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

    1.    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 is sent to the principal investigator six to eight weeks before the review date. The review form should be completed and returned to Sara Gulbrandsen at 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 appropriate federal agencies. 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".

    2.    What to report

                a.  the number of participants enrolled since the last review and the total number of participants enrolled to date;
                b.  breakdowns of the participant population by gender and other demographics;
                c.  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);

        The IRB may require changes in protocol or revisions in the consent form if the study's risks were originally underestimated or if the investigators and the IRB underestimated the benefit to research participants.
 

    3.    The review process

        A project 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 forms.

    4.    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.

        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.

    6.    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.

    7.    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.

    8.    Keeping Records

            Researchers should maintain a file of all documents concerning the use of humans in research, to include original paperwork whenever possible, and a copy of everything else. The principal investigator's records should be a mirror image of the IRB's records: where the IRB holds an original, the principal investigator should hold a copy, and vice versa.

        The documents that researchers should have on file include:

• a copy of the original application submitted to the IRB, including the consent form and the research protocol;
• an original of the IRB's response;
• a copy of responses to IRB stipulations or requests for additional information;
• the original notice of final approval;
• a copy of the "Certification of Approval" sent by the IRB to any funding agencies;
• copies or originals of all other correspondence with the IRB;
• copies of completed "Continuing Review" forms and attachments;
• the original notice of renewal of approval and certification, where applicable; and
• copies of any inspection or audit reports.

CONTINUING RE-REVIEW: PROGRESS REPORT (TEMPLATE)

DE PAUL INSTITUTIONAL REVIEW BOARD

DPU IRB Protocol No.:

Date of Initial IRB Review:

Date of Last IRB Continuing Approval ____

COMPLETE THE FOLLOWING FOR ALL RESEARCH PROTOCOLS:

    1.    Summarize the progress of your research to date, including any
            a.    preliminary results,
            b.    unanticipated risks,
            c.    early indications that one of the interventions under investigation may be significantly better or worse than the others,
            d.    relevant literature, findings or other relevant information that might affect the risk-benef it analysis or the alternatives available to participants, and
            e.    recent literature, findings or other relevant information, especially about risks associated with the research that might affect continuing the research. (Attach additional pages as necessary.)
 

    2.    Contact Information.  Who should be contacted for further information about this protocol?

Name:

Title:

Phone: E-mail address:

Date:
 
 

    3.    How many participants have been enrolled to date?

    4.    Provide a summary of the participants by gender, ethnicity, and other demographics. (Note: this information always will be required for continuing review of all studies.)
 

    5.    Have any participants declined to participate in the research after being approached?

            ___Yes ___No

            If yes, include an explanation, the number of participants, and the reasons they declined to participate.

    6.    Have any participants withdrawn from the research after initial enrollment and participation?

            __Yes _ No

            If yes, include the number of participants and the reason(s) for their withdrawal.

    7.    Has there been any new significant information that might affect participants’ willingness to enroll and/or the risks and benefits of the research?

        __ Yes __ No

            If yes, how has this information been provided to participants, e.g., revised consent form, addendum to consent form?

    8.    Summarize any complaints from participants or others.
 
 

    9.    Describe each specific amendment to the research protocol and the date of IRB approval for all previously approved amendments.
 
 

    10.    Have any other IRBs reviewed and approved this research?

        ___Yes ___No

        If yes, please provide documentation of the most recent IRB approval.
 

Principal Investigator’s Signature ______________________

Date Completed _______________