NIH EXAM ALL QUESTIONS WITH
CORRECT ANSWERS!!
simply agreeing to be a participant in research, or disclosure of findings from a research
study may bring harm to the subject? True or False
True.
These categories all involve what?
physical
psychological
social
legal
economic
risks to subjects in research.
includes pain, injury, and impairment of a sense such as touch or sight. These risks may be
brief or extended, temporary or permanent, occur during participation in the research or
arise after.
Physical risks
includes anxiety, sadness, regret and emotional distress, among others. these exist in many
different t yes of research in addition to behavioral studies.
Psychological risks
exist whenever there is the possibility that participating in research or the revelation of
data collected by investigators in the course of the research, if disclosed to individuals or
entities outside of the research, could negatively impact others' perceptions of the
participant. These risks can range from jeopardizing the individual's reputation and social
standing, to placing the individual at-risk of political or social reprisals.
Social risks
,include the exposure of activities of a research subject "'that could reasonably place the
subjects at risk of criminal or civil liability."
Legal risks
may exist if knowledge of one's participation in research, for example, could make it
difficult for a research participant to retain a job or to find a job, or if insurance premiums
increase or loss of insurance is a result of the disclosure of research data.
Economic risks
defined in the Common Rule to be "that the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests."
45 CFR 46.102 - Minimal Risks
Certificates of Confidentiality
intended to prevent investigators in the US from being forced to disclose data that can be linked
to identifiable research participants in legal proceedings. Protects participants against Legal
risks.
Investigators may elect to keep research data separate from medical records in order to
prevent this type of risk
economic risks - prevents employers and insurance companies from obtaining information that
could put the participants at risk.
True or False - Compensation is a benefit of the research?
False- Compensation IS NOT a benefit of the research
how can undue inducement of participants be minimized?
the level and kind of compensation must take into consideration the vulnerabilities of the
research population.
Why are undue inducements troublesome?
, 1. offers that are too attractive may blind prospective subjects to the risks or impair their ability
to exercise proper judgement; and
2. they may prompt subjects to lie or conceal information that, if known, would disqualify them
from enrolling - or continuing- as participants in a research project.
Define: the tendency for research participants to:
"...downplay or ignore the risks posed to their own well-being by participation...[due to]
the participants' deeply held and nearly unshakeable conviction that eery aspect of their
participation in research has been designed for their own individual benefit."
Therapeutic misconception.
how to avoid: discuss the risks and benefits of research in informed consent process to minimize
possibility of therapeutic misconception.
factors required of the investigator in the principle of beneficences
Equipoise
Protection of patient privacy and confidentiality
Establishing oversight procedures to protect the rights and welfare of the subjects and to
determine the significance of the data.
What determines equipoise in a clinical trial?
Investigators must not know that one arm of a clinical trial provides greater efficacy over
another, or there must be genuine uncertainty amongst professionals about whether one treatment
is superior to the other.
Case Study:
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
CORRECT ANSWERS!!
simply agreeing to be a participant in research, or disclosure of findings from a research
study may bring harm to the subject? True or False
True.
These categories all involve what?
physical
psychological
social
legal
economic
risks to subjects in research.
includes pain, injury, and impairment of a sense such as touch or sight. These risks may be
brief or extended, temporary or permanent, occur during participation in the research or
arise after.
Physical risks
includes anxiety, sadness, regret and emotional distress, among others. these exist in many
different t yes of research in addition to behavioral studies.
Psychological risks
exist whenever there is the possibility that participating in research or the revelation of
data collected by investigators in the course of the research, if disclosed to individuals or
entities outside of the research, could negatively impact others' perceptions of the
participant. These risks can range from jeopardizing the individual's reputation and social
standing, to placing the individual at-risk of political or social reprisals.
Social risks
,include the exposure of activities of a research subject "'that could reasonably place the
subjects at risk of criminal or civil liability."
Legal risks
may exist if knowledge of one's participation in research, for example, could make it
difficult for a research participant to retain a job or to find a job, or if insurance premiums
increase or loss of insurance is a result of the disclosure of research data.
Economic risks
defined in the Common Rule to be "that the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests."
45 CFR 46.102 - Minimal Risks
Certificates of Confidentiality
intended to prevent investigators in the US from being forced to disclose data that can be linked
to identifiable research participants in legal proceedings. Protects participants against Legal
risks.
Investigators may elect to keep research data separate from medical records in order to
prevent this type of risk
economic risks - prevents employers and insurance companies from obtaining information that
could put the participants at risk.
True or False - Compensation is a benefit of the research?
False- Compensation IS NOT a benefit of the research
how can undue inducement of participants be minimized?
the level and kind of compensation must take into consideration the vulnerabilities of the
research population.
Why are undue inducements troublesome?
, 1. offers that are too attractive may blind prospective subjects to the risks or impair their ability
to exercise proper judgement; and
2. they may prompt subjects to lie or conceal information that, if known, would disqualify them
from enrolling - or continuing- as participants in a research project.
Define: the tendency for research participants to:
"...downplay or ignore the risks posed to their own well-being by participation...[due to]
the participants' deeply held and nearly unshakeable conviction that eery aspect of their
participation in research has been designed for their own individual benefit."
Therapeutic misconception.
how to avoid: discuss the risks and benefits of research in informed consent process to minimize
possibility of therapeutic misconception.
factors required of the investigator in the principle of beneficences
Equipoise
Protection of patient privacy and confidentiality
Establishing oversight procedures to protect the rights and welfare of the subjects and to
determine the significance of the data.
What determines equipoise in a clinical trial?
Investigators must not know that one arm of a clinical trial provides greater efficacy over
another, or there must be genuine uncertainty amongst professionals about whether one treatment
is superior to the other.
Case Study:
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
