Meet Dr. Ivor Pritchard, Acting Director of OHRP!
(This article was published in PRIM&R's November Membership Newsletter.) 

In PRIM&R's September Membership Newsletter we included a fond farewell to Dr. Bernard Schwetz, the former Director of OHRP as he headed - quite literally - for greener pastures, as he is now a gentleman farmer raising alpacas and llamas.  In this issue, we are privileged to say "welcome" to Dr. Ivor Pritchard, the Acting Director of OHRP since Dr. Schwetz's departure in September of 2007.  Although Dr. Pritchard needs no introduction to most of you, as he has been at OHRP as a Senior Fellow since 2004, we'd like to share a little bit of his extensive and highly impressive background. 

Previous to his arrival at OHRP, Dr. Pritchard worked for many years at the Institute for Education Sciences at the U.S. Department of Education, where he was a Senior Research Analyst.  He joined the U.S Department of Education in 1986. 

Dr. Pritchard has written on a variety of topics and a few of his recent articles include “Power, Truth and Justice in Youth Participatory Action Research: Ethical Questions” (Practicing Anthropology, 2004), “Students as Research Subjects” (with Greg Koski, Encyclopedia of Bioethics, 2004), and “Travelers and Trolls: Practitioner Research and Institutional Review Boards” (Educational Researcher, April 2002).  Dr. Pritchard is also the author of a book titled Good Education: The Virtues of Learning (1998).

Dr, Pritchard is a sought after speaker and has graced more conference podiums than can be named or even remembered.  Dr. Pritchard is known not only for his keen intelligence, bone-deep principles and integrity, and prodigious work ethic, but also for his wry and warming sense of humor and his amazing talent as a folk guitarist and harmonica virtuoso.  Dr. Pritchard is the closest thing the research ethics field has to a rock star, and he has written and performed songs at several conferences over the past 10+ years. 

Dr. Pritchard holds a PhD in philosophy from Boston University and a BA from Haverford College.  His professional interests are wide ranging, and include research ethics, moral and civic education research and practice, and education policy.

As PRIM&R members well know, there is an ongoing debate in the field of medical ethics as to whether ethics can indeed be taught, or whether it is instead something one must learn at the knee of a parent in early childhood.  Although most of us believe that ethical behavior can be taught at any age and stage, Ivor Pritchard is someone who comes by his unshakeable commitment to ethics and human subjects protections in the most inspiring and deeply rooted way imaginable.  In fact, if ever there was an individual who was the beneficiary of both a "nature" and a "nurture" imperative to work in the "protections" field, it is Ivor Pritchard.  Dr. Pritchard's mother, Marion, a Dutch citizen, protected the lives of 150 Dutch Jews during World War II, mostly children, and sheltered a Jewish man and his three Jewish children in her home during the last three years of the war.

Marion Pritchard often risked her own life hiding Jews during the War, and as a result, she has been designated one of the "Righteous among the Nations" by Yad Vashem, the Holocaust Memorial in Jerusalem.  After the war, she worked as a social worker in displaced persons camps and while there met an American officer who was an administrator at one of the camps.  They later married and moved to New York and then to Vershire, Vermont, where she worked for many decades as a psychoanalyst and a tireless Holocaust educator.  Dr. Pritchard and his two brothers were raised in a home in which the obligation to confront and wrestle with ethical issues was in the air they breathed.  If you would like to be further inspired by Dr. Pritchard's mother, Marion, have a look at one or more of the 1,500 Google entries about her.

If you'd like to be inspired by Dr. Pritchard, please read on, as we recently spoke with him about his goals during his tenure at OHRP.  In the article below we share some of his thoughts about the future of the Office and human subjects research more broadly.  And, you don't have to just read about Dr. Pritchard, as we are delighted and grateful that he will be leading a large and strong OHRP contingent at the PRIM&R meeting, which starts this week.  We hope you'll have a chance to meet him while onsite.  If you do, you'll see why he has earned not only our respect and affection, but also why he is an accessible and very unique "fed."  Thank you Dr. Pritchard, and thanks to all of your colleagues at OHRP for being such magnificent partners and educators for all of us working in the HRPP field.
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Interview with OHRP’s Interim Director, Dr. Ivor Pritchard

PRIM&R: Hello, Dr. Pritchard.  Thank you for “sitting down” with us for a chat.  The first question we’d like to ask is about your goals during your tenure at OHRP?

