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Research Re-engagement

Safety Protocols Remain in Place

Researchers must continue to maintain at least six feet of separation at all times and wear face coverings, regardless of their vaccination status.

Tiers Approved for Human Research Activation

  • Tier 0
  • Tier 1
  • Tier 2
  • Tier 3 (effective April 1)

Last Updated: 8:10 a.m. on March 17, 2021

The following COVID-related research guidelines take effect April 1:

  • Laboratories and research spaces across the three U-M campuses may begin to operate at a density capacity that safely allows for at least six feet of social distancing between personnel. There will no longer be a mandate to maintain 144 square feet per person after March 31.

  • Operational capacity for research will remain at 75 percent through March 31.

  • All human research studies categorized as Tier 3, which have been paused since last spring, may resume in-person activity beginning April 1. These studies must first apply for activation.

  • Study teams (including those newly applying for Tier 3 activation) are required to work within the guidelines outlined in their Human Research Activation Checklist. Researchers must resubmit their checklist if they intend to transition from remote to in-person activity and/or from clinician to other study team members.

Learn more in the March 17 installment of VPR Update.


COVID-19 vaccination status

  1. I have one staff member who is vaccinated and one who is not. Can I give these staff different job duties based on vaccination status?

    1. No, you cannot. Vaccination of staff is not mandatory at this time, and should not be a factor in assigning work, including whether or not someone can work onsite.  When onsite, employees are required to wear a face covering, and should continue to follow the safety measures recommended to prevent the spread of COVID-19. March 16, 2021

  2. Can I tell my staff that they have to get vaccinated and/or have them provide me proof of their vaccination status?

    1. No. The COVID-19 vaccine is not mandatory at this time, and there is no need to track employee’s vaccination status. March 16, 2021

  3. Can I screen participants on the phone for whether they have been vaccinated, and then choose only to enroll participants who have been vaccinated?

    1. Unless COVID vaccination is an inclusion or exclusion criteria approved by your IRB and required for your study, it is not appropriate to screen out individuals who have not been vaccinated. March 16, 2021

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. 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 is seeking to 1) initiate face-to-face interactions with participants, and/or 2) have study team members leave their remote work setting for the purpose of conducting study activities, and/or 3) include contact among staff members in any setting.

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 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.

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

  4. 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 leaving their remote work setting for the purposes of conducting study activities.

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

  5. 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. 

  6. 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.

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

Human research activation committees

We anticipate that study teams will be notified within approximately 7-10 days 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)

April 1 human research activity expansion

  1. All human research studies categorized as Tier 3, which have been paused since last spring, may resume in-person activity beginning April 1. These studies must first apply for activation.

  2. Studies with Human Research Activation Committee approval for Tiers 0, 1 or 2 that had been conducting all or some study activities remotely may now conduct study activities in person if 1) those activities are essential to the integrity of the study (e.g., to optimize recruitment or data collection) and 2) appropriate mitigation strategies are in place.

  3. Study activities that can be completed remotely without compromising study integrity should continue to be completely remotely.

  4. For studies already approved by the Human Research Activation committee, Human Research Activation Checklist resubmissions are required if 1) the study previously had no face-to-face interaction with participants and will now have face-to-face interaction, or 2) the study activities requiring face-to-face interaction with participants were previously conducted entirely by clinicians during the clinical encounter and these study activities will now include study team members who are not clinicians. Checklist resubmissions are not required if changes are limited to modifying study participant characteristics, contact distance and/or contact duration. For example, if a study was already approved for face-to-face interaction between study staff and participants, and the change involves only adding additional in-person interaction time (e.g., changing survey collection from remote to in-person), a Checklist resubmission is not required.

  5. These changes do not indicate the return to pre-COVID-19 research conditions.

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 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. 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.

    5. 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 where 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. 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.

    5. 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. 

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

    7. Notify participants 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.

    8. 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.

    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 requirements of at least 6 feet between staff members.

    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. 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 ResponsiBLUE daily health screening survey 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 recommendations. 

    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. 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.

    6. 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. 

    7. Develop a plan to notify participants 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.

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

    9. 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.

    10. 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.

  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 ResponsiBLUE daily health screening survey 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 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 ResponsiBLUE daily health screening survey 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 ResponsiBLUE daily health screening survey 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 ResponsiBLUE daily health screening survey

    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. For how long will study submission to the Human Research Activation Committee continue to be required for new projects?

    1. We will continue to monitor public health conditions and adjust procedures accordingly. It is unclear when we will be able to reduce these mitigation practices for our in-person activities. OVPR will communicate any process updates or changes to the research community through VPR Update, as well as on the research website. March 16, 2021

  2. I modified my study procedures from in-person to remote survey questions, but this approach lessens the study’s data quality. Can I resume in-person survey questions (and/or other research activities) as of April 1, 2021 if I am able to conduct a research activity remotely, but it would be beneficial to study quality if the activity is in-person?

