Index
Continuing Medical Education Credit for Compliance Monitoring
The IRB Review Process: IRB/HSO/HRPP Improvements and Enhancements to Reduce Review Times
ClinicalTrials.gov - Educational Points and Best Practices
IRB ICON Course for Researchers – What’s in there, anyway?
View Recorded IRB presentations - IRB ICON Course for Researchers
NIH Webinars: Implementing the New Data Management and Sharing Policy
Medical Ethics Advisor Newsletter, June 2022
In the News
Continuing Medical Education Credit for Compliance Monitoring
By Catherine Fruehling, MBA
Beginning August 1st, 2022, the University of Iowa Human Subjects Office is pleased to offer Continuing Medical Education (CME) credit for research team personnel who participate in select Compliance Monitoring visits for biomedical research. CME credit is available to physicians, nurses, and other healthcare professionals who participate in the monitoring of their research studies.
CME credit will be offered for Post-Approval Monitoring and Education (Pam & Ed) and Post-Approval Responsibilities Review (PARR) compliance visits. The purpose of these visits is to assess investigator and research team members’ compliance with federal regulations and UI policies for the protection of human subjects. The main goals of the IRB Compliance Program are:
- To ensure research is conducted in accordance with federal regulations and University of Iowa standard operating procedures.
- To 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.
- To provide researchers one-on-one and group educational opportunities regarding human subjects research.
- To facilitate communication between the IRB/Human Subjects Office and researchers at the University of Iowa.
More information about the IRB Compliance Program can be found in the UI IRB Standard Operating Procedures and Researcher Guide, Part I, Section 11.E (Compliance Monitoring).
CME Credit Designation
The University of Iowa Roy J. and Lucille A. Carver College of Medicine has designated this live activity (compliance monitoring) for a maximum of 1.00 AMA PRA Category 1 Creditstm. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME Accreditation
This activity (compliance monitoring) has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the University of Iowa Roy J. and Lucille A. Carver College of Medicine and the University of Iowa Human Subjects Office. The Carver College of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
Nurses
Iowa nurses may use certificates of participation in ACCME-accredited education toward their CE requirement for licensure.
Other Healthcare Providers
A certificate of completion will be available after successful completion of the course. (It is the responsibility of licensees to determine if this continuing education activity meets the requirements of their professional licensure board.)
In order to receive CME credit, attendees will be required to complete a post-compliance monitoring survey. As part of the survey, you will have the opportunity to share your feedback about your experiences with the IRB Compliance Monitoring program.
Please contact Catherine Fruehling, Human Subjects Office Compliance Manager for more information.
The IRB Review Process: IRB/HSO/HRPP Improvements and Enhancements to Reduce Review Times
By Joanie Hoefer, BS, CIP, and Kelly O’Berry, BS, CIP
The Human Subjects Office (HSO), Institutional Review Board (IRB) and other committees in the UI Human Research Protection Program (HRPP) are committed to reviewing HawkIRB applications as thoroughly and as quickly as possible. Over the past year we collectively implemented enhancements to reduce review time without sacrificing the rigorous standards required by the federal regulations for the Protection of Human Subjects (45 CFR 46) and our accrediting body (the Association for the Accreditation of Human Research Protection Programs, AAHRPP).
HSO/IRB Initiatives to Reduce IRB/HRPP Review Time
In Spring/Summer 2020, several long-time HSO student employees were reallocated to prescreen new form submissions and release approved forms. This allowed experienced staff in the IRB Review Group to focus on application review and write IRB meeting minutes. Additional restructuring of the IRB Review Group added new leadership positions and additional IRB review FTEs. An IRB Chair Designee was also added at 10% effort, primarily to assist with the review and approval of modifications and continuing reviews for minimal risk, biomedical research. August 2021-December 2021, a temporary contractor provided coverage during the recruitment for several open positions and to address IRB review backlog. We will have a new temporary review contractor in July 2022 due to a backlog in staff recruitment efforts.
Increased Staffing – for Review of Social/Behavioral/Educational research (IRB-02)
In Summer 2021, the HSO was approved to hire two new, full-time staff to review IRB-02 applications. One of these positions has been filled and the new staff member is in training.
New Exempt Application Form
In January 2022, the HSO rolled out a new form for studies that qualify for Exempt Status (see the Exemption Tool). This was the culmination of approximately three years of evaluation, development, programming and testing efforts by multiple individuals and teams. The newly designed exempt application significantly reduced number of questions in the application. In conjunction with the new Exempt Application, the IRB implemented a policy to reduce modification submission requirements for exempt studies (UI Standard Operating Procedure & Researcher Guide, Section I, Part 13).
