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Research Re-engagement

Tiers Approved for Human Research Activation

  • Tier 0
  • Tier 1
  • Tier 2

Last Updated: 2:50 p.m. on October 28, 2020

Research leadership from across the three University of Michigan campuses are working together to safely continue research and scholarship, in accordance with state regulations. ​Please refer to the October 28 communication from U-M Vice President for Research Rebecca Cunningham for more information about ongoing efforts to safely continue research and scholarship across U-M.


Human Research

Guiding principles for human research during COVID-19

  1. The safety of research participants, individuals accompanying them in their research participation, the research workforce, and our broader communities, is the leading priority.

  2. The diversity of types of research across campus is a strength and critical to our research enterprise and mission. 

  3. For safety and feasibility, human research will activate in 4 Activation Tiers (0, 1, 2, 3).

  4. The order and timing of Activation Tiers is based upon the benefits of the research to individual participants balanced with the risk of COVID-19 community transmission. Greater benefit to individual participants balanced with lower risk for COVID-19 community transmission places the study in an earlier Activation Tier. Later Activation Tiers are activated when COVID-19 community transmission is lower, and deactivated when COVID-19 community transmission is high enough that potential risk of increased community transmission caused by the research activity outweighs benefits of the research to the individual participant or to society. Each study’s COVID-19 Activation Tier will guide whether the study is activated as COVID-19 transmission rates change in the community and setting in which the research takes place.

  5. Study protocols must be optimized to provide the lowest risk for COVID-19 transmission feasible while providing the greatest benefit to the individual participant and society.

  6. Activation of human research is dependent on adherence to local COVID-19 guidelines, regulations, and approvals in the setting where the research is conducted. Study procedures must be continually modified to adhere to any changes in local COVID-19 guidelines or regulations.

  7. Students or postdoctoral researchers may not be compelled to conduct research activities on campus as a condition of assistantship or associate support, while public health orders governing individual activity remain in effect.

  8. Human Research Activation Committees with faculty and staff expertise in evaluating risks and benefits in the particular research domain will assess and approve activation of each study based on a Human Research Activation Checklist (refer to a PDF of the checklist for reference - not for submission) completed by the study PI. The Checklist provides the information necessary to evaluate risks and benefits, to ensure that risks of COVID-19 community transmission have been mitigated to the greatest extent feasible while retaining benefits of the research study to individual participants and society, and helps to ensure compliance with local guidance and regulations. OVPR provides oversight of Human Research Activation Committee reviews and approvals.

  9. Ongoing studies will be prioritized over new studies.

  10. Every study involving contact with human participants must go through the Human Research Activation Procedures and develop a COVID-19 Safety Plan. These requirements do not apply to studies where all activities are and will remain fully remote. If the study includes face-to-face interactions with study participants, and/or if the staff leave their remote work setting to conduct study activities, and/or if study staff will interact face-to-face with one another in any setting, then the Checklist must be completed.

    1. This process is separate from the Institutional Review Boards and does not equate to IRB approval.

    2. IRB approval also does not equate to an approved human research activation and COVID-19 Safety Plan.

Human research activation procedures

Studies that must complete the Human Research Activation procedure outlined below include any study that was paused during the research ramp down, including exempt research, and is seeking to initiate face-to-face interactions with participants, return to U-M facilities, or a return to contact among staff members in any setting.  Studies that were permitted to continue (and did so under the defined critical and essential exceptions) during the research pause (Activation Tier 0) may continue, but must complete the Human Research Activation Procedure in a timely fashion to confirm compliance in order to continue. The Human Research Activation Procedure is not applicable if all study activities are fully remote and will remain fully remote. This means that the study will not include any face-to-face interactions with study participants, that no staff will be leaving their remote work setting to conduct study activities, and that the study staff will not interact face-to-face with one another in any setting. To find guidance and resources for moving from in-person to remote approaches, see the Human Subjects Research Starter and Fieldwork Remote Starter Toolkit.

Studies conducted concurrent with clinical encounters must submit an Activation Checklist. Studies conducted in international settings are complex in the current public health context and detailed plans explaining how the study will continuously adhere to changing public health guidance in locations around the world will be necessary.  Note activation questions will be answered by the activation committee and IRB related questions should be directed to the study IRB. Questions on Activation procedures should be directed to human-research-activation@umich.edu.

Steps in the Human Research Activation Procedure are:

  1. Review Responsibilities under the Conducting Human Research During COVID-19 section.

  2. Identify COVID-19 Community Transmission Risks of the study and mitigate to the extent feasible (see Human Research Activation Tier Framework for risks).

  3. Identify the Activation Tier for each study by referring to the Human Research Activation Tier Framework and Human Research Activation Tier Flowchart. PIs may modify (with appropriate IRB and sponsor approvals) features of the study in order to change the Activation Tier to an earlier Tier. Studies will only be approved for activation if they meet the Study Benefit Level and COVID Community Transmission Risk Level necessary for the Activation Tiers that are currently open for activation. Studies not approved for activation will be postponed and reassessed for activation following additional risk mitigation or for a later Tier.

  4. Determine if the COVID-19 Community Transmission Risk mitigation plans require IRB amendments. Consult with the IRB when uncertain.

  5. PIs, staff, and study team members must complete the Human Research During COVID-19 Training Module and the Return-to-Work Training Attestation for Human Research that appears at the end of the module.

    1. Study team members must complete the training module if any of the following are true:

      1. They will have interaction with human participants.

      2. They will be returning to work on a U-M campus.

      3. They will be returning to work and spending time in proximity to other U-M study team members.

  6. Complete the Human Research Activation Checklist in Qualtrics and submit to the Human Research Activation Committee in parallel with submission of any necessary IRB amendments. 

  7. Each study will be reviewed by the appropriate Human Research Activation Committee (see committee rosters below). Prioritization of studies will be determined by Benefit Level and Incremental Risk of COVID-19 Community Transmission as shown in the Human Research Activation Tier Framework.

  8. Prepare study team to adhere to policies outlined within the guidelines defined below.

  9. Study teams must notify their school and college leadership that they have been approved to activate their human research and adhere to any additional requirements in order to return to U-M buildings. This includes UM-Flint and UM-Dearborn Human Research.

Human research activation committees

We anticipate that study teams will be notified within one week of submission to the activation committee.

  1. Human Research Activation Committee-A

    1. Scope includes all U-M human research studies not under the oversight of the Clinical Trials Support Office, as well as any studies involving the fMRI research facility.

      1. Co-Chair,  Tabbye Chavous, Associate Vice President for Research

      2. Co-Chair, Julie Lumeng, Assistant Vice President for Clinical and Human Subjects Research 

      3. Staff: Lindsey Mitchell, UMOR

      4. Proposed members:

      5. Deb Barton,  Associate Dean for Research, Nursing

      6. Robert Eber, Director of Human Clinical Research Center, Dentistry

      7. Rich Gonzalez,  Associate Dean for Research, ISR

      8. Robert Hymes, Associate Professor, Psychology, U-M Dearborn

      9. John Meeker, Associate Dean for Research, Public Health

      10. Susan Murphy, Associate Professor, Medical School

      11. Jason Owen-Smith,  Executive Director, UMOR

      12. Paul Resnick, Associate Dean for Research, Information

      13. Others-TBD

  2. Human Research Activation Committee-B

    1. Scope includes studies under the oversight of the Clinical Trials Support Office.

      1. Co-Chair, Julie Lumeng, Assistant Vice President for Clinical and Human Subjects Research 

      2. Co-Chair, Anna Lok, Assistant Dean for Clinical Research, Medical School. 

      3. Staff: Lindsey Mitchell, UMOR

      4. Vicki Ellingrod, Associate Dean for Research, Pharmacy 

      5. Srijan Sen, Associate Vice President for Research- Health Sciences

      6. Keith Aaronson – Heart, Vessel, Blood CTSU

      7. Praveen Dayalu – Neurosciences & Sensory CTSU

      8. Peter Higgins – Ambulatory & Chronic Disease CTSU

      9. Bob Hyzy – Acute, Critical Care, Surgery & Transplant CTSU

      10. Chris Lao – Oncology CTSU

      11. Frank Moler – Children’s CTSU

      12. Stephan Taylor – Behavior, Function, Pain CTSU

      13. Angela Lyden, Science Coordinator (CTSO)

Graduate student engagement

  1. Participation of graduate students should follow guidance from Rackham, available at Resources for Graduate Students in Response to COVID-19. Specifically, the manner in which graduate students return to research projects should be mutually agreed upon by the faculty mentor/PI and the graduate student. This agreement should be part of the work plans that faculty develop with their graduate students as part of the ramp up. Faculty should create pathways for graduate students to return to research that address both the priorities of the student and the priorities of the PI’s research projects. If not fully aligned, the following factors can potentially provide flexibility:

    1. Engage the research group as a team to complete high-priority research tasks in ways that accommodate the individual situations of study team members.

    2. Incorporate variable levels of on-campus (e.g., lab work) and remote (e.g., data analysis, experimental design) research activities into the work plans of graduate students during the initial ramp up in ways that accommodate their individual situations.

    3. As needed, the student’s department or program can work with the faculty and student to develop alternative methods for academic and research progress. 

  2. In addition, the graduate student’s department or academic program should review faculty/student work plans to ensure safety and equity. In the event that the manner in which a graduate student returns to research projects cannot be mutually agreed upon by the faculty member and student, the department or academic program should assist in developing such an agreement. The graduate student, faculty member, and department can also call upon available campus resources, including those in the student’s school or college, the Rackham Resolution Office, or the Dean of Students Office of Conflict Resolution.

  3. Confidentiality of a graduate student’s individual circumstances should be maintained by the faculty mentor.

Safe research plans

  1. PIs must detail in the Human Research Activation Checklist their plans to address the items below. These plans must take into account study locations that have separate requirements of individuals in the space or interacting with individuals under its oversight in order to adhere to the governor’s executive orders for Michigan (Whitmer - Executive Orders) and/or to the specific local public health guidelines of the study site, if not in Michigan. If plans conflict with the local site facility regulations, then the facility regulations take precedence. 

