All Announcements

7/11/17 NEW!  Do you know how many forms are under review by the Human Subjects Office and IRB?  Submissions are reviewed in the order of receipt. Below is a weekly snapshot of those submissions and the number of IRB approvals issued.
Review the February 2017 IRB Regulatory and Policy Updates to see important information regarding changes in the CITI training to account for
NEW! Enhancements to the eResearch (HawkIRB) application are now live in an effort to better inform you of the federal, state, and local policies that may apply to human subject research. We hope you find these enhancements helpful in preparing the eResearch application for IRB review.
The Final Rule for Clinical Trials Registration and Results Submission (42 CFR Part 11) indicated that a checklist-based tool would be available to assist responsible parties in evaluating whether their clinical trial or study is an applicable clinical trial based on the conditions outlined in 42 CFR 11.22(b) (Determination of applicable clinical trial for a clinical trial or study initiated on
Today the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products,
Does your sponsor require a formal "Statement of Compliance" for the University of Iowa IRBs?  If yes, information can be found on the UI IRB page of the HSO website here.
Staff of the Human Subjects Office will be engaged in staff development during the following dates and times: Monday, November 14th, 10:00 a.m. to 2:45 p.m. Tuesday, November 15th, 10:00 a.m. to 5:15 p.m. Wednesday, November 16th, 10:00 a.m. to 5:15 p.m. Email and voicemail messages will be checked sporadically during these dates.
Please note there may be delays in processing single, external and commercial IRB applications due to limited staff availability. We apologize for any inconvenience this may cause.
The U.S. Department of Health and Human Services has issued a final rule about ClinicalTrials.gov.  The Human Subjects Office invites you to attend the three-part series of webinars hosted by ClinicalTrials.gov about the final rule. 
The Human Subjects Office is hiring a Senior Compliance Specialist to focus on ClinicalTrials.gov.  Applications are being accepted now through 9/16/16.  For the full posting, please see the UI jobs site, Requisition 69658.
HawkIRB will be offline for maintenance on Saturday, September 10th. The expected down time will be from 4-6 a.m. Central. Please contact us if you have any questions.
The Human Subjects Office has updated information on the ClinicalTrials.gov Requirements page.  Contact ct-gov@uiowa.edu with further questions.
Read the July 2016 edition for information about regulatory updates from NIH and OHRP, HawkIRB enhancements for ClinicalTrials.gov, a reminder about research subject compensation, and the IRB Advisor Newsletter.  Want to get the la
For Phase II-IV clinical trials, the FDA/NIH a has a draft protocol template that was announced in spring 2016.  For phase 1 or non clinical trials, see the Human Subjects Of
The Human Subjects Office and the Institutional Review Boards work hard year-round to facilitate research at the University of Iowa while protecting the health and safety of subjects under our care. Costs of administering these programs continue to rise, however, which means the Office of Research and Economic Development will need to adjust some of its fees for FY17.
The University of Iowa Human Subjects Research Protection Program is pleased to announce that staff from Western IRB (WIRB) will be conducting an on-site training with a question/answer period on Monday, April 25th, 11 a.m. - noon in the H.P. Smith Conference Room (W256 GH).
The International Committee of Medical Journal Editors (ICMJE) is currently accepting comments on their proposal for “Sharing Clinical Trial Data.”  Comments can be submitted directly to ICMJE here until 4/18/16.
Attention IRB-03 researchers:  As of February 15th 2016, the IRB 03 board will begin transitioning away from the review of research activity conducted at the University of Iowa.  This means research studies involving both the Iowa City VAHCS and the University of Iowa will have to submit two separate IRB applications, in order for the correct IRB to review the
The Food and Drug Administration (FDA) conducts site inspections of clinical investigators involved in FDA-regulated clinical trials to determine compliance with applicable regulations.  The Human Subjects Office (HSO) Compliance Staff has released the newly created FDA Site Ins
Beginning today (1/15/16) the restriction to retain all industry sponsored trials with an investigational device exemption (IDE) under IRB-01 review has been lifted.  Researchers can submit industry sponsored, industry initiated trials to WIRB.
The latest issue of the IRB Connection Newsletter is now available!  See the December edition here. 
