Lifetime Achievement Award for Excellence in Research Ethics

This award recognizes individuals who have made extraordinary contributions to the field of research ethics, "who have mastered the large body of information, have applied sound analytical methods to the resolution of particular problems and sound critical methods to the resolutions proposed by themselves or others, have synthesized their findings and those of others into new comprehensive accounts of the field, and have effectively communicated the fruits of their efforts to others." The award provides recognition by PRIM&R for those whose work has been seminal, exemplary, and the embodiment of a commitment to advancing research ethics.

Ruth MacklinPRIM&R's Board of Directors has selected Ruth Macklin, PhD, to receive the Lifetime Achievement Award (LAA) for Excellence in Research Ethics in 2017.

Dr. Macklin's impact on the fields of bioethics and research ethics is considerable and far-reaching. She is a distinguished university professor emerita (bioethics) at Albert Einstein College of Medicine in the Bronx, New York. She retired from her full-time faculty position there in 2016 after 39 years of teaching. She received a BA with distinction from Cornell University and an MA and PhD in Philosophy from Case Western Reserve University.

Dr. Macklin is known for the rigor of her thinking, which she has applied through work both in the United States and abroad. Her numerous writings have deeply influenced the field of bioethics. She has authored more than 270 publications in professional journals and scholarly books in bioethics, law, medicine, philosophy, and the social sciences, in addition to articles in magazines and newspapers for general audiences. She is author or editor of thirteen books, including Against Relativism (1999), Double Standards in Medical Research in Developing Countries (2004), and Ethics in Global Health: Research, Policy and Practice (2012). Her work has covered wide-ranging topics for both academic and lay audiences, including HIV/AIDS, human reproduction, human subjects research ethics, health policy, and medical ethics.

Beyond her teaching and writing, Dr. Macklin has served in countless other influential roles. She is a past chair of the external ethics committee at the Centers for Disease Control and Prevention (CDC), served as chair of the Ethical Review Committee at UNAIDS, where she was also a member of the Global Reference Group on HIV/AIDS and Human Rights. She is a fellow at the Hastings Center, and a past president and past Board member of the International Association of Bioethics. She has been a consultant to the World Health Organization since 1989, having served on committees in the Department of Reproductive Health and Research and the HIV Vaccine program. From 2000 to 2016 she was director of "A Training Program in Research Ethics in the Americas" funded by a grant from the Fogarty International Center of the NIH. She has received many prestigious awards, including American Society for Bioethics and Humanities' Lifetime Achievement Award in 2002, the Hastings Center's Henry Beecher Award, and an award from the Global Forum on Bioethics in Research for contributions to progress in international research ethics, both in 2014.

Dr. Macklin's colleagues note her impact both on their own development and work and on the field as a whole. One shared that she is the type of dinner guest who can keep a person enthralled in conversation for hours; another noted that she "embodies the contribution that a serious philosopher can make to bioethics." She has spent decades challenging assumptions, provoking new ways of thinking, and promoting the rights of the vulnerable. PRIM&R is honored to recognize her extraordinary career and her contributions to the field of research ethics by awarding her the 2017 Lifetime Achievement Award.

Temple GrandinPRIM&R's Board of Directors has selected Temple Grandin, PhD, to receive the Lifetime Achievement Award for Excellence in Research Ethics in 2017.

Dr. Grandin is a professor of animal science at Colorado State University. She is a speaker and autism advocate, and has done substantial consulting work for major fast food chains including McDonald's, Wendy's, and Burger King. She was instrumental to the development of new animal welfare guidelines for the meat industry. In addition, she has served as a past Board member for the Autism Society of America and has been an influential advocate for individuals with autism. Dr. Grandin received her PhD in Animal Science from University of Illinois for her work on the effect of environmental enrichment on the behavior of pigs. She earned her MS in animal science from Arizona State University, studying cattle behavior in squeeze chutes, and her BA is from Franklin Pierce College.

Dr. Grandin was the catalyst through which discussion of animals' experiences (whether in the slaughterhouse or the laboratory) entered the popular conversation among those who handle animals. In the words of Dr. Chris Newcomer, member of PRIM&R's Board of Directors:

Dr. Grandin is widely credited and visible for her unique insights into the animal's perception of the environment and her resulting seminal work on large animal facility and design, which has monumentally impacted the welfare of large agricultural animals in the U.S. and abroad. Although an appreciation for the animal's experience has long been held by small groups of proponents and practitioners, it has often been a background consideration, secondary to the issues of convenience, efficiency or other human needs in the management of animal welfare on an industrial scale. The sea change created by Dr. Grandin's work moved the animal's perception and animal welfare back into a primary consideration, improving the humane care of hundreds of millions of animals and restoring much public confidence in the caring stewardship of modern agriculture. Working from this base, Dr. Grandin has been an effective champion for research animal ethics in many other areas emphasizing the broad protection of the subject and the compassion and effective training of the animal experimenter/handler.

Dr. Grandin has published numerous works on autism and Asperger's, animal welfare, and livestock-handling best practices. She has written 13 books, including the New York Times best-seller Animals in Translation and the acclaimed The Autistic Brain.

Among her numerous awards, Dr. Grandin was named one of Time's 100 most influential people in 2010. She has received honorary degrees from Carnegie Mellon University, McGill University, Swedish University of Agricultural Sciences, Duke University, and Emory University. She was inducted into the Cowgirl Hall of Fame in 2010, the American Academy of Arts and Sciences in 2016, and the National Women's Hall of Fame in 2017. She was named a Beef Top 40 industry leader and an Honorary Fellow of the Society for Technical Communication. She received the Lifetime Achievement Award from the National Cattlemen's Beef Association in 2010, the Cold Spring Harbor Laboratory's Double Helix medal in 2011, the World Organisation for Animal Health's Meritorious Achievement Award in 2016, and the Industry Advancement Award from the American Meat Institute in 2016. In 2010, she was the subject of the semi-autobiographical HBO film Temple Grandin.

At PRIM&R's 2009 IACUC Conference, Dr. Grandin gave a Henry Spira Memorial Lecture titled "Welfare Issues during Handling, Transport, and Slaughter." PRIM&R members can access a video recording of that presentation in our Knowledge Center. PRIM&R is thrilled to honor her impact and her remarkable career by awarding her the 2017 Lifetime Achievement Award.

Bernard RollinPRIM&R’s Board of Directors have selected Bernard E. Rollin, PhD, to receive the Lifetime Achievement Award for Excellence in Research Ethics in 2016. Dr. Rollin is PRIM&R’s first Lifetime Achievement Award recipient from the animal care and use field, and, not surprisingly, has made considerable and influential contributions to that field.

Dr. Rollin brought the field of applied ethics to veterinary medicine nearly four decades ago and has prodigiously explored and influenced every dimension of veterinary ethics and the human animal relationship since. He is a creative, provocative, engaging, and even confrontational philosopher and educator who has shared his perspective and stimulated thought and discourse among diverse audiences—veterinarians, research personnel, the large- and laboratory-animal production industries, companion animal breeders, wildlife researchers, and the animal control industry. He is a prolific scholar, intent on ensuring that our actions and the regulatory framework for the consideration of animal issues reflect our moral and ethical commitments to animals.

Once rare and nearly invisible, Dr. Rollin moved “ethics” squarely and comfortably into the lexicon of veterinary medicine.

Dr. Rollin serves as University Distinguished Professor, professor of philosophy, professor of biomedical sciences, professor of animal sciences, and university bioethicist at Colorado State University. He developed the world’s first courses in veterinary medical ethics, ethical issues in animal science, and biology combined with philosophy. He served on the Pew National Commission on Industrial Farm Animal Production and serves on the Institute of Laboratory Animal Research (ILAR) Council of the National Academy of Sciences.

Dr. Rollin is the author of 17 books, including Natural and Conventional Meaning; Animal Rights and Human Morality; The Unheeded Cry: Animal Consciousness, Animal Pain and Scientific Change; Farm Animal Welfare; The Frankenstein Syndrome; Science and Ethics; and Veterinary Medical Ethics: Theory and Cases, as well as more than 600 articles. He has edited a two volume work: The Experimental Animal in Biomedical Research. For 20 years, Dr. Rollin has written a popular monthly column on veterinary ethics for the Canadian Veterinary Journal, and he recently published his autobiography, titled Putting the Horse Before Descartes.

Dr. Rollin has received numerous national and international awards, including the American Veterinary Medical Association (AVMA) Humane Award (2007). He is a founder and board member of Optibrand, an animal identification company utilizing retinal images. Dr. Rollin is also a weightlifter, horseman, and motorcyclist.

Joan RachlinThe Board of Directors selected PRIM&R’s executive director, Joan Rachlin, JD, MPH, to receive the Lifetime Achievement Award for Excellence in Research Ethics.

One would be hard pressed to find another professional in the field of research ethics who has done more in the last 39 years to “disseminate” the ethical principles that govern research in this country. Ms. Rachlin’s career spans the evolution of the field of research ethics. She came to PRIM&R in 1975, a year after the passage of the National Research Act and the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. During her first decade at PRIM&R, the public was grappling with the revelation of the US Public Health Service Syphilis Study in Tuskegee, The Belmont Report was published, and human research regulations were advancing. During her second decade, significant amendments were made to the Animal Welfare Act, The Common Rule was adopted by 16 federal agencies, and the Radiation Experiments were exposed. During her third decade at PRIM&R, AIDS activists and cancer survivors radically changed the public’s view of human subjects research, from an ominous enterprise to be feared to a hopeful opportunity for saving lives. Ironically, the terrible tragedy of Jesse Gelsinger’s death also occurred during that decade, spawning widespread recognition of the urgency for effective education in research ethics and the responsible conduct of research. And during Ms. Rachlin’s fourth decade of service, the internet and other technological advances dramatically altered the way research is conducted, giving rise to new ethical problems that were difficult to accommodate within a regulatory framework developed in a previous century.

