March 2023 IRB Connection Newsletter

Index

 

Annual Disclosure of Outside Activities Due April 30

Herky Hint: Conflict of Interest—Don’t Guess!

Human Subjects Office Staffing

Trauma-informed Research Practices

Presentation Recap: FDA Site Inspection Guide—Your Best Tool for Preparing

The Top 10 Reasons Researchers Come to Office Hours and the Guidance We Give

Medical Ethics Advisor Newsletter, February 2023

In the News

 

 

Annual Disclosure of Outside Activities Due April 30

By Martha Hedberg, MPA


All UI faculty and staff identified as key personnel that conduct human subjects research are required to complete an “Annual Disclosure of Outside Professional Activities and Interests” via the eCOI online disclosure portal by April 30, 2023. This article describes the disclosure requirements and highlights new questions that were added to the eCOI disclosure form in 2023.

The University of Iowa community is committed to the principle of free, open, and objective inquiry in the conduct of its teaching, research, and service missions. Further, the University of Iowa encourages its employees to engage in external activities that promote the University's mission, contribute to their professional fields, enhance their professional skills, and/or enhance the public good. To ensure that external activities are conducted in a manner consistent with institutional and public values, policies have been established to ensure that University employees avoid improper conflicts, and otherwise disclose activities for review and management.


Employees may monitor compliance with this annual disclosure requirement via the UI Compliance and Qualifications system accessible through UI Self-Service “My Compliances” tab.  Employees who have not completed the requirement will receive reminder emails on April 1, April 25, and April 30.  Supervisors and Compliance Administrators will be copied on the final two notifications. After April 30, employees may add new, review or edit previously-submitted reports directly using https://ecoi.uiowa.edu.

Implications of the Annual Disclosure Requirements with Human Subjects Research

If research team members identified as key personnel have not completed the 2023 annual disclosure by May 1, 2023, HawkIRB will flag them as noncompliant.  This flag will prevent the Principal Investigator (PI) from submitting any new projects, modifications or continuing reviews to the IRB until the annual disclosure of the research team member is complete.  An incomplete annual disclosure could result in removal of the team member from the IRB application and thus, participation in the conduct of any research related activities. 

Who Should Disclose

Under this policy, “key personnel” means anyone involved in the design, the conduct and/or the reporting of the research. These roles are specified because they provide opportunities for the introduction of bias into the research. If you are unsure if this applies to you, check with the PI of any studies in which you are a research team member. HawkIRB automatically defines the PI and any research team members with a faculty appointment as key personnel. 

What to Disclose

Disclosures should be submitted to the University for any outside activities and interests that are related to an employee’s role or area of expertise at the University. For more detail about what types of activities to disclose, see the Conflict of Interest in Research’s website.

International Engagement

The eCOI system continues to collect information about international engagement. NIH Grants Policy Statement defines a Foreign Component or engagement as “any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended" and includes “collaborations with investigators at a foreign site anticipated to result in co-authorship; use of facilities or instrumentation at a foreign site; or receipt of financial support or resources from a foreign entity.” 

International collaboration is often an important aspect of those activities. To ensure it is conducted in a manner consistent with institutional and public values, policies have been established to ensure that UI employees avoid improper conflicts by disclosing those relationships for review and management. Full and timely disclosure regarding research support and conflicts of interest is essential to ensure compliance with federal regulations and sponsor requirements.

Failure to disclose this information can have significant fiscal and regulatory consequences, impacting both the individual PI and the institution. This addition will assist with identifying possible risk to research integrity and security which may require conflict of interest management or adherence to other federal regulations. 

New for 2023

Each year, researchers must review educational material in eCOI. This training is required by federal regulation and university policy. This year, users will now encounter questions that must be answered throughout the training.

eCOI Logo

Institutional Policies

The Annual Disclosure fulfills the reporting requirements of the following UI policies:

Thank you for your contributions to ensuring that UI academic, health care, business, research, and teaching endeavors may be free of potential or actual conflicts of interest.

