Chamberlain IRB consent requirements: elements, reading level, and one version on both boards' desks
A consent form has to satisfy three readers who want different things. The federal rule wants a fixed set of disclosures. The person signing wants to understand, in a few minutes, what is about to happen to them. And two review bodies each want the copy in their file to be the copy that was actually approved. Most consent problems in a Chamberlain project are not disagreements about content at all — they are two files holding two slightly different pages.
Carry every element 45 CFR 46.116 names, write it so a lay reader can follow it, build it on Chamberlain's template, and keep one controlled version. The school's file and the practicum site's file must hold the same page.
Does a Chamberlain practice project need a consent form at all?
It depends on what the two boards decide, and they decide separately. Chamberlain's route for a DNP project usually runs through a prescreening decision, and its handbook notes that most DNP projects will meet prescreening criteria for determining that the project does not constitute human subjects research. A project classified that way may not require the full application package at the school — but that classification binds the body that issued it and nobody else.
The practicum site's council reaches its own conclusion beside its own patients and charts, and the same protocol is routinely a practice-change initiative to the school and a consent-requiring study at the facility. Plan on needing a document: once people answer questions, complete instruments, or have their information examined for a purpose beyond their own care, one of the two boards will ask for one.
Chamberlain publishes an informed consent form template, and its list of things to include with an application for initial review, where applicable, names informed consent materials and forms, written information sheets provided to study subjects, and parental consent or assent forms. Those three are not synonyms. A signed form, an unsigned information sheet, and a parent's permission paired with a minor's assent are different instruments for different situations, and picking the wrong one is a return waiting to happen.
Which elements must the form carry?
The federal floor is 45 CFR 46.116. Consent must open with a concise, focused account of the key information a reasonable person would want, organised to aid comprehension, under (a)(5)(i). Under (a)(3) it has to reach the person deciding in language they understand. And it may contain no exculpatory language through which anyone waives or appears to waive a legal right, under (a)(6). Beneath those framing rules sit the basic elements, and each one has a job in a practice-change project.
| Basic element | What it must actually say | Where projects slip |
|---|---|---|
| (b)(1) Purpose and procedures | That this is research, why it is happening, how long the person is involved, what will be done | The purpose is written for the committee, not the participant |
| (b)(2) Risks | Foreseeable risks or discomforts, including the realistic ones — time, awkwardness, exposure | "There are no risks", asserted rather than reasoned |
| (b)(3) Benefits | Benefits reasonably expected, to the person or to others | Compensation described as though it were a benefit |
| (b)(4) Alternatives | Appropriate alternatives, where any exist | Omitted where declining and continuing usual care is the alternative |
| (b)(5) Confidentiality | How far confidentiality of identifying records extends, and its limits | Promises the design cannot deliver |
| (b)(6) Injury provisions | Compensation and treatment if harm occurs, above minimal risk | Left in from a template when it does not apply, or dropped when it does |
| (b)(7) Contacts | Whom to ask about the project, about participant rights, and about harm | Only the project lead is named; no independent contact |
| (b)(8) Voluntariness | Participation is voluntary; refusal costs nothing; withdrawal is possible at any time | Silent on what refusal means for staff being asked by a colleague |
| (b)(9) Future use | Whether identifiers may be stripped and the data reused without asking again | Neither of the two required statements appears |
The additional elements at 46.116(c) apply when relevant. Four surface repeatedly in practice-change work: roughly how many people will take part, when you might end someone's involvement, any cost they bear, and what becomes of already-collected information if a person withdraws. That last answer must match your data security plan exactly; where consent and plan disagree on withdrawal, both boards notice.
What reading level does Chamberlain expect?
The regulation gives a standard in words rather than a number, but Chamberlain does something more useful than most institutions: it publishes worked examples at two different levels. Among its IRB samples are an adult consent form written at a fifth-grade reading level and another written at a tenth-grade reading level. The pair is instructive precisely because both are acceptable documents — the point is not that lower is always better, but that the pitch is a choice you make about a specific population and then defend.
