CITI Training: Biomedical Research Investigator & Social and Behavioral Research

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