Ask the facility what it needs before it acts. Many want a university approval letter first; some release no records without their own review. Sequence from those answers, keep one identical protocol in both folders, and tell each board about the other.
Can a facility overrule WGU's board?
It cannot approve what WGU has declined, and WGU cannot grant you access the facility withholds. The regulation states one half of that directly: at 45 CFR 46.112, research approved by an IRB "may be subject to further appropriate review and approval or disapproval by officials of the institution", but "those officials may not approve the research if it has not been approved by an IRB." Read as a rule of thumb, it means every additional reviewer can subtract and none can add.
The other half is not regulatory at all; it is ownership. The charts belong to the facility, as do the staff roster, the meeting rooms and the distribution list. WGU's published requirements for health programmes acknowledge that host-site interactions may include "project development, or conducting research", and that the university carries "contractual and legal obligations with clinical partners". Those obligations sit alongside the IRB process, not inside it.
Is the facility part of the research, or just the place it happens?
This decides whether a second board is likely to be involved at all, and OHRP's guidance on engagement is the document that answers it. Broadly, an institution counts as engaged once its own people intervene with participants, interact with them for the research, take their consent, or obtain identifiable private information "from any source" for the work.
Applied to a capstone, that turns on small operational details that are easy to arrange either way:
- A unit manager who pulls an identifiable extract and hands it to you has done something on the engaged side of the line.
- A clinical educator who recruits participants on your behalf has too.
- A facility that gives you a room, access and permission, while you do the interacting yourself, generally has not.
- A commercial service that transcribes your recordings is treated in the same guidance as performing a service rather than joining the research.
No arrangement here is better than another in the abstract. But the arrangement decides which folders you build, so settle it deliberately before anyone offers to help.
Who decides what?
| Who | What they decide | What they cannot do |
|---|---|---|
| WGU's IRB | Whether the project is human-subjects research, which review path applies, and the terms of approval | Give you access to another organisation's people or records |
| The facility's IRB or research council | Whether the work may be conducted there, and under what local conditions | Approve work the reviewing IRB has not approved |
| The facility's privacy office or health information management | Whether protected health information may be used or disclosed, and in what form | Waive the human-subjects requirements the Common Rule sets |
| A nursing, quality or practice council | Whether the project fits the unit's priorities and workload | Substitute its endorsement for either board's decision |
| The person who signs your permission letter | The specific access being granted, in writing | Grant access beyond their own authority |
Notice that the privacy office is a separate row. When records are involved, a facility may require its own IRB or privacy board to document a waiver of authorisation under 45 CFR 164.512(i) before anything is released, and it is entitled to insist that its own body do so. An approval letter from a university does not move protected health information; the covered entity does.