COVID-19

The MSU Human Research Protection Program (HRPP) has established this webpage with information about the impact of the novel coronavirus (COVID-19) on the HRPP and to address questions from researchers, which will be updated as we learn more and as the situation evolves. 

Frequently Asked Questions

For FAQs, please visit the COVID-19 Frequently Asked Questions webpage

Restart of In-Person Interactions with Participants

Tiers

The guiding principle for reactivating research at Michigan State University has been the safety of our students, staff and faculty, and the community (https://msu.edu/coronavirus/reopening-campus/recap-task-force-work.html). Any work that can be conducted remotely should still be done so, including human research. We have taken a measured approach to our return to ensure safety in our buildings by requiring safety plans for buildings and laboratories. In expanding the in-person participant interactions, we will continue to focus on the safety of the research team as well as the safety of research participants. The University has not opened widely as we are still in a pandemic and working under the Governor’s Executive Orders (EO).

As a result, we are phasing in human research that has the potential for in-person interactions with participants over several months using different tiers of criteria as our guide, focusing on study location, participant benefit, and COVID-19 risks. The initial tiers of reopening will focus on research conducted in health care clinics, campus research laboratories, and outdoor activities. A matrix of the tiers of research and the order in which they will start is available at http://hrpp.msu.edu/COVID-19/index.html.

Effective July 28, 2020, we will only accept Human Research Plans for a Safe Return applications for Tiers 0, 1 and 2. We will look at expanding beyond these tiers as experience is gained and as we acquire an understanding of the complexities associated with each tier. A major factor for expansion will be the prevailing rate of infection in Michigan and around the country.

Community, national, and international research will necessarily be delayed. Even to open research locally, investigators need to make sure that the necessary staffing, training, and resources such as personal protective equipment (PPE) are available to conduct their studies. In-person research interactions should not start until the appropriate resources and approvals are in place.

Process

The process of reactivation of in-person human participant research will be similar to that of the wet bench research.

  • Completion of a “Human Research Plan for a Safe Return” form will be required to start in-person interactions with research participants conducted by MSU individuals (e.g. faculty, staff, students, agents).
  • If the research is to be conducted by collaborators at other organizations, that organization’s requirements would be followed and they would make their own decision about conducting the research.
  • If in-person interactions were permitted during minimum basic operations over the last four months, a "Human Research Plan for a Safe Return” form will still need to be completed.
  • Principal Investigators should work through Department Chairs and Research Associate Deans to review and submit the Plan to the Office of Regulatory Affairs for review.
  • Forms and more detailed information can be found at http://hrpp.msu.edu/COVID-19/index.html.

Some buildings on campus have been opened; for others, researchers will need to work with Associate Deans for Research to ensure their building is ready. Both building preparation and Human Research Plans need to be approved before in-person research can begin. Research in health care clinics (including MSU Health Care clinics) will need approval from those partners along with the approval of the Human Research Plan. The Human Research Plan is separate from the IRB review process and study changes resulting from the Human Research Plan may require IRB approval of a modification before the in-person interaction begins. Finally, resources are available to investigators to help facilitate the safety of their research and provide guidance (e.g. when an IRB modification is needed) at the HRPP COVID-19 webpage (http://hrpp.msu.edu/COVID-19/index.html) and EHS COVID-19 Resources webpage (https://ehs.msu.edu/).

Research Continuity

Importantly, you should be prepared to pause in-person interactions again if a spike in COVID-19 infections occurs. We are better prepared now for such an event and will do all that we can to keep research open. However, if another Stay at Home EO is released, we may not have a choice. Please continue to monitor the situation.

Again, we thank you for your patience and understanding during the past four months. It has been a difficult period for everyone. Now we want to get everyone back to work, but it must be done in a manner that will ensure the safety of research participants and research teams.

Last Updated: 7/28/2020

Tiers

Tiers provide a phased approach for restarting in-person interactions with research participants.

A Human Research Plan for a Safe Return MUST be completed and approved before any in-person interaction with participants, unless the research was permitted to continue in Tier 0. Studies in Tier 0 must also complete the Human Research Plan for a Safe Return.

Last Updated: 7/28/2020

Human Research Plan for a Safe Return

The Human Research Plan for a Safe Return is completed by the research team and includes COVID-19 safety precautions that need to be followed to resume in-person interactions with participants.