With near clairvoyance, Ms. Rachlin understood the need for research ethics education from the start of her career with PRIM&R. She organized PRIM&R’s first educational conference in 1977, and fueled by the events of these decades, never relented in her quest to offer more and better educational programming during each of the years that followed. Ms. Rachlin’s passion and leadership in developing and providing this education was singular. Through her extraordinary efforts, force of will, and commitment, PRIM&R came to fill a unique role in the emerging field of research ethics education. PRIM&R educational programs provide both ethics and practical tools for the application of ethical principles. In this manner, PRIM&R’s programs and membership services have had an extraordinary impact on the field.

It is not possible to describe in a paragraph the achievements of a lifetime, but here are a few highlights. Over the course of her tenure at PRIM&R, Ms. Rachlin planned and organized more than 200 conferences and educational events, as well as produced and distributed their proceedings. In collaboration with two of PRIM&R’s Board members, she produced a CD-ROM for research scientists, Investigator 101, the rights to which were acquired by the Office for Human Research Protections (OHRP) for distribution to every major academic health center and university in the country. Under Ms. Rachlin’s stewardship, PRIM&R developed its highly acclaimed educational programs, for both IRB and IACUC professionals, including IRB 101sm, IRB Administrator 101, and Essentials of IACUC Administration. She shepherded the development of PRIM&R’s two certification programs, the Certified IRB Professional (CIP®) and the Certified Professional IACUC Administrator (CPIA®) credentials, both of which have successfully certified thousands of research professionals contributing to excellence in their respective fields. One of PRIM&R’s accomplishments in which Ms. Rachlin takes great pride is the growth of its membership from a small group of 61 Charter Members in 1986 to the large and active membership community of today including more than 4,000 research professionals from around the world.

Ms. Rachlin’s work in research ethics education extends beyond PRIM&R. She played a seminal role in the creation of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the first voluntary accreditation program. She developed and launched WISH-net, a website for women and girls interested in, or already pursuing, careers in science and medicine. She served on the faculty of several colleges, where she taught women’s health, health law, and research ethics. Ms. Rachlin is a contributor to the well-known resource, Our Bodies, Ourselves, and serves on its Advisory Board. She is a past member of the editorial board of the journal, IRB: A Review of Human Subjects Research, and of Boston-area IRBs.

And then there are the achievements accumulated before her tenure at PRIM&R. Prior to her full-time commitment to PRIM&R, Ms. Rachlin practiced law, concentrating in the areas of women’s health, civil rights, and criminal and civil litigation. She holds a JD from the Suffolk University School of Law, and an MPH from the Harvard School of Public Health.

Anyone who knows Ms. Rachlin recognizes that her greatest passion is to build and nurture relationships, both professional and personal, with an eye toward improving society. She believes that advancement of any kind is achieved through networking, mentoring, collaborating, and celebrating. The PRIM&R community, which largely owes its existence to her efforts, is proud to celebrate Joan and her extraordinary achievements.

PRIM&R’s 2013 Lifetime Achievement Award was presented to Ms. Rachlin on November 9 at the 2013 Advancing Ethical Research Conference.

Ruth R. Faden

Ruth FadenAt the time of receiving this award, Ruth Faden was the Philip Franklin Wagley Professor of Biomedical Ethics; director, Johns Hopkins Berman Institute of Bioethics; professor, department of health policy and management, Johns Hopkins Bloomberg School of Public Health; and professor, department of medicine, Johns Hopkins School of Medicine.

Dr. Faden is the founding director of the Berman Institute, and has taught what is believed to be the first public health ethics course in the country. She is also a senior research scholar at the Kennedy Institute of Ethics at Georgetown University. She is a co-founder of the Hinxton Group, a global community committed to advancing ethical and policy challenges in stem cell science, and the Second Wave project, an effort to ensure that the health interests of pregnant women are fairly represented in biomedical research and drug and device policies.

Dr. Faden has served on numerous national advisory committees and commissions including the President’s Advisory Committee on Human Radiation Experiments, which she chaired, and which produced a comprehensive report of the experiments conducted by various US federal government agencies.

At the time of receiving this award, Dr. Faden’s research focused on questions of social justice in health policy and global health, including the national and global challenges in pandemic influenza planning and response, vaccine policy and funding, health systems design, and fair access to the benefits of global investments in biomedical research. She also worked on ethical challenges in biomedical science and women’s health.

Dr. Faden is the author, co-author, and editor of many books and articles on biomedical ethics and health policy, including Social Justice: The Moral Foundations of Public Health and Health Policy (2006); AIDS, Women and the Next Generation (1991); and HIV, AIDS and Childbearing: Public Policy, Private Lives (1996).

Dr. Faden earned graduate degrees from the University of Chicago and the University of California, Berkley. She is a member of the Institute of Medicine, and is a Fellow of both the Hastings Center and the American Psychological Association. She was the 2011 recipient of the American Society for Bioethics and Humanities Lifetime Achievement Award.

Tom L. Beauchamp

Tom BeauchampAt the time of receiving this award, Tom Beauchamp was professor of philosophy and senior research scholar at the Kennedy Institute of Ethics at Georgetown University. He received graduate degrees from Yale University and The Johns Hopkins University, where he received his PhD in 1970. He then joined the faculty of the philosophy department at Georgetown University, and in the mid-1970s, accepted a joint appointment at the Kennedy Institute of Ethics at Georgetown. In 1975, he joined the staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, where he wrote the bulk of The Belmont Report (1978).

Dr. Beauchamp’s research interests include the ethics of human subjects research and animal care and use, as well as the place of universal principles and rights in biomedical ethics, methods of bioethics, Hume, the history of modern philosophy, and business ethics. At the time of receiving this award, he was conducting a study in collaboration with several other investigators, including Dr. Ruth R. Faden, which focused on the conceptual, moral, and policy dimensions of the distinction between research and treatment.

Dr. Beauchamp currently holds a National Science Foundation award to advance work in animal research ethics, together with a group of investigators headed by Hope Ferdowsian at The George Washington University. This project is centered on an analysis of the concept of vulnerability to harm, and the creation of an anatomy of potential harms from research interventions.

Another of Dr. Beauchamp’s priorities has been his participation in the development of a program in pharmaceutical ethics at the Eli Lilly Company. Lilly has been one of the first pharmaceutical companies to establish a standing bioethics committee, and Dr. Beauchamp has been involved in this initiative from its inception.

Dr. Beauchamp is the author and co-author of numerous books, including Principles of Biomedical Ethics (2008) which has become the standard book for medical ethics classes all over the world; The Human Use of Animals (2008); and Philosophical Ethics (2001). Many of his articles were republished in early 2010 under the title Standing on Principles: Collected Works (2010). Dr. Beauchamp has edited and co-edited numerous anthologies, journals, and books that span a number of distinct disciplines, including journalism and epidemiology, and he co-edited The Oxford Handbook of Animal Ethics.

Dr. Beauchamp is a 2011 recipient of the Hastings Center’s Henry Knowles Beecher Award. He was also the 2004 recipient of the American Society for Bioethics and Humanities Lifetime Achievement Award and the 2003 recipient of the Georgetown University Career Recognition Award. In 1994 Dr. Beauchamp received the McDonald-Merrill-Ketcham Memorial Award from the University of Indiana.

Albert JonsenIn 2009, PRIM&R's Board of Directors selected Dr. Jonsen as the recipient of its Lifetime Achievement Award for Excellence in Research Ethics, as his contributions to the field of research ethics have been significant and enduring over a long and illustrious career.

At the time of receiving this award, Dr. Jonsen was an emeritus professor of ethics in medicine at the University of Washington’s School of Medicine, where he was chairman of the department of medical history and ethics from 1987 to 1999. He was co-director of the program in medicine and human values at the California Pacific Medical Center in San Francisco.

From 1972 to 1987, he was chief of the division of medical ethics at the University of California, San Francisco, School of Medicine. Prior to that, he was president of the University of San Francisco, where he taught in the departments of philosophy and theology. He received his doctorate from the department of religious studies at Yale University, and his earlier education took place at Gonzaga University in Washington, and at Santa Clara University in California.

Among Dr. Jonsen’s many honors are his service as a commissioner on both the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978) and the President's Commission for the Study of Ethical Problems in Medicine (1979-1982).

He was elected a member of the Institute of Medicine, National Academy of Sciences, in 1980 and he has served twice on its Council. He was chair of the National Advisory Board on Ethics in Reproduction (1991-1996), and a member of the National Research Council Committee on AIDS Research (1987-1992).

And the list goes on... Dr. Jonsen is a member of the Medical Advisory Panel, Blue Cross-Blue Shield Association (1986-present), and he has served on the Educational Commission for Foreign Medical Graduates, the American Board of Medical Specialties, and the National Board of Medical Examiners.

We’re not finished yet, though, as Dr. Jonsen has been a visiting professor at Harvard Medical School, Georgetown University, the Johns Hopkins Medical School, and the Maastricht Institute for HealthCare Ethics in the Netherlands.

He has also been a visiting scholar at the National Library of Medicine, NIH. From 1999 to 2000, he was a Visiting professor of bioethics at Yale, and in 2002, he was a visiting professor at the University of Virginia School of Law.

Dr. Jonsen has written widely on a range of topics relevant to bioethics. He authored Bioethics Behind the Headlines (2005), A Short History of Medical Ethics (2000), The Birth of Bioethics (1998), The New Medicine and the Old Ethics (1990), and Responsibility in Religious Ethics (1971).

He is co-author of The Abuse of Casuistry (1988) and Clinical Ethics (2006, 6th edition). He is co-editor of Source Book in Bioethics: A Documentary History (1998), and Bioethics: An Introduction to the History, Methods, and Practice (1997).

Dr. Jonsen has also written chapters in more than 70 books on medicine and health care. His articles have appeared in the New England Journal of Medicine, the Journal of the American Medical Association, the Journal of Pediatrics, the Annals of Internal Medicine, the Journal of Medicine and Philosophy, the Hastings Center Report, the Cambridge Quarterly of Healthcare Ethics, the Kennedy Institute of Ethics Journal, and many other journals.

Dr. Jonsen has previously been honored with the McGovern Award of the American Osler Society, the Annual Award of the Society for Health and Human Values, the Davies Award of the American College of Physicians, the Lifetime Achievement Award of the American Association of Bioethics and Humanities, and a John Simon Guggenheim Fellowship.

