September 2023 IRB Connection Newsletter

Index

 

Research Navigation Tool – for faculty and research scientists

Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB

CITI Training at Previous Institution

External IRB Q&A: Non-UI Team Members

General Data Protection Regulation (GDPR) May Affect Your Research Plan

ClinicalTrials.gov Webinar Series (hosted by the Food and Drug Administration)

Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model

An Invitation - UI Research Services Fair (October 12, 2023)

Medical Ethics Advisor Newsletter, August 2023

In the News

 

 

Research Navigation Tool – for faculty and research scientists

By Kelly O’Berry, BS, CIP


The Research Navigation Tool provides guidance and contact information to establish various aspects of a research program at the University of Iowa. Although managed by the Human Subjects Office, this tool is for all researchers, including animal researchers and bench scientists. We request assistance from Department Executive Officers, Departmental Administrators, and others to promote this resource to biomedical and social science faculty and research scientist Principal Investigators (PIs).

Based on research plans, representatives from the following units will contact the researcher to provide guidance and support for transferring or initiating research activities:

HSO staff sends a link to the tool to all new faculty and research scientists to begin the onboarding process with Research Administration and other campus units.

Additional resources for faculty and research scientist PIs:

  • Researcher Handbook - This electronic guide for all researchers (new and existing) provides guidance for the entire lifecycle of a research project. The Handbook explains how to get started, learn about all applicable regulations, apply for funding, manage awards, conduct research responsibly, hire and supervise staff and close down a research study when it ends and prepare for a researcher to leave the UI.
  • New Faculty/Staff Researcher Orientation to the IRB - The HSO offers one-on-one IRB orientations to provide guidance, resources and support for research involving human subjects. This session provides an orientation to:
    • The Human Research Protection Program (HRPP)
    • The IRB review process and requirements for submission
    • Other committees or entities that review and approve human subjects research applications
    • Features of the eResearch application system (HawkIRB), including the delegate permission system
    • Educational resources available for all human subjects researchers

Contact the IRB Education & Outreach team to learn about other educational resources for faculty and research scientists.

 

Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB

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 IRB Education & Outreach Program offers presentations on human subjects research and the IRB review process to research methods courses, journal clubs, research teams, and other groups. Read on to learn how the HSO can help you educate new researchers!

We now offer a recording of the general IRB overview presentation that is available in the IRB ICON Course for Researchers. This presentation provides a good orientation to the UI IRB and the IRB approval requirements for human subjects research. It is an excellent supplemental lecture for any research methods or responsible conduct of research course. It is ideal for students/trainees doing research as a course requirement or as an honors, Master’s or doctoral dissertation.

This presentation covers:

  • 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
  • What to expect from the IRB review process
  • Research off campus or outside the United States
  • Course-related student projects

Please note: We can tailor the presentation to include an orientation to HawkIRB, focus on specific aspects of research activities that are unique to the group, or just offer an open question-and-answer session about the IRB and human subjects research. We will attend in person or virtually – however the group normally meets.

We recently sent out emails to instructors of research-oriented courses for Fall 2023, offering to give an IRB-related presentation. If you would like an IRB presentation for your class or group, please contact us at irb-outreach@uiowa.edu.

 

CITI Training at Previous Institution

All investigators conducting human subjects research at the University of Iowa or at the Iowa City VA Healthcare System (VAHCS) are required to complete an education program and become certified in human subject protections through the Collaborative Institutional Training Initiative program (CITI). The training modules in the CITI online course are institution specific so the University of Iowa cannot accept a CITI completion certificate from another institution. Each institution establishes the groups of modules that meet their requirements for certification. However, you will receive credit for any modules that were previously completed that are also a part of the UI training requirement.


To complete the University of Iowa CITI course modules, you will need to re-enter the CITI site and complete the course as a UI learner. To affiliate with the UI, in the ‘Select Your Organization Affiliation’ section, type in ‘University of Iowa’.

