Arena Legacy Award

PRIM&R is excited to present Linda E. Mayo, BA, CIP, with the 2020 ARENA Legacy Award. Ms. Mayo is the Director of the HRPP at the University of New Mexico.

Ms. Mayo has been a PRIM&R member since 2004. She has been a speaker for PRIM&R’s Social, Behavioral, and Educational Research (SBER) and Advancing Ethical Research (AER) conferences since 2016. In 2018 she was a speaker for PRIM&R’s Implementing the Revised Common Rule Workshop and for the AER preconference program, Critical Topics in SBER. Ms. Mayo also served on the planning committees for SBER17 and SBER19 and the workshop didactic sub-committee for AER18.

In 2016, Ms. Mayo and fellow PRIM&R member Cecilia Brooke Cholka approached PRIM&R to implement the SBER Network. Since then, the SBER Network has grown to over 450 PRIM&R members. Ms. Mayo and Ms. Cholka continue to co-facilitate the Network, working with PRIM&R staff to plan periodic virtual roundtables and on-site events at the SBER and AER conferences.

Ms. Mayo has been working in human research protections for over 17 years. She is a site visitor, team leader, and Step 1 Reviewer for the AAHRPP, Inc. She has also conducted NIH-funded research at the Mind Research Network focused on the ethics of returning incidental findings in neuroimaging research and has co-authored several publications on incidental findings.

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

“In 2016 Linda co-founded the national SBER Network, a collaborative of IRB professionals that focus on the unique issues and challenges of ethical oversight of social, behavioral, and educational research, which is hosted by PRIM&R. It has become an excellent resource for PRIM&R members.”

Ms. Mayo’s enthusiastic leadership and extraordinary contributions to building a research ethics community left a paramount impact on both the PRIM&R community and the field at large. It is the utmost honor to present her with the 2020 ARENA Legacy Award.

PRIM&R is excited to present Susan Z. Kornetsky, MPH, with the 2019 ARENA Legacy Award. Ms. Kornetsky is the Senior Director of Clinical Research Compliance at Boston Children’s Hospital.

Ms. Kornetsky has been a PRIM&R member since 1985 and was the 15th ARENA president in 2000. She was on the PRIM&R Board of Directors from 2001 to 2017, serving as vice chair from 2005 to 2007 and chair from 2016 to 2017. Ms. Kornetsky is one of the founders of the Certified IRB Professional (CIP^®) program and served on the CIP Council. She has been and continues to be an invaluable contributor to PRIM&R’s educational programs, serving as a speaker for countless events, including annual conferences, At Your Doorstep programs, workshops, and webinars. She is also a co-developer and speaker for PRIM&R’s IRB Administrator Boot Camp and is frequently involved in PRIM&R’s public policy comments. Ms. Kornetsky received the Distinguished Service Award from PRIM&R in 2003.

In Ms. Kornetsky’s 36 years at Boston Children’s Hospital, her responsibilities have included: directing an IRB administrative office, educating principal investigators regarding IRB regulations, assisting investigators with protocol development, assuring institutional compliance with all federal and state regulations pertaining to human research, establishing appropriate policies and procedures, and overseeing a quality improvement program for human research protections. In May of 2010, she completed a medical ethics fellowship at Harvard Medical School.

Throughout her career, Ms. Kornetsky has been encouraging the advancement of research oversight administrators and committee members through myriad educational efforts, including presentations, curriculum development, and publications. In addition to her commitment to PRIM&R, Ms. Kornetsky has contributed her expertise to numerous organizations, including, but not limited to, AAMC, NIH, Office for Protection from Research Risks, OHRP, Massachusetts Institute of Technology, National Counsel of University Research Administrators, and AAHRPP, Inc. She serves as faculty for educational programs run internationally through Harvard Medical School Office of Global Education and is a former faculty member for a Fogarty International grant. She additionally lectures for the Masters of Clinical Investigation and Masters of Bioethics programs at Harvard Medical School.

Ms. Kornetsky is a past member of SACHRP and served as a co-chair for the Subcommittee on Children. Currently, she serves on the SACHRP Subpart A Subcommittee. She is a past board member and site visitor for AAHRPP, Inc., as well as a current member of the AAHRPP conference planning committee. Ms. Kornetsky is a former member of the International Organization for Migration’s Committee on Clinical Research Involving Children, and also served as a consultant for several federal agencies. She serves on the steering committee of SMART IRB, and frequently participates in the Bioethics Collaborative for the Multi-Regional Clinical Trials. She is also a member of the Scientific and Research Advisory Committee for the Massachusetts Down Syndrome Congress.

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

Susan Kornetsky is an amazing person who has been committed to the professional development of IRB and IACUC administrators and members since the founding of ARENA in 1985. She is an enthusiastic supporter of individuals who have chosen IRB or IACUC administration as a career. Susan has served as a mentor to her staff at Boston Children’s Hospital and to administrators and committee members throughout the United States and the world.

Ms. Kornetsky’s dedication to research ethics and oversight has enhanced the PRIM&R community and the field at large. It is our great honor to present her with the 2019 ARENA Legacy Award.

PRIM&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.

PRIM&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 101^sm 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.

PRIM&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.

PRIM&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.

Ms. 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.

Ms. 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. 

Daniel 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.

Ms. 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.

Ms. 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.”

Dr. 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.

Dr. 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).

Dr. 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.

Ms. 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 101^sm; 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.

The Special Service Award was intended "to recognize exemplary individuals who 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).