Exempt, expedited or full board at Purdue Global: which review path your study is on
Purdue Global publishes three submission pathways you can select, and the convened board is not one of them. You can file a Human Research Determination, an exempt application or an expedited application; full review is where a study is sent when its design will not fit inside the criteria for the first three. The path is therefore not a preference. It is a reading of the study you actually drew, made against criteria the board has published in advance so that you can make the same reading yourself before you file.
Short answer
Purdue Global offers three selectable pathways: determination, exempt and expedited. Each has its own self-assessment worksheet, protocol form and participant document. Full review is not selectable — it is where the board sends a study whose design exceeds the minimal-risk criteria.
What paths can you actually select at Purdue Global?
Three, and the board names them on its Investigator Guide: Human Research Determination, Exempt Research, and Expedited Research. Each carries a self-assessment worksheet you are expected to work through before submitting anything, and each pulls a different form set behind it.
| Pathway | Self-assessment worksheet | Protocol form | Participant-facing document |
|---|---|---|---|
| Human Research Determination | IRB-310 | IRB-503b | None in the published set — the pathway asks whether the activity is research at all |
| Exempt Research | IRB-312 | IRB-503c | IRB-502b, an exempt research information sheet |
| Expedited Research | IRB-313 | IRB-503a | IRB-502a, an expedited informed consent form |
The absence in that table is the useful part. There is no fourth row you can tick. Purdue Global's own guidance on what the reviewers can send back names full review as one of three possible responses to a proposal — a determination the reviewers reach, not a queue you join. Its toolkit also carries standard operating procedures for meeting administration and for expedited reviews, so the convened board plainly exists; it is simply not a door you walk through from the outside.
What makes a study exempt?
Exemption is not a judgment that a study is unimportant, and it is not a way of avoiding review. It is a finding that a study falls inside one of the narrow categories federal regulation carves out at 45 CFR 46.104, and that finding is the institution's to make. Purdue Global's guidance sets three conditions on the pathway before the categories are even reached: the research must present no more than minimal risk, participants must be selected equitably on grounds of relevance rather than convenience, and appropriate safeguards must protect participants and their personal information.
Only then do the categories matter. These are the eight, in the terms the regulation uses:
| Category | What it covers |
|---|---|
| 1 | Research in established or commonly accepted educational settings involving normal educational practices — instructional strategies, curriculum comparison, classroom management |
| 2 | Surveys, interviews, educational testing, or watching behavior in public — under conditions covering identifiability, risk of harm, or a limited IRB review |
| 3 | Benign interventions adults agree to in advance — short, painless, harmless, physically non-invasive — where what gets collected is a spoken or written answer |
| 4 | Secondary research use of identifiable information or biospecimens where the material is publicly available, recorded without identifiers, regulated under HIPAA, or federally collected |
| 5 | Federal demonstration projects evaluating public benefit or service programs, with the project listed publicly before it begins |
| 6 | Taste and food quality evaluation and consumer acceptance studies within stated safety limits |
| 7 | Storage or maintenance of identifiable information or biospecimens for secondary research, following broad consent and limited IRB review |
| 8 | Secondary research use of identifiable information or biospecimens for which broad consent was previously obtained, following limited IRB review |
Most applied doctoral work at Purdue Global that lands here lands in categories 1, 2 or 4 — the classroom study, the anonymous survey, the analysis of records already collected for another purpose. Two things trip files at this stage. The first is identifiability: a survey is not automatically category 2 if responses can be linked back to people and disclosure could damage them. The second is the interview that stops being brief and starts being sensitive, which is a different category or a different pathway entirely.
What makes a study expedited?
Expedited review is for research that still presents no more than minimal risk but requires closer reading than exemption allows. Purdue Global describes it in those terms — risk no greater than the minimal standard, meaning risk not exceeding what daily life ordinarily brings, but scrutiny pitched above what the exemption pathway applies, with safeguards in place against risks such as criminal or civil liability or damage to financial standing.
Behind that sits the federal list of categories eligible for expedited review, published in 1998 and still the operative list. Three of its categories carry most doctoral work:
- Research on materials collected for non-research purposes. Records, documents or specimens gathered for treatment, teaching or administration and now examined for a study.
- Recordings made for research purposes. Voice, video, digital or image recordings created because of the study.
- Research into the characteristics or behavior of individuals and groups. The category naming, in as many words, methodologies of survey and interview, of oral history and focus group, of program and human factors evaluation, and of quality assurance.
Two conditions on that list are routinely missed. Being on the list does not make an activity minimal risk — the list says so itself, in as many words. And the procedure is barred where identification of participants, or of their answers, could reasonably expose them to civil or criminal liability; harm their employability, insurability, reputation or financial standing; or stigmatize them — unless safeguards hold the confidentiality and privacy exposure to no more than minimal. That clause is where studies of workplace practice, of clinicians' own errors, or of anything a participant could be disciplined over quietly stop being expedited candidates.