The Human Research Plan for a Safe Return requires approval by the:

  • Principal Investigator (PI)
  • PI's Department Chair, School Director, or Institute Director (or designee)
  • Associate Dean for Research (or designee)
  • Office of Regulatory Affairs / Environmental Health and Safety
Flow charts have been developed to help researchers determine whether the Human Research Plan for a Safe Return is required, and if so, the review process for the Human Research Plan for a Safe Return. 

Please carefully review the Human Research Plan for a Safe Return and determine how your research team will accomplish the COVID-19 safety precautions, and whether you have the necessary resources and personnel to conduct the research (e.g. face masks for subjects and other personal protective equipment, disinfectants, hand sanitizer). 

Please view the COVID-19 Tiers to see whether the Human Research Plan for a Safe Return can be submitted for approval. 

Last Updated: 7/28/2020

COVID-19 Training

All researchers must complete the COVID-19 training offered by MSU Environmental Health and Safety. Researchers should take the training appropriate to the study (for lab workers, healthcare workers, or other workers). Links to the training is available on the EHS COVID-19 Resources webpage

Last Updated: 7/28/2020

Remote Research Procedures

Research that is capable of being performed remotely must still be performed remotely.

Research procedures involving no direct in-person interactions with participants or potential for in-person interactions with participants may continue (e.g. data analysis, online surveys, telephone interviews) so long as local requirements are met.

Last Updated: 7/28/2020

Restrictions: In-Person Participant Interactions

Restrictions to in-person interactions with human research participants by MSU employees, MSU students, or agents of MSU are in place until the activity is permitted under a Tier and a Human Research Plan for a Safe Return is approved.

Michigan

All MSU human research activities conducted by MSU employees, students, or agents that take place in Michigan and that cannot be done remotely with no inter-personal interaction with participants must stop unless the study is:

  • A clinical trial activity, which if discontinued, would negatively impact the patient’s care, or

  • Related to COVID-19, particularly if they have a timeline for deployment that could address the crisis

At this time, new enrollment in clinical trials is not permitted without additional institutional approval

Outside Michigan

Regardless of location, all in-person participant interactions in MSU human research conducted by MSU employees, students, or agents, whether domestic or international, must pause unless there is the potential for direct therapeutic benefit to the participant (drug or device) and local requirements are followed

Exceptions

If you believe you need to undertake human research activities that should be considered essential but does not fall within a Tier of research permitted to restart with an approved Human Research Plan for a Safe Return, please send a request to hrpp@ora.msu.edu, and we will help coordinate the review process. 

Last Updated: 7/28/2020

Collaborative Research

If the interaction is being performed by an external collaborator who is acting under the oversight of the external organization, that organization’s requirements would be followed, including COVID-19 safety precautions, and they would make their own decision about conducting the research, following the organization's processes to restart in-person research.

MSU researchers should communicate and work with their collaborators to ensure COVID-19 risks have been addressed through COVID-19 mitigation strategies appropriate to the research and location. The expectation is that collaborating organizations have COVID-19 safety protocols in place appropriate to the location and procedures being conducted.

If there are any concerns about the collaborator’s procedures, Principal Investigators should address these with the collaborators and consult with their Department Chairs and Associate Deans for Research as needed.

Last updated: 7/28/2020

Questions about Human Research Restart of In-Person Interactions

If you have questions about the human research restart, please contact the Office of Regulatory Affairs at ora.hrpp@msu.edu.

Last Updated: 7/28/2020

HRPP and IRB Operations

The HRPP office is fully functional and we expect this to continue as we work remotely. All HRPP staff can work from home and the Institutional Review Boards (IRBs) will continue to perform reviews. Updates will be provided if there are changes that impacts HRPP operations.

Last updated: 3/16/2020

Changes Necessary to Eliminate an Apparent Immediate Hazard

For non-exempt research, changes must be approved in advance by the IRB as a modification to the study, unless they are necessary to eliminate an apparent immediate hazard to participants. See HRPP Manual Section 9-5, Unapproved Change in Protocol

For research approved by the MSU IRB, if a change in protocol is made to eliminate an apparent hazard to participants, it must be reported immediately thereafter. Please submit a “Report of New Information” through Click, explaining why the change was necessary to ensure the participant’s welfare and please include COVID-19 in the RNI title. Please contact the HRPP with any questions.

For research relying on an External IRB (MSU IRB is not the IRB of record), please check and follow the External IRB’s requirements for changes necessary to eliminate an apparent immediate hazard.

