IRB Efficiency Initiatives and Results to Date
IRB Efficiency Initiative: Current and Upcoming
Herky Hint: Help Messages
AAHRPP Accreditation: Preparing for Site Visit Interviews
Course-Related Student Projects: Is IRB Approval Required?
Learning Opportunity: IRB Overview lecture in ICON
In the News
Upcoming Educational Events
IRB Efficiency Initiatives and Results to Date
By Kelly O’Berry and Michele Countryman
Beginning in January 2024, the Human Subjects Office (HSO) rolled out six major initiatives to improve Institutional Review Board (IRB) and Human Research Protection Program (HRPP) review processes. This article provides an evaluation of previous programming changes that were presented at the May IRB Efficiency Initiative Information Session.
Here’s a brief overview of the initiatives and results to date:
60-Day Withdrawal Due to PI Inactivity (effective 1/29/24): 1,059 New Project and Modification Forms submitted since implementation. Of these, 106 forms were withdrawn (10%), 17 were recreated, and 9 were resubmitted.
DSP Approval Timing (effective mid-February 2024): The new process for faster signoffs from the Division of Sponsored Programs allowed the release of HRPP approvals an average of 48 days earlier (36 days median).
Required Actions After the IRB Meeting (effective 4/1/24): the average time to provide the PI with required actions from IRB meeting minutes has gone from 9 days to less than 24 hours since April 1.
Assign a Meeting Date Goal (effective 4/1/24): Limited data is available, but 71% of studies met the date goal. More in-depth information will be available after the June rollout that separated IRB review from HRPP Committee Approvals.
60-Day Withdrawal Due to PI Inactivity (effective 1/29/24)
HawkIRB forms are automatically withdrawn if there is no response to workflow in 60 days. This change will allow for more accurate metrics for IRB review time.
In addition to the two-week reminders, a new 55-day HawkIRB email notice states that the form will be withdrawn in five days. The form in the PI’s inbox shows the number of days in Workflow over the total days since submission. At 55 days, the form is highlighted in red in the PIs inbox.
Evaluation data for New Project forms and Modification forms:
Categories | New Project Forms | Modification Forms |
Submissions (Feb 1-mid June) | 594 | 465 |
Forms withdrawn due to PI inactivity | 95 (16%) | 11 (2%) |
Forms recreated | 16 | 1 |
Recreated forms submitted | 8 | 1 |
The 106 withdrawn forms represent a considerable timesaving for HSO staff reviewers. Most withdrawn forms have not been recreated and very few recreated forms have been submitted to the IRB.
NOTE: For a withdrawn form, the PI can only use the “recreate” link once. It is best to hold off on recreating the form until all issues that were holding up the response to the workflow questions in the original form have been resolved.
DSP Approval Timing (effective mid-February 2024)
Division of Sponsored Programs (DSP) approval is required in HawkIRB for industry-initiated, industry-funded clinical trials where a research contract is required to document institution and sponsor expectations. The research application can be approved by the IRB, but not released to the study team until DSP approval is documented. In February, DSP updated their “contract approval” process for these industry-sponsored clinical trials. DSP approval used to be documented when the contract was fully executed; contract negotiations were complete, all signatures in place (institution, PI, and sponsor), and budget approved. Now DSP issues approval in HawkIRB when contract negotiations are complete, even if signatures and/or budget remain pending. This removed a significant delay in the HRPP approval process. Note: The PI must continue to work with the sponsor to obtain signatures and finalize the budget prior to initiating the research.
This change affected 38 studies from mid-February to early June. Faster DSP sign off allowed the release of HRPP approvals 48 days earlier than the previous average. For these studies, the median turnaround for IRB approval was 36 days, which is considerably below the goal of a 45-day median from submission to approval for full board review.
Assign a Meeting Date Goal (effective 4/1/24)
Application Analysts can now set an IRB meeting date goal, and a due date for meeting this goal, at the beginning of the IRB review process.
