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Research News from the IRB
January 2022   •  View Online

This newsletter is brought to you by the Institutional Review Board and is intended to provide important updates and information that may affect members of the research community. For previous editions of the newsletter and other communications, click here.

HRPP News

COVID’s Impact on IRB Review

Like so many others, our office has been impacted by the high rate of infection of the Omicron variant. These are difficult and trying times for all, and we are doing and will continue to do our best to maintain a high level of service and responsiveness. Whether due to illness or the increased demands on parents as students return to distance learning, we know that resources are stretched thin and emotional reserves are nearly depleted. We know that this impacts both our staff and our members. We are aware of at least one meeting that lost quorum due to an unexpected absence. When this occurs, we are forced to reassign the items scheduled for review. We appreciate that these delays are frustrating, and we are committed to communicating as proactively as possible if staffing or member absences may significantly impact review timelines.

China’s New Personal Information Protection Law

The world is still waiting for guidance from the Chinese government to understand how China's Personal Information Protection Law (PIPL) will affect research. For now, we know the law applies to organizations (both controllers and processors) that handle the personal information (personally identifiable) of natural persons inside of China’s borders, as well as those that handle the personal information of persons inside of China’s borders while outside of China in certain situations:

  • Purpose of the collection is to provide goods/services to persons in China
  • Purpose of the collection is for analyzing or assessing activities of persons in China
  • Other circumstances provided in laws or administrative regulations (which are still being finalized)

The law provides that the data owner's consent is the primary basis for collecting and retaining data subject to PIPL, and the consent can be revoked. There are limited exceptions that allow a controller to retain the data.
 
Data transfers from a controller to a processor or other third party will be subject to inclusion of standard contractual provisions similar to those currently required under the EU’s General Data Protection Regulation (GDPR), but those provisions have not been finalized by the Chinese government. We will provide updated information when more guidance is released.

IRB News

Share Your Feedback - Research Community Survey

The Human Research Protection Program (HRPP) is committed to understanding and responding to the research community’s experience with the IRB.
    
To help inform this work, a survey is administered periodically to gather detailed feedback from research community members about their experience with the IRB. Survey questions focus on the quality, efficiency, and effectiveness of the IRB. This feedback allows IRB leaders to identify strengths and opportunities for improvement. 
 
Previous survey results and related action/progress reports can be found on the IRB website. Due to constraints related to the COVID-19 pandemic, there was a gap in survey administration and results from the summer 2020 survey have not been analyzed. However, respondents who requested contact from HRPP leadership have been followed up with. We look forward to once again regularly conducting and reporting on these surveys.  
 
If you have not already done so, please complete the brief survey linked below. The survey generally takes 10-15 minutes to complete. Responses will be collected through February 1, 2022.

Start Survey Now

Toolkit Feedback Under Review

Did you find a gap in our guidance? Do you have an idea on how we could provide clearer instructions? Documents in the HRPP Toolkit Library are changed periodically in response to feedback from the community, changes in best practices for human research protections, and institutional, local, or federal regulatory changes. Review of feedback is underway in preparation for the March 2022 release. Share feedback or suggestions regarding how to improve Toolkit documents, including the protocol and consent templates, by completing the HRPP Toolkit Feedback Form.

Reliance and Single IRB (sIRB)

Who, What, Where, When, How?
 
Do you have questions about whether UMN IRB will serve as the sIRB, whether you can submit to an external IRB, or whether external study personnel can be listed on a study? The Investigator Manual (HRP-103) includes guidance about sIRB and reliance processes. We would like to highlight Appendix B-5 which describes reliance and sIRB applicability for different study examples, such as:

  • Is sIRB required?
  • Will UMN IRB serve as sIRB?
  • Is an IRB Authorization Agreement (Reliance Agreement) required?
  • Will the UMN IRB allow for an Individual Investigator Authorization Agreement for external study personnel?

Dear IRBy

In this section, a real question, ripped from the IRB inbox (reprinted anonymously with permission from the sender), will be answered by the IRB team. 

Dear IRBy, 
 
I am confused by all of the dates associated with my submissions. Occasionally there is a difference between the IRB approval date and the “effective date.” Shouldn’t I be using the most recently approved version of a consent form once it is approved? How can I do that when the effective date is days or weeks after the approval date?
 
Distressed by Dates                                                                                      
 
Dear Distressed, 
 
Such a good question! When a submission is reviewed by full committee, the committee is required to determine if the criteria for IRB approval have been met. The committee’s review can result in one of four potential decisions: approved, approved with modifications required, deferred, or not approved. Understanding the dates associated with your submission requires understanding the difference between “approved” and “approved with modifications required.” In both cases, the committee has determined that the criteria for IRB approval have been met, but “approval with modifications required” means that the committee identified issues they consider to be minor or administrative in nature. In these situations, the committee is able to explain exactly what needs to be changed and how it should be changed. Assuming the PI makes the changes as described, the committee does not need to review the submission again. An IRB analyst can review the updated submission and confirm the changes have been made. The date that the changes have been confirmed becomes the effective date of the committee's decision to approve. For reviews of new applications, the approval date, not the effective date, determines the date of continuing review. 
 
