Delegates in HawkIRB: What you should know
Herky Hints for HawkIRB: Delegate Permissions
Upgrades To Research Recruitment Emails in 2025
Best Practices for Reporting Outcome Measures on ClinicalTrials.gov
The HawkIRB system allows principal investigators (PIs) to designate a delegate (or delegates) to act on their behalf. Unless the PI selects the option for “view only” when assigning permissions, delegates can serve as a proxy for the PI and will be able to
1) create and submit all HawkIRB forms,
2) modify existing forms,
3) access draft forms in the PIs inbox, and
4) respond to workflow during the IRB review process on behalf of the PI.
(Note: PIs, delegates, and contact persons will receive notifications about forms and projects from the HawkIRB system, but only the PI or delegate can respond to items in Workflow. For more information about research team roles, see the December 2024 newsletter article.)
What you should know about the delegate permissions in HawkIRB:
The PI is responsible for all content submitted to the IRB for approval, whether they or their delegate has submitted the content.
A delegate is required to attest that the PI is aware of any submission(s) made to the IRB.
If you are a delegate, you will have permission to log into a project in HawkIRB as the PI using your own HawkID credentials.
The PI must add delegates as research team members in section II.2 of the HawkIRB application if they will have access to identifiable participant data or will be interacting with study participants.
Once a PI has added a delegate, the delegate will be automatically assigned to every New Project form the PI creates. The delegate will have access to and will receive automated messages from the HawkIRB system regarding all of the PI’s studies, unless the PI uses the “Delegate Permission System” to identify delegates with specific studies.
The HawkIRB delegates permission system lets the PI specify which projects a delegate can access. This is useful when a PI has multiple projects and works with different delegates who are not involved with all of them.
We recommend that PIs use the delegate permissions so that delegates only receive notifications about projects in which they are directly involved.
When the delegate permissions are turned on, the PI can specify whether delegates see all projects or only the projects the delegate is assigned to access. The latter is the default.
A delegate cannot add or remove other delegates. However, a delegate may revoke their own position as a delegate.
This function is helpful for delegates who are no longer working on a project or have taken a new position and want to stop receiving automated notices from the HawkIRB system for the PI’s projects.
When the delegate elects to revoke their own permissions, HawkIRB sends an email with a button for the PI to approve revoking permission for each project.
Please Note: revoking delegate permissions is project-specific. If a delegate is no longer serving in that capacity, the PI should remove them as a delegate instead of revoking permissions for specific projects.
All student, resident, and postdoctoral fellow or research scientist PIs must name their faculty advisor as a delegate so the advisor can access and review draft forms prior to submission and assist with responding to Workflow questions.
Before a PI leaves the UI, they or a delegate should close projects or submit a modification form to change the PI. Naming a delegate is very helpful in case any actions need to be completed in the HawkIRB system after the PI’s departure. The delegate can prepare a modification form to change the PI, respond to workflow for pending forms, and submit project close forms.
For more information about adding delegates and changing delegate permissions, see (link to HH).
Questions about this topic? You can email the HSO Education and Outreach team or come to Office Hours to speak directly to a member of the HSO team.
Have an idea for an IRB Connection newsletter article? Let us know!
By Rachel Kinker, MPA
The HawkIRB Delegate Permission System allows a principal investigator (PI) to assign delegates to projects. There are various types of access and permissions for delegates, depending on how they are assigned.
Please note: all instructions provided below begin after the user has logged in to HawkIRB and selected “Personalize” in the toolbar at the top of the screen.
Activate the HawkIRB Delegate Permission System
From the “Personalize” page, click on “Update my profile”.
At the bottom of the page, select “Yes” under “Turn on the delegate permission system (allows you as a PI to assign permissions to projects for your delegates)”.
Click the “Update Fields” button to save the changes.
Note: When the PI creates a new project, all existing delegates are automatically granted access to the form. If the PI wants to specify certain delegates for certain projects, they must deselect specific projects for delegates who will not be involved in that project. They may also select the ‘Check/Uncheck all permissions for all delegates’ option on the User Delegates page.
Add a HawkIRB Delegate
1. From the “Personalize” page, click on “Update my delegates”.
2. Enter the HawkID, and click “Add Delegate.” (To find the HawkID, click “Campus Directory” to look it up.)
3. If the HawkIRB Delegate Permission System is turned on (see above), select which projects the delegate can access.
Designating Permissions for a Delegate
Once the PI has activated the delegate permission system, they can designate permissions for each project by checking or unchecking the boxes under each delegate’s name.
1 From the “Personalize” page, click “Update my delegates”.
2. To add a new delegate, enter the HawkID, and click “Add Delegate.” If you do not know the HawkID, click “Campus Directory” to look it up.
