Post Approval Forms

Request for Modification

Researchers are responsible for submitting to the IRB proposed changes in a research activity prior to implementing the changes.  Changes in research should not be initiated by the researcher without IRB approval, except where necessary to eliminate apparent immediate hazards to the subject. Under such circumstances the IRB should be notified immediately of such changes.   Examples of changes could be:  changes to personnel, changes in the involvement of human subjects in the research, changes to the survey, and changes to the consent form, etc.

How to Request a Renewal

Federal regulations state that the IRB must conduct a continuing review of an approved study at intervals appropriate to the degree of risk, but not less than once per year.

In most cases the anniversary date of the approval is the date set for this review.  In some cases approvals that are funded by a contract and/or grant may have a review date of less than one year, based on the term of the contract and/or grant.

Prior to the review date researchers can either request a renewal or file a completion report.  This request must be submitted to the IRB prior to the review date.  Failure to submit the proper information will cause the approval to be suspended on the review date of the approval.  Continuation of the research without approval would be in violation of campus policy and may be in violation of federal regulations as well.

To request a renewal or file a completion report you must submit one of the forms referenced below along with a summary of your research.  This summary will be used to review the project and determine that the anticipated risks and benefits are reflected in the actual experience of the subjects and that the safeguards in place at the time of original approval are, in fact, adequate to ensure the safety of the subjects.

Requests for renewal and completion reports should include a summary with at least the following information:

  • The number of subjects accrued
  • A summary of any adverse events or any unanticipated problems involving risk to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review
  • Any relevant multi-center trial reports
  • Any other relevant information, especially information about risks associated with the research
  • A copy of the current  informed consent document and any newly proposed consent document
  • For continuation requests, an explanation of why a renewal is needed (i.e. a description of additional or continuing work needs to be completed for the extension period)

Use the following guidelines to determine the correct form to submit:

Renewal

A renewal request can be submitted under the following conditions:

  • The original application required full board or expedited review
  • This is year 2 or 3 of the project.  (If you have completed the third year you must file a completion form and then submit a new application if your research is not complete)
  • There have been no changes to the proposal, grant and/or contract
  • There have been minor changes  and you are submitting a request for modification with the request for renewal.  (Ex. A change to the contract award period with no change to the scope of work).

Renewal of Exemption 

Note: Exemption of a proposal does not remove the requirement for annual review.  A determination must be made annually that no changes have been made to the research and it still qualifies for exemption.

A request for renewal of exemption can be submitted under the following conditions:

  • The original application was determined to be exempt. 
  • This is year 2 or 3 of the project. (If you have completed the third year you must file a completion form and then submit a new application if your research is not complete)
  • There have been no changes to the proposal, grant and/or contract
  • There have been minor changes and you are submitting a request for modification with the request for renewal. (Ex. A change to the contract award period with no changes to the scope of work)

Completion 

A completion report should be filed under the following conditions:

  • The human subjects portion of this study has been completed and no more human subjects will be used
  • The third year of the study has been completed under this project number.  **A new application must be submitted if the human subjects portion of the research has not been completed.
  • If there have been significant changes to the proposal, grant and/or contract you must close this project file and submit a new application.  Ex. A major change to the scope of work.