Protocol Submission and Review Process

Submission of Protocols

Effective May 1, 2020 investigators must submit new and de novo protocols for Institutional Animal Care and Use Committee (IACUC) review via GW iRIS.

Submit an IACUC Protocol via GW iRIS

Legacy forms, to modify and/or continue protocols submitted via paper format prior to May 1, 2020, may be found on the IACUC Forms page.

Types of Submissions

New Protocols

Principal investigators (PIs) must complete and submit new protocols via GW iRIS. The approval process for new proposals typically takes 4-6 weeks. Once approved, an IACUC protocol is valid for 3 years after the initial approval date. Protocols that have Department of Defense (DoD) funding or contain animals covered by the Animal Welfare Act (AWA) must submit a continuation annually which will be reviewed by the full IACUC committee. A continuation or a de novo review must be submitted a minimum of 4-8 weeks prior to expiration of the protocol.

Continuations

On an annual basis (for up to three years), principal investigators (PIs) are required to submit continuations for each approved protocol that has DoD funding or contains animals covered by the AWA. Continuations are due at least six weeks prior to the expiration date (one year after initial approval).

De Novo Reviews

All protocols must receive a complete review once every three years. PIs must submit a new IACUC application via GW iRIS at least eight weeks prior to protocol expiration. When a new protocol is created, the protocol will be assigned a new number. The approval process for de novo reviews typically takes 6-8 weeks.

Modifications

Should a PI decide that they wish to make changes to their approved IACUC protocol, they must submit a protocol modification. If the modification is classified as a significant change, the submission will either undergo a Full Committee Review (FCR) or a Designated Member Review (DMR). For minor changes, the submission may undergo an Administrative Review (AR). The timeframe for approval will depend on the type of review employed.

Types of Review

Upon receipt, IACUC administrative staff will review the submission to determine the appropriate level of review:

Full Committee Review (FCR)

  • Any protocols involving a USDA AWA covered species
  • Requires a veterinary review by the Attending Veterinarian (AV) or their designee

Administrative Review (AR)

Designated Member Review (DMR)

  • Protocols which do not require FCR and are not eligible for AR
  • Requires a veterinary review by the AV or their designee
  • Any IACUC member may request FCR during the comment period
  • If no committee member requests FCR, the IACUC Chair will appoint an IACUC member to serve as the designated reviewer

 

Protocol Submission Type Protocol Species Review Process Timeline for Approval
New Proposal USDA FCR 6-8 weeks
Non USDA DMR 4-6 weeks
Continuation USDA FCR 6-8 weeks
De Novo USDA FCR 6-8 weeks
Non USDA DMR 4-6 weeks
Modification – Significant Changes USDA FCR 6-8 weeks
Non USDA DMR 4-6 weeks
Modification – Minor Changes USDA AR 1-2 weeks
Non USDA AR 1-2 weeks