Guidance for Human Research Studying or Impacted by Violence Experienced by the MSU Community

This webpage has been developed to provide guidance on additional steps that are being taken for human research studies that involve topics that may be distressing to participants based on the violence experienced by the MSU community on 2/13/2023. The purpose of these additional steps is to protect the rights and welfare of participants, with a focus on their well-being in the time ahead. This will be a collaborative effort that involves multiple stakeholders in the research process, such as researchers, study team members, Institutional Review Board (IRB) members, Human Research Protection Program (HRPP) staff, Office of Research and Innovation staff, and other members of the university research community. We appreciate your assistance as we work together on this process. We expect that this effort will evolve over time as we work with the community to better understand the impacts to participants and what additional support and safeguards may be needed.

Researcher Considerations Related to Topic and Participants

For new or ongoing research studies that involve topics that may be distressing to participants based on the violence experienced by the MSU community on 2/13/2023, researchers should consider whether safeguards are needed in their studies. These include considerations such as:

  • Has the risk-benefit assessment changed?
  • Have potential risks been fully described in the consent document?
  • Have potential risks been fully described in the IRB submission?
  • Has the risk level increased to more than minimal?
  • Could the exempt determination status be impacted or changed?
  • Are or should crisis support resources be provided to participants?
  • Is any additional expertise needed to conduct the study?
  • What will or can be done if a participant is in distress? For example, an anonymous survey vs. an in-person, Zoom or telephone interview.
  • Are any other additional safeguards necessary?
  • For ongoing research, is it in the best interests of the participants not to stop or delay study procedures?
  • Does the proposed study have the potential for significant contributions to the knowledge base?

If a study involves participants who are members of the MSU community but does not involve topics that may be distressing to participants based on the violence experienced by the MSU community on 2/13/2023, researchers should be sensitive to the distress those individuals may be experiencing and should consider whether any study procedures should be delayed.

Specific Guidance and Processes

New MSU Studies

New MSU studies that involve topics that may be distressing to participants based on the violence experienced by the MSU community on 2/13/2023 will be reviewed by the full IRB.

Active MSU Studies

MSU researchers should consider whether they are conducting an active study that involves topics that may be distressing to participants based on the violence experienced by the MSU community on 2/13/2023 (e.g. gun violence, studies involving MSU students that are intended to invoke a negative emotional response) and that could potentially further increase distress in participants (e.g. ongoing recruitment, longitudinal study procedures). If so, please review the research considerations above to determine what modifications may be needed to continue study activities. These could include adding additional resources. Please submit a modification to describe any changes, including studies that were determined exempt and studies undergoing review by the MSU IRB or by an External IRB.

If you plan to add or revise questions in your study to address the violence experienced by the MSU community on 2/13/2023, a modification is required. This includes studies that were determined exempt as this may change the exempt determination status.

If you are unsure whether your study involves topics that may be distressful to participants or whether modifications may be needed, please contact us by email ORRS.HRPP@msu.edu to discuss.

Institutional Review

In addition to the IRB review process, further institutional review by a committee with representatives from the Office of Research and Innovation and other university experts will occur for studies that involve topics that may be distressing to participants based on the violence experienced by the MSU community on 2/13/2023. This review will be needed before new research studies with participants may begin. Ongoing research studies will be reviewed on a study specific basis in collaboration with the study team to determine what, if any, impact there will be on active research activities.

Non-MSU Research

It is possible that researchers that are not affiliated with MSU may want to conduct research related to the recent violence experienced by the MSU community. If MSU individuals become aware of such research, please direct them to ORRS.HRPP@msu.edu.

Additional institutional steps will be required, including administrative review by the MSU IRB and institutional review by the committee with representatives from the Office of Research and Innovation and other university experts. This is in addition to other standard MSU requirements such as use of bulk email (https://tech.msu.edu/about/guidelines-policies/guidelines-bulk-email/).

Resources

We are working to provide resources, such as template informed consent language and Frequently Asked Questions, and will provide updated information on hrpp.msu.edu when available.

Questions

Thank you again for your assistance as we work together on this process. If you have any questions about this process, please email ORRS.HRPP@msu.edu.

Crisis Support Resources

As a reminder, there are a number of MSU resources that have been provided if you, a member of your research team, or others may need crisis support. Please visit MSU Counseling & Psychiatric Services for links to crisis support resources: https://caps.msu.edu/emergency/feb2023crisisresponse/

Help & Requirements