Every element a WGU consent document must carry, in the order a reader meets them
Nine elements are required whenever consent is sought, a further nine apply when the project calls for them, and the whole document has to open with the part that helps somebody decide. Reviewers read a consent sheet twice: once as a regulator counting elements, once as a person on a break-room chair with four minutes and a pen.
Nine required elements, conditional ones where they apply, a concise opening that carries the key information first, ordinary language a reasonable person can act on, no language waiving anyone's rights, and wording that matches the application and the recruitment materials word for word.
What is the consent document actually doing?
Two jobs, pulling in different directions. The first is evidentiary: 45 CFR 46.116 requires legally effective consent before anyone is involved in covered research, and the document is how that gets recorded. The second is practical: the same rule wants wording the reader can follow, an encounter unhurried enough to think and to ask, and a setting where nobody feels pushed. A sheet that does the first and fails the second is the commonest thing a reviewer returns.
Two lines in the regulation catch people who have written consent sheets before. Whatever a sensible reader would want to know before answering has to be on the page — a test built around what the reader needs, not around how thorough the author feels. And no consent may contain exculpatory language, meaning wording through which someone appears to waive a legal right or to release the investigator or the institution from liability for negligence. Sentences like by signing you agree not to hold anyone responsible are not merely poor form; they are prohibited.
Which elements are required, and which are conditional?
The nine at 45 CFR 46.116(b) apply whenever consent is sought and no exception is in play. Not a suggested outline: a reviewer ticks them off.
| Required element | What it looks like on the page |
|---|---|
| That this is research, its purpose, how long participation lasts, what will happen, and which parts are experimental | Plain description of the survey, the huddle, the observation window, and how often you will ask |
| Reasonably foreseeable risks or discomforts | Often social rather than physical: time, awkwardness, the worry of a colleague recognising an answer |
| Benefits that may reasonably be expected, to the person or to others | Honest and unpromised. No claim that the unit will improve because someone answered |
| Other courses open to the person instead, where the design offers any | Frequently nothing applies, and writing that down beats leaving a gap |
| How far anything identifying will be held in confidence, if at all | The one line that must agree with the data security plan, exactly |
| Above minimal risk: whether care or payment exists should somebody be harmed | Usually out of scope for improvement work, and its presence signals a heavier branch |
| Whom to contact about the study, about participants' rights, and about a research-related injury | You for the study; the board's office for rights. Two contacts, never merged into one |
| Taking part is a choice; declining forfeits nothing already owed; stopping partway forfeits nothing either | The sentence a reviewer reads hardest when you work where you are recruiting |
| For identifiable information: whether de-identified material might later be used or shared for future work, or will not be | One of two statements. Choosing neither is an omission the rule does not allow |
The conditional elements at 46.116(c) come in when they fit: unforeseeable risks, circumstances in which you might end someone's participation without asking, added costs, what happens when a person withdraws partway, significant new findings, the approximate number of participants, and — for specimen work — commercial use and genome sequencing. Most improvement projects need one or two. Naming which, in the application, reads as competence rather than padding.
What does the key information rule change about the first page?
Since the 2018 revisions to the Common Rule, a consent document opens with a tight, focused account of whatever weighs most on the decision, arranged so that it can be taken in. The rule then says something about the document as a whole, and it is unusually blunt for a regulation: a run of disconnected facts will not do. The page has to let a reader see the case for taking part and the case against.
That turns the old habit inside out. The traditional sheet opened with institutional throat-clearing and buried the ask on page two. The current shape leads with four things — what you want the person to do, roughly how long it takes, what could go wrong, and the fact that saying no costs them nothing — then goes into detail underneath. Reviewers see the difference in the first paragraph.
Write the opening for the person deciding, then write the rest for the record.
How plain does the language have to be?
The regulation sets a comprehension standard rather than a grade band: understandable to the person, containing what a reasonable person would want. Whether WGU asks you to evidence a specific reading level, and how, belongs to WGU's current handbook or IRB portal — ask before you draft, because retrofitting readability into a finished document is slower than writing plainly the first time.
What travels well regardless of the target is unglamorous. Short sentences carrying one idea. Second person throughout, so the reader is you and never the subject. Every acronym opened on first use, since familiarity belongs to your job and not to the reader's. Clinical shorthand translated: chart review becomes looking at records that already exist. And nothing conditional tucked into a subordinate clause, because that is where a reviewer expects the catch.
One test costs nothing. Read the document aloud to someone outside health care and stop where they frown. Those are the sentences a board will circle.
What does WGU's own template ask for beyond the regulation?
WGU's published consent template runs a recognisable spine: an introduction naming you and your WGU affiliation and summarising the project; a description of the project; benefits and risks; confidentiality; voluntary participation and withdrawal; a block for questions, complaints and rights; and consent statements above a signature, printed name and date. Three features are worth planning for rather than discovering.
