University Times

Last week, Randy P. Juhl, dean of Pitt's School of Pharmacy since 1986, was named vice chancellor for research conduct and compliance, effective July 1. He had been serving part time as associate vice chancellor for research conduct and compliance, in addition to performing his duties as dean.

Juhl will be stepping down as pharmacy dean, but will continue to head the Research Conduct and Compliance Office reporting directly to Chancellor Mark Nordenberg as a member of the senior administration.

Juhl almost did not become a Pitt dean. In 1984-1985, a proposed University-wide restructuring plan called for the School of Pharmacy to be closed, with its faculty and programs to be absorbed by the medical and the nursing schools. "We still refer to the day we got word of that as 'Black Tuesday,'" Juhl said. "It was a pitiful time. The former dean didn't handle it very well and left in a huff. An interim dean was appointed. I was a green department chair, and two senior faculty members came to my office and said, 'If we're going to get out of this, you're going to have to do it' [as dean]. That day changed my life. We were on a mission to show the University they were wrong about us as a viable school."

Under Juhl's leadership, the School of Pharmacy has risen to sixth nationally in terms of National Institutes of Health research support.

A 1968 graduate of Waldorf College in Forest City, Iowa, Juhl earned his Ph.D. degree from the University of Iowa College of Pharmacy in 1976.

He served as the inaugural chair of the non-prescription drug advisory committee of the Food and Drug Administration (FDA) from 1992 to 1996. He is a consultant for researchers, helping them prepare for FDA advisory committee presentations.

Juhl was interviewed by University Times staff writer Peter Hart last week.

UNIVERSITY TIMES: Why did you decide to step down as pharmacy dean and accept the position of vice chancellor for research conduct and compliance?

JUHL: There were two considerations. First, the chancellor asked me to join the senior administration team and report directly to him, an indication of the importance that we do everything by the book in our research conduct and compliance and do nothing to jeopardize the $425 million enterprise that we've got. Of our billion-dollar budget, that's a pretty big chunk.

Second, and more importantly for me, the school is in good shape, including research support from the NIH, the leadership team we have, our teaching programs and clinical service programs, and the kind of support we have now, in both spirit and financially, from Dr. [Arthur] Levine. Also, I think the change in leadership should be relatively easy with Pat Kroboth taking over.

That doesn't stop a lot of tears being shed because of the friendships [I've built at the school], but in terms of the organization itself, we've come an awfully long way since "Black Tuesday."

What were your accomplishments as dean?

Several things: One, in our primary educational program, we've changed our curriculum from a 5-year bachelor of pharmacy degree to a 6-year doctor of pharmacy degree. That took much of the 1990s to plan and implement. We changed not only the program but we've really changed the way we deliver our educational product. Most of the credit goes to the faculty for saying we need to change the way we teach, because that's difficult.

Our facilities are greatly improved. When we started remodeling Salk Hall in 1987, this place, quite frankly, was a dump. It was an old hospital with institutional green walls and ugly green tile, poor lighting and labs many years out of date. Now people can come to work in an enjoyable and nice place.

We've maintained a small but very high-quality graduate program. We have a clinical pharmaceutical sciences graduate program, which, when it started, was unique in the country and still commands a fair amount of respect nationally.

We did our own strategic planning and selective and careful hiring, and when Dr. Levine came he provided us some additional funds. Two years ago, all the stars lined up: We moved from a middle of the pack pharmacy school up to No. 7 in NIH funding. That was my red-letter day.

Even more important than the dollars, we're doing important research. One thing that pharmacy research does is to help us use drugs better, to make them more effective, safer and less costly.

The patient care activities of our faculty are outstanding, both at UPMC and the VA and other affiliated sites. We have a group of clinicians that when they give a lecture about a disease, they're so good, I wished I had the disease (laughs).

Any disappointments?

I wish we got to where we are sooner. I suppose there's some value in doing it right and doing things sequentially, but it took the patient efforts of a very supportive faculty, staff, students and alumni to get here.

Will you have a continued role with the school?

Not being dean will be different, but I'll be a very interested observer. I'll still be on the faculty, and I'll try to maintain my ties and hopefully I'll be asked to give a lecture occasionally.

As vice chancellor for research conduct and compliance you'll continue to head up Pitt's Research Conduct and Compliance Office (RCCO), which includes the Institutional Review Boards (IRBs), the Institutional Animal Care and Use Committee, the Radiation Safety Office and the Recombinant DNA Office. Now that you will be devoting more time to RCCO in this elevated position, will your duties change?

Three years ago the RCCO was established to take different organizations within the University that were responsible for these kinds of things and put them into one group with a central focus. The mission is twofold: one, compliance with regulations is not optional, and second, we want to make life as easy as possible for our investigators to conduct their research in a regulatory-compliant way. All those committees have regulatory responsibility. My job is to run the office that supports their activities. And that's a real important differentiation, because I can't say to a committee, 'You should approve this, or approve that.' They have their own responsibility to apply their judgment independently to the research that's being proposed to that group.

I would it's say the human subject protection part that is most critical to our mission. The safety of human subjects has to be primary for two reasons: one, our money to do research comes from the people and our subjects to do research come from the people. And they're the ones with the least control.

With Pitt's sponsored research funding more than doubling over the last few years, is there a correspondingly greater possibility for errors?

Yes, the bigger you are, the more opportunity there is for shortfalls. The government has closed down universities' research activities for various things ranging from a subject dying in a clinical trial to poor management of records.

The rate of growth we've seen at Pitt has just been fantastic. For example, IRB submissions are up 50 percent just from the year 2000, with total submissions approaching 5,000 a year.

The downside is that the infrastructure needs to grow along with that. Every government body that has some level of responsibility for clinical research and human subject protection has seen fit to issue its own blizzard of edicts. It's all well-intentioned: With human subject research, you want to get it right.

But if those of us in the RCCO who think and live and breathe these things every day are having a difficult time keeping up, you can only imagine what it's like for the investigators. They're becoming overwhelmed and frustrated.

Quite frankly, we knew our paper-handling system was broken and we hired consultants to come in and make recommendations. Last year we had a consultant look at our regulatory compliance. (See Jan. 24 University Times.) This one was to look at our office processes.

We picked up a number of interesting and very practical helpful solutions to our problem.

Dr. Levine and Provost [James] Maher have both provided additional resources, including more staff, and hopefully over the summer and during the fall semester we'll be able to implement these changes. We need to hire and train staff, and we're going to go from four IRBs meeting once a week to eight IRBs with two meetings a week, which means we need to recruit and train more IRB members.

We recognize that we have problems, not in our compliance, but in our efficiency and effectiveness of handling investigators' submissions. So we recognize the problems, we recognize the cause of the problems, we know what the solutions are and we've got the resources to implement the solutions. That will be my responsibility. We only ask for a little more patience from our scientists.

Will you have other duties in your new position?

I'm very excited about the opportunity to work in the chancellor's office as part of the team. Mark and I have been friends for a long time. He's two days older than I am, which I constantly remind him.

My job is about 50 percent with the Research Conduct and Compliance Office and the other 50 percent, quite frankly, we're still working on. I'm sure there will be issues that come through the chancellor's office that Mark thinks I'm the best person to handle. He'll put things on my desk, and I'll deal with them.