Supervisor signoff on new research no longer required by IRB-01 as of November 15, 2012
Dr. R. Peter Iafrate, Chairman of Internal Review Board-01 and Dr. David Norton, Vice President for Research
For several decades, IRB-01 policy required researchers to obtain their supervisor’s signoff before submitting new research studies to the IRB-01. The rationale for the supervisor’s signoff was threefold:
*Insure to the IRB-01 that the PI is qualified to conduct the research;
*Assume responsibility for the study should the PI be unable to conduct the research (e.g. leave the institution); and
*Verify that there are adequate department resources to initiate and complete the research, and on a department level approve the use of those resources.
Item 1 is determined with or without the signoff; items 2 and 3 are implicit. Although the new on-line myIRB software allows for department approval before the submission is sent to the IRB, there is no federal requirement for this process. Maintaining the accuracy of this sign-off, and allowing for all the delegation being requested, has resulted in some significant delays for investigators submitting to the IRB-01. In order to facilitate timely processing and ease of use, the IRB will no longer require departmental approval either via myIRB or on paper submissions.
As of November 15th, 2012, department approvers who are already established in myIRB will be deactivated, and the myIRB system will no longer request a supervisor sign off. Also at this time, Addendum A will be changed to remove the supervisor signature section.
The IRB will investigate a method for department\division chairs and other appropriate individuals to be able to view their employees IRB approved studies, information on this is forthcoming.