  2. Daily Health Screening 

    1. Prior to presenting to work each day all study team members will be required to complete the ResponsiBLUE daily health screening survey. Research personnel who screen positive  must follow the next steps provided by the Health Screen.

    2. Research personnel should remain home if ill. 

    3. Any research personnel who have a positive Health Screen should follow-up with the Occupational Health Services Hotline. (734-764-8021). 

      1. Occupational Health Services (OHS) will conduct the initial triage for any research personnel (employees, students) with a positive screen.

      2. OHS employees are trained to determine the need for a COVID-19 test, etc.

      3. Environment, Health and Safety will conduct contact tracing for any individuals who test positive.

      4. Research personnel will not be allowed to work until cleared by OHS.

    4. According to the U-M Chief Health Officer, individuals who are at high risk for complications of COVID-19 are not required to return to work. If an employee has a concern that they may be at high risk, they should contact their health care provider or OHS. Some examples of high risk factors are:

      1. Age greater than 65, 

      2. Persons with primary or acquired immunodeficiency,

      3. Persons on anti-rejection therapy following solid organ transplant or bone marrow transplant,

      4. Persons on biologic therapeutic agents, such as tumor necrosis factor inhibitors,

      5. Persons with malignancy and ongoing or recent chemotherapy, or

      6. Persons receiving system immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day or prednisone for >2 weeks. 

    5. Screen participants and any individual(s) accompanying the study participant prior to the start of the study visit (e.g., parent, partner, spouse, child) for a COVID-19  diagnosis and, using current questions from the U-M Daily Health Screen. Ideally this COVID health screen is done   1-3 days BEFORE the scheduled study visit AND at the time of the study visit. Note the UM Daily screen is for employees and UM affiliates only-- as the responses direct people to call OHS. Thus researchers/ studies can refer to these questions for the most current health screen questions but should not direct study participants to the site.

    6. If the participant has a recent COVID-19 diagnosis with the exception of studies related to COVID specifically, or does not pass the U-M Health Screen questions, the study visit must be rescheduled. If the individuals accompanying the participant to the study visit have a recent COVID-19 diagnosis or do not pass the U-M Health Screen, the individuals may not accompany the participant to the study visit, or the study visit must be rescheduled. Study participants and those accompanying them who have a recent diagnosis of COVID-19 or do not pass the U-M Health Screen should not follow the next steps provided by U-M Daily Health Screen because these pathways are specific to U-M personnel.  Instead, these individuals should be encouraged to seek guidance from their health care provider about COVID-19 related concerns.

  3. Social Distancing

    1. All work that does not require staff/personnel to be on site should remain remote. Office tasks should not occur on site. Research team meetings should remain remote by conference call/ Zoom.

    2. Conduct study elements remotely if at all possible. Studies should use remote informed consent procedures when feasible.

    3. For studies that require interaction with participants at less than 6 ft for some period (e.g., blood draw, therapeutic treatment procedure in a clinic site, etc.), all efforts should be made to minimize the duration of contact as much as possible.

    4. Necessary contact with other research groups, clinical personnel, or other work contacts should be made via phone or electronic means, except in cases of extreme emergency. 

    5. Routine study items should be disinfected before and after participant use. For high-risk settings or populations, consider a no-contact approach. Transfer of items should be arranged by leaving them in the hallway or other designated area for a no-contact approach, as opposed to handing them over in person. The timing of these transfers should be closely coordinated to ensure the safety of all involved, as well as to eliminate the potential for lost or otherwise unattended items in these settings.

    6. Use of shared facilities and other research groups’ equipment must be pre-arranged in order to avoid accidental contact. Be sure that all users understand any research space sign-in procedures. 

    7. Review workflow with staff to minimize face-to-face interactions between staff and participants during study visits. 

    8. Notify participants in Activation Tiers 0, 1, and 2 that they must attend study visits alone if at all possible with the exception of study participants requiring a caregiver or legally authorized representative  (e.g., minors, individuals with disabilities or conditions requiring an accompanying caregiver). Individuals who are vulnerable (>65 years and/or immunocompromised) or individuals who cannot wear a mask (e.g., children younger than 2 years) may not accompany the participant to the study visit.

    9. Research team members should come to work only on days with study visits that require direct face-to-face interactions with participants or involve activities that require presence on the  U-M campus, according to the schedule developed with the PI.

  4. Hygiene and Disinfecting Procedures

    1. PIs must formally assign a daily research space sanitation role which includes daily decontamination of research space procedures including the cleaning of all work spaces, door handles and lock keypads, keyboards/mice/desks for shared equipment, computers, telephones, printer, cameras, control panels, etc. These daily disinfection activities should be logged and logs should be retained to be reviewed upon request.

    2. All shared equipment must be disinfected before and after each use. Any items or equipment used for the research activity  (incremental to clinical care activities)  that multiple study participants come in contact with (e.g., an iPad, an fMRI scanner, a treadmill) must be disinfected between participants.

    3. If it can be done safely, use paper towels or CDC approved disinfectant wipes when handling common research items, equipment, and cabinet handles.

    4. Wipe or spray door handles with 70% ethanol (or other EPA-registered disinfectant) after use. See EHS guidelines

    5. All individuals entering the research space should wash hands with soap upon entering and before leaving the research space/area, and wash them after touching shared accessory devices like phones (use speaker phone if possible).

    6. Minimize shared items (e.g., pens, notebooks, objects that research participants touch, etc.). As much as possible, each person should have their own.

  5. Masks and Personal Protective Equipment (PPE)

    1. Studies should  follow the guidelines for face coverings at their site location. These will vary by site location. Practices for use of face coverings must adhere to local public health guidance of the study location.

      1. In Michigan Medicine facilities, all individuals entering the facilities are provided with a disposable mask which is not allowed to be reused. 

      2. In study locations outside Michigan Medicine facilities, cloth masks are acceptable. Refer to EHS Face Covering Usage for COVID-19

    2. Study PI’s must ensure that a supply of face coverings is made available to study team members, research participants, and individuals accompanying research participants.  

    3. Research personnel should wear the face covering unless their research procedures dictate heightened personal protective equipment (PPE) requirements. When not wearing the PPE required for their work, personnel should reapply their face covering. Proper hand hygiene before and after using any face covering is critical.

    4. Research participants and individuals accompanying them should wear face coverings (studies should have some to provide if they present without one), unless specifically accounted for and approved as part of study procedures.

    5. Research personnel must wear a face shield, in addition to a face covering, when working with participants ages 65 and older.

  6. Density 

    1. Develop a schedule of activities that is compliant with social distancing and density recommendations: No more than 1 research staff member may work onsite on any given day unless each staff member has at least 144 sq ft in the work space.

    2. Sign-up sheets for scheduling shared research spaces (e.g., procedure rooms, observation rooms, etc.) should be developed to allow for scheduling in advance. Disinfection should occur between users.

    3. Post a map inside the research space entryway with maximum room/space occupancy to maintain social distancing. 

    4. Develop a means of signifying who is present in the research space at any given time, preferably through an online sign-in tool to minimize touching items such as a physical sign-in sheet, or other mechanism of controlling the number of people in the research space at the same time. 

    5. Stagger break times to minimize contact between people in rooms. Conference rooms will be closed off and cannot not be used. Ensure eating and drinking is not occuring in research space.

    6. Minimize the number of people in each room and all associated spaces (for example, break rooms) at any one time.

    7. Buildings should not be used for social gatherings or group meetings, and conference rooms and other group spaces will be off limits.

    8. Tape should be used to mark out 6-foot spaces for high traffic areas or bottlenecks.

    9. Post necessary signage related to reducing infection risk (maintaining social distance, capacity limits in elevators etc).

    10. If possible participants should remain out of the building/research site area and be called in only when they are ready for the study interaction. 

    11. Research interaction with participants must be scheduled to ensure mandated social distancing and space density directives. 

    12. If at all possible, research participants should not spend time in waiting areas for research activity, or a plan must be developed to manage the waiting area to achieve social distancing.

  7. Contact Tracing

    1. If an employee tests positive for COVID-19:

      1. EHS will contact and confidentially, interview relevant personnel in order to identify potential close contact exposures. For COVID-19, a close contact is defined as any individual within 6 feet of an infected person for at least 15 minutes starting from 2 days before illness onset (or, for asymptomatic individuals, 2 days prior to a positive specimen collection) until the time the individual is isolated.

      2. Close contacts with symptoms of COVID-19 should make testing their first priority. However, testing too soon after an exposure may give a negative result, even if a close contact has been infected. If exposed and a close contact develops symptoms, testing that day or the next is recommended. If exposed and and the close contact does not develop symptoms, waiting 5 days after exposure to get a test is recommended. Close contacts must stay in quarantine for the entire 14 days even if a test is negative. Testing is available through OHS. Call the OHS Hotline at 734- 764-8021 for scheduling.

      3. If a close contact tests positive refer to the Return to Work Guidelines for COVID-19 Positive Employees. 

  8. Create a culture and opportunity for continuous improvement of health safety

    1. OVPR and EHS will frequently communicate with the research community regarding research safety, research re-engagement, and important public health updates.

    2. Report safety issues, including personnel who are ill or not following safety protocols, via the U-M compliance hotline website. You can also report concerns by calling 866-990-0111 or contacting EHS at 734-647-1143 or emailing EHS.

    3. OVPR and Occupational Health Services will track aggregate data on COVID-19 illness in research spaces with weekly reports.

Responsibilities in conducting human research during COVID-19

  1. PI Responsibilities (including co-Investigators, as applicable)

    1. Complete required Human Research During COVID-19 Training Module and attestation.

    2. All Research Personnel must complete the U-M Daily Health Screen before reporting to work. In addition researchers need to comply with the entry procedures for their local worksite. The daily health screen self assessment is mandatory.

    3. Develop onsite or other staffing schedule that is compliant with social distancing and density recommendations: No more than 1 research staff member may work onsite on any given day unless each coordinator has at least 144 sq ft in the work space. 

