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Anniversaries are always a time for reflecting on the past and the future, how we got here and where we are going. We do not always take time to give this tradition the undivided attention it deserves, and too often, the opportunity to reflect passes almost unnoticed. That could easily have happened to me in this case, distractible and distracted as I am. I am glad it did not and gratefully acknowledge that the persistence of strident editors can be remarkably effective! It is perhaps more than a bit presumptuous to believe that anyone else would have much interest in one's personal reflections, unless one is a president, a rock star or the like. Being none of these, I was flattered by the Journal's solicitation of my reflections on the occasion of the 40th Anniversary of the Society of Research Administrators International (SRA), and am honored to have these thoughts included herein. Nevertheless, I ask for your patience and understanding as you venture into this highly personal exercise in self-indulgence--I will try at least to make it worth your time. Forty years is an interesting time frame for reflection, being short of a major milestone like a half-century, which seems very long, but long enough to encompass significant changes in one's life and times, long enough to afford some perspective. Forty years ago, I was just graduating from high school, a young man with dreams of being a doctor and a scientist, pursuing a career that would bring the benefits of science to humanity through research and its translation to new therapies and diagnostics. These were noble, practical and even achievable goals, and it seemed that Harvard would be as good a place as any to pursue them. Looking back after 40 years, having spent my entire academic career at this bastion of tradition, my adolescent assessment has been validated. The road to today has pretty much followed the path I envisioned back then, but there have been a few unexpected detours along the way. Robert Frost once noted that taking a road less traveled can make a big difference; and to this I can attest.
For one, that I would ever be writing an article for the Journal of Research Administration, or any other publication dedicated to the management and conduct of research, still surprises me. Frankly, I still cringe whenever some one refers to me, even with the very best of intention and respect, as "a regulator." I have never seen myself as a regulator, even when I actually was one. When the topic arises, I feel a bit like the fellow in the poem written in 1895 by Gelett Burgess entitled The Purple Cow:
Somehow, being "a regulator" conjured up a picture of government agents in dark suits carrying Codes of Federal Regulations and striking fear into the hearts of researchers and university administrators at every turn, from Baltimore to San Diego, Come to think of it, I once saw a picture of my friends, Gary Ellis, Tom Puglisi, and Mike Carome back in '98 or '99 taken in the Office for Protection from Research Risks (OPRR) portraying precisely that image. There can be little doubt that the photo, which was published with a long story in a major national news magazine about the compliance crackdown underway, burned an indelible image into the minds of research administrators, managers, and Institutional Review Board (IRB) members across the country that still haunts them, and the entire research community. I am not sure who was in charge of news and public affairs for the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS) back then, or just what they were trying to accomplish by posing the OPRR leadership that way; but I can assure you, if that was what being "a regulator" was all about, I would rather have been a purple cow!
Ironically, while the perception of regulators has probably changed little over the past 40 years, that of being a purple cow has. Today, being a purple cow carries a very different connotation. In his 2003 book for innovators in business, which by the way made the best seller lists for Business Week, the Wall Street Journal and the New York Times, author Seth Godin uses the purple cow to illustrate the importance of being bold and original, as well as different if one is to distinguish one's product in the marketplace. In his review entitled "In Praise of the Purple Cow," Fast Company's Bill Mayer says:
So, you want to be a leader? Maybe being a purple cow is not so bad after all, and it sure sounds better than being a regulator, especially when traveling in Fast Company--more about that later. When I first became involved in research ethics, regulatory affairs and management some 15 years ago, the decision was one of conscience, not consciousness. Having served for a few months on Massachusetts General Hospital's (MGH) Subcommittee for Human Studies, the IRB for the hospital, learning something about research ethics and protection of human subjects seemed like a good idea, or at least the responsible thing to do. No one had to, of course, because at that time, no one expected IRB members to have any specific training or knowledge about research ethics or federal regulations for protection of human subjects in research. After all, no one expected that of investigators, so why would IRB members?
