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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)
