Research Re-engagement @ GVSU - Our Plan

Laboratory and Studio Research

On May 15, 2020 Governor Gretchen Whitmer signed Executive Order 2020-90 authorizing the limited reopening of research activities.  In response, the University has developed a plan outlined below that will resume overall research operations in a strategic, phased approach that is compliant with state regulations while honoring GVSU’s commitment to the health and well-being of our students, faculty, and staff.  (Governor Whitmer has since superseded EO 2020-90 with more current executive orders, but limitations surrounding research activities remain.) 

1.     Government Guidance . Decisions on how GVSU will safely ramp up research activities are guided by the Executive Orders of the Governor of the State of Michigan and recommendations from regional county public Health Officers and Center for Disease Control.

2.     Person-first Approach. No student, staff, or faculty researcher shall be required to conduct research activities on campus, or in the field, if they are concerned about their health or working conditions.

3.     Rigorous Safety Practices. Safe practices within laboratories, studios, and in shared areas must be carefully planned and maintained, with adequate access to Personal Protection Equipment (PPE), utilization of social distancing, and other safety-related practices and supplies.

4.     Research Community Commitment. Our ability to sustainably return all of our research activities to “normal” will depend on the dedication of researchers to actively implement physical distancing and other safety measures, both inside and outside of the GVSU work environment.

5.     Continuation of Remote Operations. Some research activities have successfully and safely transitioned to being fully remote, requiring infrequent or no access to university spaces. Those activities are considered important and essential; however, they should continue remotely in order to limit the number of individuals on our campus.

 Provide notification of intent to return to research complete the Research Ramp-Up Questionnaire. For single brief visits to campus notify your College for access requirements.

 

Read and be prepared to comply with the provisions of the COVID Preparedness and Response Plan for Research Activities and Executive Order No. 2020-161 Safeguards to protect Michigan's workers from COVID-19. (The provisions covering research laboratories are found in Item #5 of Executive Order No. 2020-161.)

 

Complete Lab Specific Infection Control and Response Procedures using this template or a similar document.  

 

Anyone involved in lab or field research must complete GVSU’s Infection Prevention and Control Training in Blackboard.   Click here to access the Safety Training Blackboard Page.  If you are unable to access the page click here to request access or contact Lab Safety directly.

 

Any employee or student coming onto campus must complete the University's COVID-19 Self-Assessment screening questionnaire and be cleared to travel to campus prior to arriving on campus.

Standard procedures:

The safety and well-being of the GVSU community and the general public are the guiding principles for this Plan. If resumption of research activities present unreasonable risks, they may be terminated without warning.   

 

The provisions outlined in this plan are based upon current public health guidance.  These requirements may change over time based upon regulatory guidance and the developing understanding of disease transmission.

 

Access to campus will be permitted only where it is essential for the research activity.  Wherever possible, minimize the time on campus and work remotely.  

 

General Procedures:

  • All faculty are required to notify the Vice Provost for Research Administration to request access to campus for research.  Only critical approved personnel will be granted access.
  • If research can be done remotely, the work must continue to be done remotely until the University has implemented a campus-wide return to work plan.
  • Faculty must provide Research-specific Infection Control and Response Procedures to the Director of Laboratory Safety.
  • COVID-19 training must be completed by all faculty and staff associated with research activities.
  • International and non-essential domestic travel is not permitted as consistent with university guidelines.
  • Guests, visitors or anyone else not affiliated with GVSU may not access the buildings (unless required for clinical studies as approved by the Institutional Review Board [IRB]).
  • In-person human subjects research is prohibited unless the IRB has evaluated and approved infection control plans.
  • Common areas and office spaces may not be used unless the faculty office is the only space the research can be conducted (specialized technology, sensitive data, etc).
  • Use of shared equipment and lab supplies must be approved by the Department Chair and coordinated with the Laboratory Supervisor.
  • Failure to follow policies and procedures outlined in this Plan, University guidelines, or the Executive Order will result in loss of access to research and could be subject to criminal charges.