Robert LevineOn December 4, at the 2005 Annual HRPP Conference, PRIM&R leadership was honored and thrilled to present the 2005 Lifetime Achievement Award for Excellence in Research Ethics to Robert J. Levine, MD, for his leadership, his scholarship, and his many other achievements in the field.

Dr. Levine, known simply as “Bob” to his many friends both within PRIM&R and throughout the bioethics world, has been a Professor of Medicine and a Lecturer in Pharmacology at Yale University School of Medicine since 1973, having first arrived at Yale in 1962 as an instructor in medicine. His career at Yale has been long and distinguished, and he has been both a respected teacher and a cherished mentor to many students and colleagues alike. While at Yale, Dr. Levine chaired the Institutional Review Board (IRB) at Yale-New Haven Medical Center for over 30 years, served as Chief of the Section of Clinical Pharmacology, and is presently the Director of the Law, Policy and Ethics Core of Yale University’s Center for Interdisciplinary Research on AIDS. He is also the Co-Chair of the Executive Committee of Yale’s Interdisciplinary Bioethics Project.

Dr. Levine has been on the PRIM&R Board of Directors since 1986, and, for almost all of those years, has been a member of the small but stalwart planning committees that organize PRIM&R’s conferences. In addition to his inexhaustible knowledge of the issues, Dr. Levine has been our very own version of a one man band; he has not only helped plan the meetings, identified and recruited many of the faculty, given many of the talks, moderated many of the panels and debates, and edited the conference proceedings, but has also served as one of our surest guides to PRIM&R’s professional galaxy.

Dr. Levine’s CV is long and impressive, and his accomplishments numerous. Highlights include his past service as a consultant to several federal and international agencies involved in the development of policy for the protection of human subjects, including the National Commission on the Protection of Human Subjects. Dr. Levine was the founding editor of IRB: A Review of Human Subjects Research, and served as that publication’s editor from 1979 to 2000. He is currently the Chair of its Editorial Board. He is presently preparing the third edition of his book, Ethics and Regulation of Clinical Research , which is a seminal resource for those who conduct and/or review research with human subjects.

Dr. Levine has also served over fifty other organizations including The Hastings Center, the American Society of Law, Medicine and Ethics, the Connecticut Humanities Council, the Society of Bioethics Consultation, the World Association of Medical Editors, and the Bayer Institute for Health Care Communications.

In addition, Dr. Levine has served on the Council of International Organizations of Medical Sciences
(CIOMS) as Chair of the Steering Committee for Revision of International Ethical Guidelines for Biomedical Research. He was the Chair for the Working Group for Revision of the Declaration of Helsinki at the World Medical Association. He has also served on the Ethics Committee at the United States Centers for Disease Control and Prevention, as well as on the Human Subjects Research Council Workgroup of the National Institute of Mental Health. He participated in the Project on Ethics in HIV Vaccine Trials for the Joint United Nations Programme on HIV/AIDS (UNAIDS), and consulted on the Programme’s development of their Guidance Document for trials of preventive HIV vaccines. He was also a part of the Pan American Health Organization’s International Bioethics Advisory Board.

Dr. Levine’s contributions to protecting human subjects could fill volumes and, in fact, have! During his illustrious career, Dr. Levine’s research, teaching, and publications have all been an essential part of the canon for those involved with human subjects research, and he was selected for the Lifetime Achievement Award for Excellence in Research Ethics as a result of these both wide and deep accomplishments. Researcher, clinician, teacher, writer, mentor, “testifier,” commentator, advocate, policy expert, chair of more IRB meetings than anyone can count, and always, a cherished friend to PRIM&R.

We might get bleary-eyed reading such a catalogue of achievements, but Dr. Levine never seems to tire of his globe-trotting quest to make research ethics a more principled and accessible endeavor. He is a very kind, very patient, very calm, very generous, and very smart man, and it is an honor and a privilege to bestow this Award upon him.

PRIM&R, and all those who know Bob, salute him, thank him, and look forward to many more years of our shared commitment to protecting those who participate as human subjects in research.

Charles McCarthyIn conjunction with PRIM&R’s December 2003 presentation to Dr. Charles McCarthy of its Lifetime Achievement Award for Excellence in Research Ethics, the Board of Directors thought it would be fitting to gather and compile Dr. McCarthy’s writings. Dr. McCarthy was only the second recipient of that Award, which honors those who have, over an extended period of time, made a major contribution to the ethics that govern research. Such a “major contribution” could include scholarship, administration, and/or leadership. Dr. McCarthy’s contributions include all three.

Dr. McCarthy has dedicated his professional life to the protection of human and animal subjects, and has done so with distinction and unparalleled commitment. As the longest serving Director of the Office for Protection from Research Risks (OPRR), he played a seminal role in the development of sound and reasoned regulations and guidelines for IRB operations. The continued responsiveness of OPRR to the changing environment of human subjects research was due in large part to his initiatives.

When Dr. McCarthy retired from OPRR, PRIM&R elected him to its board of directors, recognizing the contribution he would make to our work. As anticipated, Charlie has become crucial to almost everything we have done by serving as an officer, by chairing our key committees, and by continuing to contribute to PRIM&R meetings as keynote speaker, panelist, and workshop leader. He has worked tirelessly, not only with us, but also with Virginia Commonwealth University, where his leadership on IRB issues has been similarly invaluable.

Charlie’s (no one else in the research ethics field is known by only one name!) singular and enormous contributions to our shared work have left an indelible, and indelibly constructive, mark on every aspect of an IRB’s and IACUC’s work. His wisdom, common sense, fairness, and reservoir of compassion have all made the difference between the mere development of a field and the establishment of a noble calling to protect those who participate as subjects of research.

Charlie has been a peacemaker, a bridge builder, and a mentor to so many of us. Both his teaching and his example have helped IRBs, IACUCs, regulators, institutional officials, subject advocates, ethicists, industry representatives, journalists, attorneys, and all others who are stakeholders in the research protection enterprise.

We are therefore proud to share this anthology of Charlie’s writings as a tribute to, and in gratitude for, his life and his work. Also between these pages is our everlasting respect and admiration for Charlie’s monumental contribution to the field of research ethics.

Jay KatzOn December 3, 2001, at the 2001 Annual IRB Conference, PRIM&R awarded its first Lifetime Achievement Award for Excellence in Research Ethics to Dr. Jay Katz, author of "Experimentation with Human Beings". To further honor Dr. Katz, PRIM&R presented him with a bound collection of his writings. This 750-page book, entitled, "Collected Writings of Jay Katz," includes 705 pages of 48 journal articles, book chapters, and academic works. These works spanned a broad range of medical and research ethics topics and were written over a 39-year period.

Dr. Robert Levine, in presenting the award to Dr. Katz, stated that the great contributors to the field of ethics are those who "have mastered the large body of information; have applied sound analytical methods to the resolution of particular problems and sound critical methods to the resolutions proposed by themselves or others; have synthesized their findings and those of others into new comprehensive accounts of the field; and have effectively communicated the fruits of their efforts to others." He concluded that Jay Katz’s "work in research ethics exemplifies all of the features of a great contributor to the field."

Joan Rachlin, Executive Director of PRIM&R, noted that "Jay Katz is not only the founder and father of the research ethics field, but has been its moral compass since the publication of his groundbreaking book in 1972."

Distinguished Service Award

The Distinguished Service Award (DSA) was established in 1996 to honor the exceptional accomplishments of deserving PRIM&R members. Candidates for the DSA have made a significant impact in the field of research ethics, and have attained distinction in promoting the purpose and ideals of the organization through writing, teaching, or research.

PRIM&R is pleased to present B. Taylor Bennett, DVM, PhD, DACLAM, DACAW with a 2018 Distinguished Service Award. Dr. Bennett is the senior scientific advisor for the National Association for Biomedical Research (NABR).

Dr. Bennett has made numerous invaluable contributions to the organization. He was a member of PRIM&R's IACUC Conference Planning Committee from 2008 to 2018, and served as co-chair of the committee from 2009 to 2012. During the conference planning process, he consistently provided ideas for keynote speakers, and extended his expertise to ensure the conference agenda included timely and late-breaking topics of critical importance to the field of research ethics and animal care and use. He has been a speaker at PRIM&R's annual IACUC conference since 2004, conducting numerous panels and workshops.

In addition to his contributions to PRIM&R, he spent 36 years at the University of Illinois at Chicago (UIC) overseeing the animal care and use program. The last 10 of those years he served as the associate vice chancellor for research resources where he oversaw 14 campus wide research support core facilities. He also served as the program director for an ACLAM approved postdoctoral training program in laboratory animal medicine.

In the words of the PRIM&R member who nominated Dr. Bennett:

Dr. Bennett knows and understands more about the oversight process for humane animal research than any individual in biomedical research. Having been intimately involved in the oversight process since at least 1985 (when considerable amendments to the Animal Welfare Act (AWA) were deliberated by Congress), Dr. Bennett understands the federal regulations and the AWA better than many at the United States Department of Agriculture, the agency charged with enforcement of the AWA. As such, he is frequently sought as a resource by the government. His command of these issues has led to an untold number of experts in biomedical research seeking his guidance when considering compliance issues and, indeed, many laboratory animal veterinarians spent time under his tutelage before going on to advise some of the world's most notable pharmaceutical companies, universities, and contract research organizations on how to ensure animal welfare and follow the rules.

In Dr. Bennett's role at NABR, he has assisted many professionals in the animal care and use community with strategizing and coping with specific areas of disagreement with federal regulatory bodies. He has also participated in recent national discussions related to the continued use of nonhuman primates in research, implementation of the 21st Century Cures Act, and adherence to regulatory expectations to comply with animal welfare expectations and research objectives.

Given his service to the field, Dr. Bennett is the recipient of several awards: the Chicago Branch-AALAS Robert J. Flynn Award; the AVMA Charles River Prize; the UIC College of Veterinary Medicine Special Service Award; the AALAS Joseph J. Garvey Award; the Foundation for Biomedical Research Lifetime Achievement Award; the AVMA Animal Welfare Award; and the Wilford S. Bailey Distinguished Alumni Award from Auburn School of Veterinary Medicine.