    4. Train research staff and monitor compliance on safe practices that include:

      1. Social distancing within the context of a research encounter and work environment

      2. Wearing of masks or face coverings adhering to public health guidance for the research location

      3. Hand washing and sanitizing including work areas

      4. Additional PPE requirements as indicated

      5. Necessary signage related to reducing infection risk (maintaining social distance, capacity limits in elevators etc) 

    5. Identify which studies must complete a Human Research Activation Checklist.

    6. Identify based on the Human Research Activation Tier Framework the Activation Tier (0, 1, 2 , or 3) of each study. 

    7. Confirm that access to the building or location where the research will take place is permitted, and determine processes for access for research activities with leadership responsible for oversight of the building or location.

    8. Verify accurate completion of the Human Research Activation Checklist for each study and submit to the assigned Human Research Activation Committee. In parallel, amend the IRB application to reflect changes and notify the sponsor.

    9. Identify all elements of each study that can be altered to mitigate COVID community transmission risk and implement.

      1. Determine which study visits or procedures can be done remotely.

      2. Review workflow with staff to minimize face-to-face interactions between staff and participants during study visits. 

    10. Develop a plan to notify participants in Tiers 0, 1, and 2 that they must attend study visits alone if at all possible with the exception of study participants requiring a caregiver or legally authorized representative  (e.g., minors, individuals with disabilities or conditions requiring an accompanying caregiver). Individuals who are vulnerable (>65 years and/or immunocompromised) or individuals who cannot wear a mask (e.g., children younger than 2 years) may not accompany the participant to the study visit.

    11. Ensure that a supply of face coverings is made available to study team members, research participants, and individuals accompanying research participants.

    12. Develop a plan to maintain contact information of study participants and those accompanying them (e.g., phone numbers, email addresses) if needed for contact tracing if research staff who have been within 6 feet of a study participant for more than 15 minutes for incremental research activity (i.e., research  interaction that extends beyond clinical interaction in the case of clinical care) have a positive COVID test in the days subsequent to the encounter. Study teams and participants do not perform contact tracing. Health Departments perform contact tracing. The study team and participants should be able to provide contact information if requested by the health department.

    13. If the research is taking place face-to-face in a US state or territory outside of Michigan, ensure that the research procedures adhere to the current public health guidance in that state or territory.  

    14. If the PI is not a faculty member, obtain a signature on the Activation Checklist of a mentor/supervisor who is a faculty member.

  2. Research Team (e.g., Staff, Graduate Students, Post-Doctoral Fellows) Responsibilities

    1. Complete required Human Research During COVID-19 Training Module and attestation.

    2. Conduct study procedures and assessments via remote or virtual platforms whenever possible.

    3. Come to work only on days with study visits that require direct face-to-face interactions with participants or require access to restricted data that can only be accessed on U-M campus, according to the schedule developed with PI.

    4. Adhere to location-specific regulations for entry to the location or building where the research will take place.

    5. All research personnel will complete the U-M Daily Health Screen before reporting to work. In addition researchers need to comply with the entry procedures for their local worksite. The daily health screen self assessment is mandatory.

    6. Adopt work flows developed with PI to minimize direct face-to-face interactions with participants. 

    7. Maintain social distancing,  wear a mask/face covering, practice hand hygiene, and execute sanitization procedures. 

    8. Notify participants in Tiers 0, 1, and 2 that they must attend study visits alone if at all possible with the exception of study participants requiring a caregiver or legally authorized representative  (e.g., minors, individuals with disabilities or conditions requiring an accompanying caregiver). If study participants must be accompanied, individuals who are vulnerable (>65 years and/or immunocompromised) or individuals who cannot wear a mask (e.g., children younger than 2 years) may not accompany the participant to the study visit.

    9. Screen participants and any individual(s) accompanying the study participant to the study visit (e.g., parent, partner, spouse, child) for a COVID-19  diagnosis and, using the U-M Daily Health Screen questions, ideally before  the scheduled study visit. If the participant has a recent COVID-19 diagnosis with the exception of studies related to COVID specifically, or does not pass the U-M Health Screen, the study visit must be rescheduled. If the individuals accompanying the participant to the study visit have a recent COVID-19 diagnosis or do not pass the U-M Health Screen, the individuals may not accompany the participant to the study visit, or the study visit must be rescheduled. Study participants and those accompanying them who have a recent diagnosis of COVID-19 or do not pass the U-M Daily Health Screen should not follow the next steps provided because these pathways are specific to U-M personnel. Instead, these individuals should be encouraged to seek guidance from their health care provider about COVID-19 related concerns.

    10. Ensure participants and any individual(s) accompanying the participant to practice social distancing, wear a mask (unless there is a contraindication to wearing a mask) and practice hand hygiene during the study visit. If the research participant and/or any individual(s) accompanying the participant does not have a mask or face covering that adheres to the public health guidance of the study location, provide an appropriate mask or face covering to the individual. 

    11. Implement the plan developed by the PI  for securely tracking contact information of study participants and those accompanying them (e.g., phone numbers and email addresses)  if needed for contact tracing if research staff who have been within 6 feet of a study participant for more than 15 minutes for incremental research activity (i.e.,research interaction that extends beyond clinical interaction in the case of clinical care) have a positive COVID test in the days subsequent to the encounter.  For U-M employees, COVID-19 contact tracing procedures can be found here: COVID-19 Exposure, Testing, and Mandatory Contact Tracing Guidance for Employees and SupervisorsStudy teams and participants do not perform contact tracing. Health Departments perform contact tracing. The study team and participants should be able to provide contact information if requested by the health department.

    12. If the research is taking place face-to-face in a US state or territory outside of Michigan, ensure that the research procedures adhere to the current public health guidance in that state or territory.

  3. Responsibilities of Study Participants and Those Accompanying Them to the Study Visit

    1. With the exception of studies related to COVID specifically, do not participate in face-to-face interaction for the purpose of research if you have had a recent diagnosis of COVID-19 or do not pass the health screen questions in the  U-M Daily Health Screen

    2. Adhere to building regulations for entry.

    3. Maintain social distancing.

    4. Practice hand hygiene.

    5. Wear a mask or face covering (with the exception of individuals who are unable to wear a mask, such as children <age 2 years).

    6. Provide your contact information (phone numbers and email addresses) to the study team to provide to the public health department for contact tracing if needed.  For Washtenaw County, COVID contact tracing procedures can be found here: Contact Tracing can Help Slow the Spread of COVID-19

    7. Provide the contact information of the study team to the  public health department if requested for the purpose of contact tracing.  For Washtenaw County, COVID contact tracing procedures can be found here: Contact Tracing can Help Slow the Spread of COVID-19Study teams and participants do not perform contact tracing. Health Departments perform contact tracing. The study team and participants should be able to provide contact information if requested by the health department.

    8. If the research is taking place face-to-face in a US state or territory outside of Michigan, adhere to the current public health guidance in that state or territory.

Human Research FAQs (Categorized by themes)

Overall activation process

  1. When are human research studies able to start?

    1. Studies may begin engaging with human participants when: (1) they have received approval from the Human Research Activation Committee; (2) they have received necessary IRB and sponsor approvals to do so: (3) they have received approval from their school or college; (4) the Tier for which their study is approved is currently posted on the research re-engagement webpage as currently active. July 19, 2:40 p.m.

  2. How do I get feedback on my application? Will I receive feedback after I submit?

    1. This process is different from other processes that investigators may be used to, where the application is more iterative. We expect up to 6,000 applications for activation, and we know that study teams are eager to move forward efficiently and correctly. In order to move work forward efficiently, teams will be given limited feedback on applications and referred to read the guidelines once again, or submit the application to the best of their ability and current understanding and await review. We recommend that faculty be very involved in the completion of the Activation Checklist, and also seek additional guidance from their school or college research leadership. October 6, 1 p.m.

  3. I am confused by activation procedures for human research. Where can I ask questions?

    1. For questions regarding research space in your unit, please refer to your department or school/college/unit leadership. If you still have questions after reviewing these FAQs and the guidance documentation, please contact the Human Research Activation Committee at human-research-activation@umich.eduJuly 19, 2:40 p.m.

  4. How do we report someone who we feel is not following the mask rule or social distancing?

    1. We have many new practices in place for public health. If you feel someone is not acting safely in mask wearing or social distancing, the first guidance is a gentle, but clear reminder. If you are reminded that you are not following best practices, the only acceptable response is to thank your co-worker who cares enough to remind you. If polite reminders are not creating the behavior change needed, or you do not feel comfortable having this conversation, you can submit complaints to the U-M Compliance Hotline. July 19, 2:40 p.m.

  5. Do I need to check with my school about my plan to return to human research work and office space?

    1. Yes. Each school’s procedures are slightly different. Please work with your leadership in your school. July 19, 2:40 p.m.

  6. Will we receive some kind of official statement that the study has been approved for activation? And are there additional steps beyond the checklist submission?

    1. Study teams must wait for official review notification from the Human Research Activation Committee before beginning study activation. Once approved, study teams are responsible for obtaining regulatory approvals (such as IRB amendments, if needed) to activate their study. Some studies will not require amendments to the protocol. Human Research COVID Activation Committee approval is not Institutional Review Board approval. If you are uncertain whether you need an amendment, contact your IRB (irbhsbs@umich.edu or irbmed@umich.edu). A further step is that study teams must also notify their school/college leadership that they have been approved to activate human research and adhere to any additional school/college requirements, including processes required to return to U-M space. July 19, 2:40 p.m.

  7. ​Can biospecimen collection for research continue if my human research study is not yet reactivated?

    1. Not if the collection is only for a biorepository and the specimen collection is performed by U-M personnel, even if the research is indicated as minimal risk. Biospecimens collected remotely by the participant (e.g., cheek swabs) can be sent to the research laboratory. Biospecimens can also be collected as part of an IRB-approved clinical research protocol at the time of clinical care (e.g., an extra tube of blood at the time of a necessary clinical blood draw) or other if the biospecimen collection is already occurring as part of clinical care and a portion is secondarily allocated for research (e.g., to-be discarded blood or cerebrospinal fluid). June 18, 5:20 p.m.

  8. ​I am interested in conducting research related to COVID-19. What is required?

    1. Complete all of the necessary regulatory applications for human participants, basic laboratory, or animal research and complete the Reactivation application process if working with human participants.

    2. Working with the live infectious SARS-CoV-2 virus (causative agent of COVID-19) in culture is considered permissible only at BSL3. Contact the EHS Biosafety Officer at 734-647-1143 for information regarding the use of the U-M BSL3 facility, anticipated activation date and operational capacity for these facilities.