The Human Subjects Office has published a memo related the use of gadolinium based contrast agents in MRI imaging done for research purposes.
The Department of Health and Human Services and fifteen other Federal Departments and Agencies are extending by 30 days the comment period on the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking (NPRM).  The Notice announcing that extension is available for public inspection on the Office of the Federal Register’s website today, November 24, and can be accessed
The Human Subjects Office will be closed during the morning of Friday, November 13th so staff can attend an continuing education session. Staff will be available to answer phones at 12:30 p.m.
The 2017 edition of the International Compilation of Human Research Standards has now been released and is available on-line: http://www.hhs.gov/ohrp/international/index.html.  The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 120 countries, as well as standards issued
The launch of the external & central IRB modules has occurred overnight 10/22/15.  Please review the below memo and the HSO website under Central and External IRBs for additional details. 
Please note - Changes for IRB-03 studies:  The Veterans Health Administration (VHA) has revised the following forms: VA Form 10-0493, Authorization for Use and Release of Individually Identifiable Health Information Collected for VHA Research, dated Sept 2015 and VA Form 10-10116, Revocation of Authorization for Use & Release of Individually Identifiable Health Information for Veter
HawkIRB will be undergoing maintenance on Sunday, October 18 beginning at 8:30 a.m. for approximately one hour. HawkIRB will not be available during this time. We apologize for any inconvenience this may cause.
NEW! OHRP Webinar Series on the Common Rule Notice of Proposed Rulemaking (NPRM) Looking for a summary of the long and complex NPRM? Here’s an opportunity to get a comprehensive synopsis from OHRP!
The WIRB webpage on the HSO website is down for updates. It should be back up shortly. We apologize for any inconvenience. If you have any questions about WIRB or a WIRB application, please contact the WIRB Coordinator, Kathy Beck, at 335-7297.
The Human Subjects Office has two openings for interested job seekers. The first position is for an Application Analyst. If you are interested in applying, please see Requisition # 66867 on the University of Iowa Jobs@Iowa site.
There has been a wording change to VI.13.  The question has added a new bullet to address the enrollment of non veterans under IRB-03 studies.  However, all IRB (01,02,03) applications will see this update even though they may not indicate IRB-03 in I.1.  The question reads the following:  VI.13 Describe EACH of your subject populations
On Monday, April 20, 2015, from 1:00 p.m. – 2:00 p.m. EDT, the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers.
The Office for Human Research Protections (OHRP) Research Co-hosted with Governors State University, Illinois
We are delighted to announce a one-day workshop on human research protections jointly organized by the HHS Office for Human Research Protections (OHRP) and the Office of Extramural Research (OER) of the National Institutes of Health (NIH) entitled
Follow the link found here and click on the category title for a list of  frequently asked questions pertaining to that topic.  
The "Help" information icon is available--get more detailed information on a question specific basis, definitions, and/or explanations for regulatory or institutional requirements behind the question.
The HSO has an opening for a Compliance & Education Manager (Requisition # 65900). You can learn more about this opportunity and apply here.
Updates have been made to Section VII.A in the HawkIRB application.  These changes were made to address guidance for the research community when the University of Iowa Principal Investigator is the lead PI for a multi site study.  In situations when the UI is the lead coordinating center, additional information is required to reflect evidence of a plan to ensure appropriate oversight responsibi
Requisition # 65900: Compliance and Education Manager, Human Subjects Office
The University of Iowa Office of the Vice President for Research and Economic Development seeks a self-motivated professional to serve as IRB Application Assistant in the Human Subjects Office.
Please consider this NINDS-sponsored neuroscience clinical trials methodology course with 2 tracks – a foundations course and an adaptive trials course. The PIs for the course include Chris Coffey and Laurie Gutmann from the University of Iowa, Will Meurer from University of Michigan, and Roger Lewis from UCLA/Harbor. 
The Human Subjects Office will only be open from 12:00-3:00 pm Friday November 5th due to a continuing education opportunity for all staff.  For events requiring an urgent response, please review the contact us page and page an IRB Chair otherwise calls will be returned during the hours of operation on Friday.  Thank you.
Effective January 1, 2015 Western IRB's new fee schedule will be in effect.  You can find the updated fee schedule letter here and the new fee schedule here.
