consent documents
Everything a participant will be handed, attached.
Herzing's Research Protocol Application asks for all informed consent documents that will be provided to participants before they take part, and asks separately for a written account of how privacy will be maintained and confidentiality guaranteed. It publishes no template for either. That means the elements come from the regulation, the plainness comes from the people signing, and the version discipline comes from you.
Olivia Tremblay, MSN, RN · filed 2026-08-23
Attach every consent document a participant will receive, in language they can genuinely read, leading with what anyone deciding would want to know first. Herzing supplies no template, so 45 CFR 46.116 supplies the elements and 46.117 the signature rules.
Which Herzing application asks for consent documents?
The Research Protocol Application does, in two separate checklist lines. One asks you to attach all informed consent documents that will be provided to participants before they participate. The other asks for attached information describing how a participant's privacy will be maintained and how confidentiality will be guaranteed — a distinct document, not a paragraph inside the consent.
The Healthcare Improvement or Innovation Project Application carries neither line. Its checklist asks for signatures, any questionnaires or surveys, a CITI certificate, an external board's paperwork where one exists, and a Program Chair letter where one applies. It is tempting to read that silence as permission to skip consent. It is not. Herzing's own framing is that the board reviews the request precisely to decide whether the work meets the Common Rule's definitions — the determination belongs to the board, not to whichever form you downloaded. The Statement of Principles says so plainly: where it remains uncertain after reading the definitions, consult the IRB before starting.
The practical rule is therefore the opposite of the intuitive one. An improvement project that turns out to interact with identifiable people about identifiable information needs consent documents built to the same standard as any other folder. Where they genuinely are not required, say why in the application's own words rather than leaving the pocket empty and unexplained.
What has to be in the document?
With no Herzing template to copy, the content comes from 45 CFR 46.116 — and the general requirements sitting above its list of elements are the part most often skipped. The wording has to be understandable to whoever is signing. The document has to open with a short, focused block carrying what matters most to the decision, arranged so it can be taken in rather than waded through. And nothing in it may sign away legal rights or absolve anyone of negligence.
Then the basic elements. Each row below pairs the requirement with the sentence that most often fails it.
| Element | What a reviewer is checking | The line that fails |
|---|---|---|
| A statement that this is research, what it is for, roughly what taking part will involve and over what stretch, and which procedures are experimental | That someone reading only this page knows what will be asked of them | "You are invited to participate in a project about care quality." Invited to do what, exactly? |
| Reasonably foreseeable risks or discomforts | That risk is named rather than reassured away | "There are no risks." Almost never true where privacy is in play. |
| Benefits that can reasonably be expected — for the person signing, or for anyone else | That benefit is stated honestly and not oversold | Promising improved care to the person signing when the design cannot deliver it |
| Any alternative procedure or course of treatment that exists | That declining leaves a real path open | Silence, which reads as though there is no alternative |
| How confidentiality of records will be maintained | That this paragraph matches the data security plan filed with it | "Data will be kept confidential" with no mention of where, or who reaches it |
| Compensation and treatment for injury where the research is more than minimal risk | That any compensation named here matches the application's own compensation answer | A gift card described in one document and not the other |
| Three contacts: one for questions about the work, one for questions about participants' rights, one for an injury arising out of it | That the rights contact is not simply the person running the project | One email address doing all three jobs |
| That taking part is voluntary, that a refusal costs nothing otherwise owed, and that anyone may stop partway through | That this is unqualified, especially where the participants are colleagues | "Participation is voluntary, but your unit is counting on full response." |
| What happens to identifiable information or identifiable specimens afterwards, including any future research use | That the answer here agrees with the retention and disposition you promised the board | An open-ended pledge to keep the data for later work that the plan never mentions |
Further elements attach where they apply: unforeseeable risks, grounds on which the investigator may end someone's participation, any costs, how to withdraw and what becomes of data already gathered, new findings bearing on willingness to continue, and how many people will take part. A reviewer holding a design that plainly triggers one of these and a document that omits it has found the gap in a single pass.
How plainly does it have to read?
Herzing publishes no reading-level target, and any specific figure you find quoted around the internet belongs to some other institution's handbook. What the regulation demands is understandable language and a presentation organised to help comprehension — and Herzing's own Statement of Principles frames the same idea through its Respect value, honouring the autonomy, dignity and rights of participants, informed consent included.
In practice that turns into four habits. Put the key information first, in its own short block, so that someone who reads nothing else still knows what is being asked, why, what it might cost them and that they may decline. Replace vocabulary that belongs to your discipline rather than to the reader — intervention, data extraction, de-identified — with what actually happens. Keep sentences short enough to be read once. And write in the second person, because a document addressed to "the participant" is describing someone else.