Dr. Bennett has made a remarkable impact not only on the PRIM&R community, but on the entire research ethics field. It is the utmost honor to celebrate his enduring impact by presenting him with a Distinguished Service Award.

P. Pearl O'RourkePRIM&R is pleased to present P. Pearl O'Rourke, MD with a 2018 Distinguished Service Award. Dr. O'Rourke is the director of human research affairs at Partners HealthCare System, Inc., in Boston, MA, and an associate professor of pediatrics at Harvard Medical School.

Dr. O'Rourke has an esteemed history with the organization. She was a member of PRIM&R's Board of Directors from 2001 to 2016, and was appointed as chair in 2007. She has been a speaker at PRIM&R's annual Advancing Ethical Research (AER) conference since 2003 and beginning in 2007, has served on and co-chaired the AER Core Conference Planning Committee (CCPC) for numerous years. Dr. O'Rourke continues to be involved with PRIM&R as a member of the AER18 CCPC and the organization's Public Policy Committee. In addition to her wide-ranging contributions to PRIM&R, Dr. O'Rourke has worked as a pediatric critical care physician at Boston Children's Hospital and at the Children's Hospital at University of Washington in Seattle where she was the director of the Pediatric Intensive Care Unit and a member of the institutional review board for many years. Throughout her career in pediatric critical care, she conducted clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. Dr. O'Rourke has also been involved in international medical care, serving in China and Indonesia with Project HOPE.

Dr. O'Rourke was a Robert Wood Johnson Health Policy Fellow in 1995-1996 and worked for Senator Edward Kennedy (Democrat-MA) as a member of the Labor Committee Staff. Following this fellowship, she became the deputy director of the Office of Science Policy in the Office of the Director at the NIH where she worked on issues such as privacy, gene therapy (transfer), embryonic stem cells, and genetic discrimination. Since 2001, she has been the director of human research affairs at Partners HealthCare System, Inc., where she leads the oversight systems for human subjects protections and stem cell research.

In the words of the PRIM&R member who nominated Dr. O'Rourke:

There are few people more deserving of the Distinguished Service Award than Pearl O'Rourke. Her unique contributions are wide-ranging, enduring, and ongoing. Pearl is a pediatric intensivist, who did her clinical work in critical care and conducted clinical research on ECMO and related technologies. Since the 1990s, Pearl has made many significant and valuable contributions to the ethical conduct of research… Dr. O'Rourke has attained distinction and wide recognition in promoting the purpose and ideals of PRIM&R through writing, teaching, and research. Her work is consistent with the stated mission of PRIM&R in that she strives to advance the highest ethical standards in the conduct of biomedical, behavioral, and social science research.

Dr. O'Rourke has made a remarkable impact not only on the PRIM&R community, but on the entire research ethics field. It is the utmost honor to celebrate her enduring impact by presenting her with the Distinguished Service Award.

Paula KnudsonMs. Knudson is a longtime mentor of IRB members and administrators, who has actively supported the education of anyone who expresses an interest in learning about ethical research. She has inspired generations of medical students and researchers, imparting the importance of ethical conduct in research, while teaching ways to operationalize the Belmont principles in everyday practice. Although she has held many positions, Ms. Knudson has always taken it upon herself to teach those around her.

For the last 10 years, Ms. Knudson has served as the special advisor for human subject research and faculty in the Center for Clinical Research and Evidence Based Medicine at The University of Texas Health Science Center Houston (UTHSCH). Previously she was the executive coordinator for the Committee for the Protection of Human Subjects for 27 years.

In addition to the many contributions she has made at UTHSCH, Ms. Knudson has also been a leader in the field of human subjects protections. She was instrumental in providing commentary on the emergency waiver provision of 45 CFR 46, and has similarly worked with OPRR, OHRP, and FDA when new regulations and guidance were being considered. As noted by one of the two individuals who nominated her, Ms. Knudson "has been a voice for the protection of research participants since the beginning. She has many interests within the human subjects protections field, including community consultation, HIV/AIDS, international research, conflicts of interest, and the inclusion of women and minority populations in research, to name a few.

Ms. Knudson has been a driving force within the PRIM&R community as well. She has served on the planning committees and as faculty at nearly every PRIM&R human subjects protections conference since the 1980s, and hosted four successful conferences in Houston. Ms. Knudson has served as a member of the IRB 101sm faculty, and has taught nationally and internationally. She served on PRIM&R’s Board of Directors from 1984 to 2010, helping guide the organization from its early years to the thriving entity that we know today. She served on the Board’s Nominations and Elections Sub-committee for six years and on the Governance Committee for four years. Ms. Knudson also served as creator and editor of PRIM&R Through the Years, a compilation of presentations from more than 50 PRIM&R conferences held between 1974 and 2005. Ms. Knudson is passionate about her work and dedicated to the advancement of ethical research as evidenced by her continuing commitment to both PRIM&R and those working in the field.

Mary Jo ShepherdA self-proclaimed IACUC “geek,” Dr. Shepherd has been a tireless and effective advocate for her fellow IACUC administrators/coordinators and the critical role they play in ensuring quality animal care and use programs. She has actively promoted and participated in the education of all those who have expressed an interest in learning more about IACUCs, and that is but one of the many reasons why she is so deserving of this award.

Dr. Shepherd is also a generous and talented volunteer for a number of organizations working in the laboratory animal field. In fact, one can only wonder how she manages to maintain her “day job,” given the unending extracurricular activities in which she participates. The answers can be found in the reams of positive evaluations she receives each time she teaches, speaks, or writes, since, in addition to these considerable professional skills, it is Dr. Shepherd’s generous spirit, personal warmth, and easy humor that make her a beloved colleague to all who know her.

As the director of the Office of the IACUC at Columbia University, Dr. Shepherd administers two IACUCs for one of the largest animal care and use programs in the country. She has worked in the field of laboratory animal medicine since 1988, when she first became an IACUC member. Since that time, she has served as instructor, clinical veterinarian, attending veterinarian, IACUC member, consultant, scientist, and finally, as the professional administrator/director of several well-respected IACUCs, including at Pfizer, Merck, the University of Pennsylvania, and Columbia.

Dr. Shepherd has also volunteered for the American Association for Laboratory Animal Science at the local and national levels as a trustee, member of the editorial review board and branch president. For more than 10 years, she has been actively involved in the planning of the New Jersey Association for Biomedical Research’s annual IACUC seminar. Dr. Shepherd was also on the board of directors of Americans for Medical Progress for five years.

Dr. Shepherd has written numerous articles for magazines and journals, including Advances in Ocular Toxicology, Contemporary Topics in Laboratory Animal Science, Lab Animal, ILAR Journal, and Medical Device and Diagnostic Industries.

Beginning in 2001, she chaired multiple planning committees for PRIM&R’s annual IACUC Conferences, served as a faculty member at each of these meetings, and also been a central member of the preconference program faculties for Essentials of IACUC Administration. In addition, at the time of receiving this award, she was a member of PRIM&R’s Certification Committee, and was a founding member and past chair of the Council for Certified Professional IACUC Administrators (CCPIA). As chair of the CCPIA, she has worked hard to provide those in the profession with a highly visible and highly credible way to advance their knowledge and perform their duties in a professional manner. Largely through her dedication and the sheer force of her passion, Dr. Shepherd has been a key driver and sustainer of the CPIA credential.

Ivor PritchardDr. Pritchard has generously and graciously shared his time by being a PRIM&R faculty member since 1995. He has also co-chaired the Planning Committee for the Advancing Ethical Research Conference, taught at several of the pre-conference programs, and served as a speed mentor.

Dr. Pritchard has worked tirelessly in the field of research ethics at the national level for 25 years. In 1986, he joined the US Department of Education’s Institute for Education Sciences, a department for which he would serve as a senior research analyst until 2004. That same year he transitioned to the Office for Human Research Protections (OHRP) as a senior fellow. At the time of receiving this award, he was the senior advisor to the director of OHRP, where his responsibilities included advising the director, developing policies and guidance documents, and representing OHRP at the national meetings focused on the protection of human subjects in research.

Dr. Pritchard is a widely published author and co-author of articles on human subjects protections including, “Searching for ‘Research Involving Human Subjects:’ What is Examined? What is Exempt? What is Exasperating?” (IRB: Ethics & Human Research, 2001); “Travelers and Trolls: Practitioner Research and Institutional Review Boards” (Educational Researcher, 2002); “Ethical Standards of the American Educational Research Association: Cases and Commentary” (2002); “Students as Research Subjects” (The Encyclopedia of Bioethics, 2004); and “Power, Truth and Justice in Youth Participatory Action Research: Ethical Questions” (Practicing Anthropology: A Career-Oriented Publication of the Society for Applied Anthropology, 2004). He is also the author of a book titled, Good Education: The Virtues of Learning (1998).

Dr. Pritchard earned a bachelor’s degree in philosophy at Haverford College (with honors in philosophy) and a master’s degree and a PhD in philosophy from Boston University.

Yvonne HigginsMs. Higgins has been contributing to the cause of ethics and responsibility in human subjects protections with devotion and diligence for more than 15 years. She is a strong advocate for ethical research and has worked hard to ensure that those charged with protecting subjects are educated and equipped with the tools that they need to excel in their jobs. In her “spare time,” Ms. Higgins is as a hands-on and tireless contributor to PRIM&R’s work. At the time she received this award, she was the executive director of the human research protections office at the University of Pennsylvania.

Ms. Higgins was one of the first people to become a Certified IRB Professional (CIP®) in October 2000. She has been an active member of PRIM&R, has served as a dedicated and enthusiastic co-chair of the Workshop/Didactic Sub-Committee for PRIM&R’s Advancing Ethical Research Conferences, and has served as faculty at many PRIM&R conferences.

Charlotte ColeyMs. Coley has dedicated her career to the advancement of ethical research through the development and implementation of effective educational programs. In her current position at Duke University, where she is the director of IRB educational programs, Ms. Coley is responsible for developing and implementing an educational plan for the research community on IRB regulations, ethical principles, orientation for new IRB members, and education and training programs for new researchers and support staff. She also designs and implements lunch seminars, workshops and class lectures. She is a Certified IRB Professional (CIP®) and has 14 years of experience working with both behavioral and biomedical IRBs.

