Provide a list of the IRB members who reviewed the protocol.
Describe penalties that may be imposed for non-participation. - Answer- Provide
potential subjects with information at the appropriate reading comprehension level.
Data are made anonymous by:
Reporting data in aggregate form in publications resulting from the research.
Requiring all members of the research team to sign confidentiality agreements.
Keeping the key linking names to responses in a secure location.
Destroying all identifiers connected to the data. - Answer- Destroying all identifiers
connected to the data.
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?
The subjects' privacy has been violated.
Confidentiality of the data has been breached.
AND ANSWERS
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?
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.
The therapist creates her clients' records; therefore, she does not need parents'
permission to use the information for research purposes.
If it is the best interests of the community that the children participate in the study,
parental permission is optional.
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. -
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.
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?
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.
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.
,In the event of any distress you may have related to this research, you will be given
access to appropriate resources.
The researcher may stop yo - 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.
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 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.
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.
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 study involving decision-making games in which s - Answer- 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:
The investigator has no convenient place to store signed consent forms separate from
the research data
The only record linking the subject and the research is the consent document and the
principal risk is a breach of confidentiality.
Potential subjects might find some of the research questions embarrassing, personal, or
intrusive
, The subjects are literate in their own language; however, they do not read, write, or
speak English - Answer- 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:
Provide potential subjects with information at the appropriate reading comprehension
level.
Recommend that potential subjects discuss their decision to participate with family
members.
Provide a list of the IRB members who reviewed the protocol.
Describe penalties that may be imposed for non-participation. - Answer- Provide
potential subjects with information at the appropriate reading comprehension level.
Data are made anonymous by:
Reporting data in aggregate form in publications resulting from the research.
Requiring all members of the research team to sign confidentiality agreements.
Keeping the key linking names to responses in a secure location.
Destroying all identifiers connected to the data. - Answer- Destroying all identifiers
connected to the data.
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?
The subjects' privacy has been violated.
Confidentiality of the data has been breached.
