The Department of Health and Human Services has issued an Advanced Notice of Proposed Rule Making (ANPRM) as the first step in revising the Common Rule (45 CFR 46), the code of federal regulations governing research with human subjects. These changes could greatly impact the IRB review process and requirements. The ANPRM requests comments on how current regulations might be modernized and revised to be more effective and how to better protect subjects while facilitating research and reducing burden, delay, and ambiguity for investigators. The comment period on this proposal has been extended by 30 days and will end on October 26, 2011.
You are invited to help develop UC’s institutional comments on the ANPRM via a series of organized teleconference calls. The last one-hour teleconference call is scheduled for this Friday, September 2nd at 3PM and is open to the general UC research community. The discussion will focus on the proposed changes to the regulations pertaining to data collection, oversight and harmonization. In order to collect input and focus the discussion, a survey has been created with the Advanced Notice questions pertaining to these topics.
Note: This is the last of the three surveys distributed. However, all three surveys will remain open until September 16th, so if you haven’t provided comments to the previous two surveys, you are encouraged to do so.
Previous weeks’ surveys:
Survey #1, “Risk Based Protections”
Survey #2 “Consent”
Log-in information for the conference call is as follows:
Call-in #: 866-740-1260; Access Code: 9870688.
PowerPoint slides for the discussion can be accessed by logging into www.readytalk.com and entering 9870688 as your access code.
September 9, 2011 Update:
As previously announced, UC’s Office of the President invited the research community to help develop institutional comments via three surveys and related conference calls. Although the conference calls are now complete, all three surveys will remain open until Friday, September 16, 2011. You are welcome to contribute your input.
Survey #1 - “Risk Based Protections”
Survey #2 - “Consent”
Survey #3 - “Data Collection, Oversight, and Harmonization”