Guidance on Engaged Research Process – Best Practices

Prepared by the IRB and Engaged Research Task Force, which includes community members and UT faculty and staff

This working document is intended to help scholars envision what engaged research projects generally look like. The below steps champion a collaborative process with a community partner and support the development of a scholarship project that can be submitted to UT’s IRB, implemented, and disseminated. Components of this process may also be helpful with other types of projects, such as engaged teaching, when collaborating with a community partner. For general guidelines on collaboration, see the collaboration and international engagement page on ORIED’s UT intranet site.

Each of the stages below should be considered iterative, in that it may be necessary to return to planning processes in the event that IRB requirements need to be met via revisions to the activity plan.

1. Project Planning: These steps would generally be completed prior to starting the IRB process and should include community partners unless they choose to opt out of any given step. Those involved may consult with the Office of Community Engagement and Outreach for assistance. Consider developing a formal collaboration agreement to support the relationship.
   1. Coordinate with Community Partners: UT personnel and community partners work together to:
      1. Define needs
      2. Determine potential interventions or activities
      3. Determine potential standards for a successful project
      4. Assess existing infrastructure within UT and partner organizations and reassess needs
   2. Determine the nature of any products or takeaways from the project and all collaborators’ roles in these. See also community agreement document templates, including communication expectations, conflict resolution processes, etc. This may also include a discussion of expectations for authorship credit. See resources on scholarship here.
   3. Plan for Activity: UT personnel and community partners define a sequence of actions to be undertaken.
      1. Identify and outline roles and responsibilities of all necessary project members.
      2. Identify resources to be mobilized.
      3. Identify and obtain any existing instruments related to the intervention or data collection process.
      4. Sketch implementation timeline with tasks/steps assigned and goals to be met, beginning with IRB requirements, which includes identifying if more than the UT IRB needs to be involved. Note that at this point, community partners should decide which parts of the process they want to opt out of, particularly as regards roles requiring IRB training or approval.
         1. Roles — IRB staff are available to discuss and confirm requirements for specific roles:
            1. Act as a representative (extension) of the PI — for example, answering questions, coordination with the research team.
            2. Conduct recruitment activities
            3. Administer consent processes
            4. Collect data
            5. Have access to or analyze identifiable information
         2. Options: CITI or CIRTification
         3. Note that federal funding may have additional training requirements.
      5. Identify if data use agreements are needed.
      6. Track activity plans and expectations using shared documentation available to all collaborators (for example, memoranda of understanding, community agreements, or other records), and clarify responsibility for editing the documents.
2. Collaboration with UT’s IRB: These steps would generally be completed after there is an activity plan, but the preparation process will likely overlap with some of the above planning processes; several iterative steps might involve moving back and forth between this and the preceding step.
   1. Prepare for IRB Application: Relevant project personnel (determined in step 1, above, and including community partners unless they opt out) collaborate with UT IRB staff to begin to prepare the project for IRB review. All collaborators should maintain continuous communication as they prepare these documents; for large projects involving many active collaborators, it may be useful to create shared draft documents and edit them before uploading to IRB software.
   2. Project and IRB personnel work together to use the basic features to outline key issues, including:
      1. Training obligations for relevant personnel, depending on role (including community partners as needed; it’s worth noting that only those working with identifiable data, or communicating with participants on behalf of the PI or project, need to receive training)
      2. Primary vs. secondary data
      3. Need for letters of support
      4. Privacy of potential participants
      5. Confidentiality of participation and data
      6. Risk profile of research-related activities
      7. Data management
   3. Compose Study Synopsis and Status of the Field: These segments of the IRB application govern what other segments might need to be composed, and should be prepared first, and circulated among all personnel involved in the project.
      1. As an additional consideration, the project personnel may want to consider outlining contingency plans, if there are known areas where organizational procedures may change. If possible, these should be written into the protocol.
   4. Obtain Letters of Support: If the project will take place within community partner organizations, the IRB may need letters indicating the appropriate permission to collect data there, or depending on the organization, the IRB may need to coordinate with the organization’s internal regulatory body.
      1. The IRB will need an agreement for community partners engaged in:
         1. Collecting data
         2. Obtaining informed consent
         3. Analyzing identifiable data
         4. Answering questions about the research for current, potential, or past participants
   5. Confirm Human Subjects Training: Ensure that all UT personnel and community partner staff have appropriate human subjects training and other needed documentation.
   6. Prepare Informed Consent Documents: Usually a consent form and a recruitment instrument will be needed here; they often help us compose other parts of the application.
   7. Prepare Additional IRB Elements: The rest of the application follows from the above components.
   8. Submit IRB Application: For most projects that are well-written and address secondary data, it’s useful to submit the application about 1 month before approval will be needed, but this timeline may vary if a full board review is necessary. The HRPP reports a median turnaround for Exempt studies of 10 days, for Expedited studies of 20 days, and more varied (longer) timeframes for Full Board studies.
   9. Receive IRB Approval: For paper forms, it’s often useful to download and store IRB-stamped consent, recruitment, and data collection documents for easy retrieval and use.
3. Implement the Project: Much of the activities below should have been detailed in the IRB application, so completing them will mostly involve following the established protocol. However, if the study needs to change its procedures, IRB updates may be needed. For this reason, the additional consideration is added to the procedures in Step 2. NOTE: Past conversations have suggested that procedural changes have presented barriers for study completion in past projects, given that IRB approval is often a.) needed, and b.) time consuming. This may represent an area for further task force examination or discussion.
   1. Conduct the Intervention or Activity
   2. Collect Informed Consent
      1. Store Informed Consent
   3. Collect Data Elements
      1. Store Data Elements
   4. Revise IRB Application as Needed
4. Analysis of Data: Members of the project with data access should retrieve the data; authorized members of the project should compile and deidentify the data, and it may be useful to have some authorized project personnel review the deidentified data for potentially identifying information. After this point, however, those working with the data need not be added to the IRB application.
   1. Retrieve data from storage (IRB authorized personnel)
   2. Link and deidentify data for analysis as needed (IRB authorized personnel)
   3. Conduct analysis procedures (qualified personnel)
5. Drafting of Dissemination Documents: Consider disseminating the scholarship in outlets that are important to all partners, which may include non-academic outlets. Look for opportunities in which the method of dissemination allows showcasing the partnership (for example, a town hall presentation co-led by a UTK representative and a community representative).

August 2024