Who We Are

Dr. Patricia Blount is currently the Managing Director of ProtocolsByDesign, LLC, a research compliance consulting company. Dr. Blount earned her medical degree from Medical College of Georgia, completed an internship at Washington University in St. Louis and a residency in internal medicine at University of Washington in Seattle. She subsequently completed her gastroenterology research fellowship (physician scientist track) at the University of Washington. She was a clinical investigator for more than 25 years, first conducting research studies at the University of Washington as a member of the clinical faculty and subsequently at the Fred Hutchinson Cancer Research Center, Seattle, as a staff physician. 

While an academic researcher, Dr. Blount also served as a consultant to a Seattle biotechnology company, assisting with moving novel pipeline drugs from the pre-clinical to the clinical phase of development, served on biopharma advisory committees, NCI advisory boards, and as a member of the board of trustees of a Seattle non-profit that funds research for diseases of the lung and esophagus. 

Dr. Blount’s knowledge and intense interest in human subjects research regulations from the investigator’s perspective led to her interest in the IRB, first serving as a Fred Hutchinson alternate IRB member and subsequently as a full-time affiliated IRB member and Vice Chairperson of Quorum Review IRB (now Advarra). 

In 2015, she launched ProtocolsByDesign, LLC with the goal of bridging the gap between the investigator perspective and the IRB perspective in human subjects regulatory compliance. Her clients have included a telemedicine start-up, a regulatory consulting firm, and university-based IRB, HRPP and clinical research directors. Her special interests are in preserving research participants’ autonomy, investigator and institutional conflict of interest management, and an ethical, rather than a command-and-control, approach to research compliance. In addition to her medical degree, she holds a Master of Studies in Law (MSL) from University of Pittsburgh School of Law and a certification in Healthcare Research Compliance (CHRC).

Elizabeth Buchanan, Ph.D., CIP, is a research ethicist and research administrator with over 25 years of professional experience. She received her Bachelor of Arts with a double major in Philosophy and English from Rutgers University (1992), after which she completed a Master of Library and Information Science (1996) and a multidisciplinary Ph.D. (1999) from the University of Wisconsin-Milwaukee. 

Elizabeth has held numerous academic positions, including Assistant then Associate Professor; Director, Center for Information Policy Research (1999-2011, UW-Milwaukee); Endowed Chair in Ethics and Director, Center for Applied Ethics (2012-2020, UW-Stout); Senior Research Scientist and Director, Office of Research and Sponsored Programs (2020-2023, Marshfield Clinic Research Institute), and currently, Associate Vice-President, Research Administration, University of Rhode Island. She is known for her scholarship in Internet research ethics, with one of the first scholarly handbooks in the field published in 2003. Her recent publications include: “How to Think About Online Research Ethics,” (Sage, 2022); co-author, “Navigating the Ethical and Methodological Dimensions of a Farm Safety Photovoice Project,” Bioethical Inquiry (2023); and co-author, “Capturing a Moving Target: Ethical Research Practices for Hashtag Activism,” in Hashtag Activism Interrogated and Embodied: Case Studies on Social Justice Movements (Utah University Press, 2023). Her administrative experience began in 2014, and has included oversight of sponsored programs, IRB, IACUC, data and material transfer agreements, research navigation, and scientific writing.

Elisa Butler is currently a Clinical Trials Regulatory Specialist at a leading academic research entity. She has worked as an IRB professional at large for-profit IRBs, academic and research institutions. She has a Masters degree in Bioethics from Case Western Reserve University and is dedicated to facilitating and fostering ethical research with human subjects. 

Dr. Coco is a practicing clinician, certified by the American Board of Internal Medicine in Internal Medicine, Hematology and Medical Oncology. He has been Chief of Hematology and Medical Oncology at the New England Baptist Hospital, where he is Director of Medical Education, and he is on teaching faculty at Harvard Medical School. Dr. Coco is currently vice Chairman of Massachusetts Medical Society Committee on CME Accreditation. He is in clinical practice, seeing patients at MetroWest Medical Center. Dr. Coco has been a clinical researcher for over twenty years in the area of clinical oncology.

Cindi Hart is a Registered Nurse working in medical informatics supporting principal investigators. A two-time cancer survivor and caregiver to her husband who is also a cancer survivor, Cindi is an internationally recognized cycling and speed skating coach, and President and Founder of Spokes of Hope, a nonprofit organization focused on survivorship. Ms. Hart and Spokes of Hope support patients with cancer and survivors in remission, “emphasizing that cancer isn’t contagious, but that hope is, Cindi is changing the way cancer is perceived and cycling towards the future to empower, unify and inspire cancer survivors.”

