NIH FINAL EXAM QUESTIONS WITH
CORRECT ANSWERS!!
Substantial scientific uncertainty about which treatments will benefit subjects most, or a
lack of consensus in the field that one intervention is superior to another.
eqipoise- researchers must consider this due to beneficence
A state of "equipoise" is required for conducting research that may pose risks to research
participants.
if there is a definite understanding of the best treatment (meaning no equipoise) then no
research would need to be done
yeah
There are two standard treatments for autistic children who display a specific set of
characteristics. One treatment is a cognitive behavioral intervention, and the other is a
dietary and biomedical intervention. Both treatments have equally strong clinical evidence
supporting their efficacy. A researcher proposes a comparison of the two interventions to
determine which is preferable. The children will be randomized to one of two groups: half
of the children will receive the cognitive behavioral intervention and the other half of the
children will receive the dietary and biomedical intervention.
this study is in eqipoise
"free from unsanctioned intrusion."
privacy
holding secret all information relating to an individual, unless the individual gives consent
permitting disclosure.
confidentiality
who is responsible for privacy and confidentiality
the investigators
, After the conclusion of a clinical trial in a small rural community, an investigator is
anxious to publish findings. Understanding the NIH policies encouraging the reporting of
demographic differences in intervention effect, and concerned about protecting the
confidentiality of research participants, the investigator publishes only general
demographic data such as sex, age, state, and county. Is this an appropriate and acceptable
way to protect the confidentiality of research participants?
NO- you can not publish demographic data in a rural setting- only when the populaiton is large
enough
maintaining confidentiality is a matter of following some established practices, for
example:
Properly disposing of data sheets and other paper records
Limiting access to identified data; and/or
Storing research records in locked cabinets or secured databases
Research with coded private information or specimens does not involve human subjects if:
1. The private information or specimens were not collected specifically for the currently
proposed research project through an interaction or intervention with living individuals; and
2. The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded
private information or specimens pertain
You are an investigator proposing to use data from a colleague�s database to conduct
secondary analyses. You want to examine the behavior and attitudes in male spouses of
female business executives. Your colleague will provide coded data for your proposed
studies, and you and he enter into an agreement by which he will keep the key to the code
and will have no other involvement in the research. Therefore, your colleague is not an
investigator in your research. Does this involve human subjects
no
Institutional Review Boards (IRBs) are specialized committees required by ___ regulations
that safeguard the rights and welfare of human subjects
HHS
CORRECT ANSWERS!!
Substantial scientific uncertainty about which treatments will benefit subjects most, or a
lack of consensus in the field that one intervention is superior to another.
eqipoise- researchers must consider this due to beneficence
A state of "equipoise" is required for conducting research that may pose risks to research
participants.
if there is a definite understanding of the best treatment (meaning no equipoise) then no
research would need to be done
yeah
There are two standard treatments for autistic children who display a specific set of
characteristics. One treatment is a cognitive behavioral intervention, and the other is a
dietary and biomedical intervention. Both treatments have equally strong clinical evidence
supporting their efficacy. A researcher proposes a comparison of the two interventions to
determine which is preferable. The children will be randomized to one of two groups: half
of the children will receive the cognitive behavioral intervention and the other half of the
children will receive the dietary and biomedical intervention.
this study is in eqipoise
"free from unsanctioned intrusion."
privacy
holding secret all information relating to an individual, unless the individual gives consent
permitting disclosure.
confidentiality
who is responsible for privacy and confidentiality
the investigators
, After the conclusion of a clinical trial in a small rural community, an investigator is
anxious to publish findings. Understanding the NIH policies encouraging the reporting of
demographic differences in intervention effect, and concerned about protecting the
confidentiality of research participants, the investigator publishes only general
demographic data such as sex, age, state, and county. Is this an appropriate and acceptable
way to protect the confidentiality of research participants?
NO- you can not publish demographic data in a rural setting- only when the populaiton is large
enough
maintaining confidentiality is a matter of following some established practices, for
example:
Properly disposing of data sheets and other paper records
Limiting access to identified data; and/or
Storing research records in locked cabinets or secured databases
Research with coded private information or specimens does not involve human subjects if:
1. The private information or specimens were not collected specifically for the currently
proposed research project through an interaction or intervention with living individuals; and
2. The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded
private information or specimens pertain
You are an investigator proposing to use data from a colleague�s database to conduct
secondary analyses. You want to examine the behavior and attitudes in male spouses of
female business executives. Your colleague will provide coded data for your proposed
studies, and you and he enter into an agreement by which he will keep the key to the code
and will have no other involvement in the research. Therefore, your colleague is not an
investigator in your research. Does this involve human subjects
no
Institutional Review Boards (IRBs) are specialized committees required by ___ regulations
that safeguard the rights and welfare of human subjects
HHS
