Talks focused on regulatory issues and emerging topics in research. Regulatory Education and Events Series
At a glance
Opportunity for
  • Continuing education on regulatory compliance and emerging issues
  • Open to all (some sessions may open only to Harvard-affiliated researchers); sessions are geared to researchers, research staff, and/or institution officials and administrators.
Session Dates
  • Varies; see below for details

The Harvard Catalyst Regulatory Foundations, Ethics, and Law Program hosts events that focus on regulatory topics and emerging issues in the interdisciplinary conduct of research. The events series features local and national experts who offer guidance, present case studies, and engage participants in discussion on a range of topics of interest to researchers as well as research administrators and IRB members.

Upcoming Seminars

OHRP Research Community Forum
Informed Consent: Content, Communications and Emerging Technologies

May 1-2, 2018
Joseph B. Martin Conference Center
Harvard Medical School

Registration and full agenda forthcoming.

Keynote Speakers:

David C. Fajgenbaum, MD, MBA, MSc
Assistant Professor of Medicine, Translational Medicine & Human Genetics Associate Director, Patient Impact, Orphan Disease Center, University of Pennsylvania
Executive Director, Castleman Disease Collaborative Network

David Fajgenbaum, MD, MBA, MSc, is assistant professor of medicine and associate director of the Orphan Disease Center at the University of Pennsylvania, co-founder/executive director of the Castleman Disease Collaborative Network (CDCN), and a patient battling the same rare and deadly disease — idiopathic multicentric Castleman disease (iMCD) — that he studies. Fajgenbaum was diagnosed with iMCD during medical school.

Between five life-threatening flares and hospitalizations, Fajgenbaum created the CDCN, which has become a model for international collaboration and an innovative approach for accelerating research. He has published research that has changed the way iMCD is researched and treated. Currently, he is in his longest remission ever thanks to a precision treatment that he identified, which had never been used for iMCD. Fajgenbaum's work has been profiled by the New York Times, Science, Today Show, Reader's Digest, Everylife Foundation's 2016 RareVoice Award, Global Genes' 2015 RARE Champion of Hope: Science award, and Forbes Magazine's 2015 30 Under 30 Healthcare List. Fajgenbaum received his BS from Georgetown University, MSc from Oxford University, his MD from the University of Pennsylvania, and MBA from the Wharton School of Business.

Steven Joffe, MD, MPH
Emanuel and Robert Hart Professor Medical Ethics and Health Policy Chief, Division of Medical Ethics
University of Pennsylvania Perelman School of Medicine

Steven Joffe, MD, MPH, is the Emanuel and Robert Hart Professor of Medical Ethics and Health Policy and professor of pediatrics at the University of Pennsylvania Perelman School of Medicine. He is chief of the Division of Medical Ethics and directs the department's postdoctoral training programs in bioethics and in the ethical, legal, and social implications of genomics. Joffe attended Harvard College, received his MD from the University of California at San Francisco (UCSF), and received his MPH from UC Berkeley.

Joffe trained in pediatrics at UCSF and in pediatric hematology/oncology at the Dana-Farber Cancer Institute and Boston Children's Hospital, and his clinical work focuses on stem cell transplantation in children. His research addresses the ethical challenges that arise in clinical and translational investigation. He has led or participated in NIH-, PCORI-, and foundation-funded studies that examine the roles and responsibilities of principal investigators in multicenter randomized trials, accountability in the research enterprise, governance within learning healthcare systems, return of genetic results to research participants, and the integration of genomic sequencing technologies into cancer care.

Joffe is a member of the U.S. Food and Drug Administration's (FDA) Pediatrics Ethics Subcommittee and the National Human Genome Research Institute's Genomics and Society Working Group.

Sponsored by:

For more information, please email us.

Ongoing Opportunities

For IRBs

  • Onsite SBER Training and Education (Request Consultation)
    A customizable, case-based curriculum delivered and moderated by IRB experts.
  • IRB Visiting Program (Request schedule and more information)
    Local IRB members have the opportunity to observe the deliberations of another IRB to help identify best practices and innovative processes in the review of clinical and translational research.

For Investigators

  • Onsite SBER Training and Education (Request Consultation)
    A customizable, case-based curriculum delivered and moderated by IRB experts.
  • Reporting (Request Consultation)
    Obtain assistance with required reporting to from the Harvard Catalyst Biostatistics Program.