SACHRP October 9-10, 2012 Presentation Materials

October 9, 2012

Subpart A Subcommittee Report (SAS)

• Subpart A Subcommittee Report Report by Dan Nelson and David Borasky (PDF -2091KB)
• Draft Recommendations regarding Informed Consent and Waiver of Consent ( PDF - 77KB )
• Revised by SACHRP 10/09/12 - Recommendations regarding Informed Consent and Waiver of Consent (PDF - 112 KB)
• Draft Recommendations regarding Investigator Responsibilities ( PDF - 57KB )
• Revised by SACHRP 10/09/12 - Recommendations regarding Investigator Responsibilities (PDF - 110 KB )

Legal Status of E-Signatures

• Legal Status of E-Signatures by Laura M. Odwazny, J.D. (PDF - 336KB)

Informed Consent Challenges in Cluster-Randomized Trials

• Informed Consent Challenges in Cluster Randomized Trials by Andrew McRae, M.D., Ph.D. (PDF - 222KB )

October 10, 2012

Subcommittee on Harmonization Report (SOH)

• Subcommittee on Harmonization Report by Mark Barnes and David Forster (PDF - 640KB)
• Draft SACHRP Comments on OHRP and FDA Guidance Documents regarding IRB Transfers (PDF - 52KB)
• Revised by SACHRP 10/10/12 - SACHRP Comments on OHRP and FDA Guidance Documents regarding IRB Transfers (PDF - 50 KB )
• Draft SACHRP Recommendation on Consideration of Local Context with respect to Increasing Use of Single IRB Review (PDF - 60KB)
• Revised by SACHRP 10/10/12 - SACHRP Recommendation on Consideration of Local Context with respect to Increasing Use of Single IRB Review (PDF - 92 KB)

The NeuroNEXT IRB Experience

• The NeuroNEXT Central IRB Model by P. Pearl O'Rourke, M.D. (PDF - 376KB)
• NINDS' NeuroNEXT the Central IRB Experience by Louise Ritz, MBA (PDF - 184KB)

Internet Research

• Draft Considerations and Recommendations concerning Internet Research and Human Subject Research Regulations (PDF - 632KB)
• Revised by SACHRP 10/10/12 - Considerations and Recommendations concerning Internet Research and Human Subject Research Regulations (PDF - 674KB)