Please download and complete the current version of the applicable form(s).

Revise

All revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating the change(s).  Examples of revisions include changes to advertisements, study team members, survey questions, methods and procedures, or an increase in subject enrollment.  Some revisions may necessitate changes to the consent forms.  All revisions described on the project revision form must be incorporated into the appropriate study documents and submitted for review in track changes.

Project Revision Form

Minor changes can often be reviewed faster than major changes. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:

  • the level of risks to subjects
  • the research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change)
  • the number of subjects enrolled in the research (no greater than 10% of the total requested)
  • the qualifications of the research team (change in PI is not considered to be minor)
  • the facilities available to support safe conduct of the research, or
  • any other factor which would warrant review of the proposed changes by the convened IRB or was used to initially to evaluate the risk:benefit ratio or any other criteria for approval

Submit the Minor Change Form to request this type of change to an existing, acknowledged or approved study.

If you are adding study team members and need more space than the project revision or minor change form tables provide, please complete and submit the additional study team members table.

Certain revisions to exempt studies can be made without review.

Please see the Exempt Project Revision Guidance for information on when to submit project revisions.

Renew

Non-exempt studies must be reviewed and re-approved prior to the expiration date.  It is the responsibility of each investigator to be aware of when their study expires and submit a continuing review application (or final report) to the HRPP Office at least 30 days prior to that date.  In the event that a study expires prior to the submission of the renewal application, the study will be closed and a new application must submitted.  No research activities, including data analysis, may be conducted in the absence of a current IRB approval.

Continuing Review Application

Exemptions are granted for five years and renewals during that time are not required. If there is a plan to extend the study beyond the expiration date, the investigator must request a new exemption. Investigators are asked to submit a final report to the IRB if the project is completed prior to the 5 year term.

Report

Protocol deviations, exceptions, adverse events and unanticipated problems must be reviewed by the IRB.  The timeline for these submissions depends on the nature of the event.

Protocol Deviation   |   Exceptions   |    Adverse Events  |  Unanticipated Problems         

Close

Final reports should be submitted at least 30 days prior to the annual expiration date or sooner if all study activities, including data analysis, are complete.

Final Report Form