3. Under each delegate’s name, check or uncheck the boxes to grant or remove access to projects.
4. Select “Save Permission Information.”
The PI can specify how delegates view their inbox. Below the field to add a delegate, select whether to show all projects (even those the delegate cannot access) or hide projects the delegate cannot access.
Remove a HawkIRB Delegate
1. From the “Personalize” page, click on “Update my delegates”.
2. Click the “remove” link on the right side of the screen.
If you select the ’View Only’ box, the delegate will not be able to make any edits or changes to any projects.
Revoke Your Own Access as a Delegate
This functionality is helpful for delegates who are no longer working on a project or have taken a new position and want to stop receiving automated notices from the HawkIRB system for the PI’s projects.
1. From the “Personalize” page, click “Revoke My Delegate Access”
2. You will see a list of all PIs who have named you as a delegate and all the projects you can access. Check the boxes next to the projects to revoke your delegate permissions.
3. Click “Submit”
4. The HawkIRB system will send an email to the PI with an option to accept your request to remove your delegate permissions for the projects selected. You are cc’d on this email. After they approve your request, you will receive another email stating that the request was approved.
Other Delegate Information
Login
The delegate logs in to the HawkIRB system with their own HawkID and password. Then they click “Delegate Login” in the upper right corner. They do not need the PI’s HawkID and password to access the system on their behalf.
When logged in as a delegate, it will be indicated in the “logged in as” drop down menu bar along the top of the page.
Change the PI for a Draft Form
The PI is automatically assigned when a new project form is created. Before beginning a new project form, double-check that you are logged in as a delegate for the PI. If a delegate generates the new project form in their own inbox before they log in as a delegate for a PI, then the delegate will be listed as the PI of the project.
If a delegate has accidentally started a form under their own HawkIRB account, they cannot change the PI of a draft form.
To transfer the information in the form under the delegate account to the correct PI account,
Open the form created under the delegate account and go to the form review tab. Click the link on the right, just below the tab header bar, to create a ‘printer-friendly version of this form. This will open in a new browser tab, where it can be printed or saved as an html file).
Go back to the main HawkIRB tab, and login as a delegate for the PI.
Copy and paste the answers into the correct form.
Delegate Attestation: PI Review of Forms Prior to Submission
Make sure the PI reviews the form prior to submission. The PI should also review responses to workflow and the preparation of any Reportable Event Forms (REFs). The delegate can generate a printer-friendly version of the form to share with the PI, or the PI can log in to the HawkIRB system and review the form. The delegate will be required to attest that the PI has reviewed the submission and is in agreement with the content.
PI leaving the UI (Deactivated PI)
When the PI leaves the UI and they no longer have an active HawkID, the delegate can perform limited actions in HawkIRB on behalf of a deactivated PI. The delegate can respond to workflow of pending forms and submit Project Close forms. If the PI leaves the UI and has not named a delegate, contact the IRB (at irb@uiowa.edu) to request temporary access to the HawkIRB system.
Before a PI leaves the UI, the IRB expects either a “Project Close” form or a “Modification” form to change the PI. The PI should also name a delegate in case any actions need to be completed in the HawkIRB system after their departure.
Upgrades To Research Recruitment Emails in 2025
The Office of the Vice President for Research (OVPR), working with Information Technology Services, the Human Subjects Office (HSO) and the Office of Strategic Communication, has implemented upgrades to research recruitment messages for the new calendar year.
These upgrades include a new look and feel for email messages, improved functionality for the audience, and best practices for researchers who are recruiting subjects via email.
The changes align with the new University of Iowa mass email policy, which took effect January 13. The new policy preserves emails as an important tool for recruiting potential research subjects and ensures that the messages are accessible, concise, consistent, and coordinated.
Research mass emails now appear in a standardized black-and-gold IOWA email template, aligning the look and feel with other internal messages. Clear links to unsubscribe from future research emails will be also embedded in each message. This change is in response to feedback provided via a 2023 communications preferences survey to faculty, staff, and students.
Moreover, beginning in February, the research emails will also include a consistent tool for potential subjects to reach out to the study team. A button labeled “I’m interested in participating,” will redirect the reader to an email address, survey link, or other URL provided by the research team.
In addition, the HSO and OVPR have also released new guidance or best practices for crafting a compelling research recruitment message. Tips include how to submit a mass mail request, craft a clear and concise subject line, and categorize information consistently across messages. The resources are available on the HSO website.
Finally, the Office of the Vice President for Research urges researchers to use mass email judiciously so as not to overburden our campus audiences, particularly students, with a high volume of email. OVPR will continue to review requests in workflow to ensure that they are directed to the most relevant university classifications (e.g. faculty, staff, students, or retirees) based on eligibility criteria.