Dr. Pritchard: My overall goal is to focus on enhancing the quality of HRPP operations.

PRIM&R: What is your vision of an “ideal” HRPP?

Dr. Pritchard: Let me give you two of the main features of such an HRPP: The first feature would be the creation of a program where investigators welcome the opportunity to solicit and receive feedback from a knowledgeable, disinterested, and yet interested, engaged committee about the ethical dimensions of their planned research projects.

A second feature would require establishing an environment in which prospective human subjects already understand the fundamental features of research even before they are ever approached about their personal participation in a specific protocol.

PRIM&R: What steps can OHRP take to promote this “ideal” model?

Dr. Pritchard: We can use OHRP’s various educational resources, policy development authority, compliance oversight responsibilities, and leadership activities to try to focus the community's attention on the key features of the HRPP process. In so doing, we hope to encourage institutions to pay attention to the most important elements of the subject protection process, rather than be distracted by bureaucratic requirements that don’t seem to make sense or add value.

We also want to identify when and how education can be most effective for all of the parties involved in the HRPP process, from investigators to IRB members to potential human subjects. We will then work hard to encourage institutions to seek that kind of education.

PRIM&R: What do you see as the greatest challenges for OHRP in the coming months?

Dr. Pritchard: I think they are the same as they have been in the past, i.e., the issues likely to get particular attention over the coming months are those presently being considered by SACHRP and its sub-committees. These include Subpart A, adults with impaired decision-making capacity, and education and training, as OHRP is planning to publish a Federal Register notice on that topic.

And, as long as there are hurricanes, wildfires, and terrorists, many in our community will continue to worry about the issues involved in carrying out research activities in the wake of such public health emergencies, so those are also issues we will continue to be concerned about.

PRIM&R: What do you see as the greatest opportunities for advancing the ethical conduct of research?

Dr. Pritchard: The greatest opportunities are created by a number of things that are currently increasing the amount of “noise” in the IRB/HRPP community, such as debates about the different kinds of IRBs (e.g., local vs. central vs. commercial/independent vs. consortia, etc.) and their respective impacts. There are more and more information available comparing the different types of IRBs and how each is working, and we need to review and consider that data. 

With the continued expansion of multi-site projects -- whether they are handled by centralized reviews or reviews by the local IRB at each of the different sites -- there is much more looking over the IRB’s shoulder to see how they are doing things. 

As a result, there has been a surge in the number of empirical studies looking at IRBs and HRPPs to see how they operate and what can be learned from the kinds of results they are producing. Some of these new studies are comparing IRBs that have reviewed the same or similar projects and are looking at the variations in their findings.

I think that these kinds of comparisons make it easier to determine what are the real obstacles to ethical review and ethical research, and to determine what are the unnecessary impediments to the IRB review process. This kind of data presents an opportunity in and of itself to try to reduce or eliminate waste and inefficiency in the HRPP world, and it also presents a real opportunity to do more than just be distressed about perceived problems.

Another benefit that arises when one looks at differences in IRB outcomes and/or results will be that of clarifying what factors most favorably impact subject protections. Until now, there has been genuine disagreement by some IRBs as to how to handle certain protocols, and some of this new empirical research will hopefully address the ethical questions posed when IRB A, IRB B, or IRB C handles a given study differently. Usually, when three different IRBs come up with three different results, people assume that something is wrong, but it’s also possible that these three IRBs have each come up with a different way of handling the same problem. I hope that the new data will help us find the best practices for reviewing protocols and thus improving the ethical conduct of research with human subjects.

