Informational risk, institutional review, and autonomy in the proposed changes to the common rule.

In 2011, the Department of Health and Human Services proposed changes to the regulations which govern human subjects protection in Federally funded research. The proposed changes involve modifying inclusion standards for minimal risk research and removing the necessity of review from certain categories of non-invasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act (HIPAA).

Strangers at the benchside: research ethics consultation.

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated.