Clinical Trials Support Office: Human Research Reactivation

Research leadership from across the University of Michigan campuses are working together to safely re-engage research through carefully managed waves, in accordance with state regulations. For safety and feasibility, human research will activate in four Activation Tiers - Tier 0, Tier 1, Tier 2, and Tier 3. Activation Tiers for human research studies can be determined by referring to the Human Research Activation Tier Framework and Human Research Activation Tier Flowchart.​ As a reminder, all human research work that can be done remotely should continue in that manner. 

View the UMOR Research Re-engagement website for the latest updates on the following:

  • Guiding Principles for Human Research During COVID-19
  • Human Research Reactivation Procedures
  • Human Research Reactivation Committees
  • Responsibilities in Conducting Human Research During COVID-19
  • Human Research Re-engagement FAQs

ATTENTION: 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 must complete the Human Research Activation Procedures found on the UMOR Research Re-engagement website. Studies that were permitted to continue during the research pause must also complete the Human Research Activation Procedures in a timely fashion to confirm compliance in order to continue. Questions on activation procedures should be directed to human-research-activation@umich.edu.

Activation Checklist 

The Human Research Reactivation Committee is accepting applications via the Human Research Activation Checklist for studies to safely re-engage research. Submissions to the Reactivation Committee for existing studies are to occur in parallel with the submission of any necessary IRB amendments (see IRBMED Guidance: Human Research Reactivation). Study teams should be notified of their activation within one week after their application. 

New studies are to submit their checklist after IRB approval. Make sure to consider COVID-19 safety planning methods that minimize the risk of community transmission when writing a protocol. 

Training Module & Return-to-Work Training Attestation

PIs, staff, and study team members are required to 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.

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

  • They will interact with human participants.
  • They will be returning to work on a U-M campus.
  • They will be returning to work and spending time in proximity to other U-M study team members.
     

Safe Research Plans

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. 

Daily Health Screening

  1. Prior to presenting to work each day, all study team members will be required to complete the U-M Daily Health Screen. 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. Employee Health Services 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.

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.

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 speakerphone 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.

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.
     
    • In Michigan Medicine facilities, all individuals entering the facilities are provided with a disposable mask that is not allowed to be reused. 
    • 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. Based on updated CDC recommendations and guidelines issued by the U-M Medical Group, please remember to wear eye protection when providing care to patients and when in a patient room/care space. Eye protection can include any of the following devices:
     
    • Goggles
    • Face Shield
    • Plexiglass Barrier
    • Side Shields for Eyeglasses
    • Face Guards

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 workspace.
     
  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 another 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 can not be used. Ensure eating and drinking are not occurring 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.

Contact Tracing

  1. Contact tracing will be conducted by EHS for university employees in addition to local county health procedures. Procedures are county-specific, but involve contacting recent contacts of individuals with COVID-19 and recommending isolating or quarantining while monitoring for new cases. For Washtenaw County, COVID contact tracing procedures can be found here: Contact Tracing can Help Slow the Spread of COVID-19. In order to facilitate contact tracing, individuals who spend more than 15 minutes within 6 feet of each other for the research encounter (incremental to any clinical interaction and including both participants and those accompanying them) should be logged in a secure Research Contact Log. 
     
  2. Include in the Research Contact log the contact information of study participants and those accompanying them (e.g., phone numbers, email addresses) and respond to public health department contact tracing requests. 
     
  3. Ensure that study participants received contact information for the research study so if the public health department is seeking contact information to reach the study team, the study participant will be able to provide the study team’s contact information to the public health department.   

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.

Michigan Medicine Steps for Activation

Once a study has been approved by UMOR for activation, study teams are to take additional steps required by the Medical School Office of Research in advance of proceeding with a study. 

Medical School Office of Research Requirements

  1. Sponsor has been notified and approved of any protocol modifications.
     
  2. The IRB (and any non-UM IRB if applicable) has approved any study modifications that were necessary. Review the IRBMED website for information on various topics including remote consenting, amendments, and reporting protocol deviations/modifications.
     
