Learn Before
Protocol Modification Approval
If a researcher needs to make anything other than a minor change to their study after it has begun, they must seek additional formal approval from the Institutional Review Board (IRB) or relevant ethics committee before implementing the modification to the research design or procedure.
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Research Methods in Psychology - 4th American Edition @ KPU
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Protocol Modification Approval
Monitoring Participants for Unanticipated Reactions
During an ongoing study, what must a researcher do if they need to make significant adjustments to their previously approved research plan?
In a psychology study, a researcher is ethically permitted to implement significant modifications to their approved plan as long as they notify the institutional review board shortly after the changes have been put into practice.
A researcher is conducting an approved laboratory study on attention. Halfway through data collection, the researcher decides to change the computer task to a more challenging version to better capture the effect they are looking for. Arrange the steps the researcher must take to ethically implement this change in the correct order.
Match each researcher's action to the appropriate analysis of their ethical obligation regarding protocol adherence.
A researcher is ethically obligated to adhere strictly to the submitted research protocol throughout the entire duration of a study, even after receiving institutional approval.
In psychological research, what does it mean for a researcher to have an 'ongoing ethical obligation' to adhere to their protocol after receiving institutional approval?
A researcher who has received IRB approval for a study later considers several adjustments during data collection. Match each adjustment to the appropriate protocol-adherence decision a researcher must apply.
When analyzing whether a mid-study change requires new institutional review board approval, the central distinction is whether the modification is _____ or significant—researchers can proceed with the former on their own authority, but must obtain IRB review and approval before implementing the latter.
A researcher is midway through an IRB-approved study and determines that a meaningful procedural change is needed—one that goes beyond a minor adjustment. Evaluate and arrange the steps below into the ethically correct order the researcher must follow before and after making the change.
In the ethical evaluation of a researcher's conduct, implementing a modification to an approved study without first obtaining permission from the _____ is considered a violation of protocol adherence, regardless of the researcher's personal justification.
Describe the scope and duration of a researcher's ethical obligations concerning protocol adherence after their study receives initial institutional approval, including the protocol modification process.
Based on the rules of protocol adherence, diagnose the ethical issue in the researcher's decision to change the task length and explain what action they should have taken.
A psychological researcher has institutional approval to conduct a study where participants view pictures of household objects. The researcher decides mid-study to change the stimulus to pictures of aggressive animals to investigate a different emotional response. Apply the rules of protocol adherence to state what the researcher must do before executing this change.
Learn After
After a study has received initial ethics approval and data collection has begun, a researcher who wants to make a significant change to the research procedure must obtain additional formal approval from the ethics review board before implementing that change.
A psychology researcher determines that their experimental stimuli need to be updated to better test their hypothesis after the study has already begun. Arrange the steps the researcher must take to ethically modify their protocol.
Dr. Kim is halfway through a study investigating how peer pressure affects decision-making in teenagers. After reviewing early data, Dr. Kim decides to add a new physiological measure—galvanic skin response (GSR)—to better capture participants' emotional arousal. According to ethical standards for research, what is the most appropriate next step for Dr. Kim?
A psychology researcher is evaluating several proposed modifications to their ongoing study. Match each scenario with the correct ethical assessment and the rationale for that classification based on protocol approval standards.
When a researcher decides to make a non-minor modification to their psychological study after it has already begun, what is the required ethical procedure?
Under the ethical guidelines for protocol modification, a researcher must seek additional formal IRB approval for every change made to their study, including minor administrative adjustments like fixing a typographical error on a participant instruction sheet.
A psychology researcher adds an extra set of personality questions to an ongoing study, arguing that the addition is 'minor' and improves the study's scientific value. In evaluating the ethicality of this action, the researcher's self-assessment is insufficient because the protocol requires _____ from the Institutional Review Board before the modification is enacted.
Match each scenario of study modification with the correct regulatory requirement based on the ethical protocol guidelines.
A psychology researcher wants to update their experimental procedure after data collection has already begun. According to the guidelines for protocol adherence, the researcher must obtain additional formal approval from the IRB or ethics committee before implementing the modification if the change is classified as anything other than a _____ change.
A researcher has evaluated their ongoing study and determined that they must modify their research design to address a confound. Arrange the steps the researcher must take to ethically execute and implement this modification.