SACHRP March 12-13, 2013 Presentation Materials

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SACHRP Background and the Rulemaking Process

• SACHRP Background, Impact and the Guidance and Rulemaking Process by Julia Gorey, J.D. (PDF - 1,319KB)
• OHRP Guidance Development Process by Irene Stith-Coleman, Ph.D. (PDF -213KB)
• Statutes, Regulations, Guidance and FAQs:  Process for Modification by Laura Odwazny and Andrew Zacher (PDF -180KB)

HIPAA/HITECH Rulemaking Changes

• HIPAA/HITECH Omnibus Final Rule by Christina Heide, J.D. (PDF - 313KB)

Subcommittee on Harmonization Report (SOH)

• Subcommittee on Harmonization Report by Mark Barnes and David Forster, SOH Co-Chairs  (PDF - 1,349 KB)
• Draft SOH Recommendation on Regulatory Issues in Cluster Studies (PDF - 259KB)
• Corrective Actions and Investigator Sanctions to Remedy Non-Compliance by Mark Barnes (PDF - 60KB)

Focus: Improving the Informed Consent Process

• Improving Informed Consent by Jeremy Sugarman, MD, MPH, MA (PDF - 145KB)
• Improving the Informed Consent Process by Heather Pierce, JD, MPH (PDF - 1,065KB)
• Making Consent Forms more Concise:  Revising the NCI's Consent Form Template by Jeanne M. Adler, RN, MPH, CCRP and Jeffrey S. Abrams, MD (PDF - 334KB)

Subpart A Subcommittee Report (SAS)

• Subpart A Subcommittee Report by David Borasky and Daniel Nelson, SAS Co-Chairs (PDF - 3,091KB)
• Draft Expedited Review Categories (PDF - 155KB)
• Approved at SACHRP Expedited Review Categories (PDF -153KB)

Human Subjects Research and the Internet

• Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations with Revisions by Elizabeth Buchanan and Dean Gallant (PDF - 440KB)