 

Herky Hint: Conflict of Interest—Don’t Guess!

By Rachel Kinker, MPA


The University of Iowa is responsible for determining whether a financial conflict of interest in research exists. Each researcher is responsible for disclosing all financial interests annually in the eCOI Disclosure system. These disclosures are reviewed by the Conflict of Interest in Research Office through the lens of research conducted at the University of Iowa. The UI policy can be found in University Operations Manual.

How to submit in HawkIRB:

The questions pertaining to financial conflicts of interest can be found in Section III. of the New Project application in HawkIRB. For the University of Iowa, this would be Section III. 3 and Section III.4 for VA applicants.

UI III.3


VA III.4

  • If you are filling the form out on behalf of a Principal Investigator, send a link to the UI policy to each team member. Ask them to provide the information needed to complete the section on their behalf.
  • Questions III.3 and III.4 apply to individuals as well as their immediate family members.
  • Ask research team members each time a new project form is submitted or continuing review is required. Even if there wasn’t a previous conflict, something could have changed.

Herky the Hawkeye says "Herky Hints"

 

Human Subjects Office Staffing

By Kelly O’Berry, BS, CIP


We are pleased to share that in the last few months, the Human Subjects Office has filled six vacant staff positions and one new position. Onboarding and training are in progress for all these positions.  This article provides an overview of current staffing in each program.

The Human Subjects Office employs 30 staff members, including two part-time temporary positions.

Application Review Program

With 16 positions, this is the largest program in the Human Subjects Office. Review Group staff are involved with all aspects of application review and work on behalf of the IRB-01, IRB-02 and IRB-03. Their responsibilities include:
  • Prescreen new HawkIRB submissions and routing forms for the next step in the review process
  • Conduct application analysis to prepare for review by an IRB Chair or the convened board
  • Process External and Commercial IRB applications and establish reliance agreements
  • Coordinate IRB meetings – scheduling forms to meetings, making sure we have the appropriate expertise among meeting attendees to review each study on the agenda
  • Attend IRB meetings and writing minutes
  • Attend weekly IRB-01 Chairs meetings and bi-monthly IRB-02 Chairs meetings
  • Conduct ongoing quality assurance/quality improvement initiatives to improve the IRB review process


Since July 1, 2022, the Application Review Program filled three open positions: a Full Board Coordinator and two Application Analysts that specialize in prescreening HawkIRB submissions to IRB-01/03 and IRB-02. This program currently has two student employees.

ClinicalTrials.gov

This program provides guidance and support to ensure compliance with federal regulations that require registration and results reporting for certain clinical trials in a public database, the ClinicalTrials.gov Protocol Registration and Results System (PRS). In January 2023, the ClinicalTrials.gov Program doubled in size with the addition of a Senior ClinicalTrials.gov Specialist.

Compliance and Education Program

This program went through a rebuilding process in 2022 after the departure of several long-term employees. Staff in this program conduct a wide variety of compliance monitoring and quality assurance/quality improvement (QA/QI) related activities. A Senior Compliance and Education Specialist started in October 2022 and a Specialist position will be filled in July 2023.

Education and Outreach Program

This program provides a wide variety of education and resources to the UI research community and also to IRB members and Human Subjects Office staff. These resources include:

A Senior IRB Education and Outreach Specialist started full time in January 2023 after working part-time from September through December 2022. This program currently has one student employee.

HSO Administration

This program is responsible for maintaining accreditation materials and conducts administrative activities to support the Human Subjects Office and the IRB. This includes:

  • Operational and financial activities
  • Metrics reporting,
  • Various compliance reporting such as
    • Deactivated PIs,
    • Projects with lapsed IRB approval
    • Projects that have otherwise languished in the workflow system.

There is one full time staff person and one student employee.

