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7. Once my research has been approved, does it ever need re-review by the IRB? IRB review is an ongoing process, not a one-time step. Since risks are better understood only after research has begun, regular re-evaluation ("continuing review") ensures that research is conducted responsibly. Unexpected developments in a project can raise questions about the conduct of the research, and new findings can raise questions about the project.

"Continuing review" refers to regularly scheduled complete reappraisals of a project. The goals of continuing review are to ensure: that the risk/benefit ratio is still acceptable; that the measures taken to safeguard participants are adequate; that the approved protocol is followed; and that the project reflects any changes that have been made in the regulations for human research since the last approval.

The IRB may require changes in protocol or revisions in the consent form if the study's risk were originally underestimated , but the converse can also occur: the investigators and the IRB may have underestimated the benefit to research participants.

When continuing review is required

Continuing review occurs at least annually, but high-risk projects sometimes require more frequent review. The terms of the review, as well as the documentation required for any special review, are delineated when approval is originally granted.

A notice for renewal and a "continuing review form" are sent to the principal investigator six to eight weeks before the review date. The form should be completed and returned to the OSPR office. If the approval status lapses, new approval must be applied for. A lapse means that the study is not approved. Lapses in approval are extremely difficult to justify to regulatory and funding agencies. The IRB is required to report such lapses to the National Institutes of Health's Office for Protection from Research Risks and the Food and Drug Administration. If the investigator does not respond to the final notice, the IRB will classify the study as "inactive." If the study is completed, an investigator is asked to complete several portions of the continuing review form as a "final report" on the project.

a. What to report

Continuing review requires the following information:

1. the number of participants enrolled since the last review and the total number of participants enrolled to date;
2. breakdowns of the participant population by gender and other demographics;
3. a summary of the results of the research to date, including:

any unanticipated risks or adverse outcomes, and
any early indication that one of the treatments under study is significantly better or worse than others;
any difficulties recruiting or retaining participants, an explanation of the difficulties, and the number of participants who withdrew from the study;
any proposed changes to the research protocol;
any proposed changes in principal investigators;
a copy of the consent form currently in use (as approved by the IRB);

b. The review process

A project usually merits the same level of review in continuing review as it
received originally. Hence, most projects require full review. As in the initial
review, the IRB may require revisions in the protocol or the consent
documents. B. Making changes in research protocols

Once the IRB has approved a project, it must be carried out as planned.
Any changes in participant population, recruitment plans, research procedures,
study instruments, study sites, or major research personnel must be
approved by the IRB.

Researchers planning a change should:

write to the IRB office citing the title and code number of the approved study;
describe the proposed change in lay language;
explain why the change is needed;
describe the implications for the participants; and
provide revised consent documents, if the change will affect the participants.

Changing the principal investigator

If a principal investigator is on sabbatical leave from the University, an
interim PI must be appointed. The IRB should be informed of this person's
qualifications. If a researcher leaves the University permanently, the IRB
should be notified both of any interim investigators and of the final
replacement.

New findings

New findings are unexpected problems whose nature, severity, and frequency are not described in the information provided to the IRB or to participants. Examples include unexpected complications in a participant, missteps in the consent documentation, or breaches of confidentiality.

Adverse events should be reported to the IRB within 10 working days. Sometimes a study must be suspended to ensure participants' safety. The report of the event should discuss:

the facts of the case, including the date and a description of the participant(s);

whether the event is related to the study's procedures or to the participant's condition;

the steps that have been taken to address the problem;

whether the event is likely to recur; and

whether the event provides new information about the study's risks that should be conveyed to participants, in a revised consent form.

These reports usually receive expedited review, but in some cases the full IRB is involved.