Washington University’s Community Engaged Research (CEnR) program has been developed by the Washington University (WU) Human Research Protection Office (HRPO) to address the needs of WU researchers engaged in research collaborations or affiliations with community partners, and to ensure regulatory compliance for researchers at WU and their research affiliates.
WU, under certain circumstances, will agree to serve as the IRB of record for community partners that do not have their own IRB. This will be done on a per study basis in instances when there is a Principal Investigator (PI) from WU. General IRB oversight will not be provided for non-WU organizations that are not collaborating with a WU PI. Non-WU researchers may not apply independently for WU IRB oversight. View an overview of the Washington University Community Engaged Research Process.
A community partner can be a community based organization (CBO) or other entity not affiliated with WU. A community partner may also be an individual who is employed or volunteering at a community site and/or an individual that is self-employed, in private practice or is otherwise involved where research is being conducted by a WU investigator. Normally, community partners are not affiliated with an academic institution and/or are not under the auspices of another Institutional Review Board (IRB). The community partner becomes “engaged” in the research and requires IRB oversight when they interact or intervene with human subjects or their private, identifiable information.
WU students that participate in research studies at WU are not considered community partners.
This checklist should be used when developing your community engaged research project. Greater details are found under the Getting Started Step by Step section below.
This checklist will assist researchers at Washington University when they are conducting research in a community or are partnering with a community individual or community organization. Greater details are found under the Getting Started Step by Step section below.
Getting Started Step by Step
Do you have a WU-Community Organization partnership? If not, contact the WU Institute of Clinical and Translational Sciences.
Work with your WU researcher to identify possible funding sources for the type of work you wish to conduct. Nationally, the National Institutes of Health (NIH), has many funding opportunities. The Washington University Vice Chancellor for Research also has information on possible funding opportunities.
If you need assistance designing a study or developing a recruitment plan the Institute of Clinical and Translational Sciences (ICTS) has a variety researcher services.
We have dedicated staff to help you with your community engaged research project. Request a consultation and be sure to indicate Community Based Participatory Research as your topic.
A WU Conflict of Interest (CoI) Form must be completed by all key personnel on the grant, including community partners. To obtain a Conflict of Interest form for community partners, send an email to: COI@wustl.edu.
The WU departmental Grants Administrator with which the WU researcher is affiliated can assist as well with obtaining the conflict of interest form.
Visit the Office of the Vice Chancellor for Research for more information pertaining to Research Conflicts of Interest at WUSTL.
A Letter of Intent (LOI) may be required. Generally, a letter of intent (LOI) is not binding but does demonstrate interest on the part of the individual issuing the letter. These letters are usually short 1 – 2 paragraphs, will identify the title of study or lead researcher by legal name, and briefly outline what functions or duties will be carried out by the person or entity writing the letter in support of the study. A LOI is applicable at the proposal/applications stage.
Email our Education Specialist to obtain example letters appropriate for your study.
A Memo of Understanding (MOU) may be required. A MOU is an agreement that outlines the terms and details of an agreement between parties, including each party’s expected activities and goals. The Memo of Understanding is a more formal agreement between parties regarding terms and responsibilities outlined within; however, an MOU is not binding. It may/may not be developed with the assistance of legal counsel depending on the use and activities specified.
The WU Departmental Grants Administrator with which the WU researcher is affiliated can assist with subawards or subcontracts. Visit the Office of Sponsored Research Services for more information.
When the WU IRB oversees a study, a reliance agreement is required. For more information see How to Request Washington University as the IRB of Record. If the community partner is associated with a community based organization (CBO) or other entity, an IRB Authorization Agreement (IAA) is required. If the individual is not associated with a CBO or other entity, an Individual Investigator Agreement (IIA) is required.
When the community partner is associated with a community based organization or other entity, and the research is federally funded a Federal Wide Assurance (FWA) is required. For more information on the FWA see Obtaining an Assurance.
Verification of human subjects education is required for all key personnel on the grant. When Washington University is overseeing the study, it becomes the IRB record and will require training through the Collaborative Institutional Training Initiative (CITI Program). For community partners, there are face-to-face, paper, and electronic options. The Determination and Completion Human Subjects Education flow chart can help you determine what education is needed. Approvals for the level of education and mode of delivery are made by HRPO prior to training taking place. Email our Education Specialist for more information.
The study will be approved once,
- All engaged community partners have completed necessary human subjects training
- All Federal wide Assurance (FWA), IRB Authorization Agreement (IAA) or Individual Investigator Agreement (IIA) are signed by the community partner and Washington University so that WU will provide oversight for community based research studies done in collaboration with WU researchers.
- All contingencies regarding the study have been resolved.
Do not begin any research activity without IRB approval. WU researcher will receive all approval notices.
Modifications to the research may not occur without prior IRB approval unless the change is to alleviate an immediate harm. It is the responsibility of the WU researcher to submit modifications to the IRB prior to implementation. Check with your WU researcher to make sure you are following the study as approved by the IRB.
WU HRPO expects that any research study conducted under its auspices will abide by the “Washington University Institutional Review Board Policies and Procedures, section X. Investigator Reporting Requirements and IRB Review of Reportable Events.”
If the study required review by the full IRB committee, ongoing renewals are likely required. This continuing review is usually required on a 12 month interval but sometimes can be less time, such as 3 or 6 months. If a study is not reviewed and approved by the due date, no further activity may occur on that study until it is renewed. Check with your WU researcher to ensure you know the approval period for the study you are conducting.
Content current as of 10/5/2022