What sends a study to the convened board?
Failing to fit. If the design carries more than minimal risk, or reaches a population the regulations protect with additional safeguards, or involves procedures outside every expedited category, the criteria stop being satisfiable by a single reviewer and the study goes to the full committee. That is a routing decision about the design, not a demerit, and plenty of important work is reviewed that way as a matter of course.
What it does change is the shape of the file. A convened board reads a protocol against the full criteria for approval at 45 CFR 46.111 — that risks are minimized, that they are reasonable relative to anticipated benefits, that selection is equitable, that consent is sought and documented or properly waived, that data are monitored where appropriate, that privacy and confidentiality are protected, and that additional safeguards exist where participants are vulnerable. Purdue Global's toolkit publishes reviewer worksheets for criteria for approval and criteria for consent, which is worth knowing for a plain reason: those worksheets are the marking scheme. A file drawn against them is a file drawn against how it will actually be read.
Can an expedited reviewer turn a study down?
No, and this is one of the most useful asymmetries in the whole system. Under 45 CFR 46.110 the work is done either by the chair of the IRB or by experienced reviewers the chair designates, and those reviewers are without power to disapprove research. Disapproval requires the full, non-expedited procedure. The board must also keep its members informed of what has been approved this way.
So a study that goes in on the expedited pathway comes back approved, comes back with modifications required, or gets escalated. The worst realistic outcome of an honest expedited filing is a longer route, not a closed door — which is another reason claiming the category you actually designed costs less than claiming the one that sounds lighter.
Does exempt mean lighter documents?
Different, not lighter. The pathway changes what the participant receives: exempt studies use an information sheet, expedited studies use a consent form built to the elements of consent at 45 CFR 46.116 — purpose and procedures, foreseeable risks, benefits, how far confidentiality extends, a contact for questions, and an unambiguous line saying a person may decline at the start or stop partway with nothing lost. Using the wrong one is a defect that has nothing to do with the quality of the study and everything to do with the pathway it was filed on.
What does not change across pathways is the rest of the packet: the research plan, the recruitment materials as they will actually run, the site permission in writing, the ethics training certificate. The application checklist takes each of those apart. And whichever path you are on, data may only begin to exist once the approval or determination does, as the step-by-step sequence sets out.
What happens if you claim the wrong path?
You redraw, rather than revise. A study filed as exempt that reads as expedited arrives with the wrong protocol form and the wrong participant document, and the correction is a new file rather than an edited paragraph. A study filed as quality improvement that reads as research — the case we take up in the determination article — has to be rebuilt from the aim statement outward.
The reviewer is not adjudicating your intentions. The reviewer is measuring one dimension across several documents and noticing when it reads two ways: a category claimed on the cover sheet that the methodology section contradicts. That is a tolerance failure, and it is entirely measurable before submission, by you or by anyone reading carefully on your behalf. The questions page answers the neighboring questions in the same form.
What to do next
Not being certain which pathway your design belongs on is itself a finding, and it happens to be the cheapest one on the sheet to settle. Send the aim, the method and any documents that exist through the intake sheet; the first measure is free. What comes back is a written reading — the pathway the design sits on, the criteria it already meets, and the specific sentences that would move it somewhere else. Nothing needed means nothing needed, and we say so. Alternatively the entire sequence can change hands: category, documents, filing, and each reviewer reply answered for as long as they keep coming. Your work stays your work. The board reaches its own reading, which may not match ours. How it works covers the three moves and what each one includes.
Sources
- Purdue Global IRB, Investigator Guide (three pathways, worksheets, protocol forms, templates): purdueglobalwriting.center/irb-investigator-guide/
- Purdue Global IRB, IRB Toolkit (SOP 301 exemption determinations, SOP 302 initial review, SOP 303 expedited reviews, reviewer worksheets IRB-314 and IRB-314a): purdueglobalwriting.center/irb-toolkit/
- Purdue University Global IRB, home and FAQ (the three possible reviewer responses): sites.google.com/purdueglobal.edu/purdueuniversityglobalirb/home
- 45 CFR 46.104, exempt research categories: law.cornell.edu/cfr/text/45/46.104
- 45 CFR 46.110, expedited review procedures: law.cornell.edu/cfr/text/45/46.110
- 45 CFR 46.111, criteria for IRB approval of research: law.cornell.edu/cfr/text/45/46.111
- 45 CFR 46.116, general requirements for informed consent: law.cornell.edu/cfr/text/45/46.116
- OHRP, Categories of Research That May Be Reviewed Through an Expedited Review Procedure (1998): hhs.gov/ohrp — expedited review categories
- 45 CFR 46.102, definition of minimal risk: law.cornell.edu/cfr/text/45/46.102