Submitting a Protocol

All studies that fulfill the federal definition of "research" and involve "human subjects" (click for definition) must be reviewed and approved by the IRB before any procedures are initiated. All research must be re-reviewed at least annually, and any changes to an approved protocol require prior review and approval.

Adverse events, protocol violations, complaints, and other new information relevant to the research must be reported to the IRB in a timely fashion as each may alter the assessment of study risks or benefits.

 

At the time of submission, all studies are assigned a level of review based on risk, subject vulnerability, and to some extent the complexity of the proposed work.

  • Studies that involve procedures that are "more than minimal risk" can only be approved by the convened IRB, also known as the Full Board.

  • Minimal risk research and minor changes to approved research studies can be approved by the IRB Chair, or delegated to an IRB member for review and approval. This is referred to as expedited review.

  • The PI-IRB utilizes a subcommittee review process for initial review of studies that require final review by the Full Board. The subcommittee also reviews and can approve other, minimal risk research.

Amendments

All changes to previously approved protocols must be submitted to the IRB for review and approval before they are implemented (this includes changes initiated by a study sponsor). If you are unsure if the changes requires review, send us an email.

If your study has been created in PRISM, the modification must also be submitted in PRISM. If you have not created your study in PRISM this is a good time to do so.

To initiate review of a modification:

  • In PRISM, submit the amendment with or without a cover memo to detail the change and rationale for the change. Provide your assessment of the effect of the study's risks and benefits and if consent form revisions are required.
  • Include a revised copy of all relevant material. For example, if you are adding personnel to the study, you will need to submit a summary form.
  • If you are proposing a change to the compensation structure of the study, you will need to submit a revised copy of the protocol summary¬† form and the consent forms.
  • To facilitate review, please highlight all changes. Provide an un-highlighed copy of the consent for stamping.

To request a protocol exception ( a one time change to inclusion/exclusion criteria, procedures, or any other element of the study), write to IRBMail