Keane observations: reflecting on 32 years of service

The executive director of the Human Research Protection Program, Moira Keane began her University of Minnesota career in 1980 in the College of Continuing Education. But her maroon and gold roots run even deeper: she enrolled as a freshman at the university in 1973.

Before retiring on June 15, 2012, she looks back on a career that spans three decades — and looks forward to what lies ahead.

Witness to positive change

Since accepting a position in 1987 with the Institutional Review Board’s Committee on the Use of Human Subjects in Research, Keane has seen many dramatic changes. When she started, there were two full-time employees (and one half-time). The group was housed in the Sponsored Projects Administration offices. There was no vice president for research.

Today, the Human Research Protection Program counts 21 employees and includes the Institutional Biosafety Committee, as well as the IRB.

“There are certain products and research areas that were considered highly experimental when I first started that now are standard of care, or very routine and commonplace. For instance, the nicotine patch was experimental when I first started doing this work, and now you can buy them over the counter.

“Statins were just being studied in clinical trials, but now are very commonplace items in any formulary. MRI was considered an experiment at the time, and now we have very sophisticated, high-Tesla magnets.

“In the AIDS clinical trials I’ve seen tremendous change, and in the entire infectious disease arena. Cancer clinical trials as well, particularly in pediatrics: I’m very pleased to say that we now have long-term survival studies, and that’s due to the progress in that clinical area.”

Creating a culture of protection

Keane has played a key role in the evolution of the university’s approach to studies involving human subjects. Due to mounting concerns in the late 1990s, including the suspension of federally funded human subjects research at some large institutions, a number of organizations recognized the need to create a self-regulating accrediting body that was peer-driven and educational in nature.

The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) was created to address those needs.

Public Responsibility in Medicine and Research (PRIM&R), the principal policy and membership organization for IRB-related activity, also has been a significant force in Keane’s career.

Keane has been active in both, most recently serving as chair of the council on accreditation and conducting site visits for AAHRPP. She is currently serving on the board of directors of PRIM&R, and chairing the certification committee.

“There has been a considerable evolution at the U in understanding of the need not just for compliance, but an aspiration to excellence in the way research is conducted. There is a culture around protection and adherence to the requirements that is much more sophisticated now than when I first started.”

Advice for her successor

While her shoes will be hard to fill, Keane is gracious in sharing wisdom. First and foremost, she says her successor must take the work very seriously, because it’s serious work.

“It’s important, it’s valuable to the institution, and it’s valuable to people who don’t even know we’re doing it. The people who are in the studies are usually unaware of the function that we serve.

“By the same token, it’s important to not take ourselves too seriously. It’s very easy to criticize this function and to be critical of it — it’s too much, it’s not enough, it’s too slow — and it would be easy to take those kinds of criticism personally. It’s important not to. Having some balance in life so that the work is not all-consuming is very important.

“This role will continue to grow into more of a multifunctional kind of position that looks more at the whole of the human research protection program. The scope is expanding in that there is more contact with more entities at the university, and more contact with partner institutions.

“When I first started, most of the research was single institution-based, federally funded research. Now, much of the research is multicenter clinical trials, multicenter studies in general, and much more dispersed in terms of the players who are involved.

“The coordination of that presents some challenges, as when we’re partnering with institutions that have different norms or cultures. Even some of the mechanics are sometimes awkward. I think there will be ongoing challenges going forward in those areas.”

Final thoughts and future plans

“I have most enjoyed working with really smart, dedicated people. That includes the leadership, the IRB and IBC members, the researchers and the staff. People who really care about protecting the people in the research projects and in the research labs.

“They put up with a lot of inconvenience and put forth a lot of effort to make sure that the projects we have here are good. That’s impressive, and something I’ll miss.”

To help keep in touch with that energy and commitment, Keane plans to continue her involvement with AAHRPP and PRIM&R after retirement.

But she’s also looking forward to a different pace in retirement. Her husband retired in early May, so they plan to spend more time at their cabin and do some traveling. She has two grown daughters, both married.

And, thanks to some extremely fortuitous timing, Keane and her husband recently learned that they will welcome their first grandchild in October.

Keane’s career, by the numbers

32 years at the U
6 presidents
5 vice presidents for research
142% increase in number of studies reviewed annually
5 changes in office location
640 lunches at the Campus Club

Photo by Eric Vegoe