2008 Webinar: NIH GWAS Policy

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Overview

This webinar featured a discussion of the 2007 NIH GWAS Policy, including how to understand and apply the policy to your work.  Audience members heard from the NIH as well as from an institution with experience in submitting and accessing data from the NIH GWAS Repository.

Laura Lyman-Rodriguez, a representative of the NIH, reviewed:

  • Who and what does this policy cover? 
  • What does adhering to the policy entail? 

She answered questions such as:

  • How do you submit data into the NIH GWAS Repository? 
  • How do you access data from the NIH GWAS Repository? 
  • What is the role of Data Access Committees (DACs)? 

P. Pearl O’Rourke, a representative of a local institution working with the NIH GWAS Repository, illustrated, with real-life examples, some of the challenges of implementing the NIH GWAS policy. For example, she addressed:

  • What is the role of the local institutional review board (IRB)? 
  • How do you assess the adequacy of your informed consent under this policy? 
  • How do you handle data submissions that involve multiple sites? 
  • How do the roles of IRBs and DACs overlap?  

Faculty

P. Pearl O'Rourke, MD
Pearl O’Rourke is the Director of Human Research Affairs at Partners HealthCare Systems in Boston and an Associate Professor of Pediatrics at Harvard Medical School.  As the Director of Human Research Affairs, she is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research.  Dr. O’Rourke is the past chair of PRIM&R’s Board of Directors, and has been a speaker at a number of PRIM&R meetings, addressing topics such as privacy, human embryonic stem cells, and the reporting of serious adverse events.  She is also Chair of Partners Healthcare System’s newly formed ESCRO Committee.

Dr. O’Rourke has worked as a pediatric critical care physician at Children's Hospital, Boston and at the Children's Hospital, University of Washington in Seattle where she was the Director of the Pediatric Intensive Care Unit. Additionally, in Seattle, she served many years as a member of the IRB.  Dr. O’Rourke has also been involved in international medical care, serving in China and Indonesia with Project HOPE. In 1995-1996, she did a Robert Wood Johnson Health Policy fellowship and worked for Senator Edward Kennedy (Democrat-MA) as a member of the Labor Committee Staff.  Following this fellowship, she became the Deputy Director of the Office of Science Policy in the Office of the Director at the NIH where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination.

Laura Lyman Rodriguez, PhD
Laura Lyman Rodriguez, PhD, is the Senior Advisor to the Director for Research Policy at the National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH).  As both a member of the Office of the Director and the Policy and Program Analysis Branch, Dr. Rodriguez works to develop and implement policy for research initiatives at the NHGRI, as well as trans-NIH programs. She is particularly interested in the policy and ethics questions related to the inclusion of human research participants in genomics and genetics research. Highlights from Dr. Rodriguez’ activities at the NIH include drafting an update to the 1993 IRB Guidebook chapter on genetics research and work on the development of the NIH Policy for Data Sharing in Genome-Wide Association Studies (GWAS).  Her leadership within the GWAS initiative includes service throughout the policy development and efforts to craft procedures for implementing and overseeing the policy across the agency.  In addition, Dr. Rodriguez has spent time overseeing operations within the Immediate Office of the NHGRI Director, and has thereby had the opportunity to contribute to a variety of tasks and initiatives in support of the broader NHGRI and NIH missions.