      1. Other manipulations that do not involve virus propagation, such as inactivation, extractions and PCR, are considered BSL2 and require the use of a biosafety cabinet for the inactivation step. Learn more about CDC guidanceMarch 30, 7:30 a.m.

Risks, benefits and tiers

  1. On the COVID Community Transmission Risk matrix, my study qualifies as low-risk for some factors, but medium-risk on others. What is the overall risk for my study?

    1. The study risk category is determined by the highest COVID Community Transmission Risk Category. Therefore, this study would be classified as a medium-risk study. July 19, 2:40 p.m.

  2. My study converted to fully remote during ramp down, but the procedures are not ideal and very expensive (i.e., mailing blood pressure cuffs to participants) and we believe we could fit in Tier 2 with some modifications. Can we do this?

    1. Yes. Studies can be altered, with appropriate IRB and sponsor approval, to meet the criteria for a given Tier. Please note that there is a possibility, if public health conditions change, that your study may need to return to a remote plan. Investigators should consider the scientific implications. July 19, 2:40 p.m.

  3. My study is producing critically important findings. Why would it be classified as “no benefit”? Is the assessment of benefit biased to favor health-related studies?

    1. U-M investigators have an incredible breadth of human research studies that generate critically important and valuable research. For the purposes of the activation process, the “benefit” classification is only in reference to the narrow benefit to the individual research participant, not the broader benefit to science or society. This is due to the fact that the individual participant will incur the COVID risks. In most cases, mitigation strategies can be put in place to enable study activation and completion of the work. July 19, 2:40 p.m.

  4. My study is in a health care setting where study participants are receiving clinical care. Since they are already receiving clinical care, and I am following Michigan Medicine PPE policies, does my study qualify as having zero incremental risk of COVID-19 transmission?

    1. If the face-to-face interaction for research is being conducted by the study participant’s clinical care providers, the interaction is considered to confer no incremental risk of COVID-19 transmission. If there is face-to-face interaction for research with research personnel who otherwise would have had no interaction with the study participant, this interaction with an additional individual confers incremental risk and must be rated accordingly -- even if appropriate PPE is worn. This incremental risk is considered carefully for studies that provide no benefit to the individual participant. For studies that provide potential benefit to the individual participant, in the current public health context, the potential benefit is considered to outweigh the potential risk of COVID-19 transmission, and all of these studies are able to activate in Tier 1 or Tier 2. July 19, 2:40 p.m.

  5. ​I have a study that will take place in the clinic, and study visits can be concurrent with a clinical encounter. We can do the consent by phone. We can probably ask the physician to do most of the study procedures. This will be followed by blood sample collection by clinical phlebotomist. Can I indicate “Yes” to the question on the checklist: “Will ALL interactions with participants for research be completed entirely by clinical care providers during a Michigan Medicine clinical encounter? (There are no interactions with research staff)?”

    1. You can indicate YES only if:

      1. The clinical team seeing this patient is part of the study team as listed in your IRB application, AND

      2. You are certain that the special exam required for this study can be done in clinic, AND

      3. You are certain that the clinical team can conduct ALL of the study required procedures during the time allotted for the clinic appointment for ALL the participants, AND

      4. You are certain that research blood draw will only occur if the participant requires a clinical blood draw on day of clinical encounter. July 24, 8:25 a.m.

  6. Why are tiers needed to weigh risk and benefit? Isn’t it the purpose of an IRB-approved informed consent to weigh the risk versus benefit of participating in a study?

    1. The purpose of an informed consent is to allow the individual study participant to weigh the risks versus benefits for themselves as a participant in the study. The informed consent does not ask the study participant to weigh the benefit of their study participation against the risk of COVID-19 transmission to participants or to study personnel. Further, studies need to now account for ways that they can mitigate COVID transmission risk that differ from their typical study procedures. Some of these mitigation measures are as simple as hand hygiene, masks and prescreen for covid for participants; however, they still need to be built in to activation. July 19, 2:40 p.m.

  7. My research includes very young children who cannot wear a face covering (or will not keep it on). Does this mean I cannot do any research?

    1. Any study that has potential therapeutic benefit to the individual is permitted to be activated in Tiers 0, 1 or 2. Studies that involve children who are unable to wear masks and provide no direct benefit to the participant should explain in the Checklist how you reasoned through the mitigation options, as well as what you will do to mitigate the risk of COVID-19 transmission and how you arrived at your proposed strategy. The committee will review your proposal. October 6, 1 p.m.

  8. My survey-based research involves going to people's homes to collect data. What Tier is this and is it safe to restart?

    1. Research that does not directly benefit the individual should be done remotely, if possible. If that is not possible, it can be done with low-risk populations, or in a low- or medium-risk manner in Tier 2. Such studies can consider modifying procedures to mitigate risk and therefore allow activation in an earlier Tier. If the study is with vulnerable populations and cannot be mitigated using control measures, then it may not be able to restart at this time without study procedure modification. July 19, 2:40 p.m.

  9. My research with human subjects consists of secondary analysis or computational work. It does not involve any interaction with human participants. I am eager to return to campus and work in my office. What Tier is my research in and when will I be able to return

    1. According to the Governor’s Executive Order, all work that can occur remotely will continue to be done in that manner, including office and dry lab work. Therefore, secondary analysis and computational work that does not involve interaction with human participants must remain remote at this time. We understand this is difficult for teams to stay connected and will be working to provide suggestions to support this. July 19, 2:40 p.m.

  10. During the COVID-19 restrictions, I was able to conduct most of my research with participants using remote tools. Some of my participants do not have Internet access or computers. Will I be permitted, during the appropriate tier, to re-engage in face-to-face interactions with these participants?

    1. Yes, with the appropriate COVID-19 precautions, this will be permitted. However, as some Tiers may be paused again in the future if infection rates escalate, the study team should continue remote interaction where possible. If you do revert to in-person, you should consider the scientific implications. July 19, 2:40 p.m.

  11. As part of my observational study, research subjects often learn of important risks about their health. What is the benefit classification of my study?

    1. Observational studies generate some of the most impactful knowledge in the research enterprise and can often indirectly help participating subjects. Consistent with the NIH definition, however, observational studies are considered to provide “no direct benefit” to subjects. July 19, 2:40 p.m.

  12. The study is a trial. The intervention is an implanted device and the participants are in long-term follow-up to ensure safety and efficacy of the device. Is this study considered Benefit Level 4?

    1. Studies that included interventions and are in a follow-up phase to confirm safety and efficacy are still considered to be trials in the assessment of Benefit level. Ensuring safety of an experimental intervention is essential. July 19, 2:40 p.m.

Do I need to complete a checklist?

  1. My research study has moved entirely to remote, and thus is Tier 0. Do I need to submit a checklist?

    1. There are three reasons study teams need to submit a checklist: (1) if they wish to have face-to-face interactions with study participants; (2) if any members of the study team must leave their remote work setting to conduct study activities; and/or (3) if study staff will interact with one another in any setting. October 11, 1:30 p.m.

  2. ​​My study takes place only in a Michigan Medicine clinical setting, and Michigan Medicine clinicians are conducting all of the data collection during a clinical encounter. Do I need to submit an Activation Checklist?

    1. Yes. July 19, 2:40 p.m.

  3. Must researchers from the Dearborn and Flint campuses submit a checklist to activate their human research studies?

    1. Yes. July 19, 2:40 p.m.

IRB and study sponsor

  1. Should I notify the industry sponsor or IRB (external or otherwise) that I plan to resume or modify research activities on my clinical trial or other human research project?

    1. Yes. July 19, 2:40 p.m.

  2. If the IRB has approved my study to start, but the Human Research Activation Committee has not approved my study to start, may I start my study?

    1. The study must be approved by both the IRB and the Activation Committee to start. July 19, 2:40 p.m.

  3. Is the University of Michigan permitting sponsor visits for study initiation, study monitoring and study close out?

    1. Sponsor visits for study initiation, study monitoring and study close out should be conducted remotely to the extent possible.

    2. In-person sponsor visits should be fully justified and will only be permitted when:

      1. Michigan Medicine or the study site clinic allows visitors, AND

      2. Study has been approved by UMOR for activation, AND

      3. Sponsor/Contract Research Organization (CRO) permits staff travel and the state of Michigan does not have any travel ban on interstate travel if the visitor is traveling from or through another state.

    3. In-person sponsor visits should be limited to as few visitors as possible ideally: ONE visitor who will observe U-M policy of safe practice, including (but not limited to): completion of the ResponsiBLUE health screening survey prior to entry, use of face covering, social distancing, hand sanitizing and disinfection of common equipment after use.

    4. In-person sponsor visits should be planned in advance to identify a location that will allow for social distancing and to minimize the number of staff the visitor will directly interact with, as well as the duration of direct interaction.

    5. Study team should keep a log of the visit to record contact information of the visitor and list of staff that the visitor interacted with. July 23, 1:35 p.m.

  4. ​Must the IRB approve amendments to the study protocol before implementing changes?

    1. Submit an amendment to the IRB to indicate the modifications and obtain approval. If the change is necessary to prevent an imminent harm to the participants, the change may be instituted immediately and reported promptly to the IRB (within 5 days). Refer to the IRBMED and IRB-HSBS webpages for important guidance and additional information. March 20, 11:10 a.m.

  5. Is an amendment necessary if I wish to change the mode of data collection for my exempt study?

    1. No, amendments to change from person-to-person to phone or electronic data collection are not required. Do not submit amendments for these studies. March 18, 2:55 p.m.

  6. Where can I find more information about FDA-regulated research regarding the COVID-19 situation?

    1. Please refer to the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic webpageJune 18, 5:20 p.m.

  7. ​​I am conducting FDA-regulated research for which I am the sponsor of an IND or IDE. Do I need to notify the FDA when I reactivate my study?

    1. Yes. The FDA will need to be notified as soon as feasible. Contact the MICHR IND/IDE Investigator Assistance Program (MICHRMIAP@med.umich.edu) for specific guidance and information on the notification process. June 18, 5:20 p.m.

