For more recent announcements, please see the Announcements page found here.
7/5/11 Updated OHRP Guidance on Written IRB Procedures. OHRP has updated its Guidance on Written IRB Procedures.
7/5/11 Guidance on Reporting Incidents to OHRP. OHRP has posted on its website a finalized guidance document entitled, “Guidance on Reporting Incidents to OHRP.” This guidance has been updated to clarify what information regarding serious or continuing noncompliance by the institutional review board needs to be reported, and to update OHRP's contact information.
3/28/11 Important Updates for Human Subjects Research at Iowa. New information regarding ClinicalTrials.gov and the University of Iowa can be found here as part of a list of important updates for human subjects research at Iowa. This information was also sent as a mass email to all Principal Investigators, research team members and delegates the week of 3/28/11.
10/18/10 OHRP FAQ Update. The FWA Frequently Asked Question #4 (When is an institution considered to be "engaged in research"?) has been revised by OHRP.
10/4/10 OHRP has issued a clarification on the meaning of "noninvasive" in Expedited Review Category 3. OHRP has posted a new item of correspondence on its view about the meaning of “noninvasive” as the term is used in expedited review category 3, which is the expedited review category that applies to the prospective collection of biological specimens for research purposes by noninvasive means. OHRP's statement can be viewed at http://www.hhs.gov/ohrp/policy/expedited98.html. The link to the categories of research that may be reviewed by the IRB through an Expedited Review Procedure can be found here. This clarification is consistent with the Food and Drug Administration's position on these procedures.
10/01/10 The Human Subjects Office/IRB is pleased to announce our most recent addition to the HawkIRB electronic application system: "The Human Subjects Research Determination" (HSRD) form. This is an electronic tool to assess whether or not a research proposal constitutes "human subjects research". This tool adapts the "smart form" technology of the HawkIRB electronic application into a series of short questions to assess if your proposal meets the regulatory definition of human subjects research.
9/14/10 New FDA Warnings. The FDA has released new warnings for researchers who may be using, or plan to use, a gadolinium based contrast research agent with MRI imagining done for research purposes. Click here for more information.
Archived HSO news items can be reviewed here.