IRB Guidance: Community Based Research Review Practices

This page addresses research taking place at community sites, in conjunction with community partners, etc.

The Education and Social/Behavioral Science IRB (ED/SBS IRB) office follows the federal regulations and established campus policies when reviewing community-based research protocols.  The ED/SBS IRB has members with experience and expertise in community-based research, and has addressed the topic at training sessions with IRB members.  In addition, under campus policy, the IRB may contact a consultant to review any research study where additional expertise may be required, including community-based research.

Study teams should keep the following in mind when submitting community-based projects to the ED/SBS IRB:

Determining the appropriate IRB for review
The ED/SBS IRB can only review certain types of research projects, as defined by campus policy.  If a proposed study requires medical expertise in order to evaluate the study, the application should be submitted to the Health Sciences Minimal Risk IRB via ARROW.  

The ARROW application will change depending on the identified reviewing IRB.

Community-based IRB or other review process
If the community partner or site(s) do not have their own IRB, it is likely the UW study team will need to request for UW-Madison to serve as the IRB of Record for the project on the protocol application.

More information about non-UW collaborators can be found here.

If community partners are involved in research activities (recruitment, consenting, data collection, data analysis, answering questions, etc.), they will likely be considered engaged in human subjects research.  All engaged personnel must complete human subjects training, and be listed as a non-UW collaborator on the application.

More information about non-UW collaborators can be found here.

Consent Documents
As always, consent documents should be reviewed to ensure the reading level and language is appropriate for the identified subject population. Translated documents will be required if there will be non-English speaking participants.

Data Sharing
The protocol application and supporting documents should include details about which data will be shared with community partner(s), and how it will be shared.  The IRB may request information be included on consent documents to inform participants of the data release/sharing.

Private Homes
If any research activities will take place in participants' homes, the study team must address issues of mandated reporting under state laws, etc. The IRB will likely request information be included on the consent documents about breaking confidentiality and reporting requirements.

Community Site Permission
For research activities taking place at community sites, the IRB will require permission letters from each site, allowing research to take place there.

See IRB Guidance: Site Permission for more information

Keywords:community, partners, sites, engagement, site permission   Doc ID:42861
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-08-13 10:03 CSTUpdated:2018-10-19 15:06 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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