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Greater Than Minimal Risk Research
Greater than minimal risk research involves studies that expose participants to risks exceeding those encountered in daily life or during routine physical or psychological evaluations. Because they pose an elevated level of potential harm—such as the potential to cause psychological distress or harm that is more than minor and temporary—these studies do not qualify for exempt or expedited review. Instead, their research protocols must undergo a rigorous, comprehensive review by the full institutional review board (IRB).
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Research Methods in Psychology - 4th American Edition @ KPU
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Greater Than Minimal Risk Research
Which of the following best describes the characteristics and review process of expedited research?
The expedited review process allows for a research study to be approved by a single member of a review board, provided the risks to participants are no greater than those typically encountered in daily life.
A psychology researcher is preparing a study that qualifies for an expedited review. Match each specific aspect of the study's design or review process to the justification that explains why it meets the criteria for this category.
A university ethics committee receives a proposal for a new psychology study. Arrange the following steps in the logical sequence the committee must follow to categorize the study as expedited research.
In the context of institutional review board (IRB) procedures, who is authorized to conduct an expedited review for research that poses no more than minimal risk to participants?
A psychology researcher is preparing a study that qualifies for an expedited review. To demonstrate your understanding of this category, match each core aspect of expedited research to the statement that best describes its meaning.
An IRB's decision to approve a study via a(n) _____ review process reflects an evaluative judgment that the research procedures pose no more than 'minimal risk' to participants, making the deliberation of the full committee unnecessary for participant safety.
Dr. Smith is planning a study in which participants complete a computerized attention task. He determines the risks are slightly higher than exempt research, but do not exceed the risks of routine cognitive testing encountered in daily life. True or False: This study can be approved by a single member of the Institutional Review Board (IRB) rather than the full committee.
When analyzing the procedural requirements of a study that poses a higher risk than exempt research but does not exceed the risks healthy people face in daily life, an IRB can utilize a(n) _____ review process, allowing a single member or subcommittee to approve the study instead of the full committee.
Evaluate the standard decision-making sequence an Institutional Review Board (IRB) follows to process and approve a study under the expedited review pathway. Order the steps from first to last.
State the definition of expedited research, describing how its risk level compares to exempt research and what constitutes 'minimal risk' according to institutional review board standards. Additionally, identify who is authorized to review such studies.
Based on this scenario, explain why this study qualifies for expedited review and describe how the administrative review process will differ from a standard full-board review.
Imagine you are a researcher submitting a study on how listening to music affects student concentration during a spelling test. Assuming the study poses no more than minimal risk, how would you justify requesting an expedited review, and who would be responsible for reviewing your proposal?
Greater Than Minimal Risk Research
According to federal research regulations, which of the following statements accurately describes 'exempt research'?
If a psychological study analyzing existing public data is classified as representing the lowest level of risk, it will still require regular, continuous review by an institutional review board after its initial approval.
Match each psychology research scenario to the specific category of Exempt Research it best illustrates according to federal regulations.
A psychology researcher is planning a study using standard, non-sensitive psychological measures to evaluate participant stress levels while ensuring complete confidentiality. Arrange the following regulatory milestones in the correct sequence to reflect the process for 'Exempt Research'.
According to federal regulations, what specific conditions must be met for a research study using standard psychological measures to qualify for 'Exempt Research' status?
To demonstrate your understanding of the scope and oversight of 'exempt' research in psychology, match each category or regulatory condition to the description that best defines its role in federal guidelines.
In federal research regulations, the ethical justification for designating a study as 'Exempt'—thereby removing the requirement for ongoing monitoring—is based on the evaluative conclusion that the research poses the _____ level of risk to participants.
Dr. Aris designs a study to evaluate a standard educational activity in his college course. According to federal guidelines, once this study receives initial approval, Dr. Aris is required to submit it for regular, continuous reviews by the Institutional Review Board.
A researcher is using standard, non-sensitive psychological measures to study personality traits. To determine if this study qualifies as exempt research and is thus exempt from ongoing IRB review after initial approval, the researcher must ensure the administration of these measures maintains _____.
A psychology researcher wants to conduct a study using existing public data. Order the regulatory milestones for this study from the initial assessment of risk to the final oversight status under federal regulations.
According to federal research regulations, what level of risk does exempt research represent, what are three specific examples of studies that qualify for this designation, and what is the status of such studies regarding ongoing IRB review after initial approval?
Explain why Dr. Vance's proposed study meets the federal criteria for exempt research, and clarify what her ongoing IRB review requirements will be once she obtains initial approval.
A developmental psychologist plans to conduct a study using existing public data from a government census. Apply federal regulations to identify the risk level of this study, and determine if it will require continuous IRB monitoring after its initial approval.
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Justifying Greater Than Minimal Risk Research
What is the primary characteristic that classifies a study as 'greater than minimal risk' research?
What type of Institutional Review Board (IRB) review is required for a research study that exposes participants to risks exceeding those encountered in daily life?
In psychological research, a study is categorized as 'greater than minimal risk' if the potential for participant harm is no higher than the risks typically encountered in daily life or during routine examinations.
Psychological research studies must be categorized according to the potential level of risk to participants. Match each of the following research scenarios to the most appropriate description of its risk status and review requirement.
A researcher proposes a study where participants are told they have a serious, undiagnosed personality disorder to observe their reaction to distressing medical information. Arrange the logical steps in the correct order to analyze why this study is categorized as 'greater than minimal risk' and how it must be reviewed.
Suppose you are tasked with designing a psychological study to investigate the impact of extreme social isolation. Which of the following research protocols would you construct if your specific objective is to develop 'Greater Than Minimal Risk Research' that necessitates a rigorous, full-board review by the Institutional Review Board (IRB)?
Research protocols classified as 'greater than minimal risk' are eligible for expedited review by a single Institutional Review Board (IRB) member.
In psychological research, studies are classified based on their risk level to protect human participants. Match each core characteristic of a study categorized as 'greater than minimal risk' with its correct description.
In the process of evaluating a research proposal that involves deceiving participants into believing they have failed a high-stakes competency exam, the Institutional Review Board (IRB) concludes that the potential for psychological harm is more significant than the risks encountered in a typical day. By making this judgment, the IRB categorizes the study as _____ than minimal risk research.
An IRB evaluates a study simulating severe public embarrassment to see if the scientific benefits justify the risks. Since the potential psychological distress is more than minor and temporary, they judge the protocol as greater than minimal risk, meaning it must undergo a comprehensive review by the _____.
Define 'greater than minimal risk research' and explain the specific administrative process its protocol must undergo for IRB approval compared to exempt or expedited reviews.
Based on the rules governing research risk, explain why Dr. Aris's request for an expedited review must be denied, and explain the administrative pathway this protocol must follow instead.
A psychology department plans to run a study where participants are exposed to loud, unpleasant noises to test their physiological stress responses, which exceeds the sensory experiences of their typical day. Applying risk-level standards, what category of risk does this study fall under, and what level of IRB review is required?