Effective October 27th, all external IRB applications will be submitted through a new feature recently developed in the HawkIRB application system. Several training sessions are taking place in Hardin Library's Commons West on October 30th, November 3rd, and November 4th.  Please select the link below to register for a session.  All are encouraged to participate!  
It usually takes weeks to months after starting an antidepressant for people with depression to feel substantially better. Researchers at the National Institute of Mental Health (NIMH) have been experimenting with new medications that rapidly decrease symptoms of depression within just a few hours.
NPR is featuring a series of stories this week about how the NIH funds scientists. One post features a tool that allows the user to search NIH grant data by institution. Another story profiles scientists who simply give up on their research careers because they can't find money to advance their work.
Changes to the Pharmacy & Therapeutics (P&T) Review and Approval of Human Subjects ResearchEffective immediately, any IRB-01 or IRB-03 researchers conducting human subjects research requiring P&T approval needs to be aware that the Pharmacy & Therapeutics Committee and the Pharmacy & Therapeutics Investigational Drug Service (IDS) reviews have now been split.
The July 21-22 2014 meeting of the Secretary’s Advisory Committee for Human Research Protections (SACHRP) will be webcast live at http://videocast.nih.gov.
 6/3/14 ALL ICON courses related to Human Subjects Research for UI/VA Researchers & non-UI Research Partners maintained by the Human Subjects Office are temporarily unavailable while we evaluate and update the course content after the recent ICON upgrade.  We will notify you when the courses are available again.  We apologize for any problems you are encountering.  Thank yo
OHRP has released the recording of the recent video cast on Conducting Internet Research: Challenges and Strategies for IRBs.  Here is the link to watch the videocast. Other archived videos are also available. 
Office hours will be in N153 Lindquist Center on Monday, April 28th. Come talk with our staff and get answers to your questions!
The presentation will be held in Braley Auditorium, due to a departmental scheduling conflict, instead of the HP Smith conference room.  
The Research Clinic, a Web-based interactive training video aimed at teaching clinical and social researchers how to better protect research subjects and avoid research misconduct, was released today by the U.S.
The IRB is no longer requiring the overall CTSA grant be referenced in the funding source section (Question III.1) of the HawkIRB application or the informed consent document if you are using the Institute for Clinical and Translational Science (ICTS) Clinical Research Coordination Core services, REDCAP, or the Clinical Research Unit (CRU).  As a reminder however, by requesting and using ICTS s
Recently, the Food and Drug Administration (FDA) issued a final guidance document, Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (
Please note!  As of January 21, 2014, there will be changes to the Research Subject Compensation requirements.  The University of Iowa HSO\IRB has been working with University of Iowa Accounting leadership to streamline the research subject compensation process.  Previously, the collection of Social Security Number(s) (SSN) has been required for any form of monetary compensatio
The HSO has an opening for an Application Analyst. See the full job listing on Jobs@UIOWA. 
The newest IRB Connection Newsletter is out!  IRBNEWS (IRB listserv) sends out the monthly IRB Connection newsletter and periodically sends out announcements and updates regarding human subjects research at the University of Iowa.
Follow the link to view the new edition: http://www.hhs.gov/ohrp/international/index.htmlThe Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 107 countries, as we
November IRB Connection
The UI Investigator's Guide has been updated, and new translations are available.  Check out our list of availabl
On Thursday 11/7, the HSO business office will be open from 9 am - 1 pm only; we WILL be having open Office Hours as usual in Hardin Library. Friday 11/8, the HSO business office will be open from 10 am - 1 pm, and from 2:30 pm - 4:00 pm. Eastside Office Hours WILL still be held, with a minor time adjustment.
Please see our CITI page for instructions on creating a profile and completing required IRB modules. 
The newest IRB Connection Newsletter is out!  IRBNEWS (IRB listserv) sends out the monthly IRB Connection newsletter and periodically sends out announcements and updates regarding human subjects research at the University of Iowa.
OHRP has revised its response to the Frequently Asked Question (FAQ) “When does compensating subjects undermine informed consent or parental permission?” (http://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).
On August 27, 2013, FDA issued final guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed." All of the parties who conduct or have oversight responsibilities for biomedical research—sponsors, clinical investigators, and institutional review boards (IRBs)—have responsibility for ensuri
Open the newsletter to read August’s topics.