Best regards, 
IRBy

Updates from Our Virtual Office

Staff Updates

On January 12, the HRPP office welcomed Jayden Myles as its newest IRB analyst I.
 
Jayden has a background in community-focused nonprofit organizations, most recently at Rainbow Health, where he worked as a MNsure coordinator, delivering training and educational support for clients, benefits counselors, and social services providers, executing state grant reports and MNsure grant applications, and developing and implementing enrollment events. He holds a BA from Hamline University. 
 
Please welcome Jayden to the office!

IRB Membership Updates

IRB members serve on the IRB, but their service is to the University of Minnesota research community. Their gifts of expertise and time make possible all human subjects research at the University.   
 
This month, Elizabeth Braunlin, professor of Pediatrics in the Division of Pediatric Cardiology, was appointed IRB Chair of Panel F. We thank Dr. Braunlin for serving in this important role!
 
We greatly appreciate the time and commitment of our members, as well as the support our members receive from their departments. We continue to seek new members to fill critical expertise needs. If you are interested in becoming an IRB member, or if you would like to learn more about membership expectations or needs, please reach out to us at irb@umn.edu.

IRB Submission Tips from the Experts

We asked the IRB analysts to share tips with the community to help make the IRB review process more efficient. This month’s tips are from Jeni O'Keefe:

Determination Form Submission Tips

To submit a Determination Form (HRP-503), you must submit the completed form in ETHOS. This is the only way to receive a formal IRB determination. Once received, the IRB will evaluate your submission against the definition of human research using Human Research Determination (HRP-310). If the project constitutes human research, you will be asked to withdraw/discard the submission and create a new study.

Please do:

  • Complete all sections of the determination form.
  • Submit any interview or survey questions.
  • If you are a student investigator, have your advisor submit the Determination Form (HRP-503). Please note that student investigators should create the ETHOS submission.

Please do not:

  • Do not submit consent forms.
    • These materials can be submitted as part of a new study submission if your project is determined to meet the definition of human subjects research. 
  • Do not submit recruitment materials.
    • These materials can be submitted as part of a new study submission if your project is determined to meet the definition of human subjects research..         
  • Do not submit HRPP Checklists or Worksheets.
    • These tools are for the use of IRB staff and members as a reference when reviewing IRB submissions to enhance compliance with federal, state, and local requirements. Study teams never need to submit these documents. 

Quality Assurance Corner

Did You Know?

Principal investigators are expected to plan for the protection of data that could be identified with individuals or groups. The plan must be described in the protocol and should be appropriate to the way in which the data are collected, analyzed, stored, or transmitted. Provisions for confidentiality should be explained to prospective participants in consent documents and during the consent process. 
 
In order to manage data security risks, units and UMN community members must ensure that their electronic devices and other resources which store, transmit, or process University information meet the information security processes and standards contained in the Information Security Policy
 
For most types of human subjects research, University policy requires that a professional IT organization manage the systems, or that an exception to University policy is filed. If a principal investigator manages their own research data storage or IT systems, a gap analysis to the University information security standards is required. A gap analysis may also be useful for a data management plan. Related resources include:
 
Policies and Guidance
●  Policy and Guidance for Information Security 
●  Classifying Research Data
●  Practices for the Information Security Policy 
 
Procedures
●  Setup and Use Two-Factor Authentication
●  Enable Security Features on Your Device

Educational Opportunities

ICYMI - 2021 NIH Regionals, OHRP Presentations on Human Subjects Research

Didn’t get a chance to attend the 2021 NIH Regionals? Watch recordings of OHRP presentations on human subjects research and investigator responsibilities for protecting participants in research: 
 
"What is Human Subjects Research? Review of the Common Rule and Its Application" explains the complex concept of human subjects research and how to address related considerations in the NIH grant application process.
 
"Part II: What Investigators Should Know About IRB Review" helps investigators understand the thoughts and considerations needed for writing a successful plan to protect human research participants that would pass the muster of reviewers. (This topic starts at 51:16 in the presentation.)

Ongoing IRB Support Services

HRPP Staff Are Here to Help!

HRPP staff are available to assist you via Zoom, email, and phone. The HRPP staff list provides contact information and working hours for all HRPP employees. 
 
You may also schedule an appointment with an IRB representative: 

  • If you would like to speak with an analyst or manager and don’t want to play phone tag, the HRPP front desk can schedule a phone call. Please call the front desk at 612-626-5654.
  • If you would like to set up a virtual appointment/project consultation via Zoom, IRB staff members are available to do so. To request an appointment, email irb@umn.edu. 
  • IRB staff also maintain regular (virtual) office hours at the Clinical Research Support Center.
Share Feedback & Concerns
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