Purdue Global IRB and an employer's or hospital's board: when you need both, and which goes first
You ask your hospital for permission to run the study, and somebody answers that their research office will need to review it. Meanwhile Purdue University Global's board will not approve a file until it can see what the site has agreed to. That looks like a deadlock and is not one. The question underneath it has a name — engagement — Purdue Global carries a worksheet for deciding it, and the answer determines which documents exist, which board holds oversight, and in what order the two approvals arrive.
Short answer
If the site is only granting access, one letter of collaboration is enough and Purdue Global reviews. If the site's own people interact with participants, consent them, or hand over identifiable information, it is engaged — and a second review or a reliance agreement follows.
What is "engagement", and why does it decide the question?
Engagement is the concept that allocates responsibility between institutions. Purdue Global's engagement worksheet puts it plainly: engagement means the organisation's human research protection programme is responsible for the research, so being engaged makes the board legally and ethically responsible for oversight. The worksheet exists for exactly the case where it is unclear which board should provide the primary review, and notes that where another entity is engaged, an external collaborator flowchart determines what must be filed.
Its conditions, read as a test of the site, are the questions to ask before you assume a letter will do.
- The site's employees or agents intervene with participants for research purposes, by performing procedures or manipulating the environment.
- They interact with participants for research purposes.
- They obtain the informed consent of participants for the research.
- They obtain identifiable private information or identifiable specimens from any source for the research.
- The organisation receives a federal award for the non-exempt human research, even where another organisation carries out all activities involving participants.
The worksheet underlines the fourth: in general, an organisation whose employees obtain identifiable private information for non-exempt human research is engaged even where they never interact with a participant. "We are only pulling the data for you" is not the neutral act it sounds like.
It also lists what does not engage an organisation, and this is the list that rescues most workplace studies. A site is not engaged merely by permitting use of its facilities for interaction by outside investigators; by informing prospective participants that the research exists without consenting them or acting as the investigators' representative; by giving people information about contacting the investigators; by seeking permission for investigators to contact them; or by releasing identifiable private information to investigators elsewhere. Note the asymmetry in that last item — releasing identifiable information does not engage the releasing organisation, while obtaining it engages the receiving one.
Two Purdue Global-specific notes sit in the same worksheet. Engagement, for Common Rule purposes, applies only to non-exempt human research. And Purdue Global states that, as an online institution, it does not participate in research regulated only by the Food and Drug Administration.
A letter of collaboration is not a review
Where the site is not engaged, the instrument is a letter, and Purdue Global supplies its parameters and a template. Research at an offsite location — the guidance names schools, daycares, medical facilities, workplaces and businesses — requires a letter from an appropriate administrator or official permitting the research. The guidance is explicit that the letter does not substitute for IRB review and approval; it is a critical part of the application, not an alternative to it.
The template shows what the letter must carry, and the specificity is the point. It sits on the site's letterhead. It confirms that an authorised representative allows the named investigator and key personnel access to conduct study activities there. It names the exact study title. It details the activities occurring at that site — the template's own examples are surveys distributed to site employees, interviews, interventions with patients, or database access. It details the support the site will provide, and states an anticipated end date.
Three sentences in the template do work people overlook. The signatory confirms they are authorised to decide on the organisation's behalf. They acknowledge that any HIPAA, FERPA or other regulatory compliance at that site must be addressed before permission is granted. And the site acknowledges that its participation runs only during the active approval period, and that all activities must cease if approval expires or is suspended.
What if the site says "bring us Purdue Global's approval first"?
This is the most common version of the deadlock, and Purdue Global's own guidance dissolves it. Where letters of collaboration are pending, indicate that in the application and submit for review anyway: the board will conduct a review but withhold final approval pending receipt of the letters.
So the sequence exists. You submit with the pending status declared, the board reads the documents, the site receives whatever documentation of the board's position it needs, the letter is signed, and final approval follows. What breaks it is silence — an application not saying the letters are pending is simply one missing a required document.
