Comment on FR Doc # 2011-22341

Generally speaking, I applaud the revisions you have laid forth for the ANPRM - thank you! These changes will make the ability for me to conduct exempt and minimal risk research (under which all of our studies fall) with greater ease and less delay, which is critical both to securing projects and implementing them. In turn, we can hope that we will improve the lives of the people we serve through our research!
Specifically, proposed changes to Issues 6, 9, 11, 12, 16, 17, and 19 are enthusiastically welcomed!
For Issue 13, we might suggest that a list of pointed questions be created to ensure that the study does indeed fall under expedited review status and to collect some very basic information about the study design and procedures, rather than requiring the full set of approval criteria as for studies needing full board review.
For all issues related to expedited research protocols, we would suggest requiring the IRB to review within a certain number of days deemed reasonable.
Also as regards expedited review, we would suggest requiring IRBs to allow for in-person communication (particularly for expedited research protocols), as only allowing written communication for official approval is often cumbersome and often leads to miscommunication that can take weeks (soley through written communication) to clarify.