Category | Totals | Notes |
Met Meeting Date Goal | 10 (71%) | Two of these were assigned to an earlier meeting than the original goal. |
Not assigned | 3 (21%) | This can happen if we do not have the necessary IRB expertise scheduled for meetings around the time of the typical goal date. |
Missed Deadline | 1 (7%) | The form was not returned in time to keep the original meeting date goal. Scheduled to a later meeting. |
Total | 14 |
|
NOTE: There were several limiting factors for evaluation of this change. IRB meeting agendas were full through April 22 when this change took effect on April 1. The first New Project form included in this evaluation was submitted on April 2 and scheduled to a meeting on May 9. This evaluation is based on data from early May through mid-June.
Also, when this change took effect the hold for three Human Research Protection Program (HRPP) committees prevented scheduling forms to an IRB meeting. The IRB Efficiency Initiative rollout on June 14, 2024, lifted this hold by separating the IRB and HRPP Committee approvals. Future data will provide a more in-depth evaluation.
Required Actions After the IRB Meeting (effective 4/1/24)
HSO staff can now provide required actions to the PI shortly after the IRB meeting, which gives the PI/research team a head start to address required actions before receiving the full set of IRB meeting minutes.
Before April 1, 2024, the average time to provide required actions to the PI in the full meeting minutes was 9 days. The goal is to provide required actions within 24 hours and the full set of meeting minutes within four business days.
Of 167 sets of meeting minutes completed between April 1 and mid-June, HSO staff effectively decreased the average time to provide required actions to the PI to less than 24 hours. The research community has provided positive feedback about this change.
Seventeen sets of minutes (10%) did not meet the goal due to the complexity of the issues the board discussed. Approximately half of these minutes were from a monthly IRB-01 Executive Committee meeting. The Executive Committee reviews more complex study design and compliance-related issues.
IRB Efficiency Initiative Announcements and Updates
See IRB Efficiency Initiative Announcements and Updates for information about other initiatives that are in progress or have been implemented since June 2024, including: launching the new HSO website, adding a chair designee to assist with IRB-02 post-approval forms, onboarding a new IRB-02 chair, Primary Reviewer process enhancements and more.
IRB Efficiency Initiative: Current and Upcoming
By Kelly O’Berry and Michele Countryman
The IRB Efficiency Initiative rollout in June 2024 separated IRB review and approval from the other Human Research Protection Program (HRPP) committee approvals. This article provides an overview of that change and a summary of other initiatives in progress, updated documents, policies and procedures and information session/demonstration recordings.
Separate IRB and HRPP Committee Approvals - June 2024 Rollout
HawkIRB programming changes rolled out June 14, 2024, separated IRB review and approval from other HRPP Committee approvals. Prior to this change, the IRB could not begin the convened board review process until the issuance of approval from three committees/entities: Conflict of Interest in Research (CIRC), Protocol Review and Monitoring Committee (PRMC, in Holden Comprehensive Cancer Center), and Research Billing Compliance (RBC). The HSO can now schedule a New Project or Modification form to a convened IRB meeting before the completion of these HRPP committee reviews/approvals.
The second programming change allows the IRB to grant full IRB approval before the issuance of all HRPP approvals. Prior to this efficiency initiative, the IRB would hold approval pending approval from these additional HRPP committees: Pharmacy & Therapeutics (P&T), Medical Radiation and Protection Committee (MRPC), Institutional Biosafety Committee and Nursing Research Committee (NRC). Additionally, the IRB can now grant approval before the Division of Sponsored Programs (DSP) signs off on the grant or contract.
The Principal Investigator (PI) can now submit a Modification form in HawkIRB to address requests from HRPP Committees that complete their review after the IRB approves the New Project form. The New Project form is released when the Modification form is approved and released in HawkIRB.
Several documents, policies and procedures were updated or added in June. See a detailed list at the end of this article.
What’s Next for the IRB Efficiency Initiative?
