COVID-19 Updates

Electon microscope image of Covid 19

A message from the Dean

Dear members of the Mandel School community,

With the arrival of COVID-19 (novel coronavirus) in Cuyahoga County, I want to assure you that the university is treating the potential threat of the virus very seriously. The safety and well-being of our students, faculty and staff are our highest priority. While we are a relatively small community, those who we interact with make our community much larger. All of us will play a part in how the university responds to COVID-19, and your involvement is both critical and appreciated.

Announcements about COVID-19 and how it affects our campus can be found on the University Health and Counseling Services' COVID-19 Health Updates webpage. The CDC's website also provides the most recent global COVID-19 information.

Health officials in the university are monitoring developments locally and nationally, and plans are evolving as we prepare to move to the remote delivery of courses. 

If you have specific situations or concerns, I encourage you to talk to your supervisor. We want everyone to feel comfortable where they work and where they learn. In the meantime, we should all follow the common-sense precautions that are advised: clean your hands often, avoid close contact, stay home if you’re sick, cover coughs and sneezes, and clean and disinfect.

In good health,
Grover "Cleve" Gilmore

Mandel-specific communications

Campus-wide communications

Netiquette refers to the rules of etiquette that apply when communicating over computer networks, the Internet and online course rooms. In other words, netiquette helps to define our professional interactions in the course room and live sessions. Think of the course room as a professional environment. Verbal and written communication should be appropriate for professional and academic settings.

The following netiquette guidelines are recommended when interacting with peers, faculty and instructors in the course room and during live video streams.

During Live Sessions 

  • Please log into the live session link 10-15 minutes before the start of the live session. This will allow you to test your audio and camera prior to the start of the session.
  • Full participation in live sessions is expected each week. Full participation includes being live on camera with audio/microphone features activated. This means that your face should be visible on camera for the duration of the live session, unless you need to step away momentarily.
  • Minimize eating and drinking on camera. This can be distracting to others during the live session. It is appropriate to take occasional sips of a beverage during a live session to remain hydrated.
  • Minimize environmental distractions such as telephones, roommates, children, TV, pets, smoking, video games, and side conversation. Identifying a private and quiet space prior to the start of the live session is ideal. It may be helpful to communicate with friends and family in advance to support you in your efforts to decrease distractions during your live session learning experience.
  • When possible, sit facing the light source. Often light sources that are behind you can appear very bright on camera to other video participants and wash out the details of your face. A light source that comes from below your neck area can mimic scary movie scenes.
  • Your attire for video conferences should be appropriate for the classroom setting. It is easy to want to become comfortable and relaxed during live sessions. This is particularly true if you are attending live sessions from your home. However, remember live sessions are a part of your academic and professional environment. Apparel such as pajamas or clothing with offensive text are not appropriate for the classroom setting.
  • If you are not speaking, it is best to mute your mic. This minimizes the background noise other participants may hear.
  • Give consideration to your immediate environment that will appear on camera. When possible, try to position yourself in front of a solid light colored wall. Laying across your bed or sitting in front of signs with messages inappropriate for an educational setting may be offensive to others.

Here are some helpful tips provided by Zoom.

Reference material on dictionary.com.

University Hospitals IRB logo

FAQs Regarding Human Research Procedures Related to Coronavirus COVID-19

Do I need to amend my protocol to reflect clinical screening procedures for coronavirus COVID-19?

No. New mandatory clinical screening procedures are not considered part of the “IRB approved procedures” for your protocol and therefore do not necessarily trigger the need for an amendment to the protocol. These screening procedures do not constitute a change in IRB-approved research procedures unless you choose to incorporate the data collected under the mandatory screening into your study plan as part of the research.

I am a PI of an investigational drug/device trial. Do I need to pause my trial?

No, if there is a potential benefit from the trial that outweighs any additional risk from COVID-19, trials with investigational treatments, including drugs and devices, should continue.

What changes am I allowed to make to my protocol right now in light of COVID-19? Can I cancel study visits?

Any changes in IRB-approved research procedures must be reported to the IRB and may not be implemented prior to review and approval by the IRB except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule (38 CFR §16.108(a)(3)(iii)) and FDA regulations (21 CFR §56.108(a)(4)) in order to prevent investigators from delaying the initiation of safety changes to eliminate apparent immediate hazards to subjects.

University Hospitals also has a responsibility to ensure the safety of its staff. As such, interim measures to eliminate immediate hazards to staff, which may involve deviating from approved study procedures prior to securing IRB approval, may be warranted. Examples of modifications or safety changes include, but are not limited to: 

  • cancelling non-essential study visits
  • conducting phone visits in lieu of in-person visits
  • conducting safety screening (initiated by the Principal Investigator) prior to in-person visits occurring
  • other changes as deemed appropriate to eliminate immediate hazards to subjects because of the risk of exposure to this highly communicable disease.

All modifications must be authorized by the Principal Investigator and, unless an immediate hazard is apparent, the funding agency or sponsor must also provide prior approval. In all cases, the funding agency or sponsor must be notified of any modifications within one(1) business day. If it is anticipated that changes made to the study to eliminate apparent immediate hazards will be sustained for a duration that would allow time to submit an amendment to cover such changes, then approval of a protocol amendment must be sought.

In some cases, these protocol changes may involve the Principal Investigator temporarily stopping subject recruitment or placing a temporary hold on all study procedures. If you are conducting an FDA regulated, investigator initiated research study and you are the holder of the IND or IDE, you will also need to notify the FDA of any modifications.

If I make any modifications to the Protocol do I need to document them?

Yes. All changes should be documented in your regulatory binder. Be sure to include details about communication with the funding agency, sponsor, or FDA as well as justifications for any changes made. You should also submit an RNI (Reportable New Information) form through SpartaIRB to document that you informed the IRB of the alternative procedures.

If I am considering pausing or modifying study procedures for a study that uses an external IRB (ex: Advarra), do I need to notify the IRB of Record?

The regulations allow implementation of a change to study procedures without prospective IRB approval when it is necessary to avoid imminent hazards to subjects; however, each IRB makes its own decisions with regard to the approval process. The UH IRB does not have the authority to make decisions on behalf of external IRBs.


For other issues related to COVID-19 procedures, please contact the University Hospitals IRB Administration Office at 16-844-1529 or UHIRB@UHhospitals.org. Please note that the Clinical Research Center is actively working to develop options for virtual visits. We will communicate these options as soon as they are available.

Events

Please check with the organizer of your event and/or the Mandel School's Event Calendar for the status of each event.

COVID-19 Community Offerings by the Center on Trauma and Adversity

In this time of uncertainty, stress, and trauma, the ability to regulate and to connect with others is more important than ever.  Practitioners, teachers, and providers locally and nationally have volunteered their time and their labor to lead our community in a variety of virtual practices, workshops, and classes, free of charge.

See the Center on Trauma and Adversity's website for their listing of community offerings.