In addition to her duties at Duke, Ms. Coley has been an active member of PRIM&R for more than 10 years. She has co-chaired the conference planning sub-committee responsible for developing the hundreds of workshop/didactic sessions for PRIM&R’s Advancing Ethical Research conferences. She has also served as a faculty member at several of the conferences she helped plan. In addition, Ms. Coley has devoted considerable time and always positive energy to serving the PRIM&R community as a mentor, onsite conference volunteer, and "scholar buddy."

Prior to assuming her post at Duke, Ms. Coley served as IRB administrator at Battelle Memorial Institute in Research Triangle Park, NC. Her rich and varied career has been characterized by an impressive commitment to public service, and included stints with various national departments and agencies where she worked on a range of environmental and public health projects.

Ms. Coley has a bachelor’s degree in politics from St. Andrews Presbyterian College and a Master of Arts in College Teaching in political science from the University of North Carolina, Chapel Hill.

Jerry SugarmanDr. Sugarman’s contributions to both the field of research ethics and to PRIM&R have been profound and numerous. He has presented at PRIM&R conferences in every role from keynote speaker to breakout facilitator. Dr. Sugarman is a powerful and entertaining speaker and educator. The PRIM&R conference sessions during which he presents consistently receive the highest attendance and outstanding evaluation ratings.

At the time of receiving this award, Dr. Sugarman was the Harvey M. Meyerhoff Professor of Bioethics and Medicine, professor of medicine, professor of health policy and management, and deputy director for medicine of the Berman Institute of Bioethics at The Johns Hopkins University. Dr. Sugarman conducts both theoretical and empirical research in medical ethics. His work concentrates on informed consent, research ethics, and the ethical issues associated with emerging technologies. He is the author of more than 150 publications in peer-reviewed journals, and he is the co-editor of four books. Dr. Sugarman is a contributing editor for IRB and is on the editorial boards of Accountability in Research, the American Journal of Bioethics, Clinical Trials, and Theoretical Medicine and Bioethics. He serves on the Scientific and Research Advisory Board for the Canadian Blood Service and is a member of the Maryland Stem Cell Research Commission. Among his other involvements, he is chair for the ethics working group of the HIV Prevention Trials Network, the ethics officer for the Resuscitation Outcomes Consortium, and co-chair of the Johns Hopkins’ embryonic stem cell research oversight committee.

Bonnie LeeMs. Lee began working in the field of human subjects protections in the early 1970s and first served as a staff member for the Tuskegee Syphilis Study Ad Hoc Advisory Panel. Through this early work, she became keenly aware of the abuses and tragedies that can occur when research is conducted in an unethical manner. Ms. Lee next went to work as the administrative officer of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research where she was indispensable to the production of many reports and appendices that are as relevant and helpful today as they were then. Ms. Lee next served as staff to the President’s Advisory Biomedical Research Panel.

Ms. Lee’s experience with these initiatives motivated her to devote her professional life to promoting ethical research and to ensuring that research subjects are protected. She was a committed, highly visible, and exceedingly proactive employee of the FDA for almost 30 years. While at the FDA, Bonnie worked to ensure that the research enterprise continues to remember Tuskegee and other such egregious events to ensure that future generations do not repeat the tragedies of the past.

Ms. Lee was one of the first highly placed federal representatives to form a strong bond with PRIM&R. She understood that both the government and non-governmental organizations working in the human research protections field were interested in the same big picture and she was always ready, willing, and more than able to do whatever she could to advance PRIM&R’s mission and educational goals. Ms. Lee participated in more than 50 PRIM&R conferences and was always been a highly skilled and inspiring teacher. Ms. Lee passed away on November 10, 2007.

2005 - Ernest Prentice

2003 - Gary Chadwick and Susan Kornetsky

2002 - Joan Rachlin

2001 - Karen Hansen

2000 - Robert Nelson

1999 - Marky Pitts and Molly Greene

1998 - Ada Sue Selwitz

1997 - David Bernhardt

1996 - Helen McGough

ARENA Legacy Award

The ARENA Legacy Award (ALA) was developed to honor not only the chosen individual(s), but also to honor the living legacy created by the Applied Research Ethics National Association (ARENA), which was the membership division of PRIM&R from 1986 to 2006. One of ARENA's many important contributions was to encourage the advancement of those individuals working in the field, in order to promote professional excellence and ultimately contribute to a more ethical research enterprise. The ALA is intended to keep those ideals alive by honoring individuals who both embody and consistently foster professional leadership, education, and mentoring.

Jerry CastellanoPRIM&R is pleased to present Jerry Castellano, BS, PharmD, CIP with the 2018 ARENA Legacy Award. Dr. Castellano serves as the corporate director of the institutional review board of Christiana Care Health System.

Dr. Castellano has been an active member of PRIM&R since becoming a member of ARENA in 1996. He was a member of the ARENA Council, serving as the Mid-Atlantic Regional Representative from 1996 to 2006 and as treasurer from 2004 to 2006. Dr. Castellano was a member of the Council of Certified IRB Professionals (CCIP) for fourteen years.

Prior to his current appointment, Dr. Castellano was the director of clinical services and research at Christiana Care with over 10 years of experience as a principal investigator. As such, he has both the perspective of investigator and of the IRB on human subjects protections. Dr. Castellano has authored numerous publications and given lectures throughout the country and internationally on a variety of topics; research, research and biomedical ethics, institutional review boards, and conflicts of interest. He has also served on expert panels involving human research subjects protections.

In addition to his position as the corporate director of the IRB, he currently serves on the Christiana Care Ethics Committee. He was also a member of the duPont Children’s Hospital IRB, consultant to the State of Delaware IRB, and served on the Ethics Consultation Sub-Committee, Cancer Committee, Graduate Medical Education Committee, HIPAA Privacy and Security Committee, Office of Transformation and Innovation, the Delaware CTR Advisory Committee, and the Information Technology Advisory Council. He is a member of numerous research committees of the departments at Christiana Care, including Emergency Medicine, Internal Medicine, OB/GYN, Maternal Fetal Medicine, CAR-T Gene Editing Institute, Trauma and Neurosurgery, Infectious Disease, HIV Program, and many others.

Dr. Castellano is also very active in the community with the Think First Injury Prevention Program (Delaware Chapter), Delaware Bioscience Alliance, and serves as a board member of the Delaware Stroke Initiative (DSI). He gives community based lectures on biomedical research and advanced directives, and serves as a guest lecturer in many support groups. He has served on the Executive Advisory Committee of the Collaborative IRB Training Initiative (CITI) for the past 10 years and continues to do so.

In the words of the PRIM&R member who nominated Dr. Castellano:

Jerry has been active in the field of research review and the PRIM&R organization for over two decades. He has been a continuous advocate for the advancement of the IRB field and the professional development of those working in it. During the ARENA years he was an active member of the ARENA Council, eventually serving in the role of treasurer. Jerry was actively engaged in the work of integrating ARENA into PRIM&R, and was supportive in spite of his reservations regarding the move. After ARENA, Jerry remained active in the organization, including serving multiple terms on the CIP Council.

Dr. Castellano has left an enduring mark on the PRIM&R community as well as the wider research ethics field. It is with enormous gratitude that we are honored to present him with the ARENA Legacy Award.

Ada Sue SelwitzPRIM&R is pleased to present Ada Sue Selwitz, MA, with the 2017 ARENA Legacy Award. Ms. Selwitz serves as the executive integrity/compliance advisor at the University of Kentucky in Lexington, Kentucky.

Ms. Selwitz has a distinguished history with the organization. She was one of ARENA's 61 charter members and served as its first vice president in 1986 and its second president in 1987; she also served on PRIM&R's Board of Directors from 1987 to 2016. She has chaired the Board's public policy and education committees, and has served on its membership committee. Ms. Selwitz co-founded PRIM&R's IRB 101sm program and has sat on almost two dozen PRIM&R program committees, ensuring that ethical themes and best practices in research protections remain an integral part of PRIM&R's flagship educational offerings. Ms. Selwitz was the 1998 recipient of PRIM&R's Distinguished Service Award and was the recipient of ARENA's Appreciation Award.

In the words of the PRIM&R member who nominated Ms. Selwitz:

She has a way of making education entertaining with her bold southern charm. Individuals that are now leaders in the field share common sentiments of [having felt] like a newcomer [until] being approached by an outgoing southern lady who invited them to join a lunch table, go to dinner, or chair a committee. One could fill pages describing all of the ways that Ada Sue Selwitz has promoted the education and professional development of those involved in the oversight or conduct of ethical research trough leadership and mentoring. Ada Sue was an early advocate for the professionalization of IRB staff. Her primary outlet for achieving this was PRIM&R and its former membership division ARENA.

In addition to her considerable work with PRIM&R, she has worked at the University of Kentucky in a variety of roles including director of sponsored program development, director of the Office of Research Integrity, and as the executive integrity/compliance advisor. She has an adjunct associate professor appointment in the Department of Behavioral Sciences in the College of Medicine. Ms. Selwitz has served a leadership role on both local and national levels through her participation in several national and federally sponsored education and policy development initiatives. She served on the DHHS Advisory Group on the Public Health Service Responsible Conduct of Research Policy, the NIH Regulatory Burden Committee, the DHHS Secretary Advisory Committee on Human Research Protection, and the CITI Advisory Board. Ms. Selwitz was co-faculty in the Investigator 101 CD-ROM which is distributed by the Office for Human Research Protections to all institutions with federalwide assurances.

Ms. Selwitz has left an enduring mark on the PRIM&R community as well as the wider research ethics field. It is with enormous gratitude that we are honored to present her with the ARENA Legacy Award.

Marcy BrownPRIM&R is pleased to present Marcy Brown, BS, MA, CMAR, CPIA, with the 2016 ARENA Legacy Award. Ms. Brown serves as the animal welfare regulatory compliance lead of Pfizer Global Research and Development in La Jolla, California.