This HawkIRB update reduces regulatory burden for Exempt research – for researchers, IRB Review staff and IRB Chairs. Ultimately, this form should shorten the review time for other types of projects if the Application Review Team is not spending as much time reviewing Exempt applications.
Learn more about the Exempt Application in a recorded HawkIRB training posted in the IRB ICON Course for Researchers.
Getting on the Same Page: Submission and Review of Human Subjects Research Applications (3-part lecture series)
In Spring 2021, the HSO, Division of Sponsored Programs and ICTS collaborated on a three-part lecture series about how to achieve the most efficient IRB/HRPP review of a human subjects research application. These lectures encouraged complete initial submissions so the IRB and all HRPP committees could begin the review process at the same time. They gave case examples of the parallel review by the IRB and HRPP committees. The final lecture addressed budgeting best practices for human subjects research.
If you missed the presentations, or would like a refresher, the recordings are available in the IRB ICON Course for Researchers, under “Additional Topics.”
Student PI Training Requirement
In August 2021, the IRB and the UI Graduate College implemented a policy requiring all student Principal Investigators to complete two training sessions to learn how to use the HawkIRB system and how to prepare a New Project form. This policy applies to all student PIs (graduate and undergraduate students) submitting to the biomedical research board (IRB-01) and the social/behavioral/educational research board (IRB-02). The goal was to provide education and guidance for first-time, student users of the HawkIRB system so they prepare more complete IRB submissions that go through the review process more smoothly.
All researchers are encouraged to complete this training by attending a HawkIRB training or viewing the recordings in the IRB ICON Course for Researchers.
Standardized HawkIRB Training for New HSO staff
Starting in December 2021, all new professional staff hires complete a more in-depth, standardized training to experience the researcher perspective of preparing HawkIRB forms and the IRB perspective for reviewing them. This training includes a review of the full administrative capabilities of the HawkIRB system and provides the bigger picture beyond the tasks staff might ordinarily perform in HawkIRB as part of their job responsibilities. The goal of this standardized training is to prepare staff for job-specific training and to begin learning how to respond to questions from the UI research community.
Quality Assurance for IRB Meeting Minutes
In Spring 2022, the IRB Review Group conducted a quality assurance initiative for staff who write IRB meeting minutes. According to the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46.115(a)(2)), meeting minutes must contain certain elements, including notes about any “controverted issues.” Staff training and quality assurance measures reinforced the goal of sending completed minutes to the PI within one week of the IRB meeting.
Other HawkIRB Enhancements
In April 2021, the HSO partnered with the Medical Radiation Protection Committee (MRPC) to release an electronic MRPC (eMRPC) form replacing the word document submission process. Information from HawkIRB integrates with the eMRPC form to streamline the MRPC submission process.
The HSO is actively exploring other opportunities to continue to improve Human Research Protection Program and IRB review processes. Quality Assurance reviews are also underway to evaluate the above-mentioned enhancements and determine impact on the review process. The HSO will continue to inform the research community via the IRB Connection newsletter as we implement additional enhancements or finalize the results of quality assurance reviews.
IRB Review Process Series
Previous articles in this series:
- Steps in the review process after a form is submitted in HawkIRB (October 2021 IRB Connection).
- Review time goals and factors that can interfere with the fastest possible review (April 2022 IRB Connection).
Coming soon! A future article will cover updates to IRB review metrics and reporting available to the UI research community.
ClinicalTrials.gov - Educational Points and Best Practices
There are three reasons a researcher needs to register a study on ClinicalTrials.gov: 1) It is a drug or device clinical trial that meets the regulatory criteria for registration, 2) It fulfills the NIH criteria for a clinical trial, 3) The researcher wants to publish the study in an International Committee of Medical Journal Editors (ICMJE) journal. This article provides basic guidelines for how to register a study on ClinicalTrials.gov and comply with federal regulations regarding results reporting.
Registration Requirement:
If a research study fulfills the criteria of an “Applicable Clinical trial” or “NIH Clinical Trial” the Responsible party/ PI needs to register the study with Clinicaltrials.gov as specified in the final rule 42 CFR 11.24. The ICMJE also requires registration of clinical trials as a condition of consideration for publication. The ICMJE recommends that journals publish the trial registration number at the end of the abstract.
Timeline for Registration:
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials (ACTs) to be registered within 21 days of enrollment of the first participant. In addition, the ICMJE and other journals require registration of clinical trials prior to enrollment of the first participant.