Last updated: 3/16/2020

Modifications

Information is included below on what is needed if you have determined that you need to modify your study. Please also view the HRPP Guidance on IRB Modifications Related to COVID-19 to help determine whether a change needs to be submitted.

Non-Exempt Research

For research approved by the MSU IRB:

All modifications are submitted through Click. Please note that for modifications to study staff, only changes to key project personnel must be submitted. See HRPP Manual Section 4-10, Designation as Key Project Personnel on Non-Exempt IRB Projects for who is key project personnel. The HRPP staff and the MSU IRB will be prioritizing modifications related to COVID-19. To help with this process, when summarizing the modification, please indicate that the change is related to COVID-19. You may also email (irb@msu.edu) to let us know so we can prioritize the submission. If you have any questions, please contact the MSU HRPP. Please see HRPP Manual Section 8-6, Modifications to an Approved Research Study for more information about the modification process.

Please note that actions taken for public health or clinical purposes, and not for research purposes,
are not research procedures and therefore do not require institutional review board IRB approval before being implemented. Please view the HRPP Guidance on IRB Modifications Related to COVID-19 to help determine whether a change needs to be submitted.

For studies restarting in-person interactions, please obtain approval for the Human Research Plan for s Safe Return prior to submitting any required IRB modifications. 

For research relying on an External IRB, if a modification is needed, please work with the External IRB and/or any collaborating PI to submit the changes as required by the External IRB.

Exempt Research

In general, investigators are not required to submit changes to the IRB office once a research study is designated as exempt as long as those changes do not affect the exempt category or criteria for exempt determination (changing from exempt status to expedited or full review, changing exempt category) or that may substantially change the focus of the research study such as a change in hypothesis or study design. Modifying an in-person visit to a remote option would not typically require submission to the IRB office. However, if the change impacts the exempt category or criteria (e.g. before the participant identity could not readily be ascertained, and now it can), it may require submission to the IRB. Please contact the MSU HRPP with questions. Please see HRPP Manual Section 8-1, Exemptions, for more information.

Last updated: 7/28/2020

Protocol Deviation/Violations for Non-Exempt Research

A protocol deviation/violation (deviation) is any change, divergence, or departure from the study design or procedures of a research protocol that has not been approved by the IRB, such as failure to perform a required lab test, or the study visit is conducted outside the required time frame. Deviations need to be reported even if it was outside of the researchers’ control (e.g. participant is in self-isolation or sick, hospital does not have resources to perform the test). Report the deviation to the IRB through a “Report of New Information” through Click and please include COVID-19 in the RNI title. Deviations that may affect participant’s rights, safety, or well-being and/or affect the participant’s willingness to participate in the study should be reported in 72 hours. See HRPP Manual Section 9-8, Protocol Deviations or Violations for more information.

Last updated: 3/16/2020 

Research Continuity

Research teams should consider how COVID-19 may affect the ability of the research team to conduct their study, the impact to participants, and whether that impact may present a risk to participants. Please consider what steps or plans can be made to reduce the risk to participants. Please discuss with your study’s sponsor, when appropriate.

Considerations may include:

  • Business continuity plans for the MSU research site(s) and the impacts to the study
  • Consider how the research location (e.g. school, hospital, clinic, lab) may be impacted by COVID-19, any restrictions the sites may put in place, and what provisions could be made
  • Consider the impact if members of your research team become unavailable
  • For studies that involve investigational drugs or devices, discuss how access to drugs or devices that are provided to participants as part of the study will be maintained, the risk to participants if the drugs or devices cannot be obtained, and what provisions could be made (e.g. alternative treatments, dose tapering)
  • Consider alternatives for any monitoring procedures that are necessary for participant safety
  • Consider whether modifications to the study may be necessary to protect participants

If a modification may be necessary, please see the modification section for more information. Changes may also require study sponsor approval, for externally funded research.

Last updated: 3/16/2020

Risk to Participants

If you believe that potential disruptions to your study from COVID-19 could place participants at risk (e.g. inability of participants to obtain study drug or inability of subjects to come in for a study visit which would result in a risk), please submit a “Report of New Information” in Click. This will help the IRB to identify these projects with researchers’ input and to work with the researchers.

Last updated: 3/16/2020

Main HRPP Office Contact Information

Phone: 517-355-2180
Email: irb@msu.edu
Website: hrpp.msu.edu