Ms. Brown joined PRIM&R in 2000 and has been an active member ever since. She serves as chair on PRIM&R's Council for Certified Professional IACUC Administrators, served as a member of PRIM&R's Certification Committee, and has served as faculty at seven PRIM&R Essentials of IACUC Administration pre-conference courses and at 12 PRIM&R conferences.

In addition to her work with PRIM&R, Ms. Brown is responsible for ensuring ethical and high-quality animal care and welfare at Pfizer Global Research and Development, as well as alignment with Pfizer's global comparative medicine and research and development endeavors. She serves on the board of directors of the California Biomedical Research Association (CBRA) and as an AAALAC ad hoc specialist. Ms. Brown has also devoted significant time to presenting and co-facilitating presentations, workshops, and panels at the American Association for Laboratory Animal Science (AALAS) and Massachusetts Society for Medical Research (MSMR) meetings.

In the words of the PRIM&R member who nominated Ms. Brown:

She promotes a culture of animal welfare first, and is key in influencing others to uphold our high standards. Under her watch, we continue to maintain an exemplary animal care program as evidenced through continued accreditation with AAALAC International, as well as continued compliance with USDA standards. [Ms. Brown's] passion, commitment, and recognition as an experienced author, presenter, and instructor have established her reputation as an indispensable resource to those of us in the field.

She has influenced countless individuals to aspire to the highest ethical standards in the animal welfare field within our institutional organization, the greater San Diego Area research community and at a national level. [Ms. Brown's] focus on organizing and developing educational workshops, book chapters, networking opportunities and mentoring relationships exemplify the passion and commitment that drives her pursuit of excellence in this field.

That testimonial only begins to tell the tale of Ms. Brown's significant contributions to research ethics in animal care and use that has greatly benefited the PRIM&R community, including the attendees who have joined us here in New Orleans.

Patricia MacCubbinPRIM&R is pleased to present Patricia A. MacCubbin, MS, with a 2016 ARENA Legacy Award. Ms. MacCubbin serves as the president and CEO of Research Ethics Group in Burlington, Vermont.

Ms. MacCubbin has been an active PRIM&R member since 1999. She has served as chair and a member of three SBER conference subcommittees, as a member of the Poster Abstract Sub-Committee for three conferences, on PRIM&R’s Regional Activities Committee, and as faculty at seven PRIM&R conferences.

In addition to the time she dedicates to PRIM&R, she is a chair of the ethics committee for the Association of Clinical Research Professionals (ACRP) and a member of ACRP, and serves as a consulting editor for human subjects protections for the Journal of Public Health Management and Practice. She is also senior consultant for the Scientists Center for Animal Welfare (SCAW) and serves on the planning committees for their annual conference and regional workshops.

In the words of the PRIM&R member who nominated Ms. MacCubbin:

Ms. MacCubbin has promoted the education of those involved in the oversight or conduct of ethical research throughout her career. Most prominently, she… accomplished this while employed with the City University of New York (CUNY). Overseeing 21 IRBs on 18 CUNY campuses, Ms. MacCubbin promoted attendance at [professional conferences such as AER], brought in consultants, and joined forces with other organizations to provide education to her staff, each person involved in research at the CUNY campuses, and … the community of researchers outside of CUNY. Never did Ms. MacCubbin think any question ridiculous, nor did she ever belittle anyone for not knowing something. Instead, Ms. MacCubbin encouraged questions and provided education. Her years of experience and dedication have been invaluable to learning.

The praise above only offers a glimpse of Ms. MacCubbin’s significant contributions to the PRIM&R community. We heard similar accounts from members and conference attendees.

Karen HaleMs. Hale has been a go-to faculty member for PRIM&R over the years, leading both pre-conference programs and breakout sessions at nine PRIM&R conferences, including at the 2015 AER Conference, where she is teaching session C8: A Primer in Determining When an Investigational New Drug (IND) Application Is Needed for Studies Involving Drugs or Biologics.

Ms. Hale has served in numerous conference planning roles for PRIM&R as well, including co-chair of the Core Conference Planning Committee (CCPC) for the 2008 AER Conference, and as a member in 2006 and 2009. She also served as co-chair of the Workshop Didactic Subcommittee in 2007 and as a member in 2010 and 2011. In addition, Ms. Hale was the co-chair of the Breakouts-Advanced and Hot Topics Subcommittee in 2005. Since 2012, Ms. Hale has served on the Poster Abstract Subcommittee, where her review of submitted posters has shaped the content seen onsite. In addition to contributing to our annual conferences, Ms. Hale has been a PRIM&R member since 2006, and has mentored hundreds of research professionals at her institution and beyond.

 Ms. Hale serves as the director of the Office of Responsible Research Practices and clinical assistant professor at The Ohio State University. Ms. Hale is responsible for overseeing administrative support services for the Ohio State research community and university review boards for research involving human subjects, animals, and biohazards. She also provides leadership for educational and quality improvement activities supporting accreditation of the university’s human and animal research programs.

In addition to the time she dedicates to PRIM&R, Ms. Hale is a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Subcommittee on Harmonization for the US Department of Health and Human Services, and serves as a consultant for the Office for Human Research Protections. She is a site visitor and former council member for the Association for the Accreditation of Human Research Protection Programs, Inc. Previously, Ms. Hale worked in The Ohio State University Wexner Medical Center Investigational Drug Service and served as vice chair of the university’s Biomedical Sciences IRB.

Ms. Hale’s commitment to PRIM&R and the field at large is undeniable, and our community of individuals working to advance ethical research is better for it.

Susie HoffmanMs. Hoffman is a longtime PRIM&R leader and teacher, having been a member of the organization since 1999 and a faculty member for 12 consecutive conferences. During that time, Ms. Hoffman has served as a member of the former ARENA Council (2004 and 2005), president-elect of the ARENA Steering Committee (2005), president of ARENA (2006), a member and chair of the Membership Committee (2006-2011 and 2006-2007, respectively), a member of the Poster Abstract Sub-committee (2010), and a co-chair of the Workshop/Didactic Sub-committee (WDSC) for PRIM&R’s Advancing Ethical Research Conference (2005, 2006, and 2012-2014).Given this long list, it is clear that Ms. Hoffman unfailingly devotes incredible amounts of time, energy, thought, and passion to PRIM&R.

Ms. Hoffman’s commitment to advancing ethical research is longstanding. She has served as the director of the IRB for Health Sciences Research at the University of Virginia (UVA) since 1999. In this role, Ms. Hoffman manages UVA's educational program for IRB members, research investigators, and study coordinators. A nurse by education, she has worked in the research field since 1987—as both a research coordinator and as the director of clinical trials for a radiopharmaceutical company. 

PRIM&R is especially grateful to Ms. Hoffman for her leadership in membership growth. The year she was president of ARENA, PRIM&R experienced a 27% increase in its membership community. While serving on PRIM&R’s Membership Committee, Ms. Hoffman championed the PRIM&R Regional Connections program, a benefit designed to help members connect locally by providing small grants to support networking and continuing education events. 

She has supported the regional model in her home state of Virginia, as well. The Virginia IRB Consortium Conference, an annual educational event that has received PRIM&R Regional Connections funding, has thrived and grown under Ms. Hoffman’s guidance and leadership, educating hundreds of individuals working in the field of human subjects protections in Virginia and other nearby states. With her ongoing contributions to the field, Ms. Hoffman continues to influence and shape the landscape of the PRIM&R community. 

Dan NelsonDaniel K. Nelson, MSc, CIP was selected as the 2013 recipient of the ARENA Legacy Award.

Mr. Nelson is a longtime national, institutional, and organizational leader whose career has been characterized by a passionate and tireless commitment to protecting the rights and welfare of research subjects. One of the many ways in which he has demonstrated this exceptional commitment is through tireless service to PRIM&R, as well as via his generosity in mentoring and supporting countless professionals working in the field.

Mr. Nelson received his bachelor’s degree in biology and psychology from Luther College, and his master’s degree in physiology from Southern Illinois University, Carbondale. Trained in medical physiology, Mr. Nelson has held faculty appointments at the Mayo Clinic and at the University of Rochester, where he was director of research in a clinical gastroenterology unit. He made his first foray into human subjects protections work when he became the IRB chair at a hospital affiliated with the University of Rochester.

Mr. Nelson is currently a professor of social medicine, an adjunct professor of pediatrics, and the director of the Office of Human Research Ethics at the University of North Carolina (UNC), Chapel Hill. Since joining UNC in 1998, he has worked to transform the UNC IRB system from a fragmented, school-based IRB model into a centralized, comprehensive human research protections program that provides IRB oversight for the entire university. On campus, Mr. Nelson is viewed as a leader who has successfully built bridges between the IRB and the research community.

Mr. Nelson is also a co-investigator on several projects, including a National Institutes of Health (NIH) study examining the clinical, ethical, and social questions surrounding the responsible use of whole exome sequencing; a pilot study comparing local and central IRB review; and a project designed to strengthen the bioethical training and research capacity in the Democratic Republic of Congo.

In addition to being a hands-on researcher and skilled instructor, Mr. Nelson is an accomplished writer who has made extensive contributions to textbooks, journals, and the news media. Among his publications are: “Obtaining Consent from Both Parents for Pediatric Research: What Does ’Reasonably Available’ Mean?” (Pediatrics, 2013); “IRB Chairs’ Perspectives on Genotype-Driven Research Recruitment” (IRB: Ethics and Human Research, 2012); “Recommendations for Ethical Approaches to Genotype-Driven Research Recruitment” (Human Genetics, 2012); “Researcher Conflict of Interest” and “IRB Member Conflict of Interest” (with E. Bankert and R. Amdur in Institutional Review Board Member Handbook (3rd edition), 2010); and “Getting from A to IRB: Developing an Institutional Review Board at a Historically Black University” (Journal of Empirical Research on Human Research Ethics, 2010).

Given this long and venerable list of high profile and high impact professional activities, it is all the more remarkable that Mr. Nelson has been able and willing to devote so much time to PRIM&R for almost 20 years. He served as the president of ARENA, PRIM&R’s former membership division in 2002; as a member of the Council for Certification of IRB Professionals (CCIP); as faculty for countless PRIM&R programs; and as a member of several of our conference planning committees. Additionally, in 2003, he received PRIM&R’s Special Service Award.