The University of Iowa requires the following modules for human subjects protection training.

For IRB-01 Biomedical, the required modules include:

  • Introduction
  • History and Ethical Principles
  • Basic Institutional Review Board (IRB) Regulations and Review Process
  • Informed Consent
  • Social and Behavioral Research for Biomedical Researchers
  • Records-Based Research
  • Genetics Research in Human Populations
  • Research with Protected Populations - Vulnerable Subjects: An Overview
  • University of Iowa

For IRB-02 Social & Behavioral, the required modules include:

  • Introduction
  • History and Ethical Principles - SBR
  • Defining Research with Human Subjects - SBR
  • The Regulations and the Social and Behavioral Sciences - SBR
  • Assessing Risk in Social and Behavioral Sciences - SBR
  • Informed Consent - SBR
  • Privacy & Confidentiality - SBR
  • University of Iowa

Researchers typically complete the Group 1 (biomedical) or Group 2 (social/behavioral) training based on the college or department in which they conduct research. However, there are some departments that can submit to either board and there are researchers in the College of Liberal Arts and Sciences that conduct more biomedical research.

For researchers who completed human subjects protection training at a previous institution, the CITI program will indicate UI-required modules that are INCOMPLETE.

The CITI Program sends a notice when someone completes the UI training requirement. Human Subjects Office staff manually add researchers to the Certified Investigator database associated with the HawkIRB system. We need to determine that the correct course was taken, based on the researcher’s college or department or the research project with which they are involved.

If the directory does not include the researcher’s department or college, we are not able to determine if they completed the correct basic course. We send an email to their UI email account, or the account associated with their CITI profile. We request a response that includes the UI college or department with which they are affiliated with for their research activity and/or the name of the principal investigator overseeing the research project.

PIs and departments are encouraged to send a list of individuals who will be completing the CITI Human Subjects protection training to IRB-certifications@uiowa.edu, and individuals will be added as their completions enter the queue, in order to expedite the process. Other examples of when to alert the HSO CITI administrator include:

  • Non-UI team members
  • Graduate College students that will be completing the IRB-01 Biomedical training
  • Undergraduate students that will be working in a lab, their department listed in the directory may not correspond with the CITI training they have completed for their lab position

If you have any questions regarding this process, please contact us at IRB-certifcations@uiowa.edu.

 

External IRB Q&A: Non-UI Team Members

Jarrod Feld, BA

Question: Can we add a non-UI team member to our study?

Answer: Whether a non-UI team member can be added to a research study depends on several factors: if the individual or the organization are “engaged” in research activities, if they are affiliated with an organization that has an IRB, and if the study requires the use of a single IRB model.

This article will focus exclusively on scenarios where the study is not a federally funded, multi-center trial so the use of a single IRB model is not required. (This topic will be covered in a future External IRB Q&A article.)

The collaborator is “engaged” in research

The first questions we ask are about what the non-UI collaborator will be doing. There are some levels of involvement that do not require IRB approval, such as assisting with study design, creating the protocol or instruments, advising, analysis of completely deidentified or anonymous data. They may not require IRB oversight if they are disseminating UI IRB-approved recruitment materials and referring potential subjects to the research team OR taking name and contact information to pass along to the team. However, if they are conducting the consent process, interacting with subjects, collecting data or working with identified data, they definitely need IRB oversight.

The collaborator has an IRB

If you collaborate on a research project with a colleague at another academic institution or organization that has an IRB, and there is no regulatory (or sponsor) requirement for a single IRB, they should submit an application to their institution’s IRB. UI researchers do not need to name non-UI collaborators on the research team in Section II of the HawkIRB application if their own IRB will oversee their research activities.

The collaborator does not have an IRB

If the non-UI team member does not work at another institution with an IRB, or if their work on the project is independent from their employment duties at their respective institution or organization, the UI can explore extending IRB oversight to them. When a researcher adds a non-UI team member in Section II of the HawkIRB application, it opens attachment categories for the Individual Investigator Agreement (IIA) and the IRB Authorization or Reliance Agreements. It is an institutional decision about whether to extend oversight to a non-UI team member, not an IRB decision. But researchers submit the request through the HawkIRB system.