Guidelines for Registration:
Create an Account: Send an email to the PRS administrator at ct-gov@uiowa.edu. Once the account has been created, you will receive an e-mail with instructions for logging in to the Protocol Registration and Results System (PRS). While logging in, enter “UIowa” in the organization section.
Complete Protocol Section: For clinical trials registration, investigators are required to complete the “Protocol” section of the PRS application. There are 13 subsections of the protocol section:
- Study Identification - The “Unique Protocol ID” should be “HawkIRB ID (digits only).
- Study Status - The dates in this section have the options of “Anticipated or Actual”. Update the study start date 30 calendar days after enrollment of the first subject. Update overall recruitment status within 30 calendar days after a change in overall recruitment status.
- Sponsor/Collaborators – The “Responsible Party” section has three options: Sponsor, Principal Investigator, and Sponsor-Investigator. Select “Sponsor-Investigator” option for “Sponsor/ Collaborator.” This option will create another sub-question to enter Investigator information and let the Investigator approve and release the record in the ClinicalTrials.gov PRS instead of the having PRS administrator approve and release the record.
- Oversight – Complete this section if the trial is about a U.S. FDA-regulated Drug or Device. Choose the appropriate IRB Review status from the given options.
- Study Description – The “Brief Summary” should have no more than 2500 characters. Describe the study in the “Detailed Description” section.
- Conditions and Keywords – Enter the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. For keywords, choose words or phrases that best describe the protocol. Keywords help users find studies in the database. Avoid acronyms and abbreviations.
- Study Design – Enter study type, primary purpose of the clinical trial, study phase (if applicable), study model with description, number of study arms, if there will be any masking or blinding, and anticipated enrollment target.
- Arms and Interventions – Enter information for study arms along with their assigned intervention.
- Outcome Measures – Provide primary and secondary outcome measures (if any). This information should be identical to the HawkIRB application.
- Eligibility – Provide minimum and maximum age, sex, inclusion/exclusion criteria and if the trial is enrolling healthy volunteers.
- Contacts/Locations - Enter main contact person, contact backup information and the location on the University of Iowa campus where the research activities will take place.
- Individual Participant Data (IPD) Sharing Statement - ICMJE requires details about plans for data sharing, including what type of data will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when data will become available and for how long; and how data will be shared (including with whom, for what types of analyses, and by what mechanism).
- References – Enter citations to publications related to the protocol, for background and/or results. Provide either the PubMed Unique Identifier (PMID) of an article or enter the full bibliographic citation.
Push to PRS feature of HawkIRB: For UI investigator-initiated protocols, the investigator can select “Yes” for Section VII.B.12.c in HawkIRB application and the PRS Administrator will create the study record in the PRS on behalf of the PI after the IRB approves the project. This feature will use the IRB-approved application information to complete the following sections of the new record. The sections include: unique protocol ID, brief title, official title, responsible party, record owner, U.S. FDA IND/IDE, IND/IDE Number, IRB Approval Status, study design, anticipated enrollment number, if the study is enrolling male or female participants or both with maximum and minimum age and PI contact information.
The investigator is required to complete the remaining record information to complete the registration process.
Guidelines for Submitting Results
Submit results no later than one year after the study's Primary Completion Date, as described in 42 CFR 11.44(a) of the Final Rule. The Primary Completion Date is defined as "the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated." (42 CFR 11.10)
The ICMJE policy does not require results reporting for registered trials.
Required Documents: Submit the Study Protocol and Statistical Analysis Plan. Include a cover page for each document with official title, NCT number and document date. If the study has funding from the National Institutes of Health (NIH), upload an Informed Consent Document after recruitment closes, and no later than 60 days after the last study visit by any participant.
The “Result Section” is further subdivided into 7 sub-sections:
- Participant Flow – Enter the number of the participants that started, completed, and did not complete the study. Provide the reason for why the participants did not complete the study.
- Baseline Characteristics – PRS Fields are self-explanatory for baseline characteristics for age, sex, and region of enrollment.
- Outcome Measures – Enter title, short description and time frame for each primary and secondary outcome measures.
- Adverse Events – Enter “All-Cause Mortality”, “Serious Adverse Events”, and “Other (Not Including Serious) Adverse Events” data for all anticipated and unanticipated events due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study. Provide the time frame and vent reporting description as well.