  3. Research Pharmacy (if applicable) has been notified and investigational products are available. For new studies, reach out to IDS intake team (Pharm-Research-pharmacy-requests@med.umich.edu) to help with coordination and prioritization. For reactivation, work directly with the lead pharmacist for that study.
     
  4. If your study is under the oversight of the CTSO and registered in OnCore, that OnCore has been updated accordingly with the appropriate subject visit information and IRB reviews. See OnCore Research Reactivation Flowchart for assistance.
     
  5. Workspace is available and open for research
    • If the human subjects research is conducted in a non-clinical, Medical School space, investigators should request building access HERE. Study teams must adhere to building entry procedures and COVID-related policies of the building in which their research is occurring. Access to clinical buildings does not require Medical School approval.
    • Each team must maintain a daily log of workspace and common equipment disinfection responsibilities. This log needs to be available upon request.

Sponsor Visit Guidelines

Michigan Medicine strongly encourages virtual visits. If an in-person visit must occur, visitors must adhere to the following guidelines:

  1. Sponsor visits for study initiation, study monitoring, and study closeout should be conducted remotely to the extent possible.
     
  2. In-person Sponsor visits should be fully justified and will only be permitted when
    • Michigan Medicine or the study site clinic allows visitors, AND
    • Study has been approved by UMOR for activation, AND
    • Sponsor/Contract Research Organization (CRO) permits staff travel, and Michigan state does not have any travel ban on inter-state 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 who will observe U-M policy of safe practice including but not limited to: health screening at entry, use of face mask, 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 minimize the number of staff the visitor will directly interact with, as well as the duration of direct interaction.
     
  5. Study teams should keep a log of the visit to record contact information of the visitor and list of staff that the visitor interacted with. 

To view Michigan Medicine's full guidance for study teams with sponsors performing site initiation, study monitoring, auditing, or close‐out visits for a clinical research study, click here.

Study teams can download the Michigan Medicine Site Visit Letter to inform Research Sponsors, CROs, and Study Monitors of Michigan Medicine's implementation of virtual site visits and remote study monitoring options for clinical research. 

Contract Tracing

Study Teams that have received UMOR approval for study reactivation have attested to enable contact tracing. This documentation can be relied upon should COVID-19 reach our research. Research teams must keep a daily log of study staff working on-site, as well as names and contact information of study participants evaluated and any accompanying persons, in case contact tracing for COVID transmission is necessary.

This Activity Log Template is designed to meet the contact tracing requirements. Consider this log as a model that can be modified to suit the particular needs of a study team. For Study Teams managing multiple studies, consider using a single workbook with a different tab for each study. Periodic auditing of Activity Logs will occur, whether Study Teams use this template or develop their own. Department policies should be followed in accordance with where the research occurs.

CRAO Guidance for COVID-19 Testing

For studies that require COVID-19 testing, this activity will be represented on the OnCore Billing Grid in accordance with the Calendar Review & Analysis Office’s (CRAO) standard guidance that the specification should mirror the protocol. To address charge routing for COVID-19 testing activity that is not represented on an OnCore Billing Grid, submit an Unscheduled Occurrence in the MiChart In Basket.

Michigan Clinical Research Unit (MCRU)

MCRU continues to operate during normal business hours to support research approved for reactivation. Study teams must receive tier approval from the Office of Research prior to scheduling their research visit with MCRU. Prior to all patient visits, study teams are required to call and pre-screen their patients to review for COVID symptoms within 72 hours of their visit to MCRU. 

As a reminder, please contact the MCRU-Support (MCRU-Support@med.umich.edu) for any COVID-19 studies requiring MCRU services.

 

Questions?

Contact us at MM-Clinical-Research@umich.edu

MBNI Building, 205 Zina Pitcher Place, Ann Arbor, MI 48105

A list of CTSO-CTSU contacts are available in the Personnel Directory.