SACHRP February 28-29, 2012 Meeting Presentations
February 28, 2012
- Presidential Commission for the Study of the Bioethical Issues: Moral Science: Protecting Participants in Human Subjects Research
Moral Science by COL Nelson Michael, M.D., Ph.D.
- Summary of Public Comment: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators
Advance Notice of Proposed Rulemaking: Summary of Comments by Edward Bartlett, Ph.D. - OHRP
- ANPRM: Summary of Comments by Edward Bartlett, PhD. - OHRP
- Subpart A Subcommittee Report by Dan Nelson and David Borasky
February 29, 2012
- Subcommittee on Harmonization Report by David Forster and Mark Barnes
- SACHRP Recommendation on Single Patient Treatment Use
- SACHRP Recommendation on Protocol Deviations
- SACHRP Recommendation regarding Oversight of Research Misconduct and Regulatory Noncompliance
- SACHRP Recommendation on Applicability on FDA Regulations for IRBs (21 CFR 56) and Informed Consent (21 CFR 50)
- Re-Examining Component Analysis
Component Analysis by David Forster, JD, MA, CIP
Component Analysis: Evolution of the Concept by Robert J. Levine, M.D.
Component Analysis by Robert 'Skip' Nelson, M.D., Ph.D.