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SACHRP March 8-9, 2011 Meeting Presentations

Tuesday, March 8

Federal Demonstration Partnership

FDP Current Initiatives for Reducing Burden of Regulatory Compliance by Louis Brako, Jane McCutcheon, Ann Hardy and Elizabeth Bankert

Report of Subpart A Subcommittee (SAS)

Report of Subpart A Subcommittee (SAS) by Daniel Nelson and Elizabeth Bankert, SAS Co-Chairs with David Borasky, SAS Member

Return of Individual Research Results

Insights from Research in Translational Genomics by Robert Green, MD, MPH

Points to Consider by Henry T. Greely

The Framingham Heart Study Experince by Greta Lee Splansky

CLIA and Research Results by Penelope Meyers

Wednesday, March 9

Return of Aggregate Research Results

Providing Research Participants Completed Study Findings: A (Slightly) Different Perspective by Maurie Markman, M.D

Returning of Aggregate Research Result to Study Participants by Ann H. Partridge, MD, MPH

Returning Clinical Trial Results to Patients by Elizabeth Frank

Overview of Clinical Trials.gov Reporting Requirements by Deborah A. Zarin, MD

Report of Subcommittee on Harmonization (SOH)

Subcommittee on Harmonization (SOH) Update by David Forster, JD and Mark Barnes, JD, SOH Co-Chairs