MANAGE

Requesting changes to an approved protocol

Before changes to an approved study, key personnel, or any of the supporting materials/documents used within the study can be implemented, the proposed changes must be reviewed and approved by the HRPP/IRB.

To request an amendment to an approved protocol, please submit the following:

  • Amendment Request Form
  • Revised application with all proposed changes highlighted or crossed out (Strikethrough)
  • Revised supporting materials with all proposed changes highlighted or crossed out (Strikethrough)
  • If requesting a change in PI, please also attach written support from both the currently approved PI and the proposed new PI.

Changes to a study that are deemed substantial as compared to the originally approved project may require a new application. In rare instances, the overall purpose and design of the study can change after the approval, depending on the population, context, or nature of procedures. Please contact the IRB with questions.

Requesting personnel changes to an approved protocol

Before personnel changes to an approved study can be implemented or new personnel can begin work on an approved study, the proposed changes must be reviewed and approved by the HRPP/IRB.

To request only a personnel amendment to an approved protocol, please submit the following:

  • Revised application with all proposed  new personnel highlighted
  • Revised application with all proposed removed personnel crossed out (Strikethrough)

Note:  If you are requesting changes to key personnel (e.g. PIs, Co-PIs, Co-Is, Coordinators who act as the primary contact) or any supporting materials, please follow the above “Requesting changes to an approved protocol “ submission guidance.

Adverse events

An adverse event is considered any unplanned event that occurs during the research that could negatively affect the research or a participant. These events may include, but are not limited to:

  • Unanticipated problems involving risks to subjects or others (UPIRSO)
  • Unfavorable medical occurrence in a participant (whether it is related to the participant’s enrollment in the research or not)
  • Data breach/breach of confidentiality regarding participant PHI
  • Unanticipated effects of an intervention that become apparent during the research

Deviations

A deviation is considered when a member of the research team does not follow the IRB-approved protocol or departs from study procedures. This includes, but is not limited to:

  • Any modification or departure from the approved protocol or use of supporting materials not approved by the HRPP/IRB.
  • Using outdated study materials
  • Failure to obtain informed consent from a participant who has been enrolled in the study

It is the PI’s responsibility to report all adverse events and deviations to the HRPP/IRB. To report an adverse event or deviation, please submit the following:

Exempt

To respond to an annual check in required notice or closeout an approved Exempt protocol please submit:

Non-Exempt

To respond to an annual status update required notice, seek renewal of an expiring Non-Exempt IRB approval, or closeout an existing approved protocol please summit: