Steven Anzalone

Steven Anzalone is an IRB (Institutional Review Board) Review Specialist for the Longwood Medical Area IRB, serving the Harvard School of Public Health, Harvard Medical School and Harvard School of Dental Medicine. He is responsible for reviewing new IRB submissions, modifications, and continuing renewals. Before joining the ORARC (Office of Regulatory Affairs & Research Compliance), … Continue reading “Steven Anzalone”

Leslie M. Howes

Leslie M. Howes serves as the Director for the Office of Regulatory Affairs and Research Compliance (ORARC). In this role, Leslie is responsible for overseeing ORARC’s daily operations in a broad range of research compliance activities for the Harvard Chan School, including animal research, research integrity, and lab and biosafety initiatives. Leslie also oversees the … Continue reading “Leslie M. Howes”

Alyssa Speier

Alyssa Speier, Associate Director for Regulatory Affairs & Research Compliance, serves as the primary point of contact for Harvard T.H. Chan School of Public Health faculty on developing Memorandums of Understanding (MOUs) between the School and other collaborating institutions. She also works with the School’s Associate Dean for Regulatory Affairs & Research Compliance to develop … Continue reading “Alyssa Speier”

Lisa Gabel

Lisa Gabel, Senior QA/QI Specialist, is responsible for providing Quality Improvement Program (QIP) services to the LMA research community, serving Harvard Medical School, Harvard School of Dental Medicine, and Harvard School of Public Health. As a member of the QIP team, Lisa provides a range of research support to investigators and research staff, as well … Continue reading “Lisa Gabel”

Elizabeth Ehrlich

Elizabeth is an IRB Review Specialist for the Longwood Medical Area IRB, serving the Harvard T.H. Chan School of Public Health, Harvard Medical School and Harvard School of Dental Medicine. She is responsible for reviewing initial applications (not human subjects research, exempt, expedited and full committee), modification requests and continuing renewals. Prior to joining the … Continue reading “Elizabeth Ehrlich”

Kim Serpico

As Associate Director of IRB Operations, Kim is responsible for managing the convened IRB process at Harvard Longwood Medical Area (LMA) Schools, including Harvard T.H. Chan School of Public Health, Harvard Medical School, and Harvard School of Dental Medicine. Kim continues in her role as a member of the IRB Review Specialist team reviewing initial … Continue reading “Kim Serpico”

CITI Human Research Training

Current human subjects training is required of anyone interacting/intervening with human subjects or obtaining identifiable data/specimens complete human subjects training.  To satisfy this requirement, Harvard University offers human subjects training through CITI (Collaborative IRB Training Initiative). If you do not have an HUID, you will need to have a Harvard affiliate/sponsor request one for you per … Continue reading “CITI Human Research Training”

Revised Human Research Regulations (2018 Requirements)

On January 21, 2019, the Harvard Longwood Campus (HLC) IRBs implemented the new (2018) requirements of the revised Common Rule as stipulated in the Federal Policy for the Protection of Human Subjects (45 CFR 46). The revised Common Rule is intended to add flexibility and to reduce regulatory burden. Below we provide an overview of … Continue reading “Revised Human Research Regulations (2018 Requirements)”

IRB Reliance Agreements

This webpage is designed to serve as a resource for those interested in learning more about the Harvard Longwood Campus IRB reliance process. If you need additional information or have a protocol-specific reliance question, contact Julie Chamberlin at jchamberlin@hsph.harvard.edu. Have a reliance related question?  Often a quick conversation can replace time-consuming emails.  We encourage you … Continue reading “IRB Reliance Agreements”