Conflict of Interest in Research

This program oversees activities related to conflicts of interest in research:

  • Support for the Conflict of Interest in Research Committee (CIRC)
  • Administer the institutional conflict of interest in human subjects research policy on behalf of the UI President
  • Administer the UI disclosure system, eCOI
  • Provide a wide variety of conflict of interest-based lectures and trainings

There are two full time staff; no new employees in 2022.

Organizational Chart

The Human Subjects Office Organizational Chart is posted at the very bottom of the Contact Us page of our website. We appreciate your feedback and suggestions. Please contact us at irb@uiowa.edu. If you want to thank a staff member, there are links for this at the bottom of the left-hand menu bar and in the black bar at the bottom of each page of the website. 

 

Trauma-informed Research Practices

Shane D. Soboroff, PhD


Trauma can result from disturbing experiences that have negative, long-term emotional, behavioral, and psychological consequences for an individual. Trauma-informed research practices can reduce the risk that researchers will retraumatize research participants or experience trauma themselves. Trauma-informed practices include methods that (1) properly inform participants of the risks to people with trauma during study procedures, (2) reduce or eliminate these risks wherever possible, and (3) avoid excluding people with trauma from research without a scientific rationale. As such, these practices are consistent with the three ethical principles outlined in the Belmont Report:  respect for persons, beneficence, and justice.

Understanding Trauma

Trauma occurs when individuals experience stress and/or adversity and can manifest in reduced ability to cope with future stressors. Traumatic experiences can occur at any stage of life and may be the result of many factors, including:

  • Childhood abuse
  • Domestic violence
  • Medical maltreatment
  • Economic insecurity (e.g., unemployment, housing insecurity, food insecurity).
  • Loss of a loved one

Further, trauma is more often experienced by people belonging to vulnerable populations and can impact multiple generations. Trauma-informed research seeks to understand and mitigate the effects of trauma on research participants and researchers based on their lived experiences and the communities to which they belong.

Trauma-informed Practices and Federal Regulations: Protecting Subjects and Researchers

Trauma-informed approaches center on the experiences of research subjects and go beyond “do no harm” to promote positive participant experiences. Trauma-informed research can reduce the risks that subjects are retraumatized. These practices also reduce the likelihood of research team members experiencing vicarious trauma—trauma resulting from exposure to information about another person’s trauma. Trauma-informed approaches also promote collaboration between researchers and communities to define research questions and create knowledge that benefits those exposed to trauma. Working with these communities can promote research participation by persons with trauma, increasing the generalizability of research findings.

To accomplish these goals, trauma-informed research promotes the ethical principles embodied in the Belmont Report: respect for persons, beneficence, and justice. These principles require researchers to obtain voluntary informed consent, minimize risks and balance those risks against potential benefits from conducting a study, and engage in equitable recruitment and enrollment practices while respecting the needs of economically or socially vulnerable populations. Some practical ways to support these principles in trauma-informed research include:

  • Engage communities and practitioners familiar with trauma in the design of your study.
  • Include an advocate for individuals with trauma as a study team member.
  • Include language on consent forms describing risks specifically to individuals with trauma.
  • Clearly describe any physical or psychological interventions and who will be involved.
  • Recruit individuals with trauma and avoid excluding them without a valid scientific rationale.

Trauma-informed Research Recommendations

The following suggestions have been put forward by researchers experienced with trauma-informed practices, which are still being developed as the needs of communities are assessed.

These recommendations are based on the work of Campbell et al. (2019) and Edelman (2022):

  • Identify potential “triggers” in your study that might potentially retraumatize subjects.
  • Prepare to be exposed to potentially traumatizing accounts.
  • Offer resources to aid the recovery of trauma victims.
  • Avoid penalizing subjects for leaving the study early.
  • Make your research site a safe and respectful space. Empower subjects.
  • Get to know the community or population from which subjects are recruited.

Resources about Trauma-informed Research Practices

Additional resources exist for researchers interested in trauma-informed research practices. Case Western Reserve University has developed a framework for promoting social justice through trauma-informed research. For researchers using qualitative methods, The Urban Institute offers a guide to trauma-informed qualitative practices. Additionally, Emory University provides examples of trauma-informed practices in medical research.

