Misti Ault Anderson, M.S., M.A.
Ms. Anderson serves as a Senior Advisor for Public Health Education in the Division of Education and Development of the HHS Office for Human Research Protections (OHRP).
Prior to joining OHRP, Ms. Anderson was a Senior Policy and Research Analyst at the Presidential Commission for the Study of Bioethical Issues, where she served as staff lead for the Bioethics Commission’s educational materials and for both volumes of the Bioethics Commission’s Gray Matters report on neuroscience and ethics. She holds an M.S. in Biomedical Science Policy and Advocacy from Georgetown University, an M.A. in Science Education from UNC-Chapel Hill, and a B.S. in Microbiology from Clemson University.
Michael Bingham, J.D.
Michael Bingham serves as an IRB Facilitator for multisite research for the University of Wisconsin-Madison Health Sciences IRB Office. In addition, Mr. Bingham serves as a Regulatory Affairs Officer & Ambassador for the National Center for Advancing Translational Sciences (NCATS) funded Streamlined, Multisite, Accelerated Resources for Trials (SMART IRB) initiative, as well as the IRB Facilitator for the Greater Plains Collaborative (GPC) PCORnet Clinical Data Research Network.
Prior to that, he was the Human Research Protection Program Specialist at ProHealth Care of Southeastern Wisconsin and the Assistant Director of the Education Research IRB at the University of Wisconsin-Madison. Mr. Bingham obtained his Juris Doctorate (J.D.) at Suffolk University Law School in Boston and a B.S. in Criminal Justice from the University of Massachusetts at Lowell.
Jaime Hernandez, J.D., M.Be.
Jaime Hernandez is an attorney and bioethicist who is currently a Public Health Advisor with the Division of Education and Development at the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services. Before joining OHRP, Mr. Hernandez was a Senior Research Investigator at the University of Pennsylvania, Department of Medical Ethics and Health Policy. Prior to that, he was a Litigation Associate at Hughes Hubbard & Reed, L.L.P. He also served as an Administrator for the social and behavioral science IRB at the University of Pennsylvania, Office of Regulatory Affairs.
Mr. Hernandez obtained his Juris Doctorate (J.D.) at the University of California, Berkeley School of Law (Boalt Hall) and his Masters in Bioethics (M.Be.) at the University of Pennsylvania, Perelman School of Medicine. He also holds a Bachelors in Philosophy from the University of Miami.
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Marcella Oliver
Marcella Oliver has worked in Clinical Research for 12 years, first starting at the Institutional Review Board office at Northwestern University in 2005, then in managing the Regulatory/Compliance aspects of research.
In her previous position as manager of Regulatory within the Northwestern University Clinical and Translational Sciences Institute, she was in charge of providing training/education and supervision for the Regulatory Unit staff who work with investigator teams on IRB and FDA submissions. Marcella also took the lead on a pilot study starting the Northwestern University IRB on the path of ceding review to external IRB’s. Following the success of this pilot, there was expanded use of external IRB’s throughout the entire institution.
Marcella currently serves as the IRB Reliance and Education lead serving as the key liaison between Northwestern University IRB, principal investigators, clinical study sites, individual study teams and external organizations and IRBs regarding IRB reliance issues. She is also responsible for facilitating the reliance agreement negotiation process, including working with the Northwestern University legal counsel to address legal and institutional requirements related to reliance agreements. Marcella holds a Bachelor’s of Science in Political Science from Northwestern University.
Mary Jane Welch, DNP, APRN, BC, CIP
Mary Jane Welch is the Associate Vice-President of Research Regulatory Operations and an Associate Professor at Rush University Medical Center. In this role she has regulatory oversight of the Rush IRBs, IBC, Biohazard Committee, DURC committee and the research arm of the Rush radiation committee. She currently serves as a steering committee member of the Chicago Area Patient Centered Outcomes Research Network (CAPriCORN) and as the Chair of the Ethics and Regulatory Workgroup of that group.
Dr. Welch led the implementation of the electronic research submission and management system at Rush and the successful preparation and application to the Association for the Accreditation of Human Research Protection Programs, IncÒ. While leading these projects, as part of her doctoral work, she invented the aggregation program Master Project©, and the business concept, Study Centered Research™.
Dr. Welch earned her Doctor of Nursing Practice from Rush University with a focus on executive leadership and systems theory and management. She has published numerous articles, chapters and presentations on the subjects of research ethics, research administration and multiple topics related to serious mental illness.
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Eileen Yates, M.S., CIP
Ms. Yates serves as the Compliance Manager at Northwestern University (NU) in the IRB Office. In this role, she is mainly responsible for overseeing the conduct of for-cause auditing and post approval monitoring on behalf of the NU IRB. In her role, she also works closely with research participants to follow up with any concerns or allegations of non-compliance.
Prior to coming to NU, Ms. Yates worked for 7 years at Rush University, the last 3 serving as Director of the IRB office. Ms. Yates holds an M.S. in Clinical Research and Regulatory Administration from Northwestern University and maintains certification as an IRB professional since 2000.