  8. Will a change to the method of data collection be considered a protocol violation?

    1. You should inform the study sponsor and/or the overall PI of the study of the modified procedures and what documentation requirements will need to be modified (e.g., changes to CRFs, etc.).  IRB approval should be sought for the modifications and any deviations that occurred prior to IRB approval should be reported per standard IRB guidance based on the significance of the deviation (major or minor). June 18, 5:20 p.m.

  9. What are some considerations for communicating with study sponsors?

    1. Contact study sponsors/industry for study-specific information on how to continue the study or pause the research

    2. Obtain sponsor guidance for study conduct, including:

      1. Study start-up after the pause

      2. Changes in reporting requirements

      3. Sample storage and shipping

      4. Drug shortages or delays in shipping

      5. Alternative safety assessments due to delays

      6. Delayed or missed participant contacts/visits

      7. Changing the study procedures with appropriate IRB approval June 18, 5:20 p.m.

  10. Given the reactivation plan for human subjects research, does this also impact U-M research sites that have subawards through the university? Each site has their own/local IRB approval and we only send money.

    1. As these sites are under the oversight of their local institutions/IRBs, they should be informed of the university's reactivation of the research, but they would make an independent decision as to whether to proceed with research activities at their site. June 18, 5:20 p.m.

  11. ​For survey research that is allowed to continue, which would normally involve phone consent preceded or followed by a mailed consent form, we considered amending to email consents to people. Is the expectation that we should use Sign Now for this research?

    1. Contact your IRB to discuss the appropriate consent process for your study. Many surveys and other minimal risk projects qualify for a waiver of documentation of informed consent, meaning that obtaining a copy of a signed informed consent document is not required. The consent information can be emailed to the participant without the requirement that a signed document be returned. If signed consent is necessary, SignNow is a HIPAA and FDA compliant option to route the informed consent to participants for their signature. April 21, 4:30 p.m.

COVID-19 testing and contact tracing

  1. What is our responsibility related to people who may have been exposed to COVID-19 by research personnel? Who is responsible for notifying the study participants or all other people that have been exposed?

    1. If a researcher, patient, or participant tests positive for COVID-19, the Washtenaw County Health Department will take the lead in determining who else requires notification. EHS will assist the county and will contact any U-M employees that have potentially been exposed. July 19, 2:40 p.m.

  2. If a participant presents to a research visit for a non-COVID study symptomatic, are we still able to continue with the visit? How do we keep subjects informed of this process if not part of the informed consent form?

    1. The participant needs to have been pre-screened, and if they present symptomatic for a non-COVID study, the study visit should not occur. More broadly, it is important (if possible) to pre-screen any participants before they come to their research visit as much as possible. This will take additional time, but study teams need to plan for this where possible if the population is known ahead of time. If they do have symptoms, you should direct them to their health care provider for further evaluation and consider getting tested. The State of Michigan provides no-cost testing at pharmacies and other locations throughout the state. July 19, 2:40 p.m.

  3. The Activation Checklist requires confirmation that (except for studies of COVID-19) participants with known positive COVID-19 test results in the past 14 days or new symptoms on COVID-19 health screen will be excluded. Does this refer to screening patients to determine eligibility, or does it refer to study participants who are already enrolled and have begun study procedures?

    1. Except for COVID-related studies, study activities cannot take place with a participant with known or suspected COVID-19. In some studies, this may mean that a potential participant cannot enroll at this time, and in other studies, this may mean that an enrolled participant cannot participate in a scheduled study visit. Note that, if the scheduled study visit is for participant safety (i.e., monitoring for serious side effects), careful consideration must be given on how to obtain the necessary information to ensure the safety of the participant. July 19, 2:40 p.m.

  4. ​What are the study team's responsibilities regarding contact tracing?

    1. The study team is responsible for maintaining a contact tracing log of names and phone numbers of those who attended the study visit so that, if requested, the study team can provide this information to the health department. These logs will provide contact tracers with information so that notifications can be provided to individuals who are likely to have been in close contact with the positive individual and, therefore, limit the spread of COVID-19. Study teams are NOT responsible for actually doing any contact tracing and should never communicate with participants about COVID-19 exposure or test results. If an individual has a positive COVID-19 test, the public health department in their county is notified by the health facility where the individual was tested. The public health department will contact the individual and perform contact tracing, meaning they will ask the individual where they were in the days preceding the positive test. In a scenario in which the individual had attended a study visit at U-M, the individual should be able to provide the contact tracer with information to reach the study team. Conversely, if the individual is a researcher, they should be able to provide contact information of participants to the contact tracer. Note that in some cases, a contact tracing team at U-M will perform the contact tracing for close workplace contacts instead of the public health department and researchers should follow those procedures. August 17, 7:55 a.m.

Staff requirements and training module

  1. Do all of my co-investigators and study staff need to take the training module before I submit the checklist?

    1. Co-investigators and study staff must take the Return to Human Research COVID-19 Training Module if any of the following are true: (1) They will be returning to work and spending time in proximity to other U-M study team members; (2) they will be returning to work on a U-M campus; or (3) they will have interaction with human participants. July 19, 2:40 p.m.

  2. My study participants are visiting the blood draw station after their clinic visit for clinical labs. An additional tube of blood is being drawn for research. Am I responsible for ensuring that the clinical phlebotomist complete all of the requirements of a study staff member (e.g., training module, etc)?

    1. No. Clinical ancillary staff who are not employed or overseen by the study team, as described in this scenario, do not need to complete the personnel requirements in the activation checklist. July 19, 2:40 p.m.

  3. What happens in a situation where research staff refuse to or are unable to perform research activities even when all recommended safety protocols are being met? For example, if I hire someone to collect data from participants and then they refuse to have participant contact, what options do I have?

    1. Faculty and staff are expected to work in person if their research or scholarship requires it and they are not at high risk. However, we strongly encourage work that can be done remotely to continue in that fashion. If your work requires staff presence on campus and staff do not wish to report for work, they may be able to utilize paid leave options, including the COVID-related paid time off or vacation time if approved by the supervisor. Voluntary furloughs may be a possibility. Please discuss your options with your supervisor or your HR representative.

    2. Graduate students may not be compelled to return to labs, and should work with their PI or graduate program mentor if they have concerns. Learn more on the Rackham Graduate School's COVID-19 webpageJuly 19, 2:40 p.m.

Space and density

  1. In order to complete the study, I could have two staff members in a small space with a participant for a short period of time, or one staff person in the space for a longer period of time. Which is preferable to reduce COVID-19 transmission risk.

    1. The overall goal is to reduce the amount of time that individuals spend within 6 feet of each other, and the number of individuals doing so, in order to reduce the risk of transmission. You should submit the checklist explaining how you reasoned through the ways to reduce risk, and the plan you arrived at and why. A committee of peers will review the proposed plan. We encourage you to submit the proposal describing how you could accomplish the study with the maximal amount of mitigation that is feasibleJuly 19, 2:40 p.m.

  2. I have a situation in which the number of individuals in the room would need to exceed one individual per 144 square feet. What are my options?

    1. The overall goal is to reduce the amount of time that individuals spend within 6 feet of each other, and the number of individuals doing so, in order to reduce the risk of transmission. You should submit the checklist explaining how you reasoned through the ways to reduce risk, and the plan you arrived at and why. A committee of peers will review the proposed plan. We encourage you to submit the proposal describing how you could accomplish the study with the maximal amount of mitigation that is feasible, keeping the participant safe in all regards. July 19, 2:40 p.m.

Multi-site or off-site research

  1. For collaborative studies with multiple institutions that DO NOT have contact with participants at U-M, but are in contact with participants at other sites and are conducted under IRB oversight at each institution, do we need to follow U-M guidelines for re-engaging, or can we follow the guidelines for the institution where the recruitment is taking place?

    1. Multi-site studies should first consult with the U-M IRB about their overall plans to activate. Submit the U-M checklist with the overall plan to activate the study and identify the plan for obtaining local site activation approval as the individual sites are ready to active. July 19, 2:40 p.m.

  2. My research is an observational study with K-12 students in a school site (now open), where social distancing measures will be in place. Are there special considerations or guidelines for working in schools?

    1. Certain venues (e.g., schools, child care sites, prisons) have specific state-mandated requirements for interacting with individuals in those settings. Studies must adhere to the guidelines under the governor's executive orders (Whitmer - Executive Orders) for those venues, and/or to state and local guidelines for project venues not in Michigan. In the activation checklist, PIs must detail the regulations specific to their research venue and also provide an explanation of how their study will adhere to these regulations. July 19, 2:40 p.m.

  3. I have a few multi-site studies in eResearch and am working on the activation checklist. U-M is not the IRB or record for these studies. Should I still identify them as multi-site on the activation checklist?

    1. Yes. July 19, 2:40 p.m.

  4. The University of Michigan is the IRB of Record in a multi-site research study. Do I need to inform the external sites of the research reactivation?

    1. Yes, provide notice of the research reactivation where we are the IRB of Record. Sites should  submit information updates to the U-M IRB as to the current status of research at their institution. June 18, 5:20 p.m.

Health screening procedures and rules of entry

  1. Are participants' responses to pre-screening questions recorded anywhere? Is the study required to record them?

    1. Studies are not required to record responses. If a participant screens positive, they should not attend the study visit and should be advised to contact their health care provider. July 19, 2:40 p.m.

  2. Are we allowed to conduct the COVID pre-screening questions via text message with participants? If yes, can we modify the questions slightly so they make sense via text message?

    1. As long as you can confirm that you did a health screening that aligns with EHS (U-M health screen) guidelines and do not change the meaning of the health screen questions with any wording changes, this is fine. July 19, 2:40 p.m.

  3. When staff complete the healthscreen.umich.edu prior to entering the worksite, does that information get logged somewhere?

    1. The self screen allows the user to go through the questions to make their own determination for next steps. July 19, 2:40 p.m.

PPE and disinfectant

  1. If studies are individually responsible for buying PPE/disinfectant, is there a procurement process to ensure that we're buying the correct items and have access to the amount we need?

    1. Studies in clinical settings should use the PPE provided in the clinical setting, which meets the standards for that environment. PPE/disinfectant outside the clinical setting can be purchased from M-Marketsite and the options available on this site meet the requirements. University leadership is monitoring PPE and disinfectant supply chains. July 19, 2:40 p.m.