Please reach out to irb@uiowa.edu with questions.
Best Practices for Reporting Outcome Measures on ClinicalTrials.gov
By Fozia Ghafoor, MBBS, MS
ClinicalTrials.gov plays a central role in fostering transparency and accountability in clinical research. Designed as a public-facing platform, the website and online database requires researchers to provide detailed information about their studies, including research objectives, trial design, and results reporting. The information is intended to inform the public, researchers, and health care professionals, and it also meets the regulatory requirement under Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). Compliance with FDAAA 801 mandates timely and accurate reporting on ClinicalTrials.gov, emphasizing the importance of maintaining rigorous data integrity. By adhering to these requirements, researchers contribute to a system that promotes trust, ensures accountability, and supports the advancement of medical science.
November Presentation Overview
In November, the ClinicalTrials.gov Compliance & Education Manager presented best practices for reporting outcome measures of a research study at the time of record registration and results reporting. The presentation summarized the following key points, focusing on compliance and accuracy:
How to define a research study’s outcome measure
While defining the research study outcome measure, researchers address two main questions:
What is the primary goal/main objective of the study?
What are the potential effects or benefits of the intervention?
Well-defined outcome measures are crucial for determining the effect of the experimental variable or intervention on participants. Researchers should clearly and accurately describe what will be measured and reported, ensuring that the results are intervention-specific. When outcome measures are well-defined, they lead to clear, interpretable, and credible results, enhancing the reliability and validity of the study's findings.
Types of Outcome Measures
Primary Outcome Measures are used to describe patterns of diseases/traits/associations with exposures/risk factors and treatment. Primary outcome measure means the outcome measure(s) of greatest importance specified in the study protocol, usually one(s) used in the power calculation. These are the most critical metrics outlined in the study protocol, addressing the main question the trial seeks to answer. Most clinical studies have one primary outcome measure, but a study can have more than one primary outcome measure.
Secondary Outcome Measures are of lesser importance than a primary outcome measure but are still part of a pre-specified analysis plan for evaluating the effects of an intervention and are not specified as an exploratory or other measure.
Other Pre-specified Outcome Measures: Any other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
Key Considerations for Selecting Outcome Measures
Relevance: Ensure alignment with study objectives and clinical significance.
Validity and Reliability: Confirm that the measure accurately reflects the intervention’s impact.
Sensitivity to Change: Assess the measure’s ability to detect meaningful changes.
Feasibility: Consider the practicality of collecting the data.
Regulatory Requirements: Adhere to guidelines from regulatory bodies.
The Primary Completion Date (PCD) represents the final data collection point for primary outcomes. Researchers must submit results within one year of the PCD.
Reporting Requirements for Outcome Measures: Registration requires concise titles of outcome measures, clear metric descriptions, and specific time frames. For results reporting, aims and interventions, analysis populations description, and units of measure, type of measure, and statistical analysis (if required) must be included.
Common Reporting Errors for Outcome Measures:
Ambiguous title and descriptions of outcome measure.
Lack of clinical relevance in reported measures.
Inconsistent or invalid units of measure.
Reporting multiple outcome measures within a single section.
Entering results data for outcome measure in free-text field.
Number of participants analyzed in outcome measure section appears inconsistent with other parts of the study record.
Time Frame is not outcome-specific, or inconsistent.
Best Practices
Update protocol section before creating results section.
Ensure clarity and specificity in all entries.
Use concise, descriptive titles.
Specify each outcome separately. Assessments with different units of measure must be presented in separate outcome measures, if researchers are combining results, then they need to add reason for that.
Provide clear description for outcome measure. Add information on how measure will be taken, and any methods of assessment e.g., reporting score on scale, unabbreviated scale title, min./ max values, and what higher scores/ low scores means i.e., better or worse outcome.
Timeframe should be specific for the outcome measure.
Always review the Protocol Registration and Results System (PRS) comments before addressing the errors.
Navigating the PRS support system and help content for guidance
PRS Support System: Provides section-specific assistance and definitions. For more in-depth guidance, investigators can access the PRS User’s Guide, PRS tutorials, and examples for results data entry under the “Help” tab on the ClinicalTrials.gov homepage.
Institutional Guidelines: Resources such as the ClinicalTrials.gov Investigator’s Guide and the HawkACT checklist on HSO website offer detailed compliance guidance, specifically designed to address issues related to record registration and results reporting.
To access a recording of this presentation, follow this link. For detailed federal and institutional guidelines regarding ClinicalTrials.gov PRS, please visit the ClinicalTrials.gov resources section under ClinicalTrials.gov page on the Human Subjects Office website or reach out to the PRS administrator at ct-gov@uiowa.edu.