Relevant HawkIRB Sections for non-UI team members and data sharing:

  • Section II – Click the box to add a non-UI team member. Describe the role of non-UI team members. There is a statement in this section of the form that says to contact the Human Subjects Office before adding a non-UI team member, but you do not need to do that. We need the completed Individual Investigator Agreement (IIA) Worksheet to explore the option of extending IRB oversight to a team member who is not UI faculty, staff, student or trainee.
  • Section VII.A – Indicate locations for all research activities
  • Section VII.D – Describe any involvement of non-UI team members in study recruitment and consent process.
  • Section VII.E – Describe non-UI team member involvement in study procedures
  • Section X.4 – Describe confidentiality/data security plans for transmission or transport of data to and from non-UI team members
  • Attachments – Under Individual Investigator Agreement, click the ‘Generate IIA Template’ button to fill out a worksheet about the role of each non-UI team member. This form provides information about affiliation, scope of work and level of engagement. Also, contact the External IRB Coordinator (uirb-external@uiowa.edu) to see if an IRB Authorization or Reliance Agreement is necessary.

Additionally, based on the type of study and role of the non-UI team members, you will need to explore whether a data use/sharing agreement or materials transfer agreement might be needed. Contact the Division of Sponsored Programs to establish this type of agreement.

If you have questions about adding a non-UI team member, please send an email to UIRB-External@uiowa.edu or call the Human Subjects Office (319-335-6564).

 

General Data Protection Regulation (GDPR) May Affect Your Research Plan

Joanie Hoefer, BS, CIP


The European Union General Data Protection Regulation (GDPR) regulates the processing of all personal data, in any format, of a living individual who resides within a  European Economic Area (EEA) member state. UI researchers need to know about the GDPR since it applies data collected during a research study. This article will explain what UI researchers need to know about the GDPR and how this regulation may impact the design and conduct of their research study.

What is the GDPR?

The GDPR is one of the strongest data privacy and security laws in the world. Organizations from around the globe who collect data related to people who are physically in an EEA country have obligations to meet regarding the data that they have collected. This regulation stems in part from the 1950 European Convention on Human Rights, which states, “Everyone has the right to respect for his private and family life, his home and his correspondence.” The EEA has sought to ensure the protection of this right through legislation, especially as technology has progressed and the Internet has morphed into a big data generator.


Important legal terms defined in the GDPR:

  • Personal data is any information that relates to an individual who can be directly or indirectly identified. Names and email addresses are obviously personal data, but location information, gender, and web cookies can also be personal data. Data that is identified with a pseudonym can also fall under this definition if it is relatively easy to ID someone from it.

    Additionally, some personal data is considered “special category data”. This is any data that reveals:
    • Racial or ethnic origin
    • Political opinions
    • Religious or philosophical beliefs
    • Trade union membership
    • Physical or mental health
    • Data concerning a natural person’s sex life or sexual orientation
    • Genetic data or biometric data processed for the purpose of uniquely identifying a natural person
       
  • Data processing is any action performed on data, whether automated or manual. This includes collecting, recording, organizing, structuring, storing, using, erasing, etc.
  • Data subject is the person whose data is processed. These are the actual human subjects, or their private, identifiable data or biospecimens.
  • Data controller is the person who decides why and how personal data will be processed.
  • Data processor is a third party that processes personal data on behalf of a data controller.

How does the GDPR affect a UI researcher?

