June 11, 2020
Message from the Director:
I would like to take a moment to recognize the remarkable job that RPO staff have done over the last several weeks. While transitioning to working from home, staff were able to continue their regular workload, convene Committee meetings remotely, when we had never done so previously, manage protocol modifications secondary to COVID ramp down procedures as dictated by University policy, as well as review 83 new COVID-19 related submissions. RPO staff also continued the roll out the animal module of the Click system. I feel very fortunate to have such a group of committed staff.
Please join me in thanking our RPO Analysts: Karen Crain, Sarah Wright, Gale Weld, Ryann Guayasamin, Jen Dulin, and Abbey Dattilio. Additionally, I would like to recognize the RPO Assistant Directors, Melanie Locher and Aubrie Clas as they have worked tirelessly to support our analysts during this time and to ensure that scientific connections were made between researchers for COVID collaborative research.
Resumption of Human Subjects in Research
As communicated on May 29, the first phase of reopening human subject research began as of June 1. OCTR and the IRB have received many clarifying questions. We have updated our set of FAQs which can be found here.
There has been confusion about which trials are allowed to resume. At this time, only treatment trials are allowed to resume activities. Treatment trials are trials where researchers introduce an intervention and study the effects. Observational trials are trials where researchers observe the effect of a risk factor, diagnostic test, treatment or other intervention without trying to change who is or isn’t exposed to it.
Here are a few action items we wish to bring to your attention to ensure that the institution remains in compliance.
- If you enacted an immediate change from in-person to remote interactions in March/April to avoid “immediate hazard” to the subject (including potential exposure to COVID-19), you must now submit a modification for IRB acknowledgement. It is anticipated that the majority, if not all studies, will continue to have a remote component, at least for the near future, therefore IRB review of that change is required.
- Prior IRB review and approval is required for any protocol changes you plan to make as human subjects research resumes. As the notice states, you must limit as much in-person contact as possible. If any activities can be done remotely, they should be done remotely. This type of change requires a modification to the protocol.
Now available, IRB-approved COVID information sheet for subjects regarding how their on-campus research visits will change. “Caring for You During Your Research Visit” is being used with permission from Vanderbilt. You may add staff information to this document and share with subjects. IRB approval is not necessary.
InfoEd Human Subjects Module
Access to the old InfoEd human subjects module will be discontinued with the termination of our InfoEd subscription in June of this year. At that time, current users, including, IRB staff will no longer have access to this tool for reference.
Educational Opportunities
IRB Drop-In Hours
Staff continue to work from home. Please feel free to reach out to your analyst for assistance. If you are unsure who your analyst is, you can find out by using the Who’s My Research Analyst tool found at the bottom of the IRB main page.
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June RPN Workshop – ̽̽/̽̽ Medical Center Workshop
Topic: The “How To” of Clinical Trials.gov
Presenter(s): Kim Luebbers, Annie Penfield-Cyr and Jennifer Holmes
Level: Fundamental
Date: June 16, 2020, 3:00 to 4:15 p.m.
Location: Remote
Registration: Please use the link below to register for this workshop
Objectives:
- Understand the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to Clinical Trials.gov, in accordance with Section 801 of the FDA Amendments Act (FDAAA 801)
- Provide guidance regarding obtaining clinical trials.gov account and review registration process
- Understand the definitions of applicable clinical trials
̽̽Click – IRB Tips
1. SMART Form - Short Title field – We are experiencing problems with use of study acronyms in this field. This field is being exported into the EPIC system where multiple hospital personnel, as well as patients are able to see this acronym. Unfortunately, the acronym is often only meaningful to the PI, study personnel and sponsor.
Therefore, going forward, you have two choices. If the full study title is less than 250 characters, copy that into the short title field (if space allows, you may include the acronym at the end.) If the full title is longer than 250 characters, you must simplify the title while including enough information to make it meaningful beyond the study personnel. You may include the acronym in these instances at the end of the title as space allows.
2. Reminder - When looking for a specific modification, go to the Follow On Submissions tab. This is the tab where you will find the modification descriptions.
Regulatory Updates
On March 17, the US Secretary of Health and Human Services issued a to provide liability immunity for activities related to medical countermeasures against COVID-19. As a result, potential research subjects need to be informed that their rights to sue may be restricted when they agree to participate in COVID-19 research projects.
̽̽/̽̽MC researchers who propose new research related to COVID-19 must read the declaration to determine if their protocol is applicable and ensure that this information is added to the informed consent document. Contact your IRB Analyst for assistance.
News from The Office of Clinical Trials Research
New Policy Notification: ̽̽ Health Network and LCOM Research administration recently approved a new policy entitled “Clinical Research Monitors and Monitoring Visits”. The Policy can be found on the OCTR and in the ̽̽ Health Network policies and procedures in the Research and Clinical Trials folder.
As a reminder under COVID-19 pandemic response restrictions, we are still unable to allow guests on campus, e.g. vendors or monitors, please continue to conduct monitoring visits remotely until such time this policy has been lifted.