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.

 

Standard IRB Fees

Standard IRB Fees for Industry Funded Studies

The following charges will be included in contract budgets for industry funded studies (funded by drug or device manufacturers or other for-profit sponsors) for contracts managed by RFMH or Columbia:

$3,000 for initial review, $500 each for sponsor-initiated amendments, $500 each for continuing reviews. The fee applies regardless of whether a convened meeting or expedited IRB review (including expedited review conducted by subcommittee) is involved.

  • IRB fees must be included in study budgets before submission to the RFMH, Columbia, or outside business  offices, as applicable.
  • Fees will be applied to all commercially supported human subjects research regardless of  whether the research is industry sponsored ("industry written") or investigator initiated.


To see the full RFMH policy, please visit the RFMH website at http://corporate.rfmh.org/grants/forms/standard_IRB_fees.pdf