Individuals entering university laboratories for research must complete the following:

  • Approval of each individual from the Vice Provost for Research Administration.  This is inclusive of the faculty researcher and any student employees who need access to the space.
  • Individuals’ names will be registered with the Director of Lab Services and be provided with appropriate keycard access (where applicable).
    • For the PAD/HRY/KHS science complex please email Aaron Perry with a list of the researchers who are planning to do research.  Key cards will be activated on the specific day they can start work in the laboratory.
    • Use the Science Key Card Request Form for requesting access for new students and additional spaces. Key Card Request Form 
  • Any employee or student coming onto campus must complete the University's COVID-19 Self-Assessment screening questionnaire and be cleared to travel to campus prior to arriving on campus.
  • Verification of proper face covering and proper handwashing/sanitization practices.
  • Access only the spaces which you have been given permission to enter and use.  Enter and exit the labs using the flow patterns either previously designated or as approved in your lab-specific plan.  Use restrooms designated by Facilities Services for routine cleaning.   
  • When returning to work in the lab for the first time, follow this checklist to ensure the lab can be safely used.  Report any problems to Aaron Perry, Director of Lab Services and your department Chair.

The following are minimum standards for working safely in research.  Each Principal Investigator will develop research-specific safe work practices specific for their work.

  • Physical Distancing -  Physical distance of at least 6 feet when more than one person occupies a room.  Room capacities will be adjusted to accommodate the increased spacing requirements, typically one person per research bay.  Lab specific capacities are available through the Director of Lab Services.
  • Researcher Scheduling – Where possible, schedule researchers in a way that minimizes the number of people in the space at one time.
  • Face Coverings – Cloth face coverings should be worn whenever possible.  Face covings will be provided to occupants upon request.  Face masks are not considered respirators under OSHA’s Respiratory Protection Program.
  • Personal Protective Equipment (PPE) - Most workers at high or very high exposure risk likely need to wear gloves, a gown, a face shield or goggles, and either a face mask or a respirator, depending on their job tasks and exposure risks.  Those who work closely with (either in contact with or within 6 feet of) patients known to be, or suspected of being, infected with SARS-CoV-2, the virus that causes COVID-19, should wear respirators.  Jobs with this type of exposure should complete a PPE Risk Assessment with the Director of Laboratory Safety.
  • Handwashing - Hand hygiene that removes or kills microorganisms on the hands is the single most effective way to prevent the spread of communicable diseases and infections.  Use of alcohol-based hand sanitizers are effective where hands are not visibly soiled.  Once hands have been cleaned, keep your hands away from your eyes, nose and mouth.
  • Disinfection – Lab staff are responsible for disinfecting equipment and surfaces in labs.  Workstations should be disinfected at least twice daily.  All shared equipment should be disinfected before and after use.  Follow CDC Guidelines or GVSU guidelines for disinfection procedures and products.
  • Work-related COVID-19 illnesses should be reported to Human Resources.
  • Access records will be maintained in the Chemical Supply and Inventory Management System (CSIMS).
  • Lab Specific Infection Control and Response Procedures will be reviewed and approved by the Director of Laboratory Safety and uploaded to the PI’s SOP binder in CSIMS.
  • Each lab will be subject to compliance audits by the Vice Provost of Research Administration and/or the Director of Laboratory Safety to ensure that infection control procedures are being followed.
  • Training records will be maintained in Blackboard.
  • PI’s must maintain records of training of lab staff on the Lab Specific Infection Control and Response Procedures.

Research Ramp-Up Questionaire

All faculty and staff who wish to resume research activities in a non-remote manner must complete the following questionnaire.  The CSCE will be sharing this information with your College and Department.

Research with Human Subjects

To restart in-person research interactions, the following steps must be completed :

  1. Complete the CSCE Research Ramp-Up Questionnaire.
  2. All previously approved IRB studies involving in-person interactions must be re-reviewed and approved by the IRB before the research may resume.  Researchers must submit an amendment to the IRB via IRBManager.  Refer to IRB Guidance G-19: Guidance on Conducting Human Subject Research Studies During COVID-19 for information on what needs to be included in the amendment.
  3. The IRB is working concurrently with the Institutional Biosafety Committee (IBC) to ensure compliance with biosafety regulations.  We will be sharing your amendment with them as part of a co-approval process.  As such, due to additional review processes, you should anticipate additional time for review.  Please keep this in mind for your timelines.  We will, as always, endeavor to provide you with the quickest and most efficient service.  Please note, if your study originally required IBC approval, researchers may need an IBC amendment as well. For questions regarding this, please contact the GVSU Biosafety Officer, Jim Seufert (seufertj@gsvu.edu; 616-331-8628) or the Office of Research Compliance and Integrity (rci@gvsu.edu, 616-331-3197).