Mr. Nelson’s service to the field extends well beyond his “day job” and PRIM&R activities, as he is also a highly sought after member of innumerable committees and councils for many other nonprofit and governmental organizations. He is a charter member of the AAHRPP Council for Accreditation; consults for the OHRP; was a founding co-chair of the IRB Sponsor Roundtable; and served as a liaison to the National Bioethics Advisory Commission. For the past nine years, he has co-chaired the Subpart A subcommittee of the Secretary's Advisory Committee on Human Research Protections (SACHRP), the body that advises the US Department of Health and Human Services on the regulations that govern human research protections (the "Common Rule").

Beyond his remarkable professional achievements, though, Mr. Nelson is a sterling human being who models wisdom, thoughtfulness, common sense, integrity, and “respect for persons” in all he does. He has worked continuously and energetically to promote the ethical conduct of research, and so many of those working in the field today have been touched by his generous willingness to mentor, support, teach, and otherwise help them.

PRIM&R’s 2013 ARENA Legacy Award was presented to Mr. Nelson on November 7 at the 2013 Advancing Ethical Research Conference.

Mary Jo ShepherdMs. Delano is a highly respected, longstanding, and tireless advocate for ethical research, and for the education needed to reach that end. She long ago came to understand that raising the professionalism of those charged with protecting human subjects was an important step for our field, and she has served as a core member of the group that founded and then nurtured the credentialing program for IRB administrators.

Ms. Delano has been a PRIM&R member for more than 18 years, and her devotion to the organization is evident in many aspects, but none more so than in the development of the Certified IRB Professional (CIP®) program. PRIM&R is thus especially grateful to Ms. Delano for her seminal role in spearheading the creation and maintenance of this credential for IRB professionals. She was there from the beginning when, in 1999, she participated in small meetings that led to the creation of the CIP credential. She became a founding member of the Council for Certification of IRB Professionals (CCIP) and then became chair of the CCIP in 2005, a position she held until her term ended in December 2011.

Ms. Delano is a regular presenter at PRIM&R meetings on a range of topics, including the CIP program, issues relating to vulnerable populations, those who are decisionally impaired, and informed consent. Her commitment to advancing ethical research is longstanding and deep; she first became involved with research protections in 1980 when she was hired as the IRB staff person at the State University of New York at Stony Brook. Two years later, she joined the Research Foundation for Mental Hygiene, Inc. (RFMH), a nonprofit corporation affiliated with the New York State Department of Mental Hygiene located in Albany, NY. Ms. Delano became the deputy managing director of RFMH in 2001.

In addition to being a superb teacher, leader, and administrator, Ms. Delano is an active author. Her publications include chapters on “Research Involving Adults with Decisional Impairment” and “Certification of IRB Professionals” (Institutional Review Board Management and Function, 2006), articles in journals such as “Regulating Research With Vulnerable Populations: Litigation Gone Awry” (Journal of Health Care Law and Policy, 1998), “Uninformed Decision Making: The Case of Surrogate Research Consent” (The Hastings Center Report, 1997), “Protecting Mental Health Research Subjects Without Prohibiting Progress” (Hospital & Community Psychiatry, 1994), and “Protection of Persons with Mental Disorders from Research Risk: A Response to the Report of the National Bioethics Advisory Commission,” (Archives of General Psychiatry, 1999). Ms. Delano received her bachelor’s degree at the level IIA (the equivalent of an American master’s degree) in sociology, psychology, and research methodology from the Australian National University.

Gigi McMillanMs. McMillan has been a valued PRIM&R faculty member, and has benefited all those in her presence with her unique perspective, which has been informed by her legendary advocacy for pediatric research subjects and their families.

Ms. McMillan has also been an active PRIM&R member in other ways, serving on the Workshop/Didactic Sub-Committee that is responsible for developing the Advancing Ethical Research Conference breakout sessions. She also created and co-led the community member track for unaffiliated, non-scientific IRB members; co-created a short course for community members which is now part of PRIM&R’s regular educational offerings; and has served as a speaker on PRIM&R’s webinars.

Ms. McMillan is the co-founder of We Can, Pediatric Brain Tumor Network, a nonprofit organization that reaches out to families of children with brain cancer. She has served as the executive director of We Can for 10 years.

The author of many book chapters, articles and pamphlets, Ms. McMillan’s publications include: “The Importance of the Nonscientific, Unaffiliated (Community) Member” (Community-Campus Partnerships for Health and the Tuskegee Center for Bioethics in Research and Health Care, A Case Story Collaborative Journal, October 2007); “Clinical Research: The Parent’s Dilemma” (The Monitor, April 2006); “What do Researchers Say? What do Subjects Hear?” (Protecting Human Subjects, Spring 2005); and “Childhood Brain & Spinal Cord Tumors: A Guide for Families, Friends & Caregivers,” (Patient-Centered Guides, 2002).

Ms. McMillan earned a bachelor’s degree in history with minors in German and business at Loyola Marymount University. She has four children, one of whom is a brain tumor survivor/”thriver.”

Jeff CooperDr. Cooper is one of PRIM&R’s veteran faculty members and has a long and distinguished history as an active member of PRIM&R; he served for six years on the PRIM&R Board of Directors, and has been a member for more than 15 years.

In addition to his work with PRIM&R, Dr. Cooper works as a physician and consultant, and, at the time he received the award, he was the director in the clinical research services and healthcare compliance division of Huron Consulting Group located in Arlington, VA. In this role, he uses his 21 years of experience applying DHHS and FDA regulations relevant to human research. His expertise includes medical management, standards-based evaluation of medical and research practices, and applying quality improvements to medicine and research.

Prior to his role at Huron Consulting Group, Dr. Cooper served as vice president for education and regulatory affairs at the Association for the Accreditation of Human Research Protection Programs (AAHRPP), where he was responsible for the development and operation of the accreditation process. Before that, Jeff served as associate medical director at Albany Medical Center, where he was responsible for utilization management and quality improvement, and also held the position of IRB chair.

Jeff CohenDr. Cohen has a long and distinguished history as an active member of both PRIM&R and Applied Research Ethics National Association (ARENA). He served as ARENA’s president in 1990, and has helped plan many of PRIM&R’s conferences, providing particularly needed leadership on the social, behavioral, and educational components of our curriculum. He is a past member of PRIM&R’s Council for Certification of IRB Professionals (CCIP) and is himself a Certified IRB Professional (CIP®).

Dr. Cohen received his PhD in experimental psychology from Northern Illinois University in 1974. During the early years of his career, he served as the associate director for research compliance and information management in the office for research at the University at Albany, State University of New York (SUNY). During his 20 years there, Dr. Cohen was responsible for IRB and IACUC administration, regulatory compliance, and management of the lab animal facility.

Following his long tenure at SUNY Albany, Dr. Cohen then served for four years as director, division of education and development, in the Office for Human Research Protections (OHRP), where his responsibilities included the coordination of educational workshops, the development and dissemination of educational materials, the conduct of training sessions for institutions and professional organizations, and the development of online training materials.

At the time of receiving this award, Dr. Cohen was the president of HRP Associates, LLC, (HRPA).

William FreemanDr. Freeman has a distinguished history with PRIM&R as an active member of PRIM&R and Applied Research Ethics National Association (ARENA), PRIM&R’s former membership division. He served on PRIM&R’s Board of Directors from 1994 to 2012 He was ARENA president in 1988, and he has served on the faculty of numerous PRIM&R conferences. Inspired by his work with the Indian Health Service, Dr. Freeman has worked hard to promote greater diversity within PRIM&R’s membership. In addition, he has been a strong advocate for the Certification of IRB Professionals (CIP®). Dr. Freeman is always ready to volunteer, roll up his sleeves, and get to work, digging in to all issues with dedication and intensity. He has also advocated tirelessly for the protection of vulnerable populations in research.

Dr. Freeman is the director of Tribal Community Health Programs and human protections administrator at Northwest Indian College. In these roles, he serves as teacher, IRB administrator, and principal investigator. In addition, he works as a private consultant, advising numerous universities and organizations, including American Indian, Alaska Native, Canadian First Nations, and Inuit communities and organizations. He also consults for various IRBs and research ethics boards. Dr. Freeman is the past director of research with the Indian Health Service and has served in numerous leadership and advocacy roles for American Indian and tribal communities. His research and clinical experience have focused on the health of native populations, diabetes, community and participatory research, and the ethics of research involving vulnerable populations. Dr. Freeman is one of those rare professionals who lives and works in accordance with the values he promotes.

The list of Ms. Bankert’s contributions to PRIM&R’s work and mission is long. Ms. Bankert has served as a faculty member for At Your Doorstep programs and as a member of numerous PRIM&R conference planning committees, was Applied Research Ethics National Association’s (ARENA) president in 2001, helped develop the regional meetings assistance programs that ARENA administered, was a co-chair of the 2007 Annual HRPP Conference, and willingly mentors all who seek her advice.

One of Ms. Bankert’s most important contributions to the field of HRPP administration is the textbook Institutional Review Board: Management and Function, which she co-edited. She also co-edited ARENA’s Study Guide companion to the textbook. IRB: Management and Function was first published in October 2002, and again in 2006. This book is a compilation of the works of more than 80 authors providing expertise on many topics in the realm of research with human subjects. It has become a mainstay on the desk of every IRB director, administrator, chair, and others, providing education and vital answers to daily questions, and helping to promote ethical research.

Ms. Bankert is the assistant provost at Dartmouth College. Prior to accepting this position in 2006, Ms. Bankert was the director of the IRB at Dartmouth College–Dartmouth Hitchcock Medical Center for more than 10 years. As the institutional official designee, she works closely with the IRB office and also oversees other areas of research specifically related to compliance issues.

Marky PittsMs. Pitts’ humility is legendary, as is her extraordinary service to the biomedical research community and her devotion to increasing public awareness of and understanding about the use of animals in research.