Ethical conflicts are another ongoing perceived problem that may also represent an opportunity, if those conflicts represent broader ethical issues that research has to confront in order to make real headway. As with all conflicts, some differences arise from genuine disagreements regarding the ethical conduct of research with human subjects. When these conflicts come to light, and when the system is operating properly, there should be an established forum to deal with the identified conflict(s) in a way that recognizes that these are systemic problems that are not caused by “just” a particular investigator. Therefore, conflict in and of itself may not be a bad thing, and, in any case, this is a societal problem and not just one faced by IRBs, investigators, institutions, sponsors, etc.

In addition, accreditation, which is another way of “looking over the shoulder” to examine HRPP/IRB procedures, policies, and their resultant outcomes, is another opportunity for advancing the ethical conduct of research. 

Other opportunities for advancing ethical research conduct include the fact that there are many more regional networks of IRBs in different areas of the country and of the world. These networks bring local groups of IRB administrators and institutional administrators together to talk about common issues, and this is a good thing. I’ve spoken to ones in Virginia and Maryland recently, and I will be going to meet with one in Chicago in a few weeks…

Finally, there are also many more conferences these days, and continuing education is an important way of advancing the ethical conduct of research.  In addition to the great tradition established by the annual PRIMR meeting, there are a growing number of other meetings sponsored by various organizations that offer valuable fora for dialogue about ethical issues.

PRIM&R: What actions can PRIM&R members, and the research ethics community more broadly, take to promote this ideal HRPP and to promote a strong, ethical research enterprise in general?

Dr. Pritchard: There’s a lot that the research community can do! For example, OHRP would like comments on the proposed SACHRP notice addressing research involving adults with impaired decision-making. There will be a Town Hall Meeting on December 3 at the PRIM&R Conference, and we encourage those who will be there to share their views about this difficult area either at that Town Hall Meeting or by e-mail before the period for comment  closes on December 4, 2007.

Also just posted was a notice asking for comments on the list of expedited review categories, and so OHRP also welcomes the community’s attention and comments about that proposal.

In addition, a number of the terms of some of the current SACHRP members will expire in the next year, and so OHRP has published a notice asking for nominations for new individuals to serve on SACHRP.  Therefore, anyone who would like to perform a little public service, or anyone who knows someone else who might be a suitable SACHRP member, should think about putting their names forward before the December 7th deadline. 

The current SACHRP charter expires in September 2008, and, from everything I have heard, SACHRP’s charter will be renewed so that the Advisory Committee can be kept in place.

PRIM&R: Any closing thoughts, Dr. Pritchard?

Dr. Pritchard: Yes, thanks. The first point I’d like to make is that the system for the regulation of human subjects’ research is fundamentally a decentralized one. The real authority for making the crucial decisions occurs in the exchange between investigators and the more than 5,000 IRBs that review and engage with investigators about the ethical dimensions of their research projects. There is no reason to think that PRIM&R members, and/or the research community more broadly, need to have the federal government involved each time they have a question about whether or not their own practices approach the kind of ideal that I was talking about earlier in this interview.

Instead, regulations require an understanding of local values, and so IRBs, in concert with their institution and investigators, can determine the local context necessary to develop appropriate policies and procedures. Once developed and adopted, HRPPs and IRBs can then continually reexamine and reevaluate those policies and procedures, and can also compare them with what's happening at the institution next door to see what can be learned from others about their notions of best practices in the field. It’s useful to compare the kinds of concerns and/or conflicts that arise from genuine ethical challenges in research, and to see what occurs across institutions in a given locality, in much the same way that such concerns and/or conflicts are looked at on a national or federal level.

There are some theorists of American democracy who say that our system has lasted as long as it has because the governmental apparatus is so slow-moving that it only adopts change when the value of that proposed change has been proven on a wide scale. The same thing could be said about the way in which research is developed, implemented, and improved.  Most of the best ideas and real changes usually begin at the grass roots level, and then, ten years later, the federal government sees how good those changes are only after they have been adopted by those working in the field.

PRIM&R: Thank you, Dr. Pritchard, for your time, your wisdom, and your dedication to human subjects protections.  Good luck in your new position!