Requisition # 63050: Education & Compliance Specialist, Human Subjects Office
HSO\IRB NOTICE! The Human Subjects Office will be closed on Friday, August 2, 2013 for staff continuing education. We will resume normal business hours on Monday, August 5, 2013 8:00am. We apologize for any inconvenience this may cause.
CITI Program Website Downtime for Software Upgrade Starting Monday, July 29th at 11 a.m. EDT, the CITI Program website will be unavailable for approximately two to three days to complete a major software upgrade. For more information see : https://www.citiprogram.org/Default.asp?. 
Open the newsletter to read January’s topics:
SATURDAY, June 8, 2012 4:00am-8:00am HawkIRB will not be available for use due to a University of Iowa Information Technology (ITF) datacenter infrastructure updates. For additional information on the updates please go to the ITS Data Maintenance page.
As of 16:38 pm, this issue has been resolved.  Networking issues are causing a problem with HawkIRB access; network adaptor connection restoration is underway.  Login issues will continue for approximately 30 minutes.   We apologize for the inconvenience.  If you have questions or comments, please call the HSO mainline at 335-6564.
The Human Subjects Office is excited to announce the first edition of IRB Connection. This monthly newsletter will be shared with the University of Iowa research community.
The annual financial interest disclosure period is now open. Individuals named as "key personnel" on UI routing forms or human subjects applications (HawkIRB or WIRB) must complete an annual online disclosure form prior to April 30, 2013. A disclosure form must be completed even if there is nothing to disclose.
Additional consideration is necessary for enrollment of subjects who cannot consent for themselves; minors and cognitively impaired adults.  This session will cover the requirements for obtaining informed consent from a Parent/Guardian or Legally Authorized Representative (LAR) as well as best practices for obtaining and documenting assent from subjects.
The presentation for Thursday, March 28th, Session 3 – Consent/Assent for Minor Subjects and Cognitively Impaired Adult Subjects has been postponed. The presentation will be rescheduled, and posted on the HSO calendar. We apologize for any inconvenience.
The VA has released new guidance related to: Conflict of Interest Emails to Subjects
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices.
Two new guidance documents have been posted to the FDA Clinical Trials Guidance Documents.
The Protections of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form (Form 310)  will be updated in the HawkIRB system during the month of January to adhere to the new format released by the Office of Human Research Protection (OHRP).  A copy of this form can be found
Office Hours have ceased for the winter break, and will resume on January 23rd.
Here is a great little "lay language" video explaining science.  It was targeted to hard Science and Engineers but can definitely be related to Biomedical research.  Enjoy. http://www.ted.com/talks/melissa_marshall_talk_nerdy_to_me.html
SATURDAY, DECEMBER 1, 2012 3:00pm-5:00pm HawkIRB will not be available for use due to a University of Iowa Information Technology (ITF) system server update. We apologize for any inconvenience this may cause.
FDA has issued the draft guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed."  The document is available on FDA's website: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM328855.pdf
Office Hours will be canceled for the week of 11/19/12-11/23/12 because of the University holiday. Happy Thanksgiving!
SUNDAY, OCTOBER 21, 2012 4:00am-10:00am  HawkIRB will not be available for use due to a University of Iowa Information Technology (ITF) system refresh. We apologize for any inconvenience this may cause.
The Human Subjects Office would like to inform the research community of a webinar opportunity offered by the Office for Human Research Protections (OHRP).  
Welcome to our newly redesigned website!  Knowing that you depend on our resources, we've rebuilt our site to make it easier to find and share information. Help us create a better website by providing your feedback.  If you encounter problems, have questions, or would like to provide suggestions/feedback, please send an email to:
The University of Iowa has revised its Conflict of Interest in Research policy in order to be in compliance with the federal regulation. These changes went into effect on August 24, 2012.  You can view the revised policy here.
IRB Educational Sessions, Presentations, and Office Hours has been updated for the Fall 2012 semester. Please review the Educational Resources page for details.  
Several important changes directly affecting the IRB application process are occurring in July 2012.  The Nursing Research Committee and Research Billing under the Joint Office for Compliance now require documentation of their respective review and approval as part of the review of Human Subjects Research projects.