- Certain Agreements - Provide information if there is any agreement between the sponsor or its agent and the principal investigators that restricts in any manner the ability of the principal investigators after the completion of the study, to discuss the results of the study at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the study.
- Limitations and Caveats – Enter any significant limitations related to the study. Such limitations may include not reaching the target number of participants needed to achieve target power and statistically reliable results or technical problems with measurements leading to unreliable or uninterpretable data.
- Results Point of Contact – Enter investigator information with name, organization affiliation, phone, and the email for contact in case of any questions regarding the results.
Consequences for not submitting results information: The ClinicalTrials.gov results database is compliant with Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), which requires the submission of "basic results" for certain clinical trials, generally no later than 1 year after their Primary Completion Date. If investigators do not submit required results information on time, the FDA could pursue civil monetary penalties under 21 U.S.C. 333(f)(3) against the Applicable Clinical Trial's (ACT) responsible party. For an ACT for which the FDA grantee is the responsible party, failure to submit required results information could result in not releasing remaining funding for a grant or not funding a future grant in accordance with section 402(j)(5)(A) of the PHS Act.
Good Cause Extension request: If an investigator anticipates a potential delay in submission of results information by the due date, they may submit a written request for an extension in the PRS. The guidelines for submission of a Good Cause Extension request and the review process can be found in the May 2022 IRB Connection Newsletter.
Questions?
The ClinicalTrials.gov page of the HSO website provides information about registering a clinical trial along with helpful resources. Detailed guidelines can be found in the ClinicalTrials.gov Investigator’s Guide, which was updated in March 2022. We are working on creating a checklist to assist researchers with ClinicalTrials.gov registration and results submission process. This checklist will be available to the researchers by late summer.
Should you have any questions or need assistance with the registration of a clinical trial or submission of results, please contact ct-gov@uiowa.edu or call the PRS Administrator in the Human Subjects Office at (319) 335-6564.
IRB ICON Course for Researchers – What’s in there, anyway?
By Kelly O'Berry, BS, CIP
View Recorded IRB presentations - IRB ICON Course for Researchers
The IRB Education & Outreach Program offers 3-5 research-related presentations per semester. Recordings are posted in the IRB ICON Course for Researchers and available on-demand, so researchers can view them as their schedule allows.
Note: If you receive an error message that you need permission to view the recordings, you should access the ICON Course through the Google Chrome web browser.
IRB ICON Courses for Researchers
The portal to the IRB ICON Course for Researchers is on the Education and Training page of the Human Subjects Office (HSO) website. ICON is the Learning Management System the UI uses for academic courses. The IRB ICON courses are available to anyone with a HawkID so all members of the UI and VAHCS research community should have access to these courses.
The first module is a table of contents. Click on each item to read a brief overview of what you will find in the subsequent modules.
Additional Topics
This is a warehouse for recordings of past IRB presentations. They are posted in reverse chronological order. Whenever possible, we post the presentation synopsis and pdf of the slides. Researchers can use CTRL-F to search the page for key words, to see if there are past presentations on certain topics. The following recordings were recently posted in the Additional Topics tab:
HawkIRB Carousel Index, April 2022 - The Carousel Index (also referred to as the application index) provides a wealth of information about the HawkIRB application including a brief description of each section, the information or materials you may need to complete each section and references to federal regulations, accreditation standards, UI policies and IRB policies that explain why the IRB asks for the kind of information we do. The Carousel Index was designed to assist with navigation in the HawkIRB application. This presentation reviews the layout and features of the Carousel Index and provides case examples that will allow you to roll up your sleeves and learn how to get the most out of this helpful tool in HawkIRB.
Single IRB Review Model for Federally Funded, Multi-Site Research, March 2022 - In the single IRB (sIRB) review model, one IRB oversees research at multiple study sites. The UI IRB could serve as the Lead IRB or rely on another IRB to oversee UI research activities. This presentation will provide a high-level overview of the single IRB review model, including various scenarios for when the single IRB review model could or must be used and how the roles and responsibilities of the IRB and researcher change when serving as the Lead IRB or when relying on another IRB. This recording also covers how to prepare for a grant submission that requires the use of the single IRB review model.