  2. Who pays for PPE/disinfectant?

    1. Personal Protective Equipment (PPE) and related supplies are normally treated as indirect costs whenever the PPE is not integral to achieving the goals of the sponsored project, regardless of whether donning PPE is at the discretion of the employee or mandated by U-M. PPE may be allowable as a direct cost on a sponsored project if it is necessary for achieving the objectives of the project. As with all other U-M expenses, if PPE and related supplies are used for multiple projects, then they must be allocated to each project in proportion to the "relative benefit" each project receives using a defensible and documented allocation methodology.

      Notwithstanding the above, project teams should be aware that sponsors may have policies that put additional restrictions on direct charging of PPE. For example, the National Institutes of Health recently published NOT-OD-20-164 that allows for necessary PPE to be treated as a direct cost, but only if the expense of acquiring the PPE is below $500K and if the funded project is a clinical trial or clinical research. Certain NIH institutes are even more restrictive. The National Institute of Allergy and Infectious Diseases' position on PPE has led them to return non-clinical proposals that request funding for PPE on the grounds that they do not comply with NOT-OD-20-164. Applicants to NIAID may therefore wish to consult with the sponsor prior to proposal submission. October 2, 3:45 p.m.

Vulnerable participants

  1. What defines immunocompromised? I am trying to determine if there is a certain dose of steroids that meets the threshold for being considered immunocompromised.

    1. Your PI may use his/her clinical judgment as long as it adheres to the available CDC guidelines. July 19, 2:40 p.m.

  2. If I do not know if the potential participants who I am approaching are immunocompromised, should I check the box for high risk on the checklist where it asks if my participants are immunocompromised or high risk?

    1. If it is not possible to determine before approaching a participant whether they are immunocompromised, and assumed to be representative of the general population, then do not check the box for these risks. If, however, you are recruiting from a setting where you could expect a significant proportion to be immunocompromised, then you should check the boxes. September 29, 1:30 p.m.

Is this approach to risk mitigation allowable and sufficient?

  1. The Activation Checklist requires that I attest to conducting all study procedures remotely when they can be done remotely. There are substantial practical and logistical barriers to conducting an element of the study remotely, even though it could be done. Could I propose in the Activation Checklist to conduct some of these procedures face-to-face?

    1. The overall goal is to reduce human contact as much as possible to reduce the risk of COVID transmission. You should do all that you can to mitigate risk. Explain in your application how you reasoned through the options and how you arrived at your proposed strategy. The committee will review your proposal. July 19, 2:40 p.m.

  2. Can a clinical care provider at Michigan Medicine conduct the study activities (e.g., collect a survey from a participant) instead of a research staff member and therefore reduce Risk Category of the study?

    1. Yes. July 19, 2:40 p.m.

  3. My study seeks consent from parents accompanying minors prior to surgery. Sometimes the parent is high risk or unable to wear a mask. May I still approach them for consent?

    1. Please explain on the checklist how you reasoned through options in this situation. Potential solutions may be to conduct the consent remotely (from another room) or, if possible, to obtain consent from another individual who is also a legal guardian (e.g., the other parent if possible). Present how you considered potential mitigation strategies in your activation checklist and the committee will review your proposal. July 19, 2:40 p.m.

Visitors

  1. Can visiting graduate or professional students (e.g., those who are students elsewhere and participating in a research rotation at U-M) participate in human research?

    1. As of June 5, 2020, the Governor’s Executive Order indicates that visiting scholars who were already engaged and part of the existing lab team prior to the ramp down may be incorporated into the return-to-work plans of the labs. July 19, 4:20 p.m.

  2. I have a question about in-person site qualification visits. Based on the C3RG presentation, if the visit is a must, the committee will allow it to happen as long as the Michigan Medicine visitor guidelines are followed. Does that still stand? If so, will the CRA be allowed in the building without an appointment or ID badge?

    1. They have to follow all rules for entry into our buildings, just as our researchers. Michigan Medicine strongly encourages virtual visits; if an in-person visit must occur, it should be limited to one person and they must follow all rules. July 19, 4:20 p.m.

  3. I have an upcoming new study and the sponsor has asked about the timeline for conducting an on-site initiation visit. Is there any guidance for sponsor visits?

    1. They have to follow all rules for entry into our buildings, just as our researchers. Michigan Medicine strongly encourages virtual visits; if an in-person visit must occur, it should be limited to one person and they must follow all rules. July 19, 4:20 p.m.


Laboratory and Studio Research

Guiding principles for ramping up laboratory and studio research

  1. The safety of the workforce and everyone associated with its return, including members of surrounding communities, is the leading priority.

  2. Planning recognizes the diversity of types of research across campus is a strength and critical to our research enterprise and mission.

  3. Planning recognizes that for safety and feasibility, all laboratory and studio research will not reopen at the same time and we will need a stepped approach to reopening.

  4. A required component of planning will be reversibility, in case a recurrence of COVID-19 forces another contraction of research activity.

  5. Laboratories, including shared facilities, must carefully prepare equipment and materials for occupancy after a long period of dormancy and may require additional time or planning.

  6. Planning will be as transparent as possible, to permit individual faculty to make plans that conserve their time and effort.

  7. Students or postdoctoral researchers may not be compelled to conduct research activities on campus as a condition of assistantship or associate support, while public health orders governing individual activity remain in effect.

  8. OVPR administrative review of school/college/unit staging plans in concurrence with their approvals of PI safety plans will occur to ensure coordination, effectiveness and compliance in health and safety.

Guidelines for entrance into any U-M laboratory building with research operations

  1. For all non-emergency situations, all buildings will have a wheelchair-accessible single point for entrance and exit, which everyone will be required to use.

  2. Since the university began ramping up research and scholarship on May 21, greeters were stationed at the entrance of research buildings to verify approved employees, ensure those employees completed their daily health screen and administer temperature checks. As research buildings transition to multipurpose use in preparation for the fall academic semester, beginning the week of August 10, buildings are no longer required to have a greeter at entry points.

  3. You will be required to complete the ResponsiBLUE daily health screening survey prior to entering any U-M building.

  4. If your answers to the screening disallow you from being present at work (pursuant to an applicable Executive Order, University policy, or otherwise) or if you are not approved to return to your workspace, please refrain from entering any U-M buildings.

  5. Any employee who has a positive intake screen will be referred for follow-up with the Occupational Health Services Hotline. (734-764-8021).  

    1. Occupational Health Services (OHS) will conduct the initial triage for employees with a positive screen and possible need for a COVID-19 test.

    2. OHS has put a process in place for employee testing, either with off-site testing or at University Health Service.

    3. Employees will not be allowed to work until cleared by OHS.

Guidelines for individuals performing on-campus work

  1. Approval is required from School/College/Unit to re-engage in laboratory and studio work.

  2. Before approved individuals may return to work, they must complete a training module that outlines practices for safely returning to lab work.

  3. Employees who are not feeling well are required to stay home.

  4. According to the U-M Chief Health Officer, individuals who are at high risk for complications of COVID-19 are not required to return to work. If an employee has a concern that they may be at high risk, they should contact their own doctor or Occupational Health Services. Some examples of high risk factors are:

    1. Age greater than 70, 

    2. Persons with primary or acquired immunodeficiency,

    3. Persons on anti-rejection therapy following solid organ transplant or bone marrow transplant,

    4. Persons on biologic therapeutic agents, such as tumor necrosis factor inhibitors,

    5. Persons with malignancy and ongoing or recent chemotherapy, or

    6. Persons receiving system immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day or prednisone for >2 weeks.

  5. Employees are encouraged to use personal protective equipment and hand sanitizer on public transportation, per the governor's Executive Order 2020-91.

  6. Work that can be done remotely must continue in that fashion.

  7. If your work requires your presence on campus and you do not wish to report for work, you may be able to utilize paid leave options, including the COVID-related paid time off or vacation time if approved by the supervisor. Voluntary furloughs may be a possibility. Please discuss your options with your supervisor.

  8. Graduate Student lab engagement should follow Rackham Guidance. Specifically the manner in which graduate students return to research in the laboratory or field should be mutually agreed upon by faculty mentor/PI and the graduate student. This agreement should be part of the work plans that faculty develop with their graduate students as part of the ramp up.  Faculty should create pathways for graduate students to return to research that address both the priorities of the student and the priorities of the PIs research projects. If not fully aligned, the following factors can potentially provide flexibility: (1) Engage the research group as a team to complete high-priority lab tasks in ways that accommodate the individual situations of lab members; (2) Incorporate variable levels of on-campus (e.g. lab work) and remote (e.g. data analysis, experimental design) research activities into the work plans of graduate students during the initial ramp up in ways that accommodate their individual situations; (3) as needed, the student’s department or program can work with the faculty and student to develop alternative methods for academic and research progress. 

    1. In addition, the Graduate student’s department or academic program should review faculty/student work plans to ensure safety and equity. In the event that the manner in which a graduate student returns to laboratory or field research cannot be mutually agreed upon by the faculty member and student, the department or academic program should assist in developing such an agreement. The graduate student, faculty member, and department can also call upon available campus resources, including those in the student’s school or college, the Rackham Resolution Office, or the Dean of Students Office of Conflict Resolution.

    2. Confidentiality of a graduate student’s individual circumstances should be maintained by the faculty mentor.

Guidelines for safe operations of laboratory/studio spaces

  1. Each laboratory/studio must provide all of the following items before reopening: safe laboratory schedule/plan, individual duty list, and occupancy list that, at all times, maximizes employee spacing and complies with social distancing and all relevant PPE. The plan must be approved by your school/college/unit. All of the described procedures must be followed and adhered to:  

    1. This safe laboratory plan/schedule should minimize the number of people in each laboratory room and all associated spaces (for example, break rooms) at any one time. This example form will be used by several schools to guide obtaining and approvals for this information. Approvals of safety plans will be given by each school’s research leadership, with concurrence from OVPR. Please follow guidance from your school or unit on the form and process for obtaining approval to return to the lab.

    2. Distribute a list of duties to be performed by personnel, indicating the location and designated time of day for such duties to be completed.  

