Closing a study is actually a kind of continuing review. Guidance from federal officials indicates that continuing review should be "substantive and meaningful." Criteria for review of research are provided in federal regulation, and they apply even to requests to close studies. This means that IRBs are required to review requests to close studies using the criteria, which include:
- Risks to participants are minimized
- Risks are reasonable in relation to anticipated benefits
In order to make a determination that risks to participants are minimized, the IRB needs answers to questions posed in the IRBWise application.
Example: A researcher requests to close a social/behavioral study, observational in nature, that the IRB determined did not involve greater than minimal risk at time of original review. In such a case, it will be a relatively simple matter for the researcher to demonstrate to the IRB that risks to participants are minimized (because the study was originally determined to be not greater than minimal risk). Additionally, since the study design is observational (rather than an intervention study) closing the study will not end an intervention that might put participants at a disadvantage.
Example: A researcher reports that a pharmaceutical company is closing a study of an investigational drug. Assuming the IRB, at time of original review, determined the study posed greater than minimal risk, then the IRB will need information sufficient to allow it to determine that closing the study will not increase risks to participants. The research could demonstrate this by clarifying that patients are being transferred to another therapy (one that is covered by insurance, or covered by federal drug-assistance programs). Or the researcher might indicate that the study is being closed because of unanticipated problems to participants or other issues requiring prompt reporting to the IRB. The IRB may concur that closing the study indeed minimizes risks.
As these examples suggest, the level of detail the researcher needs to provide for the IRB to make a determination about study closure depends on a number of factors, including the level of risk posed by the study, and the reasons the study is being closed. It is for these reasons that the application must be detailed. Researchers are encouraged to contact the Ethics and Human Research Protection Program for technical assistance with specific questions about study closures. It's always better to create an application rather than wait until the study's aproval period has nearly expired.