PRIM&R's 2008 Advancing Ethical Research Conference
Anatomy of a Research Misconduct Investigation: The Regulations and the Reality
This session will provide an overview of the Public Health Service research misconduct regulations and initial inquiry/investigation process. It will also feature cautionary remarks and "tips" for both institutions conducting research misconduct proceedings and researchers accused of misconduct.
The Informed Consent Process and Form When Research Involves Individuals with Impaired Decision-Making/ Consent Capacity
This session will address the legal and practical issues arising in research involving individuals with impaired decision-making or consent capacity. The session will update attendees on the status of "Part E" regulations and guidance in this area and the work of the Subcommittee on Inclusion of Individuals with Impaired Decision-Making in Research. The session will highlight not only the legal framework, but also the challenging practical questions arising in this area.