For researchers working with University of Iowa employees or students, the University offers mental health resources including 24-hour support and information for individuals specific to their UI classification.

 

Presentation Recap: FDA Site Inspection Guide—Your Best Tool for Preparing

By Catherine Fruehling, MBA

The Food and Drug Administration (FDA) conducts site inspections of clinical investigators involved in FDA-regulated clinical trials to determine compliance with applicable regulations. This article provides an overview of a February 2023 presentation about The Human Subjects Office’s FDA Site Inspection Guide, and how to use the guide to best prepare for FDA site inspections.  A recording of this presentation is available in the Additional Topics section of the IRB ICON Course for Researchers.


The HSO’s FDA Site Inspection Guide provides practical advice for Principal Investigators (PI) and research staff undergoing an FDA inspection.  The guide outlines step-by-step pre-inspection preparations, recommended study team conduct during the inspection, potential post-inspection outcomes, and directions for post-inspection activities.  The FDA Site Inspection Guide can be found on the FDA Site Inspection Guidance page of the HSO website. 

Key Takeaways

  1.  Upon Notice that an FDA inspection will occur:
    1. Complete the Initial Intake Form (Appendix 1 of the Guide).
    2. Gather requested documents and make note of any missing or incomplete documents.
    3. Review guidance found on the FDA website.
    4. Reserve a meeting room that can be locked, has a phone, and is removed from clinic/research areas.
  2. Prior to FDA Inspection
    1. Notify appropriate parties, including the following:          
      1. IRB Compliance Program- Compliance staff are required to attend the Open Meeting and Exit Interview of the FDA Site Inspection
      2. Study staff
      3. UIHC Compliance
      4. Pharmacy
      5. Department HR to arrange medical records access
      6. Any ancillary departments or labs involved in the study
    2. Review and organize study documents, including protocols, informed consent documents, study logs, reportable/adverse events, sponsor agreements, investigator brochures, and source documents.
  3. During the FDA Inspection
    1. Ask for credentials and Notice of Inspection (Form 482).
    2. Comply with all FDA requests, including access to medical records (if applicable).
    3. Make copies of all documents provided to the FDA.
    4. If the FDA requests samples, ask for a receipt.
  4. Post FDA Inspection
    1. Email a copy of the Exit Interview Summary to the IRB Compliance Program.
    2. Complete an Inspection Summary Report.
    3. Upon receipt of the FDA report, email a copy to the IRB Compliance Program.
    4. In consultation with UI General Counsel, prepare and send a written response to the FDA report within 15 working days.
    5. Work with the IRB Compliance Program to address any needed modifications and documentation of the FDA Site Inspection.

Helpful Hints

  • Identify a research team member to serve as the point person for the inspection to coordinate activities and take thorough notes.
  • When reviewing study documents, make note of errors or inaccuracies.  If there are any inaccuracies, correct what can be corrected, and develop a written corrective action plan to avoid further errors.
  • Ensure that all study team members are aware of the inspection and that requested personnel are available by phone or in person for the duration of the inspection.
  • Accompany the FDA Inspector at all reasonable times.
  • Be honest, but concise when answering FDA Inspector questions.  Do not offer information that is not asked and limit idle conversation.
  • Remove identifiers from documents/samples given to the FDA Inspector, unless specifically asked otherwise.
  • Review the questions frequently asked during FDA site inspections (Appendix 2 of the Guide).

Summary

The HSO’s FDA Site Inspection Guide is your best tool for preparing for an inspection.  Remember to use all available resources on the FDA and HSO websites, and work with the IRB Compliance staff.  We’re here to help!  Please email irb-monitors@uiowa.edu, or call (319) 335-6564, if you have any questions.

