Requirements for Continuing Review of Research (IRB)

Depending on whether your project falls under Clinical Research or Health Services Research, the Progress Report must be submitted for continuing review with the appropriate headings. The study Status Form will be sent to you in the mail with the due date inserted at the bottom of the form. Once you determine the current status of your study, select Clinical Research or Health Services Research below to access the correct narrative form for your Progress Report. Select the narrative form that matches your study's current status.

CLINICAL RESEARCH

HEALTH SERVICES RESEARCH

What are the Regulatory Requirements for Continuing Review?
HHS (45 CFR 46) and FDA (21 CFR 56) Regulations require the IRB to perform Continuing Review of research at intervals appropriate to the degree of risk but not less than once per year. It is the responsibility of all investigators to submit a Progress Report in sufficient time to permit the IRB to complete a meaningful Continuing Review of the research.

What is the Purpose of Continuing Review?
The primary purpose of Continuing Review is to ensure that (1) the selection of subjects is equitable, (2) the risk/benefit relationship of the research remains acceptable, (3) the consent document contains information that is accurate, complete and up-to-date, and (4) adequate safeguards for human subjects are in place.

At this institution, some of the information that is requested will be reviewed by Research Administration for purposes of institutional oversight.

How Much Detail is Necessary for the Continuing Review?
The following are guidelines for creating a Progress Report for Continuing Review. The IRB relies upon the investigator to provide all necessary information in sufficient detail to permit the Board to fulfill its Federal and institutional mandate to ensure that on-going human subject research continues to be justified. The status of the study determines what information is necessary for IRB review.

Continuing Review by the IRB is just as important as initial review.
Initial review and approval of research requires the IRB to make a judgement based largely upon background data and a risk/benefit analysis provided by the investigator. Continuing Review and re-approval of on going research, however, serves to verify the correctness of the decisions made by both the investigator and the IRB using the study results to date and other relevant new information to make this judgement. Continuing Review is designed to help ensure that the rights and welfare of subjects continue to be fully protected in on going research.

To facilitate IRB re-review of your project and to avoid unnecessary delays, your Progress Report must be completed according to the instructions. Please include sufficient detail to allow the IRB to perform a thorough Continuing Review. Failure to provide this detail may delay re-approval of your project and could result in a suspension. The IRB cannot grant extensions or temporary approval. Should suspension occur, all subject accrual must cease as of the date of suspension. Research elated procedures can no longer be done on human subjects who are enrolled in the study for follow up or other reasons. If suspension is a health hazard to the subjects, the IRB will grant an exception upon receipt of written justification.

Submission Deadline
Your Progress Report must be submitted on time so that expiration of IRB approval does not occur. Unless your project is re-reviewed and re-approved within twelve (12) months from the date the protocol was last reviewed by the IRB, Federal Regulations require the IRB to immediately suspend its approval. The IRB staff sends out a request for submission of the Progress Report approximately 30 days prior to the month in which it must be reviewed. The deadline for submission is noted at the bottom of the Progress Report Status Form.

Submission Documents
Submit one (1) copy of the Progress Report Status Form and your narrative (unless you checked "A" as your study status). Consent forms, and other materials that are changing (use the Request for Amendment Form--see below) or have not been approved by the IRB should be attached to the report.

For a list of narrative headings you can download, click on the appropriate link below. You should use the headings on the page or pages that relate to the study status you checked to complete your report.

After IRB review of your Progress Report, you will be given an approval letter to continue. An original (all versions) of the IRB approved consent/assent form(s) should be kept on file. If you are making copies from the original consent form, make sure any outdated forms are destroyed and the currently approved version is being used.

*Select Clinical or Health Services for headings to complete the narrative.
(Your study's classification, clinical or health services, is indicated
on the top of the Progress Report Status Form.)

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According to Federal Regulations, changes in approved research cannot be initiated without IRB review and approval unless necessary to eliminate apparent immediate hazards to the subject or provide important information germane to informed consent. In this circumstance, the IRB must be notified immediately. To review your Request for an Amendment, the IRB must have certain information according to specific criteria. Additional pages can be used if needed. The information should be put in a letter format, typed and pages numbered.

Criteria for Request for Amendment to Approved Research