    1. Yes, this is permissible if you have approval from the Human Research Activation Committee to conduct in-person study activity. If you are modifying approaches (e.g., changing from remote to in-person) or changing which study team roles will have in-person interaction with the participant (e.g., from clinician to study coordinator) from your original submission, then you will need to resubmit the Checklist. Human Research Activation approval does not constitute IRB or other regulatory approval and these approvals must still be sought as needed by the study. March 16, 2021

Risks, benefits and tiers

  1. I do not remember which tier my study is activated in. Where can I find out?

    1. Tiers assigned were provided in the approval letter from the Human Research Activation Committee and also are indicated within eResearch, at the top of your study’s homepage. March 16, 2021

  2. 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. March 16, 2021

  3. 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. 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. March 16, 2021

Do I need to complete or resubmit a checklist?

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

    1. Yes. March 16, 2021

  2. Do I need to submit a checklist?

    1. There are three reasons study teams need to submit a checklist if they do not yet have approval for any Tier: (1) if they wish to have face-to-face interactions with study participants (including research-related interactions with clinical care providers during clinical encounters); (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. March 16, 2021

  3. Do I need to resubmit the checklist?

    1. The Checklist must be resubmitted if the study has already been approved for a Tier but you are seeking to change 1) the approach (e.g., from remote to in-person interactions) or 2) which study team roles will have in-person interaction with the participant (e.g. from clinician to study coordinator) from your original submission. If you are seeking to only change 1) participant characteristics, 2) contact distance, and/or 3) contact duration, then you do NOT need to resubmit. March 16, 2021

  4. I knew that my observational study with immunocompromised participants would be Tier 3, so I modified procedures so that all participant research interactions would be completed only by a clinical care provider during a clinical encounter. The study is currently approved as Tier 0. Do I need to resubmit the Checklist if I would like the study coordinator to now conduct these study activities instead of the clinical care provider?

    1. Yes, the Checklist must be resubmitted and approved because you are introducing a new in-person interaction with the addition of the study coordinator. If study visits or procedures need to be modified, then an IRB amendment must be also submitted and approved before proceeding with any changes. March 16, 2021

  5. I have been conducting all my participant activities remotely so as to be Tier 0 but it is essential to the integrity of the study to conduct these activities in person. Do I need to submit a new Checklist?

    1. Yes, if you are modifying the approach (e.g. from remote to in-person) or changing which study team roles will have in-person interaction with the participant (e.g., from clinician to study coordinator) from your original submission, then you will need to resubmit the Checklist. If study visits/procedures need to be modified (including additional face-to-face interactions), then an IRB amendment must be also submitted and approved before proceeding with any changes. March 16, 2021

  6. One element of my observational study protocol includes being in close contact for an hour with children under 2 years old to conduct developmental testing. I omitted this key part of my protocol when I submitted my Checklist so as to be Tier 2 instead of 3. May I now include this protocol element and do I need to resubmit the Checklist in order to do so?

    1. Yes, this is permissible as of April 1, 2021 and no, you do not need to resubmit the Checklist because you already have approval for face-to-face interaction with participants outside of a clinical care encounter as a Tier 2 study. March 16, 2021

IRB and study sponsor

  1. 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. March 16, 2021

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. March 16, 2021

  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. March 16, 2021

  3. ​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. March 16, 2021

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 leaving their remote work setting for the purposes of conducting study activities; and/or 3) they will have interaction with human participants. March 16, 2021

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. Are any special protections needed for any scenarios or segments of the study population?

    1. Yes, eye protection is required to be worn in addition to a face mask by the study team when 1) having face-to-face interaction with research participants older than age 65 and/or 2) having interaction with participants who cannot wear PPE that occurs at closer than 6 feet for more than 15 minutes and/or 3) having face-to-face interaction with participants who are immunocompromised. Policies of a given setting (e.g., Michigan Medicine) that require a higher level of protection supersede these guidelines. All participants must continue to wear PPE unless they meet the CDC guidelines for exemption (COVID-19: Considerations for Wearing Masks) or the study procedures are impossible to complete while wearing a mask (i.e., upper endoscopy). March 16, 2021

  2. My study involves conducting home visits. I have been doing these outdoors to reduce COVID transmission risk but may I begin entering the home as of April 1, 2021 if the participant agrees?

    1. Yes, if conducting home visits is a substantial contributor to study quality,, then home visits are permissible as long as you continue to follow your approved safe research plans including procedures for daily health screening, social distancing, hygiene and disinfection, masks and PPE, density of work area and contact tracing. Everyone in the household must wear PPE (with the exception of those exempt by CDC guidelines- COVID-19: Considerations for Wearing Masks) at the time of the visit and social distancing must be optimized. March 16, 2021

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. March 16, 2021

  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. March 16, 2021

  3. My study takes place outside of Michigan. Am I able to conduct face-to-face interactions with immunocompromised participants as of April 1, 2021 or is this only allowable in Michigan?

    1. This work would be permissible in any setting as long as 1) you have approval from the Human Research Activation Committee to conduct face-to-face interactions and 2) this activity adheres to local COVID-19 guidelines, regulations, and approvals in the setting where the research is conducted. March 16, 2021

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. March 16, 2021

  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. March 16, 2021

  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. March 16, 2021

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. Yes. March 16, 2021

  2. 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. Visitors must 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. March 16, 2021

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.