Research can resume only upon approval/completion of all above steps. This includes approval from your Unit Head/Appointing Officer (via the CSCE questionnaire), the IRB and possibly the IBC.

Enrollment must be halted if the research requires any in-person interaction. Enrollment cannot be restarted until an amendment has been approved by the IRB describing how the research will be modified to account for increased protections regarding coronavirus transmission. Refer to the question above for information on how to do this. 

It is the responsibility of the principal investigator to identify any research procedures that would be essential to continue for the safety and well-being of the subjects, and to develop a plan to continue to deliver these procedures and monitor for safety even in the face of disruptions.

Principal investigators must identify procedures that are not essential to subject safety but that are important to the integrity of the research data, and determine whether there are alternative methods to mitigate the loss of data, such as remote contact by phone.

We strongly recommend transitioning all in-person interactions to telephone or online interactions when possible.  If the approved protocol does not allow for this, an amendment may need to be submitted before these interactions can resume. Refer to the following question for instructions. 

If you seek to use video-conferencing as an alternative to in-person interactions, we encourage the use of University-supported platforms such as Zoom or Skype for Business. However, other platforms may be utilized by the researchers, so long as they appropriately protect participants’ privacy and data.

If in-person interactions are required, consider if these could be safely delayed without affecting the integrity of the research.  If the interactions will occur in community settings such as schools or assisted-living facilities, the researcher should communicate with the site administrator to ensure the researchers are still able to come on-site and interact with research participants. The PI is also responsible for reviewing and abiding by any current executive orders pertaining to the sites.

If a research participant has already enrolled in the research and a required research interaction is delayed outside of the protocol-defined window, this is a planned protocol deviation.  It needs to be submitted as an amendment and approved by the IRB prior to implementation.  Failure to do so may be deemed research non-compliance. Refer to the following question for instructions.

Many studies are modifying their procedures to replace in-person study visits with remote options for questionnaires, surveys, check-ins, screening and consenting. 

  • If the research has previously been determined to be exempt, no amendment needs to be submitted as long as the changes do not alter the level of review or increase risk to participants.
  • If the research has been approved through expedited or full board review, an amendment must be approved before the changes can be implemented.  Be sure to document in the amendment that it is being implemented due to COVID-19 so that it can receive prioritized IRB review. Failure to submit an amendment may be deemed research non-compliance.

Researchers are reminded that data protection measures are still required for all research, regardless of level of review.  Do not store identifiable research data on unsecure devices.  Refer to IRB Policy 730 : Collection, Management and Security of Research Information and the corresponding IRB Guidance D ocument G-16 : Guidance on Data Management Requirements for Research Data  for available alternatives.  You are encouraged to contact ORCI at rci@gvsu.edu or 616-331-3197 with any questions. 

The main disruption would be the result of staffing shortages due to quarantine, isolation, care of children due to school closings, travel restrictions, etc.  Study participants may also decline to attend study visits for the same reasons.  Additional disruptions could involve being unable to obtain protective equipment or limits on the availability of services and space. 

If your research is listed at the federal site ClinicalTrials.gov and you are modifying the research procedures to complete remote visits or delaying study visits, then the ClinicalTrials.gov information for the study needs to be updated to include these changes.  The federal requirement about modifications is that any research-related changes that are communicated to the participants (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration within 30 days after IRB approval of the modification.

Yes.  The Office of Research Compliance and Integrity and the Institutional Review Board are fully operational.  We remain committed to supporting our faculty, staff and students during this uncertain time.

Working Safe @ GVSU

Anyone involved in lab or field research must complete GVSU’s Infection Prevention and Control Training in Blackboard.  Access to the training can be provided by clicking here or contacting Lab Safety.

Research involving Animals

Provide notification of intent to return to research complete the Research Ramp-Up Questionnaire. For single brief visits to campus notify your College for access requirements.

