CITI Training: Biomedical Research Investigator & Social and Behavioral Research – Flashcards
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What is included in the Nuremberg Code
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voluntary consent
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the National Research Act of 1974:
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established the National Commission
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Issued in 1974, 45 CFR 46 raised to regulatory status:
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US Public Health Service Policy
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What Belmont principle describes the application of informed consent
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respect of persons
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Result of Beecher article:
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ethical abuses are not limited to Nazi regime
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Use of prisoners in research is a concern under the the Belmont principle of justice because:
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Prisoners can only be used in research that benefits the larger society
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What brought attention to the problems of the IRB system?
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Death of Jesse Gelsinger
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Under HIPAA, "disclosure accounting" is required:
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for all human subject research that uses PHI without authorization from the data subject, except for limited data sets
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When required, the information provided to the data subject in HIPAA disclosure accounting
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must be detailed for disclosures that involve less than 50 subject records
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HIPAA's protections for health information used for research purposes:
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supplement those of Common Rule and FDA
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HIPAA includes in its definition of "research", activities related to:
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development of generalizable knowledge
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Under HIPAA, "retrospective research" (aka data mining) on collections of PHI generally:
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is research, and so requires either an authorization/meeting one of the criteria for a waiver of authorization
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recruiting into research
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can qualify as an activity "preparatory to research" at least for the initial contact, but data should not leave the covered entity
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HIPAA "minimum necessary" standard applies...
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to all human subjects research that uses PHI without an authorization from the data subject
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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:
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both magnitude and probability of harm
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risk of harm in social and behavioral sciences generally gall in three categories:
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invasion of privacy, breach of confidentiality and study procedures
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additional safeguards that may be included in a social and behavioral study may:
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remove all direct identifiers from the data as soon as possible
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primary purpose of Certificate of Confidentiality is:
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protect identifiable research information from compelled disclosure
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identify the example of when situation and time are key to assessing risk of harm in a research study:
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asking women if they've had an abortion
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the provisions of Subpart D, of the HHS regulations, Additonal Protections for Children Involved as Subjects in Research apply to:
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all research funded by HHS
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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?
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research must pose no more than minimal risk
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according to Subpart D, research with children may be eligible for exemption when:
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research involves the use of educational tests
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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?
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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
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the provisions of Subpart B, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
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all research funded by HHS
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according to Subpart D, research with children may be eligible for exemption when:
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the research involves the use of educational tests
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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?
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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.
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which of the following statements most acurrately describes the requirement for the documentation of minors' assent to participate in research?
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federal regulations do not require the documentation of minors' assent
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the specific Department of Health and Human Services (HHS) Regulations that apply to the research with children are known as:
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subpart D: additional protections for children involved as subjects in research
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according to federal regulations, "children" are defined as:
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persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which research will be conducted
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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?
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if a proposed study qualifies for exemption, federal regulations DO NOT require review at the foreign site where it will be conducted
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what are some considerations for a US researcher conducting a study in a non-US setting when obtaining inforemd consent from subjects?
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in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
