"But I WANT You to Review My Project!" An IRB’s Experience with Implementing Policy Change for Reviewing Undergraduate-Initiated Research Proposals

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Program Statement
In April 2013, our convened IRB decided it would no longer review the many undergraduate protocols submitted each year, stating that most of these “undergraduate-initiated research activities” did not actually rise to the level of “research” as defined at 45 CFR 46.102(d). Instead, the activities constituted learning exercises designed to fit within the educational mission of the University, and were thus “not human subjects research.”

The IRB members and staff quickly learned that not everyone is thrilled to hear that no IRB review is required. Some undergraduates complained to their faculty advisors, others submitted letters of protest to the IRB. There were also strong objections from department heads, faculty, and program directors. We propose to share what we learned from this unexpected sequence of events, as well as the solution-focused collaborative efforts that emerged from a series of follow-up meetings with all parties represented. 

With this poster presentation we will outline the processes, successes, and ongoing challenges of protecting the autonomy of the IRB while helping the undergraduate community to learn about conducting human research. 

Process
The IRB had to consider issues such as: faculty viewed having their students go through the IRB process as an “educational exercise; students regarded IRB approval as an academic “status symbol”; and absent IRB review, faculty, and program managers struggled with what should happen instead: What kind of review process would these projects undergo? How would already over-burdened faculty find the time to take on a new role?

Successes
The IRB created two new guidance documents that were well received by faculty and students: one addressed research design and the other pertained to ethics. Guidance clarified faculty sponsors’ responsibilities in greater detail. Program managers now match undergraduate students with graduate student mentors to assist with IRB applications. For “crunch” application times, program managers have imposed earlier internal submission deadlines. Continuing dialogue to minimize burden on the IRB if projects do not get funded.

Challenges 
Some faculty continues to submit undergraduate-initiated projects that clearly do not rise to the level of health science research. We still receive undergraduate-initiated submissions that involve greater than minimal risk and consequently need full committee review. Timeline continues to be challenging as the undergraduate program submissions converge with the IRB’s “peak season” for full as well as expedited and exempt reviews.