 

Read and be prepared to comply with the provisions of the COVID Preparedness and Response Plan for Research Activities and Executive Order No. 2020-161: Safeguards to protect Michigan's workers from COVID-19 (item 5, referring to research laboratories).

 

Complete Lab Specific Infection Control and Response Procedures using this template or a similar document.  

 

Anyone involved in lab or field research must complete GVSU’s Infection Prevention and Control Training in Blackboard.  Click here to access the Safety Training Blackboard Page.  If you are unable to access the page click here to request access or contact Lab Safety directly.

 

Any employee or student coming onto campus must complete the University's COVID-19 Self-Assessment screening questionnaire and be cleared to travel to campus prior to arriving on campus.

Standard procedures:

The safety and well-being of the GVSU community and the general public are the guiding principles for this Plan. If resumption of research activities present unreasonable risks, they may be terminated without warning.   

 

The provisions outlined in this plan are based upon current public health guidance.  These requirements may change over time based upon regulatory guidance and the developing understanding of disease transmission.

 

Access to laboratories will be permitted only where it is essential for the research activity.  Wherever possible, minimize the time on campus and work remotely.  

 

General Procedures:

  • All faculty are required to notify the Vice Provost for Research Administration to request access to campus for research.  Only critical approved personnel will be granted access.
  • If research can be done remotely, it must continue to be done remotely until the University has implemented a campus-wide return to work plan.
  • Faculty must provide Research-specific Infection Control and Response Procedures to the Director of Laboratory Safety.
  • COVID-19 training must be completed by all faculty and staff associated with research activities.
  • International and non-essential domestic travel are not permitted as consistent with university guidelines.
  • Guests, visitors or anyone else not affiliated with GVSU may not access the laboratories. 
  • Common areas and office spaces may not be used unless the faculty office is the only space the research can be conducted (specialized technology, sensitive data, etc).
  • Use of shared equipment and lab supplies must be approved by the Department Chair and coordinated with the Laboratory Supervisor.
  • Failure to follow policies and procedures outlined in this Plan, University guidelines or the Executive Order will result in loss of access to research and could be subject to criminal charges.

Individuals entering university laboratories for research must complete the following:

  • Approval of each individual from the Vice Provost for Research Administration.  This is inclusive of the faculty researcher and any student employees who need access to the space.
  • Individuals’ names will be registered with the Director of Lab Services and be provided with appropriate keycard access (where applicable).
    • For the PAD/HRY/KHS science complex please email Aaron Perry with a list of the researchers who are planning to do research.  Key cards will be activated on the specific day they can start work in the laboratory.
    • Use the Science Key Card Request Form for requesting access for new students and additional spaces. Key Card Request Form 
  • Any employee or student coming onto campus must complete the University's COVID-19 Self-Assessment screening questionnaire and be cleared to travel to campus prior to arriving on campus.
  • Verification of proper face covering and proper handwashing/sanitization practices.
  • Access only the spaces which you have been given permission to enter and use.  Enter and exit the labs using the flow patterns either previously designated or as approved in your lab-specific plan.  Use restrooms designated by Facilities Services for routine cleaning.   
  • When returning to work in the lab for the first time, follow  this checklist to ensure the lab can be safely used.  Report any problems to Aaron Perry, Director of Lab Services and your department Chair.

The following are minimum standards for working safely in research.  Each Principal Investigator will develop research-specific safe work practices specific for their work.

  • Physical Distancing - Physical distance of at least 6 feet when more than one person occupies a room.  Room capacities will be adjusted to accommodate the increased spacing requirements, typically one person per research bay.  Lab specific capacities are available through the Director of Lab Services.
  • Researcher Scheduling – Where possible, schedule researchers in a way that minimizes the number of people in the space at one time.
  • Face Coverings – Cloth face coverings should be worn whenever possible.  Face covings will be provided to occupants upon request.  Face masks are not considered respirators under OSHA’s Respiratory Protection Program.
  • Personal Protective Equipment  (PPE)- Most workers at high or very high exposure risk likely need to wear gloves, a gown, a face shield or goggles, and either a face mask or a respirator, depending on their job tasks and exposure risks.  Those who work closely with (either in contact with or within 6 feet of) patients known to be, or suspected of being, infected with SARS-CoV-2, the virus that causes COVID-19, should wear respirators.  Jobs with this type of exposure should complete a PPE Risk Assessment with the Director of Laboratory Safety.
  • Handwashing - Hand hygiene that removes or kills microorganisms on the hands is the single most effective way to prevent the spread of communicable diseases and infections.  Use of alcohol-based hand sanitizers are effective where hands are not visibly soiled.  Once hands have been cleaned, keep your hands away from your eyes, nose and mouth.
  • Disinfection – Lab staff are responsible for disinfecting equipment and surfaces in labs.  Workstations should be disinfected at least twice daily.  All shared equipment should be disinfected before and after use.  Follow CDC Guidelines or GVSU guidelines for disinfection procedures and products.