Dr. Elizabeth Hohmann is Associate Professor of Infectious Diseases and has been at Massachusetts General Hospital(MGH)/Harvard Medical School since 1990. She is an expert on intestinal infections especially Salmonella, Listeria monocytogenes and C. difficile. Her interests include clinical and translational research, and she has significant experience with live attenuated bacterial vaccines and vaccine vectors. She has a special interest in “first in human” studies, particularly those involving human challenge studies and live organisms. She also has expertise in ethical and regulatory oversight of clinical research, having served as an IRB chair at MGH and Brigham and Women’s Hospital for 25 years. She directs the MGH Core Laboratory for Fecal Microbiota Transplantation and leads research looking at modification of the gastrointestinal microbiome in infectious, metabolic and inflammatory conditions. She also works on emerging infections including COVID-19, as the MGH PI for the International NIH-sponsored ACTT Platform studies which have evaluated therapies for patients hospitalized with COVID-19, and Mpox (monkeypox) and is a member of the MGH Biothreats Team.

Elisa A. Hurley, PhD, is a philosopher and bioethicist. She most recently served as executive director of Public Responsibility in Medicine and Research (PRIM&R), stepping down in 2023, where she led the organization in the execution of its mission to advance the highest ethical standards in the conduct of research through education and professional support of research oversight professionals; represented PRIM&R at national and international meetings; and wrote and spoke on a range of issues in research ethics and human subjects protections. Prior to arriving at PRIM&R, Elisa was an assistant professor of philosophy at Western University in London, Ontario, Canada. She received a BA in philosophy from Brown University, a PhD in philosophy from Georgetown University, and held a Greenwall Fellowship in Bioethics and Health Policy at the Johns Hopkins Berman Institute of Bioethics and Georgetown University’s Kennedy Institute of Ethics. Dr. Hurley is a co-editor of the 3rd edition of IRB Management and Function (Jones & Bartlett, 2021). She is a member of the Consortium to Advance Effective Research Ethics Oversight (AEREO), a collaboration of leaders in human research protections aiming to evaluate and improve the effectiveness of institutional review boards through empirical study.

Nancy M. P. King, JD, is Emeritus Professor of Social Sciences and Health Policy at Wake Forest University School of Medicine. She has also been affiliated with the Wake Forest Institute for Regenerative Medicine and the Wake Forest University Center for Bioethics, Health, and Society and Bioethics Graduate Program. Her scholarship addresses a range of bioethics issues, including: informed consent, benefit, and uncertainty in health care and research; the development and use of novel experimental biotechnologies; international and cross-cultural questions in human subjects research; and equity and justice in health care and research. 

She has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (3rd ed., Duke University Press, 2019), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). Her most recent book is Bioethics Reenvisioned: A Path Toward Health Justice, coauthored with Larry R. Churchill and Gail E. Henderson (UNC Press 2022). Professor King has taught a variety of courses in bioethics, medical humanities, and research ethics to medical students and faculty and to graduate students in bioethics and the health sciences, and has taught bioethics in national and international settings. She is a fellow of the Hastings Center and a member of the AAHRPP Board of Directors, and has served on hospital ethics committees, IRBs, DSMBs, the NIH Recombinant DNA Advisory Committee, and the DHHS Secretary’s Advisory Committee for Human Research Protections. 

Ms. Lallemont is a healthcare regulatory attorney with experience supporting early stage startups to mature companies, as well as health system, non-profit and independent review boards. She currently serves as VP, Assistant General Counsel at One Medical, part of Amazon Health Services, focusing on clinical and regulatory issues. Ms. Lallemont has served on in-house teams at Quorum Review IRB, Seattle Children’s Hospital and Western IRB, and served as an IRB member at Seattle Children’s Hospital. She holds a JD and MPH from University of Washington. 

Sarah Luery (she/they), MA, CIP, has a decade of IRB experience, and specializes in review of social behavioral research. Sarah is a Senior IRB Analyst at the University of Southern California and a member of the North Star Review Board. She has served on PRIM&R Emerging Professionals Working Group and been a member of the PRIM&R Blog Squad. She earned a BA in Print Journalism and a Minor in Business Administration from the University of Southern California, and a MA in Sociology from California State University Northridge. Sarah is also the producer, book writer and lyricist of MONOTONY: The Musical, which she released for podcast in 2020 and as an original cast album in 2021. Her writing can be found in a number of journalistic and scientific publications including Journal of the American College of Radiology and Social Sciences. Her poetry has been featured in The UCLA BEAT.