The following initiatives are in progress or have already been implemented since the June IRB Efficiency Initiative Information Session:
New IRB review and approval structure for IRB-02 (social/behavioral research) – Effective at the start of Fiscal Year 2025, we added an IRB Chair Designee to assist with approval of post approval forms (e.g., Modification, Continuing Review, or Modification/Continuing Review) meeting an expedited or exempt criteria for approval. This enhancement is consistent with a long-standing IRB-01 review structure and is consistent with IRB practices across the nation. The new IRB-02 Chair Designee is an experienced IRB member who is already serving as an IRB-01 Chair Designee.
New IRB-02 Chair – The new IRB-02 Chair, an experienced IRB member, will begin onboarding and training in August as part of succession planning for IRB-02 Chairs.
Primary Reviewer process enhancements for full board review – HawkIRB programming is underway to update the Primary Reviewer Checklist used at convened board meetings and enhance the training process for Primary Reviewers.
HawkIRB Application Redesign – This initiative to streamline the HawkIRB application began with the rollout of Section III updates on January 29, 2024. The goal is to make forms easier for researchers to complete and more efficient for the IRB review. This is a continuation of the 2022-2023 initiative to update the HawkIRB form for projects that qualify for Exempt Status. The next HawkIRB application redesign rollout will focus on updates to the single IRB review process. This is in preparation for the anticipated FDA adoption of the revised Common Rule regulations regarding the use of a single IRB for multi-site projects.
New HSO website – The new HSO website is now live! HSO staff are still making final tweaks and corrections to URLs. It will take time for search engines to only identify pages of the new website. Use the gold buttons on the home page and the menu options to find what you need. We welcome your feedback. For assistance with finding anything on the new website or to provide feedback, please contact us at irb@uiowa.edu.
AAHRPP Accreditation Site Visit – 2024-2025 is our HRPP reaccreditation period and will involve a significant amount of HSO time and resources. There are two steps in the reaccreditation process. The UI is currently at Step I; the initial application was submitted in March, and we are currently responding to AAHRPP review of submission materials. Step II is the site visit which will occur this fall. The site visit includes interviews with select PIs and research staff. See February through July IRB Connection Newsletter articles for additional information about accreditation and preparing for the site visit.
Announcements and Updated Resources
The following documents were updated or added during the June IRB Efficiency Initiative rollout:
New Resources:
Other HRPP Committee Tool – Includes an organizational chart, information about each committee and when their review is required, and regulatory references for these reviews. [Link at end of first paragraph]
HRPP Committee Review Process Flow Chart – Illustrates the timing of steps in the IRB review process and HRPP committee approvals. [Link in first sentence of the second full paragraph]
Updated Policies and Procedures:
Trainings and Demos:
IRB ICON Course for Researchers – Slides, recordings, demo recordings and instruction documents
Herky Hint: Help Messages
By Rachel Kinker, MPA
Are you working on your HawkIRB application and not sure how to answer a particular question? Within the application, there are little blue circles with “i” (for “information”) associated with most of the questions in the HawkIRB application.
For example, the Help Message on the index page provides a lot of information:
Overview of the HawkIRB system
Template Consent Forms and Other Attachments
Resources for assistance with preparing HawkIRB applications
About the Help Messages
Resources on the Human Subjects Office website
Principal Investigator (PI) Responsibilities
HawkIRB Delegates
Guidance for Community-Based Research
Throughout the application, other Help Messages provide guidance for what information to include in response to specific questions in the HawkIRB form. When you click on the Help Message, a new window will appear with additional text describing what to include in the response to each question.
For example, in section VII.E., each Help Message describes what to submit and how to respond to the question.
The Help Messages may also contain links to other departments that you may need to connect with or specific policies you should know. For example, the cash handling policy appears in the Help Message for question VII.E.9
Utilizing the Help Messages throughout the application can answer researcher questions along the way and may expedite the application process by reducing workflow. If you have suggestions for how to improve the existing Help Messages, please contact irb-outreach@uiowa.edu.
AAHRPP Accreditation: Preparing for Site Visit Interviews
By Emily Shultz, CIP
The Human Subjects Office (HSO) is preparing for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) site visit that will take place in late summer/early fall 2024. The University of Iowa Human Research Protection Program (HRPP) has maintained accreditation since 2003. The practice of becoming accredited and maintaining accreditation is one of receiving input on how well the UI is following policies and procedures, and how well these policies and procedures meet the accreditation standards.