Yes.  The Office of Research Compliance and Integrity and the Institutional Animal Care and Use Committee are fully operational.  We remain committed to supporting our faculty, staff and students during this uncertain time.

GVSU Lab-Specific Infection Control and Response Procedures

In order to re-engage with research at Grand Valley State University, PIs must provide specific policies and procedures for controlling exposure to COVID-19.  A fillable template is available here

Field Research (Regional Based, Non-Human Subject)

  1. Separate transportation should be used whenever possible;
  2. Campus facilities should be used to the minimum extent necessary to prepare for the fieldwork;
  3. Researchers should maintain substantial physical separation (10 feet or more) whenever possible, and practice proper hygiene and safety precautions.
  4. Samples may be processed (on campus or in the field) only to the extent necessary to preserve their value, unless they have time-sensitive processing needs (ie. cannot be preserved, or must be processed to meet grant and regulatory timelines).  In such a case, researchers will maintain physical separation of 6 feet or more, and practice proper hygiene and safety precautions.
  5. On-campus computer analysis of data should be delayed unless time-sensitive analysis is needed (ie. must be processed to meet grant and regulatory timelines). In such a case, researchers will maintain physical separation of 6 feet or more, and practice proper hygiene and safety precautions.

Lab Start-up Checklist

The following guide is provided to assist researchers in their lab-specific preparations for bringing their research laboratories back online from temporary shutdown

Office of Sponsored Programs

In general, we expect that OSP will be able to submit proposals, even if personnel are working remotely. At present, all federal agencies are accepting proposal submissions as usual. In the event a COVID-19 outbreak closes a federal agency that is currently accepting proposals, we expect the agency will continue to accept proposals; however, the proposals will most likely remain in a queue (e.g., within the Grants.gov system), pending resumption of agency operations – as has been the case during recent federal budget-related shutdowns. As always, the OSP is here to support your research during this time of uncertainty.  Information will be posted on the OSP website, as necessary.

Most sponsors do not accept late proposals, and if they grant extensions, they do so on a case-by-case basis. Given that the OSP may be working remotely, and thus operational, it may prove difficult to convince a sponsor that your circumstances warrant granting an extension. Faculty who are working on a proposal now should therefore plan on submitting by the sponsor’s stated deadline regardless of whether there is an active COVID-19 outbreak at GVSU.  If you personally experience impacts from COVID-19, reviewing the sponsor's standard exception policies may be warranted.

In general, yes, provided you remain engaged in your project. Current NIH and NSF prior approval requirements regarding disengagement from the project for three (3) months or more, and effort reductions of 25 percent or more, remain in effect.

Yes. After the IRB makes specific protocol determinations, they will provide OSP with information concerning those protocols that will require a pause and follow-up communications will be sent by OSP for all impacted grants. OSP will notify each PI prior to issuing a follow-up notification to a sponsor.

Yes. The same ethical issues relating to the changed risk/benefit ratio that apply to a GVSU site apply elsewhere.

The Council on Government Relations (COGR) has compiled a listing of updates from federal sponsors. Researchers are encouraged to check this website for updates from federal sponsors: Institutional and Agency Responses to COVID-19 and Additional Resources

GRC has begun monitoring the agencies that have released guidance for those with current grants or pending applications. Most agencies now have  a COVID-19 pages even if they have not yet begun to address grant/contract-related issues. The following is a list with links provided to assist during these uncertain times:

Ramp-up Questionnaire-Undergraduate Research Assistants Access to Research Spaces

This form is required for all undergraduate research assistants requesting to engage in research activities.