Read both before drafting. A form aimed at clinicians can carry clinical vocabulary. A form going to patients in a waiting area, or to families, cannot. The honest test is whether someone reading it alone, with nobody there to explain, could afterwards describe the request, the possible downside, and the way out. If they could not, the form has failed regardless of which elements it technically contains.
Three habits do most of the work. Address the person as "you", in short sentences. Describe procedures as they will be experienced, not as they appear in a methods section. And resist importing the protocol wholesale — it was written for reviewers, the consent is written for participants, and blurring the two serves neither.
Can the signature be waived, and is that the same as waiving consent?
No, and the distinction matters. Documentation of consent is governed by 45 CFR 46.117, which ordinarily requires a written form approved by the board and signed by the participant, with a copy given to them. Subsection (c)(1) then lets a board waive the requirement for that signature in defined situations: where the signed form would itself be the only record tying the person to the project and confidentiality is the principal risk; where the work presents no more than minimal risk of harm and involves nothing that would normally require written consent outside a research context; or, for certain culturally distinct groups, where signing is not customary and an appropriate alternative mechanism documents agreement.
That is how an anonymous questionnaire can proceed on an information sheet and a click rather than a signature page. What has not happened is any waiving of consent itself — the person is still told what the project is and still chooses. Waiving the disclosure entirely is a separate and much narrower decision, and it is the board's to make, not yours to assume. Whether Chamberlain's prescreening route or the site's council entertains either request is answered by Chamberlain's current handbook or IRB portal and by the facility's own policy.
Why must one version sit on both boards' desks?
Because two files drifting apart is the failure mode that actually happens. You draft a form; the facility's council asks for its own contacts and a patient-rights line; you amend their copy, and the school's file keeps the earlier page. Two bodies have now approved two documents, and the page you hand participants matches only one.
Chamberlain treats this as more than untidiness. Its list of promptly reportable non-compliance includes use of an unapproved consent form, alongside enrolling anyone before approval exists. Its amendment route is required for changes to previously approved recruitment or informed consent materials, meaning a revision requested by the facility is not a private edit — it is a change the school's board expects to be told about. And at continuing review, Chamberlain asks for a clean copy of the current date-stamped consent document, which only exists if you have kept version control.
| May legitimately differ | Must never differ |
|---|---|
| Letterhead and logos, where the facility requires its own | What the project does and what participation involves |
| An added local contact or patient-rights line | Risks, benefits, and how confidentiality is described |
| Site-specific privacy or authorisation wording | The withdrawal statement and what happens to data |
| Approval stamps and reference numbers | Who may be approached, and how |
The discipline is easy to state and easy to abandon under pressure: one master document, dated and numbered, every requested change folded back in and carried to the other board. A facility request the school has not seen calls for an amendment, not a second draft. The article on site permission versus the site's own approval explains why the facility so often has a board you did not know about, and how it works shows where consent is drafted inside the whole route.
What to do next
Drafted your consent and your protocol at different times? Had a facility request changes you have not carried back to the school's file? That mismatch is worth finding before a reviewer finds it. Book the free application review and send the consent, the protocol, and any wording the facility asked for. A consultant will identify the missing elements, say whether the reading level suits the people you intend to recruit, and confirm which version is authoritative. If the form is sound, you will be told that instead. The FAQ sets out what the review covers, and the application checklist lists what both files need.
Sources
- Chamberlain University, Institutional Review Board — consent form template, adult consent samples at two reading levels, submission attachments, amendment and continuing-review requirements, reportable non-compliance — chamberlain.edu/chamberlain-university-institutional-review-board
- Chamberlain University, DNP Project & Practicum Handbook — prescreening criteria and the practicum site's own review — chamberlain.edu/media/3691/dnp-project-practicum-handbook.pdf
- 45 CFR 46.116 — the consent rule itself: key-information framing at (a)(5)(i), plain-language duty at (a)(3), basic elements at (b) — law.cornell.edu · section 46.116
- 45 CFR 46.117 — signature requirements, the short-form alternative, and the three grounds for setting a signature aside — law.cornell.edu · section 46.117
Templates, samples and portal fields change. Where this article and Chamberlain's current handbook or IRB portal differ, the handbook and portal govern. This practice is independent of Chamberlain University and is not affiliated with it.