Having grown up in small-town Middle America, aphorisms like "any job worth doing is worth doing right" had been inculcated into my soul since childhood by my hard-working, loving parents who wanted beyond anything else to see their children succeed. The almost daily reminders that "when the going gets tough, the tough get going" probably did not hurt too much, and may have actually been more inspiring than "C'mon dude, do something ... do anything,", a line I heard in my son's snowboarding video game when the rider simply cruised through the electronic half-pipe without trying a death defying 720 double back flip ... a different set of expectations I suppose. Anyway, my conscience delivered me to an annual meeting of an organization I would come to know well, and love, Public Responsibility in Medicine and Research (PRIM&R).
Brand new to the organization, and to the community of dedicated individuals who not only ran IRBs, but those who voluntarily served on them, sitting down to lunch with Drs. Charles McCarthy, Robert Levine, and Louis Lasagna did not seem particularly special at the time. Little did I know that I was dining with the "Dons" of human research ethics! Looking back, I realize now that I may have unknowingly sat at the table reserved for honored guests; but my undergraduate years at Harvard must have suitably prepared me to maintain an air of nonchalance, even among the elite. And so, I picked up my fork, sampled my salad, and joined the conversation.
What I heard that day would, like that picture of the OPRR police that was yet to appear a few years later, leave a lasting impression. These giants of human subjects protection expressed their growing concern that this activity, conceived as a way to protect participants in research, was increasingly becoming a regulatory activity, focused on compliance, excessively rigid, and sometimes draconian. The cogency and prescience of their collective insight cannot be understated or overlooked. That was the same day that Ros Gray, the long-time manager of the Subcommittee on Human Studies at the MGH, and now for Partners HealthCare's Human Research Committee, mentioned that Stu Lind, then chair of the committee, was leaving and that perhaps I should consider stepping into his role.
Perhaps I should have protested more vigorously. At least, in making her comment, Ros prepared me for the moment, soon to come, when Ron Newbower, the MGH vice-president for research management would pop the question. Without directly expressing his reservations that I was too inexperienced to undertake the important role of chairing the IRB alone, he suggested that an individual "with more gray hair" might serve as co-chair, a configuration that I found unsatisfactory. As the negotiation ran its course, Dr. Newbower reminded me that the hard work ahead would be rewarded not with financial compensation but with the pride of knowing that I was fulfilling an important part of the hospital's research mission and that with the legacy of Prof. Henry Beecher behind me, the position could provide a platform for national leadership on the important ethical issues that lay ahead in human research. Right, I thought, and with the token in my pocket I could get home before Charlie on the MBTA.
Accepting the chair of the IRB at the MGH was for me a tipping point in my professional life. With that decision, I essentially abandoned what I had long envisioned as a career combining laboratory science with medical practice, believing that I would be able to contribute more by facilitating human studies than by pushing neuroblastoma cells in tissue culture dishes around an incubator for the grinding and binding of biochemical pharmacology. The change was both welcome and rewarding. Being accustomed to tradition and having been steeped in the thinking of Henry Beecher, the research community at the MGH was fertile pasture on which a purple cow could graze. As a middle child and constant conflict avoider, discord upset me, and reconciliation came naturally. With the comments of Charlie McCarthy, Lou Lasagna and Bob Levine still echoing softly in my mind, and the ghost of Henry Beecher in every corridor, we launched a campaign to promote the notion of shared goals and shared responsibilities for IRBs and investigators, to foster a belief that they could, and should, be more in collaboration than confrontation, and that we should be more interested in supporting responsible research than in regulating it. The purple cow was out of the barn, and people noticed.
What began at the MGH was "Partnerized" in the late 90's when the MGH and Brigham and Women's Hospital joined forces to form a research-based, integrated academic healthcare system, Partners for short. The desire to have an efficient, cooperative, fully integrated human research protection program for the entire Partners HealthCare System needed the likes of Paul Bunyan and Babe, his Great Blue Ox, to pull the wagon, but we went with the purple cow because it was all we had.
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