Ms. Pitts served as director of the animal subjects program, University of California, San Diego (UCSD) from 1984-2004, and as director of animal research outreach in UCSD’s Public Information Office. She was also a member of the NIH Study on Regulatory Burden, Animal Care and Use Workgroup in 1998. Ms. Pitts has presented on various animal research-related issues at conferences for PRIM&R, the Scientists Center for Animal Welfare, the American Association for Laboratory Animal Science, the Council for the Advancement and Support of Education, Society for Neuroscience, Society of Research Administrators, National Council of University Research Administrators, and UCSD. She has also published articles in Lab Animal. From 1995-2005, Ms. Pitts served on the VA San Diego Healthcare System IACUC. Ms. Pitts served on the PRIM&R Board of Directors from 1998 through 2012.

Her contributions to PRIM&R have been both numerous and essential, and include her work with Molly Greene as the co-developer of the Essentials of  IACUC Administration course, her service as the organization’s liaison on the Association for Assessment and Accreditation of Laboratory Animal Care Board of Trustees, her longstanding position as the co-chair of our IACUC conference planning committees, her reliably superb performance as a panelist and workshop leader at more than 20 years of PRIM&R and  Applied Research Ethics National Association (ARENA) conferences, her work as a co-founder of IACUC 101sm; her service as chair of the editorial committee for the ARENA/OLAW IACUC Guidebook, 2nd edition; and her tenures as first a vice president (1991), and then president (1992) of ARENA, PRIM&R’s former membership division.

Founders Award

In 2005, PRIM&R was honored to recognize the notable achievements of four individuals who played critical roles in the founding of both PRIM&R and ARENA. Their leadership, dedication, and wisdom were, and continue to be, instrumental in our growth and success.

Joe ByrneJoseph J. Byrne first saw the light of day in Somerville, Massachusetts. With the exception of a few years spent at Purdue University earning a PhD in Chemistry, and a year in Stamford, Connecticut as a research chemist, the Commonwealth of Massachusetts has been the constant benefactor of Joe’s charm, wisdom, and good judgment.

Joe worked for the Monsanto Research Corporation for a decade, but was, for over thirty years, a mainstay of Tufts University, first as an invaluable member of the Tufts Faculty, and later as Research Coordinator for the Tufts Schools of Medicine and Dentistry, Administrator of the Tufts Basic Science Research Center, Associate Dean for Governmental Affairs, Director of Government Resources, and finally, as the Associate Provost for Research.

No “"snapshot" of Joe’s life would be complete without mention of his deep devotion to his wife, Katy, and to his four adult children and their ever-growing families. A more hands-on father and “grandpa” would be difficult to find, and it’s a genuine mystery as to how Joe manages to give so much of himself to so many. "Ours is not to reason why," though, but only to be grateful for his generosity and dedication to such a large number of people and organizations.

But all of the above, glorious though it is, is not why we honored Joe at our Founders Awards ceremony in 2005. Instead, we honored him for his considerable role in bringing PRIM&R into the future. Joe Byrne was a founding member of PRIM&R and served as the organization’s Treasurer for over two decades. He has guided PRIM&R’s growth with caution and wisdom and generally shepherded organizational growth from a “no money in the bank” cottage industry to the thriving organization we are today. Thanks to Joe’s stewardship, PRIM&R survived the lean years and is now in its 32nd year of existence.

But Joe is no mere “numbers man.” He has generated ideas for many of our most successful conferences. It was Joe, for example, who recommended that PRIM&R get involved with both the animal research issue and the conflict of interest/misconduct areas, both of which are now key parts of PRIM&R’s educational offerings.

Joe Byrne is a man whose "calm-come-what-may" demeanor, endless wisdom, humility, brilliance, and effective leadership are gifts to all who know him, and we are honored to publicly present him with a small token of our huge debt of gratitude.

Sanford ChodoshSanford "Sandy" Chodosh, MD and PRIM&R are synonymous and for good reason! Sandy, too, was a founding member and served as President for 22 of the organization’s 32 years. He continued to serve on the Board and is active on the Finance Committee until his death on August 30, 2010. Sandy was a man of depth and talent, and he brought a sense of vision and professionalism to every task undertaken. Quite simply, we would not be here without him.

Ever since those early years when PRIM&R was a fledgling one-horse operation to its present status as a respected and earnest group whose basic purpose remains the promotion of responsible research through the facilitation of dialogue and the systematic sharing of information, Sandy was an organizational anchor. Without having at our helm for so many years someone who both believes profoundly in PRIM&R’s mission and who has the personal and professional skills to have helped us realize it, we would still be determined, but lonely, voices in the wilderness.

When PRIM&R was a shoestring operation (not that long ago!), Sandy’s “whatever it takes to get the job done” practicality often found him washing dishes following Board and Executive Committee meetings, stuffing packets at conferences, alphabetizing name tags, posting “no smoking” signs, and graciously greeting our old and new friends. Sandy drove PRIM&R conferees to and from dinners and hotels, filled in for absentee speakers at the eleventh hour, and in general, was always willing to roll up his sleeves and help.

It is precisely that blend of professional excellence and personal humility which made Sandy not only a valued founder and leader, but also an accomplished and respected clinical researcher as well prior to his well-deserved retirement. Sandy served as the Chair of the Boston City Hospital Institutional Review Board for many years. Throughout his distinguished career he has been a leader in the research ethics community and has never wavered in his unswerving concern for the protection of human subjects in biomedical and behavioral research. His grounding idealism always placed the respect and dignity of both patient and subject as the fundamental imperative.

Natalie ReatigNatalie Reatig, co-founder along with Barbara Stanley of ARENA, is a true original, and someone who is, quite simply, unforgettable! (with apologies to Nat King Cole and Natalie Cole – gotta love those “Natalies!”) Natalie Reatig attended PRIM&R’s first conference on human subjects research in April of 1977 and was forever enshrined as the “lady in red” as a result of the vibrant red cape she wore to that inaugural meeting. We were enchanted then and we have never stopped being enchanted! Natalie was quickly recruited to the PRIM&R Board of Directors and served for over ten years.

A born leader (in her own words, “keeping a low profile is simply not my style”) and a natural creator of community, Natalie is someone who has a bottomless wellspring of creativity, endless organizational skills, the ability to build bridges across disciplines, and, no small tribute, she is one of the kindest individuals it has been our privilege to know and work with.

Natalie spent her entire professional life at the NIMH. As a young research assistant in the then newly emerging field of psychopharmacology, she had a ringside seat as the science moved from “nurture” back to “nature” – from psychological to biological theories. Natalie eventually became responsible for programmatic administration of the research grants on pharmacological treatments for “special populations” such as those affected by Attention Deficit Disorders, Anorexia Nervosa/Bulimia, Autism, and persons with the dual diagnoses of Mental Illness/Mental Retardation. Natalie was also became a nationally recognized expert on consent in vulnerable populations and routinely brought that skill set to PRIM&R/ARENA meetings.

During her long and distinguished tenure at NIMH, Natalie served in a variety of capacities and was recognized with a number of awards, including the DHHS Secretary’s Award for Distinguished Service (1996), the National Association of Protection and Advocacy Systems, Achievement Award (also 1996), the Mental Health Service Administration, Administrator’s Award for Meritorious Achievement (1995), the Public Health Service, Special Recognition Award (1995), and the National Institute of Mental Health, Director’s Award for Significant Achievement (1987).

Since her retirement, Natalie has become an avid reader of ancient history, with special focus on the nomadic tribes of Central Asia. She walks, does yoga, rides horseback, and enjoys time spent at the beach or anywhere in nature.

Barbara StanleyBarbara Stanley is the co-founder of ARENA and a longstanding linchpin of PRIM&R. Her association with the organization goes back over 25 years when she first began facilitating workshops and giving talks at PRIM&R meetings on issues relating to informed consent, competency, and special populations.

She was elected to the PRIM&R Board a few years later, and, soon after her election, began to think about better ways to educate and inform the administrators who were the backbones of IRBs and IACUCs. Along with Natalie Reatig, Barbara was the co-founder and first President of ARENA, PRIM&R’s membership division.

Barbara’s singular stamp is evident in both ARENA’s founding principles and in its enduring commitment to respect, ethics, caring, and community. Barbara is someone whose genuineness and integrity are evident to all who meet her, and she is not capable of artifice of any kind. Instead, a bone-deep commitment to the pursuit of truth and the preservation of ethical principles are the coins of her realm, and she is the kind of researcher and professional who has toiled long and hard to preserve scientific integrity and to protect those who participate as research subjects.

In her "day job," Barbara is a clinical psychologist and research scientist in the Department of Neuroscience at the New York State Psychiatric Institute and on the faculty of the Department of Psychiatry at Columbia University College of Physicians and Surgeons. She has conducted research on clinical factors, neurobiology, and on the treatment of suicidal behavior, self-injury, borderline personality disorder, and depression. She is the recipient of more than twenty years of continual funding from the NIMH and has also received grants from several private foundations.

She is the President of the American Foundation for Suicide Prevention - Metropolitan New York Chapter and serves on its Scientific Advisory Board. She also serves on the Board of the Personality Disorders Foundation and TARA Association for Personality Disorders. She has served on several Institutional Review Boards and has been a consultant for the NIH Office of Protection from Research Risks. Barbara is the past chair of the Committee on the Protection of Human Participants in Research for the American Psychological Association.

Dr. Stanley has also served as a consultant to NIMH in developing guidelines to investigators considering including suicidal patients in treatment trials. She has published over 70 articles on suicidal behavior, self-injury, borderline personality disorder, depression, informed consent, competency, and research ethics.

Former Awards

Special Service Award

The Special Service Award was intended "to recognize exemplary individuals who have made a valuable contribution to the goals of our organization and whose achievements promote the ethical conduct of research." Recipients of the Special Service Award were members or non-members who made short-term, but vital, contributions to our organization and/or to the field of applied research ethics for human or animal research. (This award was replaced by the ARENA Legacy Award in 2006.)

Recipients of the Special Service Award were: Dale Hammerschmidt (2005), Dan Nelson (2003), and Gary Ellis (2000).

President's Award

The purpose of this award was to allow the ARENA President to recognize an individual who had made a valuable contribution to the ARENA Council, but whom was not necessarily an ARENA member. The award was made once in 2002 to Paul W. Goebel, Jr.