Gianna “Gigi” McMillan, D. Bioethics, MFA, is a lecturer for the Bioethics Institute at Loyola Marymount University in Los Angeles. In 1996 she co-founded a support network for families whose children have been diagnosed with brain cancer, which evolved into a multi-state non-profit organization serving hundreds of families each year. Dr. McMillan has extensive experience as a Subject/Patient Advocate on local and national IRBs, was a member of the Subpart A Subcommittee for the Secretary’s Advisory Committee on Human Research Protection and is a patient representative on the FDA’s Pediatric Advisory Committee. Dr. McMillan was a Student Director for the American Society for Bioethics and Humanities, has been a faculty member at PRIM&R since 2004, is the Director of Community Engagement for the academic journal, Narrative Inquiry in Bioethics, and is the incoming Chair of the Board of Directors of PRIM&R. Her primary interests are consent issues in clinical research and the use of narrative as an educational tool in bioethics.

Paul Newton is an Oregon attorney with over 30 years of experience in law, regulatory affairs, compliance, ethics & bioethics, and Institutional Review Board (IRB) oversight. Prior to his involvement in IRB work, Paul spent fifteen years as a criminal defense lawyer. Since beginning his work in the IRB field in 1996, Paul has served on numerous research ethics committees such as Oregon Health Division IRB, Oregon Health & Science University (OHSU) IRB, Legacy Health IRB, Western IRB Portland State University IRB, Yale IRB, and Innovations for Poverty Action (IPA) IRB. He was also a prisoner representative on the OHSU IRB for over 25 years before becoming OHSU’s Human Research Protection Program (HRPP) Director and IRB Chair in December 2023.

Jens Rueter, M.D. is the Chief Medical Officer of The Jackson Laboratory and Medical Director for the Maine Cancer Genomics Initiative and the Associate Director for Translational Education at the JAX Cancer Center. Dr. Rueter is a practicing hematologist/oncologist in Maine and has served as Medical Director for MCGI since its inception in 2016. In 2021, Rueter was named JAX’s first CMO and serves as the institution’s principal medical advisor. As a member of the JAX senior management team, he works with a number of JAX clinical genomics and education experts as well as several national leaders on advancing the field of Precision Medicine with the goal of individualizing cancer treatments for individual patients and improving their outcomes. Since 2010, Dr. Rueter has practiced as a hematologist/oncologist Northern Light Cancer Institute. Previously, he was also the founding medical director for EMMC Biobank and translational research in Brewer, Maine. After graduating from medical school in Berlin, Germany, Rueter completed his residency in internal medicine at Tulane University and fellowship training in hematology/oncology at the University of Pennsylvania.

Megan Kasimatis Singleton, JD, MBE, CIP is Associate Dean for Human Research Protections and Director of the Human Research Protections Program at Johns Hopkins University School of Medicine. In this role she is responsible for oversight and direction of JHM’s 8 IRBs. Ms. Singleton is a licensed attorney in Pennsylvania. She earned her law degree from Temple University and her Masters in Bioethics from the University of Pennsylvania. Ms. Singleton serves as a member of the SMART IRB Harmonization Steering Committee, member of the PRIM&R Board of Directors, Chair of PRIM&R’s Nominations & Elections Committee and Co-Chair of PRIM&R’s Public Policy Committee. Ms. Singleton is also an AAHRPP, Inc. site visitor and Co-Chair of the AAHRPP Council. She also serves as a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research. Ms. Singleton currently teaches at the graduate level at the University of Pennsylvania and Johns Hopkins University, leading courses in research ethics and clinical trial management. She has developed research ethics curriculum and practical training in IRB administration tailored for national and international audiences.

Carol Weil is an independent consultant and expert in the ethical, legal and social implications of research biobanking, cancer research, and genetic/genomic research. From 2010-2021, she served as a program director for ethical and regulatory affairs at the US National Cancer Institute (NCI) where she advised research teams and policy officials on consent and data sharing strategies, biobank governance, community engagement initiatives, and approaches for disclosing research results and incidental findings. From 1999-2010 she conducted compliance investigations and did policy analysis at the US Office for Human Research Protections. She was a member of the Multi-Regional Clinical Trials Center of Harvard’s Return of Individual Results project team and the team’s subgroup on genomics. Currently, Carol is a section editor (ethical, legal and social Issues) for the Mary Ann Liebert journal Biopreservation and Biobanking.