One caution about ordering. If you expect to alter the design to satisfy the site — a different sampling frame, an extra data-handling condition, a change of recruitment route — learn that before submission rather than after. Changes agreed after approval are amendments, and Purdue Global's amendment procedure requires review and approval before implementation.
What if the site's board wants to be the reviewing board?
Then you are in one of two arrangements, and the toolkit carries an instrument for each.
Reliance. Purdue Global holds an IRB authorisation agreement template on the standard federal pattern: one institution provides the review, the other relies on the designated board for review and continuing oversight. The form records both parties' IRB registration and Federalwide Assurance identifiers, and applies either to all research covered by the relying institution's assurance or to named protocols. It states that the designated board's review will meet the relying institution's assurance requirements and that findings, actions and minutes will be reported or made available; the relying institution remains responsible for compliance with those determinations, and both parties keep the document on file for the Office for Human Research Protections.
An external board reviews, with a Purdue Global supplement. Where the protocol is reviewed elsewhere — the toolkit gives industry-sponsored and multi-site research as its examples — Purdue Global has a dedicated external IRB supplement protocol. It describes Purdue Global's own involvement and any local variations: whether enrolment, activities, data collection or analysis happen at Purdue Global or through its personnel; the design and procedures; the source records used; and the consent process, including Purdue Global's role in it.
The supplement's HIPAA section carries a rule worth knowing before you plan anything around protected health information: Purdue Global will not waive HIPAA authorisation for third parties. If you are receiving such information from another covered entity, the full or partial waiver must come from that entity. The supplement also asks how the requested identifiers are the minimum necessary to accomplish the research objectives.
Which goes first? A working order
| Situation | Instrument | Order |
|---|---|---|
| Access only; no site board | Letter of collaboration on letterhead | Request the letter early; submit with it, or with pending status declared |
| Site board wants its own review | Two reviews, two files that must match | Start both; expect each to ask what the other decided |
| Site board will be the reviewing board | IRB authorisation agreement | Settle it before the file is drawn, since it decides which templates apply |
| Protocol already approved elsewhere | External IRB supplement protocol | The external approval anchors it; the supplement describes Purdue Global's part |
Whichever row you are in, one discipline governs all of them: the two files must agree. Two boards reading the same study across two sets of documents will find any dimension that reads differently — the participant number, the instrument name, the end date. A change accepted verbally by one board and never carried into the other's file is the classic dual-review failure, and it surfaces late.
There is a programme dimension to the timing as well. Purdue Global's academic catalogue for the Doctor of Education in Leadership and Innovation states that site permission must be secured for the applied research project at the chosen site, and that failure to secure it within the designated time frame may lead to withdrawal from the programme. Treat the site conversation as the first move rather than the last.
What to do next
The engagement question is worth settling before you draft anything, because it decides which documents exist at all — a letter, a reliance agreement, or a supplement protocol — and redrawing a file around the wrong answer is the expensive kind of rework. Tell us who the site is, what its people will actually do, and what its research office has said; a consultant works the determination against Purdue Global's own worksheet and returns a written findings list. Hand the process over and we carry all of it: determination, letters drafted for signature, every document, filing, and each reply either board calls for, through to the letter. Your study and your findings never move, and each verdict stays where it belongs — with the board that issues it. Start with the free application review, see what an end-to-end engagement covers, or browse the questions candidates ask most.
Sources
- PG IRB, IRB-311 Worksheet: Engagement Determination — docs.google.com
- PG IRB, 3_Parameters for IRB Letters of Collaboration — docs.google.com
- PG IRB, 4_IRB/IEC Authorization Agreement — docs.google.com
- PG IRB, IRB-503e Protocol: External IRB Supplement Protocol — docs.google.com
- PG IRB, SOP 305: Amendment Requests — docs.google.com
- PG IRB, IRB Toolkit — purdueglobalwriting.center
- PG IRB, Investigator Guide — purdueglobalwriting.center
- PG Academic Catalog, EdD in Leadership and Innovation — catalog.purdueglobal.edu
- 45 CFR 164.514, on de-identification and the limited data set — ecfr.gov
- 45 CFR 46.102, Definitions — ecfr.gov