U.S. Department of Health & Human Services information related to Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule.
6/29/11 Updates to HawkIRB. Updates have been made to sections VI and VII.D in HawkIRB, as well as the User Delegates page and the help information for question V.21. Please review page 2 of the June HSO Newsletter for detailed information regarding the changes.
4/15/11 Notice Regarding WebSurveyor Technical Issues. Researchers using or planning to use the WebSurveyor survey tool to collect data as part of a research project should consult the ITS WebSurveyor - Known Issue page for the most up to date information regarding the technical issues and alternative options.
4/4/11 Information Regarding New Research Billing Procedures. University of Iowa Health Care, through the Joint Office for Compliance, is implementing new required procedures for investigators related to billing for items and services within research studies. Please review for more detailed information by the Joint Office for Compliance.
Effective March 31, 2011, the VHA Handbook 1200.5 has been revised to 1200.05. If you are conducting VA Research, please review the new information on the "Research at the VAMC".
3/28/11 Important Updates for Human Subjects Research at Iowa. Please review the important updates regarding consent documents, Hardin Library, the Record of Consent Policy, ClinicalTrials.gov, and the HSO Newsletter. This information was also sent out in a mass email to all Principal Investigators, research team members, and delegates the week of 3/28/11.
11/2/10 New IRB Metrics. New information is available regarding average times to approval and the number of studies released for the third quarter of 2010. Please review these charts located at the bottom of the IRB Metrics page under "How long does it take for IRB review to be completed?". The charts are broken down by the type of application (New, Modification, Modification / Continuing Review, and Continuing Review) as well as the type of review (Full Board, Expedited, and Exempt).
7/1/10 The Office of the Vice President for Research has named a new Executive Director of The Human Subjects Office. Please welcome, someone you may likely know, J. Andrew Bertolatus (Andy) to the position. Dr. Bertolatus has been involved with human subjects protections for many years and is a welcome addition to The Human Subjects Office. Please review the official announcement.
10/29/09 Revisions to the Cash Handling Policy - UI Accounting Services has implemented changes to the Cash Handling policy to address questions that have come from the Research Community. The policy changes are reflected under the sections “Policy Statement”-first paragraph, “Who Should Know This Policy”-first paragraph, and a new section at the bottom of the page. The procedure/template required to be completed and returned per the instructions on page 2 is at “Research Subject Compensation template”.
Effective Immediately - In accordance with a directive from the University of Iowa Office of Internal Audit, all NEW HawkIRB research projects submitted 10/1/09 or later that includes a form of research subject compensation using cash, check, or cash equivalent (Cash or cash equivalent is defined as coin, currency, checks, money orders, credit cards, accounts receivable charges, electronic funds transfers, tokens, gift cards, parking tickets and/or stamps) will now require documentation of an University of Iowa Accounting Services approval of a cash handling policy. It will be a required document which can be attached to the attachments page of the New HawkIRB application prior to submission and review by the Human Subjects Office. Please click here for additional information.
The Record of Consent can now be used on WIRB studies!
The Human Subjects Office is happy to announce the launch of the new Community Based Research (CBR) process!
WIRB Form A and Form B forms have been revised to include the UIHC Billing Compliance Office. See the WIRB page for more information.
PLEASE NOTE: There has been a revised Guide for Human Subjects Research and UI IRB SOP added to the HSO website. A tracked changes version of both have been added for your review you can also access the new Guide for Human Subjects Research and the SOP.
Attention Mac OS X.4 “Tiger” and OS X.5 “Leopard” users
All Mac users: The Human Subjects Office has been receiving numerous calls related to .rtf documents and Mac users not able to view the IRB stamp or save .rtf files into HawkIRB. Please review the following fix related to .rtf format templates used in HawkIRB. If you continue to have problems after using this suggested fix, please contact the Human Subjects Office.
Effective April 1st 2009, for all Full Board Biomedical (IRB01) and studies conducted at the Iowa City VAMC (IRB03), the IRB will be requiring a response to the full board meeting minutes within 14 calendar days of receipt of the minutes for studies "approved pending required actions," and 21 days for studies that are "tabled". If a response is not routed back to HSO within the above noted time limits, the application form in progress will be withdrawn from workflow. This means that the application will undergo no further processing, and must be completed and resubmitted in order to be reviewed by the IRB. This policy change is in response to HSO/IRB being requested to reduce the processing time an application remains in workflow. As future changes occur, notifications will be either posted on the HSO website or sent out via email.
Please note! Effective March 2009. The WIRB informed consent template has been revised. The Compensation for Injury section of the UIWIRB informed consent document now has two options to choose from for use in this section. Please review the UIWIRB informed consent document on the WIRB page of this website for specific details.
The SOP has been revised on the HSO website. Please see the new version and a track changes version.
Updated Investigator's Guide 8/1/08.
The new IRB-03 for the VA is live as of November 19, 2007. Click here for additional information relating to the IRB-03 review process and Full Board scheduling. For a current roster of the IRB-03 members, please email firstname.lastname@example.org. Please note the UI SOP has been updated to include the addition of the IRB-03 VA.
Beginning August 1, 2007: New Project Applications will not be accepted without a signed Assurance Document (signature page) attached to the HawkIRB application. A new attachment category at the bottom of the Consent Forms & Other Attachments page will be available on this date with instructions for scanning and attaching the signed document prior to submission. This will be required ONLY on New Project Applications submitted on or after August 1. Please review the Investigator's Guide located on the Human Subjects Office website for guidance regarding the signature page procedures.