Human Subjects Research Hot Topics and Updates, March 2022 - On March 9, 2022, the Human Subjects Office gave the triannual lecture to the UI research community about hot topics and updates for human subjects research and the Human Research Protection Program (HRPP). This recording covers the following hot topics:
- Electronic Consent (eConsent)
- Updated Educational Tools; Alternatives to In-Person Consent, Data Security Guidance, Secure Zoom Meetings and Recordings for Restricted/Critical Data
- Template Protocol Outlines
- Good Cause Extension for ClinicalTrials.gov
- Retrospective Record Reviews Qualify for Exempt Status (Category 4)
- Upcoming ICTS/IRB Lecture Series (May-July 2022)
- Requesting Assistance from the IRB/HSO
ClinicalTrials.gov: Guidelines for Reporting Results, February 2022 - This recorded presentation demonstrates how to update the results section of a ClinicalTrials.gov (CT.gov) record to comply with FDA regulations. In addition, the following topics are covered:
- CT.gov registration and results submission requirement
- Deadline for submission of results
- Purpose of results reporting
- CT.gov results database
- Steps for submitting results of a clinical trial
- Editing and updating the record results
- PRS support, training material, and assistance
- CT.gov results information review process
Other recorded presentations include:
- Exempt HawkIRB Application updates
- Research Billing Compliance (RBC)
- Understanding the external IRB review process
- Student PI and Faculty Advisor (FA) responsibilities
- Best practices for managing HawkIRB workflow
- Data security and confidentiality protections
- Use of eConsent
- Many more!
If you missed any past IRB presentations, or if you have new study coordinator or researcher who needs this information, access recordings in the IRB ICON Course for Researchers.
NIH Webinars: Implementing the New Data Management and Sharing Policy
NIH is offering a two-part webinar series on the new NIH Data Management and Sharing Policy, which will go into effect Jan. 25, 2023. UI researchers who have or seek NIH funding are encouraged to attend.
Part 1: Understanding the New NIH Data Management and Sharing Policy
August 11, 2022
12:30-2:00 pm
Register
Part 2: Diving Deeper into the New NIH Data Management and Sharing Policy
September 22, 2022
12:30-2:00 pm
Register
Medical Ethics Advisor Newsletter, June 2022
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 June 2022 Medical Ethics Advisor Newsletters.
Critical Care Nurse Researchers Must Know IRB Process
Critical Care nurses play an important role in identifying patients that might meet inclusion criteria to participate in a study. Researchers can work in collaboration by:
- Sharing what research studies are being conducted at the institution and in their field
- Explaining the role of the IRB, the review process, the consent process and the role of legally authorized representatives in giving consent, and the concepts of the study protocol
Unique Challenges for IRBs Evaluating Radiation Oncology Study Protocols
IRBs face a unique challenge when reviewing radiation oncology study protocols as the technology is rapidly advancing. Researchers can assist the IRB in the review process by providing information about radiation oncology principles and trial design, such as the longer time for the occurrence of adverse events from radiation therapy, and radiation therapy follow-up visit usually being three months out.
Participant Distress Is Concern for IRBs Reviewing Child Maltreatment Studies
In studies about the mistreatment of children, researchers and IRB members must have an accurate understanding of the potential for participant distress. Child maltreatment is prevalent in the United States and requires extensive research initiatives to understand and address family violence. Developing research in the area is challenging.
- Researchers can provide information to IRBs explaining the often infrequent and transitory participant distress that may occur and the research benefits
- Study design should focus on the ethical obligations to participants, legal liability does not extend to emotional distress
Articles in the June 2022 Issue:
- NFTs Could Give Patients Control Over Who Accesses Medical Data
- The Reproducibility Crisis in Clinical Trial Research
- Ethicists Attend ‘Unconference,’ Tackle Tough Problems Facing the Field
- Patterns of Egregious Physician Sexual Misconduct Require Ethical Response
- The Ethics of Creating a National Congenital Heart Disease Database
- Build Emergency Care Research on Strong Regulatory, Financial Foundation
- Consult Services Should Address Racism and Bias
- Conflicts Common Between ICT Clinicians
In the News, July 2022
- This Clinical Trial Wanted to End Breast Cancer Disparities. But First it Needed to Enroll Black Women, STAT
- A Rhythmic Small Intestinal Microbiome Prevents Obesity and Type 2 Diabetes, Science Daily
- Viruses Can Change Your Scent to Make You More Attractive to Mosquitoes, New Research in Mice Finds, The Conversation
- Empowering IRBs to Review Explainability Tools in Artificial Intelligence/Machine Learning Research, Ampersand, The PRIM&R blog
- Long COVID Symptoms Linked to Inflammation, NIH
- How fitness trackers monitor your sleep, Live Science
- If Not Now, Then When? Taking Disability Seriously in Bioethics, The Hastings Center
- The 41 Best Books and Podcasts on Health and Science to Check Out This Summer, STAT
