October 2023 IRB Connection Newsletter

Index

 

Herky Hint: HawkIRB Automatically Assigns Delegates to all New Projects

Presentation Recap: Unlocking the Mystery of IRB Compliance Monitoring

Recent Presentation Recordings

Medical Ethics Advisor Newsletter, September 2023

In the News

 

 

Herky Hint: HawkIRB Automatically Assigns Delegates to all New Projects

By Rachel Kinker, MPA


A Principal Investigator (PI) may name a HawkIRB Delegate who may create, edit, and submit forms on their behalf. The HawkIRB Delegate Permission System goes a step further and allows PIs to grant and restrict access to delegates on a project-by-project basis. It is important for the UI research community to know that when this functionality is turned on, HawkIRB Delegates are automatically assigned access to all New Project forms. The PI would need to manually restrict access for any Delegates not involved in the new project.

About the Delegate Permission System

The UI research community specifically requested the Delegate Permission System feature. When this system is not turned on, HawkIRB sends automated notices to all Delegates for all the PI’s projects. If the PI has Delegates who are not involved in all projects, the Delegate Permission System allows the PI to specify which delegates have access to, and receive notices for, each of their projects. This ensures that the HawkIRB system only sends automated notices for projects that the HawkIRB Delegate can access.

The PI adds HawkIRB Delegates under the “Personalize” tab and “Update my Delegates.” See below for how to activate the Delegate Permission System, assign/restrict Delegate access and log in as a Delegate.

To turn on the Delegate Permission system:

  1. Select ‘Personalize’ in the black toolbar at the top of the screen in HawkIRB.
  2. Click on ‘Update My Profile.’
  3. Select ‘Yes’ under ‘Turn on the Delegate Permission System (allows you as a PI to assign permissions to projects for your delegates).’
  4. Select ‘Update Fields.’

Once this function has been enabled, the PI can designate permission for delegates on a project-by -project basis under the “Personalize” tab and “Update my Delegates.”

Note: All New Project forms will automatically be viewable to all HawkIRB Delegates as soon as there is a response to Section I.1 (selecting the IRB).

 

To Assign or Restrict HawkIRB Delegate Permissions:

After a draft New Project form is started, the PI may select which delegates will have access to that project. For HawkIRB Delegates who are not involved with that project, the PI should uncheck the box by that form under the name of those Delegates.

  1. Login to HawkIRB.
  2. Select ‘Personalize’ from the black toolbar at the top of the screen.
  3. Select ‘Update My Delegates.’
  4. To add a delegate, enter the HawkID of the delegate you would like to add and select ‘Add Delegate’. If you do not know the HawkID, you may utilize the campus directory link next to the ‘Add Delegate’ button to look it up.
  5. Under each delegate’s name, select the checkbox for the project to which you would like to grant them access.
  6. Select ‘Save Permission Information.’
  7. The delegate will now be listed in the box titled ‘User Delegates.’

Because HawkIRB automatically assigns delegate permissions for a New Project form to all delegates, the PI must uncheck the box next to a project if the delegate will not be a delegate for that project. In the example below the first two projects were de-selected.

 

HawkIRB Delegate Role

HawkIRB Delegates can help the PI maintain an accurate assignment of delegates to each project by reminding them to log in to HawkIRB and update their Delegates, as necessary after a New Project form is started.

Principal Investigator Responsibilities:

The Principal Investigator is ultimately responsible for HawkIRB forms prepared by a HawkIRB Delegate. The PI should also maintain and update their delegates as they initiate new projects. It is the PI’s responsibility to remove Delegates who are no longer serving in that capacity, either due to a change in position/role or if they are no longer employed at the University of Iowa.

If your PIs or Delegates have any questions regarding this process, please contact us at irb@uiowa.edu.

 

Presentation Recap: Unlocking the Mystery of IRB Compliance Monitoring

By Catherine Fruehling, MBA


The UI IRB Compliance Monitoring program conducts a variety of types of visits. Compliance Monitoring is important to ensure protection of human research subjects, adherence to federal regulations and institutional policies, and consistency between IRB applications and study procedures. Any open project could be selected for monitoring. This article provides an overview of a September 2023 presentation about The Human Subjects Office’s Compliance Monitoring program and how to best prepare for monitoring visits. A recording of this presentation is available in the Additional Topics section of the IRB ICON Course for Researchers.