About six weeks prior to the site visit, AAHRPP staff will send an email that contains:
the names of the site visit team members,
a draft agenda for the site visit,
a list of personnel who will be interviewed.
During the virtual site visit, the site visitors will meet (via Zoom) with small groups of HSO staff, IRB Chairs, IRB members, UI researchers and UI research team members, as well as members of committees with research oversight responsibilities, such as:
The interviews are typically done with two site visitors and 2 or 3 interviewees. Most interview time is with the IRB chairs, IRB members, and staff.
Utilizing the documents submitted with the application for reaccreditation and the information gathered during the site visit, AAHRPP site visitors will look for evidence that, “the entire HRPP meets accreditation standards—and that protecting research participants is a shared organizational priority.” A month or two after the site visit, the HSO will receive feedback on how well the UI HRPP is meeting the requirements and will receive recommendations on areas where improvements can be made.
Site Visit Interviews
Andy Bertolatus, emeritus associate professor of internal medicine and one of the UI IRB-01 chairs, has been an AAHRPP site visitor for more than 20 years. The following information is based on insights he provided, in addition to information available from AAHRPP.
When site visitors meet with members of the research community, they do not expect anyone to be able to recite federal regulations on the required elements of consent or the criteria for approval. When interviewing researchers, the site visitors will likely ask questions about the researcher’s:
Areas of expertise and type(s) of research conducted
Approach to conducting the consent processes
Feelings about working with the IRB
How they find out about changes in IRB policies/procedures
Where they go for information or whom they contact for questions
Resources Available
For the UI research community, many resources are available online. These include, but are not limited to the following:
This is the final article in the AAHRPP Accreditation series. Previous articles are available on the HSO website IRB Connection page. Information for this article was adapted from the AAHRPP website.
Course-Related Student Projects: Is IRB Approval Required?
By Emily Shultz, CIP
Students may conduct some research projects with human participants as a course assignment without approval from the Institutional Review Board (IRB). According to the UI and IRB policies, all human subjects research conducted by University of Iowa faculty, staff, or students must have approval from the IRB prior to initiation. IRB review is required if the project is intended to “develop or contribute to generalizable knowledge,” including thesis or dissertation projects. However, research methods course projects are generally more limited in scope and are intended to help students learn how to conduct research. These projects satisfy curriculum requirements and are not intended to further scientific knowledge in a particular field or discipline.
IRB Approval Not Required
Course-related research activities would not require IRB approval if:
The purpose of the assignment is to teach research methodology.
The results of the assignment will not “contribute to generalizable knowledge” because they are only used to satisfy a course requirement or because of limits on who will have access to the results of the project.
The procedures will be limited to surveys, questionnaires, interview procedures, observation of public behavior, or standard educational exercises.
The projects will not include people who are incarcerated or minors as participants or utilize data about these two populations.
Data will be recorded without any identifying information (such as code numbers, birth dates, etc.) or identified data are not sensitive in nature (i.e., do not pose a risk of harm to the participants’ reputation, employment, financial standing, or do not put them at risk for criminal or civil liability).
The project is not receiving monetary compensation or direct financial support from an external company, organization, or agency.
The project will not be conducted at the Veteran’s Administration Health Care System (VAHCS) or use any VA resources.
The project is not conducted or supported by a federal department or agency that follows the federal regulations for the protection of human subjects (the ‘Common Rule’).
NOTE: Honors, master’s, and doctoral thesis and dissertation projects always require IRB approval if they involve research with human subjects. If any aspect of the class project is intended to be used for a thesis or dissertation, students must obtain IRB approval prior to any study activities (recruitment, data collection, etc.).
Policy and Checklist
The “Course-Related Student Project” policy specifies the parameters for class projects that can be conducted without IRB approval and contains a link to the Course-Related Student Projects Checklist.
