IRB: Ethics & Human Research

Minor Changes to Previously Approved Research: A Study of IRB Policies

We examined institutional review board (IRB) policies from the top U.S. research universities to determine how many have policies that define or provide examples of what constitutes a “minor change” to previously approved research. We sought to describe differences among definitions and to ascertain whether funding level, accreditation, public versus private status, and geographic region impact the inclusion of a definition or example of this term. Of the 184 universities that we obtained policies from, 52.2% defined “minor change,” 43.5% gave examples of what would constitute one, and 67.9% provided either a definition or examples. We found that higher funding and accreditation were positively associated with having a definition or giving examples of minor changes, but that public versus private status and geographic region had no significant impact. While our study indicates that most of the top U.S. research institutions define the term “minor change” to previously approved research (either directly or by providing examples of what would constitute one), we found that the definitions vary considerably. Additional guidance from federal agencies could help promote consistency in institutional policies and ensure uniformity in protections for human research participants.

Key words/concepts: minor changes to previously approved research, expedited review, institutional review board, human subjects research, research oversight, U.S. federal regulations

David B. Resnik, Gwen Babson, and Gregg E. Dinse, “Minor Changes to Previously Approved Research: A Study of IRB Policies,” IRB: Ethics & Human Research 34, no. 4 (2012): 9-14.