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.