The checklist is a fillable pdf that helps students and instructors determine whether a project qualifies as a course-related student project. If any aspect of the project design indicates that IRB approval might be required, a pop-up message directs the student to submit a Human Subjects Research Determination (HSRD) form in the HawkIRB system to ask if the project needs IRB approval. If that occurs, there will be a red STOP on the completed checklist.
Students should complete the Course-Related Student Project Checklist based on their project design and submit it to the instructor. Based on the completed Checklist, the instructor is authorized to determine that a project complies with the policy and can be conducted without IRB approval. If there is a red STOP in the Checklist, the instructor should advise the student to submit an HSRD form and receive a determination before conducting any research activities.
The policy and the checklist can be found in the UI Standard Operating Procedures and Researcher Guide (Section I, Part 12.D). See also the Course Instructor Responsibilities for using the Course-Related Student Project policy and checklist.
Information for Participants
Even when a course-related student project can be conducted without IRB approval, it is a recommended best-practice that the student share the following information with potential subjects:
Student name and name of the course
Course instructor name and their contact information
Who will have access to individual and summarized results (e.g., instructor, group/team members, the whole class, an outside company/agency/organization)
That participation is voluntary, and they may stop participating at any time.
Resources
For more information, students and instructors may review the Course-Related Student Research Projects web page and the Course-Related Student Research Projects Policy and Procedures educational tool the Human Subjects Office website.
Learning Opportunity: IRB Overview lecture in ICON
By Rachel Kinker, MPA
Do you work with or teach individuals who are new to the University of Iowa and learning to conduct human subjects research? The recorded IRB Overview presentation posted in the IRB ICON Course for Researchers provides a general orientation to the UI IRB and the IRB approval requirements for human subjects research.
This is an excellent supplemental lecture for any research methods or responsible conduct of research course. It is also ideal for students doing research as a course requirement. Learners must access the IRB ICON course through the portal on the HSO website. After the first login, the course will appear in your ICON Dashboard.
This presentation covers:
Regulatory definition of human subjects research
Guidelines for human subjects research: why and when IRB approval is required
Basic ethical principles for the conduct of human subjects research
Student Principal Investigator (PI) training requirements (HawkIRB Part 1 and 2 trainings)
Criteria for IRB approval
Information about the UI IRB
What to expect from the IRB review process
Research off campus or outside the United States
Course-related student projects
Additional resources exist for courses where students complete a research project as a course requirement. The IRB policy on Course Related Student Projects outlines conditions under which IRB approval is not required for these projects. Instructors should use the Course Related Student Project Checklist to determine whether IRB approval may be required.
If your class needs further guidance on specific research-related topics, please reach out to irb-outreach@uiowa.edu to discuss additional options.
In the News
IRB Efficiency Initiative Information Session
The Human Subjects Office invites the UI research community to attend monthly information sessions about the IRB Efficiency Initiative on the fourth Wednesday of the month from 12-1 pm, via Zoom. We will discuss the changes and demonstrate HawkIRB enhancements being implemented to streamline the IRB review process. The monthly sessions will cover upcoming enhancements and expected roll out dates. Pre-register to receive the Zoom link.
Wednesday, August 28, 2024
12:00 PM-1:00 PM
Office Hours
Human Subjects Office staff host IRB Office Hours via Zoom to provide assistance with electronic IRB applications (in HawkIRB) and to discuss study proposals prior to submission. All researchers are welcome to attend. No appointment is necessary.
Summer office hours run June 5th through August 28th.
Wednesdays (2:00 PM-4:00 PM) via Zoom
Visit the Human Subjects Office website for complete information about IRB Office Hours and the Zoom link.
Recorded Training
The IRB ICON Course for Researchers HawkIRB training sessions provide an orientation to the electronic IRB application and review system. These sessions are for anyone preparing to submit a HawkIRB application for the first time and for those who would like guidance about the proper completion of HawkIRB forms. Five recorded trainings are available 24/7.
The recorded trainings are available on ICON at IRB ICON Course for Researchers.
Note: HawkIRB training Parts 1 and 2 satisfy the Student PI Training Requirement.