Revised Common Rule

Recorded On: 08/14/2020

Overview
Speaker(s)

The revised Common Rule (effective January 21, 2019) is designed to strengthen protections for study participants and lighten administrative workloads for researchers and IRBs alike. These changes impact how research studies involving linkage with cancer registries, like those managed through NAACCR’s Virtual Pooled Registry, will be reviewed and processed across the country. NAACCR has partnered with the HHS Office for Human Research Protections (OHRP) to share information on the revised Common Rule, such as when research involving registries requires IRB review and the impact of the changes on research covered by the revised regulations.

Intended Audience: State/University IRBs and staff from central cancer registries involved in linking with research studies and releasing coded cancer data for matched cases.

Jaime Hernandez, J.D.; M.Be.

Management and Program Analyst, Office for Human Research Protection (OHRP)

Jaime (Hi May) Hernandez is an attorney and bioethicist at the Office for Human Research Protections (OHRP), in the 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 and his Masters in Bioethics (M.Be.) at the University of Pennsylvania, Perelman School of Medicine.

Misti Anderson, MS, MA

Senior Advisor, Office for Human Research Protection (OHRP)

Misti 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.

Castine Clerkin, MS, CTR

VPR Program Manager, NAACCR

Castine Clerkin is the Program Manager for NAACCR’s Virtual Pooled Registry Cancer Linkage System. In this role she oversees all aspects of the project, from pilot linkages to workgroup calls to system development and testing. Prior to joining NAACCR, Castine was a Program Consultant with CDC’s National Program of Cancer Registries for over 7 years and led various special projects, including early case capture of childhood cancer cases. Castine began her career in cancer surveillance in 2001, working as the epidemiologist and data manager for the Maine Cancer Registry.

Steve Friedman, MHA

Senior Advisor, Surveillance Research Program, NCI/DCCPS

SteveFriedman, MHA, joined the Surveillance Research Program as a Senior Advisor forOperations in July of 2015. He works on several major initiatives, includingSEER, Natural Language Processing (NLP), the Virtual Bio-Repository (VTR) andthe Virtual Pooled Registry (VPR). In January 2018 he was named the LeadContracting Officer Representative (COR) for the SEER Program. Mr. Friedmanserved as a founding Director for the Association for the Accreditation ofHuman Research Protection Programs and is a past President of the Board for theUlmanCancer Fund for Young Adults. He is the recipient of several NIH Merit Awardsand a NIH Director’s Award. Mr. Friedman received his Master of Health ServicesAdministration from the George Washington University and is currently AdjunctFaculty with the MPH@GWU program.