The Department of Health and Human Services (DHHS) has posted proposed changes to the 'Common Rule,' and will accept public comments through September 26, 2011.
Among the proposed changes are:
- Creating mandatory standards for data security and information protection;
- Eliminating the requirement for annual continuing review for some research;
- Requiring informed consent for research using identifiable or de-identified biospecimens;
- Expanding the types of research that can be exempted from institutional review board (IRB) review; and
- Improving informed consent forms.
Cayuse, Inc. is studying the proposed changes and will be monitoring public comments to be sure that our products stay in compliance with DHHS requirements and guidance.