Determining Requirements for Community Engaged Research
About This Tool
This decision tool is designed to support research teams conducting human participant research in collaboration with external community partners. By answering the questions provided, you’ll be guided through the documents and processes that may be required for your specific engagement. This tool is intended as a guide. You will want to consult with the necessary oversight organizations (IRB, ORC/ORS, etc.) to confirm the documentation and processes needed.
Please note: Not all activities involving community collaborators are considered “engaged in research.” For example, if a collaborator’s role is limited to serving as a co-author or advising on study design (such as participation on a Community Advisory Board) they may not need to be listed on the IRB protocol or included in formal agreements. This tool will help clarify when such documentation is necessary.
*Answer ALL THREE QUESTIONS to obtain accurate information*
Please note: Not all activities involving community collaborators are considered “engaged in research.” For example, if a collaborator’s role is limited to serving as a co-author or advising on study design (such as participation on a Community Advisory Board) they may not need to be listed on the IRB protocol or included in formal agreements. This tool will help clarify when such documentation is necessary.
*Answer ALL THREE QUESTIONS to obtain accurate information*
Language to Include in IRB documents
Sample language provided below is meant as a helpful starting point and may be need to be adjusted to better fit the specifics of your study.
If the collaborator will receive identifiable data from the Duke study team
- For IRB summary:
“The [collaborator/partner institution] will receive identifiable data (including XXX variables) from the Duke study team for the purpose of (reason).” - For consent form:
“Information about you may be shared with [collaborator/partner institution] for [purpose].”
If the collaborator will collect identifiable data or interact directly with participants
- For IRB summary:
“[Collaborator/partner institution] personnel will collect identifiable information from participants and provide to the Duke study team by [how information will be shared/transmitted]. [Collaborator/partner institution] personnel will interact directly with participants for the following study-related activities: [describe].” - For consent form:
“You may be contacted or interact with researchers and staff from [collaborator/partner institution] as part of this study. Any identifiable information shared between Duke and [partner] will be used only for approved research purposes.””
If the collaborator will provide access to potential participants
- For IRB summary:
“[Collaborator/partner organization] will assist in recruitment by providing the study team access to potential participants by (describe how access will be provided and how data will be transmitted/shared).” - For consent form:
“Your contact information may be shared with the study team by [collaborator/partner organization] so that (reason – e.g., we can contact you in the event that we are unable to reach you with information we have on file). ”
If the collaborator will provide identifiable data to the Duke study team
- For IRB summary:
“[Collaborator/partner institution] will provide the following identifiable data to the Duke study team: [list information/variables].” - For consent form:
“Information about you may be provided to the Duke study team by [collaborator/partner institution] for the purpose of [reason].”