March 2022 Announcements

Index

University of Iowa Purchases System to Facilitate Clinical Trials Management

NIH FORMS-G Changes to be Reflected on Human Subjects Clinical Trials Form

Medical Ethics Advisor Newsletter, January 2022

In the News

University of Iowa purchases system to facilitate clinical trials management

Starting in January 2020, a team was formed to evaluate the need for a Clinical Trials Management System (CTMS) for the University of Iowa research community. After gathering input from various research groups and stakeholders, it was determined that there was a need for a CTMS and working with purchasing, a request for proposals was initiated.

Six vendors were reviewed, interviewed and evaluated. Of those six, the three that had the most comprehensive systems were chosen to present to the research community. The research community provided feedback and Advarra OnCore was selected. We are pleased to announce that the University of Iowa has finalized a contract with Advarra OnCore.

We are in the beginning stages of implementing this enterprise CTMS that will help establish standard processes available to all clinical studies across the University of Iowa Healthcare. Processes supported by this CTMS include study planning (with budgets), financial tracking and management, study calendars, regulatory management, and data capture all in an environment that is 21 CFR Part 11 compliant.

A 9-month implementation process for this system will start in March 2022. If you would like to learn more about this new resource please contact Kristy Mahan, kristy-mahan@uiowa.edu .

NIH FORMS-G Changes to be Reflected on Human Subjects Clinical Trials Form (as of Feb 10)

This message is rebroadcast from an earlier February notification from the Research Administration Dispatch (RAD) from the Division of Sponsored Programs (DSP).

The Human Subjects Office is rebroadcasting a message from the DSP newsletter (RAD) as it contains important information regarding the grant submission process for human subject clinical trials. The message in its entirety is available.

This RAD article is located here

The RAD archive is located here

One of the updates will have implications for those researchers who are utilizing a single IRB (sIRB) plan. If a grant is proposing to have the University of Iowa IRB serve as the sIRB, please notify the Human Subjects Office when preparing to submit the grant application to discuss this arrangement by completing a sIRB PreGrant Survey. A member of our external IRB review team will follow up with the PI/contact for all submitted survey. Please be sure to submit the survey in advance to allow for sufficient time to evaluate the request. IRB fees will apply for this service and will be discussed as part of the pre grant survey review.

Medical Ethics Advisor Newsletter, January 2022

Rachel Kinker, MPA

Medical Ethics Advisor (a publication of Relias, LLC) is a monthly newsletter with articles about human subjects research and medical ethics. Current and past issues of Medical Ethics Advisor and IRB Advisor are posted in the “IRB ICON Course for Researchers.” The portal to this ICON Course is on the Education and Training page of the Human Subjects Office website. This month we are spotlighting some articles about human subjects research from the January 2022 Medical Ethics Advisor Newsletter.

New Data on IRB Members’ Perceptions of Violations

The two most common violations that researchers make are data storage and recordkeeping. Recommendations to prevent violations:

Providing researchers with data archiving services
Ethics and protection of human subjects training to researchers at all career stages
Education regarding the consequences of violating protections
Updating researchers on new policies and regulations
When deviations occur, IRBs should submit reports outlining corrective and preventative actions (CAPA) to take place to prevent the deviations from reoccurring

Screening Tests to Determine Study Eligibility Are Not Foolproof

Screening tests to determine which participants to include and exclude are not foolproof. Many produce false-positives and false-negatives and can exclude participants or create bias. Researchers can improve screening and recruitment by eliminating unnecessary screening tests (particularly tests that produce false-positive or false-negative results), exploring potential alternative screening tests, expanding eligibility criteria to diversify representation and remove extraneous inclusion/exclusion criteria and, in some instances, not sharing the eligibility criteria in advance. Additionally, working with statisticians to determine the percentage of participants in a trial that were not actually eligible may be useful as well.

Single IRB Concerns Include IT Limitations, Process Variations

Single IRB review is required under Common Rule Guidelines and NIH policy.

Benefits: consistency, standardization, speed, efficiency and simplification
Challenges: Timeliness, insufficient communication and uncertainty at local institutions
Issues when serving as a single IRB: IT issues; outside investigators gaining access, lack of interoperability across systems, legacy systems not designed with single IRBs in mind
Tips for IRBs: IRBs that will serve as the single IRB for multisite studies should determine if their IT system is prepared for this role, is new/additional software needed, are there time and resources to train staff on the new system