    3. Develop a means of signifying who is present in the lab/studio space at any given time, preferably through an online sign-in tool to minimize touching items such as a physical sign-in sheet, or other mechanism of controlling the number of people in the lab at the same time.

    4. Principal investigators must designate an on-site supervisor or employee to implement, monitor and report on the COVID-19 control strategies within labs, per the governor's Executive Order 2020-91.

    5. Stagger break times to minimize contact between people in rooms.  Conference rooms and cafeterias will be closed off and cannot not be used. Ensure eating and drinking is not occuring in labs.

    6. Post a map inside the lab/studio entryway with maximum room/bay occupancy to maintain social distancing.  

    7. Each lab/studio room can only accommodate a maximum of 1 person per 144 square feet. If you cannot maintain at least 6 feet of social distance, or the person per square feet requirement, then the schedule will need to be revised and/or reconfigured to achieve these.

    8. Small, narrow laboratories/facilities smaller than 288 square feet can only accommodate one person at a time.

    9. Lab Benches are not 6 feet across, thus plan for work to occur only on one side of the lab bench in most instances.

    10. Note that, depending on the research area/experiment, safety guidelines for the specific research project may require more than one person to be present in the room at any one time. Even in this case, the individuals present must maintain a 6-foot separation at all times. If the appropriate physical separation cannot be maintained, this work cannot be started.

    11. Move equipment to create at least 6 feet between users.

    12. When six feet of social distancing cannot be achieved for training purposes, an exception must be acquired and enhanced PPE (lab coat, gloves, and a cloth or surgical face mask with the addition of a face shield) must be used.

    13. Tape will be used to mark out 6-foot spaces for high traffic areas or bottlenecks.

    14. PI safety plans should include attestation that buildings must not be used for social gatherings or group meetings, that conference rooms and other group spaces will be off limits.

  2. Masks

    1. Employees authorized to return to lab work must be provided a cloth face covering and instructions on cleaning and maintenance. Refer to EHS Face Covering Usage for COVID-19

    2. A new mask will not be provided daily, so you must retain this mask and bring it with you daily, after complying with all relevant and applicable cleaning and care requirements. Refer to EHS Face Covering Usage for COVID-19

  3. Create a safe space and maintain at least 6 feet between researchers at all times.

    1. Always wear the cloth face covering provided to you unless your research procedures dictate heightened PPE requirements. When not wearing the safety PPE required for your laboratory work, reapply your provided face covering. Proper hand hygiene before and after using any face covering is critical.

    2. Wash your hands with soap upon entering and before leaving the lab/studio, and wash them after touching shared accessory devices like phones (use speaker phone if possible).

    3. Wear eye protection when there is a potential for splash or splatter to the face, or when surface contact is a possibility, e.g. microscopy work.    

    4. Minimize shared items (pens, notebooks, frequently used reagent bottles, etc.). As much as possible, each person should have their own.

    5. All principal investigators must formally assign a daily in-lab sanitation role which includes daily decontamination of lab-space procedures including the cleaning of all work benches, door handles & lock keypads, keyboards/mice/desks for shared equipment computers, telephones, printer, cameras, microscopes, control panels, etc.

    6. Provide disinfecting supplies and require workers to wipe down their work stations at least twice daily, per the governor's directive.

    7. If it can be done safely, use paper towels or Kimwipes when handling common laboratory items, laboratory equipment and cabinet handles.

    8. Wipe or spray door handles with 70% ethanol (or other EPA-registered disinfectant) after use. See EHS guidelines

    9. Lab coats, gowns or aprons are recommended to protect personal clothing. Follow EHS guidelines for cleaning and disinfecting hard, non-porous surfaces.  

    10. Remove lab coats and gloves when leaving the lab. 

    11. Consider footwear and clothing as a possible transmission source. You should have a pair of shoes that you use for external use (including working in a laboratory/facility) that you do not wear into your place of residence. Such shoes could be left just inside the door of your place of residence. 

    12. Be sure to disinfect surfaces, such as tables and chairs, before and after using such facilities. 

      1. Cups, mugs, plates, and silverware must be washed with soap before and after use. 

      2. Wash your hands after using a break room.  

      3. Food and drink are not allowed in labs. ( link coming here)

  4. Create a plan for shared equipment. All shared equipment must be disinfected before and after each use.  

    1. Wear disposable gloves when cleaning and disinfecting equipment. Discard (where supplies allow) or disinfect gloves after each use with 70% ethanol or sanitizer. 

    2. Special care should be taken to disinfect equipment that makes direct physical contact with skin, including eyepieces for microscopes, touch pads, etc.  

    3. Use disposable tissues, Kimwipes, etc. to touch surfaces that cannot be disinfected, and/or when gloves are not available.

  5. Create a plan for interacting with individuals outside the lab  

    1. Contact with other labs should be made via phone or electronic means, except in cases of extreme emergency.  

    2. Those also working in the patient care setting should change clothes prior to lab entry.

    3. Transfer of items should be arranged by leaving them in the hallway or other designated area for a no-contact approach, as opposed to handing them over in person. The timing of these transfers should be closely coordinated to ensure the safety of all involved, as well as to eliminate the potential for lost or otherwise unattended items in these settings.

    4. Research studies must be carefully and thoughtfully planned given the likelihood that support services, such as animal facilities/ULAM, central stores, core laboratories, etc. will be operating at reduced levels.

    5. Use of shared facilities and other labs’ equipment must be pre-arranged in order to avoid accidental contact. Be sure that all users understand lab sign-in procedures.  

    6. Use precautions when entering a restroom, shared use facility, or other common areas. Call out to assess occupancy or create an “occupied” door sign. Use a disposable towel or Kimwipe to touch door handles and faucets, and wash your hands upon entering and leaving.

    7. Develop a safety protocol plan for deliveries.

  6. Working safely with animals in the vivarium

    1. The Unit for Laboratory Animal Medicine (ULAM) will maintain mechanisms for providing continued daily care to all animals housed on campus. This includes continued veterinary medical care; assessment of animal health and well-being; provision of food, water, and clean cages; and maintenance of appropriate environmental conditions.

    2. Institutional Animal Care & Use Committee (IACUC) approval processes remain intact and any changes to research protocols must be submitted to the IACUC for review and approval prior to implementation, pursuant to normal processes.

    3. Although ULAM husbandry and veterinary care operations are no longer operating on a “split-shift” mode, our commitment and priority focus remains with critical standard care services. While ULAM staff may be able to perform some research support services that go beyond routine husbandry and veterinary care on an emergency, case-by-case basis, these arrangements must be made well in advance and cannot be guaranteed. Our top priority is ensuring that the highest animal welfare standards are maintained at all times and in all circumstances.

    4. Research activities during the ongoing re-engagement phase could be impacted by the potential for another subsequent ramp-down should there be a resurgence in COVID-19 cases. Accordingly, PIs must thoughtfully and carefully plan their animal ordering and breeding colony production.

    5. ULAM can now support the acquisition of new animals for research and educational purposes. Breeding colonies may be re-established to produce animals for future projects and requests will be accepted for the importation of animals from collaborating institutions (please note that requests for exporting animals should be discussed in advance with the Rodent Health Surveillance Team). Animal orders will be accepted for delivery beginning Monday, June 29, 2020.

    6. If your animal-related experiments require the use of anesthetics, analgesics, or any other pharmaceutics, ensure you have adequate supplies that are not expired prior to initiating those experiments. Similarly, gas anesthetic machines must be certified in accordance with the manufacturer’s recommendations and IACUC expectations.

    7. ULAM has begun ordering supplies for laboratories on a limited basis. Orders will be placed weekly and any lab placing an order will receive additional follow-up communications about when to expect the supplies and how they will be made available for pick-up. If you have specific questions about ordering or procurement, please contact ulam-questions@umich.edu.

    8. Vivarium re-engagement is dependent upon availability of all of the following:

      1. Appropriate ULAM staffing levels

      2. Personal Protective Equipment (PPE) required for entry to the facility as well as any additional protocol-specific PPE (i.e., for handling hazardous agents)

      3. Disinfectants required for use on surfaces within the facilities

    9. ​​Research interaction with animals and space within ULAM and animal housing rooms must be carefully scheduled/coordinated to ensure mandated social distancing and space density directives. To facilitate cooperation:

      1. Animal holding and procedure rooms will be identified with the maximum allowable occupants at a given time.

      2. ULAM will post times needed for daily animal husbandry and any veterinary clinical care activities.

      3. Inter-laboratory coordination in rooms used by more than one PI will be necessary; ULAM will post sign-up sheets for all housing and procedure rooms for scheduling in advance. The sanitation procedures needed between users will also be provided.

    10. ANY individual who has been approved to re-engage in research activities in buildings designated for re-activation should review the applicable ULAM Research Re-Engagement and Vivaria Traffic Plans** PRIOR TO building re-entry. As you review these plans, please pay special attention to the new outlined traffic patterns, donning of PPE, and sanitation practices. Amended traffic patterns in most facilities have been created to minimize the likelihood of individuals crossing paths in small corridors; as such, it is extremely important that all individuals follow the directional signage posted in each facility.

      1. Wave 1 Buildings – ULAM Research Re-Engagement & Vivaria Traffic Plans**

      2. Wave 2 Buildings – ULAM Research Re-Engagement & Vivaria Traffic Plans**

      3. Wave 3 Buildings – ULAM Research Re-Engagement & Vivaria Traffic Plans**

        **Only personnel listed on active animal use protocols in the specific buildings designated for re-activation in Waves 1–3 will have access to the protected links above.

Creating a culture and opportunity for continuous improvement of lab and health safety

  1. Frequent communication from OVPR and EHS regarding lab safety, research re-engagement and important public health updates.

  2. EHS will perform walkthroughs to help maintain public health standards so that labs can remain open.

  3. Report lab safety issues, including personnel who are ill or not following safety protocols, via the U-M compliance hotline website. You can also report concerns by calling 866-990-0111 or contacting EHS at 734-647-1143 or emailing EHS.

  4. OVPR and Occupational Health Services will track aggregate data on COVID-19 illness in labs with weekly reports.

FAQs for laboratory, studio and field research re-engagement

  1. If the State of Michigan were to move to another reopening phase, will this change how research labs operate? Will we be able to have more people in the lab?  

