Human Subjects Research

Patricia MacCubbin joined The City University of New York and the Research Foundation in 2004 as the Director of the Office of Research Conduct and was promoted to Executive Director and Special Advisor to the Vice Chancellor for Research in 2008. She came to CUNY with many years of human research subjects protection experience as well as experience as a public health researcher and manager.

She has over 15 years of experience in human research protections, having served in a variety of Institutional Review Board (IRB) settings. Her experience covers both social and behavioral research institutions and biomedical research institutions. She served as the Director of the IRBs at the New York State Department of Health in Albany and the University of Utah in Salt Lake City.

Her commitment to human research protections also extends to community service, as a volunteer for events at the Public Responsibility in Medicine and Research (PRIM&R) annual meetings, a community member and, later, a consultant for the Utah Department of Human Services IRB, a community member for the Weill Medical College of Cornell University IRB, and a consultant to the Early Detection Foundation.

She is currently a member of the Collaborative Institutional Training Initiative (CITI) Developers Group focusing on social and behavioral training modules. She serves on the Editorial Board of the Journal of Public Health Management and Practice. In that capacity she assembled a special issue focused on human subjects protection issues in public health. She has also published a chapter on human subjects protection issues in public health for a public health administration textbook.

Prior to working in the IRB world, she was an epidemiologist/biostatistician and the Assistant Director of Chronic Disease Epidemiology and Surveillance at the New York State Department of Health. She has a Master’s Degree in Applied Statistics and has supplemented that with additional graduate courses in Epidemiology, Biostatistics, and Public Health Law.

CUNY Official Nominated to National Advisory Committee

Patricia A. MacCubbin, Director of the CUNY Office of Research Conduct, has been nominated for membership on the US Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP).

This prestigious 11-member national committee provides expert advice and recommendations to the Secretary related to improvement of functions directed toward human research protections. Examples of topics of such advice, from SACHRP's Charter, include:

• Special populations, such as neonates and children, prisoners, and the decisionally impaired;
• Pregnant women, embryos, and fetuses;
• Individuals and populations in international studies;
• Populations in which there are individually identifiable samples, data, or information;
• Investigator conflicts of interest;
• Review of assurance systems;
• Application of minimal research risk standard;
• Granting of waivers;
• Education programs sponsored by OHRP; and
• Ongoing monitoring and oversight of institutional review boards (IRBs) and the institutions that sponsor research.