Are You Ready? The New Frontier in Clinical Research and the Evolving Common Rule image

Boston Bar Association, March 7, 2016
Holly Fernandez Lynch (Executive Director), Speaker


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CLE - Are You Ready? The New Frontier in Clinical Research and the Evolving Common Rule

Monday, March 7, 2016 4:00 PM to 7:00 PM
Boston Bar Association - 16 Beacon Street, Boston, MA


On September 8, 2015, sixteen federal agencies published a long-awaited Notice of Proposed Rulemaking (NPRM) to modernize the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” The proposed revisions are intended to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. 

The NPRM includes a number of changes related to privacy and data security and other changes relevant to entities seeking to conduct secondary research using collected data.  Anticipated changes may impact (i) informed consent rules; (ii) require informed consent for secondary research with a human Biospecimen, such as a blood sample, even if the specimen is not individually identifiable; (iii) the level of required administrative or Institutional Review Board (IRB) review to the potential risk to research subjects; and (iv) establish uniform privacy and security standards.  

In this program, diverse speakers ranging from academic research hospitals and their counsel to regulators and advisors, will explore and discuss the Common Rule, the intended purposes of the NPRM, and the potential impact of the NPRM should it be finalized in its present form. Speakers will focus on issues such as, research involving Biospecimen, relevant exclusions and exemptions, the believed government perspective on the NPRM and possible government monitoring and enforcement activities related to same, as well as how the NPRM will impact the conduct of clinical and biomedical research. 

Individuals who should attend this program include individuals involved in the conduct of clinical research, IRB members, academic researchers, and individuals responsible for the conduct and oversight of research and human subject protections at entities such as academic medical centers, hospitals engaged in research and pharmaceutical and medical device companies.


Sponsoring Section/Committee:

Health Law Section


  • Maureen Bennett
    Jones Day

  • Dianne J. Bourque
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

  • Holly Fernandez Lynch
    Petrie-Flom Center for Health Law, Biotechnology, and Bioethics

  • Emily Chi Fogler 
    Verrill Dana LLP

  • Laurie Halloran; 
    Halloran Consulting Group

  • Katherine L. Kraschel
    Yale New Haven Health System

  • P. Pearl O'Rourke
    Partners HealthCare System, Inc.

  • Aaron Tantleff
    Foley & Lardner LLP

  • Alexander Turchin
    Brigham & Women's Hospital

  • David Vulcano
    Hospital Corporation of America

bioethics health law policy holly fernandez lynch human subjects research research