Resources
Guidance on Engaged Research Process – Best Practices
Guidance on Access CIRTIFICATION
Guidance on Collaborative Research
Questions?
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What is Community Engaged Research?
Community Engaged Research involves a collaborative approach that actively includes community members in the research process. This method works to promote research is culturally relevant and beneficial to the communities served by UTK. Researchers engaging in community engaged research should emphasize mutual respect and understanding between UTK researchers, community members involved in the research process, and prospective participants from the community.
The IRB’s role in overseeing such projects is to ensure they adhere to federal regulations and ethical standards by protecting participant rights and welfare, promoting respect for persons, and demonstrating justice throughout the research protocol. The IRB will review community engaged research to ensure that community research partners have appropriate education, the research equitably selects participants (especially those within the community), and that community-partners share an equitable role in the research process. As applicable to an individual study, this involves evaluating how researchers plan to communicate research results with the community and ensure that community research partners are appropriately included and recognized for their contributions.
As with all protocols, the IRB must confirm that these research protocols ensure that risks are minimized in relationship to the anticipated benefits of the project, that recruitment procedures encourage equitable selection, and that informed consent is appropriately obtained. One significant challenge for researchers conducting community engaged research is balancing scientific rigor with community priorities. Researchers must design studies that meet rigorous methodological standards while also being flexible enough to address real-world issues identified by the community.
By engaging in community engaged research, researchers are promoting an equitable partnership where all parties feel their contributions are valued. By fostering transparency and ongoing dialogue between researchers and community members, the IRB ensures that community engaged research not only advances academic knowledge but also has a meaningful impact on societal well-being.
UTK’s IRB has partnered with faculty and community partners on an IRB & Engaged Research Taskforce. In addition to facilitating community engaged research, identifying areas of need, and creating action plans to improve the conduct and review community engaged research, this working group has developed a guidance document on best practices when conducting community engaged research. Any researchers considering conducting community engaged research are strongly encouraged to review and utilize this document.
GUIDANCE ON THE IRB PROCESS AND APPLICATIONS
In preparing to submit a request to conduct community engaged research, investigators should have a detailed protocol plan that includes a written description of the research process and procedures (project application), informed consent form(s), recruitment material(s), and all data collection instruments. Throughout the IRB review process, it is imperative that investigators supply the IRB with context related to the community, especially when describing characteristics that may differentiate the community participant population from a broader study population.
When writing the application, investigators should, in addition to answering the required questions in iMedris, include the following:
- Describe the characteristics surrounding the community that are often not accounted for when working with a broader study population
- Describe and define the roles and responsibilities of the UTK-affiliated investigators and the community investigators
- Describe how and by whom results of the research will be shared with the community
- Describe the work that has occurred within the local community in preparing the research project and engaging with the community.
- Describe where in the community research activities will occur and how permission (if needed) will be obtained to conduct these activities.
- In the last question, include the names, contact information, organizational affiliation (if any), and roles on the project for all community members who will be engaged in or responsible for the following:
- Collecting data
- Obtaining informed consent
- Analyzing identifiable data
- Answering questions about the research for potential, current, or past participants (or otherwise acting as an extension of the UTK-affiliated PI
- Describe how potential participants will be identified and approached to enroll in the project and define who will be responsible for conducting these procedures
- In addition to accounting for all risks associated with the research, account for specific risks to participants related to their affiliation, status, or standing in their community.
When writing the consent form, investigators should account for unique characteristics of the community to help ensure that participants are able to provide meaningful informed consent. Such differences may include (but are not limited to):
- The reading level at which the consent form is written
- Disclosure of risks and benefits that may be unique to the community
- The individuals identified for participants to contact with questions or concerns about the research
- Whether or not consent can, should, or must be signed by participants
External Investigator and Community Engaged Research Partner FAQ
UTK’s IRB requires investigators to be listed on the application when they are engaged in or responsible for the following:
- Collecting data
- Obtaining informed consent
- Analyzing identifiable data
- Answering questions about the research for potential, current, or past participants (or otherwise acting as an extension of the UTK-affiliated PI)
UTK’s IRB will require community engaged research partners to be covered by an Individual Investigator Agreement and to complete human subjects research training. When applying for IRB approval, investigators should plan to attach documentation of this training completion to the submission.
UTK’s IRB will consider a variety of training options including:
- Industry-developed training including CITI
- More information about CITI training can be found on this section of our website.
- CIRTIFICATION
- CIRTIFICATION is a training program specifically designed to support the needs of community research partners and provides a thorough overview of the process and requirements. More information about access CIRTIFICATION is available here.
- Training developed by the investigator
- If investigators elect to create their own training for their community partners, the IRB must review and approve the specific training. Documentation of investigator-developed training can be provided to the IRB.
Acknowledgment:
UTK’s Human Research Protection Program would like to extend our sincerest gratitude to the members of the IRB & Engaged Research Taskforce, whose hard work and dedication have allowed opportunities to continue to improve this process:
- Wendy Bach
- Lora Beebe
- Laura Denton
- Lisa East
- Amy Gilliland
- Lyndsey-Hornbuckle-Lampkin
- Chris Kilgore
- Kimberly Pettigrew
- Hollie Raynor
- Javeitte Samuel
- Elizabeth Strand
- Corinne Tandy
- Shreedhar Upendram
- Eboni Winford