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”

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”

The European Union (EU) General Data Protection Regulation (GDPR)

What is the GDPR? What is personal data? How does the GDPR impact my research? GDPR and Coded Data GDPR and Anonymized Data GDPR and Prospective Data Collection Need Help? Resources at Harvard What is the GDPR? The General Data Protection Regulation (GDPR) applies to all individuals, organizations with European Economic Area (“EEA”)-based operations and … Continue reading “The European Union (EU) General Data Protection Regulation (GDPR)”

Monthly Education Series

The Quality Improvement Program (QIP) is committed to providing on-going support and education to the Harvard Longwood Campus (Harvard Chan School, HMS, HSDM) research community. Human research training refresher credit will be available for those who attend three or more sessions in an academic year. All sessions will be held via Zoom. NOVEMBER 2021 Anticipating … Continue reading “Monthly Education Series”

Institutional Officials

Institutional Official for HSPH (Federalwide Assurance #00002642) Delia Wolf Christiani , MD, JD, MSCI, CIP Associate Dean, Regulatory Affairs & Research Compliance Harvard T.H. Chan School of Public Health Phone: 617-432-2148 Email: dywolf@hsph.harvard.edu Institutional Official for HMS/HSDM (Federalwide Assurance #00007071) Ara Tahmassian, PhD Chief Research Compliance Officer Office of the Vice Provost for Research Harvard … Continue reading “Institutional Officials”

ORARC Staff

Leslie Howes, MPH, CIP Director Phone: 617-432-2153 Email: lhowes@hsph.harvard.edu IRB Staff Name/Biography Title Phone # Email Address Steven Anzalone, MS, CIP IRB Review Specialist 617-432-3071 sanzalone@hsph.harvard.edu Elizabeth Ehrlich, CIP IRB Review Specialist 617-432-8382 eehrlich@hsph.harvard.edu Keren-Nicole Insalaco, MS, CIP Senior IRB Review Specialist 617-432-5132 kninsala@hsph.harvard.edu Kim Serpico, MEd, CIP Associate Director, IRB Operations 617-432-7434 kserpico@hsph.harvard.edu QIP … Continue reading “ORARC Staff”