Main Goals of IRB Compliance Monitoring

  • Make sure research is being conducted in accordance with federal regulations and University of Iowa Standard Operating Procedures.
  • Provide researchers an independent review of their research procedures, determining from a source other than the investigator’s continuing review that no material changes have occurred in the project since the previous IRB review.
  • Provide researchers one-on-one and group educational opportunities regarding human subjects research.
  • Facilitate communication between the IRB/Human Subjects Office and researchers at the University of Iowa.

More information about the Compliance Monitoring program can be found in the UI IRB Standard Operating Procedures and Researcher Guide (section I, part 11.E).

Key Takeaways

The presentation covered several topics related to compliance monitoring, including the types of visits we conduct, how and why studies are selected for monitoring, what happens during the visit, and common compliance findings and how to avoid them.

Please view the recording of this presentation in the Additional Topics section of the IRB ICON Course for Researchers for more information on these topics.

Summary

We want you to feel prepared and confident when you receive notification that your study was selected for IRB compliance monitoring. Remember to use all available resources on the HSO websites, and work with the IRB Compliance staff to help the monitoring process go smoothly. We are here to help!  Please email irb-monitors@uiowa.edu, or call (319) 335-6564, if you have any questions.

 

Recent Presentation Recordings

By Rachel Kinker, MPA


The following recordings are now available in the Additional Topics section of the IRB ICON Course for Researchers:

Unlocking the Mystery of IRB Compliance Monitoring (9/13/23) - Topics covered include:

  • Types of compliance monitoring visits
  • How and why studies are selected for monitoring visits
  • Common compliance monitoring findings and how to avoid them
     

Expanded Access to Investigational Medical Products (9/20/23) - Topics covered include:

  • Expanded access
  • Emergency use
  • Compassionate use
  • Single Patient IND (Investigational New Drug)
     

Be Resourceful: Use Available UI Research Resources (10/5/23) – Representatives from the Institute for Clinical and Translational Science (ICTS) and the Human Subjects Office (HSO) provided an overview of resources and services available from both of our offices.

  • IRB policies, guides, documents and rosters
  • Project-specific resources
  • Educational Resources
  • ICTS cores and services
  • Iowa Clinical Trial Management System (I-CTMS)
     

Human Subjects Research Hot Topics & Updates-October 2023 (10/9/23) - Topics covered include:

  • HawkIRB updates
  • Electronic (eConsent) Checklist-New!

 

Medical Ethics Advisor Newsletter, September 2023

By 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 September 2023 Medical Ethics Advisor Newsletter.
 

Ethical Approaches to Informed Consent for Genetic Testing

There is minimal guidance on what concepts to include in an informed consent document regarding genetic testing. To develop an ethical framework, a team of researchers identified the most important concepts to address in the informed consent document.

  • Genetic testing must be voluntary
  • The patient must understand why the test is recommended, what the clinicians are testing for, and the point of the research
  • What results will be returned and to whom
  • Whether there are other potential results that may be returned at a later date
  • What will happen to their data and the potential for the data to be used in future research
  • Whether the results will affect prognosis and management
  • How the participants family might be affected
  • Test limitations
  • Potential for genetic discrimination
  • Does the participant want to learn the results? Are they comfortable not learning certain types of information?
  • What resources will be made available for any needed follow-up care

Articles in the September 2023 Issue:

  • High-Intensity End-of-Life Care Remains the Default at Hospitals
  • Highly Publicized Research Fraud Erodes Public Trust
  • Ethicists Often Called to Resolve Conflicts Over Aggressive Care
  • Initiative Raises Organ Referral Rates, Expands Donor List and Transplanted Organ Supply
  • Many Ethical Consideration if Surgeons Record Procedures
  • Ethicists Are Finding Ways to Meet Needs of Rural Clinicians
  • Ethicists Are Addressing Social Determinants of Health
  • Ethics Involvement Is Needed with Medical Artificial Intelligence
  • Pediatric Hematology/Oncology Trainees Want Ethics Expertise

 

In the News, October 2023