One test costs nothing and finds more than any formula: read the document aloud to someone who resembles the people who will sign it, and mark wherever they ask a question. Every mark is a sentence the board would have stopped at too.
Signed, witnessed, or waived?
Documentation is a separate question from consent itself, governed by 45 CFR 46.117, and confusing the two produces a distinctive kind of returned folder.
- The long form. The whole document, carrying every element, cleared by the board, then signed — electronic signatures included — by the person taking part or their legally authorised representative, who keeps a written copy. This is the default.
- The short form. A brief document stating that the required information was presented orally, signed with a witness present, alongside a written summary of what was said. The witness signs the short form and the summary; the person obtaining consent signs the summary. Everyone leaves with copies.
- Documentation waived. A board may set the signature aside in defined circumstances — among them, where the signature sheet would itself be the only thing tying a person to the study and that tie is the principal risk, or where risk is no more than minimal and the procedures are ones nobody signs for in ordinary life. Waiving the signature is not waiving consent; people are still told, and the board may still require that they be handed a written statement.
If your design points toward a waiver, argue for it in the application rather than assuming it. A folder that simply arrives without signature lines has not made a case; it has left one out.
What does version-matching mean when you file by email?
This is where Herzing's process differs from the ones most guidance is written about. Herzing's own Getting Started note directs you to complete the appropriate application and send it to the IRB inbox. There is no portal quietly stamping each upload with a version number. The set of attachments on your message is the record, which puts the whole burden of coherence on the sender.
So run a deliberate pass before the message goes, in this order:
- Name the files so a stranger can sort them. Project short title, document type, version, date. A reviewer holding two files called consent final has to ask which one is real.
- Read the consent against the Methodology box. Every procedure the participant will experience should appear in both, described the same way.
- Read the compensation sentence against Step 4. The application asks whether participants receive compensation and asks you to detail it. Those words and the consent's words should be the same words.
- Read the confidentiality paragraph against the data security plan. Storage, who reaches the data, and how long it is kept are promises in one document and commitments in the other — they must not diverge. The data security plan pocket covers what belongs there.
- Read the site name against the letter and the recruitment copy. One organisation, named identically everywhere, as the recruitment materials pocket sets out.
- Attach the instruments the consent describes. Both applications ask for copies of all questionnaires and surveys used; a consent that promises a short questionnaire and an attachment running to forty items is a discrepancy a reviewer will find.
- Re-attach the whole set when anything changes. Revise one document, re-send the group, and say in the message which files moved and which did not.
One Herzing-specific line belongs on your calendar rather than in the folder. The Research Protocol Application's acknowledgements require you to keep all informed consent documents for three years following the project's completion date, and the federal record-keeping rule holds a board's own records for a comparable stretch. Signed consents are the last pocket emptied, so say in the plan where they will live meanwhile.
What to do next
Not sure a drafted consent document carries every element — or whether an improvement project needs one at all? That is a short conversation, not a long one. Ask for the free application review and hand over whatever exists: a draft, a colleague's old document, or nothing at all. Back comes a written reading of which elements are there, which are missing, and whether the plainness holds up for the people who will be signing. If the folder needs the whole set built, that is the third tab of how the practice works; the FAQ answers what happens after filing, and the application checklist shows where the consent pocket sits among the rest. Your project, its data and its findings stay with you; the determination and the decision belong to the board.
Sources
- Herzing University, Institutional Review Board (IRB) — the applications, bylaws and resources referenced here — herzing.edu/institutional-review-board-irb
- Herzing University, IRB Application for Research Protocol Approval — checklist lines for informed consent and for confidentiality and anonymity; compensation and participant questions; three-year retention of consent documents — the Research Protocol Application (PDF)
- Herzing University, IRB Application for Improvement or Innovation Project Approval — the checklist that omits consent, and the signature block — the Improvement or Innovation Project Application (PDF)
- Herzing University IRB, Getting Started: Read this First — which application to complete and where to send it — Getting Started (PDF)
- Herzing University IRB, Statement of Principles — the P.R.I.C.E. values, the human-subjects definitions, and the instruction to consult the board where uncertainty remains — Statement of Principles (PDF)
- General requirements and elements of informed consent, 45 CFR 46.116 — key information first, understandable language, no exculpatory terms — Legal Information Institute
- Documentation of informed consent, 45 CFR 46.117 — long form, short form with witness, and the grounds for waiving a signature — Legal Information Institute
- IRB record retention, 45 CFR 46.115 — Legal Information Institute
Herzing revises its IRB forms and pages without notice; where this article and Herzing's current IRB handbook or portal disagree, the current material governs. This practice is independent and is not affiliated with Herzing University.
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