Focus on protocol changes and adverse events
IRB approval is not blanket approval for ongoing studies. According to the Office for Human Research Protections’ Institutional Review Board Guidebook, initial IRB approval gives investigators "temporary" authority to conduct research.
"The responsibility for continued monitoring of approved research is as important as the initial review and approval," wrote the authors. "It is only after research has begun that the real risks can be evaluated and the preliminary results used to compute the actual risk-benefit ratio."
The requirements delineated in the 1993 guidebook were recently updated. Some things, such as a minimum annual review, did not change. The new guidance, however, includes discussions on multicenter trial reviews and expedited reviews. Federal guidelines state that continuing reviews should take place as often as the degree of risk demands or at least annually. The frequency of the continuing reviews should be determined at initial approval and then revisited at subsequent reviews.
Continuing review should include a protocol review and status report on the following:
- the number of subjects participating;
- any adverse events or unanticipated problems;
- a summary of interim findings or modifications to the research since the last review;
- any relevant multicenter reports;
- any information about risks associated with the study;
- a copy of the current informed consent document.
IRB members are charged with reviewing the protocol and considering adverse events, interim findings, and any recent literature to determine whether the study should continue.
Multicenter trials need local review
Of particular interest to IRB members should be the informed consent document. Federal policy requires that subjects be informed of new information that might affect the participant’s willingness to continue in the study. Not only must changes to the protocol be reflected in the document, but also IRBs may want to establish a policy for informing study volunteers about changes.
There are no exceptions to annual review, though certain projects, such as those that are not accepting new volunteers and those in the data analysis phase, can request an expedited review. Expedited review cannot be requested for studies involving investigational new drugs or devices.
Multicenter trials, even those being monitored by Data and Safety Monitoring Boards (DSMBs), must be reviewed by the local IRB. In such cases, the IRB can accept a current statement from the DSMB concerning protocol, adverse events, and recent literature related to the study. Local boards must still, however, obtain reports of local problems or unanticipated events.
Finally, the guidance points out that it is permissible to have an IRB designated solely for continuing review. Such an IRB must meet federal standards regarding membership — at least five members from various backgrounds, scientific and nonscientific, and at least one member who represents the mores and attitudes of the community.
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