Nih Online Training Flashcards
The Belmont Report is significant because
It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
A study proposing to involve pregnant adolescents who are detained in a juvenile detention center would only be allowed if
The requirements of Subparts A, B, C, and D are met.
An "autonomous person" is someone who:
Understands the risks and benefits of his or her participation and is able to make a voluntary decision if adequate information is provided.
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?
Respect for Persons, Beneficence, Justice
When might human subjects research require investigators to obtain informed consent?
A. Investigators must obtain informed consent if the study involves interactions with research participants.B. Investigators must obtain informed consent if the study involves interventions with research participants.C. Investigators must obtain informed consent if the study involves collection of private information from or about research participants.
In order to participate in research, children must:
Provide assent, unless the IRB determines that they are too young
Risk to research subjects includes:
A. Physical, psychological, social, legal or economic harm that may reasonably be anticipated as a result of participation in researchB. The probability that a certain harm will occur from disclosure of findingsC. Unforeseen physical harm that is possible from participation in therapeutic research
When appropriate, research data should be ___________ to prevent accidental disclosure of private information.
De-identified
When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?
For all clinical trials
The use of placebo in a clinical trial may be justified:
for conditions where there is no approved, effective treatment
IRBs reviewing research in a different geographical location and/or cultural context have a responsibility to:
B. Defer to an IRB that is in the situated within the local research contextC. Ask specialists with direct knowledge of the local research context to participate in IRB discussions
Which of the following is TRUE regarding applications for NIH-funded research overseas?
Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies
In localities where community consent is the norm,
In addition to the cultural norm, individual informed consent is required
Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule?
Subpart A which describes the required protections for all human subjects
Identify the most influential event that led to the HHS Policy for Protection of Human Research Subjects:
Syphilis Study at Tuskegee
Which entity has regulatory authority for the protection of human subjects for PHS-funded research?
OHRP
The three fundamental principle of Informed consent are
Voluntariness, Comprehension, Disclosure
Which of the following most accurately describes clinical equipoise:
Scientific uncertainty that one study intervention is superior to another.
Risks to research participants must be completely eliminated for the study to be considered ethical.
False
What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?
1. Keeping data in a password-protected database2. Storing images in a secured cabinet3. Coding data or specimens and keeping the key to the code in a separate, locked drawer
Children must be included in all NIH-supported human subjects research unless:
There are scientific and ethical reasons to exclude them
A study proposing to involve pregnant adolescents who are detained in a juvenile detention center would only be allowed if:
The requirements of Subparts A, B, C, and D are met.
Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule :
Subpart A which describes the required protections for all human subjects
For research involving pregnant women, participation requires:
Consideration of risks and potential benefits for the fetus and the pregnant woman.
Why might an individual have diminished autonomy?
1. They are a neonate.2. They are incarcerated or involuntarily confined.3. They are unconscious.
NIH has specific policies addressing:
1. Inclusion of children in research2. Inclusion of women and minorities in research3. Treatment for research subjects in HIV/AIDS antiretroviral studies following completing of trials in developing countries
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