Human Subjects|Loyola University Chicago

Human Subjects

searchform
This siteLUC.edu

Continuing Review

Federal Regulations require that the IRB conduct meaningful, substantive continuing review of every approved project at least once a year. When a project is approved, the IRB is responsible for determining the exact time interval at which continuing review must be conducted. In making this determination, the IRB considers the level of risk to participants, the nature of methodology, and the experience of the investigator.

In most instances, for projects that involve minimal risk to participants (as determined by the IRB), the IRB requires that continuing review occur once a year. The IRB may require that continuing review occur more frequently in any of the following circumstances: a) the research involves greater than minimal risk to the participants, b) the methodology is such that refinements or modifications may occur as the project progresses, c) the investigator is relatively inexperienced with the research methodology, d) there are other concerns related to participant selection, recruitment procedures, informed consent process, confidentiality, or data monitoring.

To ensure that continuing review occurs within the required interval, initial IRB approval is always time-limited. Thus, for projects that require continuing review at one-year intervals, approval is granted for a period of one year from the time of the initial review. The initial approval letter that is sent to the investigator specifies the time period for which approval is granted and indicates the date on which approval expires. The investigator is responsible for ensuring that continuing review occurs before approval expires.

Download: Application for Renewal of IRB Approval (.pdf)

 

IRB Main Page



Continuing Review Procedure:

  1. A reminder letter with detailed instructions is sent to the investigator two months prior to expiration of IRB approval.
  2. The investigator submits completed Application for Renewal of IRB Approval form, current consent form, and project summary to Compliance Manager.
  3. The Compliance Manager conducts administrative review to determine if all materials are complete. If not, investigator is contacted.
  4. For all projects that involve greater than minimal risk and/or require continuing review more than once a year: once materials are complete, the renewal application is reviewed by the IRB at the next available meeting.
  5. For all projects that involve no more than minimal risk: once materials are complete, Compliance Manager reviews renewal application, consent document, and summary report and compares to previous materials. Based on this review, applications are placed in one of 4 categories:

      * a. Data Collection Complete. No Changes or Adverse Events.

      * b. Data Collection Complete. Changes or Adverse Events.

      * c. Data Collection Continuing. No Changes or Adverse Events.

      * d. Data Collection Continuing. Changes or Adverse Events.

    • IRB Chair reviews applications in Categories (a) and (c) and makes a decision regarding continuing approval. This decision is reported to the Board at the next full meeting.

    • For Categories B and D,

      If changes have been reported that have not been reviewed and approved by IRB, the investigator is required to submit a full description of these events, (17 copies required).

      OR

      If adverse events are reported, the investigator is required to submit a full description of these events, and what was done in response to these events, if anything (17 copies required).

Next >> �� Important Notes

go back to: IX. Continuing Review



Important Notes:

  • It is very important that the investigator submit the Application for Renewal of IRB Approval before approval expires. Federal guidelines are very clear in stating that no grace period can be granted. Applications requiring IRB review (categories b and d above), are subject to submission deadlines and meeting dates, thus investigators are encouraged to plan accordingly. If the IRB does not receive an application or does not have sufficient time to process it prior to the expiration date, IRB approval will expire and all activities involving human subjects must cease.

  • This periodic review procedure in no way absolves investigators of responsibility to notify the IRB immediately of any changes in research populations or in research methods affecting human subjects. All such changes must be approved by the IRB before they are implemented.

  • Participants may be placed at risk not only when data is being gathered but also when results are published. Indeed, issues of confidentiality are important during dissemination or publication. IRB approval must therefore be renewed as indicated above, until no further related activity is contemplated.

<< Previous �� Continuing Review Procedur>

go back to: IX. Continuing Review



Edit this page