    1. At present, if the state opens up more activities or moves to another phase of reopening, we will likely continue to operate under these state regulations for operations of laboratory research. We will follow these guidelines and adhere to the best public health practices. Researchers should prepare for this controlled way of working on campus, which could be with us for months, even possibly into 2021. August 28, 3:55 p.m.

  2. Who decides which labs, researchers, or buildings get to reopen in the various waves of reopening? 

    1. Each school/college/unit set the priority for which of their buildings and labs open in which wave based on a number of factors, including: if space is shared with others units, staging of cores and vivarium, and ease of building preparation. We encourage you to reach out to your chair or research associate dean if you have questions. August 28, 3:55 p.m.

  3. How are decisions made about buildings or other facilities that house researchers or labs from more than one school?

    1. In cases where buildings or labs house researchers from multiple labs or units, we expect all involved units or PIs to be in close communication about the needs of those facilities. For cores and other shared facilities, the school/college/unit providing oversight will determine their priority through the same process as individual PI labs in conjunction with OVPR. June 18, 4:30 p.m.

  4. How will additional capacity within buildings grow after they reopen?

    1. Buildings that opened in the pilot wave can add more workers to the overall building by incorporating shifts. The implementation of shifts, if necessary, is up to the unit overseeing that building. Future waves can incrementally grow the workforce by utilizing shifts, with a goal of reaching 100% of the building’s socially distanced capacity yet maintaining only 60% density (as of October 5) at any one time. October 1, 2:50 p.m.

  5. What do I need to do to start planning for reopening my lab?

    1. You should work within your school/college/unit on completing the approval process. Mostly importantly, each laboratory/studio must have their COVID Lab Safety Plans approved by their school. Plans provide details including square footage, allowed and requested occupancy, shared equipment or other resources, times/days of access, and details about which research activities will be performed. 

    2. EHS has developed a checklist to help researchers safely and efficiently ramp-up research activities, which compliments the research continuity plans that they have developed. The checklist is meant to be implemented at the lab/research group level. Contact EHS (734) 647-1143 or your EHS representative to discuss the checklist or if you have any concerns. June 18, 4:30 p.m.

  6. My office has a door and can reasonably be sealed off from others. Can I work in my on-campus office if it is in a building with labs that are open?

    1. Not at this time. The Governor’s most recent executive order notes that all work that can be done remotely should continue in that manner. Only activities that have been deemed essential are allowed in offices, with approval to do so by your school leadership. Although individual offices may be low risk, when we fill those offices collectively we increase activity in hallways, intake stations, restrooms, parking, bus ridership—all potentially leading to increased interactions and disease transmission. Lab work cannot be done at home, which is why this is a prioritized activity as opposed to office work. June 18, 4:30 p.m.

  7. Can I perform field research if I follow local public health guidelines?

    1. Yes, field work is allowed with the submission of an appropriate safety plan and necessary approvals from research leadership. Some circumstances may still be restricted, including activities or when using specialized equipment that precludes social distancing requirements, including boats or airplanes. Please note that individuals should register their travel with the university prior to departure. October 6, 3:15 p.m.

  8. I am a graduate student. How will it be decided if i should or should not return to work with my PI?

    1. Graduate students and faculty mentors should work together to develop a mutually agreeable plan that allows for the student to return to on-campus research. The student’s graduate program or department can help by providing specific guidance for the development of work plans describing the ramp up and ensure that the ramp up in activity is accomplished in a safe and equitable manner. Further discussion and suggested practices will be presently added to Rackham’s COVID-19 resource page. PI’s will not be able to insist graduate students return to the lab unilaterally. June 18, 4:30 p.m.

  9. Can visiting scientists or scholars return to the lab?

    1. Yes. As of June 5, the Governor’s Executive Order clarified that visiting scholars including visiting graduate students who were already engaged and part of the existing lab team prior to the shutdown may be incorporated into the return to work plans of the labs. June 18, 4:30 p.m.

  10. Are researchers on the Flint and Dearborn campuses subject to the same rules around restarting research?

    1. Yes. This guidance on how labs will operate and the safety planning that needs to occur  applies to all three campuses, and indeed across the entire state for all research labs. Please work with your school and department leadership to understand how your campuses are implementing this guidance. June 18, 4:30 p.m.

  11. How is social distancing achieved in the labs or studios?

    1. Regardless of how many research groups or schools co-occupy space, current guidelines require individuals to be spaced at least 6 feet apart, with no more than one researcher for every 144 sq ft of laboratory space. Additionally, no more than 10 people can be gathered in any lab common space regardless of size and distancing. Finally, the entire research workforce of a building can not exceed 60% (as of October 5) of the full research workforce capacity during one shift. Common spaces such as lounges and break rooms must be closed off to prevent crowding. October 1, 2:50 p.m.

  12. Do I have to answer health questions every time before I enter my building? 

    1. Yes. All employees are required to complete a daily health screening survey before entering any U-M buildingsAugust 28, 4 p.m.

  13. If I work in a lab and feel ill, are there enough tests for me to be tested? How long will it take to get my result?

    1. If you feel ill, do NOT come to work.

    2. Please contact the Occupational Health Services (OHS) hotline at 734-764-8021 will conduct the initial triage for employees with any potential symptoms. If you meet the criteria for testing you will be directed to a testing site. U-M has ample testing supplies available for employees and trainees in our labs. June 18, 4:30 p.m.

  14. If someone in my lab becomes ill will I be notified if I have been in close contact with them?

    1. Occupational Health Services (OHS) will conduct the initial triage for employees with a positive screen and contact tracing will be conducted per current public health guidance. June 18, 4:30 p.m.

  15. I am worried about COVID and do not personally feel comfortable returning to the lab. What are my options? Can I decide to not return?

    1. Faculty and staff are expected to work on campus if your research or scholarship requires it. However, we strongly encourage work that can be done remotely to continue in that fashion. If your work requires your presence on campus and you do not wish to report for work, you may be able to utilize paid leave options including the COVID related paid time off or vacation time if approved by the supervisor. Voluntary furloughs may be a possibility. Please discuss your options with your supervisor.

    2. Graduate students may not be compelled to return to labs, and should work with their PI or graduate program staff if they have concerns. June 18, 4:30 p.m.

  16. Who will determine if an individual is “high risk”?

    1. It is up to the individual to identify themselves as high-risk based on a range of factors (e.g., age 70+, immunocompromised, other certain underlying health conditions). Individuals who feel they are at high risk should discuss with their health provider and Occupational Health. High risk individuals may choose to participate in permitted on campus activities but will not be required to do so. June 18, 4:30 p.m.

  17. The guidelines state that cafeterias and conference rooms will be closed, and we are not permitted to eat or drink in the labs.  Where should we instruct lab members to take breaks where they can eat or drink? 

    1. The intent of the closure of these spaces is to prevent the spread of the virus within the building. According to U-M guidance for safe lab work, conference rooms and cafeterias must remain closed to ensure social distancing and prevent people from congregating in groups. Many of our facilities managers have re-designed common spaces so that people can eat and take breaks outside the labs. This includes moving chairs so that there is only one person per table which allows for social distancing, as well as providing signage and reminders for disinfection of the area after use. Researchers are also allowed to go outside and return to the buildings without having to rescreen in order to take breaks. June 18, 4:30 p.m.

  18. Where can I find signage, equipment cleaning logs and disinfection protocols for my research laboratory?

    1. Please refer to the U-M Department of Environment, Health and Safety's COVID-19 Research Resources webpage. June 18, 4:30 p.m.

  19. As a supervisor, what should I do if an employee refuses to wear a face covering in situations where it is required? Or says that they cannot medically tolerate wearing a face covering?

    1. The first step is to have a discussion with the employee to explain that face coverings are now required to be worn as indicated by the State of Michigan executive order unless there is a medical reason that prohibits the use. If the employee states they have a medical reason for not wearing one, they must provide documentation from a medical professional to Work Connections just like any other restriction. They can be sent home using their own PTO until documentation is received, evaluated by work connections, and a determination is made. June 18, 4:30 p.m.

  20. Can I wear a face shield instead of a face covering?

    1. No. The Centers for Disease Control and Prevention does not recommend the use of face shields as a substitute for cloth face coverings. However, they can be worn in addition to a face covering when sustained close contact with other people is expected. August 28, 4 p.m.

  21. What sort of planning is happening in advance of a possible second COVID-19 outbreak later in the year or next? 

    1. We absolutely need to be prepared to ramp back down if conditions worsen. One of the primary goals of a phased approach to research re-engagement is to familiarize ourselves with how to operate at lower capacity levels if necessary. We want to avoid ramping back down if at all possible, but there may be outside factors that are beyond our control. This is also a good reason why the practices and behaviors we exhibit now will help us ensure we can maintain a safe work environment and not have to ramp back down due to our own failure to adequately prepare our labs and buildings. June 18, 4:30 p.m.

  22. Gov. Gretchen Whitmer's "Safer at Home" executive order has relaxed some restrictions on public/in-person interactions. Why aren't all research restrictions relaxed accordingly?

    1. Some of the regulation changes as it relates to interactions have not yet been extended specifically for academic research. Different public sectors (higher education, businesses, etc.) have different guidelines out of concern for public health/safety. As such, some research-specific regulations are still more stringent than general public regulations. In addition, the local policies around public interactions differ across regions within the state and beyond. Researchers should always refer to the specific local policies involving research for the sites in which they are conducting research. July 8, 2:20 p.m.

  23. Now that students are back on campus and in classrooms, why can't we bring back researchers for dry office work in U-M facilities?

    1. One key factor is site and building density, which is cited by public health experts as one of the most-important safety considerations for minimizing public transmission risk. That is, decreasing density in buildings/sites as much as possible, but privileging students and student learning, means that in order to bring students into buildings, other functions in those buildings and spaces may have to wait or move/remain in alternate forms, such as remote work. August 28, 4 p.m.


Field Research

Please refer to the U-M Field Research Re-engagement Guidelines

Questions?

If you see or feel someone is not following appropriate guidance for maintaining a research space, we encourage constructive feedback between personnel. You can also report the issue anonymously through the U-M Compliance Hotline.