- Two contacts, one of them the board. Ordinary questions route to you; unresolved questions and complaints about rights route to WGU's IRB, which publishes an address for exactly that. Both lines belong on the page.
- A workplace clause. Where the project runs inside an employer or uses an organisation's time or resources, WGU's guidance asks the document to state that you discussed the project with the appropriate department, site, corporate or HR authority and have initial approval to collect the information. In some published versions of WGU's paperwork, that authority signs the consent document itself rather than a separate page — which folds the site permission question into this document and makes its wording more consequential, not less.
- A right to see results. The template asks you to say that participants may view what the project found. A small line, and people act on it.
Whether your programme's template still matches the published one belongs to WGU's current handbook or IRB portal. Build from what the portal serves today; last term's template is the sort of thing a board returns without reading further.
When may consent be documented differently, or not at all?
Documentation and consent are separate questions, and treating them as one is a common error. The default at 45 CFR 46.117 is a form the board has cleared, signed by the person, with a copy handed straight back. There is also a short form for consent given aloud, witnessed, against a summary the board has approved. Beyond those, a board may set the signature requirement aside in three named situations: where that signature would be the sole thread tying somebody to the project and exposure is the principal danger; where risk stays minimal and nothing in the design would ordinarily be signed for outside research; or where form-signing is not the custom of a distinct cultural community and risk again stays minimal.
Anonymous survey work often lands on the second of those, and the usual shape is an information sheet read before proceeding, with no signature line. Notice what has and has not changed. Consent still happens, and the element list above is untouched. What has gone is the signature, and nothing else. Waiving consent itself is a further step with its own findings under 46.116(f), and it is not something you assert in a cover note.
How do you keep the versions matched?
Version drift sinks more consent sheets than missing elements do. A missing element earns one note; a mismatch earns a note against every page it reaches. WGU's own application form says as much. The project description it carries is meant to sit flush against the proposal approved earlier, and against whatever participants are told. Three descriptions, one story.
- The activity list in the application, the consent document and the recruitment wording name the same steps.
- The eligibility wording is identical across recruitment and consent — not similar, identical.
- The confidentiality sentence matches what the security plan actually does, including whether a linking key survives.
- Time commitment is one number everywhere it appears.
- The instruments attached are the ones the consent describes, in the form participants will see.
- Every document carries a version marker, so a returned file can be revised without guessing which copy is live.
That last habit earns its keep. Boards return files as a list of notes, and versioned documents let you answer each note precisely and resubmit as a set. Without them, one round of notes becomes two.
What to do next
Draft the opening paragraph before anything else, and draft it for whoever is holding the pen. Lay the nine required elements against it next, marking the conditional ones your design genuinely triggers. Then set application, consent sheet and recruitment wording side by side and read for one thing only: disagreements. That last pass catches most of what a board would have caught.
If you would rather hand the branch over, that is what we do. The free application review reads what exists and says plainly when a clean file needs nothing from us. Where it does, we build the consent file and everything around it, file the submission and answer each reply until approval. The project stays yours; the board's decision stays the board's. See how it works, browse the FAQ, or send us the draft.
Request the free application review
Sources
- General requirements for consent, the reasonable-person standard, the key-information opening, the exculpatory-language prohibition, and the basic and additional elements — 45 CFR 46.116 — Cornell LII, 45 CFR 46.116
- How consent is documented, the short form, and the three grounds for waiving a signature — 45 CFR 46.117 — Cornell LII, 45 CFR 46.117
- The approval criteria a reviewer applies, including equitable selection and confidentiality provisions — 45 CFR 46.111 — Cornell LII, 45 CFR 46.111
- Western Governors University Institutional Review Board, published Informed Consent template (introduction and affiliation, project description, benefits and risks, confidentiality, voluntary participation, questions and complaints routed to the IRB, consent statements and signature block) — aliciabatesmedlt.weebly.com/uploads/1/2/6/3/126370100/pdf_informed_consent.pdf
- Western Governors University Institutional Review Board, Request for Approval to Conduct Research (the instruction that the application, the approved proposal and the consent description align; the consent-procedures question; the supervisor signature reminder) — aliciabatesmedlt.weebly.com/uploads/1/2/6/3/126370100/request_for_approval_to_conduct_research__1_.pdf
- Western Governors University, Institutional Review Board (IRB), WGU policy handbook, WGU Knowledge Center (approval requirement and submission route; last updated 26 March 2026) — cm.wgu.edu
Routes, forms and portal wording at WGU move over time. Where this page disagrees with WGU's current handbook or IRB portal, believe the portal. This desk is an independent practice; it is not part of Western Governors University and does not speak for it.