Researchers who are conducting human subjects research with individuals who reside in an EEA country must be aware that these subjects have several rights with respect to the data that is collected about them. Specifically, they have the right:

  • To request access to their personal data.
  • To have inaccurate or incomplete personal data corrected.
  • To erasure of personal data, which is also called the “Right to be Forgotten.” However, this may occur only in those circumstances where there is no legitimate reason to continue to hold or process the data.
  • To restrict the processing of their personal data.
  • To data portability. This means that research subjects have the right to receive the personal data that was collected about them during the study, in a structured, commonly used, and machine-readable format, and to then provide that data to another data controller.
  • To object to the processing of their data, such as for marketing purposes, automated processing, or profiling.
  • To withdraw their consent to have their personal data processed. To withdraw consent, the EEA resident/research subject must contact the UI researcher that obtained the consent or the University’s data protection officer and follow the instructions provided.
  • To report a concern about the processing of their personal data. The EEA resident/research subject must contact the UI’s data protection officer with information describing the concern.

If the research involves collecting any special category data, the researcher MUST obtain explicit consent from the data subject to process this data. Otherwise, the processing of special category data is prohibited. Even if a research study is eligible for exempt status or a waiver of documentation of consent (where a signature is not needed to indicate consent to participate in the study), the researcher must still get the signature of the EEA resident/research subject in order to process the personal data that is collected about them. Specific language outlining the subjects’ rights listed above must go into the consent form or exempt information sheet. Contact the Human Subjects Office (HSO) for this template.

The UI may disclose personal data and special category data of EEA residents who are research subjects to external agencies to which the UI has obligations. It may also disclose such EEA residents’ personal data or special category data to examining bodies, legal representatives, police or law enforcement agencies, suppliers or service providers, research institutions, sponsoring organizations, or regulatory authorities.

What happens if the GDPR is violated?

Any violation of the GDPR at the UI could result in harsh fines levied against the institution, with penalties reaching potentially into the millions of dollars. Additionally, data subjects have the right to seek compensation for any damages. Individuals at the UI who fail to comply with the UI’s policies regarding the GDPR may be subject to university discipline and/or other legal recourse, including personal liability.

More information about the UI policy related to GDPR can be found in the UI Operations Manual (V. Administrative, Financial, and Facilities Policies, Chapter 46).

 

ClinicalTrials.gov Webinar Series (hosted by the Food and Drug Administration)

By Fozia Ghafoor, MBBS

The FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) has recently launched its webinar series, titled ClinicalTrials.gov: A Three-Part Series. This series aims to provide a comprehensive understanding of ClinicalTrials.gov, including pertinent definitions, laws, and regulations that pertain to the compliance of ClinicalTrials.gov registration and submission requirements for results information.
 

FDA Webinar Series

The webinars are available on-demand on YouTube. They provide information regarding the role and responsibilities of the CDER in overseeing ClinicalTrials.gov, along with examples of activities they have taken to encourage compliance.

The three-part series encompasses content pertaining to the following topics:

  • Part 1: Meeting the transparency and reporting requirements in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).
  • Part 2: Definitions, laws, and regulations that explain applicable clinical trial criteria, registration requirements, responsible party role, controlled clinical trials, primary and study completion dates, expectation to update the record data elements, results submission, certification for delayed results submission, good cause extension, informed consent requirements for ClinicalTrials.gov, certification of compliance (Form FDA 3674), and the implications of noncompliance with the regulations or prohibited acts under the Food Drug and Cosmetic Act.
  • Part 3: CDER’s Compliance and Enforcement Activities related to the informed consent statement regarding ClinicalTrials.gov, certification of compliance, clinical trial registration, and results information submission requirements. This presentation also provides information related to the compliance activities related to ClinicalTrials.gov that are incorporated into FDA’s bioresearch monitoring (BIMO) program, including the inspection program, complaint evaluations, and surveillance efforts, elements that can be evaluated to identify noncompliance, preliminary notice of noncompliance, notice of noncompliance, and potential penalty actions.

ClinicalTrials.gov is a web-based data entry system for registration and submission of results for a clinical study. This system is run by the National Library of Medicine (NLM) at the National Institute of Health (NIH). The primary responsibilities related to ClinicalTrials.gov are divided between the FDA, NIH, and NLM. The FDA has compliance and oversight responsibilities.

