CITI Training: Biomedical Research Investigator & Social and Behavioral Research – Flashcards

Unlock all answers in this set

Unlock answers
question
What is included in the Nuremberg Code
answer
voluntary consent
question
the National Research Act of 1974:
answer
established the National Commission
question
Issued in 1974, 45 CFR 46 raised to regulatory status:
answer
US Public Health Service Policy
question
What Belmont principle describes the application of informed consent
answer
respect of persons
question
Result of Beecher article:
answer
ethical abuses are not limited to Nazi regime
question
Use of prisoners in research is a concern under the the Belmont principle of justice because:
answer
Prisoners can only be used in research that benefits the larger society
question
What brought attention to the problems of the IRB system?
answer
Death of Jesse Gelsinger
question
Under HIPAA, "disclosure accounting" is required:
answer
for all human subject research that uses PHI without authorization from the data subject, except for limited data sets
question
When required, the information provided to the data subject in HIPAA disclosure accounting
answer
must be detailed for disclosures that involve less than 50 subject records
question
HIPAA's protections for health information used for research purposes:
answer
supplement those of Common Rule and FDA
question
HIPAA includes in its definition of "research", activities related to:
answer
development of generalizable knowledge
question
Under HIPAA, "retrospective research" (aka data mining) on collections of PHI generally:
answer
is research, and so requires either an authorization/meeting one of the criteria for a waiver of authorization
question
recruiting into research
answer
can qualify as an activity "preparatory to research" at least for the initial contact, but data should not leave the covered entity
question
HIPAA "minimum necessary" standard applies...
answer
to all human subjects research that uses PHI without an authorization from the data subject
question
a researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. direct identifiers will not be collected; however, IP addresses may be present in the data set. risk of harm should be evaluated:
answer
both magnitude and probability of harm
question
risk of harm in social and behavioral sciences generally gall in three categories:
answer
invasion of privacy, breach of confidentiality and study procedures
question
additional safeguards that may be included in a social and behavioral study may:
answer
remove all direct identifiers from the data as soon as possible
question
primary purpose of Certificate of Confidentiality is:
answer
protect identifiable research information from compelled disclosure
question
identify the example of when situation and time are key to assessing risk of harm in a research study:
answer
asking women if they've had an abortion
question
the provisions of Subpart D, of the HHS regulations, Additonal Protections for Children Involved as Subjects in Research apply to:
answer
all research funded by HHS
question
a researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools b/c nature of the research... which requirement must be met before an IRB could waive perental permission?
answer
research must pose no more than minimal risk
question
according to Subpart D, research with children may be eligible for exemption when:
answer
research involves the use of educational tests
question
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 researcher would be eligible for which type of IRB review?
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
question
the provisions of Subpart B, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
answer
all research funded by HHS
question
according to Subpart D, research with children may be eligible for exemption when:
answer
the research involves the use of educational tests
question
a study that involves interviews of adults is eligible for expedited review. the researcher wants to add an adolescent population (age 12-17) to the study and has.... no additional changes are planned. what statement about review of the revised protocol is right?
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.
question
which of the following statements most acurrately describes the requirement for the documentation of minors' assent to participate in research?
answer
federal regulations do not require the documentation of minors' assent
question
the specific Department of Health and Human Services (HHS) Regulations that apply to the research with children are known as:
answer
subpart D: additional protections for children involved as subjects in research
question
according to federal regulations, "children" are defined as:
answer
persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which research will be conducted
question
a researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. according to federal regulations, is review required at the foreign site?
answer
if a proposed study qualifies for exemption, federal regulations DO NOT require review at the foreign site where it will be conducted
question
what are some considerations for a US researcher conducting a study in a non-US setting when obtaining inforemd consent from subjects?
answer
in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
Get an explanation on any task
Get unstuck with the help of our AI assistant in seconds
New