SACHRP October 19-20, 2010 Meeting Presentations
Tuesday, October 19, 2010
- Summary of Public Comment:
The HITECH NPRM: Overview of Research Comments (PPT - 660KB)
By Christina Heide, J.D. - Report of Subcommittee on Harmonization (SOH)
Subcommitte on Harmonization (SOH) Update (PPT - 365KB)
By David Forster, J.D., SOH Co-chair, and Mark Barnes, J.D.
Recommended Comment on HITECH Notice of Proposed Rulemaking (PPT - 87KB)
By David Forster, J.D., SOH Co-chair, Mark Barnes, J.D., and Susan Stayn, J.D.
HITECH Recommendation (DOC - 74KB)
By David Forster, J.D., SOH Co-chair, Mark Barnes, J.D., and Susan Stayn, J.D.
Subcommittee on Harmonization Comments and Recommendations regarding IRB membership and definition of Scientist and Non-Scientist under 45 CFR 46 and 21 CFR 56 (DOC - 40KB)
By David Forster, J.D., SOH Co-chair, Mark Barnes, J.D., and Susan Stayn, J.D. - Report of Subpart A Subcommittee (SAS) (PPT - 322KB)
Preface to SACHRP FAQs on Informed Consent and Research Use of Biospecimens (DOC - 22KB)
By Dan Nelson, M.S., CIP, Elizabeth A. Bankert, M.A., and David Borasky, M.P.H., CIP - Update on Federated IRB Model
Overview of the Federation Model for IRB Review of the National Children's Vanguard Study (PPT - 863KB)*
By Steven Hirschfeld, MD, PhD, and Julia Slutsman, PhD - CTSA Consortium Report
SACHRP Introduction (PPT - 308KB)
By Daniel Rosenblum
Yale Clinical Research Management Changes (PPT - 1MB)*
By Tesheia H. Johnson
Harvard Catalyst IRB Reliance Agreement (PPT - 1.7MB)*
By Barbara E. Bierer, M.D. and Sabune J. Winkler, J.D.
Collaborations in Research: The Common IRB Model (PPT - 317KB)
By Eric C. Mah
Wisconsin IRB Consortium (WIC): a model for multi-site IRB review (PPT - 475KB)*
By Nichelle Cobb
Wednesday, October 20, 2010
- Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA (PPT - 995B)
Mike Carome, M.D., OHRP - The Use of Deception in Human Subjects Research
Deception and Research: Ethics and Regulation (PPT - 96KB)
By Frank G. Miller, Ph.D.
Deception Research in the Social/Behavioral Sciences (PPT - 83KB)
By Joan E. Sieber, Ph.D. - Focus on Data “Identifiability"
Identifiability: A Useful or Decrepit Concept in Research Ethics? (PPT - 1.9MB)
By Sara C. Hull, Ph.D.
Resolving membership in a study in shared aggregate genetics data (PPT - 14.8MB)*
By David W. Craig, Ph.D.
Measuring Identifiability from a "Reasonable" View (PPT - 1.4MB)
By Bradley Malin, Ph.D.
Protecting Participants in a Global Research Community (PPT - 2.4MB)
By Jane Kaye, D. Phil.
* Persons using assistive technology may not be able to fully access information in this file. For assistance, contact OHRP.