 

The Top 10 Reasons Researchers Come to Office Hours and the Guidance We Give

By Rachel H Kinker, MPA


On February 21, 2023, the Human Subjects Office (HSO) gave a lecture about common questions that occur at IRB Office Hours. Below are questions from this lecture and helpful resources related to select questions. For additional information, view the recording in the IRB ICON Course for Researchers (under Additional Topics).

10. Single IRB/External IRB and Funding Questions

  • I’m working on a multisite project and want to use a single IRB; what do I do?
  • I just got funding for a project; where do I start?

9. International/Off- Campus Research

  • I’m conducting research outside the U.S. or off-campus. What do I need to know?

8. Data Security/Data Sharing Questions

7. Data Collection Questions

  • I’m just going to talk to participants; do I need to attach anything to my application?
  • Where in HawkIRB do I describe collecting photos/video/audio?
  • I already collected data for a class project, and want to use it for a new project; what do I do?

6. Questions on Modifications

  • How do I create a modification? What do I do if I need to edit a document?
  • I have a mod pending but got notice that the Continuing Review (CR)/Biennial Review (BR) is due. What are my options?
  • Should I submit a modification to an existing project or a New Project Form?

5. Questions about Consent/Assent Documents and the Research Process

  • Do we have to do everything for every participant that we said were going to do in the consent document?
  • When do I need to re-consent enrolled subjects if study procedures change?
  • What do I do if I enroll older teens that will age up while the study is still going?

4. Workflow and General HawkIRB Issues

  • I don’t understand a request in HawkIRB workflow; what do I do?
  • The form was sent back to me but I can’t make changes in the application or the attachments. What do I do?
  • How do I get back to the workflow page (without going all the way back to the link in the original email message)?

3. New Application Guidance

  • Can I add someone to the research team who is not affiliated with the UI? If so, how?
  • This is my first application, what resources are available to help me get started? How do I answer this application question?

2. Questions about Expedited vs. Exempt Research

1. What counts as Human Subjects Research?

  • Is this project Human Subjects Research? Do I need IRB approval?
  • How do I find the determination memo after the IRB makes a determination?

 

Medical Ethics Advisor Newsletter, February 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 February 2023 Medical Ethics Advisor Newsletter.
 

Informed Consent is Central Ethical Issue for Studies of Pig Organ Transplants

When developing proposals for studies researchers should ask:

  • Are recipient safety protections reflected in the study design?
  • Is there a plan to address potential risks, such as zoonotic infection?
  • Is there a possibility of coercion from sponsors or principal investigators?
  • Are recipients aware that they may not be able to withdraw from the study (or aspects thereof), due to potential zoonotic infection and the need to quarantine?
  • Are recipients aware of the potential risks and benefits of accepting a pig organ while waiting for a human organ?
  • Have xenotransplantation informed consent forms been released publicly for peer review?

For Researchers Using Social Media Data, Consent Is Ethical Worry

Every online action, social media post, or browsing history is recorded in some capacity. This information can be utilized by researchers to identify illness outbreaks, engage in disease surveillance, or for research recruitment efforts. The internet user may not understand how their online data is stored, mined, and utilized. Best practices for social media data include:

  • Take steps to de-identify, securely store, and scrub non-health related content from the source data
  • Treat online user-generated data as private, even when it is not and is publicly available
  • Partner with patient advocacy groups for outreach as an alternative to data mining

Articles in the February 2023 Issue:

  • Is Ethics Education Part of the Solution to the Nursing Shortage?
  • Ethical Responses if Family Abandons Loved One at Hospital
  • Surrogates View Their Role Differently Than Clinicians
  • Clarity and Consistency Help Families Facing Serious Medical Decisions
  • Physician Autonomy at Issue if Patients Demand Ineffective Treatments
  • Providing Ethical Neonatal Cardiac Care
  • Ethical Oversight of Chimeric Research
  • IRBs Likely Need Outside Expertise When Reviewing Xenotransplantation Study Protocols
  • Study: New Physicians Develop Financial Ties Quickly

 

In the News, February 2023