Efficiency Changes in Store for MHRI Office of Research Integrity

The administration of an institutional review board (IRB), or any regulatory committee for that matter, can feel like death by a thousand paper cuts. Each step in the process is like a tiny paper cut: one step individually can be annoying, but not enough to do you in. However, the culmination of these injuries can have a greater overall harm. Process improvement for an IRB office requires taking a meticulous look at each step and asking these questions:

• Is the step required by regulations?

  • If no, is it a best practice or does it adhere to an industry standard?

    • If no, does it fulfill a business purpose?
      • If no, can the step be eliminated? And if so, what are the risks of eliminating the step?

The goal behind this method is to ensure the Office of Research Integrity (ORI) is effective in our processes, eliminating unnecessary red tape so that the office and its committees can focus on the things that matter, protecting human subjects and conducting animal use procedures with the highest scientific, humane, and ethical principles.

Of course, research and medical care are a heavily regulated industry. Eliminating steps or processes is not always possible. The next goal is to focus on efficiency. Can we meet these requirements in a less burdensome way?

With this as the backdrop, ORI would like to announce the following changes that may affect investigators:

1. Removing signatures and stamping of approval documents (except consent forms)
   Regulations do not require IRB approval letters to be signed. Stamping is not mentioned in the regulations. “Stamping” became a practice for consent forms because of OHRP commentary in warning letters published in the 1990s and early 2000s. Stamping was a viable solution in the 1990s and -2000s, when IRB processes were on paper. However, most abandoned the practice of “stamping” all approved documents when IRB processes moved into electronic systems. Printing, signing, stamping, scanning and inputting back into InfoEd causes delays in providing notifications back to study teams.
   Starting in June, ORI will no longer sign approval letters or stamp any approved documents except for consent forms. The IRB-approved letters will include the version and date to provide the necessary audit trail as to what documents were approved.
   Future enhancements will include evaluating InfoEd in the coming weeks to replace the physical stamp with an e-generated mark on the consent forms.
2. Reducing review times for personnel changes
   Currently, personnel changes are reviewed by the ORI staff and a voting member of the IRB. OHRP guidance states that personnel changes (other than a change in PI) are not considered “modifications to the research” and do not require IRB member review. To reduce review times for personnel-only changes, member review will no longer be required for personnel-only changes.