UI ClinicalTrials.gov Resources

The ClinicalTrials.gov program at the University of Iowa is housed in the Human Subjects Office (HSO). To seek support, UI investigators have the option to reach out to the PRS Administrator or the members of the ClinicalTrials.gov working group from various departments. The HSO website and the ClinicalTrials.gov website both have some helpful resources for researchers. Here is a list of some of these resources:

HSO website > ClinicalTrials.gov: ClinicalTrials.gov Investigator’s Guide  and ClinicalTrials.gov checklist

ClinicalTrials.gov Website: How to Register a Study, How to Submit Results, Frequently Asked Questions

Should you have any questions or need assistance with the registration of a clinical trial or submission of results, please contact the PRS Administrator by email: ct-gov@uiowa.edu or phone: (319) 335-6564.

 

Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model


Federal agencies require the use of a single IRB (sIRB) for federally funded research conducted at multiple sites. This means one IRB oversees research conducted at some or all study sites. The budget must include the fees for this type of IRB review, and additional approvals and agreements may be required for this type of research. Researchers can access information about UI IRB fees for budget planning.


For grant proposals to the National Institutes of Health (NIH) or any other federal agency that requires the sIRB model, complete the Pre-Grant Submission Survey prior to grant submission. Plan ahead and complete this survey well in advance, especially if the UI IRB will serve as the lead IRB or rely on an external IRB as an expectation of the grant. In some situations, the UI IRB cannot, or will not, serve as the lead/reviewing IRB (which will impact your study’s sIRB plan or budget).

If you have questions or need any assistance, contact the External IRB Team at uirb-external@uiowa.edu.

 

An Invitation - UI Research Services Fair (October 12, 2023)


The Research Services Fair is a vendor-style fair that provides researchers an opportunity to learn about campus resources and services available for their research and scholarship activities. Over 60 campus units are registered for the fair on Thursday, October 12, 2023 from 1:00-4:30 pm in the IMU Main Lounge (room 180, first floor).
Researchers of all levels (faculty, staff, post-docs, students) and research support staff are invited to:

  • Learn about cutting edge instruments and technology and many other services available in support of funding applications and research programs
  • Interact with centers, institutes, core facilities, and other service units
  • Network with colleagues

Registration is required. Register on the Research Services Fair web page by October 9. The Human Subjects Office and Conflict of Interest in Research will be there. Please stop by and say hi!

 

Medical Ethics Advisor Newsletter, August 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 August 2023 Medical Ethics Advisor Newsletter.
 

Community Members Help Train Research Staff

At most institutions research staff are required to go though training about the ethical principles of clinical research, however they are often not required to complete training about how to have a discussion regarding informed consent. To provide this necessary training, community members can act as simulated prospective study participants in role-playing exercises. Community members often participate in panels to act as simulated patients to train medical students and residents to take a patients’ medical history. Extending this exercise to research staff provides additional experience and an opportunity to learn to manage challenges in the consent process as they arise.

Articles in the August 2023 Issue:

  • Task Force Aims to Grow HEC-C Program
  • Ethicists View HEC-C as One Step Toward Professionalization
  • Ethicists Hold Debriefings After Critical Patient Events
  • ICU Staff Report Severe Moral Distress, But Resources Are Underused
  • Ethical Guidance for Research on Dying or Recently Deceased ICU Patients
  • For Clinicians, Discharge Safety Is a Growing Ethical Concern
  • Ethical Discharge Planning for Victims of Violence
  • Viewing Social Media Posts About Ongoing Care Could Harm Patient-Physician Relationship
  • Was Resident Involved in Surgery? Some Patients Are Not Informed
  • Community Members Help Train Research Staff
  • Real-Life Experience Allows Researchers to Obtain Ethical Consent
  • For Some Ethics Programs, ‘Tele-ethics’ Is Routine

 

In the News, September 2023